Active substance name (INN) EU DLP BfArM / BAH DLP yearly ...
Transcript of Active substance name (INN) EU DLP BfArM / BAH DLP yearly ...
Active substance name (INN) EU DLP BfArM / BAH DLP yearly PSUR 6-month-PSUR yearly PSUR bis DLP (List of Union
Reference Dates and
Frequency of
submission of Periodic
Safety Update Reports,
30 Nov. 2012)
PSUR Submission
Frequency (List of Union
Reference Dates and
Frequency of submission of
Periodic Safety Update
Reports, 30 Nov. 2012)
(iso)spagmulate 201405
[18 F] fludeoxyglucose (injection) 201411123
I-hippuran (Iodohippurate sodium I 123) 201601123
I-MIBG 201601125
I-human serum albumin (albumin, iodinated I 125 serum) 201511131
I-6-Iodo-Norcholesterol 201506131
I-MIBG 201505
17-alpha-oestradiol (topical) 201502
2-hydroxyethyl salicylat + benzyl nicotinate (benzonicotinate) 20150499
Mo/99
Tc (Tc Generator) 201505
5-aminolevulinic acid (glioma) 201503 3 years
abacavir 201312 3 years
abacavir, lamivudine 201312 3 years
abacavir, lamivudine, zidovudine 201312 3 years
abciximab 201511
acamprosate 201407
acarbose 201503 201503 3 years
acebutolol 201512 201410
acebutolol + mefruside 201503
acebutolol + nifedipine 201504
aceclidine 201304
aceclofenac 201403 201403 3 years
acediasulfone 201508
acedobene + dimepranol + inosine 201508
acemetacin 201410 201410
acenocoumarol 201407
acetazolamide 201307 202801 16 years
acetylcholine 201406
acetylcysteine 201509 201510 201509 3 years
acetylcysteine + tuaminoheptane 201509
acetyldigoxin 201310 201410
acetyldigoxin combinations 201310
acetylsalicylic acid 201302 201302
acetylsalicylic acid + clopidogrel 201312 3 years
acetylsalicylic acid + oxycodone hydrochloride 202501 13 years
acetylsalicylic acid combinations 201302 201302
acexamic Acid 201404
aciclovir 201506 201309
acipimox 201512
acitretin 201510 201310 1 year
acriflavinium chloride (acriflavine hydrochloride) + menthol + resorcinol 201411
acrivastine 201512
acrivastine + pseudoephedrine 201512
adapalene (topical) 201307
adapalene + benzoyl peroxide 201309
ademetionine (S-adenosylmethionine) 201304
adenosine 201508
adrafinil 201501
adrenaline (ephinephrine) 201305
aescin + diethylamine salicylate (diethylammonium salicylate) 201504
ajmaline 201308
albendazole 201307
alclometasone 201510
aldesleukin 201412
alendronate + colecalciferol (Vitamin D) 201401 201601 5 years
alendronate sodium 201401 201601 5 years
alfacalcidol 201502
alfentanil 201509
alfoscerate olamine 201306
alfuzosin 201511
algeldrate 201601 201405 201309 1 year
alibendole 201310
alimemazine (trimeprazine) 201512
a-Liponsäure, Lipoic acid, Tioctic Acid (oral, parenteral) 201303
aliskiren 201309 1 year
aliskiren, amlodipine 201308 1 year
aliskiren, amlodipine, hydrochlorothiazide 201306 6 months
aliskiren, hydrochlorothiazide 201401 1 year
alitretinoin 201601 3 years
alizapride 201401
allantoin 201311 201311
allantoin + combinations 201311
allopurinol 201512 201501
allopurinol + benzbromarone 201512 201501
almagate 201505
almitrine 201304
almotriptan 201406
alpha amylase 201306
alpha amylase + bacitracine 201306
alpha chymotrypsin 201507
alpha dihydroergocryptine 201407
alprazolam 201303 201601 201603 3 years
alprostadil (erectile dysfunction) 201401 201601 5 years
alprostadil (peripheral arterial occlusive diseases) 201507 201707 5 years
alteplase 201505
althiazide 201511
althiazide + spironolactone 201511
altretamine 201401
aluminium +/or calcium +/or magnesium antacids 201601
aluminium acetotartrate + methylcitrine 201503
aluminium chloride 201409
alverine 201302
alverine + simethicone 201302
amantadine 201512 201409
ambazone 201508
ambenonium 201412
ambroxol 201409 201505
ambroxol + clenbuterol 201309
ambroxol + doxycycline 201409 201505
amcinonide + neomycin 201412
amidotrizoate 201311 201311
amikacin 201506 201706 5 years
amilomer 201412
amiloride 201404 201506
amiloride + chlorthalidone 201404
amiloride + HCT + methyldopa 201404
amiloride + HCT + timolol 201404
amiloride + hydrochlorothoaizide (HCT) 201404 201506
aminoglutethimide 201410
aminohippurate 201302
aminophylline 201312
amiodarone 201412 201308
amisulpride 201501 201511 201501 5 years
amitriptyline 201501 201507 201501 3 years
amitriptyline + amitriptylinoxide 201307
amitriptyline + perphenazine 201307 201501 3 years
amitriptylinoxide 201307
amlodipine 201403 201504
amlodipine + atorvastatin 201601 201601 3 years
amlodipine + benazepril 201503
ammonia solutions 201504
ammonium chloride combinations 201511
amorolfine (topical) 201506
amoxapine 201505
amoxicillin 201503 201309 201703 5 years
amoxicillin + clavulanate 201503 201309 201703 5 years
amoxicillin + metronidazole 201503
amphetamine 201601
amphetamine + dextroamphetamine 201601
amphotericin B 201503 202703 15 years
amphotericin B + tetracycline 201503
ampicillin 201303 201306 202503 13 years
ampicillin + cloxacillin 201303
ampicillin + flucloxacillin 202001 8 years
ampicillin + sulbactam 201502 201306
amrinone 201501
amsacrine 201404
amyl nitrite 201412
amyleine (amylocaine) + chlorhexidine 201308
amylmetacresol + dichlorobenzyl alcohol 201407
amylmetacresol + dichlorobenzyl alcohol + levomenthol 201407
amylmetacresol + dichlorobenzyl alcohol + lidocaine 201407
amylsalicylate + methylnicotinate + levomenthol 201305
anagrelide 201511 201309 1 years
anastrozole 201508
androstanolone 201412
anidulafungin 201401 1 year
antazoline 201410
antazoline + naphazoline 201410
antazoline + tetryzoline (tetrahydrozoline) 201410
antazoline + xylometazoline 201410
antilymphocyte immunoglobulins 201511
apraclonidine 201405
aripiprazole 201307 1 year
aquatain 201408
artemether + lumefantrine 201510
articaine 201504
articaine + adrenaline 201504
astemizole 201407 201407
atenolol 201302 201508
atenolol + chlorthalidone 201409 201508
atenolol + indapamide 201302
atenolol + nifedipine 201310 201508
atorvastatin (6-monthly PSUR cycles for the paediatric indication only) 201304 x
atovaquone 201411
atovaquone + proguanil 201510
atracurium 201512 201512 3 years
atropine 201408
atropine + diphenoxylate 201309
attapulgite 201311
attapulgite + aluminium hydroxide and magnesium carbonate co-dried gel 201402
auranofin 201511
aureomycin (chlortetracycline) 201303
aurothiomalate 201307
azathioprine 201412 201305 201812 6 years
azelaic acid 201501
azithromycin 201404 201503
aztreonam 201508
azulenolum 201511
bacampicillin 201502
bacillus Cereus 201312
bacillus clausii multi-antibioresistant spores 201311
bacitracin 201412
bacitracin + chlorhexidine 201412
bacitracin + colistimethate sodium + hydrocortisone acetate 201412
bacitracin + neomycin 201412
bacitracin + neomycin + prednisolone 201412
baclofen (intrathecal) 201312 201512 5 years
baclofen (oral) 201409 201307
bacterial Lysate 201401
bambuterol 201512
bamifyline 201401
bamipine 201410 201410
barbexaclone 201310 202510 13 years
barium sulphate + combinations 201304 201311
barnidipine 201406
beclomethasone 201412 201410
belladonna alkaloids, ergotamine, phenobarbital 201401
belladonna extract + hyoscyamine + papaverine 201312
bemetezide + triamterene 201506
bemiparin 201304
benazepril 201311 201506
benazepril + HCT 201305 201506
bendazac 201510
bendrofluazide (bendroflumethiazide) 201305
bendroflumethiazide + propanolol + hydralazine 201503
bendroflumethiazide + spironolactone 201511 201411
benfluorex 201508
benorilate 201403
