EN Official Journal of the European Union C 101/14

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 March 2009 to 31 March 2009

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )

2009/C 101/04

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorisation Member State concerned Date of notification 4.3.2009 PhotoBarr Axcan Pharma International BV, Engelenkampstraat 72, 6131 JJ Sittard, Nederland This Decision is addressed to the Member States 5.3.2009 6.3.2009 Tritazide See Annex I See Annex I 10.3.2009 6.3.2009 Tritace See Annex II See Annex II 10.3.2009 6.3.2009 UMAN BIG See Annex III See Annex III 9.3.2009 12.3.2009 Bleomycin Pharmachemie See Annex IV See Annex IV 16.3.2009 12.3.2009 Sanohex See Annex V See Annex V 16.3.2009 12.3.2009 Sabumalin See Annex VI See Annex VI 16.3.2009 27.3.2009 Zoloft See Annex VII See Annex VII 31.3.2009

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder (Invented) name Strength Pharmaceutical form Route of administration Austria SANOFI-AVENTIS GMBH OSTERREICH SATURN Tower Leonard-Bernstein-Straße 10 A-1220 Vienna Austria Tritazide 25 mg/125 mg Tabletten Tritazide 5 mg/25 mg Tabletten 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Austria AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A-1037 Wien Austria HYPREN PLUS HYPREN PLUS FORTE 2,5 mg/12,5 mg 5 mg/25 mg Tablets Oral Belgium Sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem Belgium TRITAZIDE 5 mg – 25 mg, tabletten 5 mg/25 mg Tablet Oral Bulgaria AVENTIS PHARMA DEUTSCHLAND GMBH D-65926 Frankfurt am Main Germany TRITACE 2,5 PLUS 2,5 mg/12,5 mg Tablet Oral Bulgaria SANOFI-AVENTIS BULGARIA EOOD Alexandar Stamboliyski blvd. 103 office building Sofia Tower, fl. 8, Sofia 1303 Bulgaria TRITACE 2,5 PLUS TRITACE 5 PLUS 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Cyprus SANOFI-AVENTIS CYPRUS LTD 14, Charalambou Mouskou street 2015 – Nicosia Cyprus TRIATEC PLUS 5 mg/25 mg Tablet Oral Czech Republic sanofi-aventis, s.r.o. Evropská 2590/33c 16000 Praha 6 Czech Republic TRITAZIDE 2,5/12,5 mg TRITAZIDE 5/25 mg 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Denmark sanofi-aventis Denmark A/S Slotsmarken 13 2970 Hørsholm Denmark TRIATEC COMP 5 mg/25 mg Tablet Oral Estonia SANOFI-AVENTIS DEUTSCHLAND GMBH 65926 Frankfurt am Main Germany CARDACE COMP 2,5 mg/12,5 mg Tablet Oral Estonia SANOFI-AVENTIS ESTONIA OÜ Pärnu mnt. 139 E/211317 Tallinn Estonia CARDACE PLUS 5 mg/25 mg Tablet Oral Finland SANOFI-AVENTIS OY Huopalahdentie 24 00350 Helsinki Finland CARDACE COMP 2,5 mg/12,5 mg Tablet Oral France SANOFI-AVENTIS France 1-13 boulevard Romain Rolland 75014 Paris France COTRIATEC 5 mg/12,5 mg Tablet Oral Germany SANOFI-AVENTIS DEUTSCHLAND GMBH Brüningstraße 50 65926 Frankfurt am Main Germany Delix 2,5 plus Delix 5 plus 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Germany WINTHROP ARZNEIMITTEL GMBH Urmitzer Str. 5 56218 Mülheim-Kärlich Germany Ramilich comp 2,5 mg/12,5 mg Tabletten Ramilich comp 5 mg/25 mg Tabletten 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Germany WINTHROP ARZNEIMITTEL GMBH Urmitzer Str. 5 56218 Mülheim-Kärlich Germany RamiWin comp 2,5 mg/12,5 mg Tabletten RamiWin comp 5 mg/25 mg Tabletten 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Germany AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany Vesdil 2,5 Plus Vesdil 5 Plus 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Greece SANOFI-AVENTIS AEBE 348, Syggrou Avenue Building A 176-74 Kallithea Greece TRIATEC PLUS TRIATEC PLUS 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Hungary SANOFI-AVENTIS PRIVATE CO LTD H-1045 Budapest Tó u. 1.