ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

1 Bromocriptine containing medicinal products with Marketing Authorisation in the European Union

Member State Marketing Authorisation Holder Product name Strength Pharmaceutical Form Route of Administration

MEDA PHARMA GmbH Liesinger-Flur- Austria Parlodel 5 mg - Kapseln 5 mg Capsule Oral Use Gasse 2c, 1230 Wien, Austria

MEDA PHARMA GmbH Liesinger-Flur- Austria Parlodel 2,5 mg - Kapseln 2,5 mg Capsule Oral Use Gasse 2c, 1230 Wien, Austria

MEDA PHARMA GmbH Liesinger-Flur- Austria Parlodel SRO 10 mg - Kapseln 10 mg Capsule Oral Use Gasse 2c, 1230 Wien, Austria

MEDA PHARMA GmbH Liesinger-Flur- Parlodel SRO 2,5 mg - Austria 2,5 mg Capsule Oral Use Gasse 2c, 1230 Wien, Austria Kapseln

MEDA PHARMA GmbH Liesinger-Flur- Austria Parlodel SRO 5 mg - Kapseln 5 mg Capsule Oral Use Gasse 2c, 1230 Wien, Austria

MEDA PHARMA GmbH Liesinger-Flur- Austria Umprel 10 mg Capsule Oral Use Gasse 2c, 1230 Wien, Austria

MEDA PHARMA GmbH Liesinger-Flur- Austria Umprel 5 mg Capsule Oral Use Gasse 2c, 1230 Wien, Austria

MEDA PHARMA GmbH Liesinger-Flur- Austria Umprel 2,5 mg Capsule Oral Use Gasse 2c, 1230 Wien, Austria

Meda Pharma S.A. - N.V. Chaussee de la Belgium Parlodel 2.5 mg Tablet Oral Use Hulpe 166 - B-1170 Brussels

Meda Pharma S.A. - N.V. Chaussee de la Belgium Parlodel 10 MG 10 mg Capsule, hard Oral Use Hulpe 166 - B-1170 Brussels

2 Meda Pharma S.A. - N.V. Chaussee de la Belgium Parlodel 5 mg 5 mg Capsule, hard Oral Use Hulpe 166 - B-1170 Brussels MEDOCHEMIE Limited, 1-10 Bulgaria Constantinoupoleos Str., Zakaki, 3505- Medocriptine 2.5 mg Tablet Oral Use Limassol, Cyprus Pharma Sofia 1164 Bulgaria Square "Dzhon Paul II" office centre Parlodel 2.5 mg Tablet Oral Use "Bulgaria 2000", Bulgaria SOPHARMA - Sofia 1797 Bulgaria Bromocriptine Sopharma 2.5 mg Tablet Oral Use bul." Kliment Ohridski" №3, Bulgaria REMEDICA LTD, P.O.Box 51706, 3508 Cyprus Brameston 2.5 mg Tablet Oral Use Lemesos, Cyprus CODAL SYNTO LTD, P.O.BOX 51785, Cyprus Pirodal 2.5 mg Tablet Oral Use 3508 Lemesos, Cyprus DEMETRIADES & PAPAELLINAS Ltd, Cyprus Parlodel 2.5 mg Tablet Oral Use P.O.Box 23490, 1683, Lefkosia, Cyprus MEDOCHEMIE Limited, 1-10 Cyprus Constantinoupoleos Str., Zakaki, 3505- Medocriptine 2.5 mg Tablet Oral Use Limassol, Cyprus MEDA PHARMA s.r.o., Záhřebská, 577, Czech Republic Parlodel 2.87 mg Tablet Oral use 120 00, Praha 2, Czech Republic MEDOCHEMIE Limited, 1-10 Czech Republic Constantinoupoleos Str., Zakaki, 3505- Medocriptine 2.87 mg Tablet Oral use Limassol, Cyprus MEDA AS, Solvang 8, DK-3450 Allerød, Denmark Parlodel 2,5 mg Tablet Oral Use Denmark MEDA AS, Solvang 8, DK-3450 Allerød, Denmark Parlodel 5 mg Capsule, hard Oral Use Denmark MEDA AS, Solvang 8, DK-3450 Allerød, Denmark Parlodel 10 mg Capsule, hard Oral Use Denmark

