Medicines and Related Substances Act: Conditions of registration … · 2018-12-09 ·...

STAATSKOERANT, 9 MAART 2012 No.35128 3

GENERAL NOTICE

NOTICE 194 OF 2012

MEDICINES CONTROL COUNCIL

CONDillONS OF REGISTRATION OF A MEDICINE IN TERMS OF THE PROVISIONS OF SEcnON 15(7) OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965

(ACT 101 OF 1965)

1. The applicant shall ensure that the medicine is manufactured and controlled in terms of the current Good Manufacturing Practices as determined by Council

2. The manufacture of this medicine is subject to regular investigation and inspections by the inspectors appointed in terms of Section 26 of the Act, to assess compliance with current Good Manufacturing Practices.

3. The information in the package insert shall be updated on a regular basis to conform to the package insert recently approved by Council.

4. The applicant must comply with all the legal requirements of the Medicines and Related Substances Act, 1965 (Act 101 of 1965).

5. The registration of this medicine shall be subject to review at intervals as determined by Council regarding its quality, safety and efficacy, and the registration of this medicine may be varied subject to issues Council may deem fit.

6. The first two production batches must be fully validated in terms of the detailed process validation protocol submitted at the time of application for registration, and the validation report must be submitted within a month after completion of the validation.

7. The product may be advertised to the professions only. 8. The provisional shelf-life allocated must be confirmed with stability data over the

full shelf-life period on the first two production batches (well-known API} or first three production batches (NCE} in accordance with the Stability Guideline. Stability testing submitted on any pilot batches must also be completed and reported on. The stability report must be submitted within six months after completion of the stability trial. However, Council has to be informed immediately if any parameter shows a significant change or out-of-specification result during the stability trial.

9. A post-registration inspection must be conducted on the first production batch manufactured by each local manufacturer.

10. A post-registration inspection must be conducted on the first production batch of the imported product.

11 . Marketing of the product may only commence following a satisfactory postregistration inspection report.

12. One sample of every batch, together with four copies of the protocol for testing of the bulk lot and filling lot, and six copies of the certificate of release issued by a competent authority in the country in which the product was manufactured, must be submitted to the Council for lot release purposes.

13. The expiry date allocated shall be modified by adding a statement that the virus strains are currently recommended for South African usage in the specific year.

14. The strains of the master seed viruses must be approved by the Department of Health for each year.

MRF 15 MRF15

Registration number: 32/13.1/0335 Registration number: A40/21 .8.210771 Registration number: 41/20.1.1/0249

Name of medicine: INFANT GAVISCON ALUMINIUM FREE Name of medicine: UTROGESTAN 200 mg Name of medicine: CLAREN 125 GRANULES

Dosage form: ORAL POWDER Dosage form: SOFT GELATIN CAPSULE Dosage form: GRANULES FOR SUSPENSION

Active ingredients: EACH SACHET CONTAINS: Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH 5,0 ml SUSPENSION SODIUM ALGINATE 225,0 mg PROGESTERONE 200,0 mg CONTAINS: MAGNESIUM ALGINATE 87,5 mg CLARITHROMYCIN 125,0 mg

Conditions of registration: 1,2,3,4,5,6, 7,8 Conditions of registration: 1, 2,3,4, 5,6, 7 Conditions of registration: 1,2,3,4,5,6, 7, 8

Applicant: RECKITT BENCKISER Applicant: PHARMACEUTICALS (PTY) lTD

MEDI CHALLENGE (PTY) LTD Applicant: SPECPHARM(PTY)LTD

Manufacturer: RECKITT BENCKISER HEALTHCARE Manufacturer: CARDINAL HEALTH, BENHEIM, Manufacturer: ELPEN S.A, PIKERMI, ATIIKIS, (UK) lTD, HULL, EAST YORKSHIRE, FRANCE GREECE (1) UNITED KINGDOM MEDICAPS, PLOERMEL, ~ CIPLA MEDPRO PHARMACEUTICALS

CEDEX, FRANCE (PTY) LTD, MOBENI, DURBAN, RSA ~ ISOTRON LTD UK, BROADFORD, UK (1) ISOTRON PLC, DONCASTER, SOUTH A YORKSHIRE, UNITED KINGDOM 0

m Packer: RECKITT BENCKISER HEAL THCARE Packer: LABORATORIES BESINS Packer: ELPEN S.A, PIKERMI, A TIIKIS, :D

(UK) lTD, HULL, EAST YORKSHIRE, INTERNATIONAL, GREECE )> z UNITED KINGDOM MONTROUGE CEDEX, .:-i CIPLA MEDPRO PHARMACEUTICALS

FRANCE c.o (PTY) lTD, MOBENI, DURBAN, RSA BESINS INTERNATIONAL s: UNIPACK LTD, SHOTGATES, ESSEX,

UK BELGIQUE, DROGENBOS, ~ BELGIQUE, BELGIUM ~

laboratory: FPRC: RECKITT BENCK!SER HEAL THCARE Laboratory: LABORATORIES BESINS Laboratory: FPRC: ELPEN S.A, PIKERMI, ATIIKIS, l\:1 (UK) l TO, HULL, EAST YORKSHIRE, FPRC: INTERNATIONAL, GREECE 0 ..... UNITED KINGDOM MONTROUGE CEDEX, l\:1 CIPLA MEDPRO PHARMACEUTICALS

FRANCE (PTY) L TD,MOBENI, DURBAN, RSA BESINS INTERNATIONAL SABS PHARMACEUTICAL

CHEMISTRY LABORATORY, BELGIQUE, DROGENBOS, GROENKLOOF, PRETORIA BELGIQUE

CONSULTING CHEMICAL LABORATORIES, ATLASVILLE, BOKSBURG

FPRR: RECKITT BENCKISER (PTY) LTD, FPRR: MEDI CHALLENGE, FPRR: SPECPHARM (PTY) LTD, ELANDSFONTEIN, JOHANNESBURG, RANDBURG,JOHANNESBURG HALFWAY HOUSE, MIDRAND, RSA RSA

Shelf-life: 24 months (Provisional) Shelf-life: 24 months Shelf-life: 24 months (Provisional) z p

Dale of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 "' (11 ..... l\:1 (X)

(II

Ol

z !=I

MRF 15 MRF15 Ul 01 .....

Registration number: 41/20.1.1/0250 Registration number: 41/5.7.1/0426 Registration number: 41/20.1.1/0524 1\) (X)

Name of medicine: CLAREN 250 GRANULES Name of medicine: REACTYNE EFFERVESCENT Name of medicine: GULF CEFTRIAXONE 1 g

Dosage form: GRANULES FOR SUSPENSION Dosage form: TABLET Dosage form: POWDER FOR INJECTION

Active ingredients: EACH 5,0 ml SUSPENSION Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH VIAL CONTAINS: CONTAINS: CETIRIZINE DIHYDROCHLORIDE 10,0 mg CEFTRIAXONE SODIUM EQUIVALENT CLARITHROMYCIN 250,0 mg TO CEFTRIAXONE

1 ooo,o mg

Conditions of registration: 1' 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1,2,3,4, 5, 6, 7 Conditions of 1,2,3,4,5,6, 7,8 registration:

Applicant: SPECPHARM (PTY) LTD Applicant: PFIZER LABORATORIES (PTY) LTD Applicant: GULF DRUG COMPANY (PTY) LTD Ci) 0

Manufacturer: ELPEN S.A, PIKERMI, ATTICA. Manufacturer: HOCHLAND PHARMA GmbH, Manufacturer: LABORATORIO REIG JOFRE, < m GREECE WOLFRATSHAUSEN, GERMANY TOLEDO, SPAIN ::0 z

Packer: ELPEN S.A, PIKERMI, ATTICA, Packer: HOCHLAND PHARMA GmbH, Packer: LABORATORIO REIG JOFRE, s:: GREECE WOLFRATSHAUSEN,GERMANY TOLEDO, SPAIN m z

Laboratory: FPRC: ELPEN S.A, PIKERMI, ATTICA, Laboratory: HOCHLAND PHARMA GmbH, Laboratory: FPRC: LABORATORIO REIG JOFRE, -! GREECE FPRC: WOLFRATSHAUSEN, GERMANY TOLEDO, SPAIN Ci)

PFIZER GLOBAL MANUFACTURING, SASS COMMERCIAL (PTY) LTD )>

DIVISION OF PFIZER LABORATORIES PHARMACEUTICAL CHEMISTRY N m

(PTY) LTD, RETREAT, CAPE TOWN, RSA DEPARTMENT, GROENKLOOF, :j SABS COMMERCIAL (PTY) L TO PRETORIA. RSA PHARMACEUTICAL CHEMISTRY M&L LABORATORY SERVICES, JTl DEPARTMENT, GROENKLOOF, ORMONDE, JOHANNESBURG, RSA <.o PRETORIA, RSA CONSULTING CHEMICAL s::

LABORATORIES, ATLASVILLE, )> BOKSBURG,RSA ::0 PHARMA-Q, INDUSTRIAL WEST, 0 JOHANNESBURG,RSA :c INSTITUTE FOR PHARMACEUTICAL 1\)

SERVICES, SILVERTONDALE, 0 ..... PRETORIA, RSA 1\)

CONSULTING MICROBIOLOGICAL LABORATORY, MOREHILL, BENONI, RSA

FPRR: SPECPHARM (PTY) LTD, HALFWAY FPRR: PFIZER GLOBAL MANUFACTURING, FPRR: GULF DRUG COMPANY, MOUNT HOUSE, MIDRAND, RSA DIVISION OF PFIZER LABORATORIES EDGECOMBE,DURBAN,RSA

(PTY) LTD, RETREAT, CAPE TOWN, RSA

Shelf-life: 24 months (Provisional) Shelf-life: 36 months Shelf-life: 24 months (Provisional}

Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011

MRF 15 MRF15

Registration number: 41120.1.1/0528 Registration number: 41/21.2/0637 Registration number: 41/21.2/0638

Name of medicine: GULF CEFOTAXIME 1 g Name of medicine: METTEM 500 Name of medicine: METTEM850

Dosage fomn: STERILE POWDER FOR Dosage form: TABLET Dosage form: TABLET INJECTION

Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: CEFOTAXIME SODIUM METFORMIN METFORMIN EQUIVALENT TO HYDROCHLORIDE 500,0 HYDROCHLORIDE 850,0 CEFOTAXIME 1,0 g mg mg

Conditions of registration: 1,2,3,4, 5,6, 7,8 Conditions of registration: 1,2,3,4,5,6, 7 Conditions of 1' 2, 3, 4, 5, 6, 7 registration:

Applicant: GULF DRUG COMPANY (PTY) Applicant: ACCORD HEAL THCARE Applicant: ACCORD HEAL THCARE LTD (PTY) LTD (PTY) LTD

Manufacturer: LABORA TORIO REIG JOFRE, Manufacturer: INTAS PHARMACEUTICALS Manufacturer: INTAS PHARMACEUTICALS TOLEDO, SPAIN LTD, MATODA, SANAND, LTD, MATODA, SANAND, en

AHMEDABAD, INDIA Af1MEDABAD, INDIA ~ Packer: LABORATORIO REIG JOFRE, Packer: INTAS PHARMACEUTICALS Packer: INTAS PHARMACEUTICALS ;..;

TOLEDO, SPAIN LTD, MATODA, SANAND, LTD, MATODA, SANAND, en

" AHMEDABAD, INDIA AHMEDABAD, INDIA 0 m

laboratory: FPRC: LABORATORIO REIG JOFRE, laboratory: INTAS PHARMACEUTICALS laboratory: FPRC: INTAS ll TOLEDO, SPAIN FPRC: LTD, MATODA, SANAND, PHARMACEUTICALS L TO, )>

z SABS PHARMACEUTICAL AHMEDABAD, INDIA MATODA, SANAND, .-1 CHEMISTRY LABORATORY, CONSULTING CHEMICAL AHMEDABAD, INDIA CD GROENKLOOF, PRETORIA LABORATORIES, CONSULTING CHEMICAL ~ M&L LABORATORY SERVICES, ATLASVILLE, BOKSBURG LABORATORIES, )>

ORMONDE, JOHANNESBURG ATLASVILLE, BOKSBURG )>

CONSULTING CHEMICAL ~ LABORATORIES, ATLASVILLE, 1\)

BOKSBURG 0 .... PHARMA-Q, INDUSTRIA-WEST, 1\)

JOHANNESBURG INSTITUTE FOR PHARMACEUTICAL SERVICES, SJLVERTONDALE, PRETORIA CONSULTING MICROBIOLOGICAL LABORATORY, BEYERSPARK, BOKSBURG

FPRR: GULF DRUG COMPANY, FPRR: ACCORD HEAL THCARE, MOUNT EDGECOMBE RIVONIA, RSA

Shelf-life: 24 months (Provisional) Shelf-life: 36 months FPRR: ACCORD HEAL THCARE, z RIVONJA, RSA ?

UJ Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 Shelf-life: 36 month 0'1 ....

1\) !XI

Date of registration: 30 SEPTEMBER 2011 ~

MRF15 MRF15 iilRF 15 Q)

Registration number: 41/5.210720 Registration number: 4115.210739 Registration number: 41/20.1.1/0976 z Name of medicine: ZIAPR05 mg Name of medicine: ZIAPRO 10 mg Name of medicine: ALEMBIC ERYTHROMYCIN 250 !'

tv Dosage form: TABLET Dosage form: TABLET Dosage form: TABLET

(11 .... 1\)

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Q)

BISOPROLOL FUMARATE BISOPROLOL FUMARATE ERYTHROMYCIN STEARATE BP 5,0mg 10,0mg EQUIVALENT TO ERYTHROMYCIN

250,0mg

Conditions of 1,2,3,4,5,6, 7,8 Conditions of registration: 1' 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 registration:

Applicant: PHARMACARE LIMITED Applicant: PHARMACARE LIMITED Applicant: GULF DRUG COMPANY (PTY}

Manufacturer: THE JORDANIAN Manufacturer: THE JORDANIAN Manufacturer: ALEMBIC LIMITED, POST-TAJPURA, PHARMACEUTICAL PHARMACEUTICAL DISTRICT-PANCHMAHALS. MANUFACTURING CO, UM· MANUFACTURING CO, UM-AL· GUJARAT, INDIA G) AL-AMO, JORDAN AMD, JORDAN

~ PHARMACARE L TO, PHARMACARE LTD, KORSTEN, KORSTEN, PORT ELIZABETH PORT ELIZABETH m

::0 Packer: THE JORDANIAN Packer: THE JORDANIAN Packer: ALEMBIC LIMITED, POST-TAJPURA, z

PHARMACEUTICAL PHARMACEUTICAL DISTRICT-PANCHMAHALS, s: MANUFACTURING CO, UM- MANUFACTURING CO, UM-AL· GUJARAT, INDIA m z AL-AMO, JORDAN AMD, JORDAN -1 PHARMACARE L TO, PHARMACARE L TO, KORSTEN, G) KORSTEN, PORT ELIZABETH PORT ELIZABETH )>

Laboratory: FPRC: THE JORDANIAN Laboratory: THE JORDANIAN Laboratory: FPRC: ALEMBIC LIMITED, POST-JPURA, N m

PHARMACEUTICAL FPRC: PHARMACEUTICAL DISTRICT-PANCHMAHALS, :j MANUFACTURING CO, UM· MANUFACTURING CO, UM-AL· GUJARAT, INDIA AL-AMO, JORDAN AMD, JORDAN SABS COMMERCIAL (PTY) L TO !T1 M&L LABORATORY M&L LABORATORY SERVICES, PHARMACEUTICAL CHEMISTRY (0

SERVICES, LIMBRO LIMBRO BUSINESS PARK, DEPARTMENT, GROENKLOOF, s: BUSINESS PARK, SANDTON SANDT ON PRETORIA, RSA )> RESEARCH INSTITUTE FOR RESEARCH INSTITUTE FOR M&L LABORATORY SERVICES, ::0 INDUSTRIAL PHARMACY, INDUSTRIAL PHARMACY, LIMBRO BUSINESS PARK, 0 NORTH-WEST UNIVERSITY, NORTH-WEST UNIVERSITY, SANDTON, RSA :I POTCHEFSTROOM POTCHEFSTROOM CONSULTING CHEMICAL 1\)

0 LABORATORIES, ATLASVILLE, .... BOKSBURG, RSA J\J

PHARMA-Q, INDUSTRIAL WEST, JOHANNESBURG, RSA INSTITUTE FOR PHARMACEUTICAL SERVICES, SILVERTONDALE, PRETORIA, RSA CONSULTING MICROBIOLOGICAL LABORATORY, MOREHILL, BENONI, RSA

FPRC/FPRR: PHARMACARE L TO, FPRC/FPRR: PHARMACARE L TO, KORSTEN, FPRR GULF DRUG COMPANY, MOUNT KORSTEN, PORT ELIZABETH PORT ELIZABETH EDGECOMBE,DURBAN,RSA

FPRR: PHARMACARE LTD, FPRR: PHARMACARE L TO, Shelf-life: 24 months (Provisional) WOODMEAD, SANDTON WOODMEAD, SANDTON

Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 30 SEPTEMBER 2011

Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011

MRF15

Registration number:

Name of medicine:

Dosage form:

Active ingredients:

Conditions of registration:

Applicant:

Manufacturer:

Packer:

Laboratory: FPRC :

FPRR:

Shelf-life:

Dele of registration:

41120.1.210977

GULF /WIOXY CO 500/100

INJECTION

EACH VIAL CONTAINS: IWIOXICILLIN SODIUM EQUIVALENT TO IWIOXICILLIN 500,0mg POTASSIUM CLAVULANATE EQUIVALENT TO CLAVULANIC ACID 100,0 mg

1, 2, 3, 4, 5, 6, 7

GULF DRUG COMPANY (PTY) L TO

LABORATORIO REIG JOFRE, TOLEDO, SPAJN

LABORATORIO REIG JOFRE, TOLEDO, SPAIN

LABORATORIO REIG JOFRE, TOLEDO, SPAlN SABS COMMERCIAL (PTY) L TO PHARMACEUTICAL CHEMISTRY DEPARTMENT, GROENKLOOF, PRETORIA, RSA M&L LABORATORY SERVICES, LIMBRO BUSINESS PARK, SANDTON, RSA CONSULTING CHEMICAL LABORATORIES, ATLASVILLE, BOKSBURG,RSA PHARMA-Q, INDUSTRIAL WEST. JOHANNESBURG,RSA INSTITUTE FOR PHARMACEUTICAL SERVICES, SILVERTONDALE. PRETORIA. RSA CONSULTING MICROBIOLOGICAL LABORATORY, MOREHILL, BENONI,RSA

GULF DRUG COMPANY, MOUNT EDGECOMBE,DURBAN,RSA

36 months

30 SEPTEMBER201 i

~M~R~F~15~--------------------------------------~·F15


Name of medicine:

Dosage form:

Active ingredients:


Applicant:

Manufacturer.