-5. Hungary TRITACE HCT 2,5/12,5 Tabletta TRITACE HCT 5/25 Tabletta 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Hungary Zentiva HU Kft Népfürdő u. 22 1138 Budapest Hungary RAMIPRIL HCT – ZENTIVA 2,5 mg/12,5 mg RAMIPRIL HCT – ZENTIVA 5 mg/25 mg 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Iceland — Ireland sanofi-aventis Ireland Ltd. Citywest Business Campus Dublin 24 Ireland TRITAZIDE Tablets 2,5 mg/12.5 mg 2,5 mg/12,5 mg Tablet Oral Italy SANOFI-AVENTIS SPA Viale Bodio, 37/b 20158 Milano Italy TRIATEC HCT 2,5 TRIATEC HCT 5 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Italy SANOFI-AVENTIS SPA Viale Bodio, 37/b 20158 Milano Italy RAMIPRIL E IDROCLORITIAZIDE SANOFI-AVENTIS 2,5 mg/12,5 mg RAMIPRIL E IDROCLORITIAZIDE SANOFI-AVENTIS 5 mg/25 mg 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Italy AstraZeneca S.p.A Palazzo Volta Via Francesco Sforza 20080 Basiglio (MI) Italy UNIPRIL DIUR 2,5 mg + 12,5 mg compresse UNIPRILDIUR 5 mg + 25 mg compresse 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Italy POLIFARMA SPA Viale dell′Arte 69 00144 Roma Italy IDROQUARK IDROQUARK 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Latvia — Lithuania — Luxembourg Sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem Belgium TRITAZIDE 5 mg/25 mg Tablet Oral Malta — Netherlands SANOFI-AVENTIS NETHERLANDS B.V. Kampenringweg 45 D-E (toren D en E) NL-2803 PE Gouda The Netherlands P.O. Box 2043 NL-2800 BD Gouda The Netherlands TRITAZIDE Tabletten 5 mg/25 mg 5 mg/25 mg Tablet Oral Norway — Poland SANOFI-AVENTIS DEUTSCHLAND GMBH D-65926 Frankfurt am Main Germany TRITACE 2,5 COMB TRITACE 5 COMB 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Portugal Sanofi-Aventis Produtos Farmacêuticos, s.a. Empreendimento Lagoas Park, Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal RAMICOR D 2,5 RAMICOR D 5 2,5 mg/12.,5 mg 5 mg/25 mg Tablet Oral Portugal Sanofi-Aventis Produtos Farmacêuticos, s.a. Empreendimento Lagoas Park, Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal TRIATEC COMPOSTO TRIATEC COMPOSTO FORTE 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Romania AVENTIS PHARMA DEUTSCHLAND GMBH Brüningstraße 50 65926 Frankfurt am Main Germany TRITACE 2,5 PLUS TRITACE 5 PLUS 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Slovak Republic SANOFI-AVENTIS SLOVAKIA s.r.o., Žilinská 7-9 81105 Bratislava Slovak Republic TRITAZIDE TRITAZIDE 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Slovenia SANOFI-AVENTIS D.O.O. Dunajska cesta 119 1000 Ljubljana Slovenia TRITAZIDE 2,5 5 mg/12,5 mg tablete TRITAZIDE 5 mg/25 mg tablete 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral Spain — Sweden sanofi-aventis AB Box 14142 167 14 Bromma Sweden TRIATEC COMP MITE TRIATEC COMP 2,5 mg/12,5 mg 5 mg/25 mg Tablet Oral United Kingdom —

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing Authorisation Holder (Invented) name Strength Pharmaceutical Form Route of administration Austria SANOFI-AVENTIS GMBH OSTERREICH SATURN Tower Leonard-Bernstein-Straße 10 A-1220 Vienna Austria Tritace 1,25 mg — Tabletten Tritace 2,5 mg — Tabletten Tritace 5 mg — Tabletten Tritace 10 mg — Tabletten 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Austria AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A-1037 Wien Austria HYPREN 1,25 mg 2,5 mg 5 mg Capsule Oral Austria AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A-1037 Wien Austria HYPREN 10 mg Tablet Oral Belgium