VEDLEGG I LISTE OVER NAVN, LEGEMIDDELFORM(ER), LEGEMIDDELSTYRKE(R), ADMINISTRASJONSMÅTE(R), INNEHAVER(E) AV MARKEDSFØRINGSTILLATELSEN I MEDLEMSLANDENE

Transkript

1 VEDLEGG I LISTE OVER NAVN, LEGEMIDDELFORM(ER), LEGEMIDDELSTYRKE(R), ADMINISTRASJONSMÅTE(R), INNEHAVER(E) AV MARKEDSFØRINGSTILLATELSEN I MEDLEMSLANDENE 1

2 Østerrike Hexal Pharma GmbH Stella-Klein-Löw-Weg Wien Austria Metogastron 10 mg - Ampullen 10mg/2ml Østerrike Hexal Pharma GmbH Stella-Klein-Löw-Weg Wien Austria Metogastron 4 mg/ml - Tropfen 4mg/ml Munndråper, Oral bruk Østerrike Abbott Products GmbH Perfektastraße 84A 1230 Wien Austria Paspertin - Filmtabletten 10mg Filmdrasjerte tabletter Oral bruk Østerrike Østerrike Abbott Products GmbH Perfektastraße 84A 1230 Wien Austria Abbott Products GmbH Perfektastraße 84A 1230 Wien Austria Paspertin 10 mg - Ampullen 10mg/2ml Paspertin 50 mg - Konzentrat zur Infusionsbereitung 50mg/10ml Konsentrat til infusjonsvæske, Østerrike Abbott Products GmbH Perfektastraße 84A 1230 Wien Austria Paspertin 4 mg/ml - Tropfen 4mg/ml Munndråper, Oral bruk 2

3 Belgia Belgia Belgia Belgia Belgia Belgia Sanofi-Aventis Belgium N.V. Culliganlaan 1 C 1831 Diegem Belgium Sanofi-Aventis Belgium N.V. Culliganlaan 1 C 1831 Diegem Belgium Sanofi-Aventis Belgium N.V. Culliganlaan 1 C 1831 Diegem Belgium Sanofi-Aventis Belgium N.V. Culliganlaan 1 C 1831 Diegem Belgium Takeda Belgium Gentsesteenweg Brussel Belgium Takeda Belgium Gentsesteenweg Brussel Belgium Primperan 10mg Tablett Oral bruk Primperan 1mg/ml Mikstur, Oral bruk Primperan 10mg/2ml Primperan 20 mg 20mg Stikkpille Rektal bruk Dibertil 5mg Kapsel, myk Oral bruk Dibertil 10mg Kapsel, myk Oral bruk 3

4 Bulgaria Sopharma PLC 16 Iliensko Shosse Str. Sofia 1220 Bulgaria Antiemetin 5mg/ml Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Sopharma PLC 16 Iliensko Shosse Str. Sofia 1220 Bulgaria AWD.pharma GmbH&Co.KG Wasastrasse 50 Radebeul Lek Pharmaceuticals d.d. Verovskova 57 Ljubljana 1526 Slovenia Lek Pharmaceuticals d.d. Verovskova 57 Ljubljana 1526 Slovenia CSC Pharmaceuticals Ltd. 10 Assen Yordanov str. Sofia 1592 Bulgaria Antiemetin 5mg/ml Mikstur Oral bruk Cerucal 10mg Tablett Oral bruk Degan 10mg/2ml Degan 10mg Tablett Oral bruk Pramidin mg/spray Nesespray, Nasal bruk 4

