sign in sign up
<<
Home , Aceprometazine, Aluminium acetotartrate, Ambazone, Barbexaclone, Barnidipine, Benzododecinium bromide

Active substance name (INN) EU DLP BfArM / BAH DLP yearly PSUR 6-month-PSUR yearly PSUR bis DLP (List of Union PSUR Submission Reference Dates and Frequency (List of Union Frequency of Reference Dates and submission of Periodic Frequency of submission of Safety Update Reports, Periodic Safety Update 30 Nov. 2012) Reports, 30 Nov. 2012) (iso)spagmulate 201405 [18 F] fludeoxyglucose (injection) 201411 123I-hippuran (Iodohippurate sodium I 123) 201601 123I-MIBG 201601 125I-human serum albumin (albumin, iodinated I 125 serum) 201511 131I-6-Iodo-Norcholesterol 201506 131I-MIBG 201505 17-alpha-oestradiol (topical) 201502 2-hydroxyethyl salicylat + benzyl nicotinate (benzonicotinate) 201504 99Mo/99Tc (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 201511 acamprosate 201407 201503 201503 3 years acebutolol 201512 201410 acebutolol + mefruside 201503 acebutolol + 201504 201304 201403 201403 3 years acediasulfone 201508 acedobene + dimepranol + 201508 201410 201410 201407 201307 202801 16 years 201406 201509 201510 201509 3 years acetylcysteine + 201509 acetyldigoxin 201310 201410 acetyldigoxin combinations 201310 acetylsalicylic acid 201302 201302 acetylsalicylic acid + 201312 3 years acetylsalicylic acid + oxycodone hydrochloride 202501 13 years acetylsalicylic acid combinations 201302 201302 acexamic Acid 201404 201506 201309 acipimox 201512 acitretin 201510 201310 1 year acriflavinium chloride ( hydrochloride) + + 201411 201512 acrivastine + 201512 adapalene (topical) 201307 adapalene + benzoyl peroxide 201309 ademetionine (S-adenosylmethionine) 201304 201508 201501 (ephinephrine) 201305 aescin + diethylamine salicylate (diethylammonium salicylate) 201504 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 201511 algeldrate 201601 201405 201309 1 year alibendole 201310 (trimeprazine) 201512 a-Liponsäure, , Tioctic Acid (oral, parenteral) 201303 aliskiren 201309 1 year aliskiren, 201308 1 year aliskiren, amlodipine, 201306 6 months aliskiren, hydrochlorothiazide 201401 1 year 201601 3 years 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 201407 201303 201601 201603 3 years alprostadil (erectile dysfunction) 201401 201601 5 years alprostadil (peripheral arterial occlusive diseases) 201507 201707 5 years 201505 althiazide 201511 althiazide + 201511 altretamine 201401 +/or +/or antacids 201601 aluminium acetotartrate + methylcitrine 201503 aluminium chloride 201409 alverine 201302 alverine + simethicone 201302 201512 201409 201508 ambenonium 201412 201409 201505 ambroxol + 201309 ambroxol + 201409 201505 amcinonide + 201412 amidotrizoate 201311 201311 201506 201706 5 years amilomer 201412 201404 201506 amiloride + chlorthalidone 201404 amiloride + HCT + methyldopa 201404 amiloride + HCT + timolol 201404 amiloride + hydrochlorothoaizide (HCT) 201404 201506 201410 aminohippurate 201302 201312 201412 201308 201501 201511 201501 5 years 201501 201507 201501 3 years amitriptyline + 201307 amitriptyline + 201307 201501 3 years amitriptylinoxide 201307 amlodipine 201403 201504 amlodipine + 201601 201601 3 years amlodipine + benazepril 201503 ammonia solutions 201504 ammonium chloride combinations 201511 (topical) 201506 201505 amoxicillin 201503 201309 201703 5 years amoxicillin + clavulanate 201503 201309 201703 5 years amoxicillin + 201503 201601 amphetamine + 201601 201503 202703 15 years amphotericin B + 201503 201303 201306 202503 13 years ampicillin + cloxacillin 201303 ampicillin + 202001 8 years ampicillin + sulbactam 201502 201306 amrinone 201501 amsacrine 201404 amyl nitrite 201412 amyleine () + 201308 + dichlorobenzyl 201407 amylmetacresol + dichlorobenzyl alcohol + levomenthol 201407 amylmetacresol + dichlorobenzyl alcohol + 201407 amylsalicylate + methylnicotinate + levomenthol 201305 anagrelide 201511 201309 1 years anastrozole 201508 201412 201401 1 year 201410 antazoline + 201410 antazoline + (tetrahydrozoline) 201410 antazoline + 201410 antilymphocyte immunoglobulins 201511 apraclonidine 201405 201307 1 year aquatain 201408 artemether + lumefantrine 201510 201504 articaine + adrenaline 201504 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 201411 atovaquone + proguanil 201510 atracurium 201512 201512 3 years 201408 atropine + 201309 attapulgite 201311 attapulgite + aluminium hydroxide and magnesium carbonate co-dried gel 201402 auranofin 201511 aureomycin () 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 201412 bacitracin + chlorhexidine 201412 bacitracin + colistimethate sodium + 201412 bacitracin + neomycin 201412 bacitracin + neomycin + 201412 (intrathecal) 201312 201512 5 years baclofen (oral) 201409 201307 bacterial Lysate 201401 bambuterol 201512 bamifyline 201401 201410 201410 201310 202510 13 years barium sulphate + combinations 201304 201311 201406 beclomethasone 201412 201410 belladonna alkaloids, , 201401 belladonna extract + + papaverine 201312 bemetezide + 201506 bemiparin 201304 benazepril 201311 201506 benazepril + HCT 201305 201506 201510 bendrofluazide (bendroflumethiazide) 201305 