Packer:

Laboratory: FPRC:

FPRR

Shelf-fife:

Date of registration:

41120.1.210978

GULF AMOXY CO 1 0001200

INJECTION

EACH VIAL CONTAINS: /WIOXICILLJN SODIUM EQUIVALENT TO /WIOXICILLIN 1 000,0 mg POTASSIUM CLAVULANATE EQUIVALENT TO CLAVULANIC ACID 200,0 mg

1' 2, 3. 4, 5, 6, 7

GULF DRUG COMPANY (PTY) LTD

LABORATORIO REIG JOFRE, TOLEDO, SPAJN

LABORATORIO REIG JOFRE. TOLEDO, SPAIN

LABORATORIO REIG JOFRE, TOLEDO, SPAIN SABS COMMERCIAL (PTY) L TO PHARMACEUTICAL CHEMISTRY DEPARTMENT, GROENKLOOF, PRETORIA, RSA M&L LABORATORY SERVICES, LIMBRO BUSINESS PARK, SANDTON, RSA CONSULTING CHEMICAL LABORATORIES, ATLASVILLE, BOKSBURG, RSA PHARMA..Q, INDUSTRIAL WEST. JOHANNESBURG, RSA INSTITUTE FOR PHARMACEUTICAL SERVICES, SILVERTONDALE, PRETORIA, RSA CONSULTING MICROBIOLOGICAL LABORATORY, MORE HILL, BENONI, RSA

GULF DRUG COMPANY, MOUNT EDGECOMBE,DURBAN,RSA

36 months

30 SEPTEMBER 201 i


Name of medicine:

Dosage form·

Active ingredients:


Applicant:

Manufacturer.

Packer:

Laboratory: FPRC

FPRR:

Shelf~ife:


42120.1. 110049

MYLAN·CEFUROXIME 1,5

POWDER FOR SOLUTION FOR INFUSION

EACH VIAL CONTAINS: CEFUROXIME SODIUM EQUIVALENT TO CEFUROXIME 1,500 mg

1,2,3,4,5,6,7

XIXIA PHARMACEUTICALS (PTY) L TO

LABORATORIO REIG JOFRE, TOLEDO, SPAIN

LABORATORIO REIG JOFRE, TOLEDO. SPAIN PHARMA-Q (PTY) LTD, INDUSTRIA,JOHANNESBURG

LABORATORIO REIG JOFRE, TOLEDO, SPAIN RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, NORTH-WEST UNIVERSITY, POTCHEFSTROOM,RSA CONSULTING CHEMICAL LABORATORIES, ATLASVILLE, BOKSBURG

XIXIA PHARMACEUTICALS (PTY) L TDMODDERFONTEIN, SOUTH AFRICA

36 monfihs

30 SEPTEMBER 2011

.... MRF15 MRF15 IIIRF15 0

Registration number: 42/20.1.110050 Registration number: 42/2610146 Registration number: 4212610147 z ~

Name of medicine: MYlAN-CEFUROXIME 750 Name of medicine: ASPEN PACLITAXEL 30 mg/5 Name of medicine: ASPEN PACLITAXEL 100 (..) ml mg/16,67 ml 0'1 .....

Dosage form: POWDER FOR SOLUTION FOR Dosage form: CONCENTRATE FOR Dosage form: CONCENTRATE FOR ~ INFUSION SOLUTION FOR INFUSION SOLUTION FOR INFUSION

Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH 5,0 ml CONTAINS: Active ingredients: EACH 16.67 ml CONTAINS: CEFUROXIME SODIUM PACLITAXEL 30,0 mg PAC LIT AXEL 100,0 mg EQUIVALENT TO

CEFUROXIME 750,0mg

Conditions of registration: 1' 2, 3, 4, 5, 6, 7 Conditions of registration: 1' 2, 3, 4, 5, 6, 7 Conditions of registration: 1' 2, 3, 4, 5, 6, 7

Applicant: XIXIA PHARMACEUTICALS (PTY) Applicant: PHARMACARE LIMITED Applicant: PHARMACARE LIMITED LTD

Manufacturer: lABORATORIO REIG JOFRE, Manufacturer: S.C. SINDAN-PHARMAA.R.L, Manufacturer: S.C. SINDAN-PHARMAAR.L, G.l 0 TOLEDO, SPAIN BUCHAREST,ROMANIA BUCHAREST,ROMANIA <

lABORATORIO REIG JOFRE, S.C. SINDAN-PHARMA A.R.L, m

Packer: Packer: Packer: ~.C. SINDAN-PHARMAA.R.L, :D TOLEDO, SPAIN BUCHAREST, ROMANIA BUCHAREST,ROMANIA z PHARMA-Q (PTY) L TO, PHARMACARE LIMITED, PHARMACARE LIMITED, s:: INDUSTRIA,JOHANNESBURG KORSTEN, PORT ELIZABETH, KORSTEN, PORT ELIZABETH, m

RSA RSA z ASPEN PHARMACARE EAST ASPEN PHARMACARE EAST

-1

LONDON, WILSONIA, EAST LONDON, WILSONIA, EAST G.l )>

LONDON, RSA LONDON, RSA N Laboratory: FPRC: lABORATORIO REIG JOFRE, Laboratory: S.C. SINDAN-PHARMAA.R.L, Laboratory:: FPRC S.C. SINDAN-PHARMA A.R.L, ~ TOLEDO, SPAIN FPRC: BUCHAREST,ROMANIA BUCHAREST,ROMANIA

RESEARCH INSTITUTE FOR PHARMACARE LIMITED, PHARMACARE LIMITED, .rn INDUSTRIAL PHARMACY, NORTH- KORSTEN, PORT ELIZABETH, KORSTEN, PORT ELIZABETH, <0 WSET UNIVERSITY, RSA RSA s:: POTCHEFSTROOM,RSA ASPEN PHARMACARE EAST ASPEN PHARMACARE EAST )> CONSULTING CHEMICAL LONDON, WILSONIA, EAST LONDON, WILSON lA, EAST :D LA BORA TORIES, ATlASVILLE, LONDON, RSA LONDON, RSA 0 BOKSBURG SABS COMMERCIAL (PTY) SASS COMMERCIAL (PTY) ::r:

LTD PHARMACEUTICAL LTD PHARMACEUTICAL 1\) 0

CHEMISTRY DEPARTMENT, CHEMISTRY DEPARTMENT, ..... GROENKLOOF, PRETORIA, GROENKLOOF, PRETORIA, 1\)

RSA RSA RESEARCH INSTITUTE FOR RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, INDUSTRIAL PHARMACY, NORTH-WSET UNIVERSITY, NORTH-WSET UNIVERSITY, POTCHEFSTROOM,RSA POTCHEFSTROOM,RSA M & L lAB ORA TORY M & L lABORATORY SERVICES (PTY) L TO, UMBRO SERVICES (PTY) LTD, LIMBRO BUSINESS PARK, SANDTON, BUSINESS PARK, SANDTON, RSA RSA

FPRR: XIXIA PHARMACEUTICALS (PTY) FPRR: XIXIA PHARMACEUTICALS FPRR XIXIA PHARMACEUTICALS L TDMODDERFONTEIN, SOUTH (PTY) LTD MODDERFONTEIN, (PTY) L TDMODDERFONTEIN, AFRICA SOUTH AFRICA SOUTH AFRICA

Shelf-life: 36 months Shelf-life: 36 months Shelf-life: 36 months

Date of registration: 30 SEPTEMBER Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011

MRF 15


Name of medicine:

Dosage form:

Active ingredients:


Applicant:

Manufacturer.

Packer:

Laboratory: FPRC:

FPRR:

Shelf-life:


4212610148

ASPEN PACLITAXEL 260 mg/43,33 ml

CONCENTRATE FOR SOLUTION FOR INFUSION

EACH 43,33 ml CONTAINS: PACLITAXEL 260,0 mg

1. 2, 3, 4, 5. 6, 7

PHARMACARE LIMITED

S.C. SINDAN-PHARMAA.RL, BUCHAREST,ROMANtA

S.C. SINDAN-PHARMA A.RL, BUCHAREST, ROMANIA PHARMACARE LIMITED, KORSTEN. PORT ELIZABETH, RSA ASPEN PHARMACARE EAST LONDON, WILSONIA, EAST LONDON, RSA

S.C. SINDAN-PHARMA A.RL, BUCHAREST, ROMANIA PHARMACARE LIMITED, KORSTEN, PORT ELIZABETH, RSA ASPEN PHARMACARE EAST LONDON, WILSONIA, EAST LONDON, RSA SABS COMMERCIAL (PTY) LTD PHARMACEUTICAL CHEMISTRY DEPARTMENT, GROENKLOOF, PRETORIA, RSA RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, NORTHWSET UNIVERSITY, POTCHEFSTROOM,RSA M & L LABORATORY SERVICES (PTY) L TO, LIMBRO BUSINESS PARK, SANDTON, RSA

XIXIA PHARMACEUTICALS (PTY) L TO MODDERFONTEIN, RSA

36months

30 SEPTEMBER 2011

~M~R~F~15~------------------------------------------__,.F15 ________________________________________________ _


Name of medicine:

Dosage form:

Active ingredients:


Applicant:

Manufacturer.

Packer:

Labora1ory: FPRC:

FPRR:

Shelf-life:


42/2610149

ASPEN PACLITAXEL 300 mg/50 ml

CONCENTRATE FOR SOLUTION FOR INFUSION

EACH 50,0 ml CONTAINS: PACLITAXEL 300 mg

1. 2, 3, 4, 5. 6, 7

PHARMACARE LIMITED

S.C. SINDAN-PHARMAA.R.L, BUCHAREST,ROMANIA

S.C. SINDAN-PHARMA A.R.L. BUCHAREST, ROMANIA PHARMACARE LIMITED. KORSTEN, PORT ELIZABETH, RSA ASPEN PHARMACARE EAST LONDON, WILSONIA, EAST LONDON,RSA

S.C. SINDAN-PHARMA A.R.L, BUCHAREST. ROMANIA PHARMACARE LIMITED, KORSTEN. PORT ELIZABETH, RSA ASPEN PHARMACARE EAST LONDON, WILSONIA, EAST LONDON, RSA SABS COMMERCIAL (PTY) LTD PHARMACEUTICAL CHEMISTRY DEPARTMENT, GROENKLOOF, PRETORIA, RSA RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, NORTHWSET UNIVERSITY, POTCHEFSTROOM,RSA M & L LABORATORY SERVICES (PTY) LTD, LIMBRO BUSINESS PARK,SANDTON,RSA

XIXIA PHARMACEUTICALS (PTY) LTD MODDERFONTEIN, RSA

36 months

30 SEPTEMBER 2011


Name of medicine:

Dosage form:

Active ingredients:

CondHions of registration:

Applicant:

Manufacturer.

Packer-

Laboratory: FPRC:

FPRR:

Shelf-life:


42/11.510407

MOVIPREP

POWDER FOR ORAL SOLUTION

EACH SACHET CONTAINS: MACROGOL 3350 100,0 g SODIUM SULPHATE ANHYDROUS 7,5 g SODIUM CHLORIDE 2,691 g POTASSIUM CHLORIDE 1,015 g

1. 2. 3, 4, 5, 6, 7

NORGINE (PTY) LTD

NORGINE LIMITED, HENGOED, MIDGLAMORGAN, UNITED KINGDOM

NORGINE LIMITED, HENGOED, MIDGLAMORGAN. UNITED KINGDOM

NORGINE LIMITED, HENGOED, MIDGLAMORGAN, UNITED KINGDOM READING SCIENTIFIC SERVICES LIMITED, WHITEKNIGHTS, READING, UNITED KINGDOM CONSULTING CHEMICAL LABORATORIES (PTY) LTD, ATLASVILLE, BOKSBURG, RSA

NORGINE (PTY) LTD, PARKMORE, SANOTON, RSA

36 months

30 SEPTEMBER 2011

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MRF 15 MRF15 MRF 15 z ?

Registration number: 42120.1.110445 Registration number: 4213.210454 Registration number: 42/3.2/0455 c.u en Name of medicine: CEFEPIME-SAFELINE 2 g Name of medicine: ACTAMAX5mg Name of medicine: ACTAMAX 35 mg .....