3 GEDEON RICHTER, Gyömröi út 19-21, Estonia Promocriptin-Richter 2,5 mg Tablet Oral Use , HU-1103,

NOVARTIS Finland Oy, Metsanneidonkuja Estonia Parlodel 2,5 mg Tablet Oral Use 10 Fin-02130 ESPOO, Finland MEDA OY Lemminkäisenkatu 32 20520 Finland Parlodel 2,5 mg Tablet Oral Use Turku Finland MEDA OY Lemminkäisenkatu 32 20520 Finland Parlodel 10 mg Capsule, hard Oral Use Turku Finland MEDA OY Lemminkäisenkatu 32 20520 Finland Parlodel 5 mg Capsule, hard Oral Use Turku Finland MEDA OY Lemminkäisenkatu 32 20520 Finland Parlodel 10 mg Capsule, hard Oral Use Turku Finland MEDA OY Lemminkäisenkatu 32 20520 Finland Parlodel 5 mg Capsule, hard Oral Use Turku Finland MEDA PHARMA France 25 de l'Amiral Bruix Parlodel 5 mg Capsule Oral Use 75016 Paris, France MEDA PHARMA France 25 boulevard de l'Amiral Bruix Parlodel 10 mg Capsule Oral Use 75016 Paris, France MEDA PHARMA France 25 boulevard de l'Amiral Bruix Parlodel 2,5 mg scored tablet Oral Use 75016 Paris, France SANOFI-AVENTIS Bromocriptine France 1/13 boulevard Romain Rolland 2,5 mg scored tablet Oral Use Winthrop 75014 Paris, France SANOFI-AVENTIS France 1/13 boulevard Romain Rolland Bromokin 2,5 mg scored tablet Oral Use 75014 Paris, France SANOFI-AVENTIS France 1/13 boulevard Romain Rolland Parlodel 2,5 mg scored tablet Oral Use 75014 Paris, France

4 SANOFI-AVENTIS Bromocriptine France 1/13 boulevard Romain Rolland 5 mg Capsule Oral Use Winthrop 75014 Paris, France SANOFI-AVENTIS Bromocriptine France 1/13 boulevard Romain Rolland 10 mg Capsule Oral Use Winthrop 75014 Paris, France SANOFI-AVENTIS France 1/13 boulevard Romain Rolland Bromokin 5 mg Capsule Oral Use 75014 Paris, France SANOFI-AVENTIS France 1/13 boulevard Romain Rolland Bromokin 10 mg Capsule Oral Use 75014 Paris, France SANOFI-AVENTIS France 1/13 boulevard Romain Rolland Bromo-kin 2,5 mg Tablet Oral Use 75014 Paris, France MEDA PHARMA GmbH & Co. KG, Germany Benzstr. 1, D-61352 Bad Homburg, Pravidel 10 mg Kapseln 11.47 mg Capsule, hard Oral Use Germany MEDA PHARMA GmbH & Co. KG, Germany Benzstr. 1, D-61352 Bad Homburg, Pravidel 5 mg Kapseln 5.735 mg Capsule, hard Oral Use Germany MEDA PHARMA GmbH & Co. KG, Germany Benzstr. 1, D-61352 Bad Homburg, Pravidel 2,5 mg Tabletten 2.87 mg Tablet Oral Use Germany AbZ-PHARMA Bromocriptin AbZ 2,5mg Germany Graf-Arco-Str. 3 2.87 mg Tablet Oral Use Tabletten D-89079 Ulm, Germany BETAPHARM Arzneimittel GmbH; Germany Kobelweg 95; D-86156 Augsburg, Bromocriptin beta 5 5.735 mg Capsule, hard Oral Use Germany BETAPHARM Arzneimittel GmbH; Germany Kobelweg 95; D-86156 Augsburg, Bromocriptin beta 2,5 2.87 mg Tablet Oral Use Germany

5 CT-ARZNEIMITTEL GmbH bromocriptin-ct 5mg Germany Lengeder Str. 42a 5.735 mg Capsule, hard Oral Use Hartkapseln D-13407 , Germany CT-ARZNEIMITTEL GmbH bromocriptin-ct 2,5 mg Germany Lengeder Str. 42a 2.87 mg Tablet Oral Use Tabletten D-13407 Berlin, Germany CT-ARZNEIMITTEL GmbH bromocriptin-ct 10mg Germany Lengeder Str. 42a 11.47 mg Capsule, hard Oral Use Hartkapseln D-13407 Berlin, Germany HEXAL AG, Industriestrasse Bromocriptin Hexal 10 mg Germany 11.47 mg Capsule, hard Oral Use 25,Holzkirchen, D-83607, Germany Kapseln

HEXAL AG, Industriestrasse Germany Kamilium 10 Kps. 11.47 mg Capsule, hard Oral Use 25,Holzkirchen, D-83607, Germany

HEXAL AG, Industriestrasse Bromocriptin Hexal 5 mg Germany 5.735 mg Capsule, hard Oral Use 25,Holzkirchen, D-83607, Germany Kapseln

HEXAL AG, Industriestrasse Germany Bromoxal 5 mg 5.735 mg Capsule, hard Oral Use 25,Holzkirchen, D-83607, Germany

HEXAL AG, Industriestrasse Bromocriptin Hexal 5 mg Germany 5.735 mg Capsule, hard Oral Use 25,Holzkirchen, D-83607, Germany Kapseln

HEXAL AG, Industriestrasse Germany Bromolakt 5 mg 5.735 mg Capsule Oral Use 25,Holzkirchen, D-83607, Germany