5 Bulgaria Bulgaria CSC Pharmaceuticals Ltd. 10 Assen Yordanov str. Sofia 1592 Bulgaria Alkaloid Ltd 2 Ricardo Vakarini str. Sofia 1404 Bulgaria Pramidin mg/spray Nesespray, Nasal bruk Reglan 10mg Tablett Oral bruk Kypros Sanofi Aventis Cyprus ltd Charalambou Mouskou Strovolos Nicosia Cyprus Primperan for adults suppository 20mg 20mg Stikkpille Rektal bruk Kypros Sanofi Aventis Cyprus ltd Charalambou Mouskou Strovolos Nicosia Cyprus Primperan solution for injection 10mg/2ml 10mg/2ml Kypros Sanofi Aventis Cyprus ltd Charalambou Mouskou Strovolos Nicosia Cyprus Primperan tablets 10mg 10mg Tablett Oral bruk Kypros Medochemie ltd 1-10 Constantinoupoleos street P.O.BOX Lemesos Cyprus Elitan tablets 10mg 10mg Tablett Oral bruk 5

6 Kypros Kypros Kypros Tsjekkia Medochemie ltd 1-10 Constantinoupoleos street P.O.BOX Lemesos Cyprus Remedica ltd Aharnon street P.O.Box Lemesos Cyprus Accord Healthcare Ltd Sage House 319 Pinner Road North Harrow Middlesex HA1 4HF Lek Pharmaceuticals d.d. Verovškova Ljubljana Slovenia Elitan injection 10mg/2ml 10mg/2ml Injeksjonsvæske Cloperan tablets 10mg 10mg Tablett Oral bruk Metoclopramide Accord 10 mg tablet 10mg Tablett Oral bruk Degan 10 mg tablety 10mg Tablett Oral bruk Tsjekkia Lek Pharmaceuticals d.d. Verovškova Ljubljana Slovenia Degan 10 mg roztok pro injekci 5mg/ml Tsjekkia Hexal AG Industriestrasse Holzkirchen Mcp hexal 10 10mg Tablett Oral bruk 6

7 Tsjekkia Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c Prague Czech Republic Cerucal 10mg Tablett Oral bruk Tsjekkia Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c Prague Czech Republic Cerucal 5mg/ml Danmark Sanofi-aventis Denmark A/S Slotsmarken 13 DK-2970 Hørsholm Denmark Primperan 10mg/2ml Danmark Danmark Sanofi-aventis Denmark A/S Slotsmarken 13 DK-2970 Hørsholm Denmark Orion Corporation Orionintie 1A FI Espoo Finland Primperan 20mg Stikkpille Rektal bruk Emperal 10mg Tablett Oral bruk Danmark Temmler Pharma GmbH & Co KG, Temmlerstrasse 2 DE Marburg Gasto-Timelets 30mg Depotkapsel, hard Oral bruk 7

8 Estland Teva Pharma B.V. Computerweg DR Utrecht The Netherlands CERUCAL 10mg Tablett Oral bruk Finland sanofi-aventis Oy Huopalahdentie Helsinki Finland Primperan 20mg Stikkpille Rektal bruk Finland sanofi-aventis Oy Huopalahdentie Helsinki Finland Primperan 10mg Tablett Oral bruk Finland sanofi-aventis Oy Huopalahdentie Helsinki Finland Primperan 10mg/2ml Frankrike Sanofi Aventis France 1-13, boulevard Romain Rolland Paris France PRIMPERAN 10 mg, comprimé sécable 10mg Tablett Oral bruk Frankrike Sanofi Aventis France 1-13, boulevard Romain Rolland Paris France PRIMPERAN 10 mg, suppositoire sécable 10mg Stikkpille Rektal bruk 8

9 Frankrike Sanofi Aventis France 1-13, boulevard Romain Rolland Paris France PRIMPERAN 20 mg, suppositoire 20mg Stikkpille Rektal bruk Frankrike Sanofi Aventis France 1-13, boulevard Romain Rolland Paris France PRIMPERAN ENFANTS 2,6 mg/ml, solution buvable 2,6mg/ml Mikstur, Oral bruk Frankrike Sanofi Aventis France 1-13, boulevard Romain Rolland Paris France PRIMPERAN NOURRISSONS ET ENFANTS 2,6 mg/ml, solution buvable 2,6mg/ml Munndråper, Oral bruk Frankrike Sanofi Aventis France 1-13, boulevard Romain Rolland Paris France PRIMPERAN 0,1% ADULTES, solution buvable édulcorée au cyclamate de sodium et à la saccharine sodique 0.10% Munndråper, Oral bruk Frankrike Sanofi Aventis France 1-13, boulevard Romain Rolland Paris France PRIMPERAN 0,1%, solution buvable édulcorée à la saccharine sodique 0.10% Mikstur, Oral bruk Frankrike Sanofi Aventis France 1-13, boulevard Romain Rolland Paris France PRIMPERAN 10 mg/2 ml, solution injectable en ampoule 10mg/2ml 9

