1

2345678910

111213141516

171819202122232425262728293031

A B C D E F

Active substance name (INN) Innovator brand name (for fixed combination products

only)

Proposed EU birth date

Next DLP Firm's Name Comments

aceclidine 19660406 201004 MSDacemetacin 200810acenocoumarol 19550706 201107 Novartisacetazolamide 19551026 201012 Sanofi Aventisacetic acid 19640928 200909 J&Jacetylcarnitine 201012 same DLP as carnitineacetylcholine 19650609 201106 Novartisacetylcysteine 19630914 200909 BMSacetylcysteine + tuaminohelptane 19701203 200909 Zambon

acetyldigoxin 201010 same DLP as digoxinacetyldigoxin combinations 201010 same DLP as digoxinacetylsalicylic acid 19570105 201002 Bayeracetylsalicylic acid combinations 201002acexamic Acid 19680412 201104 Sanofi Aventisacriflavinium chloride + menthol + resorcinol

200811

acrivastine 200912adrenalin+lidocaine 200903 same DLP as lidocaineadrenaline 19780125 201103 UCBadrenaline + prilocaine Citanest -Adrenaline 19630101 200812 AstraZenecaaescin + diethylamine salicylate 200904 Bayeralcohol polyvinilicus 201101alfacalcidol 200902algeldrate 201001alibendole 19701019 201010 Sanofi Aventisalimemazine 19560605 200912 Sanofi Aventisallantoin 201011allantoin + combinations 201011allopurinol 19660101 200912 GSKallopurinol + benzbromarone 200912

Draft additional list of EU HBDs and DLPs, alphabetic order, version 20080422

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

3233343536

37

3839404142434445464748495051525354555657

585960

alpha amylase 19670606 201006 Sanofi Aventis

alpha amylase + bacitracine Maxilase Bacitracine 201006alpha chymotrypsin 19590703 200907 Sanofi Aventisaltizide 200911altizide + spironolactone 200911aluminium +/or calcium +/or magnesium antacids

201001 All antacids have the same DLP

aluminium acetotartrate+ methylcitrine

Cataplasmeà l'acetotartrate d'alumine / GEL D'ALUMINE

19550302 200903 Sanofi Aventis

alverine 19500210 201002 Sanofi Aventisalverine + simeticone METEOSPASMYL 19900605 201002 Mayoly Spindleramantadine 19651214 200912 Novartisambazone 200908ambenonium 19561214 200812 Sanofi Aventisambroxol + clenbuterol 200809ambroxol + doxycycline 200809amidotrizoate 201011amiloride 19690425 201012 MSDamiloride + chlortalidone 19690425 201012amiloride + furosemide 19690425 201012amiloride+ hydrochlorthiazide 19690425 201012 MSDaminohippurate 19630224 201012 MSDaminophylline 19630224 201012 Recordati S.p.A.amiodarone 19661220 200812 Sanofi Aventisamitriptyline 19610731 201007 Lundbeckamitriptyline + amitriptylinoxide 19610731 201007 Sanofi Aventisamitriptyline + perphenazine 19610731 201007amitriptylinoxide 201007ammonium chloride combinations 200911 same DLP as Ipecacuanha

amoxapine 200912amoxicillin 19720307 200903 GSK

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

616263

6465666768697071

72

73

7475767778798081

82838485868788

amoxicillin + clavulanate Augmentin 19720307 200903 GSKamoxicillin + metronidazole 19720307 200903amphetamine 201001amphetamine + extroamphetamine 201001

amphotericin B 19580319 200903 BMSampicillin 19660219 200902 Pfizerampicillin + cloxacillin 200902ampicillin + sulbactam Unasyn IM/IV 19831129 200902 Pfizeramrinone 19840102 200901 Sanofi Aventisamyl nitrite 19730131 200812 UCBamyleine + chlorhexidine 201008 same DLP as chlorhexidineamylmetacresol + dichlorobenzyl alcohol

201107

amylmetacresol + dichlorobenzyl alcohol + levomenthol

201107

amylmetacresol + dichlorobenzyl alcohol + lidocaine

201107

antazoline 200810antazoline + naphazoline Antistin-Privin 19610601 200810 Novartisantazoline + tetryzoline Spersallerg 19721003 200810 Novartisantazoline + xylometazoline Otrivin/Otrivine-antistin 19660101 200810 Novartisantipyrine + tetracaine 200906 same DLP as tetracaineapraclonidine 19670816 201105 Alcon Lab. same DLP as clonidinearticaine 19750429 200904 Sanofi Aventisarticaine + adrenaline ULTRACAIN DS /

SUPRARENINA 19750429 200904 Sanofi Aventis

astemizole 201107atenolol 19760219 201002 AstraZenecaatenolol + indapamide 201002atropine 19450831 200808 Novartisatropine+diphenoxylate Lomotil 19600929 201009 Pfizerattapulgite 19621114 201011 IPSEN

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

899091929394959697

9899

100101102103104105

106107

108

109110111

112

attapulgite+ aluminium hydroxide and magnesium carbonate co-dried gel

Gastropulgite 19670221 201001 IPSEN

aureomycine 19920818 201003 UCBaurothiomalate 19470729 201007 Sanofi Aventisazathioprine 19651213 200812 GSKazulenolum 200911bacampicillin 200902 same DLP as amplicillinbacillus Cereus 19530101 201011 Sanofi Aventisbacitracin 19620402 200812bacitracin + chlorhexidine 200812bacitracin + colistimethate sodium + hydrocortisone acetate

19620402 200812 MSD

bacitracin + neomycin 200812bacitracin + neomycin + prednisolone

200812

baclofen 19630116 200809 Novartisbacterial Lysate IRS19, Imudon 19880119 201101 Solvaybamifyline 19780206 201101 UCBbamipine 200810barbexaclone 19661004 201010 Abbottbarium sulphate + combninations Micropaque, Micropaque

Colon, Micropaque Scanner, Micropahe H.D. oral, Microstat

201004 Guerbet

beclomethasone 19661231 200812 GSKbelladona alkaloids, ergotamine, phenobarbital

Bellergal 19340115 201101 Novartis

belladonna extract + hyoscyamine + papaverine

Antispasmina Colica 19500221 201012 Recordati S.p.A.

bendazac 19681109 200910 ACRAF S.p.A.bendrofluazide 19610526 201005 Pfizerbendroflumethiazide + spironolactone

200911

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

113114115

116

117

118

119

120

121

122

123

124

125126127128129

130131

132

benorilate 197504 201103 UBCbenserazide + levodopa 200910benzalkonium chloride 200810benzalkonium chloride + benzyl alcohol + chlorhexedine

200810 same DLP as benzalkonium chloride

benzalkonium chloride + cetrimide 200810 same DLP as benzalkonium chloride

benzalkonium chloride + chloroxylenol + disodium edetate

200810 same DLP as benzalkonium chloride

benzalkonium chloride + dequalinium chloride

200810 same DLP as benzalkonium chloride

benzalkonium chloride + dimethicone

200810 same DLP as benzalkonium chloride

benzalkonium chloride + dimethicone + hydrocortisone + nystatin

200908 same DLP as nystatin

benzalkonium chloride + hexylresorcinol

200810 same DLP as benzalkonium chloride

benzalkonium chloride + lidocaine 200903 same DLP as lidocaine

benzalkonium chloride + oxymetalozine

201008 same DLP as oxymetalozine

benzalkonium chloride + tolnaftate 200810 same DLP as benzalkonium chloride

benzatropine 201003benzbromarone 200901benzethonium chloride 201005benzocaine 200907benzocaine + Cetylpyridium chloride 200907

benzocaine + chlorhexidine 200907benzocaine + dequalinium hydrochloride

200907

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

133134135136137138139

140

141142143

144145

146

147

148149150151152153154155156157158

benzocaine + tyrothricin 201106 same DLP as tyrothricinbenzododecinium bromide 201006benzoyl peroxide 201104benztropine mesylate 19590713 201007 MSDbenzydamine 19640710 200910 ACRAF S.p.A.benzylbenzoate 201002benzylnicotinate 200904benzylnicotinate + hydroxyethyl salicylate