benserazide + levodopa 201506 201601
benzalkonium chloride (incl ocular) 201410
benzalkonium chloride + benzyl alcohol + chlorhexedine 201410
benzalkonium chloride + cetrimide 201410
benzalkonium chloride + chloroxylenol + disodium edetate 201410
benzalkonium chloride + dequalinium chloride 201410
benzalkonium chloride + dimethicone 201410
benzalkonium chloride + dimethicone + hydrocortisone + nystatin 201508
benzalkonium chloride + hexylresorcinol 201410
benzalkonium chloride + lidocaine 201503
benzalkonium chloride + oxymetazoline 201308
benzalkonium chloride + tolnaftate 201410
benzatropine (benztrophine) 201303
benzbromarone 201410 201501
benzethonium chloride 201305
benzocaine 201507
benzocaine + cetylpyridinium chloride 201507
benzocaine + chlorhexidine 201507
benzocaine + chloroxylenol 201507
benzocaine + dequalinium hydrochloride 201507
benzocaine + triclosan 201507
benzocaine + tyrothricin 201406
benzododecinium bromide 201306
benzoxonium chloride 201410
benzoyl peroxide 201404 201404
benztropine mesylate 201512
benzydamine 201510
benzydamine + benzalkonium 201510
benzydamine +cetylpyridinium 201510
benzylbenzoate 201302
benzylnicotinate 201504 201504
benzylnicotinate + hydroxyethyl salicylate 201504
benzylnicotine + campher (camphora) + dimethyl sulphate + turpentine oil 201303
benzylpenicillin 201406 202001 8 years
benzylpenicillin combinations 201408
beractant (beta cardone) 201310
beta-carotene 201304 201304
betahistine 201412 201412
betaine citrate 201507
betamethasone 201509 201505
betamethasone combinations 201509
betamethyldigoxin 201310
betaxolol 201505
bezafibrate 201507 201505
bicalutamide 201402 201402 3 years
biclotymol 201506
bifonazole 201512 201309
bile acids and salts 201308
biotin 201411
biperiden 201308 201309
bisacodyl 201304
bisacodyl combinations 201304
bismuth salts and combinations 201506
bisoprolol 201309 201509
bisoprolol + HCT 201511 201509
bisulepin 201309
bleomycin 201403 201302
bopindolol 201511
borax/boric acid (opthalmic bath) 201308
bosentan 201311 1 year
botulinum toxin A - haemagglutinin complex (yearly PSURs) 201512 bis 201212 201512 3 years
botulinum toxin A (yearly PSURs) 201312 x 201512 3 years
bretylium 201504
brimonidine 201409 201412
brimonidine + timolol 201409
brivudine 201406
bromazepam 201409 201412 201408 3 years
bromelains 201312 201312
bromhexine 201401 201510
bromhexine + eucalyptin etheroeum + ainisi aetheroleum + foeniculi etheroleum + levomentholum + menthae piperitae eleum + origani etheroleum201401
bromocryptine 201510 201304
bromperidol 201511
brompheniramine 201408
brotizolam 201312
buclizine 201406
budesonide 201304 201508
budesonide + formoterol 201308
bufexamac 201507 201412
bufexamac + lidocaine 201412 201412
buflomedil 201405 201601
buformin 201310
bumetanide 201510
bupivacaine 201404
bupivacaine + adrenaline 201404
buprenorphine 201407 201407 3 years
bupropion 201312 bis 201012
buserelin 201408
buspirone 201304 201308
busulphan 201501
butamirate 201311
butamirate + guaifenesin 201505
butenafine 201505
butoconazole 201402
butorphanol 201408
butylscopolaminium 201308
cabergoline 201503 201503 3 years
cafedrine 201311
caffeine 201302 201302
caffeine + diphenhydramine 201503
caffeine + ergotamine 201511 201511 3 years
caffeine + isometheptene + metamizole 201504
caffeine + phenazone 201409
calcipotriol 201401
calcitonin/calcitonin salmon 201506 201505
calcitriol 201501 201307
calcium (oral, parenteral) 201307
calcium carbonate + famotidine + magnesium hydroxide 201409 3 years
calcium + dexamethasone + lidocaine 201503
calcium + lidocaine 201503
calcium +/or aluminium +/or magnesium antacids 201601
calcium levofolinate 201303
calcium salts not used in antacids or vitamin preparations 201307
calcium trinatrium pentetate + indium (111in) 202001 8 years
calcium/cholecalciferol 201307
camphor 201505
camphor + combinations 201505
candesartan 201504
candesartan + HCT 201504
cannabidiol 202501 13 years
canrenoate 201409 201406
capreomycin 201401
capsaicin 201409 201705 5 years
captopril 201304 201506
captopril + HCT 201304 201506
carbachol 201601
carbaethopendecinium 201403
carbamazepine 201512 201412 202412 12 years
carbamoylphenoxyacetic acid + theophylline 202501 13 years
carbasalate calcium 201307
carbasalate calcium+ metoclopramide 201307
cabazitaxel
carbazochrome 201503
carbenicillin 201408
cabergoline 201503 3 years
carbetocin 201506 201306 1 year
carbidopa monohydrate 201310 1 year
carbidopa + levodopa 201510 201601 201310 1 year
carbidopa + entacapone + levodopa 201310 1 year
carbimazole 201506 201506
carbocisteine 201509
carbocisteine + prenoxdiazine 201509 201406
carbolevure 201302
carbomer (artificial tears) 201401
carboplatin 201601 201310 201601 3 years
carboprost 201401
carboxymethylcellulose (eye preparation) 201507
carbutamide 201304
carglumic acid 201501 5 years
carisoprodol 201405
carmustine 201504
carnitine 201506
carteolol 201403
carvedilol 201510 201501
caspofungin 201312 2 years
catalase + neomycin 201412
CE (conjugated estrogens) + MPA (Medroxyprogesterone acetate) 201508
cefaclor 201408 201411
cefadroxil 201507 201501
cefalexin (oral) 201510
cefalotin sodium 201501
cefamandole 201508
cefatrizine 201308
cefazolin 201411 201304
cefdinir 201510
cefepime 201506 201506 3 years
cefixime 201506
cefodizime 201503
cefonicid 201406
cefoperazone 201401
cefoperazone-sulbactam (sulperazone) 201401
ceforanide 201506
cefotaxime 201512 201310
cefotiam 201410 201509
cefoxitin 201303
cefpiramide 201407
cefpirome 201509
cefpodoxime 201508
cefprozil 201512
cefsulodin 201410
ceftazidime 201510 201302
ceftibuten 201507
ceftizoxime 201510
ceftriaxone 201502 201504
cefuroxime axetil (oral) 201504 201507
cefuroxime sodium (injection) 201504 201507
celecoxib 201412
celiprolol 201501 201511
celsior 201503
cephalexin 201403
cephapirin 201312
cephradine (cefradine) 201411
cernitin 201311
certoparin (heparin) 201407
cetalkonium + choline salicylate 201303
cetalkonium + lidocaine 201503
cetirizine 201511 201507
cetirizine + pseudoephedrine 201408
cetrimide + chlorhexidine 201308
cetylpyridinium 201508 201511
cetylpyridinium + ascorbic acid 201508
cetylpyridinium + dequalinium chloride 201508 201511
cetylpyridinium + lidocaine 201508
cetylpyridinium + lysozyme 201508
cetylpyridinium + menthol 201508
charcoal activated 201508
chenodeoxycholic acid + ursodeoxycholic acid 201511
chenodesoxycholic acid 201405
chlorambucil 201309
chloramphenicol 201306
chloramphenicol + aminoacids + Vitamin A 201303
chloramphenicol + combinations not further specified 201306
chloramphenicol + dexamethasone 201405
chloramphenicol + hydrocortisone (ocular) 201311
chlordiazepoxide 201501
chlordiazepoxide + combinations 201501
chlorhexidine 201308 201601
chlorhexidine + cetrimonium 201308
chlorhexidine + dexpanthenol 201310
chlorhexidine + lidocaine 201503 201601
chlorhexidine + neomycin 201412
chlorhexidine + sodium fluoride 201406
chlorhexidine + tolnaftate 201510
chlormadinone 201511
chlormadinone acetate + ethinylestradiol 201411
chlornitrofenol 201302
chlorobutanol + levomenthol + thymol + pine oils + terpineol 201511
chlorocresol 201412
chlorocresol combinations 201412
chloropyramine 201408
chloroquine 201508
chlorothiazide 201311
chloroxine 201408
chloroxylenol 201304
chloroxylenol + dibucaine 201305