HEXAL AG, Industriestrasse Germany Bromoktin 5 mg 5.735 mg Capsule Oral Use 25,Holzkirchen, D-83607, Germany

HEXAL AG, Industriestrasse Bromocriptin Hexal 2,5 mg Germany 2.87 mg Tablet Oral Use 25,Holzkirchen, D-83607, Germany Tabletten

6 HORMOSAN PHARMA GmbH Germany Postfach 600340 Kirim 5 T 5.74 mg Tablet Oral Use D-60333 Frankfurt, Germany HORMOSAN PHARMA GmbH Germany Postfach 600340 Kirim 2,5 2.87 mg Tablet Oral Use D-60333 Frankfurt, Germany TAURUS PHARMA GmbH Germany Benzstr. 11 Kirim gyn 2.87 mg Tablet Oral Use D-61352 Bad Homburg, Germany

RATIOPHARM Graf-Arco-Strasse 3, DE- Bromocriptin-ratiopharm 10mg Germany 11.47 mg Capsule, hard Oral Use 89079 Ulm, Germany Hartkapseln

RATIOPHARM Graf-Arco-Strasse 3, DE- Bromocriptin-ratiopharm 5mg Germany 5.735 mg Capsule, hard Oral Use 89079 Ulm, Germany Hartkapseln

RATIOPHARM Graf-Arco-Strasse 3, DE- Bromocriptin-ratiopharm 2,5mg Germany 2.87 mg Tablet Oral Use 89079 Ulm, Germany Tabletten

SANDOZ Pharmaceuticals GmbH, Bromocriptin Sandoz 10mg Germany Raiffeisenstr. 1, D-83607 Holzkirchen, 11.47 mg Capsule, hard Oral Use Hartkapseln Germany SANDOZ Pharmaceuticals GmbH, Bromocriptin Sandoz 5mg Germany Raiffeisenstr. 1, D-83607 Holzkirchen, 5.735 mg Capsule, hard Oral Use Hartkapseln Germany MEDA PHARMACEUTICALS S.A. Greece Greece, 3 Evritanias Street, Halandri Attikis Parlodel 5 mg Capsule, hard Oral Use 15231, Greece MEDA PHARMACEUTICALS S.A. Greece Greece, 3 Evritanias Street, Halandri Attikis Parlodel 10 mg Capsule, hard Oral Use 15231, Greece

7 GEDEON RICHTER, Gyömröi út 19-21, Hungary Bromocriptine-Richter 2.5 mg Tablet Oral Use Budapest, HU-1103, Hungary ICEPHARMA hf., Lynghálsi 13, 110 Iceland Parlodel 5 mg Capsule, hard Oral Use Reykjavík, Iceland ICEPHARMA hf., Lynghálsi 13, 110 Iceland Parlodel 10 mg Capsule, hard Oral Use Reykjavík, Iceland ICEPHARMA hf., Lynghálsi 13, 110 Iceland Parlodel 2,5 mg Tablet Oral Use Reykjavík, Iceland MEDA Health Sales Ireland Ltd, Office 10 Ireland Dunboyne Business Park, Dunboyne, Co. Parlodel 2.5 mg Tablet Oral Use Meath, Ireland

MEDA Health Sales Ireland Ltd, Office 10 Ireland Dunboyne Business Park, Dunboyne, Co. Parlodel 5 mg Capsule Oral Use Meath, Ireland MEDA PHARMA SpA - Via Le Brenta, 18 Italy Parlodel 10 mg Capsule Oral Use - 20139, Milano, Italy MEDA PHARMA SpA - Via Le Brenta, 18 Italy Parlodel 5 mg Capsule Oral Use - 20139, Milano, Italy DOROM Srl - VIA Giulio Richard 7 - Italy Bromocriptina Dorom 10 mg Capsule Oral Use MILANO (IT), Italy DOROM Srl - VIA Giulio Richard 7 - Italy Bromocriptina Dorom 5 mg Capsule Oral Use MILANO (IT), Italy LEK PHARMACEUTICALS Pr.d.d., Latvia Verovškova 57, SI-1000, Ljubljana, Bromergon 2,5 mg Tablet Oral Use Slovenia GEDEON RICHTER, Gyömröi út 19-21, Latvia Bromocriptin-Richter 2,5 mg Tablet Oral Use Budapest, HU-1103, Hungary

NOVARTIS Finland Oy, Metsanneidonkuja Latvia Parlodel 2,5 mg Tablet Oral Use 10 Fin-02130 ESPOO, Finland

8 GEDEON RICHTER, Gyömröi út 19-21, Lithuania Bromocriptin-Richter 2,5 mg Tablet Oral Use Budapest, HU-1103, Hungary

NOVARTIS Finland Oy, Metsanneidonkuja Lithuania Parlodel 2,5 mg Tablet Oral Use 10 Fin-02130 ESPOO, Finland

POLI INDUSTRIA chimica S.p.A. Via Lithuania Volturno 45/48-Quinto de Stampi-20089 Bromocriptine Poli 2,5 mg Tablet Oral Use Rozzano Milano, Italy

