UK Public Assessment Report - Medicines and … is a summary of the Public Assessment Report (PAR)...

UK Public Assessment Report

Compound Macrogol Powder for oral solution

PL 17740/0015 PL 17740/0016

Hermes Arzneimittel GmbH

UKPAR Compound Macrogol Powder for oral solution PL 17740/0015 & 0016

2

Lay Summary Compound Macrogol Powder for oral solution

(macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride)

This is a summary of the Public Assessment Report (PAR) for Compound Macrogol Powder for oral solution (PL 17740/0015 & 0016). It explains how Compound Macrogol Powder was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use this product. This PAR reflects two identical product licences that share the same product name. Throughout this report ‘Compound Macrogol Powder for oral solution’ will be referred to as ‘Compound Macrogol Powder’ for ease of reading. For practical information about using Compound Macrogol Powder, patients should read the Patient Information Leaflet (PIL) or contact their doctor or pharmacist. What is Compound Macrogol Powder and what is it used for? This medicine is the same as Macroherm powder for oral solution, sachet (PL 17740/0008), which is already authorised. Hermes Arzneimittel GmbH has used the scientific data presented for Macroherm powder for oral solution, sachet (PL 17740/0008) as a basis for the grant of two identical licences for Compound Macrogol Powder (informed consent). Compound Macrogol Powder is a laxative used for the treatment of long-term constipation. How does Compound Macrogol Powder work? Compound Macrogol Powder contains the active substances macrogol 3350, sodium chloride, sodium hydrogen carbonate and potassium chloride. Macrogol makes the faeces softer and easier to pass, giving the patient relief from constipation. The electrolytes (salts) help to maintain the body’s normal levels of sodium, potassium and water while being treated for constipation. How is Compound Macrogol Powder used? The solution of Compound Macrogol Powder is taken by mouth. A single sachet should be opened and the contents poured into a glass. About 125 ml or a quarter pint of water should then be added to the glass. The solution should be stirred well until the powder is dissolved before the solution is swallowed. The recommended dose for constipation in adults, children (aged 12 years and above), and the elderly is one sachet taken one to three times daily. This product is not recommended for children below 12 years of age. For further information on how Compound Macrogol Powder is used, please see the Summary of Product Characteristics available on the MHRA website. Compound Macrogol Powder can be obtained without a prescription.


3

What benefits of Compound Macrogol Powder have been shown in studies? Compound Macrogol Powder is considered identical to the previously granted marketing authorisation for Macroherm powder for oral solution, sachet (PL 17740/0008), with the same benefits and risks. No new studies have been provided for Compound Macrogol Powder but reference is made to the studies for Macroherm powder for oral solution, sachet. What are the possible side effects from Compound Macrogol Powder? Like all medicines, this medicine can cause side effects, although not everybody gets them. For information about side effects that may occur with using Compound Macrogol Powder, please refer to the PIL or the Summary of Product Characteristics (SmPC) available on the Medicines and Healthcare products Regulatory Agency (MHRA) website. Why is Compound Macrogol Powder approved? No new or unexpected safety concerns arose from these applications. It was, therefore, considered that the benefits of Compound Macrogol Powder outweigh the risks, and the grant of these marketing authorisations was recommended. What measures are being taken to ensure the safe and effective use of Compound Macrogol Powder? A risk management plan has been developed to ensure that Compound Macrogol Powder is used as safely as possible. Based on this plan, safety information has been included in the Summary of Product Characteristics and the PIL for this product, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore, new safety signals reported by patients and healthcare professionals will be monitored and reviewed continuously as well. Other information about Compound Macrogol Powder The marketing authorisations were granted in the UK on 28 November 2014. For more information about taking Compound Macrogol Powder, read the PIL, or contact your doctor or pharmacist. This summary was last updated in January 2015. The full PAR for Compound Macrogol Powder follows this summary.


4

Table of Contents

I Introduction Page 5 II Quality aspects Page 6 III Non-clinical aspects Page 7 IV Clinical aspects Page 7 V User consultation Page 9 VI Overall conclusion, benefit/risk assessment and

recommendation Page 9

Table of content of the PAR update for MRP and DCP

Page 20


5

I Introduction The Medicines and Healthcare products Regulatory Agency (MHRA) granted Hermes Arzneimittel GmbH marketing authorisations for the medicinal product Compound Macrogol Powder for oral solution (PL 17740/0015 & 0016) on 28 November 2014. This pharmacy (P) medicine is used for the treatment of chronic constipation. This PAR reflects two identical product licences that share the same product name. This product will be referred to as Compound Macrogol Powder throughout this report. These applications were submitted as two identical abridged simple applications for one product, according to Article 10c of Directive 2001/83/EC, as amended. The applicant has cross-referred to Macroherm powder for oral solution, sachet (PL 17740/0008), which was authorised to Hermes Arzneimittel GmbH on 12 October 2010. This medicinal product contains the active substances macrogol 3350, sodium chloride, sodium hydrogen carbonate and potassium chloride. Macrogol 3350 induces a laxative effect through its osmotic action in the gut. It increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the softened stools and a facilitation of the defaecation. Electrolytes combined with macrogol 3350 are exchanged across the intestinal barrier (mucosa) with serum electrolytes, and excreted in faecal water without net gain or loss of sodium, potassium and water. No new data were submitted nor were they necessary for these simple applications, as the data are identical to those of the previously granted cross-reference product. The MHRA has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place for this product type at all sites responsible for the manufacture and assembly of this product. A Risk Management Plan (RMP) and summary of the pharmacovigilance system have been provided with these applications, and are satisfactory.