bendroflumethiazide + propanolol + hydralazine 201503 bendroflumethiazide + spironolactone 201511 201411 201508 201403 benserazide + levodopa 201506 201601 (incl ocular) 201410 benzalkonium chloride + benzyl alcohol + chlorhexedine 201410 benzalkonium chloride + cetrimide 201410 benzalkonium chloride + chloroxylenol + disodium edetate 201410 benzalkonium chloride + chloride 201410 benzalkonium chloride + dimethicone 201410 benzalkonium chloride + dimethicone + hydrocortisone + 201508 benzalkonium chloride + 201410 benzalkonium chloride + lidocaine 201503 benzalkonium chloride + 201308 benzalkonium chloride + 201410 (benztrophine) 201303 benzbromarone 201410 201501 201305 201507 benzocaine + 201507 benzocaine + chlorhexidine 201507 benzocaine + chloroxylenol 201507 benzocaine + dequalinium hydrochloride 201507 benzocaine + 201507 benzocaine + 201406 benzododecinium 201306 201410 benzoyl peroxide 201404 201404 benztropine mesylate 201512 201510 benzydamine + benzalkonium 201510 benzydamine +cetylpyridinium 201510 benzylbenzoate 201302 benzylnicotinate 201504 201504 benzylnicotinate + hydroxyethyl salicylate 201504 benzylnicotine + campher (camphora) + dimethyl sulphate + turpentine oil 201303 201406 202001 8 years benzylpenicillin combinations 201408 beractant (beta cardone) 201310 beta-carotene 201304 201304 betahistine 201412 201412 betaine citrate 201507 201509 201505 betamethasone combinations 201509 betamethyldigoxin 201310 betaxolol 201505 bezafibrate 201507 201505 201402 201402 3 years biclotymol 201506 201512 201309 bile acids and salts 201308 biotin 201411 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/ (opthalmic bath) 201308 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 201504 201409 201412 brimonidine + timolol 201409 brivudine 201406 201409 201412 201408 3 years bromelains 201312 201312 201401 201510 bromhexine + eucalyptin etheroeum + ainisi aetheroleum + foeniculi etheroleum201401 + levomentholum + menthae piperitae eleum + origani etheroleum bromocryptine 201510 201304 201511 201408 201312 201406 201304 201508 budesonide + formoterol 201308 201507 201412 bufexamac + lidocaine 201412 201412 201405 201601 201310 201510 201404 bupivacaine + adrenaline 201404 201407 201407 3 years 201312 bis 201012 buserelin 201408 201304 201308 busulphan 201501 201311 butamirate + 201505 201505 201402 201408 butylscopolaminium 201308 201503 201503 3 years cafedrine 201311 201302 201302 caffeine + 201503 caffeine + ergotamine 201511 201511 3 years caffeine + + 201504 caffeine + 201409 calcipotriol 201401 /calcitonin salmon 201506 201505 calcitriol 201501 201307 calcium (oral, parenteral) 201307 calcium carbonate + famotidine + magnesium hydroxide 201409 3 years calcium + + 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 201505 camphor + combinations 201505 candesartan 201504 candesartan + HCT 201504 202501 13 years canrenoate 201409 201406 capreomycin 201401 201409 201705 5 years captopril 201304 201506 captopril + HCT 201304 201506 201601 carbaethopendecinium 201403 201512 201412 202412 12 years carbamoylphenoxyacetic acid + 202501 13 years 201307 carbasalate calcium+ 201307 cabazitaxel carbazochrome 201503 carbenicillin 201408 cabergoline 201503 3 years 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 201509 carbocisteine + 201509 201406 carbolevure 201302 carbomer (artificial tears) 201401 carboplatin 201601 201310 201601 3 years 201401 carboxymethylcellulose (eye preparation) 201507 201304 carglumic acid 201501 5 years 201405 carmustine 201504 carnitine 201506 carteolol 201403 201510 201501 201312 2 years catalase + neomycin 201412 CE (conjugated ) + 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 201412 celiprolol 201501 201511 celsior 201503 cephalexin 201403 cephapirin 201312 cephradine () 201411 cernitin 201311 certoparin () 201407 cetalkonium + salicylate 201303 cetalkonium + lidocaine 201503 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 201306 chloramphenicol + aminoacids + Vitamin A 201303 chloramphenicol + combinations not further specified 201306 chloramphenicol + dexamethasone 201405 chloramphenicol + hydrocortisone (ocular) 201311 201501 chlordiazepoxide + combinations 201501 chlorhexidine 201308 201601 chlorhexidine + 201308 chlorhexidine + dexpanthenol 201310 chlorhexidine + lidocaine 201503 201601 chlorhexidine + neomycin 201412 chlorhexidine + 201406 chlorhexidine + tolnaftate 201510 chlormadinone 201511 + 201411 chlornitrofenol 201302 + levomenthol + + pine oils + terpineol 201511 chlorocresol 201412 chlorocresol combinations 201412 201408 chloroquine 201508 chlorothiazide 201311 201408 chloroxylenol 201304 chloroxylenol + dibucaine 201305 chloroxylenol + disodium edetate 201304 chloroxylenol + edetic acid + triclosan 201304 (chlorpheniramine) 201310 chlorphenamine combinations (except with ) 201310 201405 201311 201303 chlortalidone 201306 201508 chlortalidone + metoprolol 201512 chlortalidone + oxprenolol 201509 chlortalidone + 201302 chlortetracycline 201503 chlortetracycline + + tetracycline 201403 201505 chlorzoxazone + 201505 cholecalciferol + calcium 201310 cholecalciferol concentrate + sodium fluoride 201512 