DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

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1 DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH 1

2 Zdravila, ki vsebujejo bromokriptin, z dovoljenjem za promet z zdravili v Evropski uniji Država članica Imetnik dovoljenja za promet z zdravilom Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe zdravila MEDA PHARMA GmbH Liesinger-Flur- Gasse 2c, 1230 Wien, Austria MEDA PHARMA GmbH Liesinger-Flur- Gasse 2c, 1230 Wien, Austria MEDA PHARMA GmbH Liesinger-Flur- Gasse 2c, 1230 Wien, Austria Parlodel 5 mg - Kapseln 5 mg Kapsula Parlodel 2,5 mg - Kapseln 2,5 mg Kapsula Parlodel SRO 10 mg - Kapseln 10 mg Kapsula MEDA PHARMA GmbH Liesinger-Flur- Gasse 2c, 1230 Wien, Austria Parlodel SRO 2,5 mg - Kapseln 2,5 mg Kapsula MEDA PHARMA GmbH Liesinger-Flur- Gasse 2c, 1230 Wien, Austria MEDA PHARMA GmbH Liesinger-Flur- Gasse 2c, 1230 Wien, Austria MEDA PHARMA GmbH Liesinger-Flur- Gasse 2c, 1230 Wien, Austria MEDA PHARMA GmbH Liesinger-Flur- Gasse 2c, 1230 Wien, Austria Meda Pharma S.A. - N.V. Chaussee de la Hulpe B-1170 Brussels Meda Pharma S.A. - N.V. Chaussee de la Hulpe B-1170 Brussels Parlodel SRO 5 mg - Kapseln 5 mg Kapsula Umprel 10 mg Kapsula Umprel 5 mg Kapsula Umprel 2,5 mg Kapsula Parlodel 2.5 mg Kapsula Parlodel 10 MG 10 mg Kapsula, trda 2

3 Bolgarija Bolgarija Bolgarija Ciper Ciper Ciper Ciper Češka Češka Danska Danska Danska Meda Pharma S.A. - N.V. Chaussee de la Hulpe B-1170 Brussels MEDOCHEMIE Limited, 1-10 Constantinoupoleos Str., Zakaki, Limassol, Cyprus NOVARTIS Pharma Sofia 1164 Square "Dzhon Paul II" office centre "Bulgaria 2000", Bulgaria SOPHARMA - Sofia 1797 bul." Kliment Ohridski" 3, Bulgaria REMEDICA LTD, P.O.Box 51706, 3508 Lemesos, Cyprus CODAL SYNTO LTD, P.O.BOX 51785, 3508 Lemesos, Cyprus DEMETRIADES & PAPAELLINAS Ltd, P.O.Box 23490, 1683, Lefkosia, Cyprus MEDOCHEMIE Limited, 1-10 Constantinoupoleos Str., Zakaki, Limassol, Cyprus MEDA PHARMA s.r.o., Záhřebská, 577, , Praha 2, Czech Republic MEDOCHEMIE Limited, 1-10 Constantinoupoleos Str., Zakaki, Limassol, Cyprus MEDA AS, Solvang 8, DK-3450 Allerød, Denmark MEDA AS, Solvang 8, DK-3450 Allerød, Denmark MEDA AS, Solvang 8, DK-3450 Allerød, Denmark Parlodel 5 mg 5 mg Kapsula, trda Medocriptine 2.5 mg Tableta Parlodel 2.5 mg Tableta Bromocriptine Sopharma 2.5 mg Tableta Brameston 2.5 mg Tableta Pirodal 2.5 mg Tableta Parlodel 2.5 mg Tableta Medocriptine 2.5 mg Tableta Parlodel 2.87 mg Tableta Medocriptine 2.87 mg Tableta Parlodel 5 mg Kapsula, trda Parlodel 10 mg Kapsula, trda 3