chloroxylenol + disodium edetate 201304
chloroxylenol + edetic acid + triclosan 201304
chlorphenamine (chlorpheniramine) 201310
chlorphenamine combinations (except with dexchlorpheniramine) 201310
chlorpromazine 201405
chlorpropamide 201311
chlorprothixene 201303
chlortalidone 201306 201508
chlortalidone + metoprolol 201512
chlortalidone + oxprenolol 201509
chlortalidone + reserpine 201302
chlortetracycline 201503
chlortetracycline + demeclocycline + tetracycline 201403
chlorzoxazone 201505
chlorzoxazone + paracetamol 201505
cholecalciferol + calcium 201310
cholecalciferol concentrate + sodium fluoride 201512
cholestyramine 201505
choline salicylate 201303
chondroitin 201411
chondroitin + glucosamine 201411
chromium (51
Cr) EDTA 201411
cibenzoline (cibenline) 201510
ciclesonide 201308
cicletanine 201501
ciclopirox + oxolamine 201404
ciclopirox olamine (all formulations except shampoo) 201309
ciclopirox olamine (shampoo only) 201309
ciclosporine 201512
cidofovir 201304 1 year
cilastatin 201502
cilastatin + imipenem 201406
cilazapril 201412
cilazapril + HCT 201412
cilnidipine 201403
cilostazol 201508
cimetidine 201411 201501
cimetidine + sodium alginate 201411
cinchocaine (dibucaine) 201404
cinitapride 201306
cinnarizine 201510 201511
cinnarizine + piracetam 201510
cinoxacin 201411
ciprofibrate 201412
ciprofloxacin 201601 201511 201801 5 years
ciprofloxacine combinations 201601
cisapride (yearly PSURs) 201303 x
cisatracurium 201307 201507 5 years
cisplatin 201512 201507
citalopram 201412 201504 201612 5 years
citicoline 201412
citral + terpinol + sylvestre pine oil + serpolet (thyme) oil 201408
citric acid + glycerol + honey + lemon oil + syrup 201503
citric acid + magnesium sulfate + sodium bicarbonate 201503
citric acid + sodium bicarbonate + sodium carbonate 201503
citric acide + sodium bicarbonate + sodium carbonate + sodium citrate dihydrate201503
cladribine 201502
clarithromycin 201504 201408
clavulanic acid 201309 201309
clebopride 201406
clemastine 201310
clemastine + dexamethasone 201409
clenbuterol 201309
clindamycin 201510 201505
clobazam 201302
clobetasol 201302
clobetasone 201509
clobutinol 201304 201304
clodronate 201502 201511 201702 5 years
clofazimine 201304
clofibrate 201512 201512
clomethiazole 201510
clomiphene 201304 201404
clomipramine 201410 201512
clonazepam 201306 201506 5 years
clonidine 201405 201512 202508 13 years
clonixin 201302
clopamide + dihydroergocrystine + reserpine 201504
clopamide + pindolol 201411
cloperastine 201407
clopidogrel 201312 3 years
clorazepate 201508
clorazepate + pyridoxine 201508
cloroxine 201511
clothiapine 201506
clotiazepam 201311
clotrimazole 201509 201601
clotrimazole + dexamethasone 201509
clotrimazole + hydrocortisone 201509
clotrimazole + zinc oxide 201509
cloxacillin 201501
clozapine 201510 201508
coal tar 201406
coal tar + alcoholic extract 201406
coal tar + menthol 201406
coal tar + soya oil 201406
coal tar derivative 201406
cobamamide 201312
cocaine 201512
cod liver oil 201304
cod liver oil + zinc oxide 201304
co-danthrusate 201404
codeine 201409 201302
codeine + chlorpheniramine + ephedrine 201409
codeine + creosote 201409
codeine + diclofenac 201509
codeine + diphenhydramine 201409
codeine + erysimum (erythromycin) 201409
codeine + guaifenesin + ephedrine hydrochloride 201409
codeine + ibuprofen 201303
codeine polysulfonate + phenyltoloxamine + guaifenesin 201409
codeine polysulfonate + phenyltoloxamine + guaifenesin + thyme 201409
codeine polysulfonate + phenyltoloxamine polysulfonate 201409
codeine polysulfonate resin 201409
co-dergocrine 201504 201504 3 years
colchicine 201307 201307 5 years
colchicine + tiemonium + opium 201307
colestipol 201306
colestyramine 201504
colistimethate 201312
colistin 201312
collagenase 201312
comfrey extract + methylnicotinate 201412
comfrey root liquid extract (symphytum officinalis) 201412
corticorelin 201410
cortisone 201508
cortivazol 201304
cotrimoxazol 201504 201506
cromoglicic acid 201502 201309
crotamiton 201307
cyamemazine 201512
cyanocobalamin (57
Co) 201410
cyclizine 201601
cyclopenthiazide 201401
cyclopentolate 201402
cyclophosphamide 201402
cyclosporine 201512 201312
cyproheptadine 201412 201412 3 years
cyproterone 201305
cyproterone + ethinyl estradiol 201305 201408
cytarabine 201404
cytidine diphosphate choline 201510
dacarbazine 201302
dactinomycin 201506
dalteparin (heparin) 201408
danaparoid 201311
danazol 201506 201303
dantrolene 201501
dantrone + poloxamer 201304
dapiprazole 201510
dapsone 201305
dapsone + ferrous oxalate 201305
daptomycin 201309 1 year
daunorubicin 201506
decamethrin (deltamethin) + piperonyl (pipamperone) 201306
deferoxamine 201412
deflazacort 201503
dehydrocholic acid 201306
delapril 201501
delapril + manidipine 201506
delorazepam 201308
deltamethrin 201407
demeclocycline 201506
demoxytocin 201312
deoxyribonuclease human 201506
dequalinium chloride 201507 201303
dequalinium chloride + lidocaine 201507
desflurane 201409 3 years
desipramine 201502
deslanoside 201503
desloratadine 201607 5 years
desloratadine + pseudoephedrine 201607 5 years
desmopressin 201412 201412 3 years
desogestrel 201307
desogestrel + ethinyl estradiol 201310 201408 201509 5 years
desonide 201308
desoximetasone 201507
desoxycortone acetate 201304
detajmium 201411
dexamethasone 201401 201305
dexamethasone sodium phosphate 201401
dexamethasone + framycetin + gramicidin 201401
dexamethasone + neomycin 201401
dexamethasone + neomycin + polymyxin b 201401
dexamethasone + neomycin+ acetic acid, glacial 201401
dexamethasone + polymyxin b + trimethoprim 201401
dexamethasone + tobramycin (ophtalmic and otic use) 201403
dexamphetamine (dextroamphetamine) 201304
dexbrompheniramine combinations 201306
dexchlorpheniramine 201506 201506 3 years
dexchlorpheniramine + chlorphenamine + pseudoephedrine 201306
dexchlorpheniramine + dextromethorphan + coffein 201306
dexchlorpheniramine + pseudoephedrine 201506
dexchlorpheniramine + pseudoephedrine + guaifenesin 201506
dexetimide 201310
dexfenotrine + piperonyl butoxide 201504
dexibuprofen 201408
dexketoprofen 201510
dexpanthenol 201310
dexpanthenol, Dexpanthenol nasal 201305
dexrazoxane 201502 201602 3 years
dextran (40, 60 and 70) 201308
dextran 1 201308
dextran70 + hydroxypropylmethyl cellulose 201405
dextranomer 201309
dextromethorphan 201406 201311 201511 3 years
dextromethorphan combinations (except with chlorphenamine, dexchlorpheniramine or paracetamol)201406
diacerein 201512
diacetylmorphine 201310
diazepam 201502 201601
diazepam + pyridoxine 201502
diazoxide 201304
dibenzepine 201505
dibromopropamidine 201401
dibucaine 201311
diclofenac 201509 201507 201509 3 years
diclofenac + gentamicin 201509
diclofenac sodium/misoprostol 201507
dicloxacillin 201502
dicycloverine 201402
didanosine 201510
dienogest + estradiol 201306
dienogest + ethinyl estradiol 201303
diethylamine salicylic acid combinations 201411
diethylcarbamazine 201508
diethylstilbestrol 201401
digitoxin 201503
digoxin 201310 201410
dihydralazine 201503
dihydralazine + HCT + reserpine 201406
dihydrocodeine 201411 201302 202511 13 years
dihydrocodeine combinations 201411
dihydroergocristine 201504 3 years
dihydroergocristine + esculinum (esculin) + rutoside (rutin) 201402
dihydroergocryptine 201507 3 years
dihydroergotamine 201504 201303 201504 3 years