200904

benzylnicotine + camphora + dimethyl sulphate + turpentine oil

Capsicam 201003 JSC Grindeks

benzylpenicillin 19531215 200808 Pfizerbenzylpenicillin combinations 19531215 200808benzylpenicillin potassium + benzylpenicillin procaine

200808

benzylpenicillin procaine 200808benzylpenicillin procaine + benzylpenicillin sodium +

200808

benzylpenicillin procaine + benzylpenicillin sodium + benzathine penicillin

200808

benzylpenicillin sodium, kanamycin sulfate

200808

betacardone 19921014 201011 UCBbeta-carotene 201004betahistine 19680516 200812 Solvaybetaine citrate 19760719 200907 BMSbetamethasone 19610925 200909 GSKbetamethasone + gentamicin 200909betamethasone + salicylic acid 200909bezafibrate 200905bile acids and salts 201008biperiden 19550816 201008 Abbott

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

159160161162

163164165166167

168169170171172173174175176177178179180181182183

184185

bisacodyl 19540601 201004 BIbisacodyl combinations Prepacol 201004 Guerbetbismuth salts and combinations 200906bisulepin 201009bleomycin 19700318 201103 Baxter and Sanofi

Aventisbretylium 19910129 200904 UCBbromazepam 200812bromelains 19680330 201012 Sanofi Aventisbromhexine 19630701 201101 BIbromhexine+eucalypti etheroeum+ainisi aetheroleum+foeniculi etheroleum+levomentholum+menthae piperitae eleum+origani etheroleum

Bronchosan 201101 Slovakofarma same DLP as bromhexine

bromocryptine 19751015 200910buclizine 19530701 201008 UCBbufexamac 200812bufexamac+lidocaine 200812buformin 201010bumetanide 200910bupivacaine 19660427 200910 AstraZenecabupivacaine+adrenaline Marcaine - Adrenaline 201104 AstraZenecabusulphan 19540125 200901 GSKbutamirate 201011butylscopolaminium 201012cafedrine 201011caffeine 19690414 201002 Merck Seronocaffeine+diphenhydramine 200903 same DLP as diphenhydraminecaffeine+ergotamine Cafergot 200911 Novartiscaffeine+isometheptene+metamizole

200904

caffeine+phenazone 200809

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

186

187188189190

191192193194195

196

197

198199200201

202203204205206207208209210211212213

calcipotriol 201101calcium +/or aluminium +/or magnesium antacids

201001 All antacids have the same DLP

calcium acetate 201007calcium carbonate+vitamin d3 201007calcium chloride 201007calcium glubionate+calcium lactobionate

201007

calcium gluconate 201007calcium glutarate 201007calcium hydrogen phosphate 201007calcium lactate 201007calcium lactate+calcium phosphate+vitamin d3

201007

calcium salts not used in antacids or vitamin preparations

201007

calcium+dexamethasone+ lidocaine 200903 same DLP as lidocaine

calcium+lidocaine 200903 same DLP as lidocainecamphor 200905camphor+combinations Vicks 19050222 200905 Pfizercandesartan+hydrochlorothiazide 200904

canrenoate 19720921 200809 Pfizercapreomycin 19680119 201101 Eli Lillycapsaicin 19970614 200809 Cephalon Europecarbachol 19651110 201001 Alcon Lab. carbaethopendecinium 201103carbamazepine 19611212 200912 Novartiscarbasalate calcium 19810716 201002 BMScarbazochrome 19510319 200903 Sanofi Aventiscarbenicillin 19700806 200808 Pfizercarbidopa 19731013 200910 MSDcarbidopa+levodopa 19730813 200910 MSD

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

214215216217218219220221222223224225226227228229230231232233234235236237

238239

240241

242243244

carbimazole 200906carbocisteine 19630914 200909 BMScarbocisteine+prenoxidiazine Broncofluid 200909 Recordati S.p.A.carbolevure 19690331 201002 UCBcarisoprodol 201105carmustine 19740423 200904 BMScarnitine 19841027 200906catalase+neomycin Pulvo Neomycin 200812 Solvaycefaclor 19760819 200808 Eli Lillycefadroxil 19760712 200907 BMScefazolin 19721129 200811 Pfizercefonicid 201106cefpiramide 201107cefsulodin 19801030 201010 Takedacephalexin 19670315 201103 Eli Lillycephapirin 19721215 201012 BMScephradine 19711123 200811 BMScernitin 201011certoparin 201107cetalkonium+choline salicylate 201003cetalkonium+lidocaine 200903cetirizine+pseudoephedrine 19950904 200911 UCBcetrimide+chlorhexidine 201008cetylpyridinium 19390323 200907 Sanofi Aventiscetylpyridinium+dequalinium chloride

200907

cetylpyridinium+lidocaine 200907cetylpyridinium+vitamin c (ascorbic acid)

200907

charcoal activated 19490406 200908 Merck Seronochenodeoxycholic acid+ursodeoxycholic acid

200811

chlorambucil 19560914 201009 GSKchloramphenicol 19490625 201006 Pfizer

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

245

246

247248249250251252253254

255

256257258259260261262263264

265266

267

268

269

chloramphenicol+combinations 201006 Pfizerchlordiazepoxide 19600131 200901 Valeant

Phamaceuticals Ltdchlordiazepoxide+combinations Librax, Limitrol 200901 Valeant

Phamaceuticals Ltdchlorhexidine 19760811 201008 UCBchlorhexidine+dexpanthenol 201010 same DLP as dexpanthenolchlorhexidine+lidocaine 200903 same DLP as lidocainechlorhexidine+neomycin 200812 same DLP as neomycinchlorhexidine+sodium fluoride 201106 same DLP as sodium fluoridechlorhexidine+tolnaftate 200910 same DLP as nolnaftatechlormadinone 19741118 200911 Sanofi Aventischlormadinone acetate+ethinylestradiol

Belara, Balanca, Marnie, Chariva, Balianca, Lybella, Libeli

200811 Grünenthal DE is RMS, 6-monthly PSURs

chlorobutanol+levomenthol+thymol+pine oils+terpineol

Karvol 200911

chlorocresol combinations Cicatryl, Cyteal 200912chloropuramine 201108chloropyramine 201108chloroquine 19460815 201002 Sanofi Aventischlorothiazide 19571119 201011 MSDchloroxine 201108chloroxylenol 201004chloroxylenol+disodium edetate 201004chloroxylenol+edetic acid+trlosan 201004

chlorphenamine 201009chlorphenamine+ dextromethorphan 201009

chlorphenamine+ pseudoephedrine 201009

chlorphenamine+ammonium chloride+butatemate

201009

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

270

271272273274275276277278279280281282

283284285286287288289290291292293294295296297

298

chlorphenamine+ephedrine Fienamina 201009 Recordati S.p.A.chlorpheniramine+dextromethorphan+pseudoephedrine

