EN Official Journal of the European Union C 330/12

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2008 to 30 November 2008

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council (1) or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council (2) )

(2008/C 330/07)

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 12.11.2008 Lisonorm See Annex I See Annex I 13.11.2008 14.11.2008 Bromocriptine, dihydroergocryptine and lisuride See Annex II See Annex II 18.11.2008 14.11.2008 Cabergoline and pergolide See Annex III See Annex III 18.11.2008 19.11.2008 ZYPADHERA Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA, Houten Nederland This Decision is addressed to the Member States 21.11.2008 19.11.2008 Norfloxacin See Annex IV See Annex IV 20.11.2008 28.11.2008 Efexor See Annex V See Annex V 2.12.2008 28.11.2008 Efexor Depot See Annex VI See Annex VI 2.12.2008

(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 FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Applicant (Invented) Name Strength Pharmaceutical Form Route of administration Bulgaria Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Dironorm 10 mg/5 mg Tablets Oral use Czech Republic Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Lisonorm (1) 10 mg/5 mg Tablets Oral use Estonia Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Dironorm 10 mg/5 mg Tablets Oral use Hungary Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Lisonorm 10 mg/5 mg Tablets Oral use Latvia Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Dironorm 10 mg/5 mg Tablets Oral use Lithuania Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Dironorm 10 mg/5 mg Tablets Oral use Poland Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Dironorm 10 mg/5 mg Tablets Oral use Romania Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Lisonorm 10mg/5mg 10 mg/5 mg Tablets Oral use Slovak Republic Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Dironorm 10 mg/5 mg Tablets Oral use (1) Name approval pending.

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Bromocriptine containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Product name Strength Pharmaceutical Form Route of Administration Austria MEDA PHARMA GmbH Liesinger-Flur-Gasse 2c A-1230 Wien Parlodel 5 mg — Kapseln 5 mg Capsule Oral use Austria MEDA PHARMA GmbH Liesinger-Flur-Gasse 2c A-1230 Wien Parlodel 2,5 mg — Kapseln 2,5 mg Capsule Oral use Austria MEDA PHARMA GmbH Liesinger-Flur-Gasse 2c A-1230 Wien Parlodel SRO 10 mg — Kapseln 10 mg Capsule Oral use Austria MEDA PHARMA GmbH Liesinger-Flur-Gasse 2c A-1230 Wien Parlodel SRO 2,5 mg — Kapseln 2,5 mg Capsule Oral use Austria MEDA PHARMA GmbH Liesinger-Flur-Gasse 2c A-1230 Wien Parlodel SRO 5 mg — Kapseln 5 mg Capsule Oral use Austria MEDA PHARMA GmbH Liesinger-Flur-Gasse 2c A-1230 Wien Umprel 10 mg Capsule Oral use Austria MEDA PHARMA GmbH Liesinger-Flur-Gasse 2c A-1230 Wien Umprel 5 mg Capsule Oral use Austria MEDA PHARMA GmbH Liesinger-Flur-Gasse 2c A-1230 Wien Umprel 2,5 mg Capsule Oral use Belgium Meda Pharma S.A.-N.V. Chaussée de la Hulpe 166 B-1170 Brussels Parlodel 2,5 mg Tablet Oral use Belgium Meda Pharma S.A.-N.V. Chaussée de la Hulpe 166 B-1170 Brussels Parlodel 10 MG 10 mg Capsule, hard Oral use Belgium Meda Pharma S.A.-N.V. Chaussée de la Hulpe 166 B-1170 Brussels Parlodel 5 mg 5 mg Capsule, hard Oral use Bulgaria MEDOCHEMIE Limited 1-10 Constantinoupoleos Str. Zakaki CY-3505-Limassol Medocriptine 2,5 mg Tablet Oral use Bulgaria NOVARTIS Pharma Square ‘Dzhon Paul II’ office centre ‘Bulgaria 2000’ BG-1164 Sofia Parlodel 2,5 mg Tablet Oral use Bulgaria SOPHARMA bul. ‘Kliment Ohridski’ № 3, Bulgaria BG-1797 Sofia Bromocriptine Sopharma 2,5 mg Tablet Oral use Cyprus REMEDICA LTD P.O.Box 51706 CY-3508 Lemesos Brameston 2,5 mg Tablet Oral use Cyprus CODAL SYNTO LTD P.O.BOX 51785 CY-3508 Lemesos Pirodal 2,5 mg Tablet Oral use Cyprus DEMETRIADES & PAPAELLINAS Ltd P.O.Box 23490 CY-1683 Lefkosia Parlodel 2,5 mg Tablet Oral use Cyprus MEDOCHEMIE Limited 1-10 Constantinoupoleos Str. Zakaki CY-3505-Limassol Medocriptine 2,5 mg Tablet Oral use Czech Republic MEDA PHARMA s. r. o. Záhřebská 577 CZ-120 00 Praha 2 Parlodel 2,87 mg Tablet Oral use Czech Republic MEDOCHEMIE Limited 1-10 Constantinoupoleos Str. Zakaki CY-3505-Limassol Medocriptine 2,87 mg Tablet Oral use Denmark MEDA AS Solvang 8 DK-3450 Allerød Parlodel 2,5 mg Tablet Oral use Denmark MEDA AS Solvang 8 DK-3450 Allerød Parlodel 5 mg Capsule, hard Oral use Denmark MEDA AS Solvang 8 DK-3450 Allerød Parlodel 10 mg Capsule, hard Oral use Estonia GEDEON RICHTER Gyömröi út 19-21 H-1103 Budapest Promocriptin-Richter 2,5 mg Tablet Oral use Estonia NOVARTIS Finland Oy Metsanneidonkuja 10 FI-02130 Espoo Parlodel 2,5 mg Tablet Oral use Finland MEDA Oy Lemminkäisenkatu 32 FI-20520 Turku Parlodel 2,5 mg Tablet Oral use Finland MEDA Oy Lemminkäisenkatu 32 FI-20520 Turku Parlodel 10 mg Capsule, hard Oral use Finland MEDA Oy Lemminkäisenkatu 32 FI-20520 Turku Parlodel 5 mg Capsule, hard Oral use Finland MEDA Oy Lemminkäisenkatu 32 FI-20520 Turku Parlodel 10 mg Capsule, hard Oral use Finland MEDA Oy Lemminkäisenkatu 32 FI-20520 Turku Parlodel 5 mg Capsule, hard Oral use France MEDA PHARMA 25, boulevard de l'Amiral Bruix F-75016 Paris Parlodel 5 mg Capsule Oral use France MEDA PHARMA 25, boulevard de l'Amiral Bruix F-75016 Paris Parlodel 10 mg Capsule Oral use France MEDA PHARMA 25, boulevard de l'Amiral Bruix F-75016 Paris Parlodel 2,5 mg Scored tablet Oral use France SANOFI-AVENTIS 1/13, boulevard Romain Rolland F-75014 Paris Bromocriptine Winthrop 2,5 mg Scored tablet Oral use France SANOFI-AVENTIS 1/13, boulevard Romain Rolland F-75014 Paris Bromokin 2,5 mg Scored tablet Oral use France SANOFI-AVENTIS 1/13, boulevard Romain Rolland F-75014 Paris Parlodel 2,5 mg Scored tablet Oral use France SANOFI-AVENTIS 1/13, boulevard Romain Rolland F-75014 Paris Bromocriptine Winthrop 5 mg Capsule Oral use France SANOFI-AVENTIS 1/13, boulevard Romain Rolland F-75014 Paris Bromocriptine Winthrop 10 mg Capsule Oral use France SANOFI-AVENTIS 1/13, boulevard Romain Rolland F-75014 Paris Bromokin 5 mg Capsule Oral use France SANOFI-AVENTIS 1/13, boulevard Romain Rolland F-75014 Paris Bromokin 10 mg Capsule Oral use France SANOFI-AVENTIS 1/13, boulevard Romain Rolland F-75014 Paris Bromo-kin 2,5 mg Tablet Oral use Germany MEDA PHARMA GmbH & Co. KG Benzstr. 1 D-61352 Bad Homburg Pravidel 10 mg Kapseln 11,47 mg Capsule, hard Oral use Germany MEDA PHARMA GmbH & Co. KG Benzstr. 1 D-61352 Bad Homburg Pravidel 5 mg Kapseln 5,735 mg Capsule, hard Oral use Germany MEDA PHARMA GmbH & Co. KG Benzstr. 1 D-61352 Bad Homburg Pravidel 2,5 mg Tabletten 2,87 mg Tablet Oral use Germany AbZ-PHARMA Graf-Arco-Str. 3 D-89079 Ulm, Germany Bromocriptin AbZ 2,5mg Tabletten 2,87 mg Tablet Oral use Germany BETAPHARM Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Bromocriptin beta 5 5,735 mg Capsule, hard Oral use Germany BETAPHARM Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Bromocriptin beta 2,5 2,87 mg Tablet Oral use Germany CT-ARZNEIMITTEL GmbH Lengeder Str. 42a D-13407 Berlin bromocriptin-ct 5mg Hartkapseln 5,735 mg Capsule, hard Oral use Germany CT-ARZNEIMITTEL GmbH Lengeder Str. 42a D-13407 Berlin bromocriptin-ct 2,5 mg Tabletten 2,87 mg Tablet Oral use Germany CT-ARZNEIMITTEL GmbH Lengeder Str. 42a D-13407 Berlin bromocriptin-ct 10mg Hartkapseln 11,47 mg Capsule, hard Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Bromocriptin Hexal 10 mg Kapseln 11,47 mg Capsule, hard Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Kamilium 10 Kps. 11,47 mg Capsule, hard Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Bromocriptin Hexal 5 mg Kapseln 5,735 mg Capsule, hard Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Bromoxal 5 mg 5,735 mg Capsule, hard Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Bromocriptin Hexal 5 mg Kapseln 5,735 mg Capsule, hard Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Bromolakt 5 mg 5,735 mg Capsule Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Bromoktin 5 mg 5,735 mg Capsule Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Bromocriptin Hexal 2,5 mg Tabletten 2,87 mg Tablet Oral use Germany HORMOSAN PHARMA GmbH Postfach 600340 D-60333 Frankfurt Kirim 5 T 5,74 mg Tablet Oral use Germany HORMOSAN PHARMA GmbH Postfach 600340 D-60333 Frankfurt Kirim 2,5 2,87 mg Tablet Oral use Germany TAURUS PHARMA GmbH Benzstr. 11 D-61352 Bad Homburg Kirim gyn 2,87 mg Tablet Oral use Germany RATIOPHARM Graf-Arco-Straße 3 D-89079 Ulm Bromocriptin-ratiopharm 10mg Hartkapseln 11,47 mg Capsule, hard Oral use Germany RATIOPHARM Graf-Arco-Straße 3 D-89079 Ulm Bromocriptin-ratiopharm 5mg Hartkapseln 5,735 mg Capsule, hard Oral use Germany RATIOPHARM Graf-Arco-Straße 3 D-89079 Ulm Bromocriptin-ratiopharm 2,5mg Tabletten 2,87 mg Tablet Oral use Germany SANDOZ Pharmaceuticals GmbH Raiffeisenstr. 1 D-83607 Holzkirchen Bromocriptin Sandoz 10mg Hartkapseln 11,47 mg Capsule, hard Oral use Germany SANDOZ Pharmaceuticals GmbH Raiffeisenstr. 1 D-83607 Holzkirchen Bromocriptin Sandoz 5mg Hartkapseln 5,735 mg Capsule, hard Oral use Greece MEDA PHARMACEUTICALS S.A. Greece 3 Evritanias Street GR-15231 Halandri Attikis Parlodel 5 mg Capsule, hard Oral use Greece MEDA PHARMACEUTICALS S.A. Greece 3 Evritanias Street GR-15231 Halandri Attikis Parlodel 10 mg Capsule, hard Oral use Hungary GEDEON RICHTER Gyömröi út 19-21 H-1103 Budapest Bromocriptine-Richter 2,5 mg Tablet Oral use Iceland ICEPHARMA hf. Lynghálsi 13 IS-110 Reykjavík Parlodel 5 mg Capsule, hard Oral use Iceland ICEPHARMA hf. Lynghálsi 13 IS-110 Reykjavík Parlodel 10 mg Capsule, hard Oral use Iceland ICEPHARMA hf. Lynghálsi 13 IS-110 Reykjavík Parlodel 2,5 mg Tablet Oral use Ireland MEDA Health Sales Ireland Ltd Office 10 Dunboyne Business Park Dunboyne, Co. Meath Ireland Parlodel 2,5 mg Tablet Oral use Ireland MEDA Health Sales Ireland Ltd Office 10 Dunboyne Business Park Dunboyne, Co. Meath Ireland Parlodel 5 mg Capsule Oral use Italy MEDA PHARMA SpA Via Le Brenta, 18 I-20139 Milano Parlodel 10 mg Capsule Oral use Italy MEDA PHARMA SpA Via Le Brenta, 18 I-20139 Milano Parlodel 5 mg Capsule Oral use Italy DOROM Srl Via Giulio Richard 7 I-20143 Milano Bromocriptina Dorom 10 mg Capsule Oral use Italy DOROM Srl Via Giulio Richard 7 I-20143 Milano Bromocriptina Dorom 5 mg Capsule Oral use Latvia Lek farmacevtska drvžba d.d. Verovškova 57 SLO-1000 Ljubljana Bromergon 2,5 mg Tablet Oral use Latvia GEDEON RICHTER Gyömröi út 19-21 H-1103 Budapest Bromocriptin-Richter 2,5 mg Tablet Oral use Latvia NOVARTIS Finland Oy Metsanneidonkuja 10 FI-02130 Espoo Parlodel 2,5 mg Tablet Oral use Lithuania GEDEON RICHTER Gyömröi út 19-21 H-1103 Budapest Bromocriptin-Richter 2,5 mg Tablet Oral use Lithuania NOVARTIS Finland Oy Metsanneidonkuja 10 FI-02130 Espoo Parlodel 2,5 mg Tablet Oral use Lithuania POLI INDUSTRIA chimica S.p.A. Via Volturno 45/48-Quinto de Stampi I-20089 Rozzano Milano Bromocriptine Poli 2,5 mg Tablet Oral use Luxembourg MEDA PHARMA GmbH Benestraße 1 D-61352 BAD Hamburg Pravidel 2,5 mg Tablet Oral use Luxembourg MEDA PHARMA GmbH Benestraße 1 D-61352 BAD Hamburg Pravidel 5 mg Capsule Oral use Luxembourg MEDA PHARMA GmbH Benestraße 1 D-61352 BAD Hamburg Pravidel 10 mg Capsule Oral use Netherlands MEDA PHARMA B.V. Krijgsman 20 1186 DM AMSTELVEEN/NL Nederland Parlodel 10 mg 10 mg Capsule Oral use Netherlands MEDA