SANOFI-AVENTIS BELGIUM Culliganlaan 1C B-1831 Diegem Belgium Tritace 1,25 mg, comprimés Tritace 2,5 mg, comprimés Tritace 5 mg, comprimés Tritace 10 mg, comprimés 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Belgium Aventis Pharma S.A. Boulevard de la Plaine, 9 B-1050 Bruxelles Tazko 5 mg, comprimés à liberation prolongée 5 mg Prolonged-release tablet Oral Belgium Aventis Pharma S.A. Boulevard de la Plaine, 9 B-1050 Bruxelles Tazko 2,5 mg, comprimés à liberation prolongée 2,5 mg Prolonged-release tablet Oral Belgium SANOFI-AVENTIS BELGIUM Culliganlaan 1C B-1831 Diegem Belgium Tritace 10 10 mg Capsule Oral Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels Belgium Ramace 1,25 mg Ramace 2,5 mg Ramace 5 mg 1,25 mg 2,5 mg 5 mg Tablet Oral Bulgaria SANOFI-AVENTIS BULGARIA EOOD Alexandar Stamboliyski blvd. 103 office building Sofia Tower, fl. 8, Sofia 1303 Bulgaria Tritace 2,5 Tritace 5 Tritace 10 2,5 mg 5 mg 10 mg Tablet Oral Cyprus SANOFI-AVENTIS CYPRUS LTD 14 Charalambou Mouskou street 2015 – Nicosia Cyprus Triatec 2,5 mg 5 mg 10 mg Tablet Oral Czech Republic SANOFI-AVENTIS, S.R.O. Evropská 2590/33c 16000 Praha 6 Czech Republic Tritace 1,25 Tritace 2,5 Tritace 5 Tritace 10 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Czech Republic AVENTIS PHARMA DEUTSCHLAND GMBH Industriepark Höchst 65926 Frankfurt am Main Germany RAMIPRIL WINTHROP 1,25 mg 2,5 mg 5 mg Capsule Oral Denmark SANOFI-AVENTIS DENMARK A/S Slotsmarken 13 DK-2970 Hoersholm Denmark Triatec 1,25 mg 2,5 mg 5 mg Tablet Oral Denmark SANOFI-AVENTIS DENMARK A/S Slotsmarken 13 DK-2970 Hoersholm Denmark Triatec 10 mg Capsule, hard Oral Estonia SANOFI-AVENTIS ESTONIA OÜ Pärnu mnt. 139 E/2 11317 Tallinn Estonia Cardace 5 mg 10 mg Tablet Oral Estonia SANOFI-AVENTIS DEUTSCHLAND GMBH Industriepark Hoechst D-65926 Frankfurt am Main Germany Cardace 2,5 mg Tablet Oral Finland SANOFI-AVENTIS OY Huopalahdentie 24 00350 Helsinki Finland Cardace 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Finland SANOFI-AVENTIS OY Huopalahdentie 24 00350 Helsinki Finland Cardace 10 mg Capsule Oral Finland SANOFI-AVENTIS OY Huopalahdentie 24 00350 Helsinki Finland Ramipril medgenerics 1,25 mg tabletti Ramipril medgenerics 2,5 mg tabletti Ramipril medgenerics 5 mg tabletti Ramipril medgenerics 10 mg tabletti 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral France SANOFI- AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France Triatec 1,25 mg comprime Triatec 2,5 mg comprime sécable Triatec 5 mg comprime sécable Triatec 10 mg comprime sécable Triateckit, comprime sécable Ramikit, comprime sécable 1,25 mg 2,5 mg 5 mg 10 mg 2,5 mg/5 mg/10 mg 2,5 mg/5 mg/10 mg Tablet Oral France SANOFI- AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France Triatec faible 1,25 mg, gélule Triatec 2,5 mg, gélule Triatec 5 mg, gélule 1,25 mg 2,5 mg 5 mg Capsule Oral France SANOFI- AVENTIS FRANCE 1-13, boulevard Romain Rolland F-75014 Paris France Ramipril winthrop 1,25 mg Ramipril winthrop 2,5 mg, comprime secable Ramipril winthrop 5 mg, comprime secable Ramipril winthrop 10 mg, comprime secable 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Germany SANOFI-AVENTIS DEUTSCHLAND GMBH Industriepark Hoechst D-65926 Frankfurt am Main Germany Delix 2,5 mg Tabletten Delix 5 mg Tabletten Delix protect 10 mg Tabletten Delix HOPE 10 mg Tabletten Delix HOPE startset Delix protect startset 2,5 mg 5 mg 10 mg 10 mg 2,5 mg/5 mg/10 mg 2,5 mg/5 mg/10 mg Tablet Oral Germany SANOFI-AVENTIS DEUTSCHLAND GMBH Industriepark Hoechst D-65926 Frankfurt am Main