Rinodeks 200910 JSC Grindeks

chlorpromazine 19520529 201105 Sanofi Aventischlorpropamide 19581119 201011 Pfizerchlorprothixene 19590331 201003 Lundbeckchlortalidone 19590624 201006 Novartischlortalidone+reserpine Hygroton-Reserpine 201006 Novartischlortetracycline 19740108 200908 UCBchlorthalidone+metoprolol Logroton 200902 Novartis same DLP as metoprololchlorthalidone+oxprenolol Trasitensin 200902 Novartis same DLP as oxprenololchlorxylenol+dibucaine Xilen 201005 Recordati S.p.A.chlorzoxazone 200905chlorzoxazone+paracetamol Parafon Forte 200905 J&Jcholecalciferol concentrate+sodium fluoride

Fluor-Vigantoletten 200912 Merck Serono

cholestyramine 19650402 200904 BMScholine salicylate 19631210 201003 Napp Pharmac.chondroitin+glucosamine Many 200811chromium 19751130 200811 GE Healthcareciclopirox+ciclopir oxolamine 19750402 201104 Sanofi Aventiscilastatin 200902cilnidipine 19950929 200909 UCBcilostazol 200908cimetidine 19761109 200811 GSKcimetidine+sodium alginate 200811cinchocaine 201104cinnarizine 19611031 200910 J&Jcinnarizine+piracetam 200910citicoline 19661231 200912 Takedacitral+terpinol+sylvestre pine oil+serpolet oil

BRONCHORECTINE FOR INFANT, suppository

200808 Mayoly Spindler

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

299

300

301

302303304305306307308309310311312313314315316317

318319320321322323324325

citric acid+glycerol+honey+lemon oil+syrup

200903

citric acid+magnesium sulfate+sodium bicarbonate

200903

citric acid+sodium bicarbonate+sodium carbonate

200903

citric acide+sodium bicarbonate +sodium carbonate+sodium citrate dihydrate

200903

clavulanic acid 201009clemastine 201010clindamycin 19691016 200910 Pfizerclobazam 19700206 201002 Sanofi Aventisclobetasol 19730221 201002 GSKclobetasone 19750917 200909 GSKclobutinol 201004clofazimine 19690424 201004 Novartisclofibrate 200912clomethiazole 19591101 200910 AstraZenecaclomiphene 19620401 201004 Sanofi Aventisclomipramine 19651018 200810 Novartisclonazepam 201006clonidine 201105clonixin 19750228 201002 Sanofi Aventisclopamide+dihydroegocrystine+ reserpine

Brinerdin 200811 Novartis

clopamide+pindolol Viskaldix 200811 Novartiscloperastine 19810812 201107 Zambonclorazepate 19660803 200908 Sanofi Aventiscloroxine 200911clothiapine 19660615 200906 Novartisclotrimazole 200909clotrimazole+dexamethasone 200909 same DLP as clotrimazole

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

326327328329330331332333334335336337338339

340

341

342343

344345346347348

349350351

352

clotrimazole+hydrocortisone 200909 same DLP as clotrimazoleclotrimazole+zinc oxide 200909 same DLP asclotrimazolecloxacillin 19620105 200901 BMSclozapine 19691024 200910 Novartiscoal tar 201106coal tar derivative 201106coal tar+alcoholic extract 201106coal tar+soya oil 201106cobamamide 19691127 201012 Recordati S.p.A.cocaine 200912cod liver oil 201004 Same DLP as fish oil+zinc oxidecod liver oil+zinc oxide 19450411 201004 Sanofi Aventisco-danthrusate 19911126 201104 UCBcodeine 19540906 200809 Pfizercodeine polysulfonate +phenyltoloxamine polysulfonate

Codipront 19660808 200809 Pfizer

codeine polysulfonate +phenyltoloxamine+guaifenesin

Codipront Retard Cum Expectorans

19730116 200809 Pfizer

codeine polysulfonate +phenyltoloxamine+guaifenesin+ thyme

Codipront Retard Cum Expectorans

19700911 200809 Pfizer

codeine polysulfonate resin Codipront Mono 19750217 200809 Pfizercodeine+chlorpheniramine+ ephedrine

Corex 200809 Pfizer

codeine+creosote 200809codeine+diclofenac Combaren 200809 Novartiscodeine+diphenhydramine 200809codeine+erysimum EUPHON, syrup 200809 Mayoly Spindlercodeine+guaifenesin+ephedrine hydrochloride

200809

codeine+ibuprofen 200809co-dergocrine Hydergine 200904 Novartiscolchicine 19470730 201007 Sanofi Aventis and

opocalcium lab

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

353354355356357358359360361362363364365366367368369370371372373374375376377378379380381382383384385386

colchicine+tiemonium+opium COLCHIMAX, tablet 201007 Opocalcium labcolecalciferol+calcium CALCIDOSE VIT.D, sachet 201010 Opocalcium labcolestipol 19760603 201006 Pfizercolestyramine 200905colistimethate 19621008 201012 Grünenthalcolistine 19560623 201012 UCBcollagenase 19691212 201012 Abbottcomfrey extract+methylnicotinate Kytta-Balsam F 200812 Merck Seronocortisone 19520618 200908 Sanofi Aventiscortivazol 19700501 201004 Sanofi Aventiscotrimoxazole 19690501 200905 GSKcromoglicic acid 19690201 200902 Sanofi Aventiscrotamiton 201007cyamemazine 19730922 200912 Sanofi Aventiscyanocobalamin 19640101 200810 Pfizercyanocobalamin combinations 19571015 200810 Pfizercyclizine 201001cyclopenthiazide 19610111 201101 Novartiscyclopentolate 19570219 201102 Alcon Lab. cyclophosphamide 201102cyproheptadine 201003cyproterone 201005cyproterone+ethinylestradiol 200808cytarabine 19690417 201104 Pfizerdactinomycin 19630701 200906 MSDdanazol 19740610 200906 Sanofi Aventisdantrolene 19740131 200901 Procter & Gambledantrone+poloxomer Co-danthramer 19880809 201004 Napp Pharmac.dapiprazole 19850806 200910 ACRAF S.p.A.dapsone 201005dapsone+ferrous oxalate 19740101 201005 Sanofi Aventisdaunorubicin 19660608 200906 Pfizerdecamethrin+piperonyl 201006deferoxamine 19621201 200812 Novartis

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

387388389390391392393394395396

397398399400401

402403

404

405

406407408409410411

412

dehydrocholic acid 201006delapril 19890117 200901 Takedadelapril combinations 19890117 200901 Takedadelorazepam 201008deltamethrin 201107demoxytocin 201012 JSC Grindeksdequalinium chloride 200907dequalinium chloride+lidocaine 19620601 200907 Sanofi Aventisdesipramine 19620115 200902 Novartisdeslanoside 19381215 200903 Novartisdesmopressin 197212 200812 Ferring

Pharmaceuticals ASdesonide 201008desoximetasone 19680123 200907 Sanofi Aventisdesoxycortone acetate 19570101 201004 Sanofi Aventisdexamethasone 19520101 201101 Alcon Lab. dexamethasone+framycetin+gramicidin

SOFRAMYCINE / SOFRAMYCINE HYDROCORTISONE / SOFRADEX / SOFRACORT

19540810 201101 Sanofi Aventis

dexamethasone+neomycin 19590831 201101 MSDdexamethasone+neomycin+ polymyxin b

Maxitrol 19520101 201101 Alcon Lab.

dexamethasone+neomycin+acetic acid, glacial

201101

dexamethasone+polymyxin b +trimethoprim

Otix 19520101 201101 Alcon Lab.

dexamethasone+tobramycin 201101dexamphetamine 19921013 201004 UCBdexetimide 19711001 201010 J&Jdexpanthenol 201010 Bayerdexpanthenol combinations 201010 Bayerdextran70+hydroxypropylmethyl cellulose

Tears Naturale 19760501 201105 Alcon Lab.