4 Estonija Estonija Finska Finska Finska Finska Finska GEDEON RICHTER, Gyömröi út 19-21, Budapest, HU-1103, Hungary NOVARTIS Finland Oy, Metsanneidonkuja 10 Fin ESPOO, Finland MEDA OY Lemminkäisenkatu Turku Finland MEDA OY Lemminkäisenkatu Turku Finland MEDA OY Lemminkäisenkatu Turku Finland MEDA OY Lemminkäisenkatu Turku Finland MEDA OY Lemminkäisenkatu Turku Finland MEDA PHARMA 25 boulevard de l'amiral Bruix Paris, France MEDA PHARMA 25 boulevard de l'amiral Bruix Paris, France MEDA PHARMA 25 boulevard de l'amiral Bruix Paris, France SANOFI-AVENTIS 1/13 boulevard Romain Rolland Paris, France SANOFI-AVENTIS 1/13 boulevard Romain Rolland Paris, France SANOFI-AVENTIS 1/13 boulevard Romain Rolland Paris, France Promocriptin-Richter 2,5 mg Tableta Parlodel 10 mg Kapsula, trda Parlodel 5 mg Kapsula, trda Parlodel 10 mg Kapsula, trda Parlodel 5 mg Kapsula, trda Parlodel 5 mg Kapsula Parlodel 10 mg Kapsula Bromocriptine Winthrop 2,5 mg Tableta Bromokin 2,5 mg Tableta 4

5 SANOFI-AVENTIS 1/13 boulevard Romain Rolland Paris, France SANOFI-AVENTIS 1/13 boulevard Romain Rolland Paris, France SANOFI-AVENTIS 1/13 boulevard Romain Rolland Paris, France SANOFI-AVENTIS 1/13 boulevard Romain Rolland Paris, France SANOFI-AVENTIS 1/13 boulevard Romain Rolland Paris, France MEDA PHARMA GmbH & Co. KG, Benzstr. 1, D Bad Homburg, Germany MEDA PHARMA GmbH & Co. KG, Benzstr. 1, D Bad Homburg, Germany MEDA PHARMA GmbH & Co. KG, Benzstr. 1, D Bad Homburg, Germany AbZ-PHARMA Graf-Arco-Str. 3 D Ulm, Germany BETAPHARM Arzneimittel GmbH; Kobelweg 95; D Augsburg, Germany BETAPHARM Arzneimittel GmbH; Kobelweg 95; D Augsburg, Germany Bromocriptine Winthrop Bromocriptine Winthrop 5 mg Kapsula 10 mg Kapsula Bromokin 5 mg Kapsula Bromokin 10 mg Kapsula Bromo-kin 2,5 mg Tableta Pravidel 10 mg Kapseln mg Kapsula, trda Pravidel 5 mg Kapseln mg Kapsula, trda Pravidel 2,5 mg Tabletten 2.87 mg Tableta Bromocriptin AbZ 2,5mg Tabletten 2.87 mg Tableta Bromocriptin beta mg Kapsula, trda Bromocriptin beta 2, mg Tableta 5

6 CT-ARZNEIMITTEL GmbH Lengeder Str. 42a D Berlin, Germany CT-ARZNEIMITTEL GmbH Lengeder Str. 42a D Berlin, Germany CT-ARZNEIMITTEL GmbH Lengeder Str. 42a D Berlin, Germany bromocriptin-ct 5mg Hartkapseln bromocriptin-ct 2,5 mg Tabletten bromocriptin-ct 10mg Hartkapseln mg Kapsula, trda 2.87 mg Tableta mg Kapsula, trda HEXAL AG, Industriestrasse 25,Holzkirchen, D-83607, Germany Bromocriptin Hexal 10 mg Kapseln mg Kapsula, trda HEXAL AG, Industriestrasse 25,Holzkirchen, D-83607, Germany Kamilium 10 Kps mg Kapsula, trda HEXAL AG, Industriestrasse 25,Holzkirchen, D-83607, Germany Bromocriptin Hexal 5 mg Kapseln mg Kapsula, trda HEXAL AG, Industriestrasse 25,Holzkirchen, D-83607, Germany Bromoxal 5 mg mg Kapsula, trda HEXAL AG, Industriestrasse 25,Holzkirchen, D-83607, Germany Bromocriptin Hexal 5 mg Kapseln mg Kapsula, trda HEXAL AG, Industriestrasse 25,Holzkirchen, D-83607, Germany HEXAL AG, Industriestrasse 25,Holzkirchen, D-83607, Germany Bromolakt 5 mg mg Kapsula Bromoktin 5 mg mg Kapsula HEXAL AG, Industriestrasse 25,Holzkirchen, D-83607, Germany Bromocriptin Hexal 2,5 mg Tabletten 2.87 mg Tableta 6