MEDA PHARMA GmbH, Benestrasse 1, Luxembourg Pravidel 2.5 mg Tablet Oral Use D-61352 BAD Hambourg, Germany

MEDA PHARMA GmbH, Benestrasse 1, Luxembourg Pravidel 5 mg Capsule Oral Use D-61352 BAD Hambourg, Germany

MEDA PHARMA GmbH, Benestrasse 1, Luxembourg Pravidel 10 mg Capsule Oral Use D-61352 BAD Hambourg, Germany MEDA PHARMA B.V. Krijgsman 20, Netherlands 1186 DM AMSTELVEEN/NL, Parlodel 10 mg 10 mg Capsule Oral Use Netherlands MEDA PHARMA B.V. Krijgsman 20, Netherlands 1186 DM AMSTELVEEN/NL, Parlodel 2.5 mg 2.5 mg Tablet Oral Use Netherlands MEDA PHARMA B.V. Krijgsman 20, Netherlands 1186 DM AMSTELVEEN/NL, Parlodel 5 mg 5 mg Tablet Oral Use Netherlands LEK S.A., ul. Podlipie 16, 95-010 Stryków, Poland Bromergon 2,5 mg Tablet Oral Use Poland FILOFARM, Farmaceutyczna Spółdzielnia Poland Pracy "Filofarm", ul. Pułaskiego 39, 85-619 Bromocorn 2,87 mg Tablet Oral Use Bydgoszcz, Poland

9 Meda Aktiebolag - Pipers vag 2, Box 906 - Poland Parlodel 2,5 mg Tablet Oral Use SE-17009 Solana - Sweden

POLFA, Grodziskie Zakłady Farmaceutyczne POLFA Sp. z o.o., ul. Poland Ergolaktyna 2,5 mg Tablet Oral Use Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Poland MEDA PHARMA - Produtos Portugal Farmacêuticos, S.A.Rua do Centro Cultural, Parlodel 2,5 mg Tablet Oral Use 13 1749-066 Lisboa, Portugal

MEDA PHARMA - Produtos Portugal Farmacêuticos, S.A.Rua do Centro Cultural, Parlodel 5 mg Capsule Oral Use 13 1749-066 Lisboa, Portugal

MEDA PHARMA - Produtos Portugal Farmacêuticos, S.A.Rua do Centro Cultural, Parlodel 10 mg Capsule Oral Use 13 1749-066 Lisboa, Portugal GENERIS Farmacêutica, S.A. Office Park da Beloura - Edifício 4 - Quinta Bromocriptina Generis 2,5 mg Portugal 2,5 mg Tablet Oral Use da Beloura Comprimidos 2710-444 Sintra Portugal S.C. BIOFARM S.A., Str. Logofat Tautu Romania Brocriptin 2.5mg Tablet Oral Use nr. 99, sector 3, Bucharest, Romania

MEDA PHARMA s.r.o., Záhřebská, 577, Slovak Republic Parlodel 2,5 mg Tablet Oral Use 120 00, Praha 2, Czech Republic MEDOCHEMIE Limited, 1-10 Slovak Republic Constantinoupoleos Str., Zakaki, 3505- Medocriptine 2,5 mg 2,5 mg Tablet Oral Use Limassol, Cyprus

10 LEK farmacevtska družba, d.d., Verovškova Slovenia Bromergon 2,5 mg Tablet Oral Use 57, 1000 Ljubljana, Slovenia

MEDA PHARMA SAU AVDA Castilla, 2 Spain Edif Berlin 2º planta, parque empresarial Parlodel 2,5 mg Comprimidos 2,5 mg Tablet Oral Use San Fernando de Henares, Spain

MEDA PHARMA SAU AVDA Castilla, 2 Spain Edif Berlin 2º planta, parque empresarial Parlodel 5 mg Capsulas 5 mg Capsule Oral Use San Fernando de Henares, Spain

MEDA AB, Box 906, 170 09, Solna Sweden Pravidel 2,5 mg Tablet Oral Use Sweden

MEDA AB, Box 906, 170 09, Solna Sweden Pravidel 5 mg Capsule, hard Oral Use Sweden

MEDA AB, Box 906, 170 09, Solna Sweden Pravidel 10 mg Capsule, hard Oral Use Sweden

MEDA PHARMACEUTICALS LIMITED; Building 2000, Beach Drive, United Kingdom Parlodel 2.5 mg Tablets 5 mg Tablet Oral Use Cambridge Research Park, Waterbeach, Cambridgeshire, CB5 9PD, UK

MEDA PHARMACEUTICALS LIMITED; Building 2000, Beach Drive, United Kingdom Parlodel 2.5 mg Tablets 10 mg Tablet Oral Use Cambridge Research Park, Waterbeach, Cambridgeshire, CB5 9PD, UK