PHARMA B.V. Krijgsman 20 1186 DM AMSTELVEEN/NL Nederland Parlodel 2,5 mg 2,5 mg Tablet Oral use Netherlands MEDA PHARMA B.V. Krijgsman 20 1186 DM AMSTELVEEN/NL Nederland Parlodel 5 mg 5 mg Tablet Oral use Poland Lek S.A. ul. Podlipie 16 PL-95-010 Stryków Bromergon 2,5 mg Tablet Oral use Poland Filofarm Farmaceutyczna Spółdzielnia Pracy ‘Filofarm’ ul. Pułaskiego 39 PL-85-619 Bydgoszcz Bromocorn 2,87 mg Tablet Oral use Poland Meda Aktiebolag Pipers vag 2 P.O. Box 906 S-170 09 Solana Parlodel 2,5 mg Tablet Oral use Poland POLFA Grodziskie Zakłady Farmaceutyczne POLFA Sp. z o.o. ul. Poniatowskiego 5 PL-05-825 Grodzisk Mazowiecki Ergolaktyna 2,5 mg Tablet Oral use Portugal MEDA PHARMA — Produtos Farmacêuticos, SA Rua do Centro Cultural, 13 P-1749-066 Lisboa Parlodel 2,5 mg Tablet Oral use Portugal MEDA PHARMA — Produtos Farmacêuticos, SA Rua do Centro Cultural, 13 P-1749-066 Lisboa Parlodel 5 mg Capsule Oral use Portugal MEDA PHARMA — Produtos Farmacêuticos, SA Rua do Centro Cultural, 13 P-1749-066 Lisboa Parlodel 10 mg Capsule Oral use Portugal Generis Farmacêutica, SA Office Park da Beloura Edifício 4 Quinta da Beloura P-2710-444 Sintra Bromocriptina Generis 2,5 mg comprimidos 2,5 mg Tablet Oral use Romania S.C. BIOFARM S.A. Str. Logofat Tautu nr. 99, sector 3 București, România Brocriptin 2,5mg Tablet Oral use Slovak Republic MEDA PHARMA s. r. o. Záhřebská 577 CZ-120 00 Praha 2 Parlodel 2,5 mg Tablet Oral use Slovak Republic MEDOCHEMIE Limited 1-10 Constantinoupoleos Str. Zakaki CY-3505-Limassol Medocriptine 2,5 mg 2,5 mg Tablet Oral use Slovenia Lek farmacevtska družba d.d. Verovškova 57 SLO-1000 Ljubljana Bromergon 2,5 mg Tablet Oral use Spain MEDA PHARMA SAU Avda Castilla, 2 Edif Berlin 2a planta, parque empresarial E-28830 San Fernando de Henares Parlodel 2,5 mg comprimidos 2,5 mg Tablet Oral use Spain MEDA PHARMA SAU Avda Castilla, 2 Edif Berlin 2a planta, parque empresarial E-28830 San Fernando de Henares Parlodel 5 mg capsulas 5 mg Capsule Oral use Sweden MEDA AB Box 906 S-170 09 Solna Pravidel 2,5 mg Tablet Oral use Sweden MEDA AB Box 906 S-170 09 Solna Pravidel 5 mg Capsule, hard Oral use Sweden MEDA AB Box 906 S-170 09 Solna Pravidel 10 mg Capsule, hard Oral use United Kingdom MEDA Pharmaceuticals Limited Building 2000 Beach Drive Cambridge Research Park Waterbeach Cambridgeshire CB5 9PD United Kingdom Parlodel 2,5 mg tablets 5 mg Tablet Oral use United Kingdom MEDA Pharmaceuticals Limited Building 2000 Beach Drive Cambridge Research Park Waterbeach Cambridgeshire CB5 9PD United Kingdom Parlodel 2,5 mg tablets 10 mg Tablet Oral use United Kingdom MEDA Pharmaceuticals Limited Building 2000 Beach Drive Cambridge Research Park Waterbeach Cambridgeshire CB5 9PD United Kingdom Parlodel 2,5 mg tablets 2,5 mg Tablet Oral use United Kingdom MEDA Pharmaceuticals Limited Building 2000 Beach Drive Cambridge Research Park Waterbeach Cambridgeshire CB5 9PD United Kingdom Parlodel 1 mg tablets 1 mg Tablet Oral use United Kingdom NORTON Healthcare Limited Albert Basin Royal Docks London E16 2QJ United Kingdom Bromocriptine tablets BP 2,5 mg 2,5 mg Tablet Oral use United Kingdom GENERICS (UK) Limited Station Close Potters Bar Herts EN6 1TL United Kingdom Bromocriptine tablets BP 2,5 mg 2,5 mg Tablet Oral use United Kingdom NOVARTIS Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Parlodel LAR injection 50 mg 50 mg Powder for injection Intramuscular use United Kingdom NOVARTIS Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Parlodel LAR injection 100 mg 100 mg Powder for injection Intramuscular use Dihydroergocryptine containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Product name Strength Pharmaceutical Form Route of administration Austria Defiante Farmaceutica Lda. Rua dos Ferreiros 260 P-9000-082 Funchal/Madeira Hydergin — Fas 4,5 mg — Filmtabletten 4,5 mg Tablet Oral use Austria Defiante Farmaceutica Lda. Rua dos Ferreiros 260 P-9000-082 Funchal/Madeira Hydergin 1 mg/ml — Tropfen 1 mg/ml Oral drops Oral use Austria Defiante Farmaceutica Lda. Rua dos Ferreiros 260 P-9000-082 Funchal/Madeira Hydergin 3 mg/ml — Tropfen 3 mg/ml Oral drops Oral use Austria Defiante Farmaceutica Lda. Rua dos Ferreiros 260 P-9000-082 Funchal/Madeira Hydergin 1 mg — Tabletten 1 mg Tablet Oral use Austria Defiante Farmaceutica Lda. Rua dos Ferreiros 260 P-9000-082 Funchal/Madeira Hydergin 2 mg — Tabletten 2 mg Tablet Oral use Austria Defiante Farmaceutica Lda. Rua dos Ferreiros 260 P-9000-082 Funchal/Madeira Hydergin 0,3 mg/1 ml — Ampullen 0,3 mg/1 m Solution for injection Intravenous use Austria Defiante Farmaceutica Lda. Rua dos Ferreiros 260 P-9000-082 Funchal/Madeira Hydergin SRO 6 mg — Kapseln 6 mg Capsule Oral use Austria RATIOPHARM Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 A-1140 Wien Co-Dergocrin ‘ratiopharm’ retard 5 mg — Kapseln 5 mg Capsule Oral use Austria RATIOPHARM Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 A-1140 Wien Co-Dergocrin ‘ratiopharm’ retard 2,5 mg — Kapseln 2,5 mg Capsule Oral use Austria SANOVA Pharma GmbH Haidestraße 4 A-1110 Wien Dorehydrin 1 mg/ml — Tropfen 1 mg/ml Oral drops Oral use Austria SANOVA Pharma GmbH Haidestraße 4 A-1110 Wien Dorehydrin retard 2,5 mg — Kapseln 2,5 mg Capsule Oral use Austria SANOVA Pharma GmbH Haidestraße 4 A-1110 Wien Dorehydrin retard 4,5 mg — Kapseln 4,5 mg Capsule Oral use Austria WABOSAN Arzneimittelvertriebs GmbH Anton Anderer Platz 6/1 A-1210 Wien Ergomed retard- Kapseln 0,875 mg Capsule Oral use Austria WABOSAN Arzneimittelvertriebs GmbH Anton Anderer Platz 6/1 A-1210 Wien Ergomed — Tabletten 0,33 mg Tablet Oral use Austria WABOSAN Arzneimittelvertriebs GmbH Anton Anderer Platz 6/1 A-1210 Wien Ergomed — Tropfen 0,33 mg/ml Oral drops Oral use Belgium NOVARTIS PHARMA nv. Medialaan 40 B-1800 Vilvoorde Hydergine 1 mg/ml Oral drops, solution Oral use Belgium NOVARTIS PHARMA nv. Medialaan 40 B-1800 Vilvoorde Hydergine 1,5 mg 1,5 mg Tablet Oral use Belgium NOVARTIS PHARMA nv. Medialaan 40 B-1800 Vilvoorde Hydergine 4,5 mg 4,5 mg Tablet Oral use Belgium NOVARTIS PHARMA nv. Medialaan 40 B-1800 Vilvoorde Hydergine FAS 4,5 mg 4,5 mg Gastro-resistant tablet Oral use Belgium LABORATOIRES PHARMACOBEL Avenue de Seheut, 46-50 B-1070 Bruxelles Dystonal 2,5 mg (N.F.) 2,5 mg Tablet Oral use Belgium NYCOMED BELGIUM Gentsesteenweg 615 B-1080 Brussel Stofilan 1,5 mg Tablet Oral use Belgium NYCOMED BELGIUM Gentsesteenweg 615 B-1080 Brussel Stofilan 1 mg/ml Oral solution Oral use Belgium NYCOMED BELGIUM Gentsesteenweg 615 B-1080 Brussel Stofilan 4,5 mg Tablet Oral use Belgium SANDIPRO s.a. Chaussée de Gand, 615 B-1080 Bruxelles IBEXONE 1,5 mg 1,5 mg Tablet Oral use Belgium SANDIPRO s.a. Chaussée de Gand, 615 B-1080 Bruxelles IBEXONE 1 mg/ml Oral solution Oral use Belgium SANDIPRO s.a. Chaussée de Gand, 615 B-1080 Bruxelles IBEXONE 4,5 mg 4,5 mg Tablet Oral use Belgium SANDIPRO s.a. Chaussée de Gand, 615 B-1080 Bruxelles IBEXONE 3 mg/ml Oral solution Oral use Bulgaria POLI INDUSTRIA chimica S.p.A. Via Volturno 45/48-Quinto de Stampi I-20089 Rozzano Milano Almirid 5 5 mg Capsule, hard Oral use Bulgaria POLI INDUSTRIA chimica S.p.A. Via Volturno 45/48-Quinto de Stampi I-20089 Rozzano Milano Almirid 5 20 mg Tablet Oral use Czech Republic POLICHEM S.A. 50, Val Fleuri L-1526 Luxembourg Almirid 20 mg Tablet Oral use Czech Republic POLICHEM S.A. 50, Val Fleuri L-1526 Luxembourg Almirid 5 mg Capsule, hard Oral use Finland Novartis Finland Oy Metsänneidonkuja 10 FI-02130 Espoo Hydergin 1mg Tablet Oral use Finland Novartis Finland Oy Metsänneidonkuja 10 FI-02130 Espoo Hydergin 1,5mg Tablet Oral use France Novartis Pharma SAS 2 & 4 Rue Lionel Terray F-92506 Rueil Malmaison Cedex Hydergine 0,3 mg/1 ml Solution for injection Oral use France Novartis Pharma SAS 2 & 4 Rue Lionel Terray F-92506 Rueil Malmaison Cedex Hydergine 1 mg/1 ml Oral solution Oral use France Novartis Pharma SAS 2 & 4 Rue Lionel Terray F-92506 Rueil Malmaison Cedex Hydergine 4,5 mg Tablet Oral use Germany DESITIN Arzneimittel GmbH Postfach 630164 D-22311 Hamburg, Germany Almirid 20 mg Tablet Oral use Germany DESITIN Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Almirid 40 mg Tablet Oral use Germany DESITIN Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Almirid 5 mg Capsule Oral use Germany TAURUS PHARMA GmbH Benzstr. 11 D-61352 Bad Homburg Cripar 20 20 mg Tablet Oral use Germany TAURUS PHARMA GmbH Benzstr. 11 D-61352 Bad Homburg Cripar forte 40 40 mg Tablet Oral use Germany TAURUS PHARMA GmbH Benzstr. 11 D-61352 Bad Homburg, Germany Cripar 5 5 mg Capsule Oral use Germany Defiante Farmaceutica Lda. Rua dos Ferreiros 260 P-9000-082 Funchal/Madeira Hydergin 1 mg/ml Tropflösung 0,333 mg Oral drops, solution Oral use Germany Defiante Farmaceutica Lda. Rua dos Ferreiros 260 P-9000-082 Funchal/Madeira Hydergin forte 2 mg Tabletten 0,666 mg Tablet Oral use Germany Defiante Farmaceutica Lda. Rua dos Ferreiros 260 P-9000-082 Funchal/Madeira Hydergin forte 2 mg/ml Tropflösung 0,67 mg Oral drops, solution Oral use Germany Defiante Farmaceutica Lda. Rua dos Ferreiros 260 P-9000-082 Funchal/Madeira Hydergin Spezial 1,33 mg Film-coated tablet Oral use Germany DESITIN Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Ergodesit forte 2 mg 0,66 mg Tablet Oral use Germany DESITIN Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Ergodesit spezial 5 mg 1,66 mg Prolonged-release tablet Oral use Germany OPFERMANN Arzneimittel GmbH Robert-Koch-Str. 2 D-51674 Wiehl Orphol forte 3 mg/ml 1 mg Oral solution Oral use Germany OPFERMANN Arzneimittel GmbH Robert-Koch-Str. 2 D-51674 Wiehl Orphol Spezial 1,5 mg Tablet Oral use Germany OPFERMANN Arzneimittel GmbH Robert-Koch-Str. 2 D-51674 Wiehl Orphol Brausetabletten 1,5 mg Effervescent tablet Oral use Germany Amdipharm Limited Temple Chambers 3 Burlington Road Dublin 4 Ireland DCCK Tropflösung 1 mg Prolonged-release capsule, hard Oral use Germany Amdipharm Limited Temple Chambers 3 Burlington Road Dublin 4 Ireland DCCK Depot 4,5 1,5 mg Prolonged-release capsule, hard Oral use Germany FARMASAN Arzneimittel GmbH & Co.KG Postfach 410440 D-76204 Karlsruhe Sponsin forte 0,833 mg Prolonged-release capsule, hard Oral use Germany FARMASAN Arzneimittel GmbH & Co.KG, Postfach 410440 D-76204 Karlsruhe, Germany Sponsin spezial 1,5 mg Prolonged-release capsule, hard Oral use Germany RATIOPHARM Graf-Arco-Straße 3 D-89079 Ulm Hydro-Cebral-ratiopharm Tropfen 0,33 mg Oral solution Oral use Germany RATIOPHARM Graf-Arco-Straße 3 D-89079 Ulm Hydro-Cebral-ratiopharm 2,5 mg 0,833 mg Prolonged-release capsule, hard Oral use Germany RATIOPHARM Graf-Arco-Straße 3 D-89079 Ulm Hydro-Cebral-ratiopharm 5,0 mg 1,666 mg Prolonged-release capsule, hard Oral use Greece PHARMANEL PHARMACEUTICALS S.A. Marathonos 106 GR-15344 Gerakas Daverium 5 mg Capsule, hard Oral use Greece PHARMANEL PHARMACEUTICALS S.A. Marathonos 106 GR-15344 Gerakas Daverium 20 mg Tablet Oral use Greece Novartis (Hellas) S.A.C.I. 12 Klm National Road No 1 GR-14451 Athens Hydergine LPD 0,1 % 15 ml Oral solution Oral use Hungary POLICHEM S.A. 50, Val Fleuri L-1526 Luxembourg Almirid 20 mg Tablet Oral use Hungary POLICHEM S.A. 50, Val Fleuri L-1526 Luxembourg Almirid 5 mg Capsule Oral use Ireland POLICHEM S.A. 50, Val Fleuri L-1526 Luxembourg Almirid 5mg Capsule Oral use Ireland POLICHEM S.A. 50, Val Fleuri L-1526 Luxembourg Almirid 20 mg Tablet Oral use Italy MARVECSPHARMA SERVICES Srl Via Felice Casati, 16 I-20124 