1\) INJECTION (X)

Dosage form: INJECTION Dosage form: TABLETS Dosage form: TABLETS

Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: CEFEPIME HCI Risedronic sodium Risedronic sodium MONOHYDRATE hemipentahydrate equivalent hemipentahydrate equivalent EQUIVALENT TO CEFEPIME to Risedronate sodium 5,0 to 2,0 g mg Risedronate sodium 35,0 mg

Conditions of registration: 1, 2, 3,4, 5,6, 7 Conditions of registration: 1' 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Ci)

Applicant: SAFELINE Applicant: PHARMA DYNAMICS (PTY) Applicant: PHARMA DYNAMICS (PTY) 0 PHARMACEUTICALS (PTY) LTD LTD < m LTD JJ

z Manufacturer: DEMO S.A., ATHENS, Manufacturer: PHARMATHEN S.A., Manufacturer: PHARMATHEN S.A, ~

GREECE PALLINI, ATTIKIS, GREECE PALLINI, ATTIKIS, GREECE m z

Packer: DEMO S.A., ATHENS, Packer: PHARMATHEN SA, Packer: PHARMATHEN SA, -i Ci)

GREECE PALUNI, ATTIKIS, GREECE PALLINI, ATTIKIS, GREECE )> FAMAR S.A., ANTHOUSA, FAMAR S.A., ANTHOUSA, N GREECE GREECE 3 PHARMANEL PHARMANEL PHARMACEUTICALS S.A., PHARMACEUTICALS S.A., .m LAMIA HIGHWAY, ATHENS, LAMIA HIGHWAY, ATHENS, <0

GREECE GREECE ~ )>

laboratory: FPRC: INSTITUTE FOR laboratory: FPRC: PHARMATHEN S.A., laboratory: FPRC: PHARMATHEN S.A., JJ (')

PHARMACEUTICAL PALLINI, ATTIKIS, GREECE PALLINI, ATTIKJS, GREECE :r: SERVICES, CONSULTING CHEMICAL CONSULTING CHEMICAL 1\)

SIL VERTONDALE, LABORATORIES (PTY) LABORATORIES (PTY) 0 ... PRETORIA, RSA LTD, ATLASVILLE, LTD, ATLASVILLE, 1\)

BOKSBURG, GAUTENG, BOKSBURG, GAUTENG, RSA RSA

FPRR: SAFE LINE FPRR: PHARMA DYNAMICS (PTY) FPRR: PHARMA DYNAMICS (PTY) PHARMACEUTICALS (PTY) LTD,VVESTLAKE,CAPE L TO, WESTLAKE, CAPE L TO, FLORIDA, RSA TOWN,RSA TOWN, RSA



MRF 15 MRF15 IIIRF15

Registration number: 42/2.210537 Registration number: 42126/0657 Registration number: 42126/0658

Name of medicine: BIO-ZOPICLONE 7,5 Name of medicine: MYLAN PACLITAXEL30 mg Name of medicine: MYLAN PACLITAXEL100 mg

Dosage fomn: TABLET Dosage form: INJECTION Dosage fomn: INJECTION

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS: ZOPICLONE 7,5 mg PAC LIT AXEL 30,0 mg PACLITAXEL 100,0 mg

Conditions of 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1,2,3,4,5,6, 7 Conditions of 1,2,3,4,5,6, 7 registration: registration:

Applicant: BIOTECH LABORATORIES (PTY) Applicant: XIXIA PHARMACEUTICALS Applicant: XIXIA PHARMACEUTICALS (PTY) LTD LTD (PTY) LTD

Manufacturer: DRAGENOPHARM APOTHEKER Manufacturer: ONCOTEC PHARMA GmbH, Manufacturer: ONCOTEC PHARMA GmbH, ROD LEBEN, PUSCHL GmbH, TITIMONING, RODLEBEN,GERMANY GERMANY GERMANY en

Packer: DRAGENOPHARM APOTHEKER Packer: ONCOTEC PHARMA GmbH, Packer: ONCOTEC PHARMA GmbH, RODLEBEN, ~ PUSCHL GmbH, TITTMONING, RODLEBEN,GERMANY GERMANY ~ GERMANY PHARMA..Q (PTY) L TO, PHARMA..Q (PTY) LTD, INDUSTRIA, en

INDUSTRIA, JOHANNESBURG, JOHANNESBURG,RSA ;;'I; 0 RSA m

Laboratory: FPRC DRAGENOPHARM APOTHEKER laboratory: FPRC: CONSULTING CHEMICAL Laboratory: FPRC: CONSULTING CHEMICAL LABORATORIES JJ )>

PUSCHL GmbH, TITIMONING, LABORATORIES (PTY) LTD, (PTY) LTD,ATLASVILLE, BOKSBURG, RSA z GERMANY ATLASVILLE, BOKSBURG, RSA PHARMA-Q {PTY) L TO, INDUSTRIA, .:-1 M&L LABORATORY SERVICES, PHARMA-Q (PTY) L TO, JOHANNESBURG,RSA c.o LIMBRO BUSINESS PARK, INDUSTRIA, JOHANNESBURG, RESEARCH INSTITUTE FOR INDUSTRIAL s: SANDTON, RSA RSA PHARMACY, NORTH-WEST UNIVERSITY, )> CONSULTING CHEMICAL RESEARCH INSTITUTE FOR POTCHEFSTROOM,RSA )> LABORATORIES, ATLASVILLE, INDUSTRIAL PHARMACY, SABS COMMERCIAL (PTY) L TO JJ BOKSBURG,RSA NORTH-WEST UNIVERSITY, PHARMACEUTICAL CHEMISTRY -1 RESEARCH INSTITUTE FOR POTCHEFSTROOM,RSA DEPARTMENT, GROENKLOOF, PRETORIA, 1\)

0 INDUSTRIAL PHARMACY, NORTH- SABS COMMERCIAL (PTY) L TO RSA ..... WEST UNIVERSITY, PHARMACEUTICAL IMPFSTOFFWERK DESSAU TORNAU 1\)

POTCHEFSTROOM,RSA CHEMISTRY DEPARTMENT, GmbH (IDT), RODLEBEN, GERMANY INSTITUTE FOR PHARMACEUTICAL GROENKLOOF, PRETORIA, WOLFENER ANAL YTIK, BITIERFELD, SERVICES, SILVERTONDALE, RSA GERMANY PRETORIA, RSA IMPFSTOFFWERK DESSAU

TORNAU GmbH (lOT), RODLEBEN,GERMANY WOLFENER ANAL YTIK, BITIERFELD, GERMANY

FPRR: BIOTECH LABORATORIES (PTYO XIXIA PHARMACEUTICALS FPRR: XIXIA PHARMACEUTICALS (PTY) LTD, LTD, MIDRAND, RSA FPRR: (PTY) L TO, MODDERFONTEIN, MODDERFONTEIN, GAUTENG, RSA

GAUTENG, RSA

Shelf-life: 24 months Shelf-life: 36 months Shelf-life: 36 months z 9

Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 (I) 0'1 ..... 1\) (X)

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MRF 15 MRF15 MRF 15

Registration number: 42126/0659 Registration number: 42120.2.8/0820 Registration number: 4212.6.5/0880 z !'

Name of medicine: MYLAN PACLITAXEL 300 mg Name of medicine: ANVIRO 500 TABLETS Name of medicine: QUETIWIN 25 mg VJ 01 ....

Dosage form: INJECTION Dosage form: TABLET Dosage form: TABLET 1'1:) (X)

Active Ingredients: EACH VIAL CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: PACLITAXEL 300,0mg Valaciclovir Hydrochloride Monohydrate QUETIAPINE FUMARATE EQUIVALENT TO

equivalent to QUETIAPINE 25,0 mg ValaciclovirSOO,O mg

Conditions of registration: 1,2,3,4, 5,6, 7 Conditions of registration: 1,2,3,4, 5,6, 7 Conditions of 1,2,3,4, 5,6, 7, 8 registration:

Applicant: XIXIA PHARMACEUTICALS (PTY) Applicant: ZYDUS HEAL THCARE SA (PTY) L TO Applicant: WINTHROP PHARMACEUTICALS (PTY) L TO LTD

Manufacturer: ONCOTEC PHARMA GmbH, Manufacturer: ZVDUS CADILA HEALTHCARE LTD, Manufacturer: MATRIX LABORATORIES LIMITED, SINNAR, (j)

RODLEBEN,GERMANY SANAND, AHMEDABAD, INDIA NASHIK, MAHARASHTRA, INDIA 0 <

Packer: ONCOTEC PHARMA GmbH, Packer: ZYDUS CADI LA HEAL THCARE l TO, Packer: MATRIX lABORATORIES LIMITED, SINNAR, m JJ

RODLEBEN,GERMANY SANAND, AHMEDABAD, INDIA NASHIK, MAHARASHTRA, INDIA z PHARMA..Q (PTY)l TO, WINTHROP PHARMACEUTICALS (PTY) s: INDUSTRIA, JOHANNESBURG, lTD, WAL TLOO, PRETORIA, RSA m RSA NYCOMED PHARMA Sp. Z o.o., z

LYSZKO~CE,POLAND -; (j)

Laboratory: FPRC: CONSULTING CHEMICAL laboratory: FPRC: ZYDUS CADILA HEAL THCARE L TO, Laboratory: FPRC: MATRIX LABORATORIES LIMITED, SINNAR, > LABORATORIES (PTY) LTD, SANAND, AHMEDABAD, INDIA NASHIK, MAHARASHTRA, INDIA N

m ATLASVILLE, BOKSBURG, RSA INSTITUTE FOR PHARMACEUTICAL & WINTHROP PHARMACEUTICALS (PTY) :t PHARMA-Q (PTY) LTD, CHEMICAL SERVICES, LTD, WALTLOO, PRETORIA, RSA INDUSTRIA, JOHANNESBURG, SILVERTONDALE, PRETORIA, RSA RESEARCH INSTITUTE FOR INDUSTRIAL .rn RSA INSTITUTE FOR INDUSTRIAL PHARMACY, NORTH-WEST UNIVERSITY, <0 RESEARCH INSTITUTE FOR PHARMACY, NORTH-WEST POTCHEFSTROOM,RSA s: INDUSTRIAL PHARMACY, NORTH· UNIVERSITY, POTCHEFSTROOM, > WEST UNIVERSITY, RSA JJ POTCHEFSTROOM,RSA (') SABS COMMERCIAL (PTY) LTD ::r: PHARMACEUTICAL CHEMISTRY 1'1:)

DEPARTMENT, GROENKLOOF, 0 ... PRETORIA, RSA 1'1:)

IMPFSTOFFWERK DESSAU TORNAU GmbH (101), RODLEBEN, GERMANY WOLFENER ANAL YTIK, BITIERFELO, GERMANY

FPRR: XIXIA PHARMACEUTICALS (PTY) FPRR: ZYDUS HEAL THCARE, FPRR: WINTHROP PHARMACEUTICALS (PTY) LTD, MODDERFONTEIN, GAUTENG, POTCHEFSTROOM,RSA LTD, MIDRAND, RSA RSA ~NTHROP PHARMACEUTICALS (PTY)

l TO, WAL TLOO, PRETORIA, RSA

Shelf-life: 36 months Shelf-life: 24 months Shelf-life: 24 months (Provisional)


MRF 15 MRF15 MRF 15

Registration number: 42/2.6.5/0881 Registration number: 42/2.6' 510882 Registration number: 42/5.10/0891

Name of medicine: QUETIWIN 1 00 mg Name of medicine: QUETIWIN 300 mg Name of medicine: ALEPET4

Dosage fonn: TABLET Dosage form: TABLET Dosage form: INJECTION

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH VIAL CONTAINS: QUETIAPINE FUMARATE QUETIAPINE FUMARATE ODANSETRON HCI DIHYDRATE EQUIVALENT TO QUETIAPINE 100,0 EQUIVALENT TO QUETIAPINE EQUIVALENT TO mg 300,0 mg ODANSTERON 4,0mg

Conditions of registration: 1' 2, 3, 4, 5, 6, 7' 8 Conditions of registration: 1' 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1,2,3,4,5,6, 7

Applicant: WINTHROP PHARMACEUTICALS Applicant: WINTHROP PHARMACEUTICALS Applicant: ACCORD HEAL THCARE (PTY) (PTY) LTD (PTY) LTD LTD

Manufacturer: MATRIX LABORATORIES LIMITED, Manufacturer: MATRIX LABORATORIES LIMITED, Manufacturer: INTAS PHARMACEUTICALS SINNAR, NASHIK, MAHARASHTRA, SINNAR, NASHIK, MAHARASHTRA, LTD, MATODA, SANAND, (/)

INDIA INDIA AHMEDABAD, INDIA ~ Packer: MATRIX LABORATORIES LIMITED, Packer: MATRIX LABORATORIES LIMITED, Packer: INTAS PHARMACEUTICALS ?:i

SINNAR, NASHIK, MAHARASHTRA, SINNAR, NASHIK, MAHARASHTRA, LTD, MATODA, SANAND, (/)

INDIA INDIA AHMEDABAD, INDIA 6 WINTHROP PHARMACEUTICALS WINTHROP PHARMACEUTICALS m (PTY) LTD, WALTLOO, PRETORIA, (PTY) L TO, WAL TLOO, PRETORIA, J] RSA RSA )> NYCOMED PHARMA Sp. Z o.o., NYCOMED PHARMA Sp. Z o.o., z LYSZKOWICE,POLAND LYSZKOWICE,POLAND .:-i

CD Laboretory: FPRC: MATRIX LABORATORIES LIMITED, Laboratory: MATRIX LABORATORIES LIMITED, Laboratory: FPRC INTAS PHARMACEUTICALS s:: SINNAR, NASHIK, MAHARASHTRA, FPRC: SINNAR, NASHIK, MAHARASHTRA, LTD, MATODA, SANAND,

~ INDIA INDIA AHMEDABAD, INDIA WINTHROP PHARMACEUTICALS WINTHROP PHARMACEUTICALS =I (PTY) L TO, WAL TLOO, PRETORIA, (PTY) LTD, WALTLOO, PRETORIA, RSA RSA 1\)

0 RESEARCH INSTITUTE FOR RESEARCH INSTITUTE FOR .... INDUSTRIAL PHARMACY, NORTH· INDUSTRIAL PHARMACY, NORTH· 1\)

WEST UNIVERSITY, WEST UNIVERSITY, POTCHEFSTROOM,RSA POTCHEFSTROOM,RSA

FPRR: WINTHROP PHARMACEUTICALS FPRR: WINTHROP PHARMACEUTICALS FPRC/FPRR: ACCORD HEAL THCARE (PTY) (PTY) LTD, MIDRAND, RSA (PTY) L TO, MIDRAND, RSA L TO, RIVONIA, GAUTENG, RSA WINTHROP PHARMACEUTICALS WINTHROP PHARMACEUTICALS (PTY) LTD, WAL TLOO, PRETORIA, (PTY) LTD, WAL TLOO, PRETORIA, RSA RSA

24 months Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Shelf-life:


z p (1,) Q1 .... 1\) (X)

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MRF 15 MRF 15 (X)

Registration number: 42/5.10/0892 Registration number: 42/5.10/0893 Registration number: 4215.1010894

Name of medicine: ALEPET8 Name of medicine: ACCORD- Name of medicine: ACCORO-ONOANSETRON 8 mg ONOANSETRON 4 mg

Dosage form: INJECTION Dosage form: INJECTION Dosage form: INJECTION

Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS: OOANSETRON HCI OOANSETRON HCI OOANSETRON HCI DIHYDRATE OIHYORA TE EQUIVALENT DIHYDRATE EQUIVALENT TO G)

TO ODANSTERON 8,0 mg EQUIVALENT TO OOANSTERON DIHYDRATE ~ OOANSTERON 4,0mg 8,0mg m

J] Conditions of 1,2,3,4,5,6, 7 Conditions of 1,2,3,4,5,6, 7 Conditions of 1, 2;3,4, 5, 6, 7 z registration: registration: registration: s:

ACCORD HEAL THCARE (PTY) m Applicant: ACCORD HEAL THCARE Applicant: ACCORD HEAL THCARE Applicant: LTD ~ (PTY) LTD (PTY) LTD

G)

Manufacturer: INTAS PHARMACEUTICALS Manufacturer: I NT AS Manufacturer: INTAS PHARMACEUTICALS > N

LTD, MATOOA, SANAND, PHARMACEUTICALS L TO, MA TOOA, SANANO, m AHMEDABAD, INDIA LTD, MATOOA, SANANO, AHMEDABAD, INDIA ~

AHMEDABAD, INDIA m Packer: INTAS PHARMACEUTICALS Packer: INTA3 Packer: INTAS PHARMACEUTICALS <0

LTD, MATOOA, SANANO, PHARMACEUTICALS LTD, MATOOA, SANANO, s: > AHMEDABAD, INDIA L TO, MATODA, SANAND, AHMEDABAD, INDIA J]

AHMEDABAD, INDIA (') :r:

Laboratory: INTAS PHARMACEUTICALS Laboratory: I NT AS Laboratory: INTAS PHARMACEUTICALS 1\)

FPRC: L TO, MATOOA, SANAND, FPRC: PHARMACEUTICALS FPRC: LTD, MATOOA, SANANO, 0 ..... AHMEDABAD, INDIA LTD, MATOOA, SANANO, AHMEDABAD, INDIA 1\)

AHMEDABAD, INDIA

FPRCIFPRR: ACCORD HEAL THCARE FPRCIFPRR: ACCORD HEAL THCARE FPRCIFPRR: ACCORD HEAL THCARE (PTY) (PTY) L TO, RIVONIA, (PTY) L TO, RIVONIA, L TO, RIVONIA, GAUTENG, RSA GAUTENG,RSA GAUTENG,RSA



MRF15 MRF15 MRF15

Registration number: 42/11.4.3/0944 Registration number: 42/11.4.3/0945 Registration number: 43/8.2/0021

Name of medicine: DRL PANTOPRAZOLE 20 Name of medicine: DRL PANTOPRAZOLE 40 Name of medicine: ARIXTRA 5,0 mg/0,4 ml

Dosage form: TABLET Dosage form: TABLET Dosage form: SOLUTION FOR INJECTION

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH SYRINGE (0,4 ml) CONTAINS: Pantoprazole sodium Pantoprazole sodium FONDAPARINUX SODIUM 5,0mg sesquihydrate equivalent to sesqulhydrate equivalent to Pantoprazole 20,0mg Pantoprazole 40,0 mg

Conditions of registration: 1' 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1,2,3,4,5,6, 7,8 Conditions of registration: 1,2,3,4, 5,6, 7

Applicant: DR REDDY'S LABORATORIES Applicant: DR REDDY'S LABORATORIES Applicant: GLAXOSMITHKLINE SOUTH AFRICA (PTY) LTD (PTY) LTD (PTY) LTD