7 HORMOSAN PHARMA GmbH Postfach D Frankfurt, Germany HORMOSAN PHARMA GmbH Postfach D Frankfurt, Germany TAURUS PHARMA GmbH Benzstr. 11 D Bad Homburg, Germany Kirim 5 T 5.74 mg Tableta Kirim 2, mg Tableta Kirim gyn 2.87 mg Tableta RATIOPHARM Graf-Arco-Strasse 3, DE Ulm, Germany Bromocriptin-ratiopharm 10mg Hartkapseln mg Kapsula, trda RATIOPHARM Graf-Arco-Strasse 3, DE Ulm, Germany Bromocriptin-ratiopharm 5mg Hartkapseln mg Kapsula, trda RATIOPHARM Graf-Arco-Strasse 3, DE Ulm, Germany Bromocriptin-ratiopharm 2,5mg Tabletten 2.87 mg Tableta Grčija Grčija SANDOZ Pharmaceuticals GmbH, Raiffeisenstr. 1, D Holzkirchen, Germany SANDOZ Pharmaceuticals GmbH, Raiffeisenstr. 1, D Holzkirchen, Germany MEDA PHARMACEUTICALS S.A. Greece, 3 Evritanias Street, Halandri Attikis 15231, Greece MEDA PHARMACEUTICALS S.A. Greece, 3 Evritanias Street, Halandri Attikis 15231, Greece Bromocriptin Sandoz 10mg Hartkapseln Bromocriptin Sandoz 5mg Hartkapseln mg Kapsula, trda mg Kapsula, trda Parlodel 5 mg Kapsula, trda Parlodel 10 mg Kapsula, trda 7

8 Madžarska Islandija Islandija Islandija Irska Irska Italija Italija Italija Italija Latvija Latvija Latvija GEDEON RICHTER, Gyömröi út 19-21, Budapest, HU-1103, Hungary ICEPHARMA hf., Lynghálsi 13, 110 Reykjavík, Iceland ICEPHARMA hf., Lynghálsi 13, 110 Reykjavík, Iceland ICEPHARMA hf., Lynghálsi 13, 110 Reykjavík, Iceland MEDA Health Sales Ireland Ltd, Office 10 Dunboyne Business Park, Dunboyne, Co. Meath, Ireland MEDA Health Sales Ireland Ltd, Office 10 Dunboyne Business Park, Dunboyne, Co. Meath, Ireland MEDA PHARMA SpA - Via Le Brenta, , Milano, Italy MEDA PHARMA SpA - Via Le Brenta, , Milano, Italy DOROM Srl - VIA Giulio Richard 7 - MILANO (IT), Italy DOROM Srl - VIA Giulio Richard 7 - MILANO (IT), Italy LEK PHARMACEUTICALS Pr.d.d., Verovškova 57, SI-1000, Ljubljana, Slovenia GEDEON RICHTER, Gyömröi út 19-21, Budapest, HU-1103, Hungary NOVARTIS Finland Oy, Metsanneidonkuja 10 Fin ESPOO, Finland Bromocriptine-Richter 2.5 mg Tableta Parlodel 5 mg Kapsula, trda Parlodel 10 mg Kapsula, trda Parlodel 2.5 mg Tableta Parlodel 5 mg Kapsula Parlodel 10 mg Kapsula Parlodel 5 mg Kapsula Bromocriptina Dorom 10 mg Kapsula Bromocriptina Dorom 5 mg Kapsula Bromergon 2,5 mg Tableta Bromocriptin-Richter 2,5 mg Tableta 8