Milano Daverium 20 mg Tablet Oral use Italy Novartis Farma S.P.A. Largo Umberto Boccioni 1 I-21040 Origgio Varese Hydergina 1 mg Oral solution Oral use Italy Novartis Farma S.P.A. Largo Umberto Boccioni 1 I-21040 Origgio Varese Hydergina 1,5 mg Tablet Oral use Luxembourg NOVARTIS Pharma GmbH Roonstraße 25 D-90429 Nurnberg Hydergin 1 mg/ml Tropflösung 0,333 mg Oral drops, solution Oral use Luxembourg NOVARTIS Pharma GmbH Roonstraße 25 D-90429 Nurnberg Hydergin forte 2 mg/ml Tropflösung 0,67 mg Oral drops, solution Oral use Luxembourg NOVARTIS Pharma GmbH Roonstraße 25 D-90429 Nurnberg Hydergin Spezial 1,33 mg Film-coated tablet Oral use Netherlands CENTRAFARM SERVICES B.V. Nieuwe Donk 9 4879 AC ETTEN-LEUR/NL Nederland Co-dergocrinemesilaat 1,5 mg Tablet Oral use Poland POLICHEM S.A. 50, Val Fleuri L-1526 Luxembourg Almirid 20 mg Tablet Oral use Portugal POLICHEM S.A. 50, Val Fleuri L-1526 Luxembourg Cripar 20 20 mg Tablet Oral use Portugal POLICHEM S.A. 50, Val Fleuri L-1526 Luxembourg Cripar 5 5 mg Capsule Oral use Portugal Novartis Farma Produtos Farmacêuticos S.A. Rua do Centro Empresarial Edifício 8, Quinta da Beloura P-2710-44 Sintra Hydergine 1,5 mg 1,5 mg Tablet Oral use Portugal Novartis Farma Produtos Farmacêuticos S.A. Rua do Centro Empresarial Edifício 8, Quinta da Beloura P-2710-44 Sintra Hydergine 4,5 mg 4,5 mg Tablet Oral use Portugal Novartis Farma Produtos Farmacêuticos S.A. Rua do Centro Empresarial Edifício 8, Quinta da Beloura P-2710-44 Sintra Hydergine 1 mg/ml 1 mg/ml Oral drops, solution Oral use Portugal Novartis Farma Produtos Farmacêuticos S.A. Rua do Centro Empresarial Edifício 8, Quinta da Beloura P-2710-44 Sintra Hydergine 3 mg/ml 3 mg/ml Oral drops, solution Oral use Slovak Republic POLICHEM S.A. 50, Val Fleuri L-1526 Luxembourg Almirid 20 mg Tablet Oral use Slovak Republic POLICHEM S.A. 50, Val Fleuri L-1526 Luxembourg Almirid 5 mg Capsule Oral use Spain Novartis Farmacéutica, S.A. Gran Via de los Corts Catalanes, número 184 E-08013 Barcelona Hydergina 4,5 mg Tablet Oral use Spain Novartis Farmacéutica, S.A. Gran Via de los Corts Catalanes, número 184 E-08013 Barcelona Hydergina 1 mg/ml Oral solution Oral use Sweden Novartis Sverige AB Kemistvägen 1B Box 1150 S-183 11 Täby Hydergine 1 mg Tablet Oral use United Kingdom Novartis Pharmaceuticals Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Hydergine 1,5 mg 1,5 mg Tablet Oral use United Kingdom Novartis Pharmaceuticals Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom Hydergine 4,5 mg 4,5 mg Tablet Oral use Lisuride containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Product name Strength Pharmaceutical Form Route of administration Austria BAYER GmbH Herbststraße 6-10 A-1160 Wien Dopergin — Tabletten 0,2 mg Tablet Oral use France LABO LISA pharm 9 bis, boulevard J. Jaures F-92100 Boulogne Billancourt Arolac 0,2mg Tablet Oral use France Bayer Schering Pharma ZI roubaix est rue de touflers F-59390 Lys-les-Lannoy Dopergine 0,2 mg Tablet Oral use France Bayer Schering Pharma ZI roubaix est rue de touflers F-59390 Lys-les-Lannoy Dopergine 0,5mg Tablet Oral use Germany BAYER Vital GmbH D-51368 Leverkusen Dopergin-0,5 mg Tablette 0,5 mg Tablet Oral use Germany BAYER Vital GmbH D-51368 Leverkusen Dopergin-0,2 mg Tablette 0.2 mg Tablet Oral use Italy SCHERING SpA Via E. Schering, 21 I-20090 Segrate (MI) Dopergin 0,2 mg Tablet Oral use Italy SCHERING SpA Via E. Schering, 21 I-20090 Segrate (MI) Dopergin 0,5 mg Tablet Oral use Spain Química Farmaceutica Bayer SL, Pau Claris, 196 E-08037 Barcelona Dopergin 0,2 mg comprimidos 0,2 mg Tablet Oral use

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Cabergoline containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Product name Strength Pharmaceutical Form Route of administration Austria PFIZER Corporation Austria GmbH Floridsdorfer Hauptstraße 1 A-1210 Wien Cabaseril 2 mg Tablet Oral use Austria PFIZER Corporation Austria GmbH Floridsdorfer Hauptstraße 1 A-1210 Wien Cabaseril 4 mg Tablet Oral use Austria PFIZER Corporation Austria GmbH Floridsdorfer Hauptstraße 1 A-1210 Wien Cabaseril 1 mg Tablet Oral use Austria PFIZER Corporation Austria GmbH Floridsdorfer Hauptstraße 1 A-1210 Wien Dostinex 0,5 mg Tablet Oral use Austria SANDOZ GmbH Biochemiestraße 10 A-6250 Kundl Cabergolin ‘Sandoz’ 0,5 mg — Tabletten 0,5 mg Tablet Oral use Austria SANDOZ GmbH Biochemiestraße 10 A-6250 Kundl Cabergolin ‘Sandoz’ 1 mg — Tabletten 1 mg Tablet Oral use Austria SANDOZ GmbH Biochemiestraße 10 A-6250 Kundl Cabergolin ‘Sandoz’ 2 mg — Tabletten 2 mg Tablet Oral use Austria SANDOZ GmbH Biochemiestraße 10 A-6250 Kundl Cabergolin ‘Sandoz’ 4 mg — Tabletten 4 mg Tablet Oral use Austria TEVA Pharmaceuticals Europe B.V. Computerweg 10 3542 DR Utrecht Nederland Cabergolin Teva 0,5 mg Tabletten 0,5 mg Tablet Oral use Austria TEVA Pharmaceuticals Europe B.V. Computerweg 10 3542 DR Utrecht Nederland Cabergolin Teva 1 mg Tabletten 1 mg Tablet Oral use Austria TEVA Pharmaceuticals Europe B.V. Computerweg 10 3542 DR Utrecht Nederland Cabergolin Teva 2 mg Tabletten 2 mg Tablet Oral use Austria TEVA Pharmaceuticals Europe B.V. Computerweg 10 3542 DR Utrecht Nederland Cabergolin Teva 4 mg Tabletten 4 mg Tablet Oral use Belgium PFIZER S.A Boulevard de la Plaine 17 B-1050 Bruxelles Dostinex 0,5 mg Tablet Oral use Belgium PFIZER S.A Boulevard de la Plaine 17 B-1050 Bruxelles Sostilar 0,5 mg Tablet Oral use Belgium TEVA Pharma Belgium N.V. Laarstraat 16 B-2610 Wilrijk Cabergoline Teva 0,5 mg 0,5 mg Tablet Oral use Belgium TEVA Pharma Belgium N.V. Laarstraat 16 B-2610 Wilrijk Cabergoline Teva 1 mg 1 mg Tablet Oral use Belgium TEVA Pharma Belgium N.V. Laarstraat 16 B-2610 Wilrijk Cabergoline Teva 2 mg 2 mg Tablet Oral use Belgium TEVA Pharma Belgium N.V. Laarstraat 16 B-2610 Wilrijk Cabergoline Teva 4 mg 4 mg Tablet Oral use Bulgaria Pfizer Enterprises SÀRL Rond Point du Kirchberg/51, avenue JF Kennedy L-1855 Luxembourg Dostinex 0,5 mg Tablet Oral use Bulgaria Pfizer Enterprises SÀRL Rond Point du Kirchberg/51, avenue JF Kennedy L-1855 Luxembourg Cabaser 2 mg Tablet Oral use Bulgaria Pfizer Enterprises SÀRL Rond Point du Kirchberg/51, avenue JF Kennedy L-1855 Luxembourg Cabaser 1 mg Tablet Oral use Cyprus GEO PAVLIDES & ARAOUZOS Ltd P.O.Box 24899 CY-1305 Lefkosia Dostinex 0,5 mg Tablet Oral use Cyprus TEVA Pharma B.V. P.O. Box 43011 3540 AA Utrecht Nederland Cabergoline Teva 1 mg Tablet Oral use Cyprus TEVA Pharma B.V. P.O. Box 43011 3540 AA Utrecht, Nederland Cabergoline Teva 2 mg Tablet Oral use Cyprus TEVA Pharma B.V. P.O. Box 43011 3540 AA Utrecht Nederland Cabergoline Teva 4 mg Tablet Oral use Cyprus TEVA Pharma B.V. P.O. Box 43011 3540 AA Utrecht Nederland Cabergoline Teva 0,5 mg Tablet Oral use Czech Republic PFIZER spol. s. r. o. Stroupežnického 17 CZ-150 00 Praha 5 Dostinex 0,5 mg Tablet Oral use Czech Republic HEXAL Industriestraβe 25 D-83607 Holzkirchen Cabergolin Sandoz 0,5 mg 0,5 mg Tablet Oral use Czech Republic HEXAL Industriestraβe 25 D-83607 Holzkirchen Cabergolin Sandoz 1 mg 1 mg Tablet Oral use Czech Republic HEXAL Industriestraβe 25 D-83607 Holzkirchen Cabergolin Sandoz 2 mg 2 mg Tablet Oral use Czech Republic HEXAL Industriestraβe 25 D-83607 Holzkirchen Cabergolin Sandoz 4 mg 4 mg Tablet Oral use Czech Republic TEVA Pharmaceuticals ČR s. r. o. Radlická 3185/1C CZ-150 00 Praha 5 Cabera 0,5 mg Tablet Oral use Czech Republic TEVA Pharmaceuticals ČR s. r. o. Radlická 3185/1C CZ-150 00 Praha 5 Cabera 1 mg Tablet Oral use Czech Republic TEVA Pharmaceuticals ČR s. r. o. Radlická 3185/1C CZ-150 00 Praha 5 Cabera 2 mg Tablet Oral use Czech Republic TEVA Pharmaceuticals ČR s. r. o. Radlická 3185/1C CZ-150 00 Praha 5 Cabera 4 mg Tablet Oral use Denmark PFIZER Aps Lautrupvang 8 DK-2750 Ballerup Cabaser 1 mg Tablet Oral use Denmark PFIZER Aps Lautrupvang 8 DK-2750 Ballerup Cabaser 2 mg Tablet Oral use Denmark PFIZER Aps Lautrupvang 8 DK-2750 Ballerup Cabaser 4 mg Tablet Oral use Denmark PFIZER Aps Lautrupvang 8 DK-2750 Ballerup Dostinex 0,5 mg Tablet Oral use Denmark HEXAL A/S Kanalholmen 8-12 DK-2650 Hvidovre Cabergolin ‘Hexal’ 1 mg Tablet Oral use Denmark HEXAL A/S Kanalholmen 8-12 DK-2650 Hvidovre Cabergolin ‘Hexal’ 2 mg Tablet Oral use Denmark HEXAL A/S Kanalholmen 8-12 DK-2650 Hvidovre Cabergolin ‘Hexal’ 4 mg Tablet Oral use Denmark HEXAL A/S Kanalholmen 8-12 DK-2650 Hvidovre Cabergolin ‘Hexal’ 0,5 mg Tablet Oral use Finland PFIZER OY Tietokuja 4 FI-00330 Helsinki Cabaser 1 mg Tablet Oral use Finland PFIZER OY Tietokuja 4 FI-00330 Helsinki Cabaser 2 mg Tablet Oral use Finland PFIZER OY Tietokuja 4 FI-00330 Helsinki Cabaser 4 mg Tablet Oral use Finland PFIZER OY Tietokuja 4 FI-00330 Helsinki Cabaser 1 mg Tablet Oral use Finland PFIZER OY Tietokuja 4 FI-00330 Helsinki Cabaser 2 mg Tablet Oral use Finland PFIZER OY Tietokuja 4 FI-00330 Helsinki Cabaser 4 mg Tablet Oral use Finland PFIZER OY Tietokuja 4 FI-00330 Helsinki Dostinex 0,5 mg Tablet Oral use France PFIZER holding France 23-25, rue du docteur Lannelongue F-75014 Paris Dostinex 0,5 mg Tablet Oral use France PFIZER holding France 23-25, rue du docteur Lannelongue F-75014 Paris Cabaser 1 mg Tablet Oral use France PFIZER holding France 23-25, rue du docteur Lannelongue F-75014 Paris Cabaser 2 mg Tablet Oral use France PFIZER holding France 23-25, rue du docteur Lannelongue F-75014 Paris Cabaser 4 mg Tablet Oral use Germany PHARMACIA GmbH Pfizerstr. 1 D-76139 Karlsruhe Dostinex 0,5 mg Tablet Oral use Germany PHARMACIA GmbH Pfizerstr. 1 D-76139 Karlsruhe Cabaseril 1 mg Tablet Oral use Germany PHARMACIA GmbH Pfizerstr. 1 D-76139 Karlsruhe Cabaseril 2 mg Tablet Oral use Germany PHARMACIA GmbH Pfizerstr. 1 D-76139 Karlsruhe Cabaseril 4 mg Tablet Oral use Germany ALIUD PHARMA GmbH & Co.KG Postfach 1380 D-89146 Laichingen Cabergolin AL 0,5 mg Tabletten 0,5 mg Tablet Oral use Germany ALIUD PHARMA GmbH & Co.KG Postfach 1380 D-89146 Laichingen Cabergolin AL 1 mg Tabletten 1 mg Tablet Oral use Germany ALIUD PHARMA GmbH & Co.KG Postfach 1380 D-89146 Laichingen Cabergolin AL 2 mg Tabletten 2 mg Tablet Oral use Germany ALIUD PHARMA GmbH & Co.KG Postfach 1380 D-89146 Laichingen Cabergolin AL 4 mg Tabletten 4 mg Tablet Oral use Germany CT-ARZNEIMITTEL GmbH Lengeder Str. 42a D-13407 Berlin Cabergolin-CT 1 mg Tabletten 1 mg Tablet Oral use Germany CT-ARZNEIMITTEL GmbH Lengeder Str. 42a D-13407 Berlin Cabergolin-CT 2 mg Tabletten 2 mg Tablet Oral use Germany CT-ARZNEIMITTEL GmbH Lengeder Str. 42a D-13407 Berlin Cabergolin-CT 4 mg Tabletten 4 mg Tablet Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Cabergolin HEXAL 0,5 mg Tabletten 0,5 mg Tablet Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Cabergolin HEXAL 1 mg Tabletten 1 mg Tablet Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Cabergolin HEXAL 2 mg Tabletten 2 mg Tablet Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Cabergolin HEXAL 4 mg Tabletten 4 mg Tablet Oral use Germany MERCK Dura GmbH Alsfelder Str. 19 D-64289 Darmstadt Cabergolin dura 0,5 mg Tabletten 0,5 mg Tablet Oral use Germany MERCK Dura GmbH Alsfelder Str. 19 D-64289 Darmstadt Cabergolin dura 1 mg Tabletten 1 mg Tablet Oral use Germany MERCK Dura GmbH Alsfelder Str. 19 D-64289 Darmstadt Cabergolin dura 2 mg Tabletten 2 mg Tablet Oral use Germany MERCK Dura GmbH Alsfelder Str. 19 D-64289 Darmstadt Cabergolin dura 4 mg Tabletten 4 mg Tablet Oral use Germany SANDOZ Pharmaceuticals GmbH Raiffeisenstr. 