Germany Ramipril protect 2,5 mg Tabletten Ramipril protect 5 mg Tabletten Ramipril protect 10 mg Tabletten Ramipril protect startset 2,5 mg 5 mg 10 mg 2,5 mg/5 mg/10 mg Tablet Oral Germany WINTHROP ARZNEIMITTEL GmbH Urmitzer Str. 5 56218 Mülheim-Kärlich Germany Ramilich 2,5 mg Tabletten Ramilich 5 mg Tabletten Ramilich 10 mg Tabletten Ramilich startset 2,5 mg 5 mg 10 mg 2,5 mg/5 mg/10 mg Tablet Oral Germany WINTHROP ARZNEIMITTEL GmbH Urmitzer Str. 5 56218 Mülheim-Kärlich Germany RamiWin 2,5 mg Tabletten RamiWin 5 mg Tabletten RamiWin 10 mg Tabletten 2,5 mg 5 mg 10 mg Tablet Oral Germany AVENTIS PHARMA DEUTSCHLAND GmbH 65926 Frankfurt am Main Germany Delix 1,25 mg Tabletten 1,25 mg Tablet Oral Germany AVENTIS PHARMA DEUTSCHLAND GmbH 65926 Frankfurt am Main Germany Delix 1,25 mg Kapseln Delix P 2,5 mg Kapseln Delix P 5 mg Kapseln Delix P 10 mg Kapseln 1,25 mg 2,5 mg 5 mg 10 mg Capsule, hard Oral Germany AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany Vesdil 1,25 mg Kapseln Vesdil 2,5 mg kapseln Vesdil 5 mg Kapseln 1,25 mg 2,5 mg 5 mg Capsule, hard Oral Germany AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany Vesdil 1,25 mg Tabletten Vesdil 2,5 mg Tabletten Vesdil N 2,5 mg Tabletten Vedil 5 mg Tabletten Vesdil N 5 mg Tabletten Vesdil protect 10 mg Tabletten 1,25 mg 2,5 mg 2,5 mg 5 mg 5 mg 10 mg Tablets Oral Greece SANOFI-AVENTIS AEBE 348, Syngrou Av.-Building A 176 74 Kallithea Greece Triatec 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Hungary SANOFI-AVENTIS PRIVATE CO LTD H-1045 Budapest Tó u. 1.-5. Hungary Tritace mite 1,25 mg tablet Tritace 2,5 mg tablet Tritace 5 mg tablet Tritace 10 mg tablet 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Hungary SANOFI-AVENTIS PRIVATE CO LTD H-1045 Budapest Tó u. 1.-5. Hungary Ramipril prevent 1,25 mg tablet Ramipril prevent 2,5 mg tablet Ramipril prevent 5 mg tablet Ramipril prevent 10 mg tablet 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Hungary Zentiva HU Kft Népfürdo u.22 1138 Budapest Hungary Ramipril — Zentiva 1,25 mg Ramipril — Zentiva 2,5 mg Ramipril — Zentiva 5 mg Ramipril — Zentiva 10 mg 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Iceland — Ireland Sanofi-Aventis Ireland Ltd. Citywest Business Campus, Dublin 24 Ireland Tritace 1,25 mg tablets Tritace 2,5 mg tablets Tritace 5 mg tablets Tritace 10 mg tablets 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Ireland Sanofi-Aventis Ireland Ltd. Citywest Business Campus Dublin 24 Ireland Tritace 1,25 mg capsules Tritace 2,5 mg capsules Tritace 5 mg capsules Tritace 10 mg capsules 1,25 mg 2,5 mg 5 mg 10 mg Capsule Oral Ireland Sanofi-Aventis Ireland Ltd. Citywest Business Campus Dublin 24 Ireland Loavel 1,25 mg Loavel 2,5 mg Loavel 5 mg Loavel 10 mg 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Ireland Sanofi-Aventis Ireland Ltd. Citywest Business Campus Dublin 24 Ireland Loavel 1,25 mg capsules Loavel 2,5 mg capsules Loavel 5 mg capsules Loavel 10 mg capsules 1,25 mg 2,5 mg 5 mg 10 mg Capsule Oral Ireland Sanofi-Aventis Ireland Ltd. Citywest Business Campus Dublin 24 Ireland Ramipril 1,25 mg tablets Ramipril 2,5 mg tablets Ramipril 5 mg tablets Ramipril 10 mg tablets 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Ireland Sanofi-Aventis Ireland Ltd. Citywest Business Campus Dublin 24 Ireland Ramipril 1,25 mg capsules Ramipril 2,5 mg capsules Ramipril 5 mg capsules Ramipril 10 mg capsules 1,25 mg 2,5 mg 5 mg 10 mg Capsule Oral Italy SANOFI-AVENTIS SPA Viale Bodio, 37/b 20158 Milano Italy Triatec 1,25 Triatec Triatec 5 Triatec