MEDA PHARMACEUTICALS LIMITED; Building 2000, Beach Drive, United Kingdom Parlodel 2.5 mg Tablets 2.5 mg Tablet Oral Use Cambridge Research Park, Waterbeach, Cambridgeshire, CB5 9PD, UK

11 MEDA PHARMACEUTICALS LIMITED; Building 2000, Beach Drive, United Kingdom Parlodel 1 mg Tablets 1 mg Tablet Oral Use Cambridge Research Park, Waterbeach, Cambridgeshire, CB5 9PD, UK NORTON HEALTHCARE Limited, Bromocriptine Tablets BP 2.5 United Kingdom Albert Basin, Royal Docks, London E16 2.5 mg Tablet Oral Use mg 2QJ, UK GENERICS (UK) Limited, Station Close, Bromocriptine Tablets BP 2.5 United Kingdom 2.5 mg Tablet Oral Use Potters Bar, Herts EN6 1TL, UK mg NOVARTIS PHARMACEUTICALS UK LIMITED, Frimley Business Park, Frimley, United Kingdom Parlodel LAR Injection 50 mg 50 mg Powder for Injection Intramuscular Use Camberley, Surrey, United Kingdom, GU16 7SR, NOVARTIS PHARMACEUTICALS UK LIMITED, Frimley Business Park, Frimley, United Kingdom Parlodel LAR Injection 100 mg 100 mg Powder for Injection Intramuscular Use Camberley, Surrey, United Kingdom, GU16 7SR,

12 Dihydroergocryptine containing medicinal products with Marketing Authorisation in the European Union

Member State Marketing Authorisation Holder Product name Strength Pharmaceutical Form Route of Administration Defiante Farmaceutica Lda., Rua dos Hydergin - Fas 4,5 mg - Austria Ferreiros 260, PT 9000-082 4,5 mg Tablet Oral Use Filmtabletten Funchal/Madeira, Portugal Defiante Farmaceutica Lda., Rua dos Austria Ferreiros 260, PT 9000-082 Hydergin 1 mg/ml - Tropfen 1 mg/ml Oral Drops Oral Use Funchal/Madeira, Portugal Defiante Farmaceutica Lda., Rua dos Austria Ferreiros 260, PT 9000-082 Hydergin 3 mg/ml - Tropfen 3 mg/ml Oral Drops Oral Use Funchal/Madeira, Portugal Defiante Farmaceutica Lda., Rua dos Austria Ferreiros 260, PT 9000-082 Hydergin 1 mg - Tabletten 1 mg Tablet Oral Use Funchal/Madeira, Portugal Defiante Farmaceutica Lda., Rua dos Austria Ferreiros 260, PT 9000-082 Hydergin 2 mg - Tabletten 2 mg Tablet Oral Use Funchal/Madeira, Portugal Defiante Farmaceutica Lda., Rua dos Hydergin 0,3 mg/1 ml Austria Ferreiros 260, PT 9000-082 0,3 mg/1 m Solution for Injection Intravenous use Ampullen Funchal/Madeira, Portugal Defiante Farmaceutica Lda., Rua dos Austria Ferreiros 260, PT 9000-082 Hydergin SRO 6 mg - Kapseln 6 mg Capsule Oral Use Funchal/Madeira, Portugal RATIOPHARM Arzneimittel Vertriebs- Co-Dergocrin "ratiopharm" Austria GmbH, Albert-Schweitzer Gasse 3 1140 5 mg Capsule Oral Use retard 5 mg - Kapseln Wien, Austria RATIOPHARM Arzneimittel Vertriebs- Co-Dergocrin "ratiopharm" Austria GmbH, Albert-Schweitzer Gasse 3 1140 2,5 mg Capsule Oral Use retard 2,5 mg - Kapseln Wien, Austria SANOVA Pharma GmbH, Haidestraße 4, Austria Dorehydrin 1 mg/ml - Tropfen 1 mg/ml Oral Drops Oral Use 1110 Wien, Austria