dihydroergotamine + etilefrine 201303
dihydroergotoxin + HCT + reserpine 201504
dihydroergotoxine 201305 201504 3 years
dihydrotachysterol 201303
diiodohydroxyquinoline 201403
diisopropylamine 201405
diltiazem 201505 201408
dimefline 201312
dimenhydrinate 201510 201601
dimercaptosuccinic acid (DMSA) 201505
dimethindene 201304
dimethoxanate 201405
dimethyl sulfoxide 201406
dimeticone 201404
dimeticone combinations 201404
dinoprost trometamol (tromethamine) 201305
dinoprostone 201309
diosmectite (smecta) 201311
diosmin 201305 201305
diosmine + hesperidine 201503
diphemanil (methylsulfate) 201408
diphenhydramine 201503 201306
diphenhydramine combinations (except with paracetamol) 201503 201306
dipivefrin 201309
dipyridamole 201312
dirithromycin 201504
disopyramide 201404
distigmine 201504
disulfiram 201403
dixyrazine 201504
DL-Methionine, L-Cystine, Calcium panthotenate, Thiamine HCl, Pyridoxine HCl, Paraaminobenzoic Acid, Chelated Minerals-Zn, Fe, Cu, Millet Extract, Wheat germ extract, Barm Yeast201306
dobesilate calcium 201307
dobutamine 201503 201304
docetaxel 201311 3 years
docusate 201511 201306
dolasetron 201509
domiphen 201312
domperidone 201601 201601 201401 1 year
donepezil 201411
dopamine 201410 201306
dopexamine 201409
dornase alfa (deoxyribonuclease I) + fibrinolysin 201304
dornase alfa (deoxyribonuclease I) + fibrinolysin + chloramphenicol 201304
dorzolamide 201305
dorzolamide + timolol 201302
dosulepin 201404
doxapram hydrochlorid 201312
doxazosin 201312 201601
doxepin 201503 201409
doxorubicine 201510 201311
doxycycline 201305 201505
doxylamine 201402 201402
drofenine + propyphenazone 201408
dronedarone 201307 1 year
droperidol 201304 202504 13 years
droperidol + fentanyl 201304
dropropizine 201407
drospirenone + estradiol 201412
drospirenone + ethinylestradiol 201309
drotaverin 201312
dutasteride 201511
dydrogesterone 201404
ebastine 201305 201305 5 years
eberconazole 201501
econazole 201511
econazole combinations 201511
eculizumab 201304 6 months
efavirenz 201504 3 years
eflornithine 201308
eletriptan 201401
embramine 201408
enalapril 201303 201506
enalapril + HCT 201507 201506
enalapril + nitrendipine 201501
enflurane 201404
enoxaparin (heparin) 201504
enoximone 201510
enoxolone 201401
epervudine 201408
ephedrine 201506
ephedrine combinations (except with chlorphenamine) 201506
epinastine (ophthalmic) 201510
epinephrine 201312
epirubicin 201406 201511 201406 3 years
epitizide (epithiazide) + triamterene 201411
eplerenone 201503
epoietine alpha 201508
epoprostenol 201503
eprosartan 201504
eprosartan + HCT 201504
erdosteine 201408
ergometrine 201411
ergometrine + oxytocin 201406
ergotamine 201410
ertapenem 201403 3 years
erwinia asparaginase 201312
erythromycin 201503 201501
esbiothrin 201309
escherichia coli asparaginase 201307
escitalopram 201412
esculoside 201504
eslicarbazepine acetate 201310 1 year
esketamine 201408 201608 5 years
esmolol 201402
esomeprazole 201403 201603 5 years
estazolam 201504
estradiol (17 beta) + trimegestone 201503
estradiol (17-beta) 201408 201304
estradiol (17-beta) + gestodene 201412
estradiol (17-beta) + norgestimate 201510
estradiol + dydrogesterone 201402
estradiol + norethisterone acetate (norethindrone) 201503
estradiol + testosterone 201402
estramustine 201405 201403
estriol 201312 201510
estrogens, conjugated 201305
estropipate 201505
etacrynic acid 201505
etamsylate 201404
ethambutol 201507
ethambutol + isoniazid 201509
ethambutol + isoniazid + pyrazinamide + rifampicine 201504
ethambutol + isoniazid + rifampicine 201504
ethinylestradiol 201510
ethinylestradiol + etonogestrel 201507
ethinylestradiol + gestodene 201403
ethinylestradiol + levonorgestrel 201304 201408
ethinylestradiol + norelgestromin 201511
ethinylestradiol + norethisterone (norethindrone) 201508 201408
ethinylestradiol + norgestimate 201410
ethionamide 201406
ethosuximide 201506 201401 202503 13 years
ethyl esters of iodised fatty acids from poppyseed oil 201601
ethyl loflazepate 201511
ethynylestradiol + lynestrenol 201303 201408
etidronate 201509 201305 201709 5 years
etilefrine 201312 201304
etodolac 201508 201306
etofenamate 201306
etofylline 201511
etomidate 201509
etonogestrel 201309 201509 3 years
etoperidone 201510
etoposide 201302 201509
etoricoxib (yearly PSURs) 201303 x 201703 5 years
etravirine 201309 6 months
etynodiol 201502
etynodiol + ethynyl estradiol 201502
etynodiol + mestranol 201502
eucalyptol 201509
eucalyptol combinations 201509
everolimus 201507
exametazime 201601
exemestane 201312
ezetimibe 201510
ezetimibe + simvastatin 201403 201403 3 years
famciclovir 201512
famotidine 201409 201512
felbamate 201309 201309 3 years
felbinac 201509
felodipine 201512 201509
felodipine + metoprolol 201512
felodipine + ramipril 201303
fenbufen 201408
fenofibrate 201407 201407 201407 3 years
fenoldopam 201512
fenoprofen 201601
fenoterol 201302
fenoterol + ipratropium 201302
fenspiride 201404 201404 3 years
fentanyl 201504 201310
fenticonazole 201312
ferric gluconate salts 201508
ferric hydroxide polymaltose complex 201508
ferric hydroxide polymaltose complex + folic acid 201508
ferric hydroxide sucrose complex 201308
ferric salts + folic acid 201508 201309
ferrous fumarate 201408
ferrous glycine sulfate (ferroglycine sulfate) 201501
ferrous salts 201501
ferucarbotran 201509
ferumoxsil (siloxane coated superparamagnetic ironoxide) 201305
ferumoxtran-10 (superparamagnetic ironoxide) 201408
fexofenadine + combinations 201503
finasteride (yearly PSURs) 201308 201307 x 201308 1 year
fingolimod 201308 6 months
flavodate 201504
flavoxate 201312
flecainide 201506
floctafenine 201407
fluanisone 201310
flubendazole 201502
flucinolone acetonide + neomycin sulphate 201312
flucloxacillin 201503 202001 8 years
fluconazole 201403 201501
flucytosine 201509
fludarabine 201508
fludrocortisone 201310
fludrocortisone + gramicidin + neomycin 201412
fluindione 201409
flumazenil 201505
flumetasone 201406
flumetasone + clioquinol 201406
flunarizine 201505 201307
flunisolide 201312
flunitrazepam 201310 201304
fluocinolone + metronidazole + nystatin 201411
fluocinolone acetonide (incl. acetate ester fluocinonide) 201312
fluocinolone acetonide + clioquinol 201312
fluocinolone acetonide + lidocaine 201503
fluorescein 201404
fluorescein + oxybuprocaine 201404
fluoride 201501 201402
fluoride + malic acid 201501
fluoride + monofluorophosphate 201501
fluoride sodium + strontium acetate hemihydrate 201406
fluorometholone 201307
fluorometholone + gentamicin 201312
fluorometholone + tetryzoline 201310
fluorouracil 201412 201503 201412 3 years
fluoxetine 201509 201504 201709 5 years
flupentixol 201311
flupentixol + melitracene 201311
fluphenazine 201512
flupirtine 201502
fluprednidene + miconazole 201402
flurazepam 201503
flurbiprofen 201311
fluspirilene 201506 201506
flutamide 201507 201508
fluticasone 201502
fluticasone + salmeterol (yearly PSURs) 201410 x 201410 5 years
fluvastatin 201508
fluvoxamine 201507 201502
folic acid 201506 201601
folic acid + nicotinamide 201506 201310
folinic acid / (di)sodium folinate / calcium folinate 201408
fomepizole 201404
formoterol 201405
foscarnet 201503
fosfomycin 201307
fosinopril 201507 201506
fosinopril + HCT 201507
fosphenytoin 201408 202508 13 years
fotemustine 201408 202504 13 years
framycetin 201502
fructose + glucose + xylitol 201402