Ramipril sanofi-aventis 1,25 mg 2,5 mg 5 mg 10 mg 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Italy AstraZeneca S.p.A Palazzo Volta Via Francesco Sforza 20080 Basiglio (MI) Italy Unipril 1,25 mg compresse Unipril 2,5 mg compresse Unipril 5 mg compresse Unipril 10 mg compresse 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Italy Polifarma S.p.A. Viale Dell’ Arte, 69 I – 00144 Roma Italy Quark Quark Quark Quark 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Latvia Sanofi-Aventis Latvia SIA Kr.Valdemara 33-8 LV1010 - Riga Latvia Cardace 2,5 mg 5 mg 10 mg Tablet Oral Lithuania UAB SANOFI-AVENTIS LIETUVA A. Juozapavičiaus g. 6/2 LT-09310 Vilnius Lithuania Cardace 2,5 mg 5 mg 10 mg Tablet Oral Luxembourg SANOFI-AVENTIS BELGIUM Culliganlaan 1C B-1831 Diegem Belgium Tritace 1,25 mg, comprimés Tritace 2,5 mg, comprimés Tritace 5 mg, comprimés Tritace 10 mg, comprimés 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Luxembourg SANOFI-AVENTIS BELGIUM Culliganlaan 1C B-1831 Diegem Belgium Tritace 10 mg Capsule Oral Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels Belgium Ramace 1,25 mg Ramace 2,5 mg Ramace 5 mg 1,25 mg 2,5 mg 5 mg Tablet Oral Malta — Netherlands SANOFI-AVENTIS NETHERLANDS B.V. Kampenringweg 45 D-E (toren D en E) NL-2803 PE Gouda The Netherlands P.O. Box 2043 NL-2800 BD Gouda The Netherlands Tritace 1,25 Tritace 2,5 Tritace 5 Tritace 10 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Netherlands SANOFI-AVENTIS NETHERLANDS B.V. Kampenringweg 45 D-E (toren D en E) NL-2803 PE Gouda The Netherlands Tritace 1,25 Tritace 2,5 Tritace 5 Tritace 10 1,25 mg 2,5 mg 5 mg 10 mg Capsule Oral Norway SANOFI-AVENTIS NORGE AS Strandveien 15 P.O.Box 133 NO-1325 Lysaker Norway Triatec 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Norway SANOFI-AVENTIS NORGE AS Strandveien 15 P.O.Box 133 NO-1325 Lysaker Norway Triatec 10 mg Capsule Oral Norway WINTHROP MEDICAMENTS 1-13 Boulevard Romain Rolland F-75159 Paris, Cedex 14 France Ramipril winthrop 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Poland SANOFI-AVENTIS DEUTSCHLAND GMBH D-65926 Frankfurt am Main Germany Tritace 2,5 Tritace 5 Tritace 10 2,5 mg 5 mg 10 mg Tablet Oral Portugal Sanofi-Aventis Produtos Farmacêuticos, s.a. Empreendimento Lagoas Park, Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal Triatec 2,5 mg 5 mg 10 mg Tablet Oral Portugal Sanofi-Aventis Produtos Farmacêuticos, s.a. Empreendimento Lagoas Park, Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal Triatec 1,25 mg 2,5 mg 5 mg 10 mg Capsule Oral Romania AVENTIS PHARMA DEUTSCHLAND GMBH Brüningstraße 50 65926 Frankfurt am Main Germany Tritace 2,5 mg 5 mg 10 mg Tablet Oral Romania SC ZENTIVA S.A. Bulevardul Theodor Pallady, nr. 50, sector 3 Bucuresti ROMANIA Zenra 2,5 Zenra 5 Zenra 10 2,5 mg 5 mg 10 mg Tablet Oral Slovak Republic SANOFI-AVENTIS SLOVAKIA s.r.o. Žilinská 7-9 81105 Bratislava Slovak Republic Tritace 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Slovenia SANOFI-AVENTIS D.O.O. Dunajska cesta 119 1000 Ljubljana Slovenia Tritace 1,25 mg teblete Tritace 2,5 mg tablete Tritace 5 mg tablete Tritace 10 mg tablete Tritace Startset 1,25 mg 2,5 mg 5 mg 10 mg 2,5 mg/5 mg/10 mg Tablet Oral Spain SANOFI-AVENTIS S.A. Josep Pla 2 08019 Barcelona Spain Acovil 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Sweden Sanofi-Aventis AB Box 14142 167 14 Bromma Sweden Triatec Triatec H.O.P Triatec Start 1,25 mg 2,5 mg 5 mg 10 mg 2,5 mg/5 mg/10 mg 2,5 mg/5 mg/10 mg Tablet Oral Sweden WINTHROP MEDICAMENTS 1-13, Boulevard