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

413414

415416417418419420421422423424

425426427428429430

431432

433434435436

437438439440

dextranomer 201009dextrometorphan 201106dextrometorphan combinations RHINATHIOL

TOUX SECHE / TUSSORHINATHIOL

19671215 201106 Sanofi Aventis

dextropropoxyphene 19620605 201006 Sanofi Aventisdiacethylmorphine 201010diazepam 19621206 200812 Pfizerdiazoxide 19721229 201004 Schering Ploughdibenzepine 19640515 200905 Novartisdibromopropamidine 19590116 201101 Sanofi Aventisdibucaine 201011dicloxacillin 19610224 200902 BMSdicycloverine 201102diethylamine salicylic acid+myrtecaine

Algesal Forte 19671120 200811 Solvay

diethylcarbamazine 19740109 200908 Sanofi Aventisdiethylstilbestrol 201101digitoxin 19520911 200903 Merck Seronodigoxin 19301101 201010 GSKdihydralazine 19530323 200903 Novartisdihydralazine+hydrochlorothiazide+reserpine

Adelphan-Esidrex 19590615 200903 Novartis

dihydrocodeine 19211111 200811 Abbottdihydroergocristine+esculinum +rutoside

Anavenol 201102

dihydroergotamine 19460701 200904 Novartisdihydroergotamine+etilefrine Dihydergot Plus 19820319 200904 Novartisdihydroergotamine+oxytocin Syntometrine 19600615 200904 Novartisdihydroergotoxin+hydrochlorothiazide+reserpine

200904 same DLP as dihydroergotoxine

dihydroergotoxine 200904dihydrotachysterol 19590401 201003 Merck Seronodiiodhydroxyquinoline 201103

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

441442443444445446447448449450451452453454455456457458459460461462463

464465466467468469470471472473

diisopropylamine 201105dimefline 19740412 201012 Recordati S.p.A.dimenhydrinate 19500210 200910 Braccodimethoxanate 19610301 201105 Sanofi Aventisdimethyl sulfoxide 201106dimeticone 19651117 201104 Pfizerdimeticone combinations Pepsane 201104 Rosa Phytopharmadinoprost trometamol Minprostin F2 Alpha Amp. 19730508 201005 Pfizerdinoprostone 19720926 201009 Pfizerdiosmectite 19751112 201011 IPSENdiosmine 201005diosmine+hesperidine 200903 GSKdiphenhydramine 200903diphenhydramine combinations 200903dipyridamole 19591111 201012 BIdisopyramide 19670418 201104 Sanofi Aventisdisulfiram 19710304 201103 Sanofi Aventisdixyrazine 19610401 200904 UCBdobesilate calcium 201007docusate 200911dopamine 19751009 200810 Solvaydopexamine 19891113 200809 Cephalon Europedornase alfa+fibrinolysin Fibrolan 19620509 201004 Pfizerdornase alfa+fibrinolysin+ chloramphenicol

Fibrase 19620423 201004 Pfizer

dosulepin 19730417 201104 Abbottdoxepin 19680301 200903 Pfizerdoxorubicine 19711015 200910 Pfizerdoxycycline 19670505 201005 Pfizerdoxylamine 201102 Bayerdrofenine+propyphenazone Spasmo-Cibalgin 19370727 201108 Novartisdroperidol 201004droperidol+fentanyl Thalamonal 19740814 201004 J&Jdropropizine 201107

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

474475476477478479480481482483484485486487488489490491492493494495496497498499

500501502

503504

drotaverin 19621229 201012 Sanofi Aventisdydrogesterone 19600422 201104 Solvayeflornithine 19900101 201008 Sanofi Aventisembramine 201108enflurane 19720429 201104 Abbottenoxaparin 19870403 200904 Sanofi Aventisepervudine 201108ephedrine 200906ephedrine combinations 200906epitizide+triamterene 200811erdosteine 200902ergometrine 20011007 200811 UCBergometrine+oxytocin 200811erythromycin 19540311 200903 Abbottesbiothrin 201009 Bayeresculoside 200904esmolole 19861231 200812 Baxterestazolam 19750430 200904 Takedaestradiol and testosterone Estandron prolongatum 19760301 201102 Organonestradiol+dydrogesterone Femoston 19950222 201102 Solvayestramustine 19710519 201105 Pfizerestriol Ovestin 19570101 201012 Organonestrogen 200908estropipate Ogen 0.625 19770519 200905 Pfizeretacrynic acid 19650514 200905 MSDetamsylate 19870422 201104 Sanofi Aventisethambutol+isoniacid+ pyrazinamid +rifampicin

200908

ethionamide 19610608 201106 Sanofi Aventisethosuximide 19600624 200906 Pfizerethyl esters of iodised fatty acids from poppyseed oil

Lipiodol Ultra-FluidLipiodol 190

201001 Gerbet

ethynylestradiol+lynestrenol 200808

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

505506507508509510511512513514515516517518519520521522523524525

526527

528529530531532533

534535

etilefrine 19520417 201012 BIetofenamate 201006etofylline 200911etoperidone 19760211 200910 ACRAF S.p.A.etynodiol 19721025 200902 Pfizeretynodiol+ethynylestradiol Demulen 1/50-28 19700424 200902 Pfizeretynodiol+mestranol Metrulen 19650212 200902 Pfizereucalyptol 200909eucalyptol combinations 200909fenofibrate 201107fenoldopam 200912fenoprofen 201001fenoterol 201002 BIfenticonazole 19860416 201012 Recordati S.p.A.ferric gluconate 201003ferrous salts 19490101 200901 Sanofi Aventisferrous+folic acid Ferro Gyn 19990330 200901 Schwarz Pharmaflavoxate 19670804 201012 Recordati S.p.A.floctafenine 19720705 201107 Sanofi Aventisfluanisone 19861001 201010 Sanofi Aventisflucloxacillin 19700303 200903 GSKflucytosine 19751001 200909 Valeant

Phamaceuticals Ltdfludrocortisone 19541028 201010 BMSfludrocortisone+gramicidin+ neomycin

200812 same DLP as neomycin

fluindione 19690902 200809 Procter & Gambleflumetasone 19640101 201106 Novartisflumetasone+clioquinol Locacorten Vioform 19660215 201106 Novartisflunisolide 19820825 201012 Recordati S.p.A.fluocinolone 19650226 201012 Recordati S.p.A.fluocinolone+metronidazole+ nystatin

200811 Bayer same DLP as metronidazole

fluorescein 19610412 201104 Alcon Lab.