fusidic acid 201309
furazolidone 201310
furosemide 201501 201411 201501 3 years
furosemide combinations 201501 201411
fusafungine 201312
gabapentin 201302 201508 201602 3 years
gadobenate dimeglumine 201511
gadobutrol 201502
gadodiamide 201601
gadopentetic acid dimeglumine 201505
gadoteric acid (intraarticular) 201307 201307 5 years
gadoteric acid (IV and intravascular) 201309 201309 5 years
gadoteridol 201302 201502 5 years
gadoxetic acid disodium 201403
galactose (contrast medium) 201306
galactose + palmitic acid 201306
galacturoglicano 201507
galantamine 201502 201702 5 years
gallium (67
Ga) citrate 201503
gallopamil 201312 201508
ganciclovir 201306
gelatin absorbable 201411
gemcitabine 201601
gemfibrozil 201506 201302 202506 13 years
gentamicin 201503 201505 202502 13 years
gestrinone 201601
ginkgo biloba extract + heptaminol hydrochloride acid + troxerutin 201401
ginkgo biloba extract + troxerutin 201401
glatiramer 201411 201611 5 years
glibenclamide (micro) 201502 201512 202512 13 years
glibenclamide (non micro) 201502 202512 13 years
glibornuride 201307
gliclazide 201402 201602 5 years
glimepiride 201506 201706 5 years
glimepiride + pioglitazone hydrochloride 201307 6 months
glipizide 201601 201601 3 years
glipizide + metformin 202501 13 years
gliquidone 201408
glucosamine 201503
glutethimide 201505
glycerol 201505
glyceryl trinitrate (nitroglycerin) 201408 201307
glycine 201307 201307
glycopyrronium (glycopyrrolate) 201509
glycopyrronium (glycopyrrolate) + neostigmine 201509
gonadorelin 201311
goserelin 201405
gramicidin 201412
gramicidin + neomycin 201412
gramicidin, neomycin, naphazoline, phenylephrine 201412
granisetron 201412
griseofulvin 201307
guafenesin + pseudoephedrine 201505
guaifenesin 201505
guaifenesin + pseudoephedrine + triprolidine 201505
guanfacine 201309
halcinonide 201505
halofantrine 201505
haloperidol, haloperidol decanoate, haloperidol buzepide 201401 201510
halothane 201407
HCT 201512 201506
HCT + telmisartan 201505 3 years
HCT + triamterene 201509 201506
HCT + propranolol + triamterene 201509 201509
HCT + reserpine + triamterene 201509 201506
heparin 201503 201505
heparin combinations 201503
heparinoid (sodium alginate sulfate) 201601
heparinoid + ibuprofen 201601
heptaminol 201501
hexamidine 201509 201401
hexamidine + isethionate + lidocaine HCL 201509
hexamidine + tetravacaine 201509
hexaminolevulinate hydrochloride 201503
hexetidine 201307 201307
hexylresorcinol 201410
horse chestnut seed extract (escin) 201304
human chorionic gonadotropin (HCG) 201306
hyaluronate sodium 201408
hyaluronate zinc 201408
hyaluronidase 201505
hydralazine 201303
hydrocortisone 201408 201505
hydrocortisone + lidocaine 201512
hydrocortisone + oxytetracycline 201305
hydrocortisone + urea 201512
hydrocortisone acetate + neomycine + centella extract 201402
hydromorphone 201511
hydromorphone + atropine 201511
hydroquinidine 201403
hydrotalcite 201303 201503
hydroxychloroquine 201504
hydroxycobalamin 201309
hydroxyethylsalicylate 201504 201504
hydroxysine, hydroxysine chloride; hydroxysine pamoate and all fixed combination products containing hydroxyzine 201412
hydroxyurea (hydroxycarbamide) 201503
hymecromone 201307
hyoscine 201406
hyoscine butylbromide (butylscopolamine bromide, scopolamine butyl bromide)201403 201310
hypericin 201509
hypochlorite sodium 201408
hyprolose 201306
hypromellose (hydroxypropyl methylcellulose) 201512
ibopamine 201408
ibuprofen 201402 201512 201402 3 years
ibuprofen + lysine 201409
ibuprofen + pseudoephedrine 201307 201307 1 year
ibutilide 201512
ichthyol (ammonium ichthosulfonate (ichthosulfol)) 201309
idarubicin 201311
idebenone 201409
idoxuridine 201411
ifenprodil 201303
ifosfamide 201307
iloprost 201501 201309 1 year
imidapril 201409
imipramine 201503
imiquimod 201401 3 years
indapamide 201511
indium [111
In] choride 201508
indium [111
In] oxyquinoline 201504
indobufen 201405
indomethacin 201506 201307
indoramin 201309
influenza vaccines 201505
inosine 201306
Inositol nicotinate 201401
insulin human 201410 201310
interferon alfa-2a 201512
interferon gamma-1b 201601
iobitridol 201304
iodamide 201510
iodate 201507
iodide 201504 201507
iodide (131
I) sodium 201409
iodine 201507
iodixanol 201304
iohexol 201505 201309
iomeprol 201304
iopamidol 201412 201601
iopromide 201506
iotrolan 201411
ioversol 201403
ioxaglic acid 201302
ioxitalamic acid 201408
ipecacuanha (ipecac) + combinations 201408
ipratropium 201311
ipratropium + salbutamol 201401
irinotecan 201405
isoflurane 201410
isoniazide 201411
isoniazide + pyrazinamide + rifampin (rifampicin) 201305
isoniazide + rifampin (rifampicin) 201305
isoprenaline (isoproterenol) 201509
isosorbide dinitrate 201309 201505
isosorbide mononitrate 201412 201508
isotretinoin (yearly PSUR) 201308 201311 x 201505 3 years
ispaghula husk + mebeverine 201302
isradipine 201601
itopride 201306
itraconazole 201503
ivermectin 201304
josamycin 201503
kalium (Potassium) 201507
kaliumiodid, Kalium 201507
ketamine 201512 201406
ketanserin 201509
ketobemidone 201405
ketocaine + fluocinonide 201312
ketocaine HCL + fluocinolone acetonide 201312
ketoconazole 201505
ketoprofen 201507 201312
ketoprofen (topical use only - yearly PSUR) 201309 x 201309 1 year
ketorolac 201507 201507 3 years
ketotifen (all formulations except eye drops) 201410 201501
ketotifen (eye drops) 201506 201501
klebsiella pneumonia glycoproteins 201507
labetalol 201302
l-acetyl carnitine 201506
lacosamide 201508 3 years
lacidipine 201410
lactitol 201509
lactobacillus LB 201405
lactulose 201405 201302
lamotrigine 201511 201504 201711 5 years
lanreotide 201405
lansoprazole 201412
laropiprant + nicotinic acid 201311 1 year
latanoprost 201310 x
latanoprost + timolol 201406
lauromacrogol 400 201403
lauromacrogols combinations 201403
leflunomide 201309 1 year
lenalidomide 201312 1 year
lenograstim 201310 201310 3 years
lercanidipine 201408
letrozole 201410
leuprorelin (leuprolide) 201507
levetiracetam 201311 1 year
levobunolol 201406 201312 201406 3 years
levobupivicaine 201512
levocabastine 201511
levocarnitine 201409
levocetirizine 201407 201607 5 years
levodopa 201310 1 year
levodropropizine 201505
levofloxacin 201510 201510 3 years
levomepromazine 201506 201312
levonorgestrel (implant & IUS) 201312
levonorgestrel (oral formulations) 201312
levosimendan 201309
levosulpiride 201403
levothyroxine, levothyroxine sodium 201308 201601 3 years
lidocaine (inj. + cardio inj.) 201309 201412
lidocaine (topical) 201512 201412
lidocaine + adrenaline (Epinephrine) 201309
lidocaine + bismuth gallate 201412
lidocaine + prilocaine 201503
lidocaine + tetracaine 201306
lidocaine + zinc oxide 201512
lincomycin 201501
linezolid (yearly PSURs) 201304 x 201704 5 years
linsidomine 201512
liothyronine 201512
lisinopril 201309 201506
lisinopril + HCT 201402 201506
lisuride 201411
lithium 201302 201401
lodoxamide 201407
lofepramine 201601
lomefloxacin 201306
lomefloxacin (ophtalmic preparations) 201310
lomustine 201306 201306 3 years
lonazolac 201406 201406
loperamide 201505 201503 2012
lopinavir + ritonavir 201509 3 years
loprazolam 201507
loracarbef 201512
loratadine 201502 201405
loratadine + pseudoephedrine 201502
lorazepam 201312
lormetazepam 201412 201404
losartan 201309 x
losartan + HCT 201302
lovastatin 201307 201512
loxapine 201512