Manufacturer: DR REDDY'S LABORATORIES Manufacturer: DR REDDY'S LABORATORIES Manufacturer: GLAXO WELLCOME PRODUCTION, C/) LIMITED, QUTHUBULLAPUR LTD,QUTHUBULLAPUR NOTRE DAME DE BONDEVILLE, ~ MANDAL, RANGA REDDY MANDAL, RANGA REDDY FRANCE DISTRICT, ANDHRA PRADESH, DISTRICT, ANDHRA PRADESH, ~ INDIA INDIA C/)

il\ Packer: DR REDDY'S LABORATORIES Packer: DR REDDY'S LABORATORIES Packer: GLAXO WELLCOME PRODUCTION, 0

LIMITED, QUTHUBULLAPUR LTD,QUTHUBULLAPUR NOTRE DAME DE BONDEVILLE, m MANDAL, RANGA REDDY MANDAL, RANGA REDDY FRANCE JJ

)> DISTRICT, ANDHRA PRADESH, DISTRICT, ANDHRA PRADESH, GLAXOSMITHKLINE SOUTH AFRICA z INDIA INDIA (PTYO LTD, EPPING, CAPE TOWN, RSA .-1

Laboratory: FPRC: DR REDDY'S LABORATORIES Laboratory: DR REDDY'S LABORATORIES Laboratory: FPRC GLAXO WELLCOME PRODUCTION, <.0

LIMITED, QUTHUBULLAPUR FPRC: LTD,QUTHUBULLAPUR NOTRE DAME DE BONDEVILLE, !1:: MANDAL, RANGA REDDY MANDAL, RANGA REDDY FRANCE ~ DISTRICT, ANDHRA PRADESH, DISTRICT, ANDHRA PRADESH, GLAXOSMITHKLINE SOUTH AFRICA

~ INDIA INDIA (PTY) LTD, EPPING, CAPE TOWN, RSA INSTITUTE FOR INSTITUTE FOR 1\:)

PHARMACEUTICAL SERVICES, PHARMACEUTICAL SERVICES, 0 ..... SILVERTONDALE, PRETORIA, SILVERTONDALE, PRETORIA, 1\:)

RSA RSA RESEARCH INSTITUTE FOR RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, INDUSTRIAL PHARMACY, NORTH-WEST UNIVERSITY, NORTH-WEST UNIVERSITY, POTCHEFSTROOM,RSA POTCHEFSTROOM,RSA

FPRR: DR REDDY'S LABORATORIES, FPRR: DR REDDY'S LABORATORIES, FPRR: GLAXOSMITHKLINE SOUTH AFRICA MURRAYFIELD, PRETORIA, RSA MURRAYFIELD, PRETORIA, (PTY) LTD, EPPING, CAPE TOWN, RSA

RSA

Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Shelf-life: 36 months

Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 z !=> U) Ol .... 1\:) 00

...

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z MRF15 MRF15 MRF15 ?

(I) Registration number: 43/8.2/0022 Registration number: 43/8.2/0023 Registration number: 43/21. 12/0055 (J1 ... Name of medicine: ARIXTRA 7,5 mg/ 0,6 ml Name of medicine: ARIXTRA 10,0 mg/ 0,8 ml Name of medicine: ACCORD FINASTERIDE

1\) (X)

1 mg

Dosage form: SOLUTION FOR INJECTION Dosage form: SOLUTION FOR INJECTION Dosage form: TABLET

Active ingredients: EACH SYRINGE (0,6 ml) Active ingredients: EACH SYRINGE (0,8 ml) Active ingredients: EACH TABLET CONTAINS: CONTAINS: CONTAINS: FINASTERIDE 1,0mg FONDAPARINUX SODIUM FONDAPARINUX SODIUM 7,5 mg 10,0 mg

Conditions of registration: 1,2,3,4,5,6, 7 CondiUons of registration: 1,2,3,4,5,6, 7 Conditions of registration: 1,2,3,4, 5,6, 7 G)

Applicant: GLAXOSMITHKLINE SOUTH Applicant: GLAXOSMITHKLINE SOUTH Applicant: ACCORD HEAL THCARE 0 AFRICA (PTY) L TO AFRICA {PTY) L TO {PTY) LTD < m

Manufacturer: GLAXO WELLCOME Manufacturer: GLAXO WELLCOME Manufacturer: ;NTAS PHARMACEUTICALS JJ z PRODUCTION, NOTRE DAME PRODUCTION, NOTRE DAME LTD, MATODA, SANAND, s:: DE BONDEVILLE, FRANCE DE BONDEVILLE, FRANCE AHMEDABAD, INDIA m z

Packer: GLAXO WELLCOME Packer: GLAXO WELLCOME Packer: INTAS PHARMACEUTICALS -1

PRODUCTION, NOTRE DAME PRODUCTION, NOTRE DAME LTD, MATODA, SANAND, G) > DE BONDEVILLE, FRANCE DE BONDEVILLE, FRANCE AHMEDABAD, INDIA N

GLAXOSMITHKLINE SOUTH GLAXOSMITHKLINE SOUTH g AFRICA (PTYO LTD, EPPING, AFRICA (PTYO L TO, EPPING, CAPE TOWN, RSA CAPE TOWN, RSA .m

co Laboratory: FPRC: GLAXO WELLCOME Laboratory: GLAXO WELLCOME Laboratory: FPRC INTAS PHARMACEUTICALS s:: PRODUCTION, NOTRE DAME FPRC: PRODUCTION, NOTRE DAME LTD, MATODA, SANAND, >

DE BONDEVILLE, FRANCE DE BONDEVILLE, FRANCE AHMEDABAD, INDIA JJ GLAXOSMITHKLINE SOUTH GLAXOSMITHKLINE SOUTH PHARMASPEC (')

::r AFRICA {PTY) L TO, EPPING, AFRICA (PTY) L TO, EPPING, CONSULTING 1\) CAPE TOWN, RSA CAPE TOWN, RSA LABORATORIES, 0 ...

FERNDALE,RANDBURG, 1\)

JOHANNESBURG CONSULTING CHEMICAL LABORATORIES, ATLASVILLE, BOKSBURG

FPRR: GLAXOSMITHKLINE SOUTH FPRR: GLAXOSMITHKLINE SOUTH FPRR: ACCORD HEAL THCARE AFRICA {PTY) LTD, EPPING, AFRICA {PTY) L TO, EPPING, {PTY) LTD, RIVONIA, CAPE TOWN, RSA CAPE TOWN, RSA GAUTENG,RSA



MRF15 MRF15 MRF15 Registration number: 43/21.12/0056 Registration number: 43/21.12/0057 Registration number: 43/21.12/0058

Name of medicine: ACCORD FINASTERIDE Name of medicine: INTAS FINASTERIDE 1 mg Name of medicine: INTAS FINASTERIDE 5 mg 5mg

Dosage form: TABLET Dosage form: TABLET Dosage form: TABLET

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET Active ingredients: EACH TABLET CONJAINS: FINASTERIDE 5,0mg CONTAINS: FINASTERIDE 5,0mg

FINASTERIDE 1,0 mg

Conditions of registration: 1,2,3,4,5,6, 7 Conditions of registration: 1,2, 3,4,5,6, 7 Conditions of registration: 1,2,3,4,5,6, 7

Applicant: ACCORD HEAL THCARE Applicant: ACCORD HEALTHCARE Applicant: ACCORD HEAL THCARE (PTY) LTD (PTY) LTD (PTY) LTD en

Manufacturer: INTAS PHARMACEUTICALS Manufacturer: I NT AS Manufacturer: INTAS PHARMACEUTICALS ~ LTD, MATODA, SANAND, PHARMACEUTICALS LTD, LTD, MATODA, SANAND, ~ AHMEDABAD, INDIA MATODA, SANAND, AHMEDABAD, INDIA en

AHMEDABAD, INDIA ;J\ 0

Packer: INTAS PHARMACEUTICALS Packer: I NT AS Packer: INTAS PHARMACEUTICALS m

LTD, MATODA, SANAND, PHARMACEUTICALS L TO, LTD, MATODA, SANAND, ~ AHMEDABAD, INDIA MATODA, SANAND, AHMEDABAD, INDIA z

:-1 AHMEDABAD, INDIA (I)

laboratory: FPRC: INTAS PHARMACEUTICALS laboratory: I NT AS laboratory: FPRC INTAS PHARMACEUTICALS s:: LTD, MATODA, SANAND, FPRC: PHARMACEUTICALS L TO, LTD, MATODA, SANAND, ~ AHMEDABAD, INDIA MATODA, SANAND, AHMEDABAD, INDIA ~ PHARMASPEC AHMEDABAD, INDIA PHARMASPEC CONSULTING

1\) CONSULTING PHARMASPEC LABORATORIES, FERNDALE, 0 LABORATORIES, CONSULTING RANDBURG, ....

1\) FERNDALE,RANDBURG, LABORATORIES, JOHANNESBURG JOHANNESBURG FERNDALE,RANDBURG, CONSULTING CHEMICAL CONSULTING CHEMICAL JOHANNESBURG LA BORA TORIES, LABORATORIES, CONSULTING CHEMICAL ATLASVILLE, BOKSBURG ATLASVILLE, BOKSBURG LAB ORA TORIES,

ATLASVILLE, BOKSBURG

FPRR: ACCORD HEALTHCARE FPRR: ACCORD HEAL THCARE FPRR: ACCORD HEAL THCARE (PTY) LTD, RIVONIA, (PTY) LTD, RIVONIA, (PTY) LTD, RIVONIA, GAUTENG, RSA GAUTENG,RSA GAUTENG,RSA

Shelf-life: 24 months Shelf-life: 24 months Shelf-life: 24 months z Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER Date of registration: 30 SEPTEMBER 2011 ~

2011 (A) 0'1 .... 1\) (X)

.... co

1'1) MRF 15 MRF15 MRF 15 0

Registration number: 43/24.1/0215 Registration number: 4317.5/0480 Registration number: 43/7.5/0481 z Name of medicine: IMMUNOI.ATE 500 Name of medicine: ATORVASTATIN WINTHROP 10 mg Name of medicine: ATORVASTATIN WINTHROP !'.>

20mg (A) (}1 .....

Dosage form: TABLET Dosage form: TABLET Dosage form: TABLET I\) (X)

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: MYCOPHENOI.ATE MOFETIL ATOVASTATIN CALCIUM ATOVASTATIN CALCIUM 500,0mg EQUIVALENT TO EQUIVALENT TO

ATORVASTATIN 10,0 mg ATORVASTATIN 20,0 mg

Conditions of registration: 1' 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, B Conditions of registration: 1, 2,3,4, 5, 6, 7, 8

Applicant: ZYDUS HEAL THCARE SA (PTY) Applicant WINTHROP PHARMACEUTICALS Applicant: WINTHROP LTD (PTY) LTD PHARMACEUTICALS (PTY) LTD

Manufacturer: ZYDUS CADILI.A HEAL THCARE Manufacturer: ZENTIVA a.s., U KABELOVNY, Manufacturer: ZENTIVA a.s., U KABELOVNY, LIMITED, SANAND, AHMEDABAD, PRAGUE, CZECH REPUBLIC PRAGUE, CZECH REPUBLIC G> INDIA ZENTIVA a.s., NITRIANSKA, ZENTIVA a.s., NITRIANSKA, 0

SLOVAKIA SLOVAKIA < m Packer: lYDUS CADILI.A HEAL THCARE Packer: ZENTIVA a.s., U KABELOVNY, Packer: ZENTIVA a.s., U KABELOVNY, :D z

LIMITED, SANAND, AHMEDABAD, PRAGUE, CZECH REPUBLIC PRAGUE, CZECH REPUBLIC s: INDIA ZENTIVA a.s., NITRIANSKA, ZENTIVA a.s., NITRIANSKA, m

SLOVAKIA SLOVAKIA ~ WINTHROP PHARMACEUTICALS WINTHROP (PTY) L TO, WAL TLOO, PRETORIA, PHARMACEUTICALS (PTY) G> RSA LTD, WALTLOO, PRETORIA, ~ RSA m

Laboratory: FPRC: lYDUS CADILI.A HEAL THCARE Laboratory: ZENTIVA a.s .. U KABELOVNY, Laboratory: FPRC ZENTIVA a.s., U KABELOVNY, ~ LIMITED, SANAND, AHMEDABAD, FPRC: PRAGUE, CZECH REPUBLIC PRAGUE, CZECH REPUBLIC .m INDIA ZENTIVA a.s., NITRIANSKA, ZENTIVA a.s., NITRIANSKA, tO INSTITUTE FOR SLOVAKIA SLOVAKIA s: PHARMACEUTICAL & CHEMICAL WINTHROP PHARMACEUTICALS WINTHROP )> SERVICES, SILVERTONDALE, (PTY) lTD, WAL TLOO, PRETORIA, PHARMACEUTICALS (PTY) :D PRETORIA, RSA RSA LTD, WAL TLOO, PRETORIA, 0 INSTITUTE FOR INDUSTRIAL RSA :r PHARMACY, NORTH-WEST I\)

UNIVERSITY, POTCHEFSTROOM, 0 ..... RSA 1\)

FPRR: ZYDUS HEAL THCARE SA (PTY) FPRR: WINTHROP PHARMACEUTICALS FPRR: WINTHROP L TO, POTCHEFSTROOM, RSA (PTY) LTD, WALTLOO, PRETORIA, PHARMACEUTICALS (PTY)

RSA l TO, WAL TLOO, PRETORIA, WINTHROP PHARMACEUTICALS RSA (PTY) L TO, MID RAND, GAUTENG, WINTHROP RSA PHARMACEUTICALS (PTY)

LTD, MIDRAND, GAUTENG, RSA

Shelf-life: 24 months Shelf-life: 24 months (Provisional) - Zentiva - Shelf-life: 24 months (Provisional) - Zentiva Czech Republic - Czech Republic 48 months- Zentiva- Slovakia 48 months - Zentiva - Slovakia


MRF 15 MRF15 ~F 15

Registration number: 4317.510482 Reijistralion number: 4315.3/0487 Registration number: 4315.3/0488

Name of medicine: ATORVASTATIN WINTHROP 40 mg Name of medicine: ARIMENTIA 5 mg Name of medicine: ARIMENTIA 10 mg

Dosage form: TABLET 00S6ije form: TABLET Dosage form: TABLET

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: DONEPEZEL Active ingredients: EACH TABLET CONTAINS: ATOVASTATIN CALCIUM EQUIVALENTTO HCI 5,0mg DONEPEZEL HCI 10,0mg ATORVASTATIN 40,0mg

Conditions of reijistration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of reijistratlon: 1, 2. 3, 4, 5. 6, 7 Conditions of registration: 1, 2, 3, 4, 5. 6.7

Applicant WINTHROP PHARMACEUTICALS (PTY) Applicant: PHARMACARE LIMITED Applicant PHARMACARE LIMITED LTD

Manufacturer. ZENTIVA a.s .• U KABELOVNY, PRAGUE. Manufacturer. McDERMOTI LABORATORIES L TO. T/A Manufacturer. McOERMOTI LABORATORIES LTD. T/A CZECH REPUBLIC GERARD LABORATORIES. DUBLIN, GERARD LABORATORIES. DUBLIN, IRELAND ZENTIVA a.s., NITRIANSKA, SLOVAKIA IRELAND MERCK FARMA Y QUIMICA. BARCELONA.