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

536537

538539540541542543544545546547548549

550551552553554555556557558559560561562563564565566567

fluorescein+oxybuprocaine Colircusi Fluotest 19610412 201104 Alcon Lab. fluoride 200901fluoride sodium + strontium acetate hemihydrate

201106

fluoride+malic acid 200901 same DLP as fluoridefluoride+monofluorophosphate 200901 Procter & Gamblefluorometholone 19720501 201012 Alcon Lab. fluorometholone+gentamicin Infectoflam 19940101 201012 Novartisfluorometholone+tetryzoline Efemoline 19771019 201012 Novartisfluorouracil 19771216 200812 Pfizerflupentixol 19651130 201011 Lundbeckflupentixol+melitracene Deanxit 19710131 201011 Lundbeckfluphenazine 19591218 200912 BMSflupirtine 201005fluprednidene+miconazole 201102 RBflurazepam 19730302 200903 Valeant

Phamaceuticals Ltdfluspirilene 200906folic acid 19471213 200906 Sanofi Aventisfolic acid+nicotinamide 200906folinic acid 201004fosphenytoin 19960805 201108 Pfizerframycetin 200902furazolidone 201010furosemide 19610101 201104 Sanofi Aventisfurosemide combinations 19610101 201104 Sanofi Aventisgabapentin 19930205 201002 Pfizergalantamine 200902 SE=RMS; yearly PSURsgallium 19720331 200903 GE Healthcaregallopamil 19861230 201012 Abbottganciclovir 19901107 201012gelatin Absorbable 19471111 200811 Pfizergemcitabine 19950112 201001 Eli Lillygemfibrozil Lopid 19810601 200906 Pfizer

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

568

569570571

572573574575576577578579580581

582583584

585586587

588589590591592593594

gentamicin 19660907 200903 Merck Seronoginkgo biloba extract + heptaminol hydrochloride + troxerutin

Ginkor Fort, Ginkor Procto, Perivar forte

19701009 201104 IPSEN

glibenclamide (micro) Daonil N / Euglucon 19820218 200902 Sanofi Aventisglibenclamide (non micro) 19690205 200902 Sanofi Aventisglibornuride Glutrid 19710801 201007 Valeant

Phamaceuticals Ltdglipizide Glibenese 19710101 201001 Pfizergliquidone Glurenorm 19690916 200808 BIglucosamine 19960731 200903 Rottapharm S.p.A.glutethimide 2002 200905glyceryl trinitrate 19580901 200808 GSKglycine 201007glycopyrronium 200911gonadorelin 201011gramicidin 200812gramicidin, neomycin ,naphazoline, phenylephrine

Neo-priphen 19560517 200812 Minerva Pharmaceutical

same DLP as neomycin

griseofulvin 19590716 201007 GSKguafenesin + pseudoephedrine 200901 GSKguafenesin + pseudoephedrine + triprolidine

200901 GSK

guaifenesin 200901halcinonide 19730514 200905 BMShaloperidol, haloperidol decanoate, haloperidol buzepide

Haldol, Haldol Decanoas, Vesadol

19600424 201101 J&J

halothane 201107heparin Heparin 19390331 200903 Sanofi Aventisheparin combinations 200903heparinoid 201001heparinoid + ibuprofen 201001heptaminol 19650128 200901 Sanofi Aventis

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

595

596597

598599600

601602603

604

605606

607608

609

610611612613614

615616617618

hexamidine Hexomedine 19510329 200909 Sanofi Aventis

hexamidine + isetionate+ lidocaine HCL

19510329 200909 Sanofi Aventis

hexamidine + tetravacaine 19510329 200909 Sanofi Aventishexaminolevulinate hydrochloride 20040917 200903 GE Healthcare

hexetidine 201007hexylresorcinol 200810human chorionic gonadotropin (HCG)

Pregnyl 19320630 201006 Organon

hyaluronate sodium 201108hyaluronidase 200905 Sanofi Aventishydralazine Apresoline

(tabs+amps)19520313 201003 Novartis

hydrastinine HCL + oxedrine tartrate 19710222 200902 MSD

hydrochlorothiazide Esidrex 19581222 200912 Novartis and MSDhydrochlorothiazide + triamterene 200909

hydrochlorothiazide + metoprolol 200909hydrochlorothiazide + propranolol + triamterene

200909

hydrochlorothiazide + reserpine + triamterene

200909

hydrocortisone 19521215 200912 Pfizerhydrocortisone + lidocaine 201102hydrocortisone + oxytetracycline 201005hydrocortisone + urea 200912hydrocortisone acetate + neomycine + centella extract

201102

hydroxychloroquine 19550418 200904 Sanofi Aventishydroxyethylsalicylate 200904hydroxyurea (hydroxycarbamide) 19660322 200903 BMS

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

619620621622623624625626627628

629630631632633634635636637638639640641642643

644645646

hydroxyzine, hydroxysine chloride, hydroxysine pamoate and all fixed comnination products containing hydroxyzine

19551214 200812 UCB and Pfizer

hymecromone 19650727 201007 Merck Seronohyoscine butylbromide Buscopan 19520101 201106 BIhyoscyamine 201010hypochlorite sodium 200808 AMUCHINA S.p.A.ibopamine 19840623 200808 Zambonibuprofen 19690219 200809 Reckitt Benckiser ibuprofen + codeine Ardinex 19930305 200809ibuprofen + lysine 200809ibuprofen + pseudoephedrine 200809ichthyol (ammonium ichthosulfonate)

19550901 201009 Solvay

idebenone 19860930 200809 Takedaidoxuridine 19781120 200811 Sanofi Aventisifenprodil 19740306 201003 Sanofi Aventisifosfamide 201007 Baxterimipramine Tofranil 19580313 200903 Novartisindomethacin 19630622 200906 MSDinfluenza vaccine 200905insulin human 19801026 200810 Eli Lillyiodamide 19690926 200910 Braccoiodate 200907iodide 200907iodide (131I) sodium 19731001 200809 GE Healthcareiodine 200907iotalamic acid 19650313 200910 Braccoioxitalamic acid Telebrix 12 Na, Telebrix 35,

Telebrix 30M, Telebrix Hystero, Telebrix Gastro

201108 Guerbet

ipecacuanha + combinations 201108ipratropium 19740814 201011 BI

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

647

648649650651652653654655656

657658659660

661662663664665666667

668669670671672673674675676

isoniazid 19730228 200811 UCBisoniazide + pyrazinamide + rifampicin

Rifater 200811 Sanofi Aventis

isoniazide + rifampicin Rifinah 200811 Sanofi Aventisisoprenaline 19770404 200909 UCBisosorbide dinitrate/mononitrate Sorbangil 19630917 201009 Pfizerispaghula husk + mebeverine 201002itopride 19950630 201003 Abbottjosamycin 197003 200903ketamine Ketolar 19681210 200912 Pfizerketocaine + fluocinonide Proctonide 19831006 201012 Recordati S.p.A.ketocaine HCl + fluocinolone acetonide

Proctolyn 19690908 201012 Recordati S.p.A.

l-acetyl carnitine 19840601 200906 Braccolactulose 19640521 201105 Solvaylansoprazole 19901231 200812 Takedalauromacrogol 400 Aethoxysklerol 19660525 201103 Kreussler&Co. GmbH

lauromacrogols combinations 201103leuprorelin 19840731 200907 Takedalevocetirizine 20010103 201107 UCB DE=RMSlevomepromazine 19560704 200906 Sanofi Aventislevosulpiride 19860401 201103 Abbottlevothyroxine 19670323 200905levothyroxine combinations Novothyral 19680527 200912 Merck Serono

lidocaine 19640331 200903 AstraZenecalincomycin Lincocin 19600101 200901 Pfizerlithium 19670220 201002 GSKlodoxamide 19900702 201107 Alcon Lab. lofepramine 19760227 201001 Merck Seronolonazolac 201106lorazepam 19631231 201012 UCBl-propionyl carnitine 19941115 201012 Bracco

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

677678679

680681682

683

684685686687688689690691

692693694695696697698699700701702703704705706

l-tryptophan 201011lynestrenol Exluton/Orgametril 19730320 201003 Organonlynestrenol+ ethinylestradiol Restovar 19730330 201003 Organonlysine acetylsalicylic acid + metoclopramide

Migpriv 19931208 200909 Sanofi Aventis

macrogol 19970901 201009 UCBmagaldrate 201107magnesium +/or calcium +/or aluminium antacids

201001 All antacids have the same DLP

magnesium combinations (excluding antiacids)