l-propionylcarnitine (propionyl-L-carnitine) 201312
l-tryptophan 201311 201311
lymecycline 201401
lynestrenol 201303
lysine acetylsalicylate 201509
lysine acetylsalicylic acid + metoclopramide 201512
macrogol 3350 201305
macrogol 4000 201305
macrogol 4000 and combinations 201305
magaldrate 201407 201407
magnesium +/or calcium +/or aluminium antacids 201601
magnesium combinations (excluding antacids) 201306 201407
malathion 201503
manidipine 201506
mannitol 201402
maprotiline 201409 201303
marine fish oil 201601
mazindol 201506
mebendazole 201305
mebeverine 201302
mecillinam 201308
meclofenamate (meclofenamic acid) 201509
meclozine (meclizine) 201308
meclozine hydrochloride, fixed combinations 201308
medazepam 201308
medroxyprogesterone acetate 201507 201504
mefenamic acid 201503
mefloquine 201504 201304 1 year
mefruside + nifedipine 201507
megestrol 201408 201307
meglumine 201401
melarsoprol 201505
meldonium 201308
meloxicam 201307
melperone 201501 201504
melphalan 201409
menotrophin 201512
menthol 201508
mepartricin 201511
mephenesin 201601
mephenoxalone 201402
mepivacaine 201303 201408
mepivacaine + adrenaline (Epinephrine) 201303
meprobamate 201310
meprobamate + aceprometazine 201309
mepyramine 201312
mercaptopurine 201409
meropenem 201508 201508 3 years
mesalazine (mesalamine) 201302 201401
mesnum (mesna) 201407
mestranol + norethindrone 201508
mesuximide 202501 13 years
metamizole 201504
metamizole (dipyrone) combinations 201504 201312
metformin 201504 201305
metformin + glibenclamide 201507
metformin + pioglitazone 201307 6 months
methadone 201412 201302
methenamine 201408
methenamine + phenazopyridine 201408
methionine 201303 201501
methotrexate 201406 201503 201406 3 years
methsuximide 201507
methyl aminolevulinate (topical) 201506
methyl butetisalicylate 201408
methyl salicylate + clove oil + capsicum oil 201405
methyl salicylate + menthol 201411
methyl salicylate + menthol + eugenol 201401
methyldigoxin 201503
methyldopa 201312 201601
methyldopa + HCT 201404
methylene diphosphonic acid 201408
methylergometrine maleate 201402
methylphenidate (yearly PSURs) 201310 201311 x
methylphenobarbital 201303 201803 5 years
methylprednisolone 201310 201405
methylprednisolone aceponate 201411
methylprednisolone acetate, lidocaine hydrochloride 201310
methylprednisolone acetate, neomycin sulfate 201310
methysergide 201502 201502 3 years
metipamide 201305
metixene 201402
metizoline 201510
metoclopramide 201504 201302
metoclopramide+ dimethicone 201504
metolazone 201312
metopimazine 201512
metoprolol 201502 201509
metoprolol + HCT 201502 201509
metoxybutropate 201510
metronidazole 201507 201306
metronidazole (topical) 201411
metronidazole + minocycline + nystatine 201411
metronidazole + spiramycin 201507
metyrapone 201501
mexiletine 201410
mezlocillin 201508
mianserin 201312 201304
micafungin 201310 1 year
miconazole 201308 201303
miconazole combinations 201308
microcrystalline hydroxyapatite 201403
midazolam 201508 201405
mifepristone 201305 1 year
miglitol 201508
milnacipran 201504
milrinone 201510
mineral oil + isopropyl myristate 201508
minerals and combinations (excl. with vitamins) 201307 201306
minocycline 201508 201507 201708 5 years
minoxidil (systemic) 201310 201510 5 years
minoxidil (topical) 201310 201510 5 years
mirtazapine 201309 201409
misoprostol 201406 201406 3 years
mitomycin 201410 201402
mitoxantrone 201306 201310 201306 3 years
mivacurium 201601 201801 5 years
mizolastine 201505 201705 5 years
moclobemide 201504 201502
modafinil 201508
moexipril + HCT 201506
mofebutazone 201402 201402
molsidomine 201509 201503
mometasone 201505
mometasone + salicylic acid 201505
monmectite 201307
montelukast 201507 201507 3 years
morphine 201510 201508
moxifloxacin (2 yearly PSURs) 201305 x 201305 2 years
moxifloxacin (topical use) 201605 5 years
moxonidine 201501 201411
mupirocin 201503
mycobacterium Bovis 201504
mycophenolate (mycophenolic acid) 201510
mycophenolate mofetil (prodrug of mycophenolate acid for which FR is the P-RMS)201404
nabilone 202501 13 years
nabumetone 201503
nadifloxacin 201405
nadolol 201507
nadroparin (heparin) 201503
nafarelin 201302
nafcillin 201306
naftazone 201312
naftidrofuryl (Nafronyl) 201504 201505
naftifine 201308
nalbuphine 201305 201305 5 years
nalidixic acid 201401
naloxone 201304 201305
naloxone combinations 201304 201307
naltrexone 201511
nandrolone 201312
naphazoline 201507 201402
naphazoline + tetracaine 201507
naphazoline combinations 201507
naproxen 201408 201305
naproxen combinations 201408
naratriptan 201502
nebivolol 201503
nedocromil 201510
nefazodone 201309
neomycin 201412
neomycin + hydrocortisone 201408
neostigmine 201303 201303
nesiritide 201508
netilmicin 201505
nevirapine 201505 3 years
niaprazine 201503
nicardipine 201305 201403
nicergoline 201505 201303
niclosamide 201509
nicorandil 201302
nicotine 201408
nicotine acid (nicotinic acid) 201307
nicotinic acid + simvastatin 201307 5 years
nifedipine 201508 201508
niflumic acid (morniflumate) 201601
nifuratel 201302
nifuratel + nystatin 201303
nifuroxazide 201508
nifurtoinol 201408
nilutamide 201507
nilvadipine 201512
nimesulide (6-monthly PSURs) 201306 x 201506 3 years
nimodipine 201511 201504
nimorazole 201505
nisoldipine 201507
nitrazepam 201303 201402
nitrendipine 201503 201302
nitric oxide 201412 3 years
nitrofural 201310
nitrofurantoin 201302 201403 201502 3 years
nitroglycerin (oral) 201408
nitroglycerin (transdermal) 201408
nitroprusside 201411
nitroxoline 201311
nizatidine 201508
nonivamide 201409
nonoxynol-9 (in contraceptive creams) 201505
noradrenaline (norepinephrine) 201309 202510 13 years
norethisterone 201508
norethisterone (norethindrone) combinations 201405
norfenefrine 201503
norfloxacin 201311 201503
nortriptyline 201303
noscapine 201402
nystatin 201508 201405
obidoxime 201403
octenidine dihydrochloride + phenoxyethanol 202501 13 years
octreotide 201406
ofloxacin (non-ophtalmic preparations) 201504 201504 3 years
ofloxacin (ophtalmic preparations) 201504 201510 201504 3 years
olmesartan 201410
olmesartan + amlodipine (6-monthly PSUR) 201304 x
olmesartan + hydrochlorothiazide 201410
olmesartan medoxomil + hydrochlorothiazide + amlodipine besilate 201304 x
olsalazine 201505
omega-3 fatty acids 201401 201401
omeprazole 201504 201308
omoconazole 201309
ondansetron 201502 201408
opipramol 201510
orciprenaline 201512
orlistat 201307 6 months
ornidazole 201406
orphenadrine 201508
ouabain 201502
oxaceprol 201510
oxacillin 201601
oxaliplatin 201504 201504 3 years
oxamniquine 201409
oxandrolone 201508
oxaprozin 201511
oxatomide (yearly PSURs) 201401 x
oxazepam 201512 201503
oxcarbazepine 201308 201308 3 years
oxeladin 201406
oxetorone 201408
oxilofrine 201403 201403
oxitropium 201310
oxolamine 201510
oxolamine + propyphenazone 201510
oxomemazine 201502
oxomemazine combinations 201502
oxprenolol 201502
oxybuprocaine 201508
oxybutynin 201507 201306
oxycodone 201304 201804 5 years
oxycodone + naloxone 201304 202505 13 years
oxycodone + paracetamol 202501 13 years
oxymetazoline 201308
oxymetazoline combinations 201308
oxytetracycline 201305
oxytetracycline combinations 201305
oxytocin 201406 201501
paclitaxel 201512 201509
pamidronate 201305 201308 201505 3 years
pancreas powder (Rizolipase) 201405 201403
pancreatic extracts 201405
pancreatin 201405 201401