10 Frankrike Sanofi Aventis France 1-13, boulevard Romain Rolland Paris France PRIMPERAN 100 mg, solution injectable 100mg/5ml Frankrike Laboratoire Renaudin Z A. Errobi Itxassou Cambo les Bains France CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN 10 mg/2 ml, solution injectable en ampoule 10mg/2ml Frankrike Laboratoire Renaudin Z A. Errobi Itxassou Cambo les Bains France CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN 20 mg/ml, solution injectable 20mg/ml Frankrike Panpharma ZI du Clairay Luitré Fougères France DICHLORHYDRATE DE METOCLOPRAMIDE PANPHARMA 100 mg/5 ml, solution injectable (IM, IV) en ampoule 100mg/100 ml Frankrike Laboratoires Richard rue du Progrès ZI des Reys de Saulce Saulce sur Rhone France CHLORHYDRATE DE METOCLOPRAMIDE RICHARD 1 mg/ml, solution buvable 1mg/ml Mikstur, Oral bruk Frankrike Mylan SAS 117, allée des Parcs Saint-Priest France METOCLOPRAMIDE MYLAN 10 mg, comprimé sécable 10mg Tablett Oral bruk 10

11 Frankrike Sandoz 49, avenue Georges Pompidou Levallois-Perret France METOCLOPRAMIDE SANDOZ 10 mg, comprimé sécable 10mg Tablett Oral bruk Frankrike Meda Pharma France 25, boulevard de l'amiral Bruix Paris France ANAUSIN METOCLOPRAMIDE 15 mg, comprimé à libération prolongée 15mg Depottablett Oral bruk Frankrike Techni-Pharma 7, rue de l'industrie BP Monaco Cedex Monaco PROKINYL L.P. 15 mg, gélule à libération prolongée 15mg Depotkapsel, hard Oral bruk 1 A Pharma GmbH Keltenring D Oberhaching MCP Tropfen-1 A-Pharma 4.21mg/1g Mikstur, Oral bruk Abbott Arzneimittel GmbH Freundallee 9A Hannover Paspertin 10mg/2ml Ampullen 10mg/2ml Abbott Arzneimittel GmbH Freundallee 9A Hannover Paspertin 50mg/10ml Ampullen 50mg/10ml Konsentrat til infusjonsvæske, 11

12 Abbott Arzneimittel GmbH Freundallee 9A Hannover Paspertin Filmtabletten 10mg Filmdrasjerte tabletter Oral bruk Abbott Arzneimittel GmbH Freundallee 9A Hannover Paspertin Tropfen 4mg/ml Mikstur, Oral bruk AbZ-Pharma GmbH Graf-Arco-Str Ulm MCP AbZ 5 mg/ml Tropfen 5.91mg/ml Mikstur, Oral bruk ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D Laichingen MCP AL mg Tablett Oral bruk ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D Laichingen MCP AL retard 30mg Depotkapsel, hard Oral bruk ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D Laichingen MCP AL Tropfen 4.21mg/1ml Mikstur, Oral bruk 12

13 AWD.pharma GmbH & Co.KG Wasastr. 50 D Radebeul Cerucal inject 10.54mg/2ml AWD.pharma GmbH & Co.KG Wasastr. 50 D Radebeul axcount Generika AG Max-Planck-Str. 36b D Friedrichsdorf Metoclopramid AWD 10 mg Tabletten 10.53mg Tablett Oral bruk MCP axcount Tropfen 4.21mg/ml Mikstur, Oral bruk betapharm Arzneimittel GmbH Kobelweg 95 D Augsburg MCP-beta Tropfen 4.21mg/ml Mikstur, Oral bruk CT Arzneimittel GmbH Graf-Arco-Str Ulm MCP-CT 10mg/2ml Ampullen 10mg/2ml CT Arzneimittel GmbH Graf-Arco-Str Ulm MCP-CT 30mg Retardkapseln 30mg Depotkapsel, hard Oral bruk 13