13 SANOVA Pharma GmbH, Haidestraße 4, Dorehydrin retard 2,5 mg - Austria 2,5 mg Capsule Oral Use 1110 Wien, Austria Kapseln SANOVA Pharma GmbH, Haidestraße 4, Dorehydrin retard 4,5 mg - Austria 4,5 mg Capsule Oral Use 1110 Wien, Austria Kapseln WABOSAN Arzneimittelvertriebs GmbH Austria Anton Anderer Platz 6/1, 1210 Wien, Ergomed retard- Kapseln 0,875 mg Capsule Oral Use Austria WABOSAN Arzneimittelvertriebs GmbH Austria Anton Anderer Platz 6/1, 1210 Wien, Ergomed - Tabletten 0,33 mg Tablet Oral Use Austria WABOSAN Arzneimittelvertriebs GmbH Austria Anton Anderer Platz 6/1, 1210 Wien, Ergomed - Tropfen 0,33 mg/ml Oral Drops Oral Use Austria NOVARTIS PHARMA nv. Belgium Medialaan 40 Hydergine 1 mg / ml Oral Drops, Solution Oral Use 1800 Vilvoorde, Belgium NOVARTIS PHARMA nv. Belgium Medialaan 40 Hydergine 1,5 mg 1.5 mg Tablet Oral Use 1800 Vilvoorde, Belgium NOVARTIS PHARMA nv. Belgium Medialaan 40 Hydergine 4.5 mg 4.5 mg Tablet Oral Use 1800 Vilvoorde, Belgium NOVARTIS PHARMA nv. Belgium Medialaan 40 Hydergine FAS 4.5 mg 4.5 mg Gastro-Resistant Tablet Oral Use 1800 Vilvoorde, Belgium LABORATOIRES PHARMACOBEL Belgium de Seheut, 46-50 Dystonal 2,5 mg (N.F.) 2.5 mg Tablet Oral Use 1070 Bruxelles, Belgium NYCOMED BELGIUM Belgium Gentsesteenweg 615 Stofilan 1.5 mg Tablet Oral Use 1080 Brussel, Belgium NYCOMED BELGIUM Belgium Gentsesteenweg 615 Stofilan 1 mg / ml Oral Solution Oral Use 1080 Brussel, Belgium

14 NYCOMED BELGIUM Belgium Gentsesteenweg 615 Stofilan 4.5 mg Tablet Oral Use 1080 Brussel, Belgium SANDIPRO s.a. Belgium chaussée de Gand, 615 IBEXONE 1.5 mg 1.5 mg Tablet Oral Use 1080 Bruxelles, Belgium SANDIPRO s.a. Belgium chaussée de Gand, 615 IBEXONE 1 mg / ml Oral Solution Oral Use 1080 Bruxelles, Belgium SANDIPRO s.a. Belgium chaussée de Gand, 615 IBEXONE 4.5 mg 4.5 mg Tablet Oral Use 1080 Bruxelles, Belgium SANDIPRO s.a. Belgium chaussée de Gand, 615 IBEXONE 3 mg / ml Oral Solution Oral Use 1080 Bruxelles, Belgium POLI INDUSTRIA chimica S.p.A., Via Bulgaria Volturno 45/48-Quinto de Almirid 5 5 mg Capsule, hard Oral Use Stampi-20089 Rozzano Milano, Italy POLI INDUSTRIA chimica S.p.A., Via Volturno 45/48-Quinto de Bulgaria Almirid 5 20 mg Tablet Oral Use Stampi-20089 Rozzano Milano, Italy

POLICHEM S.A. 50, Val Fleuri, L-1526, Czech Republic Almirid 20 mg Tablet Oral Use Luxembourg

POLICHEM S.A. 50, Val Fleuri, L-1526, Czech Republic Almirid 5 mg Capsule, hard Oral Use Luxembourg Novartis Finland Oy Metsänneidonkuja 10, Finland Hydergin 1mg Tablet Oral Use 02130 ESPOO Novartis Finland Oy Metsänneidonkuja 10, Finland Hydergin 1.5mg Tablet Oral Use 02130 ESPOO

15 Novartis Pharma SAS, 2 & 4 Rue Lionel France Terray 92506 Rueil Malmaison Hydergine 0.3 mg/1ml Solution for Injection Oral Use Cedex, France Novartis Pharma SAS, 2 & 4 Rue Lionel France Terray 92506 Rueil Malmaison Hydergine 1 mg/1ml Oral Solution Oral Use Cedex, France Novartis Pharma SAS, 2 & 4 Rue Lionel France Terray 92506 Rueil Malmaison Hydergine 4.5 mg Tablet Oral Use Cedex, France DESITIN ARZNEIMITTEL GmbH Germany Postfach 630164 Almirid 20 mg Tablet Oral Use D-22311 , Germany DESITIN ARZNEIMITTEL GmbH Germany Postfach 630164 Almirid 40 mg Tablet Oral Use D-22311 Hamburg, Germany DESITIN ARZNEIMITTEL GmbH Germany Postfach 630164 Almirid 5 mg Capsule Oral Use D-22311 Hamburg, Germany TAURUS PHARMA GmbH Germany Benzstr. 11 Cripar 20 20 mg Tablet Oral Use D-61352 Bad Homburg, Germany TAURUS PHARMA GmbH Germany Benzstr. 11 Cripar forte 40 40 mg Tablet Oral Use D-61352 Bad Homburg, Germany TAURUS PHARMA GmbH Germany Benzstr. 11 Cripar 5 5 mg Capsule Oral Use D-61352 Bad Homburg, Germany Defiante Farmaceutica Lda., Rua dos Germany Ferreiros 260, PT 9000-082 Hydergin 1mg/ml Tropfloesung 0.333 mg Oral Drops, Solution Oral Use Funchal/Madeira, Portugal Defiante Farmaceutica Lda., Rua dos Germany Ferreiros 260, PT 9000-082 Hydergin forte 2mg Tabletten 0.666 mg Tablet Oral Use Funchal/Madeira, Portugal

