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