MERCK FARMA Y QUIMICA, SPAIN BARCELONA. SPAIN PHARMACARE LIMITED, KORSTEN, PORT PHARMACARE LIMITED, KORSTEN, ELIZABETH, RSA PORT ELIZABETH, RSA ASPEN PHARMACARE EAST LONDON, ASPEN PHARMACARE EAST LONDON, WILSONIA, EAST LONDON, RSA (/) WILSONIA, EAST LONDON, RSA

~ Packer: ZENTIVA a.s., U KABELOVNY, PRAGUE, Packer McDERMOTI LABORATORIES L TO. T/A Packer: McDERMOTI LABORATORIES LTD. T/A CZECH REPUBLIC GERARD LABORATORIES, DUBLIN, GERARD LABORATORIES, DUBLIN, IRELAND ~

(/) ZENTIVA a.s .. NITRIANSKA. SLOVAKIA IRELAND MERCK FARMA Y QUIMICA, BARCELONA,

6 WINTHROP PHARMACEUTICALS (PTY) MERCK FARMA Y QUIMICA, SPAIN LTD, WALTLOO, PRETORIA, RSA BARCELONA, SPAIN PHARMACARE LIMITED, KORSTEN, PORT m PHARMACARE LIMITED, KORSTEN, ELIZABETH, RSA ll PORT ELIZABETH, RSA ASPEN PHARMACARE EAST LONDON, )>

ASPEN PHARMACARE EAST LONDON, WILSONIA. EAST LONDON. RSA z WILSONIA, EAST LONDON, RSA ~

laboratory: FPRC: ZENTIVA a.s., U KABELOVNY, PRAGUE, laboratory: FPRC: McDERMOTI LABORATORIES LTD. TIA laboratory FPRC McDERMOTI LABORATORIES L TO. T/A <0 CZECH REPUBLIC GERARD LABORATORIES, DUBLIN, GERARD LABORATORIES, DUBLIN, IRELAND s:: ZENTIVA a.s., NITRIANSKA, SLOVAKIA IRELAND MERCK FARMA Y OUIMICA. BARCELONA,

~ WINTHROP PHARMACEUTICALS (PTY) MERCK FARMA Y QUIMICA, SPAIN LTD, WALTLOO, PRETORIA. RSA BARCELONA, SPAIN PHARMACARE LIMITED, KORSTEN, PORT

~ PHARMACARE LIMITED, KORSTEN, ELIZABETH, RSA PORT ELIZABETH. RSA ASPEN PHARMACARE EAST LONDON, N ASPEN PHARMACARE EAST LONDON, WILSONIA, EAST LONDON, RSA 0 WILSONIA. EAST LONDON, RSA SASS COMMERCIAL (PTY) L TO ... SASS COMMERCIAL (PTY) LTD PHARMACEUTICAL CHEMISTRY DEPARTMENT, N PHARMACEUTICAL CHEMISTRY GROENKLOOF, PRETORIA, RSA DEPARTMENT, GROENKLOOF, RESEARCH INSTITUTE FOR INDUSTRIAL PRETORIA, RSA PHARMACY, NORTH-WSET UNIVERSITY, RESEARCH INSTITUTE FOR INDUSTRIAL POTCHEFSTROOM,RSA PHARMACY, NORTH-WSET UNIVERSITY, M & L LABORATORY SERVICES (PTY) LTD, POTCHEFSTROOM,RSA LIMBRO . JOHANNESBURG, RSA M & L LABORATORY SERVICES (PTY) LTD, LIMBRO BUSINESS PARK, SANDTON. RSA

FPRR: WINTHROP PHARMACEUTICALS (PTY) FPRR: PHARMACARE LIMITED, KORSTEN, FPRR PHARMACARE LIMITED, KORSTEN, PORT l TO, WAL TLOO, PRETORIA, RSA PORT ELIZABETH, RSA ELIZABETH, RSA WINTHROP PHARMACEUTICALS (PTY) PHARMACARE LIMITED, WOODMEAD, PHARMACARE LIMITED, WOODMEAD, RSA LTD, MIDRAND, GAUTENG, RSA RSA

z Shelf-tile: 24 months (Provisional)- Zentiva- Czech Shelf-life: 24 months Shelf-life: 24months !='

Republic 4B monthS- Zentiva- Slovakia (I)

Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 0'1 .... N <»

N ...

MRF 15


Name of medicine:

Dosage form:

Active ingredients:


Applicant:

Manufacturer:

Packer:

Laboratory: FPRC:

43/30.2/0526

BOOSTRIX TETRA

SUSPENSION FOR INJECTION

EACH DOSE (0,5 ml) CONTAINS: Diphtheria toxoid 2,5 Lf Tetanus toxoid 5,0 Lf Pertussis toxoid (PT) 8,0 IJg Filamentous Haemagglutinin 8,0 IJg Pertactin 2. 5 IJg Inactivated polio virus type 1 40 D-antigen unit Inactivated polio virus type 2 8 D-antigen unit Inactivated polio virus type 3 32 D-antigen unit

1,2,3,4, 5,6, 7

GLAXOSMITHKLINE SOUTH AFRICA (PTY) LTD

GLAXOSMITHKLINE BIOLOGICALS SA, RIXENSART, BELGIUM

GLAXOSMITHKLINE BIOLOGICALS SA, RIXENSART, BELGIUM GLAXOSMITHKLINE BIOLOGICALS SA, WAVRE, BELGIUM GLAXOSMITHKLINE BIOLOGICALS, DRESDEN, GERMANY GLAXOSMITHKLINE BIOLOGICALS, SAINT-AMAND-LES-EAUX, FRANCE

GLAXOSMITHKLINE BIOLOGICALS SA, RIXENSART, BELGIUM GLAXOSMITHKLINE BIOLOGICALS SA, WAVRE, BELGIUM GLAXOSMITHKLINE SOUTH AFRICA (PTY) L TO, EPPING, RSA

~M~R~F~1~5 ______________________________________ MRF1~5-----------------------------------------


Name of medicine:

Dosage form:

Active ingredients:


Applicant:

Manufacturer:

Packer:

Laboratory: FPRC:

43/1.2/0577

GULF VENLAFAXINE XR 37,5

CAPSULE

EACH CAPSULE CONTAINS: VENLAFAXINE HCI EQUIVALENT TO VENLAFAXINE 37,5 mg

1,2,3,4, 5,6, 7


ALEMBIC LIMITED, TAL-HALOL, DIST. PANCHMAHALS, GUJARAT, INDIA


ALEMBIC LIMITED, TAL-HALOL, DIST. PANCHMAHALS, GUJARAT, INDIA SABS COMMERCIAL (PTY) L TO PHARMACEUTICAL CHEMISTRY DEPARTMENT, GROENKLOOF, PRETORIA, RSA M&L LABORATORY SERVICES, LIMBRO BUSINESS PARK, SANDTON, RSA CONSULTING CHEMICAL LABORATORIES, ATLASVILLE, BOKSBURG, RSA PHARMA-Q, INDUSTRIAL WEST, JOHANNESBURG. RSA INSTITUTE FOR PHARMACEUTICAL SERVICES, SILVERTONDALE, PRETORIA, RSA CONSULTING MICROBIOLOGICAL LABORATORY, MOREHILL.


Name of medicine:

Dosage form:

Active ingredients:


Applicant:

Manufacturer:

Packer:

Laboratory: FPRC

43/1.2/0578

GULF VENLAFAXINE XR 75

CAPSULE

EACH CAPSULE CONTAINS: VENLAFAXINE HCI EQUIVALENT TO VENLAFAXINE 75,0 mg

1,2, 3,4,5, 6, 7



ALEMBIC LIMITED. TAL-HALOL, DIST. PANCHMAHALS, GUJARAT. INDIA

ALEMBIC LIMITED, TAL-HALOL, DIST. PANCHMAHALS, GUJARAT, INDIA SABS COMMERCIAL (PTY) L TO PHARMACEUTICAL CHEMISTRY DEPARTMENT, GROENKLOOF. PRETORIA, RSA M&L LABORATORY SERVICES, LIMBRO BUSINESS PARK, SANDTON, RSA CONSULTING CHEMICAL LABORATORIES, ATLASVILLE, BOKSBURG, RSA PHARMA-Q, INDUSTRIAL WEST, JOHANNESBURG, RSA INSTITUTE FOR PHARMACEUTICAL SERVICES, SILVERTON DALE,

1\) 1\)

(j) 0 < m Jl z s:: m z -1 (j) )> N m :I m (l)

s:: )> Jl (') J: 1\) 0 .... 1\)

FPRR:

Shelf-life:


GLAXOSMITHKLINE SOUTH AFRICA (PTY) LTD, BRYANSTON, RSA

36 months

30 SEPTEMBER 2011

FPRR:

Shelf-life:


BENONI, RSA

GULF DRUG COMPANY, MOUNT EDGECOMBE, DURBAN,RSA

36 months

30 SEPTEMBER 2011

FPRR:

Shelf-life:


PRETORIA, RSA CONSULTING MICROBIOLOGICAL lABORATORY, MOREHILL, BENONI, RSA

GULF DRUG COMPANY, MOUNT EDGECOMBE, DURBAN,RSA

36 months

30 SEPTEMBER 2011

MRF 15 MRF15 MRF15 1\) .p.

Registration number: 43/1.2/0579 Registration number: 43/21 .12/0590 Registration number: 43/18.8/0591 z Name of medicine: GULF VENLAFAXINE XR 150 Name of medicine: MYLAN ANASTROZOLE 1 mg Name of medicine: QLAIRA 9

c.l

Dosage form: CAPSULE Dosage form: TABLET Dosage form: TABLET (J1 .... 1\J

Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH PACK CONTAINS: (X)

VENLAFAXINE HCI ANASTROZOLE 1,0 mg Two dark yellow tablets

EQUIVALENT TO containing:

VENLAFAXINE 150,0 mg ESTRADIOL VALERATE 3,0mg Five medium red tablets containing: ESTRADIOL VALERATE 2,0mg DIENOGEST 2,0mg Ci) Seventeen light yellow tablets 0 containing: < ESTRADIOL VALERATE m

JJ 2,0mg z DIENOGEST 3,0mg s:: Two dark red tablets m z containing -1 ESTRADIOL VALERATE Ci) 1,0mg ~ Two white placebo tablets. m

Conditions of registration: 1,2,3,4,5,6, 7 Conditions of registration: 1,2,3,4,5,6, 7,8 Conditions of registration: 1,2,3,4, 5,6, 7 :I _m Applicant: GULF DRUG COMPANY (PTY) Applicant: XIXIA PHARMACEUTICALS Applicant: BAYER(PTY)LTD co

LTD (PTY) LTD s:: Manufacturer: ALEMBIC LIMITED, TAL-HALOL, Manufacturer: SYNTHON HISPANIA S.L., Manufacturer: SCHERING GmbH UNO CO

)> JJ

DIST. PANCHMAHALS, SANT BOI DE LLOBREGAT, PRODUKTIONS KG, (")

GUJARAT, INDIA BARCELONA, SPAIN WEIMAR, GERMANY I 1\J

Packer: ALEMBIC LIMITED, TAL-HALOL, Packer: SYNTHON HISPANIA S.L., Packer: SCHERING GmbH UNO CO 0 ....

DIST. PANCHMAHALS, SANT BOI DE LLOBREGAT, PRODUKTIONS KG, 1\J

GUJARAT, INDIA BARCELONA, SPAIN WEIMAR, GERMANY MPV BV, OUDEHASKE, THE BAYER SCHERING NETHERLANDS PHARMA AG, BERLIN,

GERMANY

Laboratory: FPRC: ALEMBIC LIMITED, TAL-HALOL, Laboratory: SYNTHON HISPANIA S.L., Laboratory: FPRC SCHERING GmbH UNO CO

DIST. PANCHMAHALS, FPRC: SANT BOI DE LLOBREGAT, PRODUKTIONS KG,

GUJARAT, INDIA BARCELONA, SPAIN WEIMAR, GERMANY

SABS COMMERCIAL (PTY) LTD SYNTHON BV, NIJMEGEN, BAYER SCHERING

PHARMACEUTICAL THE NETHERLANDS PHARMA AG, BERLIN,

CHEMISTRY DEPARTMENT, QUINTA-ANAL YTICA s.r.o, GERMANY

GROENKLOOF, PRETORIA, PRAGUE, CZECH REPUBLIC RESEARCH INSTITUTE

RSA LABOR L +S AG, BAD FOR INDUSTRIAL

M&L LABORATORY SERVICES, BOCKLET/GROBENBACH, PHARMACY, NORTH-WEST

LIMBRO BUSINESS PARK, GERMANY UNIVERSITY,

SANDTON, RSA MERCK PHARMACEUTICALS POTCHEFSTROOM,RSA

•.

CONSULTING CHEMICAL LABORATORIES, ATLASVILLE, BOKSBURG,RSA PHARMA-Q, INDUSTRIAL WEST, JOHANNESBURG, RSA INSTITUTE FOR PHARMACEUTICAL SERVICES, SILVERTONDALE, PRETORIA, RSA CONSULTING MICROBIOLOGICAL LABORATORY, MOREHILL, BENONI, RSA

FPRR: GULF DRUG COMPANY, FPRR: MOUNT EDGECOMBE, DURBAN,RSA

Shelf-life: 36 months Shelf-life:

Date of registration: 30 SEPTEMBER 2011 Date of registration:

MANUFACTURING (PTY) L TO, WADEVILLE, GERMISTON, RSA RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, NORTH-WEST UNIVERSITY, POTCHEFSTROOM,RSA SABS COMMERCIAL (PTY) LTD PHARMACEUTICAL CHEMISTRY DEPARTMENT, GROENKLOOF, PRETORIA, RSA

XIXIA PHARMACEUTICALS, MODDERFONTEIN, GAUTENG, RSA

24 months (Provisional)

30 SEPTEMBER 2011

FPRR:

Shelf-life:


SABS COMMERCIAL (PTY) L TO PHARMACEUTICAL CHEMISTRY DEPARTMENT, GROENKLOOF, PRETORIA, RSA BIOCHEMICAL AND SCIENTIFIC CONSULTANTS c,:;, HILTON, KWAZULUNATAL, RSA

BAYER (PTY) L TO, !SANDO, GAUTENG,RSA

36 months

30 SEPTEMBER 2011

1\) Q)

z ~

MRF15 MRF15 MRF15 c.u 01 ...

Registration number: 4318.2/0725 Registration number: 43/7.1.310771 Registration number: 43/7.1.310772 1\) (I)

Name of medicine: SPEC CLOPIDOGREL 75 Name of medicine: RAN VALSARTAN 80 Name of medicine: RAN VALSARTAN 160


Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: CLOPIDOGREL BESYLATE VALSARTAN 80,0 mg VALSARTAN 160,0 mg EQUIVALENT TO CLOPIDOGREL 75,0 mg

Conditions of registration: 1' 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1,2,3,4,5,6, 7, 8 Conditions of registration: 1' 2, 3, 4, 5, 6, 7, 8 G)

Applicant: SPECPHARM (PTY) L TO Applicant: RANBAXY (SA) (PTY) LTD Applicant: RANBAXY (SA) (PTY) L TO 0 <

Manufacturer: PHARMATHEN SA, PALLINI, Manufacturer: RANBAXY LABORATORIES Manufacturer: RANBAXY LABORATORIES m JJ

A TTIKI GREECE L TO, DIST. SIRMOUR, L TO, DIST. SIRMOUR, z HIMACHAL PRADESH, INDIA HIMACHAL PRADESH, ~

INDIA m z Packer: PHARMATHEN SA, PALLINI, Packer: RANBAXY LABORATORIES Packer: RANBAXY LABORATORIES

-1 G)

ATTIKI GREECE L TO, DIST. SIRMOUR, L TO, DIST. SIRMOUR, )> HIMACHAL PRADESH, INDIA HIMACHAL PRADESH, N m INDIA =I

Laboratory: FPRC: PHARMATHEN SA, PALLINI, Laboratory: RANBAXY LABORATORIES Laboratory: FPRC RANBAXY LABORATORIES !" ATTIKI GREECE FPRC: LTD, DIST. SIRMOUR, L TO, DIST. SIRMOUR, (0

SPECPHARM HOLDINGS (PTY) HIMACHAL PRADESH, INDIA HIMACHAL PRADESH, ~ L TO, HALFWAY HOUSE, KHULULEKANILABORATORY INDIA )>

MIDRAND, RSA SERVICES, MIDRAND, RSA KHULULEKANI JJ (')

CONSULTING CHEMICAL LABORATORY SERVICES, J: LABORATORIES, ATLASVILLE, MIDRAND, RSA 1\)

BOKSBURG,RSA CONSULTING CHEMICAL 0 ... LA BORA TORIES, 1\)

ATLASVILLE, BOKSBURG, RSA

FPRR: SPECPHARM (PTY) L TO, FPRR: RANBAXY, CENTURION, RSA FPRR: RANBAXY, CENTURION, HALFWAY HOUSE, MIDRAND, RSA RSA

Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional)


MRF 15


Name of medicine:

Dosage form:

Active ingredients:


Applicant

Manufacturer:

Packer:

laboratory: FPRC:

FPRR:

Shelf~ife:


4317.1.310773

DIOL080

TABLET

EACH TABLET CONTAINS: VALSARTANBO,O mg

1. 2. 3, 4, 5, 6, 7, a RANBAXY (SA) (PTY) l TO

RANBAXY LABORATORIES L TO, DIST. SIRMOUR, HIMACHAL PRADESH, INDIA

RANBAXY LABORATORIES l TO, DIST. SIRMOUR, HIMACHAL PRADESH, INDIA

RANBAXY LABORATORIES LTD, DIST. SIRMOUR, HIMACHAL PRADESH, INDIA KHULULEKANILABORATORY SERVICES, MIDRAND, RSA CONSULTING CHEMICAL LABORATORIES, ATLASVILLE, BOKSBURG, RSA