201006 excluding antacids

manidipine 19900629 200901 Takedamaprotiline Ludiomil 19700923 200809 Novartismazindol Teronac/ Sanorex 19730615 200906 Novartismebendazole 19710503 201005 J&Jmebeverine 19641110 201002 Solvaymeclofenamate Meclomen 19840926 200909 Pfizermeclozine 19530508 201008 UCB and Pfizermeclozine hydrochloride, fixed combinations

19530508 201008 UCB and Pfizer

medazepam 201008medroxyprogesteroneacetate 19590730 200907 Pfizermefenamic acid 19620328 200903 Pfizermegestrol 19710818 201108 BMSmeglumine 19470122 201101 Sanofi Aventismelperone 19680117 200901 Swedish Orphanmelphalan 19630926 200809 GSKmephenesin 19750120 201001 Sanofi Aventismeprobamate 19861023 201009 Sanofi Aventismeprobamate+ aceprometazine Mepronizine 19860913 201009 Sanofi Aventismepyramine 19691231 201012 Sanofi Aventismercaptopurine 19530911 200809 GSKmetamizole 19230410 200904 Sanofi Aventismetamizole combinations 19230410 200904 Sanofi Aventis

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

707708709710

711712713714

715716717718719720721

722

723724725726727728729730731732733734735

metaraminol 19540929 200909 MSDmetformin 19590319 200903 Merck Seronomethadone 19399191 200812 GSKmethenamine Mandelamine 19560802 200808 Pfizermethenamine+ phenazopyridine Azo-mandelamine tabletas

recubiertas entericas 500mg/50mg

19620628 200808 Pfizer

methsuximide Celontin 19560713 200907 Pfizermethyl butetisalicylate 19550806 200808 Sanofi Aventismethyl salicylate + menthol Baume Bengue 19521117 201105methyl salicylate+clove oil+capsicum oil

BAUME AROMA, cream 19440313 201105 Mayoly Spindler

methyldopa 19600101 201012 MSDmethyldopa + hydrochlorotiazide 19620417 201104 MSDmethylene diphosphonic acid 19760901 200808 GE Healthcaremethylphenidate 19541006 201010 Novartismethylphenobarbital 201003methylprednisolone 19571024 201005 Pfizermethylprednisolone acetate, lidocaine hydrochloride

Depo Medrol + Lidocaine 19620223 201009 Pfizer

methylprednisolone acetate, neomycin Sulfate

Neo-Medrol Acetate 19641207 200812 Pfizer

methysergide 19480215 200902 Novartismetipamide 201005metixene 19610215 201102 Novartismetizoline 19710301 200910 Braccometoclopramide 19740409 200904 Sanofi Aventismetoclopramide+ dimeticone 19740409 200904 Sanofi Aventismetolazone 19910101 201012 UCBmetopimazine 19660603 200912 Sanofi Aventismetoprolol 19750228 200902 AstraZenecametoprolol + hydrochlorothiazide Selozide (Selokomb) 19780511 200902 AstraZenecametoxybutropate 19850417 200910 ACRAF S.p.A.metronidazole 19590729 200811 Sanofi Aventis

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

736737738739740

741742743744745746747748749750751752753754

755756757758759760761762763

764765

metronidazole + spiramycin Rodogyl 19590729 200811 Sanofi Aventismetyrapone 19610614 200901 Novartismexiletine 19751006 200810 BImianserin 19740101 201012 Organonmiconazole 19710731 201008 J&Jmiconazole combinations Daktozin/ Acnidazil/ Daktacort 19710731 201008 J&J

minocycline 200907mitomycin 201102mitoxantrone 19890510 201105 Baxtermofebutazone 201102monmectite 19790719 201007 IPSENmorphine 19690414 200910 Merck Seronomorphine 200812 JSC Grindeksmycobacterium Bovis 19650422 200904 Pfizernafcillin 201006naftazone 19871218 201012 Sanofi Aventisnaftidrofuryl 19701030 200904 Merck Serononaftifine 201008nalidixic acid 19610101 201101 Sanofi Aventisnaloxone combination 201004 same DLP as naloxone on current list

nandrolone 1960/01/01 201012 Organonnaphazoline 19461016 200907 Novartisnaphazoline +tetracaine 19840802 200907 Alcon Lab. same DLP as naphazolinenaphazoline combination 200907naproxen 19610804 200808 Pfizernaproxen combination 200808nefazodone 201009neomycin 19540624 200812 Sanofi Aventisneostigmine 19320701 201003 Valeant

Pharmaceuticals Ltd

nicergoline 19720526 200905 Pfizer

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

766767768769770771

772773774775776777778779780781782783784785786787788789790791792793794795796797

niclosamide 19640323 200909 Sanofi Aventisnicotine 200808niflumic acid (morniflumate) 19600101 201001 BMSnifurtoinol 19630826 200808 Zambonnimesulide 19941031 200912 UCBnimorazole 19690530 200905 Pfizernitrazepam 19650302 201003 Valeant

Pharmaceuticals Ltd

nitrofural 201010nitrofurantoin 19530228 201002 Procter & Gamblenitroprusside 19761130 200811 Schwarz Pharmanitroxoline 201011nonivamide 19530901 200809 BInoradrenaline 201009 same DLP as adrenalinenorethisterone 19710429 201104 Pfizernorethisterone combination 201105norfenefrine 19590306 200903 Pfizernortriptyline 19630331 201003 Lundbecknoscapine 201102nystatin 19540813 200908 BMSobidoxime 19640129 201103 Merck Seronoolmesartan 200811omega-3 fatty acids 201101opipramol 19611012 200910 Novartisorciprenaline 19611101 200912 BIorphenadrine 200908ouabain 200902oxacillin 19620101 201001 BMSoxamniquine 19740905 200809 Pfizeroxandrolone 200908oxaprozin 200911oxazepam 19660516 201105 Pfizeroxeladin 19670606 201106 IPSEN

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

798799800801802803804805806807

808

809810811812813814815816817818819820

821822

823

824

oxetorone 19730820 200808 Sanofi Aventisoxilofrine 201103oxolamine 19600618 200910 ACRAF S.p.A.oxolamine + propyphenazone Uniplus 19630305 200910 ACRAF S.p.A. same DLP as oxolamineoxomemazine 19640311 200902 Sanofi Aventisoxomemazine combination 200902oxprenolol 19680226 200902 Novartisoxybuprocaine 19570320 200908 Novartisoxycodone 19951212 201004 Napp Pharmac.oxycodone + naloxone 201004 same DLP as naloxoneoxymetazoline combinations 201008

oxymetazoline 19620531 201008 Merck Serono

oxytetracycline 19500531 201005 Pfizeroxytetracycline combinations 201005oxytocin 19550602 201106 Novartispancreas powder 201105pancreatic extracts 19880622 201105 Mayoly Spindlerpancreatin 19800414 201105 Solvaypancreatin combination 19630313 201105 Sanofi Aventispancuronium 1991/01/01 201012 Organonpanthenol 201003papaverine 201009papaverine + combinations 201009papaverine + homatropine + dehydrocholic acid

Bilagit / Neo-bilagit / Papaverine Houde

19330331 201009 Sanofi Aventis same DLP as papaverine

paracetamol 200905paracetamol combinations (except with acetyl salicylic acid)

200905

paracetamol combinations (including those with acetyl salicylic acid)

201002 same DLP as acetyl salicylic acid

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

825826827

828829830831832833834835836837

838839

840841842

843844845

846847848849850851852853

paraffin 20041228 201010 UCBparaffin combinations 201010parahydroxybenzoate of benzyle 19440818 200909 Mayoly Spindlerparahydroxybenzoate of benzyle combinations