9 Litva Litva Litva Luksemburg Luksemburg Luksemburg Nizozemska Nizozemska Nizozemska Poljska Poljska GEDEON RICHTER, Gyömröi út 19-21, Budapest, HU-1103, Hungary NOVARTIS Finland Oy, Metsanneidonkuja 10 Fin ESPOO, Finland POLI INDUSTRIA chimica S.p.A. Via Volturno 45/48-Quinto de Stampi Rozzano Milano, Italy MEDA PHARMA GmbH, Benestrasse 1, D BAD Hambourg, Germany MEDA PHARMA GmbH, Benestrasse 1, D BAD Hambourg, Germany MEDA PHARMA GmbH, Benestrasse 1, D BAD Hambourg, Germany MEDA PHARMA B.V. Krijgsman 20, 1186 DM AMSTELVEEN/NL, Netherlands MEDA PHARMA B.V. Krijgsman 20, 1186 DM AMSTELVEEN/NL, Netherlands MEDA PHARMA B.V. Krijgsman 20, 1186 DM AMSTELVEEN/NL, Netherlands LEK S.A., ul. Podlipie 16, Stryków, Poland FILOFARM, Farmaceutyczna Spółdzielnia Pracy "Filofarm", ul. Pułaskiego 39, Bydgoszcz, Poland Bromocriptin-Richter 2,5 mg Tableta Bromocriptine Poli 2,5 mg Tableta Pravidel 2.5 mg Tableta Pravidel 5 mg Kapsula Pravidel 10 mg Kapsula Parlodel 10 mg 10 mg Kapsula Parlodel 2.5 mg 2.5 mg Tableta Parlodel 5 mg 5 mg Tableta Bromergon 2,5 mg Tableta Bromocorn 2,87 mg Tableta 9

10 Poljska Poljska Portugalska Portugalska Portugalska Meda Aktiebolag - Pipers vag 2, Box SE Solana - Sweden POLFA, Grodziskie Zakłady Farmaceutyczne POLFA Sp. z o.o., ul. Poniatowskiego 5, Grodzisk Mazowiecki, Poland MEDA PHARMA - Produtos Farmacêuticos, S.A.Rua do Centro Cultural, Lisboa, Portugal MEDA PHARMA - Produtos Farmacêuticos, S.A.Rua do Centro Cultural, Lisboa, Portugal MEDA PHARMA - Produtos Farmacêuticos, S.A.Rua do Centro Cultural, Lisboa, Portugal Ergolaktyna 2,5 mg Tableta Parlodel 5 mg Kapsula Parlodel 10 mg Kapsula Portugalska GENERIS Farmacêutica, S.A. Office Park da Beloura - Edifício 4 - Quinta da Beloura Sintra Portugal Bromocriptina Generis 2,5 mg Comprimidos 2,5 mg Tableta Romunija Slovaška Slovaška S.C. BIOFARM S.A., Str. Logofat Tautu nr. 99, sector 3, Bucharest, Romania MEDA PHARMA s.r.o., Záhřebská, 577, , Praha 2, Czech Republic MEDOCHEMIE Limited, 1-10 Constantinoupoleos Str., Zakaki, Limassol, Cyprus Brocriptin 2.5mg Tableta Medocriptine 2,5 mg 2,5 mg Tableta 10