pancreatin combinations 201405
pancrelipase 201410
pancuronium 201312 201312 3 years
panthenol 201303 201303
pantoprazole 201508
pantoprazole + amoxicillin + clarithromycin 201508
papaverine 201309
papaverine + combinations 201309
papaverine + homatropine + dehydrocholic acid 201309
paracetamol (acetaminophen) 201505 201302 201505 3 years
paracetamol combinations (except with acetyl salicylic acid or dexbrompheniramine)201505 201302
paracetamol combinations (including those with acetyl salicylic acid) 201302 201302
paraffin 201310
paraffin combinations 201310
parahydroxybenzoate of benzyle 201509
parahydroxybenzoate of benzyle combinations 201509
parethoxycaine 201509
paricalcitol 201308
paromomycin 201511
paroxetine 201512 201601 201712 5 years
patent blue V sodium 201304 201304 5 years
pefloxacin 201408
pemoline 201403 201403
penamecillin 201511
penciclovir (topical use only) 201408
penicillamine 201504
pentaerithrityl tetranitrate (pentaerythritol tetranitrate) 201512
pentamidine isethionate 201506
pentazocine 201509
pentazocine combinations (except those with paracetamol) 201509
pentosane (elmiron) 201307
pentosane polyester + phenylephrine 201306
pentoxifylline 201505 201512
pentoxyverine 201312
pergolide 201412 201504 201612 5 years
periciazine (pericyazine) + propericiazine 201505
perindopril 201310
permethrine 201507
permethrine + piperonyl butoxide 201507
perphenazine 201302
pethidine (meperidine) 201303
petrolatum, mineral oil (ophthalmic) 201305
phenazone (antipyridine) 201409 201409
phenazone (antipyridine) + tetracaine 201506
phendimetrazine 201303
phenelzine 201505
pheniramine 201305
phenobarbital 201501 202501 13 years
phenol 201304
phenolphtalein 201409
phenoxymethylpenicillin 201510 201303
phenprocoumon 201401 201401
phentermine 201306
phentolamine 201404
phenyl(2-hydroxybenzoate) 201403 201403
phenylbutazone 201302 201404
phenylephrine 201501
phenylsalicylate 201308
phenytoin 201501 202508 13 years
phenytoin sodium + metylphenobarbital 201501 202504 13 years
phloroglucinol 201509
phloroglucinol, trimethylphloroglucinol 201509
pholcodine 201505 201505 3 years
phosphate ( 32
P) sodium 201402
phytoestrol 201308
picloxydine 201410
picosulfate sodium 201312 201401
pidolate calcium 201510
pidolate calcium + calcium carbonate 201510
pidotimod 201310
piketoprofen 201311
pilocarpine 201507
pilocarpine (ophthalmic) 201408
pilocarpine + timolol 201302
pimecrolimus (yearly PSURs) 201303 x 201403 1 year
pimethixene 201412
pimozide 201302
pinaverium bromide 201311
pindolol 201311
pioglitazone 201307 6 months
pipamperone 201310
pipecuronium 201512
pipemidic acid 201412
piperacillin 201511 201601
piperacillin + tazobactam 201509
piperazine 201402
pipobroman 201406
pipotiazine 201303
piracetam 201504 201308
pirenzepine 201303 201403
piretanide 201504
piribedil 201403
piritramide 201403
piroxicam 201404 201504
pitofenone 201401
pivampicillin 201410
pivmecillinam 201308
pizotifen (pizotyline) 201307
Polidocanol 201404
poly (styrol, divinylbenzol) sulfonic acid 201404 201404
polycarbophil 201402
polyestradiol combinations 201403
polymyxin B 201501
polymyxin B combinations 201501
polystyrene sulfonate (polystyrene sulfonate acid) 201410
polythiazide 201410
polythiazide + reserpine 201410
polyvinyl alcohol (ophthalmic) 201504
polyvinyl alcohol + povidone 201504
poractant alfa 201508
porfimer sodium 201404
posaconazole 201310 1 year
potassium bicarbonate + sodium alginate 201601
potassium bicarbonate + sodium bicarbonate 201601
potassium chloride 201404
potassium chloride + sodium fluoride 201501
potassium chloride + sodium fluoride + triclosan 201501
potassium citrate 201501
potassium iodide + sodium iodide 201507
povidone 201411
povidone iodine 201310 201507
poyestradiol 201403
prajmalium 201412
pralidoxime 201407
pramocaine 201409
pramoxine (pramocaine) 201409
pranoprofen 201312
prasterone 201405
pravastatin 201403 201410
pravastatin + acetylsalicylic acid 201403
prazepam 201512
praziquantel 201504
prazosin 201503 201404
prednicarbate 201504
prednisolone 201306 201508
prednisone 201305 201308
pregabalin 201401 1 year
prenoxdiazine 201401
prilocaine 201412
prilocaine + adrenaline 201412
primidone 201506 202506 13 years
pristinamycin (virginiamycin) 201303
probenecid 201304
procainamide 201406
procaine 201409
procarbazine 201503
procaterol 201312
prochlorperazine 201306
procyanidol oligomer (endotelon) 201505
procyclidine 201403
progabide 201504 202504 13 years
progesterone 201312
proglumetacine 201402
proguanil 201509
promazine 201504
promegestone 201501
promethazine 201304 201308 202510 13 years
propafenone 201312 201505
propantheline 201501
proparacaine 201403
propiomazine 201406
propofol 201511 201403 201711 5 years
propranolol 201406 201509
propylthiouracil 201407
proscillaridin 201410
protamine 201601
prothipendyl 201406
protirelin 201401
prulifloxacin 201410
pseudoephedrine 201410
pseudoephedrine + triprolidine 201410
pyrantel 201512
pyrazinamide 201302
pyridostigmine 201511
pyrimethamine 201508
pyritinol 201512
pyrrolidone carboxylate sodium 201401
pyrvinium 201308
quetiapine 201407
quinagolide 201506
quinapril 201404 201506
quinapril + HCT 201404 201506
quinfamide 201403
quinidine 201601
quinine 201411
quinine combinations 201411
rabbit anti-humanthymocyte 201512
raloxifene 201312 5 years
raltitrexed 201408
ramipril 201501 201509
ramipril + furosemide 201404
ramipril + HCT 201501 201506
ramipril + piretanide 201408
ranitidine 201505 201601
ranitidine bismuth citrate 201506
rasagiline 201601 3 years
reboxetine 201304
remifentanil 201405 201605 5 years
repaglinide 201412 3 years
reserpine 201512
resorcinol 201502
resorcinol + sulphur 201511
retigabine 201403 1 year
reviparin (heparin) 201501
ribavirin (yearly PSUR) 201307 x 201307 1 year
rifabutin 201510
rifampicin (rifampin) 201305
rifamycin 201403
rilmenidine 201508
rimexolone 201310
rimexolone (ophtalmic) 201310
risedronate 201403
risperidone 201505 201705 5 years
ritodrine hydrochlorid 201508
rizatriptan 201306
rocuronium 201402 201602 3 years
ropinirole 201407 201307 3 years
ropivacaine 201509 201709 5 years
rosoxacin 201312
rosuvastatin (yearly PSURs) 201311 x
rotigotine 201402 1 year
roxatidine 201506
roxithromycin 201412 201409
rufinamide 201307 6 months
rupatadine 201306 x
rutoside (rutin) 201310
salbutamol (albuterol) 201401 201407
salicylamide 201402
salicylic acid + combinations 201509
salicylic acid and salts 201503 201509
salmeterol 201310 x 201510 5 years
secnidazole 201303
selegiline 201503 201507
selenite sodium 201407
Selenium 201402
selenium disulfide 201402
serrapeptase 201409
sertaconazole 201507
sertindole (6-monthly PSURs) 201307 x
sertraline 201403 201510
sevoflurane 201401
silver nitrate 201403
silver protein 201311
silver protein acetyltannate 201311 201405
silver sulfadiazine 201309
silver sulfadiazine + cerous nitrate (cerium nitrate) 201309
simethicone 201404 201402
simvastatin 201404 201504
sodium aurothiomalate (aurothiomalate; sodium thiomalate) 201307
sodium bicarbonate 201505 201402
sodium bicarbonate + sodium citrate + sodium fluoride 201501
sodium bicarbonate + sodium sulphate + sodium hydrogen phoshate 201401
sodium chloride (ophtalmic) 201408
sodium chloride, potassium chloride, calcium chloride dihydrate (+ glucose) (Ringer [+ glucose]), including irrigation201403