1 D-83607 Holzkirchen Cabergolin Sandoz 0,5 mg Tabletten 0,5 mg Tablet Oral use Germany SANDOZ Pharmaceuticals GmbH Raiffeisenstr. 1 D-83607 Holzkirchen Cabergolin Sandoz 1 mg Tabletten 1 mg Tablet Oral use Germany SANDOZ Pharmaceuticals GmbH Raiffeisenstr. 1 D-83607 Holzkirchen Cabergolin Sandoz 2 mg Tabletten 2 mg Tablet Oral use Germany SANDOZ Pharmaceuticals GmbH Raiffeisenstr. 1 D-83607 Holzkirchen Cabergolin Sandoz 4 mg Tabletten 4 mg Tablet Oral use Germany STADAPHARM GmbH Stadastr. 2-18 D-61118 Bad Vilbel Cabergolin STADA 0,5 mg Tabletten 0,5 mg Tablet Oral use Germany STADAPHARM GmbH Stadastr. 2-18 D-61118 Bad Vilbel Cabergolin STADA 1 mg Tabletten 1 mg Tablet Oral use Germany STADAPHARM GmbH Stadastr. 2-18 D-61118 Bad Vilbel Cabergolin STADA 2 mg Tabletten 2 mg Tablet Oral use Germany STADAPHARM GmbH Stadastr. 2-18 D-61118 Bad Vilbel Cabergolin STADA 4 mg Tabletten 4 mg Tablet Oral use Germany TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Cabergo-TEVA 0,5 mg Tabletten 0,5 mg Tablet Oral use Germany TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Cabergolin-TEVA 0,5 mg Tabletten 0,5 mg Tablet Oral use Germany TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Cabergo-TEVA 1 mg Tabletten 1. mg Tablet Oral use Germany TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Cabergolin-TEVA 1 mg Tabletten 1 mg Tablet Oral use Germany TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Cabergo-TEVA 2 mg Tabletten 2 mg Tablet Oral use Germany TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Cabergolin-TEVA 2 mg Tabletten 2 mg Tablet Oral use Germany TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Cabergo-TEVA 4 mg Tabletten 4 mg Tablet Oral use Germany TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Cabergolin-TEVA 4 mg Tabletten 4 mg Tablet Oral use Germany RATIOPHARM Graf-Arco-Straße 3 D-89079 Ulm Cabergolin-ratiopharm 0,5 mg Tabletten 0,5 mg Tablet Oral use Germany RATIOPHARM Graf-Arco-Straße 3 D-89079 Ulm Cabergolin-ratiopharm 1 mg Tabletten 1 mg Tablet Oral use Germany RATIOPHARM Graf-Arco-Straße 3 D-89079 Ulm Cabergolin-ratiopharm 2 mg Tabletten 2 mg Tablet Oral use Germany RATIOPHARM Graf-Arco-Straße 3 D-89079 Ulm Cabergolin-ratiopharm 4 mg Tabletten 4 mg Tablet Oral use Iceland PFIZER Aps Lautrupvang 8 DK-2750 Ballerup Dostinex 0,5 mg Tablet Oral use Ireland PHARMACIA Ireland Limited 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland Cabaser 1 mg Tablet Oral use Ireland PHARMACIA Ireland Limited 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland Cabaser 2 mg Tablet Oral use Ireland PHARMACIA Ireland Limited 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland Dostinex 0,5 mg Tablet Oral use Ireland PHARMACIA Laboratories Ltd Ramsgate Road Sandwich Kent CT13 9NJ England Mailing Address: Pharmacia Ireland Limited 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland Cabaser 4 mg Tablet Oral use Italy PFIZER ITALIA Srl Strada Statale, Borgo San Michele SS 156 km 50 I-04010 Latina Cabaser 4 mg Tablet Oral use Italy PFIZER ITALIA Srl Strada Statale, Borgo San Michele SS 156 km 50 I-04010 Latina Dostinex 0,5 mg Tablet Oral use Italy PFIZER ITALIA Srl Strada Statale, Borgo San Michele SS 156 km 50 I-04010 Latina Cabaser 1 mg Tablet Oral use Italy PFIZER ITALIA Srl Strada Statale, Borgo San Michele SS 156 km 50 I-04010 Latina Cabaser 2 mg Tablet Oral use Latvia PFIZER ITALIA Srl Strada Statale, Borgo San Michele SS 156 km 50 I-04010 Latina Dostinex 0,5 mg Tablet Oral use Lithuania PFIZER Italia S.r.l. Via del Commercio 25/27 I-63046 Marino del Tronto Dostinex 0,5 mg Tablet Oral use Luxembourg PFIZER S.A Boulevard de la Plaine 17 B-1050 Bruxelles Dostinex 0,5 mg Tablet Oral use Luxembourg PFIZER S.A Boulevard de la Plaine 17 B-1050 Bruxelles Sostilar 0,5 mg Tablet Oral use Malta PFIZER Hellas SA 243, Messoghion Avenue GR-154 51 N.Psychiko Dostinex 0,5 mg Tablet Oral use Malta TEVA Pharma BV Industrieweg 23 PO Bpx 217 3640 AE Mijdrecht Nederland Cabergoline Teva 0,5 mg Tablet Oral use Malta TEVA Pharma BV Industrieweg 23 PO Bpx 217 3640 AE Mijdrecht Nederland Cabergoline Teva 1 mg Tablet Oral use Malta TEVA Pharma BV Industrieweg 23 PO Bpx 217 3640 AE Mijdrecht Nederland Cabergoline Teva 2 mg Tablet Oral use Malta TEVA Pharma BV Industrieweg 23 PO Bpx 217 3640 AE Mijdrecht Nederland Cabergoline Teva 4 mg Tablet Oral use Netherlands PFIZER B.V. Rivium Westlaan 142 2909 LD Capelle a/d IJSSEL Nederland Dostinex 0,5 mg Tablet Oral use Netherlands SANDOZ B.V. Veluwezoon 22 1327 AH ALMERE Nederland Cabergoline Sandoz 0,5 mg 0,5 mg Tablet Oral use Netherlands PHARMACHEMIE B.V. Swensweg 5 Haarlem Nederland Cabergoline 0,5 PCH 0,5 mg Tablet Oral use Norway PFIZER AS Postboks 3 N-1324 Lysaker Dostinex 0,5 mg Tablet Oral use Norway PFIZER AS Postboks 3 N-1324 Lysaker Cabaser 1 mg Tablet Oral use Norway PFIZER AS Postboks 3 N-1324 Lysaker Cabaser 2 mg Tablet Oral use Norway PFIZER AS Postboks 3 N-1324 Lysaker Cabaser 4 mg Tablet Oral use Norway TEVA Sweden AB Sundstorget 2 Helsingborg P.O. Box 1070 S-251 10 Helsingborg Karbegolin Teva 0,5 mg Tablet Oral use Norway TEVA Sweden AB Sundstorget 2 Helsingborg P.O. Box 1070 S-251 10 Helsingborg Karbegolin Teva 1 mg Tablet Oral use Norway TEVA Sweden AB Sundstorget 2 Helsingborg P.O. Box 1070 S-251 10 Helsingborg Karbegolin Teva 2 mg Tablet Oral use Norway TEVA Sweden AB Sundstorget 2 Helsingborg P.O. Box 1070 S-251 10 Helsingborg Karbegolin Teva 4 mg Tablet Oral use Poland LEK farmaceutska družba d.d. Verovškova 57 SLO-1526 Ljubljana CabergoLek 0,5 0,5 mg Tablet Oral use Poland LEK farmaceutska družba d.d. Verovškova 57 SLO-1526 Ljubljana CabergoLek 1 1 mg Tablet Oral use Poland LEK farmaceutska družba d.d. Verovškova 57 SLO-1526 Ljubljana CabergoLek 2 2 mg Tablet Oral use Poland LEK farmaceutska družba d.d. Verovškova 57 SLO-1526 Ljubljana CabergoLek 4 4 mg Tablet Oral use Poland PHARMACIA & UPJOHN S.p.A. Via Robert Koch 1,2 I-20152 Milano Cabaser 1 mg Tablet Oral use Poland PHARMACIA & UPJOHN S.p.A. Via Robert Koch 1,2 I-20152 Milano Cabaser 2 mg Tablet Oral use Poland PHARMACIA & UPJOHN S.p.A. Via Robert Koch 1,2 I-20152 Milano Cabaser 4 mg Tablet Oral use Poland PHARMACIA ITALIA S.p.A. Via Robert Koch 1,2 I-20152 Milano Dostinex 0,5 mg Tablet Oral use Portugal Laboratorios PFIZER Lda. Empreendimento Lagoas Park Edifício 10 P-2740-271 Porto Salvo Dostinex 0,5 mg Tablet Oral use Portugal TEVA Pharma — Produtos Farmacêuticos Lda. Empreendimento Lagoas Park Edifício 1-3 P-2740-264 Porto Salvo Cabergolina Teva 0,5 mg Tablet Oral use Romania PFIZER Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Dostinex 0,5mg Tablet Oral use Slovakia TEVA Pharmaceuticals CR s. r. o. Drážní 7 CZ-627 00 Brno Cabest 0,5 mg 0,5 mg Tablet Oral use Slovakia TEVA Pharmaceuticals CR s. r. o. Drážní 7 CZ-627 00 Brno Cabest 1 mg 1 mg Tablet Oral use Slovakia TEVA Pharmaceuticals CR s. r. o. Drážní 7 CZ-627 00 Brno Cabest 2 mg 2 mg Tablet Oral use Slovakia TEVA Pharmaceuticals CR s. r. o. Drážní 7 CZ-627 00 Brno Cabest 4 mg 4 mg Tablet Oral use Spain PFIZER SA Avda. Europa 20, B parque empresarial la Moraleja Alcobendas Spain Sogilen 1 mg comprimidos 1mg Tablet Oral use Spain PFIZER SA Avda. Europa 20, B parque empresarial la Moraleja Alcobendas Spain Sogilen 2 mg comprimidos 2 mg Tablet Oral use Spain PFIZER SA Avda. Europa 20, B parque empresarial la Moraleja Alcobendas Spain Sogilen 4 mg comprimidos 4 mg Tablet Oral use Spain PFIZER SA Avda. Europa 20, B parque empresarial la Moraleja Alcobendas Spain Doxtinex comprimidos 0,5 mg Tablet Oral use Sweden PFIZER AB S-191 90 Sollentuna Dostinex 0,5 mg Tablet Oral use Sweden PFIZER AB S-191 90 Sollentuna Cabser 1 mg Tablet Oral use Sweden PFIZER AB S-191 90 Sollentuna Cabser 2 mg Tablet Oral use Sweden PFIZER AB S-191 90 Sollentuna Cabser 4 mg Tablet Oral use Sweden CT-ARZNEIMITTEL GmbH Lengeder Str. 42a D-13407 Berlin Cabergoline CT 1 mg Tablet Oral use Sweden CT-ARZNEIMITTEL GmbH Lengeder Str. 42a D-13407 Berlin Cabergoline CT 2 mg Tablet Oral use Sweden CT-ARZNEIMITTEL GmbH Lengeder Str. 42a D-13407 Berlin Cabergoline CT 4 mg Tablet Oral use Sweden HEXAL A/S Kanalholmen 8-12 DK-2650 Hvidovre Cabergoline Hexal 0,5 mg Tablet Oral use Sweden HEXAL A/S Kanalholmen 8-12 DK-2650 Hvidovre Cabergoline Hexal 1 mg Tablet Oral use Sweden HEXAL A/S Kanalholmen 8-12 DK-2650 Hvidovre Cabergoline Hexal 2 mg Tablet Oral use Sweden HEXAL A/S Kanalholmen 8-12 DK-2650 Hvidovre Cabergoline Hexal 4 mg Tablet Oral use Sweden MERCK Dura GmbH Alsfelder Str. 19 D-64289 Darmstadt Cabergodura 0,5 mg Tablet Oral use Sweden MERCK Dura GmbH Alsfelder Str. 19 D-64289 Darmstadt Cabergodura 1 mg Tablet Oral use Sweden MERCK Dura GmbH Alsfelder Str. 19 D-64289 Darmstadt Cabergodura 2 mg Tablet Oral use Sweden MERCK Dura GmbH Alsfelder Str. 19 D-64289 Darmstadt Cabergodura 4 mg Tablet Oral use Sweden RATIOPHARM GmbH Graf-Arco-Straße 3 D-89079 Ulm Cabergoline ratiopharm 0,5 mg Tablet Oral use Sweden RATIOPHARM GmbH, Graf-Arco-Straße 3, D-89079 Ulm Cabergoline ratiopharm 1 mg Tablet Oral use Sweden RATIOPHARM GmbH Graf-Arco-Straße 3 D-89079 Ulm Cabergoline ratiopharm 2 mg Tablet Oral use Sweden RATIOPHARM GmbH Graf-Arco-Straße 3 D-89079 Ulm Cabergoline ratiopharm 4 mg Tablet Oral use Sweden SANDOZ A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Cabergonicht 0,5 mg Tablet Oral use Sweden SANDOZ A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Cabergonicht 1 mg Tablet Oral use Sweden SANDOZ A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Cabergonicht 2 mg Tablet Oral use Sweden SANDOZ A/S C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Cabergonicht 4 mg Tablet Oral use Sweden STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Kabergolin STADA 0,5 mg Tablet Oral use Sweden STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Kabergolin STADA 1 mg Tablet Oral use Sweden STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Kabergolin STADA 2 mg Tablet Oral use Sweden STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Kabergolin STADA 4 mg Tablet Oral use Sweden STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Kabergostad 0,5 mg Tablet Oral use Sweden STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Kabergostad 1 mg Tablet Oral use Sweden STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Kabergostad 2 mg Tablet Oral use Sweden STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Kabergostad 4 mg Tablet Oral use Sweden IVAX Scandinavia AB Mailbox 386 S-111 73 Stockholm Kabergolin IVAX 0,5 mg Tablet Oral use Sweden IVAX Scandinavia AB Mailbox 386 S-111 73 Stockholm Kabergolin IVAX 1 mg Tablet Oral use Sweden IVAX Scandinavia AB Mailbox 386 S-111 73 Stockholm Kabergolin IVAX 2 mg Tablet Oral use Sweden IVAX Scandinavia AB Mailbox 386 S-111 73 Stockholm Kabergolin IVAX 4 mg Tablet Oral use Sweden TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Cabergoteva 0,5 mg Tablet Oral use Sweden TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Cabergoteva 1 mg Tablet Oral use Sweden TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Cabergoteva 2 mg Tablet Oral use Sweden TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Cabergoteva 4 mg Tablet Oral use Sweden TEVA (UK) Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom Cabergoline Teva 0,5 mg Tablet Oral use Sweden TEVA (UK) Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom Cabergoline Teva 1 mg Tablet