11 Slovenija Španija Španija Švedska Švedska Švedska Združeno kraljestvo Združeno kraljestvo Združeno kraljestvo LEK farmacevtska družba, d.d., Verovškova 57, 1000 Ljubljana, Slovenia MEDA PHARMA SAU AVDA Castilla, 2 Edif Berlin 2º planta, parque empresarial San Fernando de Henares, Spain MEDA PHARMA SAU AVDA Castilla, 2 Edif Berlin 2º planta, parque empresarial San Fernando de Henares, Spain MEDA AB, Box 906, , Solna Sweden MEDA AB, Box 906, , Solna Sweden MEDA AB, Box 906, , Solna Sweden MEDA PHARMACEUTICALS LIMITED; Building 2000, Beach Drive, Cambridge Research Park, Waterbeach, Cambridgeshire, CB5 9PD, UK MEDA PHARMACEUTICALS LIMITED; Building 2000, Beach Drive, Cambridge Research Park, Waterbeach, Cambridgeshire, CB5 9PD, UK MEDA PHARMACEUTICALS LIMITED; Building 2000, Beach Drive, Cambridge Research Park, Waterbeach, Cambridgeshire, CB5 9PD, UK Bromergon 2,5 mg Tableta Parlodel 2,5 mg Comprimidos 2,5 mg Tableta Parlodel 5 mg Capsulas 5 mg Kapsula Pravidel 2,5 mg Tableta Pravidel 5 mg Kapsula, trda Pravidel 10 mg Kapsula, trda Parlodel 2.5 mg Tablets 5 mg Tableta Parlodel 2.5 mg Tablets 10 mg Tableta Parlodel 2.5 mg Tablets 2.5 mg Tableta 11

12 Združeno kraljestvo MEDA PHARMACEUTICALS LIMITED; Building 2000, Beach Drive, Cambridge Research Park, Waterbeach, Cambridgeshire, CB5 9PD, UK Parlodel 1 mg Tablets 1 mg Tableta Združeno kraljestvo NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK Bromocriptine Tablets BP 2.5 mg 2.5 mg Tableta Združeno kraljestvo GENERICS (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL, UK Bromocriptine Tablets BP 2.5 mg 2.5 mg Tableta Združeno kraljestvo Združeno kraljestvo NOVARTIS PHARMACEUTICALS UK LIMITED, Frimley Business Park, Frimley, Camberley, Surrey, United Kingdom, GU16 7SR, NOVARTIS PHARMACEUTICALS UK LIMITED, Frimley Business Park, Frimley, Camberley, Surrey, United Kingdom, GU16 7SR, Parlodel LAR Injection 50 mg Parlodel LAR Injection 100 mg 50 mg 100 mg Prašek za raztopino za injiciranje Prašek za raztopino za injiciranje intramuskularna uporaba intramuskularna uporaba 12

13 Zdravila, ki vsebujejo dihidroergokriptin, z dovoljenjem za promet z zdravili v Evropski uniji Member State Marketing Authorisation Holder Product name Strength Pharmaceutical Form Route of Administration RATIOPHARM Arzneimittel Vertriebs- GmbH, Albert-Schweitzer Gasse Wien, Austria RATIOPHARM Arzneimittel Vertriebs- GmbH, Albert-Schweitzer Gasse Wien, Austria SANOVA Pharma GmbH, Haidestraße 4, 1110 Wien, Austria Hydergin - Fas 4,5 mg - Filmtabletten 4,5 mg Tableta Hydergin 1 mg/ml - Tropfen 1 mg/ml Peroralne kapljice Hydergin 3 mg/ml - Tropfen 3 mg/ml Peroralne kapljice Hydergin 1 mg - Tabletten 1 mg Tableta Hydergin 2 mg - Tabletten 2 mg Tableta Hydergin 0,3 mg/1 ml Ampullen 0,3 mg/1 m Raztopina za injiciranje Intravenska uporaba Hydergin SRO 6 mg - Kapseln 6 mg Kapsula Co-Dergocrin "ratiopharm" retard 5 mg - Kapseln Co-Dergocrin "ratiopharm" retard 2,5 mg - Kapseln 5 mg Kapsula 2,5 mg Kapsula Dorehydrin 1 mg/ml - Tropfen 1 mg/ml Peroralne kapljice 13