Romain Roland F-75014 Paris France Ramipril winthrop 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral Sweden AstraZeneca Sverige SE-151 85 Södertälje Sweden Pramace 1,25 mg 2,5 mg 5 mg 10 mg Start pack (1,25 + 2,5 + 5 mg) Tablet Oral Sweden AstraZeneca Sverige SE-151 85 Södertälje Sweden Pramace 10 mg Capsule Oral United Kingdom AVENTIS PHARMA LTD 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH Trading as: Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK Tritace 1,25 mg tablets Tritace 2,5 mg tablets Tritace 5 mg Tablets Tritace 10 mg tablets 1,25 mg 2,5 mg 5 mg 10 mg Tablet Oral United Kingdom HOECHST MARION ROUSSEL LTD. Denham Uxbridge UB9 5HP Trading as: Aventis Pharma 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH Or Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK Tritace 1,25 mg Tritace 2,5 mg Tritace 5 mg Tritace 10 mg 1,25 mg 2,5 mg 5 mg 10 mg Capsule Oral United Kingdom AVENTIS PHARMA LTD 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH Trading as: Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK Tritace Titration Pack 2,5 mg/5 mg/10 mg Tablet Oral United Kingdom AVENTIS PHARMA LTD 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH Trading as: Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK Tritace titration pack 2,5 mg 5,0 mg 10 mg Capsule Oral United Kingdom AVENTIS PHARMA LTD 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH Trading as: Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK Tritace Tablet Titration Pack 2,5 mg 5,0 mg 10 mg Tablet Oral

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATE Member State EU/EEA Marketing authorisation holder Applicant (Invented) Name Strength Pharmaceutical form Route of administration Content (concentration) Austria Kedrion S.p.A. Loc Ai Conti 55051 Castelvecchio Pascoli, Barga (Lucca) — ITALY UMAN BIG 180 I.E./ml Injektionslösung 180 IU/ml Solution for injection Intramuscular use 180 IU/ml 540 IU/3 ml Denmark Kedrion S.p.A. Loc Ai Conti 55051 Castelvecchio Pascoli, Barga (Lucca) — ITALY UMAN BIG 180 IU/ml Solution for injection Intramuscular use 180 IU/ml 540 IU/3 ml Germany Kedrion S.p.A. Loc Ai Conti 55051 Castelvecchio Pascoli, Barga (Lucca) — ITALY UMAN BIG 180 IU/ml Solution for injection Intramuscular use 180 IU/ml 540 IU/3 ml Hungary Kedrion S.p.A. Loc Ai Conti 55051 Castelvecchio Pascoli, Barga (Lucca) — ITALY Umanbig 180 NE/ml 180 IU/ml Solution for injection Intramuscular use 180 IU/ml 540 IU/3 ml Italy Kedrion S.p.A. Loc Ai Conti 55051 Castelvecchio Pascoli, Barga (Lucca) — ITALY UMAN BIG 180 IU/ml Solution for injection Intramuscular use 180 IU/ml 540 IU/3 ml Poland Kedrion S.p.A. Loc Ai Conti 55051 Castelvecchio Pascoli, Barga (Lucca) — ITALY UMAN BIG 180 IU/ml Solution for injection Intramuscular use 180 IU/ml 540 IU/3 ml Portugal Kedrion S.p.A. Loc Ai Conti 55051 Castelvecchio Pascoli, Barga (Lucca) — ITALY UMAN BIG 180 IU/ml Solution for injection Intramuscular use 180 IU/ml 540 IU/3 ml Sweden Kedrion S.p.A. Loc Ai Conti 55051 Castelvecchio Pascoli, Barga (Lucca) — ITALY Umanbig 180 IU/ml solution for injection 180 IU/ml Solution for injection Intramuscular use 180 IU/ml 540 IU/3 ml