200909

parethoxycaine 19730903 200909 Sanofi Aventisparomomycin 19601129 200911 Pfizerpatent Blue V 201004 Gerbetpemoline 201103penamecillin 200911penciclovir 19960228 200811 Novartispenicillamine 19740228 201002 Eli Lillypentaerithrityl tetranitrate 200912pentazocine 19660915 200909 Sanofi Aventispentazocine combinations (except those with paracetamol)

200909

pentosane 19610613 201007 Sanofi Aventispentosane polyester + phenylephrine

201006

pentoxifylline 19670514 200905 Sanofi Aventispentoxyverine 19541215 201012 UCBpericiazine + propericiazine 19630509 200905 Sanofi Aventis

perindopril 201001permethrine 200907permethrine + butoxyde of piperonyle

Charlieu anti-lice shampoo 19920108 200907 Mayoly Spindler

perphenazine 19521015 201002 Schering Ploughpethidine 19410328 201003 Sanofi Aventisphenazone 200809phendimetrazine 201003phenelzine 19590505 200905 Pfizerpheniramine 201005phenobarbital 19430127 200901 Sanofi Aventis

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

854855856857858859860861862863864

865866867868869870871872873

874875876877878879880881882883884885

phenol 19870320 201004 UCBphenolphtalein 200809phenoxymethylpenicillin 19560601 200910 Sanofi Aventisphenprocoumon 201101phentermine 201006phentolamine 19510402 201104 Novartisphenyl(2-hydroxybenzoate) 201103phenylbutazone 19520219 201104 Novartisphenylephrine 19530115 201001 BIphenylsalicylate 201008phenytoin 19360101 200901 Pfizerphenytoin sodium + metylphenobarbital

Dintoinale 19500420 200901 Recordati S.p.A. same DLP as phenobarbital

pholcodine 19580529 200905 Sanofi Aventisphosphate ( 32P) sodium 19970228 201102 GE Healthcarephotobarr 19930419 201104 Axcan Pharmaphotofrin 19930419 201104 Axcan Pharmaphytosterol 201008picloxydine 19620413 200810 Novartispicosulfate sodium 19671001 201012 BIpidolate calcium 200910pidolate calcium + calcium carbonate

Efical/Pidocal 19911029 200910 Sanofi Aventis same DLP as pidolate calcium

pidotimod 201010pimethixene 19720518 200812 Novartispimozide 19710215 201002 J&Jpinaverium bromide 19751201 201011 Solvaypindolol 19691110 201011 Novartispipamperone 19651014 201010 J&Jpipemidic acid 19741209 200812 Sanofi Aventispiperacillin + tazobactam 200911piperazine 201102pipobroman 19660701 201106 Abbottpipotiazine 19720321 201003 Sanofi Aventis

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

886887888889

890891892

893

894895896897898

899

900

piracetam 19710419 200904 UCBpiritramide 19690531 201103 J&Jpitofenone 201101pizotifen 19690714 201007 Novartispoly (styrol, divinylbenzol) sulfonic acid

201104

polyestradiol combination 19590317 201103 Pfizerpolymyxin B 19560101 200901 GSKpolymyxin B combinations Includes Polytrim (polymyxin

B sulphate + trimethoprim); Polyfax/Polysporin (polymyxin B sulphate + bacitracin zinc); Cicatrin (neomycin sulphate + bacitracin zinc); Cortisporin/Neosporin-H/Otosporin (neomycin sulphate + polymyxin B sulphate + bacitracin zinc + hydrocortisone); Neosporin (neomycin sulphate + polymyxin B sulphate + bacitracin zinc)

200901

polystyrene sulfonate 19551026 200810 Sanofi Aventis

polythiazide 19611002 200810 Pfizerpolythiazide + reserpine Renese-R 19631015 200810 Pfizer DLP polythiazideporactant alfa 19920806 200908 Chiesi Farmaceuticiporfimer Sodium 19930419 201104 Axcan Pharmapotassium bicarbonate + sodium alginate

201001

potassium bicarbonate + sodium bicarbonate

201001

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

901

902

903904

905906907908909910911912913914915916917918919920921922923924925926927928929930931

potassium chloride 19600601 201104 UCBpotassium chloride + sodium fluoride

200901 same DLP as fluoride

potassium chloride + sodium fluoride + triclosan

200901 same DLP as fluoride

potassium citrate 19710106 200901 Abbottpotassium iodide+ sodium iodide Vitreolent 19600701 200907 Novartis

poyestradiol 201103prajmalium 19721222 200812 Solvaypralidoxime 19680702 201107 Sanofi Aventispramocaine 201103pramoxine 19560914 200809 Abbottprasterone 201105prazepam 19741218 200912 Pfizerprazosin 19730314 200903 Pfizerprednisolone 19550621 201006 Pfizerprednisone 19550518 201005 Sanofi Aventisprilocaine 19630101 200812 AstraZenecaprimidone 19530630 200906 AstraZenecapristinamycin 19610327 201003 Sanofi Aventisprobenecid 19600501 201004 MSDprocainamide 201106procaine 200809procarbazine 19980330 200903 Braccoprocaterol 19841120 201012 Recordati S.p.A.prochlorperazine 19571206 201006 Sanofi Aventisprocyclidine 19530307 201103 GSKprogabide 19840419 200904 Sanofi Aventisprogesterone 19710909 201012 Lab. Besins Int.proglumetacine 19800201 201102 Rottapharm S.p.A.proguanil 19981001 200909 AstraZenecapromazine 201105promethazine 19481026 201004 Sanofi Aventis

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

932933934935936937938939940941942943944945946947948949950951952953954955956957958959960961962963964965

propafenone 200905propantheline 19530105 200901 Pfizerproparacaine 19710301 201103 Alcon Lab. propiomazine 19600620 201106 Sanofi Aventispropranolol 19650630 201106 AstraZenecapropylene glycol 20000908 200809 Schering Ploughpropylthiouracil 201107proscillaridin 19631028 200810 Abbottprotamine 19550706 201001 Sanofi Aventisprothipendyl 201106prulifloxacin 20040621 200810 ACRAF S.p.A. IT=RMSpseudoephedrine 200810pseudoephedrine + tripolidine 200810pyrantel 19701220 200912 Pfizerpyrimethamine 19520101 200908 Sanofi Aventispyritinol 19600117 200912 Merck Seronopyrrolidone carboxylate sodium 201101pyrvinium 201008quinfamide 201103quinidine 201001quinine 200811 Sanofi Aventisquinine combinations a.o. Quiniman 200811 Sanofi Aventisramipril 19890110 200901 Sanofi Aventisreserpine 200912resorcinol 200902resorcinol + sulphur 200911rifampicin 19680501 201005 Sanofi Aventisrifamycin 19620401 201103 Sanofi Aventisrilmenidine 200811rimexolone 20041227 201010 UCBrotigotine 20060215 200808 Schwarz Pharmarutoside 19891110 201010 Abbottsalbutamol 19690131 201101 GSKsalicylamide 201102

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

966967968969970971972973974975976977

978979980

981982

983

984985986987988989990991992993

salicylic acid + combinations 200909salicylic acid and salts 200909scopolamine 200904scopolamine combinations 200904secnidzole 19730605 201003 Sanofi Aventisselenite sodium 201107selenium disulphide 201102serrapeptase 19680930 200809 Takedasilver nitrate 201103silver protein 19621002 201011 Mayoly Spindlersilver protein acetyltannate 201011silver sulfadiazine 19730125 201009 Solvaysilver sulfadiazine + cerous nitrate Flammacerium 19730125 201009 Solvay

simeticone 19670428 201104 Pfizer see dimeticone simvastatin 20011029 200810 Procter & Gamblesodium aurothiomalate (see aurothiomalate)