14 SANOVA Pharma GmbH, Haidestraße 4, 1110 Wien, Austria SANOVA Pharma GmbH, Haidestraße 4, 1110 Wien, Austria WABOSAN Arzneimittelvertriebs GmbH Anton Anderer Platz 6/1, 1210 Wien, Austria WABOSAN Arzneimittelvertriebs GmbH Anton Anderer Platz 6/1, 1210 Wien, Austria WABOSAN Arzneimittelvertriebs GmbH Anton Anderer Platz 6/1, 1210 Wien, Austria NOVARTIS PHARMA nv. Medialaan Vilvoorde, Belgium NOVARTIS PHARMA nv. Medialaan Vilvoorde, Belgium NOVARTIS PHARMA nv. Medialaan Vilvoorde, Belgium NOVARTIS PHARMA nv. Medialaan Vilvoorde, Belgium LABORATOIRES PHARMACOBEL Avenue de Seheut, Bruxelles, Belgium NYCOMED BELGIUM Gentsesteenweg Brussel, Belgium NYCOMED BELGIUM Gentsesteenweg Brussel, Belgium Dorehydrin retard 2,5 mg - Kapseln Dorehydrin retard 4,5 mg - Kapseln 2,5 mg Kapsula 4,5 mg Kapsula Ergomed retard- Kapseln 0,875 mg Kapsula Ergomed - Tabletten 0,33 mg Tableta Ergomed - Tropfen 0,33 mg/ml Peroralne kapljice Hydergine 1 mg / ml Peroralne kapljice, raztopina Hydergine 1,5 mg 1.5 mg Tableta Hydergine 4.5 mg 4.5 mg Tableta Hydergine FAS 4.5 mg 4.5 mg Gastrorezistentna tableta Dystonal 2,5 mg (N.F.) 2.5 mg Tableta Stofilan 1.5 mg Tableta Stofilan 1 mg / ml Peroralna raztopina 14

15 Bolgarija Bolgarija NYCOMED BELGIUM Gentsesteenweg Brussel, Belgium SANDIPRO s.a. chaussée de Gand, Bruxelles, Belgium SANDIPRO s.a. chaussée de Gand, Bruxelles, Belgium SANDIPRO s.a. chaussée de Gand, Bruxelles, Belgium SANDIPRO s.a. chaussée de Gand, Bruxelles, Belgium POLI INDUSTRIA chimica S.p.A., Via Volturno 45/48-Quinto de Stampi Rozzano Milano, Italy POLI INDUSTRIA chimica S.p.A., Via Volturno 45/48-Quinto de Stampi Rozzano Milano, Italy Stofilan 4.5 mg Tableta IBEXONE 1.5 mg 1.5 mg Tableta IBEXONE 1 mg / ml Peroralna raztopina IBEXONE 4.5 mg 4.5 mg Tableta IBEXONE 3 mg / ml Peroralna raztopina Almirid 5 5 mg Kapsula, trda Almirid 5 20 mg Tableta Češka Češka Finska Finska Novartis Finland Oy Metsänneidonkuja 10, ESPOO Novartis Finland Oy Metsänneidonkuja 10, ESPOO Almirid 20 mg Tableta Almirid 5 mg Kapsula, trda Hydergin 1mg Tableta Hydergin 1.5mg Tableta 15

16 Novartis Pharma SAS, 2 & 4 Rue Lionel Terray Rueil Malmaison Cedex, France Novartis Pharma SAS, 2 & 4 Rue Lionel Terray Rueil Malmaison Cedex, France Novartis Pharma SAS, 2 & 4 Rue Lionel Terray Rueil Malmaison Cedex, France DESITIN ARZNEIMITTEL GmbH Postfach D Hamburg, Germany DESITIN ARZNEIMITTEL GmbH Postfach D Hamburg, Germany DESITIN ARZNEIMITTEL GmbH Postfach D Hamburg, Germany TAURUS PHARMA GmbH Benzstr. 11 D Bad Homburg, Germany TAURUS PHARMA GmbH Benzstr. 11 D Bad Homburg, Germany TAURUS PHARMA GmbH Benzstr. 11 D Bad Homburg, Germany Hydergine 0.3 mg/1ml Raztopina za injiciranje Hydergine 1 mg/1ml Peroralna raztopina Hydergine 4.5 mg Tableta Almirid 20 mg Tableta Almirid 40 mg Tableta Almirid 5 mg Kapsula Cripar mg Tableta Cripar forte mg Tableta Cripar 5 5 mg Kapsula Hydergin 1mg/ml Tropfloesung mg Peroralne kapljice, raztopina Hydergin forte 2mg Tabletten mg Tableta 16