cholestyramine 201505 choline salicylate 201303 chondroitin 201411 chondroitin + 201411 chromium (51 Cr) EDTA 201411 cibenzoline (cibenline) 201510 201308 cicletanine 201501 + 201404 ciclopirox olamine (all formulations except ) 201309 ciclopirox olamine (shampoo only) 201309 ciclosporine 201512 cidofovir 201304 1 year cilastatin 201502 cilastatin + 201406 cilazapril 201412 cilazapril + HCT 201412 201403 201508 201411 201501 cimetidine + sodium alginate 201411 (dibucaine) 201404 cinitapride 201306 201510 201511 cinnarizine + 201510 201411 ciprofibrate 201412 201601 201511 201801 5 years ciprofloxacine combinations 201601 (yearly PSURs) 201303 x cisatracurium 201307 201507 5 years cisplatin 201512 201507 201412 201504 201612 5 years 201412 citral + terpinol + sylvestre pine oil + serpolet (thyme) oil 201408 + glycerol + honey + lemon oil + syrup 201503 citric acid + + sodium bicarbonate 201503 citric acid + sodium bicarbonate + sodium carbonate 201503 citric acide + sodium bicarbonate + sodium carbonate + sodium citrate dihydrate201503 cladribine 201502 201504 201408 clavulanic acid 201309 201309 201406 201310 clemastine + dexamethasone 201409 clenbuterol 201309 201510 201505 201302 clobetasol 201302 clobetasone 201509 201304 201304 clodronate 201502 201511 201702 5 years clofazimine 201304 clofibrate 201512 201512 201510 clomiphene 201304 201404 201410 201512 201306 201506 5 years 201405 201512 202508 13 years 201302 clopamide + dihydroergocrystine + reserpine 201504 clopamide + pindolol 201411 201407 clopidogrel 201312 3 years 201508 clorazepate + pyridoxine 201508 cloroxine 201511 clothiapine 201506 201311 201509 201601 clotrimazole + dexamethasone 201509 clotrimazole + hydrocortisone 201509 clotrimazole + oxide 201509 cloxacillin 201501 201510 201508 201406 coal tar + alcoholic extract 201406 coal tar + menthol 201406 coal tar + soya oil 201406 coal tar derivative 201406 cobamamide 201312 201512 cod oil 201304 cod liver oil + zinc oxide 201304 co-danthrusate 201404 201409 201302 codeine + chlorpheniramine + 201409 codeine + 201409 codeine + 201509 codeine + diphenhydramine 201409 codeine + erysimum () 201409 codeine + guaifenesin + ephedrine hydrochloride 201409 codeine + 201303 codeine polysulfonate + + 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 + 201307 colestipol 201306 colestyramine 201504 colistimethate 201312 201312 collagenase 201312 comfrey extract + methylnicotinate 201412 comfrey root liquid extract (symphytum officinalis) 201412 201410 cortisone 201508 cortivazol 201304 cotrimoxazol 201504 201506 201502 201309 crotamiton 201307 201512 cyanocobalamin (57Co) 201410 201601 cyclopenthiazide 201401 201402 201402 cyclosporine 201512 201312 201412 201412 3 years 201305 cyproterone + ethinyl 201305 201408 cytarabine 201404 cytidine diphosphate choline 201510 dacarbazine 201302 dactinomycin 201506 dalteparin (heparin) 201408 201311 201506 201303 dantrolene 201501 dantrone + poloxamer 201304 dapiprazole 201510 201305 dapsone + ferrous 201305 daptomycin 201309 1 year daunorubicin 201506 decamethrin (deltamethin) + piperonyl () 201306 deferoxamine 201412 deflazacort 201503 dehydrocholic acid 201306 delapril 201501 delapril + 201506 201308 deltamethrin 201407 demeclocycline 201506 demoxytocin 201312 deoxyribonuclease human 201506 dequalinium chloride 201507 201303 dequalinium chloride + lidocaine 201507 201409 3 years 201502 deslanoside 201503 201607 5 years desloratadine + pseudoephedrine 201607 5 years 201412 201412 3 years 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 + 201401 dexamethasone + neomycin 201401 dexamethasone + neomycin + 201401 dexamethasone + neomycin+ , glacial 201401 dexamethasone + polymyxin b + 201401 dexamethasone + (ophtalmic and otic use) 201403 dexamphetamine (dextroamphetamine) 201304 combinations 201306 dexchlorpheniramine 201506 201506 3 years dexchlorpheniramine + chlorphenamine + pseudoephedrine 201306 dexchlorpheniramine + + coffein 201306 dexchlorpheniramine + pseudoephedrine 201506 dexchlorpheniramine + pseudoephedrine + guaifenesin 201506 201310 dexfenotrine + piperonyl butoxide 201504 201408 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, dexchlorpheniramine201406 or paracetamol) 201512 diacetylmorphine 201310 201502 201601 diazepam + pyridoxine 201502 201304 dibenzepine 201505 dibromopropamidine 201401 dibucaine 201311 diclofenac 201509 201507 201509 3 years diclofenac + 201509 diclofenac sodium/ 201507 201502 201402 didanosine 201510 + estradiol 201306 dienogest + ethinyl estradiol 201303 diethylamine combinations 201411 diethylcarbamazine 201508 201401 201503 201310 201410 dihydralazine 201503 dihydralazine + HCT + reserpine 201406 201411 201302 202511 13 years dihydrocodeine combinations 201411 201504 3 years dihydroergocristine + esculinum (esculin) + rutoside () 201402 dihydroergocryptine 201507 3 years 201504 201303 201504 3 years dihydroergotamine + 201303 dihydroergotoxin + HCT + reserpine 201504 dihydroergotoxine 201305 201504 3 years dihydrotachysterol 201303 201403 diisopropylamine 201405 201505 201408 dimefline 201312 201510 201601 dimercaptosuccinic acid (DMSA) 201505 dimethindene 201304 