RANBAXY, CENTURION, RSA


30 SEPTEMBER 2011

MRF15


Name of medicine:

Dosage form:

Active ingredients:


Applicant:

Manufacturer:

Packer:

Laboratory: FPRC:

FPRR:

Shelf~ife:


4317.1.310774

DIOLO 160

TABLET

EACH TABLET CONTAINS: VALSARTAN 160,0 mg

1. 2. 3, 4, 5, 6, 7, a RANBAXY (SA) (PTY) L TO

RANBAXY LABORATORIES LTD, DIST. SIRMOUR, HIMACHAL PRADESH. INDIA

RANBAXY LABORATORIES LTD. DIST. SIRMOUR, HIMACHAL PRADESH. INDIA

RANBAXY LABORATORIES L TO, DIST. SIRMOUR, HIMACHAL PRADESH, INDIA KHULULEKANILABORATORY SERVICES, MIDRAND, RSA CONSULTING CHEMICAL LABORATORIES, ATLASVILLE. BOKSBURG,RSA

RANBAXY, CENTURION, RSA


30 SEPTEMBER 2011

~F 15


Name of medicine:

Dosage form:

Active ingredients:


Applicant:

Manufacturer:

Packer:

laboratory: FPRC

FPRR:

Shelf-life:

Dale of registration:

43110.2.210785

TOPRAZ4

TABLET

EACH TABLET CONTAINS: Montelukast sodium equivalent to Montelukast 4,0 mg

1, 2. 3, 4, 5, 6, 7, 8

DR REDDY'S LABORATORIES (PTY) LTD

DR REDDY'S LABORATORIES LIMITED, QUTHUBULLAPUR MANOAL, RANGA REDDY DISTRICT, ANOHRA PRADESH, INDIA

DR REDDY'S LABORATORIES LIMITED, QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIA ORA PHARMACEUTICALS, ROUTE 21 CORPORATE PARK, IRENE, CENTURION, RSA TECHNIKON LABORATORIES (PTY) LTD, ROBERTVILLE, FLORIDA. GAUTENG, RSA DIVPHARM MANUFACTURING AND PACKAGING (PTY) L TO, INDUSTRIA, JOHANNESBURG. RSA

DR REDDY'S LABORATORIES LIMITED, OUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, ANOHRA PRADESH, INDIA INSTITUTE FOR PHARMACEUTICAL SERVICES, SILVERTONDALE, PRETORIA, RSA RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, NORTHWEST UNIVERSITY, POTCHEFSTROOM,RSA

OR REDDY'S LABORATORIES, MURRAYFIELD, PRETORIA, RSA


30 SEPTEMBER 201 1

CJ)

~ ~ "' 0 m :D

~ .-1 !D

~ :D -1 1\) 0 ..... 1\)

N C»

z !' (,) 01

MRF 15 MRF15 'IF 15 .... 1\)

Registration number: 43/10.2.210785 Registration number: 43/10.2.210787 Registration number: 43/10.2.2/0788 Q:)

Name of medicine: TOPRAZ5 Name of medicine: TOPRAZ10 Name of medicine: DRL MONTELUKAST 4


Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Montelukast sodium equivalent to Montelukast sodium equivalent to Montelukast sodium equivalent to Montalukast 5,0 mg Montelukast 10,0 mg Montelukasl 4,0 mg

Conditions of registration: 1, 2, 3, 4, 5, S, 7. 8 Conditions of registration: 1, 2, 3, 4, 5, s. 7 Conditions of registration: 1, 2, 3, 4. 5, s. 7, 8

Applicant: DR REDDY'S LABORATORIES (PTY) l TO Applicant: DR REDDY'S LABORATORIES (PTY) LTD Applicant: DR REDDY'S LABORATORIES (PTY) LTD G)

Manufacturer. DR REDDY'S LASORATORIES LIMITED, Manufacturer. DR REDDY'S LASORATORIES LIMITED, Manufacturer: DR REDDY'S LASORATORIES 0 < QUTHUBUlLAPUR MANDAL, RANGA QUTHUBUlLAPUR MANDAL, RANGA LIMITED, OUTHUBULLAPUR m

REDDY DISTRICT, ANDHRA PRADESH, REDDY DISTRICT, ANDHRA PRADESH, MANDAL, RANGA REDDY DISTRICT. :0 INDIA INDIA !.NOHRA PRADESH, INDIA z

Peeker: DR REDDY'S LABORATORIES LIMITED. Peeker: DR REDDY'S LASORATORIES LIMITED, Packer: OR REDDY'S LASORATORIES s.: OUTHUBULLAPUR MANDAL. RANGA QUTHUBULLAPUR MANDAL, RANGA LIMITED, QUTHUBULLAPUR m REDDY DISTRICT, ANDHRA PRADESH, REDDY DISTRICT, ANDHRA PRADESH, MANDAL, RANGA REDDY DISTRICT, z INDIA INDIA ANDHRA PRADESH. INDIA -1 ORA PHARMACEUTICALS. ROUTE 21 ORA PHARMACEUTICALS, ROUTE 21 ORA PHARMACEUTICALS, ROUTE 21 G) CORPORATE PARK, IRENE, CENTURION, CORPORATE PARK, IRENE, CORPORATE PARK, IRENE, )> RSA CENTURION, RSA CENTURION, RSA N TECHNIKON LABORATORIES (PTY) L TO, TECHNIKON LABORATORIES (PTY) L TO. TECHNIKON LABORATORIES (PTY) m ROBER1VILLE, FLORIDA, GAUTENG, RSA ROBERTVILLE, FLORIDA. GAUTENG, LTD, ROBERTVILLE, FLORIDA, ::j DIVPHARM MANUFACTURING AND RSA GAUTENG, RSA J11 PACKAGING (PTY) LTD. INDUSTRIA. DIVPHARM MANUFACTURING AND DIVPHARM MANUFACTURING AND JOHANNESBURG,RSA PACKAGING (PTY)l TD. INDUSTRIA, PACKAGING (PTY) LTD, INDUSTRIA, 1.0

JOHANNESBURG,RSA JOHANNESBURG, RSA s.: Laboratory: FPRC: DR REDDY'S LABORATORIES LIMITED, Laboratory: FPRC: DR REDDY'S LABORATORIES LIMITED, Laboratory: FPRC DR REDDY'S LASORATORIES )>

:0 QUTHUBUlLAPUR MANDAL, RANGA OUTHUBULLAPUR MANDAL, RANGA LIMITED, QUTHUBULLAPUR 0 REDDY DISTRICT, ANDHRA PRADESH. REDDY DISTRICT, ANDHRA PRADESH, MANDAL. RANGA REDDY DISTRICT, I INDIA INDIA ANDHRA PRADESH, INDIA INSTITUTE FOR PHARMACEUTICAL INSTITUTE FOR PHARMACEUTICAL INSTITUTE FOR PHARMACEUTICAL 1\)

SERVICES, SllVERTONDALE, PRETORIA, SERVICES, SILVERTONOALE, SERVICES, SILVERTONOALE. 0 .... RSA PRETORIA, RSA PRETORIA. RSA 1\) RESEARCH INSTITUTE FOR INDUSTRIAL RESEARCH INSTITUTE FOR INDUSTRIAL RESEARCH INSTITUTE FOR PHARMACY, NORTH-WEST UNIVERSITY, PHARMACY, NORTH-WEST UNIVERSITY, INDUSTRIAL PHARMACY, NORTH-POTCHEFSTROOM, RSA POTCHEFSTROOM, RSA WEST UNIVERSITY,

POTCHEFSTROOM. RSA

FPRR: DR REDDY'S LABORATORIES, FPRR: DR REDDY'S LASORATORIES. FPRR: DR REDDY'S LASORATORIES, MURRAYFIELD, PRETORIA, RSA MURRAYFIELD, PRETORIA, RSA MURRAYFIELD, PRETORIA, RSA

Shelf-life: 24 monlhs (Provisional) Shelf-life: 24 months Shelf~ife: 24 months (Provisional)

Dele of registration: 30 SEPTEMBER 2011 Dale of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011

MRF 15


Name of medicine:

Dosage !orrn:

Active ingredients:


Applicant:

Manufacturer:

Packer:

laboratory: FPRC:

FPRR:

Shalf~ife:


43/10.2.210769

DRL MONTELUKAST 5

TABLET


1, 2, 3, 4, 5, 6, 7, 8

DR REDDY'S LABORATORIES {PTY) LTD

DR REDDY'S LABORATORIES LIMITED, QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIA

DR REDDY'S LABORATORIES LIMITED, QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIA DRA PHARMACEUTICALS, ROUTE 21 CORPORATE PARK, IRENE, CENTURION, RSA TECHNIKON LABORATORIES (PTY) LTD. ROBERTVILLE, FLORIDA, GAUTENG, RSA DIVPHARM MANUFACTURING AND PACKAGING (PTY) LTD. INDUSTRIA. JOHANNESBURG,RSA

DR REDDY'S LABORATORIES LIMITED, QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIA INSTITUTE FOR PHARMACEUTICAL SERVICES, SILVERTONDALE, PRETORIA, RSA RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, NORTH-WEST UNIVERSITY, POTCHEFSTROOM,RSA

DR REDDY'S LABORATORIES, MURRAYFIELD, PRETORIA, RSA


30 SEPTEMBER 2011

~M~R~F~15~--------------------------------------~~F15----------------------------------------------Registration number:

Name of medicine:

Dosege form:

Active ingredients:


Applicant:

Manufacturer:

Packer:

laboratory: FPRC:

FPRR:

Shelf-life:


43110.2.210790

DRL MONTELUKAST 10

TABLET


1, 2, 3, 4, 5, 6, 7

DR REDDY'S LABORATORIES (PTY) LTD

DR REDDY'S LABORATORIES LIMITED, QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIA

DR REDDY'S LABORATORIES LIMITED, QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIA ORA PHARMACEUTICALS, ROUTE 21 CORPORATE PARK, IRENE, CENTURION, RSA TECHNIKON LABORATORIES (PTY) L TO, ROBERTVILLE, FLORIDA, GAUTENG, RSA DIVPHARM MANUFACTURING AND PACKAGING (PTY) LTD, INDUSTRIA, JOHANNESBURG, RSA

DR REDDY'S LABORATORIES LIMITED, OUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIA INSTITUTE FOR PHARMACEUTICAL SERVICES, SILVERTONDALE, PRETORIA, RSA RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, NORTH-WEST UNIVERSITY, POTCHEFSTROOM,RSA

DR REDDY'S LABORATORIES, MURRAYFIELD, PRETORIA, RSA

24 months

30 SEPTEMBER 2011


Name of medicine:

Dosage form:

Acttve ingredients:


Applicant:

Manufacturer:

Packer:

Laboratory: FPRC

FPRR:

Shelf~ife:


43f7.1. 3/0604

HYTENZASO

TABLET

EACH TABLET CONTAINS: LOSARTAN POTASSIUM 50,0 mg

1, 2, 3, 4, 5, 6, 7

LASARA TRADERS (PTY) LTD

PHARMATHEN S.A., PALLINI, ATTIKI, GREECE

PHARMATHEN SA, PALLINI, ATTIKI, GREECE SPECPHARM HOLDINGS, HALFWAY HOUSE, MIDRAND

PHARMATHEN S.A., PALLINI, ATTIKI, GREECE SPECPHARM HOLDINGS, HALFWAY HOUSE. MIDRAND

LASARA TRADERS, MORE LETA PARK, PRETORIA

36 months

30 SEPTEMBER 2011

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MRF 15 MRF15

Registration number: 4317.1.3/0805 Registration number: 4317.1.3/0806 Registration number: 43/7.1.3/0807

Name of medicine: HYTENZA 100 Name of medicine: HYTENZA CO 50/12,5 Name of medicine: HYTENZA CO 100/25

Dosage fomn: TABLET Dosage fomn: TABLET Dosage fomn: TABLET

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active Ingredients: EACH TABLET CONTAINS: LOSARTAN POTASSIUM Losartan Potassium50,0 mg 100,0 mg Hydrochlorothiazide 12,5 mg

Losartan Potassium 1 00,0 mg Hydrochlorothiazide 25,0 mg (j)

0 Conditions of registration: 1,2,3,4,5,6, 7 Conditions of registration: 1,2,3,4,5,6, 7 Conditions of registration: 1,2,3,4, 5,6, 7 < m Applicant: LASARA TRADERS (PTY) LTD Applicant: LASARA TRADERS (PTY) LTD Applicant: LASARA TRADERS (PTY) ll z

LTD s: m

Manufacturer: PHARMATHEN S.A., PALLINI, Manufacturer: PHARMATHEN S.A, ATTIKI, A TTIKI, GREECE GREECE

Manufacturer: PHARMATHEN S.A, ATTIKI, z GREECE -i

(j)

Packer: PHARMATHEN S.A., PALLINI, Packer: PHARMATHEN S.A. ATTIKI, A TTIKI, GREECE GREECE SPECPHARM HOLDINGS, SPECPHARM HOLDINGS HALFWAY HOUSE, MIDRAND (PTY) LTD, HALFWAY HOUSE,

Packer: PHARMATHEN S.A, ATTIKI, )> N

GREECE m SPECPHARM HOLDINGS ~ (PTY) LTD, HALFWAY .m

MID RAND HOUSE, MIDRAND (C)

Laboratory: FPRC: PHARMATHEN S.A., PALLINI, Laboratory: PHARMATHEN S.A, ATTIKI, ATTIKI, GREECE FPRC: GREECE

Laboratory: FPRC PHARMATHEN S.A, ATTIKI, s: )>

GREECE ll SPECPHARM HOLDINGS, SPECPHARM HOLDINGS HALFWAY HOUSE, MIDRAND (PTY) LTD, HALFWAY HOUSE,

MIDRAND

SPECPHARM HOLDINGS ()

(PTY) LTD, HALFWAY :c HOUSE, MIDRAND 1'\)

0 .... FPRR: LASARA TRADERS, MORELETA FPRR: LASARA TRADERS (PTY) L TO, FPRR: LASARA TRADERS (PTY) 1'\)

PARK, PRETORIA MORELETA PARK, PRETORIA L TO, MORELETA PARK, PRETORIA

Shelf-life: 24 months . Shelf-life: 36 months Shelf-life: 36 months


MRF15 MRF15 MRF15

Registration number: 43/5.4.110855 Registration number: 43/5.4.110856 Registration number: 43/5.4,1/0857

Name of medicine: PRAMIOLA 0,25 Name of medicine: PRAMIOLA 0,125 Name of medicine: SANDOZ PRAMIPEXOLE 0,25


Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Pramipexole dihydrochloride Pramipexole dihydrochloride Pramipexole dihydrochloride monohydrate 0,25mg monohydrate 0,125 mg monohydrate 0,25 mg

Conditions of registration: 1,2,3,4,5,6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6,7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7

Applicant: SANDOZ SA (PTY) L TO Applicant SANDOZ SA (PTY) L TO Applicant: SANDOZ SA (PTY) L TO

Manufacturer: SANDOZ PRIVATE LIMITED Manufacturer: SANDOZ PRIVATE LIMITED Manufacturer: SANDOZ PRIVATE LIMITED VILLAGE-DIGHE, NAVI MUMBAI, 'VILLAGE-DIGHE, NAVI MUMBAI, VILLAGE-DIGHE, NAVI MUMBAI, INDIA INDIA INDIA

en Packer: SANDOZ PRIVATE LIMITED Packer: SANDOZ PRIVATE LIMITED Packer: SANDOZ PRIVATE LIMITED )!