17 DESITIN ARZNEIMITTEL GmbH Postfach D Hamburg, Germany DESITIN ARZNEIMITTEL GmbH Postfach D Hamburg, Germany OPFERMANN ARZNEIMITTEL GmbH Opfermann Arzneimittel GmbH Robert-Koch-Str. 2 D Wiehl, Germany OPFERMANN ARZNEIMITTEL GmbH Opfermann Arzneimittel GmbH Robert-Koch-Str. 2 D Wiehl, Germany OPFERMANN ARZNEIMITTEL GmbH Opfermann Arzneimittel GmbH Robert-Koch-Str. 2 D Wiehl, Germany Hydergin forte 2mg/ml Tropfloesung 0.67 mg Peroralne kapljice, raztopina Hydergin Spezial 1.33 mg Filmsko obložena tableta Ergodesit forte 2 mg 0.66 mg Tableta Ergodesit spezial 5 mg 1.66 mg Tableta s podaljšanim sproščanjem Orphol forte 3 mg/ml 1. mg Peroralna raztopina Orphol Spezial 1.5 mg Tableta Orphol Brausetabletten 1.5 mg Šumeča tableta Amdipharm Limited Temple Chambers 3 Burlington Road IRL-Dublin 4, Ireland DCCK Tropfloesung 1 mg Kapsula s podaljšanim sproščanjem, trda 17

18 Amdipharm Limited Temple Chambers 3 Burlington Road IRL-Dublin 4, Ireland DCCK Depot 4,5 1.5 mg Kapsula s podaljšanim sproščanjem, trda Grčija Grčija Grčija Madžarska Madžarska Irska Irska FARMASAN Arzneimittel GmbH & Co.KG, Postfach D Karlsruhe, Germany FARMASAN Arzneimittel GmbH & Co.KG, Postfach D Karlsruhe, Germany RATIOPHARM Graf-Arco-Strasse 3, DE Ulm, Germany RATIOPHARM Graf-Arco-Strasse 3, DE Ulm, Germany RATIOPHARM Graf-Arco-Strasse 3, DE Ulm, Germany PHARMANEL PHARMACEUTICALS S.A., Marathonos 106, Gerakas 15344, Greece PHARMANEL PHARMACEUTICALS S.A., Marathonos 106, Gerakas 15344, Greece Novartis (Hellas) S.A.C.I., 12 Klm National Road No 1, GR-14451, Athens, Greece Sponsin forte Sponsin spezial Hydro-Cebral-ratiopharm Tropfen Hydro-Cebral-ratiopharm 2,5 mg Hydro-Cebral-ratiopharm 5,0 mg mg 1.5 mg Kapsula s podaljšanim sproščanjem, trda Kapsula s podaljšanim sproščanjem, trda 0.33 mg Peroralna raztopina mg mg Kapsula s podaljšanim sproščanjem, trda Kapsula s podaljšanim sproščanjem, trda Daverium 5 mg Kapsula, trda Daverium 20 mg Tableta Hydergine LPD 0.1% 15 ml Peroralna raztopina Almirid 20mg Tableta Almirid 5mg Kapsula Almirid 5mg Kapsula Almirid 20 mg Tableta 18