14 CT Arzneimittel GmbH Graf-Arco-Str Ulm MCP-CT 4mg/1ml Tropfen 5.2mg/ml Mikstur, Oral bruk DOCPHARM Arzneimittelvertrieb GmbH & Co Greschbachstr. 7 D Karlsruhe Metoclopramid Injektionslösung 10ml PB 52.65mg/10ml Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1 D Sankt Augustin Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1 D Sankt Augustin Gastronerton 465mg/100ml Mikstur, Oral bruk Gastronerton 8.92mg Tablett Oral bruk hameln pharmaceuticals GmbH Langes Feld 13 D Hameln Metoclo-hameln 5mg/ml, Injektionslösung 10.53mg/2ml Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D Nürnberg Gastrosil 10mg Amp. 10mg/2ml 14

15 Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D Nürnberg Gastrosil 20 mg Supp. 20mg Stikkpille Rektal bruk Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D Nürnberg Gastrosil 50mg Amp. 52.7mg/10ml Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D Nürnberg Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D Nürnberg Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D Nürnberg Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D Nürnberg Gastrosil akut Tropfen 5.97mg/ml Mikstur, Oral bruk Gastrosil retard 31.6mg Depotkapsel, hard Oral bruk Gastrosil retard mite 15.8mg Depotkapsel, hard Oral bruk Gastrosil Tabletten 10.54mg Tablett Oral bruk 15

16 Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D Nürnberg Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D Nürnberg HEXAL AG Industriestr. 25 D Holzkirchen HEXAL AG Industriestr. 25 D Holzkirchen HEXAL AG Industriestr. 25 D Holzkirchen Mylan dura GmbH Wittichstr. 6 D Darmstadt ratiopharm GmbH Graf-Arco-Str. 3 D Ulm ratiopharm GmbH Graf-Arco-Str. 3 D Ulm Gastrsosil Tropfen 5.97mg/ml Mikstur, Oral bruk MCP Heumann 10mg Tabletten 10.53mg Tablett Oral bruk MCP Hexal mg Tablett Oral bruk MCP Hexal injekt 10.53mg/2ml MCP Hexal Tropfen 4.21mg/ml Mikstur, Oral bruk MCP dura 4 mg/ml Tropfen zum Einnehmen MCP-ratiopharm 10 mg Tabletten MCP-ratiopharm 10mg Zäpfchen 4.21mg/ml Mikstur, Oral bruk 11.82mg Tablett Oral bruk 10mg Stikkpille Rektal bruk 16

17 ratiopharm GmbH Graf-Arco-Str. 3 D Ulm ratiopharm GmbH Graf-Arco-Str. 3 D Ulm ratiopharm GmbH Graf-Arco-Str. 3 D Ulm ratiopharm GmbH Graf-Arco-Str. 3 D Ulm Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D Holzkirchen Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D Holzkirchen Stadapharm GmbH Stadastr D Bad Vilbel Stadapharm GmbH Stadastr D Bad Vilbel MCP-Ratiopharm 30 mg Retardkapseln MCP-ratiopharm 4 mg/ml Tropfen MCP-ratiopharm SF 10mg/2ml Injektionslösung MCP-ratiopharm SF 50 mg/10 ml Konzentrat zur Herstellung einer Infusionslösung 30mg Depotkapsel Oral bruk 5.2mg/ml Mikstur, Oral bruk 10mg/2ml 50mg/10ml Konsentrat til infusjonsvæske, MCP Sandoz 10mg Tabletten 10.53mg Tablett Oral bruk MCP Sandoz 4mg/ml Tropfen zum Einnehmen, Lösung 4.21mg/ml Mikstur, Oral bruk MCP STADA 10 mg Tabletten 10.53mg Tablett Oral bruk MCP STADA 4mg/1ml Tropfen zum Einnehmen, Lösung 4.21mg/ml Mikstur, Oral bruk 17

