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Annex I List of the Names, Pharmaceutical Forms

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Annex I List of the Names, Pharmaceutical Forms 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 NOVARTIS 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 Budapest, HU-1103, Hungary 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 boulevard 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 Berlin, 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.
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