Oral use Sweden TEVA (UK) Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom Cabergoline Teva 2 mg Tablet Oral use Sweden TEVA (UK) Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom Cabergoline Teva 4 mg Tablet Oral use United Kingdom PHARMACIA Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Dostinex 0,5 mg Tablet Oral use United Kingdom PHARMACIA Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Cabaser 1 mg Tablet Oral use United Kingdom PHARMACIA Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Cabaser 2 mg Tablet Oral use United Kingdom PHARMACIA Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Cabaser 4 mg Tablet Oral use United Kingdom TEVA (UK) Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom Cabergoline 0,5 mg tablet 0,5 mg Tablet Oral use United Kingdom TEVA (UK) Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom Cabergoline 1 mg tablet 1 mg Tablet Oral use United Kingdom TEVA (UK) Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom Cabergoline 2 mg tablet 2 mg Tablet Oral use United Kingdom TEVA (UK) Limited Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom Cabergoline 4 mg tablet 4 mg Tablet Oral use Pergolide containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Product name Strength Pharmaceutical Form Route of administration Austria ELI LILLY GmbH Kölblgasse 8-10 A-1030 Wien Permax 0,05 mg — Tabletten 0,05 mg Tablet Oral use Austria ELI LILLY GmbH Kölblgasse 8-10 A-1030 Wien Permax 0,25 mg — Tabletten 0,25 mg Tablet Oral use Austria ELI LILLY GmbH Kölblgasse 8-10 A-1030 Wien Permax 1 mg — Tabletten 1 mg Tablet Oral use Belgium ELI LILLY BENELUX S.A. rue de l'Etuve, 52 B-1000 Brussels Permax 0,05 mg 0,05 mg Tablet Oral use Belgium ELI LILLY BENELUX S.A. rue de l'Etuve, 52 B-1000 Brussels Permax 0,25 mg 0,25 mg Tablet Oral use Belgium ELI LILLY BENELUX S.A. rue de l'Etuve, 52 B-1000 Brussels Permax 1 mg 1 mg Tablet Oral use Belgium EUROGENERICS N.V. Heizel Esplanade, b22 B-1020 Brussels Pergolide EG 0,05 mg 0,5 mg Tablet Oral use Belgium EUROGENERICS N.V. Heizel Esplanade, b22 B-1020 Brussels Pergolide EG 0,25 mg 0,26 mg Tablet Oral use Belgium IVAX Pharmaceuticals s. r. o. Ostravská 29 CZ-747 70 Opava 9 Pergolide IVAX Pharmaceuticals 1 mg 1 mg Tablet Oral use Belgium IVAX Pharmaceuticals s. r. o. Ostravská 29 CZ-747 70 Opava 9 Pergolide IVAX Pharmaceuticals 250 mcg 0,26 mg Tablet Oral use Belgium IVAX Pharmaceuticals s. r. o. Ostravská 29 CZ-747 70 Opava 9 Pergolide IVAX Pharmaceuticals 50 mcg 0,05 mg Tablet Oral use Cyprus PHADISCO LTD P.O.Box 22173 CY-1518 Lefkosia Celance 0,05 mg Tablet Oral use Cyprus PHADISCO LTD P.O.Box 22173 CY-1518 Lefkosia Celance 0,26 mg Tablet Oral use Cyprus PHADISCO LTD P.O.Box 22173 CY-1518 Lefkosia Celance 1 mg Tablet Oral use Czech Republic ELI LILLY Pobřežní 1A, building CZ-186 00 Praha 8 Permax 0,05 0,05 mg Tablet Oral use Czech Republic ELI LILLY Pobřežní 1A, building CZ-186 00 Praha 8 Permax 0,26 0,26 mg Tablet Oral use Czech Republic ELI LILLY Pobřežní 1A, building CZ-186 00 Praha 8 PERMAX 1,0 1 mg Tablet Oral use Czech Republic IVAX Pharmaceuticals ČR Opava-Komárov Czech Republic Contact is: Teva Pharmaceuticals ČR s. r. o. Radlická 3185/1C CZ-150 00 Praha 5 Hizest 0,05 mg 0,05 mg Tablet Oral use Czech Republic IVAX Pharmaceuticals ČR Opava-Komárov Czech Republic Contact is: Teva Pharmaceuticals ČR s. r. o. Radlická 3185/1C CZ-150 00 Praha 5 Hizest 0,26 mg 0,26 mg Tablet Oral use Czech Republic IVAX Pharmaceuticals ČR Opava-Komárov Czech Republic Contact is: Teva Pharmaceuticals ČR s. r. o. Radlická 3185/1C CZ-150 00 Praha 5 Hizest 1 mg 1 mg Tablet Oral use Denmark RATIOPHARM GmbH Graf-Arco-Straße 3 D-89079 Ulm Pergolid ‘Ratiopharm’ 0,25 mg Tablet Oral use Denmark RATIOPHARM GmbH Graf-Arco-Straße 3 D-89079 Ulm Pergolid ‘Ratiopharm’ 1 mg Tablet Oral use Denmark COPYFARM A/S Energivej 15 DK-5260 Odense S Pergolid ‘Copyfarm’ 0,05 mg Tablet Oral use Denmark COPYFARM A/S Energivej 15 DK-5260 Odense S Pergolid ‘Copyfarm’ 0,25 mg Tablet Oral use Denmark COPYFARM A/S Energivej 15 DK-5260 Odense S Pergolid ‘Copyfarm’ 1 mg Tablet Oral use Estonia IVAX Pharmaceuticals s. r. o. Ostravská 28 CZ-747 70 Opava-Komárov Hizest 50 mcg 0,05 mg Tablet Oral use Estonia IVAX Pharmaceuticals s. r. o. Ostravská 28 CZ-747 70 Opava-Komárov Hizest 250 mcg 0,25 mg Tablet Oral use Estonia IVAX Pharmaceuticals s. r. o. Ostravská 28 CZ-747 70 Opava-Komárov Hizest 1 mg 1 mg Tablet Oral use Estonia ELI LILLY Holding Limited Kingsclere Road Basingstocke Hampshire RG216XA United Kingdom Permax 0,05 mg Tablet Oral use Estonia ELI LILLY Holding Limited Kingsclere Road Basingstocke Hampshire RG216XA United Kingdom Permax 0,25 mg Tablet Oral use Estonia ELI LILLY Holding Limited Kingsclere Road Basingstocke Hampshire RG216XA United Kingdom Permax 1 mg Tablet Oral use Finland ELI LILLY Finland Oy Ab Rajatorpantie 41 C FI-01641 Vantaa PERMAX 0,25 mg Tablet Oral use Finland ELI LILLY Finland Oy Ab Rajatorpantie 41 C FI-01641 Vantaa PERMAX 1 mg Tablet Oral use Finland ELI LILLY Finland Oy Ab Rajatorpantie 41 C FI-01641 Vantaa PERMAX 0,05 mg Tablet Oral use France Lilly France SA 13, rue Pages F-92158 Suresnes Cedex Celance 0,05 mg Tablet Oral use France Lilly France SA 13, rue Pages F-92158 Suresnes Cedex Celance 0,26 mg Tablet Oral use France Lilly France SA 13, rue Pages F-92158 Suresnes Cedex Celance 1 mg Tablet Oral use France Société TEVA CLASSICS Le pallatin 1, 1 cour du triangle F-92936 Paris la Défence cedex Pergolide EG 0,5 mg Tablet Oral use France Société TEVA CLASSICS Le pallatin 1, 1 cour du triangle F-92936 Paris la Défence cedex Pergolide EG 0,26 mg Tablet Oral use France Bayer Schering Pharma ZI Roubaix Est, Rue de Touflers F-59390 Lys-les-Lannoy CELANCE 0,05 mg Tablet Oral use France Bayer Schering Pharma ZI Roubaix Est, Rue de Touflers F-59390 Lys-les-Lannoy CELANCE 0,26 mg Tablet Oral use France Bayer Schering Pharma ZI Roubaix Est, Rue de Touflers F-59390 Lys-les-Lannoy CELANCE 1 mg Tablet Oral use Germany MERCK Dura GmbH Alsfelder Str. 19 D-64289 Darmstadt Pergolid dura 0,05 mg Tabletten 0,065 mg Tablet Oral use Germany MERCK Dura GmbH Alsfelder Str. 19 D-64289 Darmstadt Pergolid dura 0,25 mg Tabletten 0,325 mg Tablet Oral use Germany MERCK Dura GmbH Alsfelder Str. 19 D-64289 Darmstadt Pergolid dura 1 mg Tabletten 1,3 mg Tablet Oral use Germany LILLY Deutschland GmbH Saalburgstr. 153 D-61350 Bad Homburg Parkotil 0,05 0,065 mg Tablet Oral use Germany LILLY Deutschland GmbH Saalburgstr. 153 D-61350 Bad Homburg Parkotil 0,26 0,326 mg Tablet Oral use Germany LILLY Deutschland GmbH Saalburgstr. 153 D-61350 Bad Homburg Parkotil 1,0 1,3 mg Tablet Oral use Germany AbZ-PHARMA Graf-Arco-Str. 3 D-89079 Ulm, Germany Pergolid AbZ 0,25 mg Tabletten 0,325 mg Tablet Oral use Germany AbZ-PHARMA Graf-Arco-Str. 3 D-89079 Ulm, Germany Pergolid AbZ 1 mg Tabletten 1,,.3 mg Tablet Oral use Germany BETAPHARM Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Pergolid beta 0,05 mg Tabletten 0,0653 mg Tablet Oral use Germany BETAPHARM Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Pergolid beta 0,25 mg Tabletten 0,326 mg Tablet Oral use Germany BETAPHARM Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Pergolid beta 1 mg Tabletten 1,306 mg Tablet Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Pergolid Hexal 0,05mg Tabletten 0,0653 mg Tablet Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Pergolid Hexal 0,25mg Tabletten 0,326 mg Tablet Oral use Germany HEXAL AG Industriestraße 25 D-83607 Holzkirchen Pergolid Hexal 1,0mg Tabletten 1,3 mg Tablet Oral use Germany NEURAXPHARM ARZNEIMITTEL Arzneimittel GmbH & Co.KG Postfach 400455 D-40244 Langenfeld Pergolid 0,05 mg 0,0655 mg Tablet Oral use Germany NEURAXPHARM ARZNEIMITTEL Arzneimittel GmbH & Co.KG Postfach 400455 D-40244 Langenfeld Pergolid 0,25 mg 0,3275 mg Tablet Oral use Germany NEURAXPHARM ARZNEIMITTEL Arzneimittel GmbH & Co.KG Postfach 400455 D-40244 Langenfeld Pergolid 1,0 mg 1,31 mg Tablet Oral use Germany TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Pergolid-TEVA 0,05 mg Tabletten 0,065 mg Tablet Oral use Germany TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten Pergolid-TEVA 0,25 mg Tabletten 0,325 mg Tablet Oral use Germany TEVA Generics GmbH Kandelstr. 10 D-79199 Kirchzarten, Germany Pergolid-TEVA 1 mg Tabletten 1,3 mg Tablet Oral use Germany RATIOPHARM Graf-Arco-Straße 3 D-89079 Ulm Pergolid-ratiopharm 0,25 mg Tabletten 0,325 mg Tablet Oral use Germany RATIOPHARM Graf-Arco-Straße 3 D-89079 Ulm Pergolid-ratiopharm 1 mg Tabletten 1,3 mg Tablet Oral use Germany SANDOZ Pharmaceuticals GmbH Raiffeisenstr. 1 D-83607 Holzkirchen Pergolid Sandoz 0,05 mg Tabletten 0,0653 mg Tablet Oral use Germany SANDOZ Pharmaceuticals GmbH Raiffeisenstr. 1 D-83607 Holzkirchen Pergolid Sandoz 0,25 mg Tabletten 0,3264 mg Tablet Oral use Germany SANDOZ Pharmaceuticals GmbH Raiffeisenstr. 1 D-83607 Holzkirchen Pergolid Sandoz 1 mg Tabletten 1,3056 mg Tablet Oral use Greece PHARMASERV LILLY Α.Ε.Β.Ε. 15th km National Highway Athens-Lamia P.O. BOX 51288 GR-14564 Kifissia ΣΕΛΑΝΣ This trademark exists only in Greek 0,05 mg Tablet Oral use Greece PHARMASERV LILLY Α.Ε.Β.Ε. 15th km National Highway Athens-Lamia P.O. BOX 51288 GR-14564 Kifissia ΣΕΛΑΝΣ 0,26 mg Tablet Oral use Greece PHARMASERV LILLY Α.Ε.Β.Ε. 15th km National Highway Athens-Lamia P.O. BOX 51288 GR-14564 Kifissia ΣΕΛΑΝΣ 1 mg Tablet Oral use Iceland DAC ehf., heildsala, Auðbrekku 3-5, eining 0202 IS-100 Kópavogur Permax (DAC) 0,35 mg Tablet Oral use Ireland ELI LILLY & Company Limited Lilly House Priestley Rd Basingstoke Hampshire RG24 9NL United Kingdom Celance 0,05 mg Tablet Oral use Ireland ELI LILLY & Company Limited Lilly House Priestley Rd Basingstoke Hampshire RG24 9NL United Kingdom Celance 0,26 mg Tablet Oral use Ireland ELI LILLY & Company Limited Lilly House Priestley Rd Basingstoke Hampshire RG24 9NL United Kingdom Celance 1 mg Tablet Oral use Ireland McDERMOTT Laboratories Ltd T/A Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Pergolide 0,05 mg Tablet Oral use Ireland McDERMOTT Laboratories Ltd T/A Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Pergolide 0,26 mg Tablet Oral use Ireland McDERMOTT Laboratories Ltd T/A Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Pergolide 1 mg Tablet Oral use Italy ELI LILLY Italia SpA Via Gramsci, 731/733 I-50019 Sesto Fiorentino (FI) Nopar 0,05 mg Tablet Oral use Italy ELI LILLY Italia SpA Via Gramsci, 731/733 I-50019 Sesto Fiorentino (FI) Nopar 0,26 mg Tablet Oral use Italy ELI LILLY Italia SpA Via Gramsci, 731/733 I-50019 Sesto Fiorentino (FI) Nopar 1 mg Tablet Oral use Italy EG SpA Via Domenico Scarlatti, 31 I-20124 Milano Pergolide EG 0,05 mg Tablet Oral use Italy EG SpA Via Domenico Scarlatti, 31 I-20124 Milano Pergolide EG 0,05 mg + 0,25 mg Tablet Oral use Italy EG SpA Via Domenico Scarlatti, 31 I-20124 Milano Pergolide EG 0,25 mg Tablet Oral use Italy EG SpA Via Domenico Scarlatti, 31 I-20124 Milano Pergolide EG 1 mg Tablet Oral use Italy TEVA Pharma Italia Srl Via G. Richard, 7 I-20143 Milano Pergolide TEVA 0,05 mg Tablet Oral use Italy TEVA Pharma Italia Srl Via G. Richard, 7 I-20143 Milano Pergolide TEVA 0,25 mg Tablet Oral use Italy TEVA Pharma Italia Srl Via G. Richard, 7 I-20143 Milano Pergolide TEVA 1 mg Tablet Oral use Italy MERCK GENERICS Italia SpA Via Aquileia, 35 I-20092 Cinisello Balsamo (MI) Pergolide Merck Generics 0,05 mg Tablet