18 Hellas Hellas Hellas Hellas Hellas Temmler Pharma GmbH & Co.KG Temmlerstr. 2 D Marburg Temmler Pharma GmbH & Co.KG Temmlerstr. 2 D Marburg Sanofi Aventis AEBE 348 Syngrou avenue Building A Kalithea Athens Greece Sanofi Aventis AEBE 348 Syngrou avenue Building A Kalithea Athens Greece Sanofi Aventis AEBE 348 Syngrou avenue Building A Kalithea Athens Greece Sanofi Aventis AEBE 348 Syngrou avenue Building A Kalithea Athens Greece Sanofi Aventis AEBE 348 Syngrou avenue Building A Kalithea Athens Greece Cerucal 10.54mg Tablett Oral bruk Cerucal retard 30mg Depotkapsel, hard Oral bruk PRIMPERAN 10mg Stikkpille Rektal bruk PRIMPERAN 20mg Stikkpille Rektal bruk PRIMPERAN 10mg/2ml PRIMPERAN 5mg/5ml Mikstur Oral bruk PRIMPERAN 10mg Tablett Oral bruk 18

19 Ungarn Ungarn Island Island Island Irland AWD Pharma GmbH&Co. KG Wasastrasse 50 Radebeul 1445 AWD Pharma GmbH&Co. KG Wasastrasse 50 Radebeul 1445 Nycomed Pharma AS P.O Box 205 NO-1375, Asker Norway Nycomed Pharma AS P.O Box 205 NO-1375, Asker Norway Nycomed Pharma AS P.O Box 205 NO-1375, Asker Norway Mercury Pharmacuticals (Ireland) Ltd 4045 Kingswood Road Citywest Business Park Co. Dublin Ireland CERUCAL 5 mg/ml oldatos injekció 5mg/ml Parenteral bruk CERUCAL tabletta 10mg Tablett Oral bruk Afipran 10mg Tablett Oral bruk Afipran 20mg Stikkpille Rektal bruk Afipran 5mg/ml Metoclopramide 10mg/2ml Irland Amdipharm Limited Regency House Miles Gray Road Basildon Essex, SS14 3AF Maxolon 5mg/ml 19

20 Irland Italia Italia Italia Italia Italia Italia Italia Amdipharm Limited Regency House Miles Gray Road Basildon Essex, SS14 3AF Sanofi-Aventis spa Viale Luigi BODIO, 37/B Milano Italy Sanofi-Aventis spa Viale Luigi BODIO, 37/B Milano Italy Sanofi-Aventis spa Viale Luigi BODIO, 37/B Milano Italy Sanofi-Aventis spa Viale Luigi BODIO, 37/B Milano Italy Teofarma srl Via Fratelli Cervi, Valle Salimbene Pavia Italy F.I.R.M.A. spa Via Scandicci, Firenze Italy Sirton Medicare spa Piazza XX Settembre, Villa Guardia - COMO Italy Maxolon 10mg Tablett Oral bruk PLASIL 10mg/2ml PLASIL 1mg/ml Mikstur Oral bruk PLASIL 4mg/ml Munndråper, Oral bruk PLASIL 10mg Tablett Oral bruk RANDUM 10mg Tablett Oral bruk CLOPAN 10mg PRAMIDIN 10 mg/spray Nesespray, Nasal bruk 20