201405 dimethyl sulfoxide 201406 dimeticone 201404 dimeticone combinations 201404 dinoprost trometamol (tromethamine) 201305 dinoprostone 201309 diosmectite (smecta) 201311 201305 201305 diosmine + hesperidine 201503 diphemanil (methylsulfate) 201408 diphenhydramine 201503 201306 diphenhydramine combinations (except with paracetamol) 201503 201306 dipivefrin 201309 201312 dirithromycin 201504 201404 distigmine 201504 201403 201504 DL-, L-Cystine, Calcium panthotenate, Thiamine HCl, Pyridoxine HCl,201306 Paraaminobenzoic Acid, Chelated Minerals-Zn, Fe, Cu, Millet Extract, Wheat germ extract, Barm Yeast dobesilate calcium 201307 201503 201304 201311 3 years 201511 201306 201509 domiphen 201312 201601 201601 201401 1 year 201411 201410 201306 201409 (deoxyribonuclease I) + 201304 dornase alfa (deoxyribonuclease I) + fibrinolysin + chloramphenicol 201304 dorzolamide 201305 dorzolamide + timolol 201302 201404 doxapram hydrochlorid 201312 201312 201601 201503 201409 doxorubicine 201510 201311 doxycycline 201305 201505 201402 201402 drofenine + 201408 201307 1 year 201304 202504 13 years droperidol + 201304 201407 + estradiol 201412 drospirenone + ethinylestradiol 201309 drotaverin 201312 201511 dydrogesterone 201404 201305 201305 5 years 201501 201511 econazole combinations 201511 eculizumab 201304 6 months 201504 3 years 201308 eletriptan 201401 201408 enalapril 201303 201506 enalapril + HCT 201507 201506 enalapril + 201501 201404 enoxaparin (heparin) 201504 enoximone 201510 201401 epervudine 201408 ephedrine 201506 ephedrine combinations (except with chlorphenamine) 201506 (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 201408 201411 ergometrine + 201406 ergotamine 201410 ertapenem 201403 3 years erwinia asparaginase 201312 erythromycin 201503 201501 esbiothrin 201309 escherichia coli asparaginase 201307 201412 esculoside 201504 201310 1 year 201408 201608 5 years esmolol 201402 esomeprazole 201403 201603 5 years 201504 estradiol (17 beta) + 201503 estradiol (17-beta) 201408 201304 estradiol (17-beta) + 201412 estradiol (17-beta) + norgestimate 201510 estradiol + dydrogesterone 201402 estradiol + acetate (norethindrone) 201503 estradiol + 201402 201405 201403 201312 201510 estrogens, conjugated 201305 201505 etacrynic acid 201505 201404 ethambutol 201507 ethambutol + 201509 ethambutol + isoniazid + pyrazinamide + rifampicine 201504 ethambutol + isoniazid + rifampicine 201504 ethinylestradiol 201510 ethinylestradiol + 201507 ethinylestradiol + gestodene 201403 ethinylestradiol + 201304 201408 ethinylestradiol + 201511 ethinylestradiol + norethisterone (norethindrone) 201508 201408 ethinylestradiol + norgestimate 201410 ethionamide 201406 201506 201401 202503 13 years ethyl esters of iodised fatty acids from poppyseed oil 201601 201511 ethynylestradiol + 201303 201408 etidronate 201509 201305 201709 5 years etilefrine 201312 201304 201508 201306 201306 etofylline 201511 201509 etonogestrel 201309 201509 3 years 201510 etoposide 201302 201509 (yearly PSURs) 201303 x 201703 5 years etravirine 201309 6 months 201502 etynodiol + ethynyl estradiol 201502 etynodiol + 201502 eucalyptol 201509 eucalyptol combinations 201509 201507 exametazime 201601 201312 ezetimibe 201510 ezetimibe + 201403 201403 3 years 201512 famotidine 201409 201512 201309 201309 3 years 201509 201512 201509 felodipine + metoprolol 201512 felodipine + ramipril 201303 201408 fenofibrate 201407 201407 201407 3 years 201512 201601 fenoterol 201302 fenoterol + ipratropium 201302 fenspiride 201404 201404 3 years fentanyl 201504 201310 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 sulfate (ferroglycine sulfate) 201501 ferrous salts 201501 ferucarbotran 201509 ferumoxsil (siloxane coated superparamagnetic ironoxide) 201305 ferumoxtran-10 (superparamagnetic ironoxide) 201408 + combinations 201503 (yearly PSURs) 201308 201307 x 201308 1 year fingolimod 201308 6 months flavodate 201504 201312 201506 201407 201310 flubendazole 201502 flucinolone acetonide + neomycin sulphate 201312 flucloxacillin 201503 202001 8 years 201403 201501 201509 fludarabine 201508 fludrocortisone 201310 fludrocortisone + gramicidin + neomycin 201412 fluindione 201409 201505 flumetasone 201406 flumetasone + 201406 201505 201307 201312 201310 201304 fluocinolone + metronidazole + nystatin 201411 (incl. acetate ester ) 201312 fluocinolone acetonide + clioquinol 201312 fluocinolone acetonide + lidocaine 201503 fluorescein 201404 fluorescein + 201404 fluoride 201501 201402 fluoride + malic acid 201501 fluoride + monofluorophosphate 201501 fluoride sodium + strontium acetate hemihydrate 201406 201307 fluorometholone + gentamicin 201312 fluorometholone + tetryzoline 201310 fluorouracil 201412 201503 201412 3 years 201509 201504 201709 5 years 201311 flupentixol + melitracene 201311 201512 201502 fluprednidene + 201402 201503 201311 201506 201506 201507 201508 201502 fluticasone + salmeterol (yearly PSURs) 201410 x 201410 5 years fluvastatin 201508 201507 201502 folic acid 201506 201601 folic acid + 201506 201310 folinic acid / (di)sodium folinate / calcium folinate 201408 201404 formoterol 201405 foscarnet 201503 fosfomycin 