Oral use Italy MERCK GENERICS Italia SpA Via Aquileia, 35 I-20092 Cinisello Balsamo (MI) Pergolide Merck Generics 0,25 mg Tablet Oral use Italy MERCK GENERICS Italia SpA Via Aquileia, 35 I-20092 Cinisello Balsamo (MI) Pergolide Merck Generics 1 mg Tablet Oral use Luxembourg ELI LILLY BENELUX S.A. rue de l'Etuve, 52 B-1000 Brussels Permax 0,05 mg Tablet Oral use Luxembourg ELI LILLY BENELUX S.A. rue de l'Etuve, 52 B-1000 Brussels Permax 0,26 mg Tablet Oral use Luxembourg ELI LILLY BENELUX S.A. rue de l'Etuve, 52 B-1000 Brussels Permax 1 mg Tablet Oral use Malta PHADISCO LTD 185 Yiannou Kranidioti Avenue CY-2235 Latsia Celance 0,05 mg Tablet Oral use Malta PHADISCO LTD 185 Yiannou Kranidioti Avenue CY-2235 Latsia Celance 0,26 mg Tablet Oral use Malta PHADISCO LTD 185 Yiannou Kranidioti Avenue CY-2235 Latsia Celance 1 mg Tablet Oral use Netherlands ELI LILLY Nederland BV Grootslag 1-5 3991 RA Houten Nederland Permax 0,25 0,26 mg Tablet Oral use Netherlands ELI LILLY Nederland BV Grootslag 1-5 3991 RA Houten Nederland Permax 1,0 1.0 mg Tablet Oral use Netherlands CENTRAFARM SERVICES B.V. Nieuwe Donk 9 4879 AC ETTEN-LEUR Nederland Pergolide CF 0,05 mg 0,05 mg Tablet Oral use Netherlands CENTRAFARM SERVICES B.V. Nieuwe Donk 9 4879 AC ETTEN-LEUR Nederland Pergolide CF 0,26 mg 0,26 mg Tablet Oral use Netherlands CENTRAFARM SERVICES B.V. Nieuwe Donk 9 4879 AC ETTEN-LEUR Nederland Pergolide CF 1,0 mg 1.0 mg Tablet Oral use Netherlands SANDOZ B.V. Veluwezoon 22 1327 AH ALMERE Nederland Pergolide 0,05 mg 0,05 mg Tablet Oral use Netherlands SANDOZ B.V. Veluwezoon 22 1327 AH ALMERE Nederland Pergolide 0,26 mg 0,26 mg Tablet Oral use Netherlands SANDOZ B.V. Veluwezoon 22 1327 AH ALMERE Nederland Pergolide 1,0 mg 1,0 mg Tablet Oral use Netherlands SANDOZ B.V. Veluwezoon 22 1327 AH ALMERE Nederland Pergolide start pakket combination therapy 0,05 mg + 0,26 mg Tablet Oral use Netherlands SANDOZ B.V. Veluwezoon 22 1327 AH ALMERE Nederland Pergolide start pakket mono -therapy 0,05 mg + 0,26 mg Tablet Oral use Netherlands RATIOPHARM Nederland BV Ronde Tocht 11 1507 CC Zaandam Nederland Pergolide Ratiopharm 0,25 0,26 mg Tablet Oral use Netherlands RATIOPHARM Nederland BV Ronde Tocht 11 1507 CC Zaandam Nederland Pergolide Ratiopharm 1 1,0 mg Tablet Oral use Netherlands RATIOPHARM Nederland BV Ronde Tocht 11 1507 CC Zaandam Nederland Pergolide Ratiopharm 0,05 mg 0,05 mg Tablet Oral use Netherlands SANDOZ B.V. Veluwezoon 22 1327 AH ALMERE Nederland Pergolide Sandoz 0,05 mg 0,05 mg Tablet Oral use Netherlands SANDOZ B.V. Veluwezoon 22 1327 AH ALMERE Nederland Pergolide Sandoz 0,26 mg 0,26 mg Tablet Oral use Netherlands SANDOZ B.V. Veluwezoon 22 1327 AH ALMERE Nederland Pergolide Sandoz 1,0 mg 1,0 mg Tablet Oral use Netherlands PHARMACHEMIE B.V. Swensweg 5 Haarlem Nederland Pergolide 0,05 PCH 0,05 mg Tablet Oral use Netherlands PHARMACHEMIE B.V. Swensweg 5 Haarlem Nederland Pergolide 0,26 PCH 0,26 mg Tablet Oral use Netherlands PHARMACHEMIE B.V. Swensweg 5 Haarlem Nederland Pergolide 1 PCH 1,0 mg Tablet Oral use Netherlands APOTHECON B.V. Nijverheidsweg 3 3771 ME Barneveld Nederland Pergolide 0,05 0,05 mg Tablet Oral use Netherlands APOTHECON B.V. Nijverheidsweg 3 3771 ME Barneveld Nederland Pegolide 0,25 0,26 mg Tablet Oral use Netherlands APOTHECON B.V. Nijverheidsweg 3 3771 ME Barneveld Nederland Pergolide 1,0 1,0 mg Tablet Oral use Netherlands IVAX Farma B.V. Tolnasingel 3 2411 PV Bodegraven Nederland Pergolide 0,25 0,26 mg Tablet Oral use Netherlands IVAX Farma B.V. Tolnasingel 3 2411 PV Bodegraven Nederland Pergolide 1,0 1,0 mg Tablet Oral use Netherlands IVAX Farma B.V. Tolnasingel 3 2411 PV Bodegraven Nederland Pergolide 0,05 0,05 mg Tablet Oral use Netherlands MERCK GENERICS B.V. Dieselweg 26 3752 LB Bunschoten Nederland Pergolide Merck 0,05 mg 0,05 mg Tablet Oral use Netherlands MERCK GENERICS B.V. Dieselweg 26 3752 LB Bunschoten Nederland Pergolide Merck 0,26 mg 0,26 mg Tablet Oral use Netherlands MERCK GENERICS B.V. Dieselweg 26 3752 LB Bunschoten Nederland Pergolide Merck 1,0 mg 1,0 mg Tablet Oral use Poland IVAX Pharmaceuticals s.r.o. Ostravska 28 CZ-74770 Opava-Komarov Hizest 0,05 mg Tablet Oral use Poland IVAX Pharmaceuticals s.r.o. Ostravska 28 CZ-74770 Opava-Komarov Hizest 0,25 mg Tablet Oral use Poland IVAX Pharmaceuticals s.r.o. Ostravska 28 CZ-74770 Opava-Komarov Hizest 1 mg Tablet Oral use Portugal LILLY Portugal Produtos Farmacêuticos Lda. Rua Dr. António Loureiro Borges, 1 Piso 1 - Arquiparque - Miraflores P-1499-016 Algés Permax 1 mg Tablet Oral use Portugal LILLY Portugal Produtos Farmacêuticos Lda. Rua Dr. António Loureiro Borges, 1 Piso 1 - Arquiparque - Miraflores P-1499-016 Algés Permax 0,05 mg Tablet Oral use Portugal LILLY Portugal Produtos Farmacêuticos Lda. Rua Dr. António Loureiro Borges, 1 Piso 1 - Arquiparque - Miraflores P-1499-016 Algés Permax 0,26 mg Tablet Oral use Portugal Ratiopharm Comércio e Indústria de Produtos Farmacêuticos Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso P-2790-143 Carnaxide Pergolida ratiopharm 0,25 mg comprimidos 0,26 mg Tablet Oral use Portugal Ratiopharm Comércio e Indústria de Produtos Farmacêuticos Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso P-2790-143 Carnaxide Pergolida ratiopharm 1 mg comprimidos 1 mg Tablet Oral use Portugal TEVA Pharma Produtos Farmacêuticos Lda. Empreendimento Lagoas Park - Edifício 1-3o P-2740-264 Porto Salvo Pergolida Teva 1 mg comprimidos 1 mg Tablet Oral use Portugal TEVA Pharma Produtos Farmacêuticos Lda. Empreendimento Lagoas Park - Edifício 1-3o P-2740-264 Porto Salvo Pergolida Teva 0,05 mg comprimidos 0,05 mg Tablet Oral use Portugal TEVA Pharma Produtos Farmacêuticos Lda. Empreendimento Lagoas Park - Edifício 1-3o P-2740-264 Porto Salvo Pergolida Teva 0,25 mg comprimidos 0,26 mg Tablet Oral use Portugal Generis Farmacêutica, S.A. Office Park da Beloura - Edifício 4 - Quinta da Beloura P-2710-444 Sintra Pergolida Generis 0,05 mg Tablet Oral use Portugal Generis Farmacêutica, S.A. Office Park da Beloura - Edifício 4 - Quinta da Beloura P-2710-444 Sintra Pergolida Generis 0,26 mg Tablet Oral use Portugal Generis Farmacêutica, S.A. Office Park da Beloura - Edifício 4 - Quinta da Beloura P-2710-444 Sintra Pergolida Generis 1 mg Tablet Oral use Portugal MERCK Genéricos Produtos Farmacêuticos Lda. Rua Alfredo da Silva, 3 C - 4o P-1300-040 Lisboa Pergolida Merck Genéricos 0,05 mg comprimidos 0,05 mg Tablet Oral use Portugal MERCK Genéricos Produtos Farmacêuticos Lda. Rua Alfredo da Silva, 3 C - 4o P-1300-040 Lisboa Pergolida Merck Genéricos 0,25 mg comprimidos 0,26 mg Tablet Oral use Portugal MERCK Genéricos Produtos Farmacêuticos Lda. Rua Alfredo da Silva, 3 C - 4o P-1300-040 Lisboa Pergolida Merck Genéricos 1mg comprimidos 1 mg Tablet Oral use Spain LYLLY SA, Avda de la Industria, 30 Alcobendas Spain Pharken 1 mg comprimidos 1 mg Film-coated tablet Oral use Spain LYLLY SA, Avda de la Industria, 30 Alcobendas Spain Pharken 0,05 mg comprimidos 0,05 mg Film-coated tablet Oral use Spain LYLLY SA, Avda de la Industria, 30 Alcobendas Spain Pharken 0,25 mg comprimidos 0,25 mg Film-coated tablet Oral use Spain Ratiopharm España SA Avda. Burgos, 160-5a planta E-28036, Madrid Pergolida Ratiopharm 1 mg comprimidos 1 mg Tablet Oral use Spain Ratiopharm España SA Avda. Burgos, 160-5a planta E-28036, Madrid Pergolida Ratiopharm 0,25 mg comprimidos 0,25 mg Tablet Oral use Spain TEVA Genericos Española SA German El Bueno, 33, Edificio Britania 4o, Izquierda P-28003 Madrid Pergolida Teva 0,25 mg comprimidos 0,25 mg Tablet Oral use Spain TEVA Genericos Española SA German El Bueno, 33, Edificio Britania 4o, Izquierda P-28003 Madrid Pergolida Teva 0,05 mg comprimidos 0,05 mg Tablet Oral use Spain TEVA Genericos Española SA German El Bueno, 33, Edificio Britania 4o, Izquierda P-28003 Madrid Pergolida Teva 1 mg comprimidos 1 mg Tablet Oral use United Kingdom ELI LILLY & Company Limited Lilly House Priestley Rd Basingstoke Hampshire RG24 9NL United Kingdom Celance 50 mcg tablet 0,05 mg Tablet Oral use United Kingdom ELI LILLY & Company Limited Lilly House Priestley Rd Basingstoke Hampshire RG24 9NL United Kingdom Celance 250 mcg tablet 0,26 mg Tablet Oral use United Kingdom ELI LILLY & Company Limited Lilly House Priestley Rd Basingstoke Hampshire RG24 9NL United Kingdom Celance 1 000 mcg tablet 1 mg Tablet Oral use United Kingdom BETAPHARM Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Pergolide 50 mcg tablet 0,05 mg Tablet Oral use United Kingdom BETAPHARM Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Pergolide 250 mcg tablet 0,26 mg Tablet Oral use United Kingdom BETAPHARM Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Pergolide 1 000 mcg tablet 1 mg Tablet Oral use United Kingdom DR REDDY'S Laboratories (UK) Limited 6 Riverview Road Beverley East Yorkshire HU17 0LD United Kingdom Pergolide 50 mcg tablet 0,05 mg Tablet Oral use United Kingdom DR REDDY'S Laboratories (UK) Limited 6 Riverview Road Beverley East Yorkshire HU17 0LD United Kingdom Pergolide 250 mcg tablet 0,26 mg Tablet Oral use United Kingdom DR REDDY'S Laboratories (UK) Limited 6 Riverview Road Beverley East Yorkshire HU17 0LD United Kingdom Pergolide 1 000 mcg tablet 1 mg Tablet Oral use United Kingdom HEXAL AG Industriestraße 25 D-83607 Holzkirchen Pergolide 50 mcg tablet 0,05 mg Tablet Oral use United Kingdom HEXAL AG Industriestraße 25 D-83607 Holzkirchen Pergolide 250 mcg tablet 0,26 mg Tablet Oral use United Kingdom HEXAL AG Industriestraße 25 D-83607 Holzkirchen Pergolide 1 000 mcg tablet 1 mg Tablet Oral use United Kingdom STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Pergolide 50 mcg tablet 0,05 mg Tablet Oral use United Kingdom STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Pergolide 250 mcg tablet 0,26 mg Tablet Oral use United Kingdom STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Pergolide 1 000 mcg tablet 1 mg Tablet Oral use United Kingdom NORTON Healthcare Limited Albert Basin Royal Docks London E16 2QJ United Kingdom Pergolide 50 mcg tablet 0,05 mg Tablet Oral use United Kingdom NORTON Healthcare Limited Albert Basin Royal Docks London E16 2QJ United Kingdom Pergolide 250 mcg tablet 0,26 mg Tablet Oral use United Kingdom NORTON Healthcare Limited Albert Basin Royal Docks London E16 2QJ United Kingdom Pergolide 1 000 mcg tablet 1 mg Tablet Oral use United Kingdom GENERICS (UK) Limited Station Close Potters Bar Herts EN6 1TL United Kingdom Pergolide 50 mcg tablet 0,05 mg Tablet Oral use United Kingdom GENERICS (UK) Limited Station Close Potters Bar Herts EN6 1TL United Kingdom Pergolide 250 mcg tablet 0,26 mg Tablet Oral use United Kingdom GENERICS (UK) Limited Station Close Potters Bar Herts EN6 1TL United Kingdom Pergolide 1 000 mcg tablet 1 mg Tablet Oral use United Kingdom SANDOZ Limited Woolmer Way Borden Hampshire GU35 9QE United Kingdom Pergolide 50 mcg tablet 0,05 mg Tablet Oral use United Kingdom SANDOZ Limited Woolmer Way Borden Hampshire GU35 9QE United Kingdom Pergolide 250 mcg tablet 0,26 mg Tablet Oral use United Kingdom SANDOZ Limited Woolmer Way Borden Hampshire GU35 9QE United Kingdom Pergolide 1 000 mcg tablet 1 mg Tablet Oral use United Kingdom SANDOZ Pharmaceuticals GmbH Raiffeisenstr. 1 D-83607 Holzkirchen Pergolide 50 mcg tablet 0,05 mg Tablet Oral use United Kingdom SANDOZ Pharmaceuticals GmbH Raiffeisenstr. 1 D-83607 Holzkirchen Pergolide 250 mcg tablet 0,26 mg Tablet Oral use United Kingdom SANDOZ Pharmaceuticals GmbH Raiffeisenstr. 1 D-83607 Holzkirchen Pergolide 1 000 mcg tablet 1 mg Tablet Oral use