16 Defiante Farmaceutica Lda., Rua dos Hydergin forte 2mg/ml Germany Ferreiros 260, PT 9000-082 0.67 mg Oral Drops, Solution Oral Use Tropfloesung Funchal/Madeira, Portugal Defiante Farmaceutica Lda., Rua dos Germany Ferreiros 260, PT 9000-082 Hydergin Spezial 1.33 mg Film-coated Tablet Oral Use Funchal/Madeira, Portugal DESITIN ARZNEIMITTEL GmbH Germany Postfach 630164 Ergodesit forte 2 mg 0.66 mg Tablet Oral Use D-22311 Hamburg, Germany DESITIN ARZNEIMITTEL GmbH Prolonged-Release Germany Postfach 630164 Ergodesit spezial 5 mg 1.66 mg Oral Use Tablet D-22311 Hamburg, Germany OPFERMANN ARZNEIMITTEL GmbH Opfermann Arzneimittel GmbH Germany Orphol forte 3 mg/ml 1. mg Oral Solution Oral Use Robert-Koch-Str. 2 D-51674 Wiehl, Germany

OPFERMANN ARZNEIMITTEL GmbH Opfermann Arzneimittel GmbH Germany Orphol Spezial 1.5 mg Tablet Oral Use Robert-Koch-Str. 2 D-51674 Wiehl, Germany

OPFERMANN ARZNEIMITTEL GmbH Opfermann Arzneimittel GmbH Germany Orphol Brausetabletten 1.5 mg Effervescent Tablet Oral Use Robert-Koch-Str. 2 D-51674 Wiehl, Germany Amdipharm Limited Temple Chambers Prolonged-Release Germany 3 Burlington Road DCCK Tropfloesung 1 mg Oral Use Capsule, hard IRL-Dublin 4, Ireland

17 Amdipharm Limited Temple Chambers Prolonged-Release Germany 3 Burlington Road DCCK Depot 4,5 1.5 mg Oral Use Capsule, hard IRL-Dublin 4, Ireland

FARMASAN Arzneimittel GmbH & Prolonged-Release Germany Co.KG, Postfach 410440 Sponsin forte 0.833 mg Oral Use Capsule, hard D-76204 Karlsruhe, Germany FARMASAN Arzneimittel GmbH & Prolonged-Release Germany Co.KG, Postfach 410440 Sponsin spezial 1.5 mg Oral Use Capsule, hard D-76204 Karlsruhe, Germany RATIOPHARM Graf-Arco-Strasse 3, DE- Hydro-Cebral-ratiopharm Germany 0.33 mg Oral Solution Oral Use 89079 Ulm, Germany Tropfen RATIOPHARM Graf-Arco-Strasse 3, DE- Hydro-Cebral-ratiopharm 2,5 Prolonged-Release Germany 0.833 mg Oral Use 89079 Ulm, Germany mg Capsule, hard RATIOPHARM Graf-Arco-Strasse 3, DE- Hydro-Cebral-ratiopharm 5,0 Prolonged-Release Germany 1.666 mg Oral Use 89079 Ulm, Germany mg Capsule, hard PHARMANEL PHARMACEUTICALS Greece S.A., Marathonos 106, Gerakas 15344, Daverium 5 mg Capsule, hard Oral Use Greece PHARMANEL PHARMACEUTICALS Greece S.A., Marathonos 106, Gerakas 15344, Daverium 20 mg Tablet Oral Use Greece Novartis (Hellas) S.A.C.I., 12 Klm Greece National Road No 1, GR-14451, Athens, Hydergine LPD 0.1% 15 ml Oral Solution Oral Use Greece POLICHEM S.A. 50, Val Fleuri, L-1526, Hungary Almirid 20mg Tablet Oral Use Luxembourg POLICHEM S.A. 50, Val Fleuri, L-1526, Hungary Almirid 5mg Capsule Oral Use Luxembourg POLICHEM S.A. 50, Val Fleuri, L-1526, Ireland Almirid 5mg Capsule Oral Use Luxembourg POLICHEM S.A. 50, Val Fleuri, L-1526, Ireland Almirid 20 mg Tablet Oral Use Luxembourg

18 MARVECSPHARMA SERVICES Srl - Italy Daverium 20 mg Tablet Oral Use Via Felice Casati, 16 - 20124 Milano, Italy Novartis Farma S.P.A. Largo Umberto Italy Hydergina 1 mg Oral Solution Oral Use Boccioni 1 21040 Origgio Varese, Italy Novartis Farma S.P.A. Largo Umberto Italy Hydergina 1.5 mg Tablet Oral Use Boccioni 1 21040 Origgio Varese, Italy NOVARTIS Pharma GmbH Roonstrasse Luxembourg Hydergin 1mg/ml Tropfloesung 0.333 mg Oral Drops, Solution Oral Use 25, D-90429 Nurnberg, Germany