201307 fosinopril 201507 201506 fosinopril + HCT 201507 201408 202508 13 years fotemustine 201408 202504 13 years framycetin 201502 fructose + + xylitol 201402 201309 201310 201501 201411 201501 3 years furosemide combinations 201501 201411 201312 201302 201508 201602 3 years gadobenate dimeglumine 201511 201502 201601 dimeglumine 201505 (intraarticular) 201307 201307 5 years gadoteric acid (IV and intravascular) 201309 201309 5 years 201302 201502 5 years disodium 201403 (contrast medium) 201306 galactose + palmitic acid 201306 galacturoglicano 201507 galantamine 201502 201702 5 years gallium (67Ga) citrate 201503 201312 201508 201306 gelatin absorbable 201411 gemcitabine 201601 gemfibrozil 201506 201302 202506 13 years gentamicin 201503 201505 202502 13 years 201601 ginkgo biloba extract + hydrochloride acid + 201401 ginkgo biloba extract + troxerutin 201401 glatiramer 201411 201611 5 years (micro) 201502 201512 202512 13 years glibenclamide (non micro) 201502 202512 13 years 201307 201402 201602 5 years 201506 201706 5 years glimepiride + hydrochloride 201307 6 months 201601 201601 3 years glipizide + 202501 13 years 201408 glucosamine 201503 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, 201412 201412 201307 guafenesin + pseudoephedrine 201505 guaifenesin 201505 guaifenesin + pseudoephedrine + 201505 guanfacine 201309 halcinonide 201505 halofantrine 201505 , , haloperidol buzepide 201401 201510 201407 HCT 201512 201506 HCT + 201505 3 years HCT + triamterene 201509 201506 HCT + + triamterene 201509 201509 HCT + reserpine + triamterene 201509 201506 heparin 201503 201505 heparin combinations 201503 (sodium alginate sulfate) 201601 heparinoid + ibuprofen 201601 heptaminol 201501 201509 201401 hexamidine + isethionate + lidocaine HCL 201509 hexamidine + tetravacaine 201509 hexaminolevulinate hydrochloride 201503 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 + 201305 hydrocortisone + 201512 hydrocortisone acetate + neomycine + centella extract 201402 201511 hydromorphone + atropine 201511 hydroquinidine 201403 hydrotalcite 201303 201503 hydroxychloroquine 201504 hydroxycobalamin 201309 hydroxyethylsalicylate 201504 201504 hydroxysine, hydroxysine chloride; hydroxysine pamoate and all fixed combination201412 products containing hydroxyurea (hydroxycarbamide) 201503 hymecromone 201307 hyoscine 201406 (butylscopolamine bromide, butyl bromide)201403 201310 201509 hypochlorite sodium 201408 hyprolose 201306 hypromellose (hydroxypropyl methylcellulose) 201512 201408 ibuprofen 201402 201512 201402 3 years ibuprofen + lysine 201409 ibuprofen + pseudoephedrine 201307 201307 1 year 201512 ichthyol (ammonium ichthosulfonate (ichthosulfol)) 201309 idarubicin 201311 idebenone 201409 201411 201303 ifosfamide 201307 201501 201309 1 year imidapril 201409 201503 imiquimod 201401 3 years indapamide 201511 indium [111In] choride 201508 indium [111In] oxyquinoline 201504 201405 indomethacin 201506 201307 indoramin 201309 influenza vaccines 201505 inosine 201306 nicotinate 201401 human 201410 201310 alfa-2a 201512 interferon gamma-1b 201601 201304 201510 iodate 201507 iodide 201504 201507 iodide (131I) sodium 201409 iodine 201507 201304 201505 201309 201304 201412 201601 201506 201411 201403 201302 201408 ipecacuanha (ipecac) + combinations 201408 ipratropium 201311 ipratropium + 201401 irinotecan 201405 201410 isoniazide 201411 isoniazide + pyrazinamide + rifampin () 201305 isoniazide + rifampin (rifampicin) 201305 (isoproterenol) 201509 201309 201505 201412 201508 (yearly PSUR) 201308 201311 x 201505 3 years ispaghula husk + 201302 201601 201306 201503 201304 josamycin 201503 kalium (Potassium) 201507 kaliumiodid, Kalium 201507 201512 201406 201509 201405 + fluocinonide 201312 ketocaine HCL + fluocinolone acetonide 201312 201505 201507 201312 ketoprofen (topical use only - yearly PSUR) 201309 x 201309 1 year 201507 201507 3 years (all formulations except eye drops) 201410 201501 ketotifen (eye drops) 201506 201501 klebsiella pneumonia glycoproteins 201507 labetalol 201302 l-acetyl carnitine 201506 201508 3 years 201410 lactitol 201509 lactobacillus LB 201405 lactulose 201405 201302 201511 201504 201711 5 years 201405 lansoprazole 201412 + nicotinic acid 201311 1 year 201310 x latanoprost + timolol 201406 lauromacrogol 400 201403 lauromacrogols combinations 201403 leflunomide 201309 1 year lenalidomide 201312 1 year lenograstim 201310 201310 3 years 201408 letrozole 201410 leuprorelin (leuprolide) 201507 201311 1 year levobunolol 201406 201312 201406 3 years levobupivicaine 201512 201511 levocarnitine 201409 201407 201607 5 years levodopa 201310 1 year 201505 201510 201510 3 years 201506 201312 levonorgestrel (implant & IUS) 201312 levonorgestrel (oral formulations) 201312 201309 201403 , 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 + 201503 lidocaine + 201306 lidocaine + zinc oxide 201512 lincomycin 201501 linezolid (yearly PSURs) 201304 x 201704 5 years 201512 liothyronine 201512 lisinopril 201309 201506 lisinopril + HCT 201402 201506 201411 201302 201401 201407 201601 201306 lomefloxacin (ophtalmic preparations) 201310 lomustine 201306 201306 3 years 201406 