201007

sodium bicarbonate 19770908 200905 UCBsodium bicarbonate + sodium citrate + sodium fluoride

200901 same DLP as fluoride

sodium chloride, potassium chloride, calcium chloride dihydrate (+ Glucose)

Ringer/Ringer in Glucose (including irrigation)

1971/03/22 201103 Baxter UK=RMS

sodium chromate ( 51Cr) 19971231 200812 GE Healthcaresodium citrate 201102 Abbottsotalol 19730822 200808 BMSspartocine 19621001 201009 UCBspectinomycin 19700101 200901 Pfizerspiramycin 19550208 200902 Sanofi Aventisspironolactone 19620301 200911 Pfizerspironolactone + atizide Aldactazine 19640121 200911 Pfizerspironolactone + butizide Aldozone 19680308 200911 Pfizer

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

994995996997998999

10001001100210031004

10051006

100710081009101010111012101310141015101610171018101910201021

1022

spironolactone + hydrochlorothiazide

Aldactazide 19601110 200911 Pfizer

stannousfluoride 19760731 200907 GE Healthcarestibogluconate 19660330 201003 GSKstreptomycin 19560415 201004 Sanofi Aventisstrontium (89Sr) chloride 200908sucralfate 19680223 200907 Merck Seronosulfabenzamide+sulfacetamide+sulfathiazole

Sultrin 19450912 200809 J&J

sulfacetamide 201106sulfadiazine 201107sulfafurazole 201108sulfaguanidine 19740107 201001 Sanofi Aventissulfamethopyrazine, pyrimethamine Metakelfin 19720722 200907 Pfizer

sulfamethoxazole 201108sulfamethoxazole + trimethoprim (cotrimoxazole)

200906

sulfasalazine 19420425 201104 Pfizersulfinpyrazone 19580925 200809 Novartissulfisoxazole 201108sulindac 19750630 201106 MSDsulphur 200911sulphur + triclosan 200911sulpiride 19730110 200901 Sanofi Aventissuxamethonium 19520814 200808 GSKtacalcitol 201107talinolol 201010tamoxifen 19740429 200904 AstraZenecategafur 200812 JCS Grindekstemazepam 19691126 200811 Pfizertenoate sodium 19640515 200905 Sanofi Aventistenoate sodium + eucalyptus + paracetamol

TROPHIRES 19640515 200905 Sanofi Aventis

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

1023102410251026

102710281029103010311032103310341035103610371038103910401041104210431044104510461047104810491050105110521053

terbutaline 19701231 200812 AstraZenecaterfenadine 200812terguride maleate 201011testosterone 1978/07/01 201009 Organontestosterone propionate, testosterone phenyl propionate and testosterone iso hexanoate and testosteronedecanoate

Sustanon 1965/09/30 201009 Organon

tetracaine 19730601 200906 Novartistetracosactide 19650507 201105 Novartistetracycline 201106tetrazepam 19670503 200905 Sanofi Aventistetryzoline 201106theophylline 19600630 200906 Pfizerthiamphenicol 19651214 200905 Zambonthiethylperazine 19601222 200812 Novartisthiocolchicoside 19590312 201003 Sanofi Aventisthioguanine 19660118 200901 GSKthiopental 201103thioperazine 19591214 200912 Sanofi Aventisthioridazine 19590201 201002 Novartisthiotepa 201105thiothixene 19670724 200907 Pfizerthrombin 19430316 200903 Pfizerthymol, levomenthol, salol Borostyrol, Nisacalm 19430406 201104 Mayoly Spindlerthyroglobulin 19430831 201108 Pfizerthyrotricine (or tyrothricin) 201108thyroxine 19520101 201012 GSKtiagabine 19960614 200906 Cefphalon Europetiaprofenic acid 19740826 200808 Sanofi Aventistibenzonium iodide 19761123 201012 Recordati S.p.A.ticarcillin 19730912 201009 GSKticarcillin + clavulanate Timentin 19730912 201009 GSKtilidine 19700708 200907 Pfizer

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

10541055105610571058105910601061106210631064106510661067

1068106910701071107210731074107510761077107810791080108110821083108410851086

tiliquinol + tilbroquinol Intetrix 19651115 200911 IPSENtinidazole 19720610 200906 Pfizertinidazole + nystatin Fasigyn N Ovulos 19720301 200906 Pfizertinidazole + tioconazole Fasigyn Vt 19751008 200906 Pfizertiropramide 19820330 201012 Rottapharm S.p.A.tobramycin 19731029 200810 Eli Lillytobramycin (eye drops) 20040325 200808 ACRAF S.p.A.tolazamide 201108tolbutamide 201107tolfenamic acid 200908tolnaftate 19771016 200910 Sanofi Aventistolnaftate + triclosan 200909tolperisone 200911tramadol 19730418 200908 Grünenthaltramadol + paracetamol Zaldiar/Tilalgin/Pontalsic/Dol

evar/Tramacet20010815 200908 Grünenthal

tramazoline 19640201 201012 BItranexamic acid 19660121 201001 Pfizertrazodone 19711015 200906tretinoin 19730125 200901 J&Jtriamcinolone acetonide 19531214 200907 BMStriamterene 200906tribenoside 19670406 200904 Novartistriclabendazole 19971028 200910 Novartistriclorcarban 200809triclosan 200911tridecanamine undecylenate 201001triethanolamine salicylate 201001trifluoperazine 19861001 201010 Sanofi Aventistrifluridine 201003triflusal 201108trihexyphenidyl 19560605 201012 Sanofi Aventistrimebutine 19690522 200905 Pfizertrimebutine + ruscogenin Proctolog 19731210 200905 Pfizer

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

1087108810891090109110921093109410951096

10971098

109911001101110211031104110511061107110811091110

1111111211131114111511161117

trimecaine 201105trimepiridine 200902trimetazidine 201107trimethoprim 200906trimipramine 19601005 200810 Sanofi Aventistriufluperidol 19640131 200901 J&Jtropatepine 19730327 201107 Sanofi Aventistropicamide 19510301 201103 Alcon Lab. trospium 19841017 200809 Montavittroxerutine 201106undecylenic acid + zinc undecylenate

201005

urea 201004urea (13C) HELI-KIT 75 mg, powder for

drinkable solution199705 201002 Mayoly Spindler

valproic acide (incl. sodium salt) 19670123 200901 Sanofi Aventisvalpromide 19730723 201007 Sanofi Aventisvancomycin 200902vasopressin 201006verapamil 19630125 201001 Abbottvigabatrin 19890922 200909 Sanofi Aventisviminol 19710101 200808 Zambonvinblastine 200810vincamine 19820626 201106 Sanofi Aventisvincristine 19910305 201003 Pfizervinpocetin 201107vitamines and vitamine combinations (incl minerals)

200910

warfarin 19620531 200905 Abbottxipamide 19690730 201107 Eli Lillyxylometazoline 19880513 201105 Sanofi Aventisyohimbine 19440601 200905 Sanofi Aventiszinc salts 201107zolpidem 19870609 201006 Sanofi Aventis

2

A B C D E FActive substance name (INN) Innovator brand name (for

fixed combination products only)

Proposed EU birth date

Next DLP Firm's Name Comments

11181119

zopiclone 19841210 200906 Sanofi Aventiszuclopenthixol 19760531 201005 Lundbeck