NOVARTIS Pharma GmbH Roonstrasse Hydergin forte 2mg/ml Luxembourg 0.67 mg Oral Drops, Solution Oral Use 25, D-90429 Nurnberg, Germany Tropfloesung

NOVARTIS Pharma GmbH Roonstrasse Luxembourg Hydergin Spezial 1.33 mg Film-coated Tablet Oral Use 25, D-90429 Nurnberg, Germany CENTRAFARM SERVICES B.V.; Netherlands Nieuwe Donk 9; 4879 AC ETTEN- Co-dergocrinemesilaat 1.5 mg Tablet Oral Use LEUR/NL, Netherlands POLICHEM S.A. 50, Val Fleuri, L-1526, Poland Almirid 20 mg Tablet Oral Use Luxembourg POLICHEM S.A. 50, Val Fleuri, L-1526, Portugal Cripar 20 20 mg Tablet Oral Use Luxembourg POLICHEM S.A. 50, Val Fleuri, L-1526, Portugal Cripar 5 5 mg Capsule Oral Use Luxembourg Novartis Farma - Produtos Farmacêuticos, S.A. - Rua do Centro Portugal Hydergine 1.5 mg 1.5 mg Tablet Oral Use Empresarial, Edifício 8, Quinta da Beloura, 2710-44 Sintra, Portugal Novartis Farma - Produtos Farmacêuticos, S.A. - Rua do Centro Portugal Hydergine 4.5 mg 4.5 mg Tablet Oral Use Empresarial, Edifício 8, Quinta da Beloura, 2710-44 Sintra, Portugal

19 Novartis Farma - Produtos Farmacêuticos, S.A. - Rua do Centro Portugal Hydergine 1mg/ml 1 mg/ml Oral Drops, Solution Oral Use Empresarial, Edifício 8, Quinta da Beloura, 2710-44 Sintra, Portugal Novartis Farma - Produtos Farmacêuticos, S.A. - Rua do Centro Portugal Hydergine 3mg/ml 3 mg/ml Oral Drops, Solution Oral Use Empresarial, Edifício 8, Quinta da Beloura, 2710-44 Sintra, Portugal POLICHEM S.A. 50, Val Fleuri, L-1526, Slovak Republic Almirid 20 mg Tablet Oral Use Luxembourg POLICHEM S.A. 50, Val Fleuri, L-1526, Slovak Republic Almirid 5 mg Capsule Oral Use Luxembourg Novartis Farmacéutica, S.A., Gran Via de Spain los Corts Catalanes, número 184, 08013 Hydergina 4.5 mg Tablet Oral Use Barcelona, Spain Novartis Farmacéutica, S.A., Gran Via de Spain los Corts Catalanes, número 184, 08013 Hydergina 1 mg/ml Oral Solution Oral Use Barcelona, Spain Novartis Sverige AB, Kemistvägen 1B, Box Sweden Hydergine 1 mg Tablet Oral Use 1150, 183 11 Täby, Sweden Novartis Pharmaceuticals Ltd., Frimley United Kingdom Business Park, Frimley, Camberley, Surrey Hydergine 1.5 mg 1.5 mg Tablet Oral Use GU16 7SR, UK Novartis Pharmaceuticals Ltd., Frimley United Kingdom Business Park, Frimley, Camberley, Surrey Hydergine 4.5 mg 4.5 mg Tablet Oral Use GU16 7SR, UK

20 Lisuride containing medicinal products with Marketing Authorisation in the European Union

Member State Marketing Authorisation Holder Product name Strength Pharmaceutical Form Route of Administration BAYER GmbH, Herbststraße, 6-10, 1160 Austria Dopergin - Tabletten 0,2 mg Tablet Oral Use Wien, Austria LABO LISA pharm France 9 bis boulevard J. Jaures Arolac 0,2mg Tablet Oral Use 92100 Boulogne Billancourt, France

Bayer Schering Pharma, ZI roubaix est rue France Dopergine 0,2 mg Tablet Oral Use de touflers, 59390 Lys-les-Lannoy, France

Bayer Schering Pharma, ZI roubaix est rue France Dopergine 0,5mg Tablet Oral Use de touflers, 59390 Lys-les-Lannoy, France BAYER Vital GmbH, D-51368 Leverkusen, Germany Dopergin-0,5 mg Tablette 0.5 mg Tablet Oral Use Germany BAYER Vital GmbH, D-51368 Leverkusen, Germany Dopergin-0,2 mg Tablette 0.2 mg Tablet Oral Use Germany SCHERING SpA - Via E.Schering, 21 - Italy Dopergin 0,2 mg Tablet Oral Use 20090 Segrate (MI), Italy

SCHERING SpA - Via E.Schering, 21 - Italy Dopergin 0,5 mg Tablet Oral Use 20090 Segrate (MI), Italy

Quimica Farmaceutica Bayer, SL, Pau Dopergin 0,2 mg Spain 0,2 mg Tablet Oral Use Claris , 196, 08037 Barcelona, Spain comprimidos

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