21 Italia Italia Italia Italia Italia Italia Latvia Latvia Sirton Medicare spa Piazza XX Settembre, Villa Guardia - COMO Italy Sanofi-Aventis spa Viale Luigi BODIO, 37/B Milano Italy Sanofi-Aventis spa Viale Luigi BODIO, 37/B Milano Italy Hospira Italia srl Via Orazio, 20/ NAPOLI Italy Farmakopea spa Via Cavriana, MILANO Italy Farmakopea spa Via Cavriana, MILANO Italy Pharmaceutical Works POLPHARMA SA 19 Pelplińska Street Starogard Gdański Poland Pharmaceutical Works POLPHARMA SA 19 Pelplińska Street Starogard Gdański Poland PRAMIDIN 20 mg/spray Nesespray, Nasal bruk DIGESTIVO S.PELLEGRINO 5mg Brusetablett Oral bruk DIGESTIVO S.PELLEGRINO 5mg Brusegranulater Oral bruk METOCLOPRAMIDE CLORIDRATO HOSPIRA 10mg ISAPRANDIL 5mg Brusetablett Oral bruk ISAPRANDIL 5mg Brusegranulater Oral bruk Metoclopramid Polpharma 10 mg tablets Metoclopramid Polpharma 10 mg/2 ml solution for injection 10mg Tablett Oral bruk 10mg/2ml 21

22 Latvia Teva Pharma B.V. Computerweg DR Utrecht The Netherlands Cerucal 10 mg tablets 10mg Tablett Oral bruk Litauen Teva Pharma B.V. Computerweg DR Utrecht The Netherlands Cerucal 10mg Tablett Oral bruk Litauen Medochemie Ltd. p.o box CY-3505, Limassol Cyprus ELITAN 5mg/ml Litauen Litauen Luxembourg Luxembourg Pharmaceutical Works POLPHARMA SA 19 Pelplińska Street Starogard Gdański Poland Pharmaceutical Works POLPHARMA SA 19 Pelplińska Street Starogard Gdański Poland Nycomed Belgium s.a. 615, chaussee de Gand B-1080 Bruxelles Belgium Nycomed Belgium s.a. 615, chaussee de Gand B-1080 Bruxelles Belgium Metoclopramid Polpharma 10mg Tablett Oral bruk Metoclopramid Polpharma 10mg/2ml Dibertil 10mg Kapsel, myk Oral bruk Dibertil 5mg Kapsel, myk Oral bruk 22

23 Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Dolorgiet Gmbh&Co Otto-von-Guericke-Str. 1 D Sankt Augustin Dolorgiet Gmbh&Co Otto-von-Guericke-Str. 1 D Sankt Augustin Ratiopharm GMBH Arzneimittel Graf-Arco-Str. 3 D Ulm Ratiopharm GMBH Arzneimittel Graf-Arco-Str. 3 D Ulm Ratiopharm GMBH Arzneimittel Graf-Arco-Str. 3 D Ulm Ratiopharm GMBH Arzneimittel Graf-Arco-Str. 3 D Ulm Ratiopharm GMBH Arzneimittel Graf-Arco-Str. 3 D Ulm Gastronerton 4,65mg/ml Munndråper Oral bruk Gastronerton 8,92mg Tablett Oral bruk MCP Ratiopharm 5,2mg Munndråper Oral bruk MCP Ratiopharm 10mg Stikkpille Rektal bruk MCP Ratiopharm 10mg Tablett Oral bruk mcp Ratiopharm SF 10mg/2ml MCP Ratiopharm-30 30mg Kapsler med modifisert frisetting, myk Oral bruk 23

24 Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Eurogenerics s.a. Heizel Esplanade B Laeken Belgium Sanofi-Aventis Belgium Culliganlaan 1 C 1831 Diegem Belgium Hexal AG Industriestr. 25 D Holzkirchen Hexal AG Industriestr. 25 D Holzkirchen Hexal AG Industriestr. 25 D Holzkirchen Sanofi-Aventis Belgium Culliganlaan 1 C 1831 Diegem Belgium Sanofi-Aventis Belgium Culliganlaan 1 C 1831 Diegem Belgium Sanofi-Aventis Belgium Culliganlaan 1 C 1831 Diegem Belgium Metoclopramide EG-10 10mg Kapsel, myk Oral bruk Primperan adultes 20mg Stikkpille Rektal bruk MCP Hexal-10 10mg Tablett Oral bruk MCP Hexal Injekt 10mg/2ml MCP Hexal Tropfen 4mg/ml Munndråper Oral bruk Primperan 10mg Tablett Oral bruk Primperan 10mg/2ml Primperan 1mg/ml Mikstur, Oral bruk 24