201406 201505 201503 2012 lopinavir + 201509 3 years 201507 loracarbef 201512 201502 201405 loratadine + pseudoephedrine 201502 201312 201412 201404 losartan 201309 x losartan + HCT 201302 201307 201512 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 201402 201409 201303 marine fish oil 201601 201506 mebendazole 201305 mebeverine 201302 mecillinam 201308 meclofenamate () 201509 meclozine () 201308 meclozine hydrochloride, fixed combinations 201308 201308 medroxyprogesterone acetate 201507 201504 201503 201504 201304 1 year mefruside + nifedipine 201507 megestrol 201408 201307 201401 melarsoprol 201505 meldonium 201308 201307 201501 201504 melphalan 201409 menotrophin 201512 menthol 201508 201511 201601 201402 201303 201408 mepivacaine + adrenaline (Epinephrine) 201303 201310 meprobamate + 201309 201312 mercaptopurine 201409 meropenem 201508 201508 3 years (mesalamine) 201302 201401 mesnum () 201407 mestranol + norethindrone 201508 202501 13 years metamizole 201504 metamizole (dipyrone) combinations 201504 201312 metformin 201504 201305 metformin + glibenclamide 201507 metformin + pioglitazone 201307 6 months 201412 201302 methenamine 201408 methenamine + 201408 methionine 201303 201501 methotrexate 201406 201503 201406 3 years methsuximide 201507 methyl aminolevulinate (topical) 201506 methyl butetisalicylate 201408 + clove oil + capsicum oil 201405 methyl salicylate + menthol 201411 methyl salicylate + menthol + 201401 methyldigoxin 201503 methyldopa 201312 201601 methyldopa + HCT 201404 methylene diphosphonic acid 201408 maleate 201402 (yearly PSURs) 201310 201311 x 201303 201803 5 years 201310 201405 methylprednisolone aceponate 201411 methylprednisolone acetate, lidocaine hydrochloride 201310 methylprednisolone acetate, neomycin sulfate 201310 201502 201502 3 years metipamide 201305 201402 201510 metoclopramide 201504 201302 metoclopramide+ dimethicone 201504 metolazone 201312 201512 metoprolol 201502 201509 metoprolol + HCT 201502 201509 metoxybutropate 201510 metronidazole 201507 201306 metronidazole (topical) 201411 metronidazole + + nystatine 201411 metronidazole + spiramycin 201507 201501 201410 mezlocillin 201508 201312 201304 201310 1 year miconazole 201308 201303 miconazole combinations 201308 microcrystalline hydroxyapatite 201403 201508 201405 201305 1 year 201508 201504 milrinone 201510 mineral oil + isopropyl myristate 201508 minerals and combinations (excl. with vitamins) 201307 201306 minocycline 201508 201507 201708 5 years (systemic) 201310 201510 5 years minoxidil (topical) 201310 201510 5 years 201309 201409 misoprostol 201406 201406 3 years mitomycin 201410 201402 mitoxantrone 201306 201310 201306 3 years mivacurium 201601 201801 5 years 201505 201705 5 years moclobemide 201504 201502 201508 moexipril + HCT 201506 201402 201402 201509 201503 201505 mometasone + salicylic acid 201505 monmectite 201307 montelukast 201507 201507 3 years 201510 201508 (2 yearly PSURs) 201305 x 201305 2 years moxifloxacin (topical use) 201605 5 years moxonidine 201501 201411 201503 mycobacterium Bovis 201504 mycophenolate (mycophenolic acid) 201510 mycophenolate mofetil (prodrug of mycophenolate acid for which FR is the P-RMS)201404 202501 13 years 201503 201405 nadolol 201507 nadroparin (heparin) 201503 nafarelin 201302 201306 naftazone 201312 (Nafronyl) 201504 201505 201308 nalbuphine 201305 201305 5 years 201401 201304 201305 naloxone combinations 201304 201307 201511 201312 naphazoline 201507 201402 naphazoline + tetracaine 201507 naphazoline combinations 201507 201408 201305 naproxen combinations 201408 naratriptan 201502 nebivolol 201503 201510 201309 neomycin 201412 neomycin + hydrocortisone 201408 neostigmine 201303 201303 nesiritide 201508 201505 201505 3 years 201503 201305 201403 201505 201303 niclosamide 201509 201302 201408 nicotine acid (nicotinic acid) 201307 nicotinic acid + simvastatin 201307 5 years nifedipine 201508 201508 () 201601 201302 nifuratel + nystatin 201303 201508 201408 201507 201512 (6-monthly PSURs) 201306 x 201506 3 years 201511 201504 nimorazole 201505 201507 201303 201402 nitrendipine 201503 201302 201412 3 years nitrofural 201310 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 () 201309 202510 13 years norethisterone 201508 norethisterone (norethindrone) combinations 201405 201503 201311 201503 201303 201402 nystatin 201508 201405 obidoxime 201403 octenidine dihydrochloride + phenoxyethanol 202501 13 years 201406 (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 201505 omega-3 fatty acids 201401 201401 201504 201308 201309 201502 201408 201510 201512 201307 6 months 201406 201508 ouabain 201502 201510 oxacillin 201601 oxaliplatin 201504 201504 3 years oxamniquine 201409 201508 201511 (yearly PSURs) 201401 x 201512 201503 201308 201308 3 years 201406 201408 201403 201403 oxitropium 201310 oxolamine 201510 oxolamine + propyphenazone 201510 201502 oxomemazine combinations 201502 oxprenolol 201502 oxybuprocaine 201508 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 201512 201509 pamidronate 201305 201308 201505 3 years powder (Rizolipase) 201405 201403 pancreatic extracts 201405 pancreatin 201405 201401 