VILLAGE-DIGHE, NAVI MUMBAI, VILLAGE-DIGHE, NAVI MUMBAI, VILLAGE-DIGHE, NAVI MUMBAI, INDIA INDIA INDIA ~ TECHNIKON lABORATORIES, TECHNIKON LABORATORIES, TECHNIKON LABORATORIES, en ROBERTVILLE, FLORIDA. ROBERTVILLE, FLORIDA, ROBERTVILLE, FLORIDA. 7\

0 GAUTENG,RSA GAUTENG,RSA GAUTENG,RSA m SANDOZ SA, SPARTAN, KEMPTON SANDOZ SA, SPARTAN. KEMPTON SANDOZ SA, SPARTAN, :D PARK, RSA PARK, RSA KEMPTON PARK. RSA )>

z Laboratory: FPRC: SANDOZ PRIVATE LIMITED Laboratory: SANDOZ PRIVATE LIMITED Laboratory: FPRC SANDOZ PRIVATE LIMITED .-1

VILLAGE-DIGHE, NAVI MUMBAI, FPRC: VILLAGE-DIGHE, NAVI MUMBAI, VILLAGE·DIGHE, NAVI MUMBAI, (.0 INDIA INDIA INDIA s:: CONSULTING CHEMICAL CONSULTING CHEMICAL CONSULTING CHEMICAL )> LABORATORIES, ATLASVILLE, LABORATORIES, ATLASVILLE, LABORATORIES, A TLASVILLE, )> BOKSBURG. RSA BOKSBURG,RSA BOKSBURG,RSA ~ SASS COMMERCIAL (PTY) LTD SASS COMMERCIAL (PTY) L TO SABS COMMERCIAL (PTY) L TO PHARMACEUTICAL CHEMISTRY PHARMACEUTICAL CHEMISTRY PHARMACEUTICAL 1\)

0 DEPARTMENT, GROENKLOOF, DEPARTMENT, GROENKLOOF; CHEMISTRY DEPARTMENT, .... PRETORIA, RSA PRETORIA, RSA GROENKLOOF, PRETORIA. 1\)

SANDOZ SA; SPARTAN, KEMPTON SANDOZ SA, SPARTAN, KEMPTON RSA PARK, RSA PARK, RSA SANDOZ SA, SPARTAN,

KEMPTON PARK, RSA

FPRR: SANDOZ SA, SPARTAN, KEMPTON FPRR: SANDOZSA,SPARTAN,KEMPTON FPRR: SANDOZ SA, SPARTAN, PARK,RSA PARK, RSA KEMPTON PARK, RSA



z p (j) (11 ... 1\) CJ)

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Registration number: 43/5.4.1/0856 Registration number: 43/7.1.3/0922 Registration number: 4317.1.3/0923 (I) CJ1

Name of medicine: SANDOZ PRAMIPEXOLE 0,125 Name of medicine: ATACAND PLUS 32/12,5 mg Name of medicine: ATACAND PLUS 32/25 mg 1'1:) en


Active Ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Pramipexole dihydrochloride CANDESARTAN CILEXETIL 32,0 mg CANDESARTAN CILEXETIL 32,0 monohydrate 0,125 mg HYDROCHLOROTHIAZIDE 12,5 mg mg

HYDROCHLOROTHIAZIDE 25,0 mg

Conditions of registration: 1' 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, e Conditions of registration: 1. 2. 3,4, 5, e, 7, a

Applicant: SANDOZ SA (PTY) L TO Applicant: ASTRAZENECA Applicant: ASTRAZENECA (j) PHARMACEUTICALS (PTY) L TO PHARMACEUTICALS (PTY) L TO 0

ManUfacturer: SANDOZ PRNATE LIMITED Manufacturer: ASTRAZENECA AB, SODERTALJE, Manufacturer: ASTRAZENECA AB, < m VILLAGE-DIGHE, NAVI MUMBAI, SWEDEN SODERTALJE, SWEDEN :0 INDIA z

Packer: SANDOZ PRIVATE LIMITED Packer: ASTRAZENECA AB, SODERTALJE, Packer: ASTRAZENECA AB, s:: m

VILLAGE-DIG HE, NAVI MUMBAI, SWEDEN SODERTALJE, SWEDEN z INDIA ASTRAZENECA AB, UMEA, ASTRAZENECA AB, UMEA, -l TECHNIKON LABORATORIES, SWEDEN SWEDEN (j) ROBERTVILLE, FLORIDA, ~ GAUTENG,RSA

9 SANDOZ SA, SPARTAN, KEMPTON PARK, RSA

.m Laboratory: FPRC: SANDOZ PRIVATE LIMITED Laboratory: ASTRAZENECAAB, SODERTALJE, Laboratory: FPRC ASTRAZENECA AB, co

VILLAGE-DIGHE, NAVI MUMBAI, FPRC: SWEDEN SODERTALJE, SWEDEN s:: INDIA AFRIKA BIOPHARMA AFRIKA BIOPHARMA )> CONSULTING CHEMICAL MANUFACTURING (PTY) L TO, MANUFACTURING (PTY) L TO. :0 LABORATORIES, ATLASVILLE, ALRODE, ALBERTON ALROOE, ALBERTON () BOKSBURG,RSA CONSULTING CHEMICAL CONSULTING CHEMICAL :I: SABS COMMERCIAL (PTY) L TO LABORATORIES (PTY) LTD LABORATORIES (PTY) LTD 1'1:)

PHARMACEUTICAL CHEMISTRY 0 ..... DEPARTMENT, GROENKLOOF, 1'1:)

PRETORIA, RSA SANDOZ SA, SPARTAN, KEMPTON PARK, RSA

FPRR: SANDOZSA,SPARTAN,KEMPTON FPRR: ASTRAZENECA FPRR: ASTRAZENECA PARK, RSA PHARMACEUTICALS (PTY) L TO, PHARMACEUTICALS (PTY)

SUNNINGHILL L TO, SUNNING HILL

Shelf-life: 24 months Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional)

Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 September 2011

MRF 15 MRF15 MRF 15

Registration number: 43/34/1010 Registration number: 4317.1.3/1032 Registration number: 43/7.1.3/1033

Name of medicine: AFINITOR 5 mg Name of medicine: AURO PERINDOPRIL 2 mg Name of medicine: AURO PERINDOPRIL 4 mg


Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: EVEROLIMUS 5,0mg PERINDOPRIL TERT-BUTYLAMINE PERINDOPRIL TERT-

2,0 mg BUTYLAMINE 4,0mg

Conditions of registration: 1, 2,3,4,5,6, 7,8 Conditions of registration: 1' 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1,2,3,4,5,6, 7,8

Applicant: NOV ARTIS SOUTH AFRICA (PTY) Applicant: AUROBINDO PHARMA (PTY) LTD Applicant: AUROBINDO PHARMA (PTY) LTD LTD

Manufacturer: NOVARTIS PHARMAAG, BASEL, Manufacturer: AUROBINDO PHARMA LTD, UNIT Manufacturer: AUROBINDO PHARMA LTD, SWITZERLAND Ill, QUTHUBULLAPUR MANDAL, UNIT Ill, QUTHUBULLAPUR NOV ARTIS PHARMA STEIN AG, HYDERABAD, ANDHRA PRADESH, MANDAL, HYDERABAD, SCHAFFHAUSERSTRASSE, STEIN, INDIA ANDHRA PRADESH, INDIA Ul SWITZERLAND ~

Packer: NOVARTIS PHARMAAG, BASEL, Packer: AUROBINDO PHARMA l TO, UNIT Packer: AUROBINDO PHARMA LTD, !j SWITZERLAND Ill, QUTHUBULLAPUR MANDAL, UNIT Ill, QUTHUBULLAPUR Ul NOV ARTIS PHARMA STEIN AG, HYDERABAD, ANDHRA PRADESH, MANDAL, HYDERABAD, 7\ SCHAFFHAUSERSTRASSE, STEIN, INDIA ANDHRA PRADESH, INDIA 0

m SWITZERLAND Jj KONAPHARMA AG, PRATTELN, )> SWITZERLAND z ORA PHARMACEUTICALS, ROUTE -~ 21 CORPORATE PARK, IRENE, <0 CENTURION, RSA s: SANDOZ SA, SPARTAN, KEMPTON ~ PARK, RSA

Jj Laboratory: FPRC: NOVARTIS PHARMAAG, BASEL, Laboratory: AUROBINDO PHARMA l TO, UNIT Laboratory: FPRC AUROBINDO PHARMA LTD, ~

SWITZERLAND FPRC: Ill, QUTHUBULLAPUR MANDAL, UNIT Ill, QUTHUBULLAPUR 1\) 0 NOV ARTIS PHARMA STEIN AG, HYDERABAD, ANDHRA PRADESH, MANDAL, HYDERABAD, .....

SCHAFFHAUSERSTRASSE, STEIN, INDIA ANDHRA PRADESH, INDIA 1\)

SWITZERLAND M&l LABORATORY SERVICES, M&l LABORATORY SERVICES, NOV ARTIS PHARMAL YTICA SA, LIMBRO BUSINESS PARK, LIMBRO BUSINESS PARK, LOCARNO, SWITZERLAND SANOTON, RSA SANOTON, RSA SANDOZ SA, SPARTAN, KEMPTON KHULULEKANILABORATORY KHULULEKANILABORATORY PARK, RSA SERVICES, MIDRAND, RSA SERVICES, MIDRAND, RSA M&l LABORATORY SERVICES, UMBRO BUSINESS PARK, SANDTON, RSA

FPRR: NOV ARTIS SA, SPARTAN, FPRR: AUROB!NDO PHARMA, FPRR: AUROBINDO PHARMA, KEMPTON PARK, RSA MEYERSDAL,JOHANNESBURG, MEYERSDAL,

RSA JOHANNESBURG,RSA

z Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional} Shelf-life: 24 months (Provisional) ~

30 SEPTEMBER 2011 30 SEPTEMBER 2011 30 SEPTEMBER 2011 (j)

Date of registration: Date of registration: Date of registration: 01 ..... ~ (,\) (,\)

~

z MRF 15 MRF15 !:>

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Registration number: 43/7.1.3/1034 Registration number: 43/7.1.3/1039 Registration number: 43/7.1.3/1040 (.11 ..... 1\)

Name of medicine: AURO PERINDOPRIL 8mg Name of medicine: BINDACE2mg Name of medicine: BINDACE4mg Ol


EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS:

Active ingredients: PERINDOPRIL TERT-PERINDOPRIL TERT- PERINDOPRIL TERT- BUTYLAMINE 4,0mg BUTYLAMINE 8,0mg BUTYLAMINE 2,0mg

Conditions of registration: 1,2,3,4,5,6, 7,8 Conditions of registration: 1,2,3,4, 5,6, 7,8 Conditions of registration: 1,2,3,4, 5,6, 7,8

Applicant: AUROBINDO PHARMA (PTY) Applicant: AUROBINDO PHARMA (PTY) Applicant: AUROBINDO PHARMA LTD LTD (PTY) LTD G)

0 Manufacturer: AUROBINDO PHARMA LTD, Manufacturer: AUROBINDO PHARMA L TO, Manufacturer: AUROBINDO PHARMA LTD, <

UNIT Ill, QUTHUBULLAPUR UNIT Ill, QUTHUBULLAPUR UNIT Ill, QUTHUBULLAPUR m lJ

MANDAL, HYDERABAD, MANDAL, HYDERABAD, MANDAL, HYDERABAD, z ANDHRA PRADESH, INDIA ANDHRA PRADESH, INDIA ANDHRA PRADESH, INDIA ~

m Packer: AU ROB INDO PHARMA L TO, Packer: AUROBINDO PHARMA L TO, Packer: AUROBINDO PHARMA LTD, z

-1 UNIT Ill, QUTHUBULLAPUR UNIT Ill, QUTHUBULLAPUR UNIT Ill, QUTHUBULLAPUR G) MANDAL, HYDERABAD, MANDAL, HYDERABAD, MANDAL, HYDERABAD,

~ ANDHRA PRADESH, INDIA ANDHRA PRADESH, INDIA ANDHRA PRADESH, INDIA

Laboratory: FPRC: AUROBINDO PHARMA L TO, Laboratory: AUROBINDO PHARMA L TO, Laboratory: FPRC AUROBINDO PHARMA L TO, ~ UNIT Ill, FPRC: UNIT Ill, QUTHUBULLAPUR UNIT Ill, QUTHUBULLAPUR _m QUTHUBULLAPUR MANDAL, MANDAL, HYDERABAD, MANDAL, HYDERABAD, 1D HYDERABAD,ANDHRA ANDHRA PRADESH, INDIA ANDHRA PRADESH, INDIA ~ PRADESH, INDIA M&L LABORATORY M&L LABORATORY > M&L LABORATORY SERVICES, SERVICES, LIMBRO SERVICES, LIMBRO lJ

() LIMBRO BUSINESS PARK, BUSINESS PARK, SANDTON, BUSINESS PARK, J: SANDTON,RSA RSA SANDTON,RSA 1\)

KHULULEKANILABORATORY KHULULEKANILABORATORY KHULULEKANI 0 ..... SERVICES, MIDRAND, RSA SERVICES, MIDRAND, RSA LABORATORY SERVICES, 1\)

MIDRAND, RSA

FPRR: AUROBINDO PHARMA, FPRR: AUROBINDO PHARMA, FPRR: AUROBINDO PHARMA, MEYERSDAL, MEYERSDAL, MEYERSDAL, JOHANNESBURG,RSA JOHANNESBURG,RSA JOHANNESBURG,RSA



MRF 15 MRF15 MRF 15

Registration number: 4317.1.3/1041 Registration number: 43120.1.1/1084 Registration number: 43/11.4.3/1091

Name of medicine: BINDACE Bmg Name of medicine: DYNA CEFPODOXIME Name of medicine: ARROW RANITIDINE 150 SUSPENSION

Dosage form: TABLET Dosage form: POWDER FOR ORAL SUSPENSION Dosage form: TABLET

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH 5,0 ml CONTAINS: Active ingredients: EACH TABLET CONTAINS: PERINDOPRIL TERT-BUTYLAMINE Cefpodoxime Proxetil equivalent to RANITIDINE HCI EQUIVALENT

e,omg Cefpodoxime 40,0mg TO RANITIDINE 150,0 mg

Conditions of registration: 1,2,3,4,5,6, 7,B Conditions of registration: 1,2,3,4,5,6, 7,B Conditions of registration: 1, 2, 3, 4, 5, 6, 7, B

Applicant: AUROBINDO PHARMA (PTY)l TD Applicant: PHARMA DYNAMICS (PTY) l TO Applicant: ARROW PHARMA SOUTH AFRICA (PTY) lTD

Manufacturer: AUROBINDO PHARMA l TO, UNIT Ill, Manufacturer: LUPIN LIMITED, RAISEN, MADHYA Manufacturer: Rx MANUFACTURING INC, en QUTHUBULLAPUR MANDAL. PRADESH, INDIA MISSISSAUGA, ONTARIO,

~ HYDERABAD, ANDHRA PRADESH, CANADA INDIA ;;,;

Packer: AUROBINDO PHARMA l TO, UNIT Ill, Packer: LUPIN LIMITED, RAISEN, MADHYA Packer: Rx MANUFACTURING INC. en ;ll\

QUTHUBULLAPUR MANDAL, PRADESH, INDIA MISSISSAUGA, ONTARIO, 0 HYDERABAD, ANDHRA PRADESH, CANADA m INDIA TECHNIKON LABORATORIES ll

(PTY) l TO, ROBERTVILLE, )> z FLORIDA, RSA _-I

DIVPHARM MANUFACTURING AND PACKAGING, LONGDALE, <0

INDUSTRIA, JOHANNESBURG, s:: RSA )>

)>

Laboratory: FPRC: AUROBINDO PHARMA l TO, UNIT Ill, laboratory: CONSULTING CHEMICAL Laboratory: FPRC RX MANUFACTURING INC, ll -1

QUTHUBULLAPUR MANDAL, FPRC: LABORATORIES (PTY) lTD, MISSISSAUGA, ONTARIO, 1\) HYDERABAD, ANDHRA PRADESH, ATLASVILLE, BOKSBURG CANADA 0 INDIA TECHNIKON LABORATORIES .... M&LLABORATORY SERVICES, (PTY) l TO, ROBERTVILLE,

1\)

LIMBRO BUSINESS PARK, FLORIDA, RSA SANDTON,RSA SEDEK AGRICHEM, KHULULEKAN!LABORATORY KAMEELDRIFT-EAST, SERVICES, MIDRAND, RSA PRETORIA, RSA

FPRR: AUROBINDO PHARMA, FPRR: PHARMA DYNAMICS {PTY) l TO, FPRR: ARROW PHARMA SOUTH MEYERSDAL, JOHANNESBURG, WESTLAKE,CAPETOWN,RSA AFRICA (PTY) l TO RSA VVOODMEAD, RSA


Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 z ~ c.l (11 .... 1\) C1J

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Registration number. 43/11.4.311092 Registration number: 4313411133 Registration number: 44/20.2.8/!l332 U) 01 ....