ANNEX IV LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Applicant (Invented) Name Strength Pharmaceutical form Route of administration Content (concentration) Austria Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomycin ‘Pharmachemie’15 000 I.E. - Pulver zur Herstellung einer Injektionslösung 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Local injection 15 U (USP)/vial Belgium Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands BLEOMYCINE TEVA 15U poeder voor oplossing voor injectie 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Bulgaria Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomycine Teva 15U, прах за инжекционен разтвор 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Czech Republic Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomycin-Teva 15U, prášek pro přípravu injekčního roztoku 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Denmark Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomycin ‘Teva’ 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Estonia Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomycin Teva 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial France Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomycine TEVA 15 000 UI, poudre pour solution injectable 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Germany Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleo-TEVA 15 mg Pulver zur Herstellung einer Injektionslösung 15 U (USP)/vial powder for solution for injection Intramuscular injection Intravenous administration Intra-pleural injection 15 U (USP)/vial Italy Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomicina TEVA, 15 U polvere per soluzione iniettabile 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Latvia Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomycin Teva 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Lithuania Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomycin Teva 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Luxembourg Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands BLEOMYCINE TEVA 15U poudre pour solution injectable 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Local/Intratumoral injections 15 U (USP)/vial Netherlands Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomycine 15 U (USP), poeder voor oplossing voor injectie 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Norway Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomycin Teva, Pulver og væske til injeksjonsvæske, oppløsning 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Poland Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomycin Teva 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Portugal Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomicina Teva 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Slovak Republic Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomycin-Teva prášok na injekčný roztok 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Slovenia Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomicin Teva 15 U (USP), prašek za raztopino za injiciranje 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial Spain Pharmachemie B.V. Swensweg 5 P.O. Box 552 2003 RN Haarlem, The Netherlands Bleomicina Teva 15 UI polvo para solución inyectable EFG 15 U (USP)/vial powder for solution for injection Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections 15 U (USP)/vial