pancreatin combinations 201405 pancrelipase 201410 pancuronium 201312 201312 3 years 201303 201303 pantoprazole 201508 pantoprazole + amoxicillin + clarithromycin 201508 papaverine 201309 papaverine + combinations 201309 papaverine + + 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 201511 201512 201601 201712 5 years patent blue V sodium 201304 201304 5 years 201408 201403 201403 penamecillin 201511 penciclovir (topical use only) 201408 penicillamine 201504 pentaerithrityl tetranitrate (pentaerythritol tetranitrate) 201512 isethionate 201506 201509 pentazocine combinations (except those with paracetamol) 201509 pentosane (elmiron) 201307 pentosane polyester + phenylephrine 201306 201505 201512 201312 201412 201504 201612 5 years (pericyazine) + propericiazine 201505 perindopril 201310 permethrine 201507 permethrine + piperonyl butoxide 201507 perphenazine 201302 (meperidine) 201303 petrolatum, mineral oil (ophthalmic) 201305 phenazone (antipyridine) 201409 201409 phenazone (antipyridine) + tetracaine 201506 201303 phenelzine 201505 201305 phenobarbital 201501 202501 13 years 201304 phenolphtalein 201409 phenoxymethylpenicillin 201510 201303 201401 201401 201306 201404 phenyl(2-hydroxybenzoate) 201403 201403 201302 201404 phenylephrine 201501 phenylsalicylate 201308 201501 202508 13 years phenytoin sodium + metylphenobarbital 201501 202504 13 years phloroglucinol 201509 phloroglucinol, trimethylphloroglucinol 201509 201505 201505 3 years phosphate ( 32P) sodium 201402 phytoestrol 201308 201410 picosulfate sodium 201312 201401 pidolate calcium 201510 pidolate calcium + calcium carbonate 201510 pidotimod 201310 201311 201507 pilocarpine (ophthalmic) 201408 pilocarpine + timolol 201302 (yearly PSURs) 201303 x 201403 1 year 201412 201302 201311 pindolol 201311 pioglitazone 201307 6 months pipamperone 201310 pipecuronium 201512 201412 piperacillin 201511 201601 piperacillin + tazobactam 201509 201402 pipobroman 201406 201303 piracetam 201504 201308 201303 201403 201504 201403 piritramide 201403 201404 201504 pitofenone 201401 pivampicillin 201410 pivmecillinam 201308 (pizotyline) 201307 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 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 + sodium iodide 201507 povidone 201411 povidone iodine 201310 201507 poyestradiol 201403 prajmalium 201412 pralidoxime 201407 pramocaine 201409 pramoxine (pramocaine) 201409 201312 201405 pravastatin 201403 201410 pravastatin + acetylsalicylic acid 201403 201512 praziquantel 201504 201503 201404 prednicarbate 201504 prednisolone 201306 201508 201305 201308 201401 1 year prenoxdiazine 201401 prilocaine 201412 prilocaine + adrenaline 201412 201506 202506 13 years pristinamycin (virginiamycin) 201303 201304 201406 201409 procarbazine 201503 procaterol 201312 201306 procyanidol oligomer (endotelon) 201505 201403 201504 202504 13 years 201312 proglumetacine 201402 proguanil 201509 201504 201501 201304 201308 202510 13 years 201312 201505 propantheline 201501 proparacaine 201403 201406 201511 201403 201711 5 years propranolol 201406 201509 propylthiouracil 201407 proscillaridin 201410 protamine 201601 201406 protirelin 201401 201410 pseudoephedrine 201410 pseudoephedrine + triprolidine 201410 pyrantel 201512 pyrazinamide 201302 pyridostigmine 201511 pyrimethamine 201508 pyritinol 201512 pyrrolidone carboxylate sodium 201401 pyrvinium 201308 201407 201506 quinapril 201404 201506 quinapril + HCT 201404 201506 quinfamide 201403 201601 quinine 201411 quinine combinations 201411 rabbit anti-humanthymocyte 201512 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 201601 3 years reboxetine 201304 remifentanil 201405 201605 5 years 201412 3 years reserpine 201512 resorcinol 201502 resorcinol + sulphur 201511 201403 1 year reviparin (heparin) 201501 ribavirin (yearly PSUR) 201307 x 201307 1 year 201510 rifampicin (rifampin) 201305 201403 rilmenidine 201508 201310 rimexolone (ophtalmic) 201310 risedronate 201403 201505 201705 5 years ritodrine hydrochlorid 201508 rizatriptan 201306 rocuronium 201402 201602 3 years 201407 201307 3 years 201509 201709 5 years 201312 rosuvastatin (yearly PSURs) 201311 x 201402 1 year roxatidine 201506 201412 201409 201307 6 months 201306 x rutoside (rutin) 201310 salbutamol (albuterol) 201401 201407 201402 salicylic acid + combinations 201509 salicylic acid and salts 201503 201509 salmeterol 201310 x 201510 5 years 201303 201503 201507 selenite sodium 201407 201402 201402 serrapeptase 201409 201507 (6-monthly PSURs) 201307 x 201403 201510 201401 silver 201403 silver protein 201311 silver protein acetyltannate 201311 201405 silver 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) (Ringer201403 [+ glucose]), including irrigation sodium chromate ( 51Cr) 201412 sodium citrate 201402 201402 sodium ibandronate 201406 3 years sodium iodide [l123] 201303 201603 3 years sodium iodide [I131] 201310 1 year sodium tetradecyl sulphate 201704 5 years 201406 somatorelin 201401 201506 201507 somatropin 201403 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 + 201502 streptokinase 201502 201304 streptozocin 201505 201305 6 months strontium (89Sr) chloride 201505 