Name of medicine: ARROW RANITIDINE 300 Name of medicine: AFINITOR 10 mg Name of medicine: ADCO TENOFOVIR 300 mg N CXl


Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients· EACH TABLET CONTAINS: RANITIDINE HCI EQUIVALENT TO EVEROLIMUS 10,0mg Tenofovir disoproxil fumarate equivalent RANITIDINE 300,0 mg to

Tenofollir disoproxil300.0 mg

Conditions of registration: 1, 2. a, 4, 5, 6, 7, a Conditions of registration: 1, 2. 3, 4, 5, 6, 1. a Conditions of registration: 1, 2. 3, 4, 5, 6, 7, a Applicant ARROW PHARMA SOUTH AFRICA (PTY) Applicant: NOV ARTIS SOUTH AFRICA (PTY) L TO Applicant: ADCOCK INGRAM LIMITED

LTD

Manufacturer. Rx MANUFACTURING INC, MISSISSAUGA, Manufacturer. NOV ARTIS PHARMA AG, BASEL. Manufacturer: HETERO DRUGS L TO, JEEDIMETLA, G) ONTARIO, CANADA SWITZERLAND HYDERABAD, INDIA 0 NOV ARTIS PHARMA STEIN AG. ADCOCK INGRAM HEAL THCARE < SCHAFFHAUSERSTRASSE, STEIN, (PTY) L TO, WADEVtLLE, m SWilZERLAND GERMISTON, RSA Jl

Packer: Rx MANUFACTURING INC, MISSISSAUGA, Packer: NOV ARTIS PHARMA AG, BASEL, Packer: HETERO DRUGS L TO, JEEDIMETLA, z ONTARIO, CANADA SWITZERLAND HYDERABAD, INDIA s:: TECHNIKON LABORATORIES (PTY) L TO, NOV ARTIS PHARMA STEIN AG, ADCOCK INGRAM HEAL THCARE m ROBERTVILLE, FLORIDA, RSA SCHAFFHAUSERSTRASSE, STEIN. (PTY) L TO, WADEVILLE, z DIVPHARM MANUFACTURING AND SWilZERLAND GERMISTON, RSA -1 PACKAGING, LONGDALE, INDUSTRIA, KONAPHARMAAG, PRATIELN, G) JOHANNESBURG,RSA SWITZERLAND )>

ORA PHARMACEUTICALS, ROUTE 21 N CORPORATE PARK. IRENE. ~ CENTURION. RSA SANDOZ SA, SPARTAN, KEMPTON .m PARK, RSA

co laboratory: FPRC: RX MANUFACTURING INC, laboratory: FPRC: NOV ARTIS PHARMA AG, BASEL, Laboratory: FPRC HETERO DRUGS L TO, JEEDIMETLA. s:: MISSISSAUGA, ONTARIO, CANADA SWilZERLAND HYDERABAD, INDIA

TECHNIKON LABORATORIES {PTY) L TO, NOV ARTIS PHARMA STEIN AG. )>

ROBERTVILlE, FLORIDA. RSA SCHAFFHAUSERSTRASSE, STEIN, Jl SEDEK AGRICHEM, KAMEELDRIFT-EAST, SWITZERLAND 0 PRETORIA, RSA NOV ARTIS PHARMAl YTICA SA, I

LOCARNO, SWITZERLAND N SANDOZ SA, SPARTAN. KEMPTON 0 .... PARK, RSA N M&L LABORATORY SERVICES, LIMBRO BUSINESS PARK, SANDTON, RSA

FPRR: ARROW PHARMA SOUTH AFRICA (PTY) FPRR: NOVARTIS SA, SPARTAN, KEMPTON FPRCIFPRR: ADCOCK INGRAM HEAL THCARE, l TO WOODMEAD. RSA PARK, RSA WADEVIlLE, GERMISTON

ADCOCK INGRAM L TO, RESAERCH AND DEVELOPMENT, AEROTON, JOHANNESBURG

Shelf-life: 24 months (Provisional) Shelf~ife: 24 months (Provisional) FPRR: ADCOCK INGRAM L TO, ERAND GARDENS. MIDRAND

Oete of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 Shelf-life: 24 months (Provisional)

Date of registration: 30 SEPTEMBER 2011

MRF 15


Name of medicine:

Dosage fomn:

Active ingredients:


Applicant:

Manufacturer:

Packer:

Laboratory: FPRC:

FPRC/FPRR:

FPRR:

Shelf-life:


44/20.2.8/0333

TAIDOF 300 mg

TABLET

EACH TABLET CONTAINS: Tenofovir disoproxll fumarate equivalent to Tenofovir disoproxil 300,0 mg

1,2,3,4,5,6, 7,8

ADCOCK INGRAM LIMITED

HETERO DRUGS LTD, JEEDIMETLA, HYDERABAD, INDIA ADCOCK INGRAM HEALTHCARE (PTY) LTD, WADEVILLE, GERMISTON, RSA

HETERO DRUGS LTD, JEEDIMETLA, HYDERABAD, INDIA ADCOCK INGRAM HEAL THCARE (PTY) L TO, WADEVILLE, GERMISTON. RSA

HETERO DRUGS L TO, JEEDIMETLA, HYDERABAD, INDIA

ADCOCK INGRAM HEAL THCARE, WADEVILLE, GERMISTON ADCOCK INGRAM L TO, RESAERCH AND DEVELOPMENT, AEROTON, JOHANNESBURG

ADCOCK INGRAM L TO, ERAND GARDENS, MIDRAND


30 SEPTEMBER 2011

MRF15


Name of medicine:

Dosage fomn:

Active ingredients:


Applicant:

Manufacturer:

Packer:

Laboratory: FPRC:

FPRC/FPRR:

FPRR:

Shelf-life:


44120.2.8/0334

TENOFOVIR PROPAN

TABLET

EACH TABLET CONTAINS: Tenofovir disoproxil fumarate equivalent to Tenofovir disoproxil 300,0 mg

1, 2, 3,4, 5, 6, 7, a

ADCOCK INGRAM LIMITED

HETERO DRUGS L TO, JEEDIMETLA, HYDERABAD, INDIA ADCOCK INGRAM HEAL THCARE (PTY) LTD, WADEVILLE, GERMISTON, RSA

HETERO DRUGS LTD, JEEDIMETLA, HYDERABAD, INDIA ADCOCK INGRAM HEAL THCARE (PTY) L TO, WADEVILLE, GERMISTON. RSA

HETERO DRUGS L TO, JEEDIMETLA, HYDERABAD, INDIA

ADCOCK INGRAM HEALTHCARE, WADEVILLE, GERMISTON ADCOCK INGRAM LTD, RESAERCH AND DEVELOPMENT. AEROTON.JOHANNESBURG

ADCOCK INGRAM LTD, ERAND GARDENS, MIDRAND


30 SEPTEMBER 2011


Name of medicine:

Dosage form:

Active ingredients:


Applicant:

Manufacturer:

Packer:

Laboratory: FPRC

FPRR:

Shelf-life:


44/20. 1.1/0538

DEZZO CIPROFLOXACIN 250

TABLET

EACH TABLET CONTAINS: CIPROFLOXACIN HCI EQUIVALENT TO CIPROFLOXACIN 250,0 mg

1' 2, 3, 4, 5, 6, 7

DEZZO TRADING 392 (PTY) LTD, T/A INDO PHARMA

INDOCO REMEDIES LIMITED, L-14 VERNA GOA, INDIA

INDOCO REMEDIES LIMITED, L-14 VERNA GOA, INDIA

INDOCO REMEDIES LIMITED, L-14 VERNA GOA, INDIA CONSULTING CHEMICAL LABORATORIES (PTY) LTD, ATLASVILLE, BOKSBURG, RSA

DEZZO TRADING 392 (PTY) LTD, TIA INDO PHARMA, LENASIA, GAUTENG, RSA

24 months

30 SEPTEMBER 2011

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Registration number: 44/20.1.1/0539 Registration number: 44/20.1.1/0540 Registration number: 44/20.1.1/0541

Name of medicine: DEZZO CIPROFLOXACIN 500 Name of medicine: DEZZO CIPROFLOXAC!N 750 Name of medicine: PROFLOXIN 250


Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: CIPROFLOXACIN HCI CIPROFLOXACIN HCI CIPROFLOXACIN HCI EQUIVALENT TO EQUIVALENT TO EQUIVALENT TO CIPROFLOXACIN 500,0 mg CIPROFLOXACIN 750,0 mg CIPROFLOXACIN 250,0 mg G)

Conditions of registration: 1, 2,3,4, 5,6, 7 Conditions of registration: 1,2,3,4,5,6, 7 Conditions of registration: 1,2,3,4,5,6, 7 0 < m

Applicant: DEZZO TRADING 392 (PTY) Applicant: DEZZO TRADING 392 (PTY) Applicant: DEZZO TRADING 392 (PTY) JJ LTD, T/A INDO PHARMA LTD, T/A INDO PHARMA LTD, T/A INDO PHARMA z

s:: Manufacturer: INDOCO REMEDIES LIMITED, Manufacturer: INDOCO REMEDIES LIMITED, Manufacturer: INDOCO REMEDIES m z

L-14 VERNA GOA, INDIA L-14 VERNA GOA, INDIA LIMITED, L-14 VERNA GOA, -1 INDIA G)

Packer: INDOCO REMEDIES LIMITED, Packer: INDOCO REMEDIES LIMITED, Packer: INDOCO REMEDIES i!:i m L-14 VERNA GOA, INDIA L-14 VERNA GOA, INDIA LIMITED, L-14 VERNA GOA, ~ INDIA m Laboratory: FPRC: INDOCO REMEDIES LIMITED, Laboratory: INDOCO REMEDIES LIMITED, Laboratory: FPRC INDOCO REMEDIES lO

L-14 VERNA GOA, INDIA FPRC: L-14 VERNA GOA, INDIA LIMITED, L-14 VERNA GOA, s:: CONSUL T!NG CHEMICAL CONSULTING CHEMICAL INDIA )>

LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD, CONSULTING CHEMICAL JJ (")

ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, LABORATORIES (PTY) LTD, :r RSA ATLASVILLE, BOKSBURG, 1\)

RSA 0 .... 1\)

FPRR: DEZZO TRADING 392 (PTY) FPRR: DEZZO TRADING 392 (PTY) FPRR: DEZZO TRADING 392 (PTY) LTD, T/A INDO PHARMA, LTD, T/A INDO PHARMA, LTD, T/A INDO PHARMA, LENASIA, GAUTENG, RSA LENASIA, GAUTENG, RSA LENASIA, GAUTENG, RSA



•

MRF15 MRF15 MRF 15

Registration number: 44/20.1.110542 Registration number: 44120. 1.1/0543 Registration number: 44/1 .210594

Name of medicine: PROFLOXIN 500 Name of medicine: PROFLOXIN 750 Name of medicine: RITALIN LA 10

Dosage form: TABLET Dosage form: TABLET Dosage form: CAPSULES

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH CAPSULE CONTAINS: CIPROFLOXACIN HCI EQUIVALENT CIPROFLOXACIN HCI EQUIVALENT METHYLPHENIDATE HCI10,0 TO CIPROFLOXACIN 500,0 mg TO CIPROFLOXACIN 750,0 mg mg

Conditions of registration: 1' 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1' 2, 3, 4, 5, 6, 7

Applicant DEZZOTRADING 392 (PTY) LTD, Applicant: DEZZO TRADING 392 (PTY) L TO, Applicant: NOV ARTIS SOUTH AFRICA TIA INDO PHARMA TIA INDO PHARMA (PTY) LTD

Manufacturer: INDOCO REMEDIES LIMITED, L-14 Manufacturer: INDOCO REMEDIES LIMITED, L-14 Manufacturer: ELAN HOLDINGS, INC., VERNA GOA, INDIA VERNA GOA, INDIA GAINESVILLE, GEORGIA, USA

Packer: INDOCO REMEDIES LIMITED, L-14 Packer: INDOCO REMEDIES LIMITED, l-14 Packer: ELAN HOLDINGS, INC., VERNA GOA, INDIA VERNA GOA, INDIA GAINESVILLE, GEORGIA, USA en

NOVARTIS PHARMACEUTICAL ~ CORPORATION, SUFFERN, NEW YORK, USA ~ CAT ALENT PHARMA en SOLUTIONS, RED LION ROAD, 6 PHILADELPHIA, USA m ORA PHARMACEUTICALS, ::D IRENE, RSA > SANDOZ SA (PTY) LTD, z SPARTAN, KEMPTON PARK, .-1 RSA <0 DIVPHARM MANUFACTURING s:: AND PACKAGING (PTY) LTD, ~ INDUSTRIA, RSA

~ laboratory: FPRC: INDOCO REMEDIES LIMITED, l-14 Laboratory: INDOCO REMEDIES LIMITED, l-14 Laboratory: FPRC ELAN HOLDINGS, INC., 1\)

VERNA GOA, INDIA FPRC: VERNA GOA, INDIA GAINESVIllE, GEORGIA, USA 0 CONSULTING CHEMICAL CONSULTING CHEMICAL NOVARTIS PHARMACEUTICAL .... LABORATORIES (PTY) LTD, LABORATORIES (PTY) LTD, CORPORATION, SUFFERN, 1\)

ATLASVILLE, BOKSBURG, RSA ATLASV!LLE, BOKSBURG, RSA NEW YORK, USA M & L LABORATORY SERVICES (PTY) L TO, LIMBRO BUSINESS PARK,SANDTON,RSA SANDOZ SA (PTY) lTD, SPARTAN, KEMPTON PARK, RSA

FPRR: DEZZO TRADING 392 (PTY) l TO, FPRR: DEZZO TRADING 392 (PTY) LTD, FPRR: NOVARTIS SOUTH AFRICA TIA INDO PHARMA, LENASIA, TIA INDO PHARMA, LENASIA, (PTY) LTD, SPARTAN, RSA GAUTENG,RSA GAUTENG,RSA

Shelf-life: 24 months Shelf-life: 24 months Shelf-life: 24 months z !=>

Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011 (I) (11 .... 1\) CD

w 10

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z MRF 15 MRF15 !'

Registration number: 44/20.2.8/0881 Registration number: 44/20.2.8/0882 (,) 01 ...

Name of medicine: CAVEERAH 100/25 Name of medicine: CAVEERAH 200/50 1\) co

Dosage form: TABLET Dosage form: TABLET

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: LOPINAVIR 100,0 mg LOPINAVIR 200,0 mg RITONAVIR 25,0 mg RITONAVIR 50,0 mg

Conditions of registration: 1,2,3,4,5, 6, 7 Conditions of registration: 1,2,3,4, 5,6, 7

Applicant: PHARMACARE LIMITED Applicant: PHARMACARE LIMITED

Manufacturer: MATRIX LABORATORIES LTD, Manufacturer: MATRIX LABORATORIES LTD, Ci) 0

SINNAR, NASHIK SINNAR, NASHIK < MAHARASHTRA, INDIA MAHARASHTRA, INDIA m ASPEN PORT ELIZABETH, ASPEN PORT ELIZABETH, ll z KORSTEN, PORT ELIZABETH KORSTEN, PORT ELIZABETH ~

m Packer: MATRIX LABORATORIES L TO, Packer: MATRIX LABORATORIES LTD, z

SINNAR, NASHIK SINNAR, NASHIK -1

MAHARASHTRA, INDIA MAHARASHTRA, INDIA Ci) )>

ASPEN PORT ELIZABETH, ASPEN PORT ELIZABETH, N KORSTEN, PORT ELIZABETH KORSTEN, PORT ELIZABETH m

~ Laboratory: FPRC: MATRIX LABORATORIES LTD, Laboratory: MATRIX LABORATORIES LTD, m

SINNAR, NASHIK FPRC: SINNAR, NASHIK co MAHARASHTRA, INDIA MAHARASHTRA, INDIA

~ M&L LABORATORY SERVICES, M&L LABORATORY )> LIMBRO BUSINESS PARK, SERVICES, LIMBRO ll SANDTON BUSINESS PARK, SANDTON ()

RESEARCH INSTITUTE FOR RESEARCH INSTITUTE FOR I 1\)

INDUSTRIAL PHARMACY, INDUSTRIAL PHARMACY, 0

NORTH-WEST UNIVERSITY, NORTH-WEST UNIVERSITY, ... 1\)

POTCHEFSTROOM POTCHEFSTROOM SABS PHARMACEUTICAL SABS PHARMACEUTICAL CHEMISTRY LABORATORY, CHEMISTRY LABORATORY, GROENKLOOF, PRETORIA GROENKLOOF, PRETORIA

FPRC/FPRR: ASPEN PORT ELIZABETH, FPRC/FPRR: ASPEN PORT ELIZABETH, KORSTEN, PORT ELIZABETH KORSTEN, PORT ELIZABETH

FPRR: PHARMACARE L TO, FPRR: PHARMACARE L TO, WOODMEAD, SANDTON WOODMEAD, SANDTON

Shelf-life: 24 months Shelf-life: 24 months

Date of registration: 30 SEPTEMBER 2011 Date of registration: 30 SEPTEMBER 2011

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