ANNEX IV LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Austria Stada Arzneimittel GmbH Heiligenstädter Straße 52/2/8 A-1190 Wien Floxacin 400 mg — Filmtabletten 400 mg Film-coated tablet Oral use Austria Merck Sharp & Dohme GmbH Donau-City-Straße 6 A-1220 Wien Norfloxacin ‘MSD’ — Filmtabletten 400 mg Film-coated tablet Oral use Austria Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 A-1140 Wien Norfloxacin ‘ratiopharm’ — 400 mg Filmtabletten 400 mg Film-coated tablet Oral use Austria Sandoz GmbH Biochemiestraße 10 A-6250 Kundl Norfloxacin Sandoz — 400 mg Filmtabletten 400 mg Film-coated tablet Oral use Austria Merck Sharp & Dohme GmbH Donau-City-Straße 6 A-1220 Wien Zoroxin — Filmtabletten 400 mg Film-coated tablet Oral use Belgium Merck, Sharp et Dohme Chaussée de Waterloo, 1135 B-1180 Bruxelles Zoroxin 400 mg Tablet Oral use Belgium Docpharma N.V Ambachtenlaan 13H B-3001 Heverlee Docnorfloxa (ex: Floxolone) 400 mg Film-coated tablet Oral use Belgium Socobom N.V Louizalaan 149 B24 B-1050 Brussel Floxolone 400 mg 400 mg Film-coated tablet Oral use Belgium Ratiopharm Belgium S.A Rue St-Lambert, 141 B-1200 Bruxelles Norfloxacin — Ratiopharm 400 400 mg Tablet Oral use Belgium Eurogenerics Heizel Esplanade B22 B-1020 Brussel Norfloxacine EG 400 mg Film-coated tablet Oral use Belgium Teva Generics Belgium NV Laarstraat 16 B-2610 Wilrijk Norfloxacine Teva 400 mg 400 mg Coated tablets Oral use Bulgaria Krka, d.d.Novo Mesto Smarjeka cesta 6 SLO-8501 Novo mesto Nolicin 400 mg Film-coated tablet Oral use Bulgaria Hexal AG Industriestraße 25 D-83607 Holzkirchen NorfloHexal 400 mg Film-coated tablet Oral use Cyprus Merck Sharp & Dohme BV Waarderweg 39 2031 BN Haarlem Noroxin 400 mg Tablet Oral use Cyprus Medochemie Ltd P.O Box 51409 CY-Lemesos Gyrablock 400 mg Tablet Oral use Cyprus Remedica Ltd P.O Box 51706 CY-Lemesos Trizolin 400 mg Tablet Oral use Czech Republic Medochemie Ltd, Limassol Constantinoupoleos St. 1-10 P.O.Box 51409 CY-3505 Limassol Gyrablock 400 400 mg Film-coated tablet Oral use Czech Republic Krka d.d. Šmarješka cesta 6 SLO-8501 Novo mesto Nolicin 400 mg Coated tablet Oral use Czech Republic Ratiopharm GmbH Graf-Arco-Straße 3 D-89070 Ulm Norfloxacin-Ratiopharm 400 mg 400 mg Film-coated tablet Oral use Denmark Tad Pharma GmbH Heinz-Lohmann Straße 5 D-27472, Cuxhaven Norflocux 400 mg Film-coated tablet Oral Estonia Krka d.d. Šmarješka cesta 6 SLO-8501 Novo mesto Nolicin 400 mg Tablet Oral use Finland Sandoz GmbH Biochemiestraße 10 A-6250 Kundl Norfloxacin Sandoz 200 mg Film-coated tablet Oral use Finland Sandoz GmbH Biochemiestraße 10 A-6250 Kundl Norfloxacin Sandoz 400 mg Film-coated tablet Oral use Finland Ratiopharm Oy Vitikka 1 F P.O Box 67 FI-02630 Espoo Norfloxacin-Ratiopharm 400 mg Film-coated tablet Oral use France Arrow Génériques 26, av. Tony Garnier F-69007 Lyon Norfloxacine Arrow 400 mg Tablet Oral use France Biogaran 15, Bd Charles de Gaulle F-92700 Colombes Norfloxacine Biogaran 400 mg Tablet Oral use France EG Labo ‘Le Quintet’ — bâtiment A 12, rue Danjou F-92517 Boulogne Billancourt Cedex Norfloxacine EG 400 mg Tablet Oral use France Ivax Pharmaceuticals SAS 1, cour du triangle Immeuble palatin 1 F-92936 Paris la Défense cedex Norfloxacine Ivax 400 mg Tablet Oral use France Merck Génériques 34, rue Saint-Romain F-69359 Lyon Cedex 08 Norfloxacine Merck 400 mg Tablet Oral use France Laboratoire Qualimed 34, rue Saint-Romain F-69008 Lyon Norfloxacine Qualimed 400 mg Tablet Oral use France Laboratoire RPG 4, place Louis Armand F-75012 Paris Norfloxacine Ranbaxy 400 mg Tablet Oral use France Ratiopharm GmbH Graf Arco Straße 3 D-89079 Ulm Norfloxacine Ratiopharm 400 mg Tablet Oral use France Sandoz 49, avenue Georges Pompidou F-92300 Levallois-Perret Norfloxacine Sandoz 400 mg Tablet Oral use France Socitété Teva Classics Le Palatin 1 1, cour du Triangle F-92936 Paris la Défense Cedex Norfloxacine Teva 400 mg Tablet Oral use France Sanofi Aventis France 1/13, Bd Romain Rolland F-75014 Paris Norfloxacine Winthrop 400 mg Tablet Oral use France Merck Sharp — Dohme Chibret 3, avenue Hoche F-75114 Paris Cedex 08 Noroxine 400 mg Tablet Oral use Germany 1 A Pharma GmbH Keltenring 1 + 3 D-82041 Oberhaching Norflox-1A Pharma 400 mg Film-coated tablet Oral use Germany AbZ-Pharma GmbH Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren Norfloxacin AbZ 400 mg Filmtabletten 400 mg Film-coated tablet Oral use Germany Aliud Pharma GmbH & Co.KG Gottlieb-Daimler-Str. 19 D-89150 Laichingen Norfloxacin AL 400 mg 400 mg Film-coated tablet Oral use Germany Apogepha Arzneimittel GmbH Kyffhäuserstr. 27 D-01309 Dresden Bactracid 400 mg Film-coated tablet Oral use Germany CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Norflox-CT 400 mg Filmtabletten 400 mg Film-coated tablet Oral use Germany Heumann Pharma GmbH & Co.Generica.KG Südwestpark 50 D-90449 Nürnberg Norfloxacin Heumann 400 mg Filmtabletten 400 mg Film-coated tablet Oral use Germany Hexal AG Industriestr. 25 D-83607 Holzkirchen Norflohexal 400mg 400 mg Film-coated tablet Oral use Germany Ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Norfloxacin-ratiopharm 400 mg 400 mg Film-coated tablet Oral use Germany Ruhrpharm AG Heidsieker Heide 114 D-33739 Bielefeld Norfluxx 400 mg Film-coated tablet Oral use Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Norflox-Sandoz 400 mg Filmtabletten 400 mg Film-coated tablet Oral use Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Norflox-Sandoz 400 mg 400 mg Film-coated tablet Oral use Germany Schwarz Pharma Deutschland GmbH Alfred-Nobel-Str. 10 D-40789 Monheim Firin 400 mg Film-coated tablet Oral use Germany Stada Arzneimittel AG Stadastr. 2-18 D-61118 Bad Vilbel Norfloxa Stadapharm 400 mg 400 mg Film-coated tablet Oral use Germany Stadapharm GmbH Stadastr. 2-18 D-61118 Bad Vilbel Norfloxacin Stada 400 mg 400 mg Film-coated tablet Oral use Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5 D-27472 Cuxhaven Norflosal 400 mg Film-coated tablet Oral use Germany Teofarma S.R.L Via F.Iii Cervi 8 I-27010 Valle Salimbene (PV) Barazan 400 mg Film-coated tablet Oral use Germany Uropharm AG Erfurtstr. 64 D-53125 Bonn Norflox-Uropharm 400 mg 400 mg Film-coated tablet Oral use Greece Anfarm Hellas A.E K. Paleologou & Perikleous 27, GR-15232 Halandri Fluseminal 400 mg Film-coated tablet Oral use Greece Rafarm Aebe Korinthou 12, GR-15451 N. Psychiko Pistofil 400 mg Coated tablet Oral use Greece Vianex S.A Tatoiou Street GR-14671 Nea Erythrea Norocin 400 mg Film-coated tablet Oral use Greece Bros Epe Avgis & Gallinis 15 N. Kifissia Greece Constilax 400 mg Coated tablet Oral use Greece Faran Abee Production and Trading Medicines Averof 19A GR-10433 Athens Sofasin 400 mg Film-coated tablet Oral use Greece Xrispa Alpha Farmaceuticals S.A 16th Km Marathonos Avenue GR-15344 Pallini Alenbit 400 mg Coated tablet Oral use Greece Vilco S.A Pefkon Street 121 GR-14122 N. Irakleion Setanol 400 mg Coated tablet Oral use Greece Medicrom S.A 6 Km Markopoulo-Koropi Avenue GR-19003 Markopoulo Mesogeion Steinaclox-Medichrom 400 mg Capsule Oral use Greece Genepharm A.E 18th Km Marathonos Avenue, Pallini GR-15351 Attikis Grenis 400 mg Coated tablet Oral use Greece Biospray Abee 18th Km Marathonos Avenue GR-15344 Pallini Sinobid 400 mg Film-coated tablet Oral use Greece Specifar Abee 28th October Street No 1 GR-12351 Agia Barbara Urospes-N 400 mg Film-coated tablet Oral use Greece Coup Abee Agias Varvaras 53-55 Dafni GR-17235 Athens Lorcamin 400 mg Coated tablet Oral use Greece Viofar Epe Ethnikis Antistaseos & Trifyllias GR-13671 Aharnai Vetamol 400 mg Film-coated tablet Oral use Greece Sandoz GmbH, Kundl, Austria Biochemiestrasse 10 A-6520, Kundl Austria Urobacid 400 mg Film-coated tablet Oral use Hungary Krka Magyarország Kereskedelmi Kft Pacsirtamező u. 5 H-1036 Budapest Nolicin 400 mg Tablet Oral use Hungary Krka Magyarország Kereskedelmi Kft Pacsirtamező u. 5 H-1036 Budapest Nolicin-S 400 mg Film-coated tablet Oral use Hungary AC Helcor Hungary Kft Madarász Viktor u. 27 H-1131 Budapest Norfloxacin-Helcor 400 mg Film-coated tablet Oral use Hungary Ratiopharm Hungária Kft. Uzsoki u. 36/a H-1145 Budapest Norfloxacin-Ratiopharm 400 mg Film-coated tablet Oral use Ireland Tad Pharma GmbH, Heinz-Lohmann-Strasse 5 D-27472 Cuxhaven Norflocux 400 400 mg Tablet Oral use Italy Sede legale: ABC Farmaceutici S.p.A. Corso Vittorio Emanuele II, 72 Torino Italy Norfloxacina 400 mg Capsule Oral use Italy Actavis Italy SpA V. Jose'Escrivia De Balaguer, 6 I-21047 Saronno (VA) Norfloxacina 400 mg Film-coated tablet Oral use Italy Boniscontro & Gazzone s.r.l. Via Pavia, 6 I-20136 Milano Renoxacin 400 mg Film-coated tablet Oral use Italy EG S.p.A. Via Pavia, 6 I-20131 Milano Norfloxacina EG 400 mg Film-coated tablet Oral use Italy Farmaceutici Caber S.p.A. Viale Città d'Europa, 681 I-00144 Roma Flossac 400 mg Capsule Oral use Italy GlaxoSmithKline S.p.A. Via A. Fleming, 2 I-37135 Verona Sebercim 400 mg Tablet Oral use Italy Jet Generici s.r.l. Via Mario Lalli, 8 I-56127 Pisa Norfloxacina 400 mg Capsule Oral use Italy Sede legale: Laboratori Alter s.r.l. Via Egadi, 7 I-20144 Milano Norfloxacina 400 mg Film-coated tablet Oral use Italy Merck Sharp & Dohme S.p.A. Via G. Fabbroni, 6 I-00191 Roma Noroxin 400 mg Film-coated tablet Oral use Italy Neopharmed S.p.A Via G. Fabbroni, 6 I-00191 Roma Utinor 400 mg Film-coated tablet Oral use Italy Pliva Pharma S.p.A. Via Tranquillo Cremona, 10 I-20092 Cinisello Balsamo (MI) Norfloxacina 400 mg Film-coated tablet Oral use Italy Sandoz S.p.A. Largo Umberto Boccioni, 1 I-21040 Origgio (VA) Norfloxacina Sandoz 400 mg Film-coated tablet Oral use Italy So. Se. Pharm S.r.l. Via dei Castelli Romani, 22 I-00040 Pomezia (RM) Uticina 400 mg Film-coated tablet Oral use Italy Tad Pharma Italia S.r.l. Via Felice Casati, 16 I-20124 Milano Norfloxacina 400 mg Film-coated tablet Oral use Italy Francia Farmaceutici Industria Farmaco Biologica Srl Via dei Pestagalli, 7 Milano Diperflox 540 mg of Norfloxacin pivaloil-oxy- methyl-ester as 400 mg of Norfloxacin Tablet Oral use Italy Francia Farmaceutici Industria Farmaco Biologica Srl Via dei Pestagalli, 7 Milano Diperflox 100 ml contains 5,4 g of Norfloxacin pivaloil-oxy- methyl-ester as 4,0 g of Norfloxacin Oral suspension Oral use Italy Pliva Pharma S.p.A Via Tranquillo Cremona, 10 I-20092 Cinisello Balsamo (MI) Norflox 540 mg of Norfloxacin pivaloil-oxy- methyl-ester as 400 mg of Norfloxacin Tablet Oral use Italy Pliva Pharma S.p.A. Via Tranquillo Cremona, 10 I-20092 Cinisello Balsamo (MI) Norflox 100 ml contains 5,4 g of Norfloxacin pivaloil-oxy- methyl-ester as 4,0 g of Norfloxacin Oral suspension Oral use Latvia Cipla (UK) Ltd Old Post House Hithrow Road Webbger Bridge Surrey KT 138TS United Kingdom Norflox 400 mg Film-coated tablet Oral use Latvia Krka d.d. Šmarješka cesta 6 SLO-8501 Novo mesto Nolicin 400 mg Film-coated tablet Oral use Latvia Laboratorios Inkeysa S.A. Juran XXIII, 15-19, 3a planta ES-08950, Esplugas de Llobregat Barcelona Spain Norflok 400 mg Tablet Oral use Latvia Ranbaxy (UK) Ltd. 20 Balderton Street London W1K6TL United Kingdom Norbactin 400 mg Film-coated tablet Oral use Lithuania Krka d.d. Šmarješka cesta 6 SLO-8501 Novo mesto Nolicin 400 mg Film-coated tablet Oral use Lithuania Ranbaxy (UK) Ltd. C.P. House 97/107 Uxbridge Road Ealing London W5 5TL United Kingdom Norbactin 400 mg Film-coated tablet Oral use Luxembourg Merck Sharp & Dohme Chaussée de Waterloo, 1135 B-1180 Bruxelles Zoroxin 400 mg Tablet Oral use Luxembourg Eurogenerics Esplanade Heysel, B.22 B-1020 Bruxelles Norfloxacin — Eurogenerics 400 mg Tablet Oral use Luxembourg TAD Pharm. Werk Heinz-Lohmann Str. 5 D-27472 Cuxhaven Norflosal 400 mg Tablet Oral use Malta Merck Sharp & Dohme Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Utinor 400 mg tablets 400 mg Tablet Oral use Malta Anfarm Hellas S.A. K Paleologou & Perikleous GR-153 32 Halandri Athens Fluseminal 400 mg tablets 400 mg Tablet Oral use The Netherlands Ratiopharm Nederland BV Ronde Tocht 11 1507 CC Zaandam Nederland Norfloxacine ratiopharm 400 mg 400 mg Tablet Oral use Netherlands Centrafarm Services B.V. Nieuwe Donk 9, 4879 AC Etten-Leur Nederland Norfloxacine CF 400 mg 400 mg Film-coated tablet Oral use Netherlands Sandoz B.V. Veluwezoom 22 1327 AH Almere Nederland Norfloxacine Sandoz tablet 400 400 mg Film-coated tablet Oral use Netherlands Merck Generics BV Dieselweg 25 3752 LB Bunschoten Nederland Norfloxacine Merck 400 mg 400 mg Film-coated tablet Oral use Poland Krka d.d. Šmarješka cesta 6 SLO-8501 Novo Mesto Nolicin 400 mg Tablet Oral use Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego 5 PL-95-200 Pabianice Norsept 400 mg Film-coated tablet Oral use Portugal Labesfal — Laboratórios Almiro, S.A. P-3465-051 Campo de Besteiros Besflox 400 mg Coated tablet Oral use Portugal Cinfa Portugal, Lda. Av. Tomás Ribeiro, 43 — Bloco 2, 3o F — Edifício Neopark P-2790-221 Carnaxide Norfloxacina Cinfa 400 mg comprimidos 400 mg Coated tablet Oral use Portugal Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro — Edifício Tejo — 6o Piso, P-2790-143 Carnaxide Norfloxacina ratiopharm 400 mg comprimidos Revestidos 400 mg Coated tablet Oral use Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte Edifício Vasco da Gama 19 — Porto Salvo P-2770-192 Paço d' Arcos Noroxin 400 mg Film-coated tablet Oral use Portugal Bialfar — Produtos Farmacêuticos, S.A. Av. da Siderurgia Nacional P.O. Box 56 P-4745-457 S. Mamede do Coronado Uroflox 400 mg Coated tablet Oral use Romania S.C. AC Helcor S.R.L. Str. Victor Babeș nr 50 Jud. Maramureș RO-430092 Baia Mare H-NORFLOXACIN 400 mg 400 mg Film-coated tablets Oral use Romania S.C. Labormed-Pharma S.A. Splaiul Independenţei nr. 319E Sector 6 RO-060044 București Norfloxacina LPH 400 mg 400 mg Film-coated tablet Oral use Romania Krka d.d . Šmarješka cesta 6 SLO-8501 Novo mesto Nolicin 400 mg 400 mg Film-coated tablet Oral use Romania Ozone Laboratories Ltd 38 Princes Court 88 Brompton Road Knightsbridge SW3 1ES London United Kingdom Norfloxacin 400 mg 400 mg Film-coated tablet Oral use Romania Ozone Laboratories Ltd 38 Princes Court 88 Brompton Road Knightsbridge SW3 1ES London United Kingdom Norfloxacin Ozone 400 mg 400 mg Film-coated tablet Oral use Romania S.C. Terapia S.A. Str. Fabricii nr. 124 RO-400640 Cluj-Napoca Norfloxacina Terapia 400 mg 400 mg Film-coated tablet Oral use Romania S.C. Laropharm S.R.L. Șoseaua Alexandriei nr. 145 A Jud. Ilfov RO-077025 Comuna Bragadiru Norfloxacin 400 mg 400 mg Film-coated tablet Oral use Slovak Republic Krka d.d. Šmarješka cesta 6 SLO-8501 Novo mesto Nolicin 400 mg Film-coated tablet Oral use Slovak Republic Medochemie Ltd. P.O.Box 51409 CY-3505 Limassol Gyrablock 400 mg 400 mg Film-coated tablet Oral use Slovenia Krka d.d. Šmarješka cesta 6 SLO-8501 Novo mesto Nolicin filmsko obložene tablete 400 mg 400 mg Film-coated tablet Oral use Spain Sharp & Dohme, S.A Josefa Valcárcel, 38 E-28027 Madrid Noroxin 400 mg comprimidos recubiertos con película 400 mg Film-coated tablet Oral use Spain VP Pharma Baru, S.L. C/ Valle de Tobalina, 16 Nave 3 E-28021 Madrid Xasmun 400 mg comprimidos 400 mg Film-coated tablet Oral use Spain Abbott Laboratories, S.A Avda. de Burgos, 91 E-28050 Madrid Baccidal 400 mg Capsule Oral use Spain Sandoz Farmaceutica, S.A Avenida de Osa Mayor 4 E-28023 Aravaca Madrid Nalion comprimidos 400 mg Film-coated tablet Oral use Spain Inkeysa, S.A Juan XXIII, 15 - 19, 3a planta E-08950 Esplugas de Llobregat Norflok comprimidos 400 mg Film-coated tablet Oral use Spain Biosarto, S.A Foc, 68-82 E-08038 Barcelona Senro cápsulas 400 mg Capsule Oral use Spain Almirall Prodesfarma S.A Ronda General Mitre, 151 E-08022 Barcelona Uroctal comprimidos 400 mg Film-coated tablet Oral use Spain Alacan S.A Capricornio, 5 E-03006 Alicante Esclebin 400 mg comprimidos recubiertos con película 400 mg Film-coated tablet Oral use Spain Quimifar, S.A Comadran, 37 E-08210 Barbera del Valles Amicrobin capsulas 400 mg Capsule Oral use Spain Qualigen Avda, Barcelona, 69 E-08970 Sant Joan Despi Barcelona Norfloxacino Qualigen 400 mg comprimidos recubiertos con película 400 mg Film-coated tablet Oral use Sweden Astra Zeneca AB S-151 85 Södertälje Lexinor 200 mg 400 mg Film-coated tablet Oral use Sweden Stada Arzneimittel Stadastraße 2-18 D-61118 Bad Vilbel Norfloxacin Stada 400 mg Film-coated tablet Oral use Sweden Sandoz GmbH Biochemiestraße 10 A-6250 Kundl Norfloxacin Sandoz 400 mg Film-coated tablet Oral use Sweden Recip AB Box 906 S-170 09 Solna Norfloxacin Astra Zeneca 200 mg 400 mg Film-coated tablet Oral use Sweden Alternova AB Vallgatan 11 S-170 67 Solna Norfloxacin Alternova 200 mg 400 mg Film-coated tablet Oral use Sweden Krka Sverige AB Göta Ark 175 Medborgarplatsen 25 S-118 72 Stockholm Norfloxacin Krka 200 mg 400 mg Film-coated tablet Oral use United Kingdom Merck Sharpe & Dohme Limted Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom Utinor Tablets 400 mg 400 mg Coated tablet Oral use United Kingdom TAD Pharma GmbH Heinz-Lohmann-Straße 5 D-27472Cuxhaven Norfloxacin 400 mg Tablets 400 mg Coated tablet Oral use United Kingdom TAD Pharma GmbH Heinz-Lohmann-Straße 5 D-27472 Cuxhaven Norflocux 400 mg Coated tablet Oral use United Kingdom Ratiopharm GmbH Graf-Arco-Straße 3 D-89079 Ulm Norfloxacin-Ratiopharm 400 400 mg Coated tablet Oral use United Kingdom Ratiopharm GmbH Graf-Arco-Straße 3 D-89079 Ulm Norquin 400 400 mg Coated tablet Oral use United Kingdom Ratiopharm GmbH Graf-Arco-Straße 3 D-89079 Ulm Norflocin 400 400 mg Coated tablet Oral use

ANNEX V LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder (Invented) Name Strength Pharmaceutical Form Route of administration Austria Wyeth-Lederle Pharma GmbH Storchengasse 1 A-1150 Vienna Efectin 50 mg — Tabletten 50 mg Tablets Oral use Cyprus Wyeth Hellas S.A. 126, Kyprou & 25th Martiou str. GR-164 52 Argyroupolis-Athens Efexor 37,5 mg Tablets Oral use Cyprus Wyeth Hellas S.A. 126, Kyprou & 25th Martiou str. GR-164 52 Argyroupolis-Athens Efexor 50 mg Tablets Oral use Cyprus Wyeth Hellas S.A. 126, Kyprou & 25th Martiou str. GR-164 52 Argyroupolis-Athens Efexor 75 mg Tablets Oral use Denmark John Wyeth & Brother Ltd. New Lane Havant Hants PO9 2NG United Kingdom Efexor 37,5 mg Tablets Oral use Finland John Wyeth & Brother Ltd. New Lane Havant Hants PO9 2NG United Kingdom Efexor 37,5 mg Tablets Oral use Finland John Wyeth & Brother Ltd. New Lane Havant Hants PO9 2NG United Kingdom Efexor 75 mg Tablets Oral use France Wyeth Pharmaceuticals France Coeur Défense — Tour A — la Défense 4 F-92931 Paris la Défense Cedex Effexor 25 mg Tablets Oral use France Wyeth Pharmaceuticals France Coeur Défense — Tour A — la Défense 4 F-92931 Paris la Défense Cedex Effexor 50 mg Tablets Oral use France Wyeth Pharmaceuticals France Coeur Défense — Tour A — la Défense 4 F-92931 Paris la Défense Cedex Trevilor 50 mg Tablets Oral use Germany Wyeth Pharma GmbH Wienburgstraße 207 D-48159 Muenster Trevilor Tabletten 25 mg 25 mg Tablets Oral use Germany Wyeth Pharma GmbH Wienburgstraße 207 D-48159 Muenster Trevilor Tabletten 37,5 mg 37,5 mg Tablets Oral use Germany Wyeth Pharma GmbH Wienburgstraße 207 D-48159 Muenster Trevilor Tabletten 50 mg 50 mg Tablets Oral use Germany Wyeth Pharma GmbH Wienburgstraße 207 D-48159 Muenster Trevilor Tabletten 75 mg 75 mg Tablets Oral use Greece Wyeth Hellas S.A. 126, Kyprou & 25th Martiou str. GR-164 52 Argyroupolis-Athens Efexor 25 mg Tablets Oral use Greece Wyeth Hellas S.A. 126, Kyprou & 25th Martiou str. GR-164 52 Argyroupolis-Athens Efexor 37,5 mg Tablets Oral use Greece Wyeth Hellas S.A. 126, Kyprou & 25th Martiou str. GR-164 52 Argyroupolis-Athens Efexor 50 mg Tablets Oral use Greece Wyeth Hellas S.A. 126, Kyprou & 25th Martiou str. GR-164 52 Argyroupolis-Athens Efexor 75 mg Tablets Oral use Iceland John Wyeth & Brothers Ltd New Lane, Havant Hants P09 2NG United Kingdom Efexor 37,5 mg Tablets Oral use Ireland John Wyeth & Brother Ltd trading as Wyeth Laboratories Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom Efexor 37,5 mg Tablets Oral use Ireland John Wyeth & Brother Ltd trading as Wyeth Laboratories Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom Efexor 75 mg Tablets Oral use Italy Wyeth Medica Ireland Little Connell — Newbridge Co. Kildare Ireland Efexor 25 mg Tablets Oral use Italy Wyeth Medica Ireland Little Connell — Newbridge Co. Kildare Ireland Efexor 37,5 mg Tablets Oral use Italy Wyeth Medica Ireland Little Connell — Newbridge Co. Kildare Ireland Efexor 50 mg Tablets Oral use Italy Wyeth Medica Ireland Little Connell — Newbridge Co. Kildare Ireland Efexor 75 mg Tablets Oral use Italy Wyeth Medica Ireland Little Connell — Newbridge Co. Kildare Ireland Faxine 37,5 mg Tablets Oral use Italy Wyeth Medica Ireland Little Connell — Newbridge Co. Kildare Ireland Faxine 50 mg Tablets Oral use Italy Wyeth Medica Ireland Little Connell — Newbridge Co. Kildare Ireland Faxine 75 mg Tablets Oral use Malta John Wyeth & Brother Ltd trading as Wyeth Laboratories Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom Efexor 37,5 mg Tablets Oral use Malta John Wyeth & Brother Ltd trading as Wyeth Laboratories Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom Efexor 75 mg Tablets Oral use Norway John Wyeth & Brother Ltd trading as Wyeth Laboratories Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom Efexor 37,5 mg Tablets Oral use Spain WYETH FARMA S.A. Ctra. De Burgos Km 23 Desvio Algete E-28700 San Sebastián de los Reyes VANDRAL 37,5 mg comprimidos 37,5 mg Tablets Oral use Spain WYETH FARMA S.A. Ctra. De Burgos Km 23 Desvio Algete E-28700 San Sebastián de los Reyes VANDRAL 50 mg comprimidos 50 mg Tablets Oral use Spain WYETH FARMA S.A. Ctra. De Burgos Km 23 Desvio Algete E-28700 San Sebastián de los Reyes VANDRAL 75 mg comprimidos 75 mg Tablets Oral use Spain Laboratorios Almirall, S.A. General Mitre, 151 E-08022 Barcelona Dobupal 37,5 mg comprimidos 37,5 mg Tablets Oral use Spain Laboratorios Almirall, S.A. General Mitre, 151 E-08022 Barcelona Dobupal 50 mg comprimidos 50 mg Tablets Oral use Spain Laboratorios Almirall, S.A. General Mitre, 151 E-08022 Barcelona Dobupal 75 mg comprimidos 75 mg Tablets Oral use United Kingdom John Wyeth & Brother Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom Efexor 25 mg Tablets Oral use United Kingdom John Wyeth & Brother Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom Efexor 37,5 mg Tablets Oral use United Kingdom John Wyeth & Brother Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom Efexor 50 mg Tablets Oral use United Kingdom John Wyeth & Brother Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom Efexor 75 mg Tablets Oral use