sucralfate 201507 201311 sufentanil 201511 201411 sulbactam 201311 201306 sulbutiamine 201502 201509 sulfabenzamide + + 201409 sulfacetamide 201507 sulfadiazine 201407 (sulfisoxazole) 201408 201601 sulfamethopyrazine () + pyrimethamine 201507 201408 sulfamethoxazole / Trimethoprim 201506 201404 201312 201409 sulfisoxazole 201408 201406 sulphur 201511 sulphur + triclosan 201511 201501 201412 201304 sultamicillin 201311 202501 13 years 201410 sumatriptan 201409 201409 5 years suxamethonium 201408 201408 3 years tacalcitol 201407 (yearly PSURs) 201303 x tacrolimus (systemic formulations) 201503 3 years tacrolimus (topical formulations) 201403 1 year tafamidis 201305 6 months talinolol 201310 201504 201412 201407 201405 tauroselcholic acid [75Se] 201601 tazarotene 201412 technetium (99mTc) albumin nanocolloid 201511 technetium (99mTc) bicisate 201310 technetium (99mTc) DMSA 201505 technetium (99mTc) macrosalb 201302 technetium (99mTc) mebrofenin 201511 technetium (99mTc) oxidronate 201303 technetium (99mTc) pentetate 201511 technetium (99mTc) sestamibi 201512 technetium (Tc-99m) pyrophosphate 201402 technetium (Tc-99m) tiatide 201405 tegafur 201412 teicoplanin 201411 201611 5 years telmisartan 201304 1 year 201411 temocillin 201410 teniposide 201304 tenoate sodium 201505 tenoate sodium + eucalyptus + paracetamol 201505 201502 201502 3 years tenofovir 201403 1 year 201511 201501 201509 201510 201709 5 years terbutaline 201412 201306 201512 201412 201412 202501 13 years maleate 201311 201504 tertatol 201410 testosterone (implants) 201309 testosterone propionate, testosterone phenyl propionate and testosterone iso hexanoate201309 and testosteronedecanoate testosterone, testosterone undecanoate (oral) 201309 tetrabenazine 201410 tetracaine 201506 tetracosactide (cosyntropin) 201405 tetracycline 201511 201406 201505 201411 tetrofosmin 201505 tetryzoline 201406 201406 201310 1 year thallous [201Tl] chloride 201508 theophylline 201506 thiamazole (methimazole) 201307 201508 201008 thiamphenicol 201505 201412 201303 thioguanine 201501 thiopental 201403 thioperazine () 201512 201302 thiotepa 201503 thiothixene 201507 201503 thymol + levomenthol + salol 201404 thyroglobulin 201408 thyrotricine (or tyrothricin) 201408 201408 thyrotropin releasing hormone (synthetic) 201302 thyroxine 201312 thyroxine combinations 201512 201506 201506 3 years 201506 201507 201408 tibenzonium iodide 201312 201312 ticarcillin 201309 ticarcillin + clavulanate 201309 tice BCG (BCG vaccine) 201508 201305 201501 tigecycline 201406 3 years tilactase 201511 tilidine 201304 201307 tiliquinol + 201511 tiludronic acid 201502 201502 3 years timolol (opthalmic preparations) 201407 201512 201506 tinidazole + nystatin 201506 tinidazole + 201506 tinzaparine 201302 tioconazole 201404 tiopronine 201508 201403 tiotropium 201410 201305 tiropramide 201312 201311 201512 tobramycin 201410 tobramycin (for inhalation) 201412 tobramycin (ophtalmic drops) 201403 201408 201407 201508 201501 tolnaftate 201510 tolnaftate + nystatine 201510 tolnaftate + triclosan 201510 201511 201309 201501 201701 5 years topotecan 201505 3 years torasemide 201511 201505 tosylchloramide 201303 201405 201310 201405 3 years tramadol + paracetamol 201508 201508 3 years tramazoline 201312 trandolapril 201402 trandolapril + 201303 tranexamic acid 201601 201409 201609 5 years 201406 201308 201505 3 years tretinoin 201501 tretinoin + tocopherols 201408 tretinoin (topical formulations) 201708 5 years acetonide 201507 triamcinolone combinations 201507 triamterene 201506 201506 201507 201504 tribenoside + lidocaine 201401 triclabendazole 201510 triclorcarban 201409 triclosan 201511 tricoflos 201308 tridecanamine undecylenate 201601 triethanolamine salicylate 201601 201310 201501 201303 201408 201312 201309 201505 trimebutine + ruscogenin 201505 201405 trimepiridine 201502 trimetazidine 201502 201308 6 months trimethoprim 201506 201506 201410 201502 triptorelin 201503 201407 201403 201502 trospium 201409 troxerutine 201406 201406 + zinc undecylenate 201305 201509 urapidil 201507 urea 201304 urea (13C) 201302 urofollitropin 201503 201312 ursodeoxycholic acid 201411 201411 valaciclovir 201512 valganciclovir 201409 valproic acid (incl. salts) 201501 201404 201501 3 years 201307 202507 13 years valsartan (6-monthly PSUR cycles for the paediatric indication only) 201304 x 201304 valsartan + HCT 201404 201501 201502 201501 5 years 201305 1 year 201306 vecuronium bromide 201311 201311 3 years 201505 verapamil 201601 201502 hydrochloride 201308 1 year (yearly PSURs) 201309 x 201409 3 years viminol 201408 vinblastine 201410 201410 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 201302 vitamin D + calcium (oral) 201307 vitamin D3 201307 vitamin E 201511 vitamins and vitamin combinations (incl dexpanthenol and minerals) 201510 201402 1 year 201505 202505 13 years xipamide 201407 201601 xylometazoline 201405 201310 201505 201305 1 year 201512 201712 5 years zanamivir (yearly PSURs) 201401 x zidovudine 201503 zinc salts 201407 201407 201307 x zofenopril 201401 zofenopril + HCT 201502 zolmitriptan 201503 201306 201509 201403 1 year 201505 201409 201312 201305