ANNEX V LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES Member State EU/EEA Marketing Authorisation Holder Applicant (Invented) Name Strength Pharmaceutical Form Route of administration Content (concentration) Austria Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol ‘Hexal’ 100 μg/Dosis — Dosieraerosol 100 μg/dose Pressurised inhalation, suspension Inhalation use Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany SalbuHEXAL N Dosieraerosol 100 μg/dose Pressurised inhalation, suspension Inhalation use Ireland Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbul 100 micrograms Pressurised Inhalation Suspension 100 μg/dose Pressurised inhalation, suspension Inhalation use Spain Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol Hexal 100 mcg/dosis suspensión para inhalación en envase a presión EFG 100 μg/dose Pressurised inhalation, suspension Inhalation use Sweden Hexal AG Industriestr. 25 83607 Holzkirchen Germany Sanohex 100 μg/dose Pressurised inhalation, suspension Inhalation use

ANNEX VI LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Applicant (Invented) Name Strength Pharmaceutical form Route of administration Content (concentration) Belgium Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol Sandoz 100 μg Aërosol, suspensie 100 μg/dose Pressurised inhalation, suspension Inhalation use Denmark Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol Sandoz 100 μg/dose Pressurised inhalation, suspension Inhalation use Estonia Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol Sandoz 100 mikrogrammi/annuses 100 μg/dose Pressurised inhalation, suspension Inhalation use Finland Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol Sandoz 100 μg/dose Pressurised inhalation, suspension Inhalation use Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol Sandoz 100 mikrogramm Dosieraerosol Druckgas-inhalation, Suspension 100 μg/dose Pressurised inhalation, suspension Inhalation use Greece Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol/Sandoz 100 μg/dose Pressurised inhalation, suspension Inhalation use Hungary Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol Sandoz 100 μg túlnyomásos inhalációs szuszpenzió 100 μg/dose Pressurised inhalation, suspension Inhalation use Italy Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamolo Sandoz 100 μg/dose Pressurised inhalation, suspension Inhalation use Latvia Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol Sandoz 100 μg/dose Pressurised inhalation, suspension Inhalation use Lithuania Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol Sandoz 100 μg/dose Pressurised inhalation, suspension Inhalation use Netherlands Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol Sandoz aërosol 100 μg/dosis, aërosol, suspensie 100 microgram per dosis 100 μg/dose Pressurised inhalation, suspension Inhalation use Norway Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol Sandoz 100 μg/dose Pressurised inhalation, suspension Inhalation use Poland Hexal AG Industriestr. 25 83607 Holzkirchen Germany SalbuLEK 100 μg/dose Pressurised inhalation, suspension Inhalation use Portugal Sandoz Farmacêutica, Lda. Alameda da Beloura - Edifício 1, Piso 2 - Escritório 15 2710-693 Sintra Portugal Salbutamol Sandoz 100 μg/dose Pressurised inhalation, suspension Inhalation use Slovenia Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol Lek 100 mikrogramov inhalacijska suspenzija pod tlakom 100 μg/dose Pressurised inhalation, suspension Inhalation use Spain Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol Sandoz 100 mcg/dosis suspensión para inhalación en envase a presción EFG 100 μg/dose Pressurised inhalation, suspension Inhalation use Sweden Hexal AG Industriestr. 25 83607 Holzkirchen Germany Sabumalin 100 μg/dose Pressurised inhalation, suspension Inhalation use United Kingdom Hexal AG Industriestr. 25 83607 Holzkirchen Germany Salbutamol 100 microgram per actuation pressurised inhalation, suspension 100 μg/dose Pressurised inhalation, suspension Inhalation use