19 Italija Italija Italija MARVECSPHARMA SERVICES Srl - Via Felice Casati, Milano, Italy Novartis Farma S.P.A. Largo Umberto Boccioni Origgio Varese, Italy Novartis Farma S.P.A. Largo Umberto Boccioni Origgio Varese, Italy Daverium 20 mg Tableta Hydergina 1 mg Peroralna raztopina Hydergina 1.5 mg Tableta Luksemburg NOVARTIS Pharma GmbH Roonstrasse 25, D Nurnberg, Germany Hydergin 1mg/ml Tropfloesung mg Peroralne kapljice, raztopina Luksemburg NOVARTIS Pharma GmbH Roonstrasse 25, D Nurnberg, Germany Hydergin forte 2mg/ml Tropfloesung 0.67 mg Peroralne kapljice, raztopina Luksemburg Nizozemska Poljska Portugalska Portugalska Portugalska Portugalska NOVARTIS Pharma GmbH Roonstrasse 25, D Nurnberg, Germany CENTRAFARM SERVICES B.V.; Nieuwe Donk 9; 4879 AC ETTEN- LEUR/NL, Netherlands Novartis Farma - Produtos Farmacêuticos, S.A. - Rua do Centro Empresarial, Edifício 8, Quinta da Beloura, Sintra, Portugal Novartis Farma - Produtos Farmacêuticos, S.A. - Rua do Centro Empresarial, Edifício 8, Quinta da Beloura, Sintra, Portugal Hydergin Spezial 1.33 mg Filmsko obložena tableta Co-dergocrinemesilaat 1.5 mg Tableta Almirid 20 mg Tableta Cripar mg Tableta Cripar 5 5 mg Kapsula Hydergine 1.5 mg 1.5 mg Tableta Hydergine 4.5 mg 4.5 mg Tableta 19

20 Portugalska Portugalska Slovaška Slovaška Španija Španija Švedska Združeno kraljestvo Združeno kraljestvo Novartis Farma - Produtos Farmacêuticos, S.A. - Rua do Centro Empresarial, Edifício 8, Quinta da Beloura, Sintra, Portugal Novartis Farma - Produtos Farmacêuticos, S.A. - Rua do Centro Empresarial, Edifício 8, Quinta da Beloura, Sintra, Portugal Novartis Farmacéutica, S.A., Gran Via de los Corts Catalanes, número 184, Barcelona, Spain Novartis Farmacéutica, S.A., Gran Via de los Corts Catalanes, número 184, Barcelona, Spain Novartis Sverige AB, Kemistvägen 1B, Box 1150, Täby, Sweden Novartis Pharmaceuticals Ltd., Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, UK Novartis Pharmaceuticals Ltd., Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, UK Hydergine 1mg/ml Hydergine 3mg/ml 1 mg/ml 3 mg/ml Peroralne kapljice, raztopina Peroralne kapljice, raztopina Almirid 20 mg Tableta Almirid 5 mg Kapsula Hydergina 4.5 mg Tableta Hydergina 1 mg/ml Peroralna raztopina Hydergine 1 mg Tableta Hydergine 1.5 mg 1.5 mg Tableta Hydergine 4.5 mg 4.5 mg Tableta 20

21 Zdravila, ki vsebujejo lizurid, z dovoljenjem za promet z zdravili v Evropski uniji Member State Marketing Authorisation Holder Product name Strength Pharmaceutical Form Route of Administration Italija Italija BAYER GmbH, Herbststraße, 6-10, 1160 Wien, Austria LABO LISA pharm 9 bis boulevard J. Jaures Boulogne Billancourt, France Bayer Schering Pharma, ZI roubaix est rue de touflers, Lys-les-Lannoy, France Bayer Schering Pharma, ZI roubaix est rue de touflers, Lys-les-Lannoy, France BAYER Vital GmbH, D Leverkusen, Germany BAYER Vital GmbH, D Leverkusen, Germany SCHERING SpA - Via E.Schering, Segrate (MI), Italy SCHERING SpA - Via E.Schering, Segrate (MI), Italy Dopergin - Tabletten 0,2 mg Tableta Arolac 0,2mg Tableta Dopergine 0,2 mg Tableta Dopergine 0,5mg Tableta Dopergin-0,5 mg Tablette 0.5 mg Tableta Dopergin-0,2 mg Tablette 0.2 mg Tableta Dopergin 0,2 mg Tableta Dopergin 0,5 mg Tableta Španija Quimica Farmaceutica Bayer, SL, Pau Claris, 196, Barcelona, Spain Dopergin 0,2 mg comprimidos 0,2 mg Tableta 21