6

II Quality aspects II.1 Introduction These are two informed consent applications for Compound Macrogol Powder, submitted under Article 10c of Directive 2001/83/EC, as amended. The applicant has cross-referred to Macroherm powder for oral solution, sachet (PL 17740/0008). The current applications are considered valid. This product is presented as a powder for oral solution and contains 13.125 g of macrogol 3350, 0.3507 g of sodium chloride, 0.1785 g of sodium hydrogen carbonate and 0.0466 g of potassium chloride. The excipients in the product are: colloidal anhydrous silica, saccharin sodium, orange flavour (containing flavouring substances and flavouring preparations, maltodextrin, acacia gum and alpha-tocopherol) and lemon/lime flavour (containing flavouring preparations, maltodextrin, mannitol, gluconolactone, sorbitol (E420), acacia gum and colloidal anhydrous silica)

The powder is packed in a sachet, which is composed of paper, ethylene/methacrylic acid co-polymer and aluminium. This is packed in cartons of 2, 6, 8, 10, 20, 30, 50, 60 (2x30) and 100 (2x50) sachets. The packaging and pack sizes are identical to that of the cross-reference product. II.2 Drug Substance The proposed drug substance specifications conform to the current European Pharmacopoeia monograph for macrogol 3350, sodium chloride, sodium hydrogen carbonate, and potassium chloride, and are in line with those for the cross-reference product. European Directorate for the Quality of Medicines and Healthcare (EDQM) Certificates of Suitability for the manufacture of macrogol 3350, sodium chloride, sodium hydrogen carbonate, and potassium chloride, have been provided. The active substance manufacturers are the same as those for the cross-reference product. II.3 Medicinal Product Pharmaceutical development The proposed qualitative and quantitative composition is consistent with the details registered for the cross-reference product. The applicant has referred to the data for the cross-reference product, Macroherm powder for oral solution, sachet (PL 17740/0008), to which it claims to be identical. This is acceptable. Manufacture of the product The proposed manufacturing sites are consistent with those registered for the cross-reference product. Evidence of Good Manufacturing Practice (GMP) compliance has been provided, which is identical to that of the reference product.


7

The proposed manufacturing processes are identical to those of the reference product and are acceptable. The maximum full-scale batch sizes are stated. No materials of animal or human origin are included in this product. This is consistent with the cross-reference product. Finished Product Specification The proposed finished product specifications, at release and shelf-life, are in line with the details registered for the cross-reference product. Stability of the product The proposed shelf-life for the product is 36 months for an unopened sachet and 24 hours for the reconstituted solution, with storage conditions “Do not store above 25°C” for unopened sachet and “Store covered in a refrigerator (2°C to 8°C)” for the reconstituted solution. The shelf-life and storage conditions are identical to those for the cross-reference product and are satisfactory.

II.4 Discussion on chemical, pharmaceutical and biological aspects The quality data for these applications are consistent with those previously assessed for the marketing authorisation for Macroherm powder for oral solution, sachet (PL 17740/0008) and, as such, have been judged to be satisfactory. The grant of marketing authorisations is recommended for these applications. III Non-clinical aspects As these are abridged applications submitted under Article 10c of Directive 2001/83/EC, as amended, no new non-clinical data has been supplied and none are required. The grant of marketing authorisations is recommended for these applications. IV Clinical aspects As these are abridged applications submitted under Article 10c of Directive 2001/83/EC, as amended, no new clinical data have been supplied and none are required. Risk Management Plan (RMP) The applicant has submitted an RMP, in accordance with the requirements of Directive 2001/83/EC as amended, describing the pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to Compound Macrogol Powder. A summary of safety concerns and planned risk minimisation measures, as approved in the RMP, are listed below:


8

Summary table of safety concerns

Summary table of risk minimisation measures


9

V User consultation A user consultation with target patient groups on the PIL has been performed on the basis of a bridging report that makes reference to Compound Macrogol Oral Powder (MA Holder: Hermes Arzneimittel GmbH). The bridging report submitted by the applicant has been found acceptable. VI Overall conclusion, benefit/risk assessment and recommendation The quality of the product is acceptable and no new non-clinical or clinical concerns have been identified. The applicant’s product is identical to the cross-reference product. Extensive clinical experience with macrogol 3350, sodium chloride, sodium hydrogen carbonate and potassium chloride are considered to have demonstrated the therapeutic value of the compounds. The benefit/risk is, therefore, considered to be positive. The Summary of Product Characteristic (SmPC), Patient Information Leaflet (PIL) and labelling are satisfactory, in line with current guidelines and consistent with the cross-reference product. In accordance with Directive 2012/84/EU, the current approved UK versions of the SmPC and PIL for this product is available on the MHRA website. The currently approved labels are listed below:


10

Labelling text for PL 17740/0015


11


12


13


14


15

Labelling text for PL 17740/0016


16


17


18


19


20

Table of content of the PAR update for MRP and DCP

Steps taken after the initial procedure with an influence on the Public Assessment Report (Type II variations, PSURs, commitments)

Scope Procedure

number Product information affected

Date of start of the procedure

Date of end of procedure

Approval/ non approval

Assessment report attached Y/N (version)

UK Public Assessment Report - Medicines and … is a summary of the Public Assessment Report (PAR)...

Documents

Transcript of UK Public Assessment Report - Medicines and … is a summary of the Public Assessment Report (PAR)...