sodium chromate ( 51
Cr) 201412
sodium citrate 201402 201402
sodium ibandronate 201406 3 years
sodium iodide [l123
] 201303 201603 3 years
sodium iodide [I131]
sodium oxybate 201310 1 year
sodium tetradecyl sulphate 201704 5 years
solifenacin 201406
somatorelin 201401
somatostatin 201506 201507
somatropin 201403
sotalol 201408 201508
spartocin 201309
spectinomycin 201501
spiramycin 201502
spirapril 201401
spironolactone 201511 201411
spironolactone + altizide 201511
spironolactone + butizide 201511
spironolactone + HCT 201511
stannousfluoride 201507
stannousfluoride + medronate 201601
stibogluconate 201303
streptodornase 201502
streptodornase + streptokinase 201502
streptokinase 201502
streptomycin 201304
streptozocin 201505
stiripentol 201305 6 months
strontium (89
Sr) chloride 201505
sucralfate 201507 201311
sufentanil 201511 201411
sulbactam 201311 201306
sulbutiamine 201502
sulconazole 201509
sulfabenzamide + sulfacetamide + sulfathiazole 201409
sulfacetamide 201507
sulfadiazine 201407
sulfafurazole (sulfisoxazole) 201408
sulfaguanidine 201601
sulfamethopyrazine (sulfalene) + pyrimethamine 201507
sulfamethoxazole 201408
sulfamethoxazole / Trimethoprim 201506
sulfasalazine 201404 201312
sulfinpyrazone 201409
sulfisoxazole 201408
sulindac 201406
sulphur 201511
sulphur + triclosan 201511
sulpiride 201501 201412
sulprostone 201304
sultamicillin 201311
sultiame 202501 13 years
sultopride 201410
sumatriptan 201409 201409 5 years
suxamethonium 201408 201408 3 years
tacalcitol 201407
tacrolimus (yearly PSURs) 201303 x
tacrolimus (systemic formulations) 201503 3 years
tacrolimus (topical formulations) 201403 1 year
tafamidis 201305 6 months
talinolol 201310
tamoxifen 201504 201412
tamsulosin 201407 201405
tauroselcholic acid [75
Se] 201601
tazarotene 201412
technetium (99m
Tc) albumin nanocolloid 201511
technetium (99mTc) bicisate 201310
technetium (99mTc) DMSA 201505
technetium (99m
Tc) macrosalb 201302
technetium (99m
Tc) mebrofenin 201511
technetium (99mTc) oxidronate 201303
technetium (99m
Tc) pentetate 201511
technetium (99m
Tc) sestamibi 201512
technetium (Tc-99m) pyrophosphate 201402
technetium (Tc-99m) tiatide 201405
tegafur 201412
teicoplanin 201411 201611 5 years
telmisartan 201304 1 year
temazepam 201411
temocillin 201410
teniposide 201304
tenoate sodium 201505
tenoate sodium + eucalyptus + paracetamol 201505
tenoxicam 201502 201502 3 years
tenofovir 201403 1 year
terazosin 201511 201501
terbinafine 201509 201510 201709 5 years
terbutaline 201412 201306
terconazole 201512
terfenadine 201412 201412 202501 13 years
terguride maleate 201311
terlipressin 201504
tertatol 201410
testosterone (implants) 201309
testosterone propionate, testosterone phenyl propionate and testosterone iso hexanoate and testosteronedecanoate201309
testosterone, testosterone undecanoate (oral) 201309
tetrabenazine 201410
tetracaine 201506
tetracosactide (cosyntropin) 201405
tetracycline 201511 201406
tetrazepam 201505 201411
tetrofosmin 201505
tetryzoline 201406 201406
thalidomide 201310 1 year
thallous [201
Tl] chloride 201508
theophylline 201506
thiamazole (methimazole) 201307 201508 201008
thiamphenicol 201505
thiethylperazine 201412
thiocolchicoside 201303
thioguanine 201501
thiopental 201403
thioperazine (thioproperazine) 201512
thioridazine 201302
thiotepa 201503
thiothixene 201507
thrombin 201503
thymol + levomenthol + salol 201404
thyroglobulin 201408
thyrotricine (or tyrothricin) 201408 201408
thyrotropin releasing hormone (synthetic) 201302
thyroxine 201312
thyroxine combinations 201512
tiagabine 201506 201506 3 years
tianeptine 201506
tiapride 201507
tiaprofenic acid 201408
tibenzonium iodide 201312
tibolone 201312
ticarcillin 201309
ticarcillin + clavulanate 201309
tice BCG (BCG vaccine) 201508
ticlopidine 201305 201501
tigecycline 201406 3 years
tilactase 201511
tilidine 201304 201307
tiliquinol + tilbroquinol 201511
tiludronic acid 201502 201502 3 years
timolol (opthalmic preparations) 201407 201512
tinidazole 201506
tinidazole + nystatin 201506
tinidazole + tioconazole 201506
tinzaparine 201302
tioconazole 201404
tiopronine 201508 201403
tiotropium 201410
tirofiban 201305
tiropramide 201312
tixocortol 201311
tizanidine 201512
tobramycin 201410
tobramycin (for inhalation) 201412
tobramycin (ophtalmic drops) 201403
tolazamide 201408
tolbutamide 201407
tolfenamic acid 201508
tolmetin 201501
tolnaftate 201510
tolnaftate + nystatine 201510
tolnaftate + triclosan 201510
tolperisone 201511
tolterodine 201309
topiramate 201501 201701 5 years
topotecan 201505 3 years
torasemide 201511 201505
tosylchloramide 201303
tramadol 201405 201310 201405 3 years
tramadol + paracetamol 201508 201508 3 years
tramazoline 201312
trandolapril 201402
trandolapril + verapamil 201303
tranexamic acid 201601
trapidil 201409 201609 5 years
trazodone 201406 201308
treprostinil 201505 3 years
tretinoin 201501
tretinoin + tocopherols 201408
tretinoin (topical formulations) 201708 5 years
triamcinolone acetonide 201507
triamcinolone combinations 201507
triamterene 201506 201506
triazolam 201507
tribenoside 201504
tribenoside + lidocaine 201401
triclabendazole 201510
triclorcarban 201409
triclosan 201511
tricoflos 201308
tridecanamine undecylenate 201601
triethanolamine salicylate 201601
trifluoperazine 201310
trifluperidol 201501
trifluridine 201303
triflusal 201408
trihexyphenidyl 201312 201309
trimebutine 201505
trimebutine + ruscogenin 201505
trimecaine 201405
trimepiridine 201502
trimetazidine 201502 201308 6 months
trimethoprim 201506 201506
trimipramine 201410 201502
triptorelin 201503
tropatepine 201407
tropicamide 201403
tropisetron 201502
trospium 201409
troxerutine 201406 201406
undecylenic acid + zinc undecylenate 201305
unoprostone 201509
urapidil 201507
urea 201304
urea (13
C) 201302
urofollitropin 201503
urokinase 201312
ursodeoxycholic acid 201411 201411
valaciclovir 201512
valganciclovir 201409
valproic acid (incl. salts) 201501 201404 201501 3 years
valpromide 201307 202507 13 years
valsartan (6-monthly PSUR cycles for the paediatric indication only) 201304 x 201304
valsartan + HCT 201404
vancomycin 201501 201502 201501 5 years
varenicline 201305 1 year
vasopressin 201306
vecuronium bromide 201311 201311 3 years
venlafaxine 201505
verapamil 201601 201502
vernakalant hydrochloride 201308 1 year
vigabatrin (yearly PSURs) 201309 x 201409 3 years
viminol 201408
vinblastine 201410 201410
vincamine 201406
vincristine 201303 201304
vindesine 201504
vinorelbine 201504
vinpocetin 201407
vitamin A 201304
vitamin B -complex (oral) 201504
vitamin B1 (oral, parenteral) vitamin B1 + vitamin B6 (oral, parenteral) 201504
vitamin B12 (oral, parenteral) 201504
vitamin B2 201504
vitamin B6 (oral, parenteral) 201504
vitamin C 201302
vitamin D + calcium (oral) 201307
vitamin D3 201307
vitamin E 201511
vitamins and vitamin combinations (incl dexpanthenol and minerals) 201510
voriconazole 201402 1 year
warfarin 201505 202505 13 years
xipamide 201407 201601
xylometazoline 201405 201310
yohimbine 201505 201305 1 year
zafirlukast 201512 201712 5 years
zanamivir (yearly PSURs) 201401 x
zidovudine 201503
zinc salts 201407 201407
ziprasidone 201307 x
zofenopril 201401
zofenopril + HCT 201502
zolmitriptan 201503
zolpidem 201306 201509
zonisamide 201403 1 year
zopiclone 201505 201409
zotepine 201312
zuclopenthixol 201305