25 Malta Malta Malta Malta Malta Malta Accord Healthcare Ltd Sage House 319 Pinner Road North Harrow Middlesex HA1 4HF Antigen International Limited Chandler House Castle Street, Roscrea County Tipperary Ireland Hameln Pharmaceuticals Ltd. Nexus, Gloucester Business Park Gloucester GL3 4AG Medochemie Limited 1-10 Constantinoupleos Str 3011 Limassol Cyprus Medochemie Ltd. 1-10, Constantinoupleos Street 3011 Limassol Cyprus Remedica Ltd. Limassol Industrial Estate Aharnon Street P.O. Box Limassol Cyprus Metoclopramide 10 mg tablets 10mg Tablett Oral bruk Metoclopramide Injection BP 10mg/2ml Solution for Injection Metoclopramide 5 mg/ml Injection 10mg/2ml 5mg/ml Elitan 10mg tablet 10mg Tablett Oral bruk Elitan Injection, 10mg/2ml, Solution for Injection 10mg Cloperan 10 10mg Tablett Oral bruk 25

26 Nederland Nederland Nederland Nederland Nederland Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands Pharmachemie B.V. Swensweg GA HAARLEM The Netherlands Primperan injectie 10/2 ml, oplossing voor injection 10 mg/2 ml Primperan drank, drank 1 mg/ml 10mg/2ml 1mg/ml Mikstur, Oral bruk Primperan 10, zetpillen 10 mg 10mg Stikkpille Rektal bruk Primperan 20, zetpillen 20 mg 20mg Stikkpille Rektal bruk Metoclopramide HCl 10 PCH, tabletten 10 mg 10mg Tablett Oral bruk Nederland Centrafarm B.V. Nieuwe Donk AC Etten Leur The Netherlands Metoclopramide HCl CF 10 mg, tabletten 10mg Tablett Oral bruk Nederland Accord Healthcare B.V. De Waterman 15 A 4891 TL Rijsbergen The Netherlands Metoclopramidemonohydrochlor ide Accord 10 mg Tabletten 10mg Tablett Oral bruk 26

27 Norge Nycomed Pharma AS Postboks Asker Norway Afipran 5mg/ml Norge Nycomed Pharma AS Postboks Asker Norway Afipran 20mg Stikkpille Rektal bruk Norge Nycomed Pharma AS Postboks Asker Norway Afipran 100 mg/ml Konsentrat til infusjonsvæske, Norge Nycomed Pharma AS Postboks Asker Norway Afipran 1mg/ml Mikstur, Oral bruk Norge Nycomed Pharma AS Postboks Asker Norway Afipran 10mg Tablett Oral bruk Polen Polen Zakłady Farmaceutyczne Polpharma SA ul. Pelplińska Starogard Gdański Poland Zakłady Farmaceutyczne Polpharma SA ul. Pelplińska Starogard Gdański Poland Metoclopramidum 0,5% Polpharma 5mg/ml Metoclopramidum Polpharma 10mg Tablett Oral bruk 27

28 Portugal Portugal Portugal Portugal Portugal Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7-3º Piso Porto Salvo Portugal Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo Santiago de Besteiros Portugal Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo Santiago de Besteiros Portugal Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7-3º Piso Porto Salvo Portugal Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7-3º Piso Porto Salvo Portugal Primperan 10mg/2ml Metoclopramida Labesfal 10mg/2ml Metoclopramida Labesfal 10mg Tablett Oral bruk Primperan 1mg/ml Mikstur, Oral bruk Primperan 10mg Tablett Oral bruk 28

29 Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. l Ribeiro de Pavia, 1-1º - Venda Nova Amadora Portugal Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia Venda Nova Amadora Portugal Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia Venda Nova Amadora Portugal Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia Venda Nova Amadora Portugal Romania S.C. LAROPHARM S.R.L. Şos. Alexandriei, nr 145 A B07-Bragadiru, jud Ilfov România Metoclopramida Medinfar 10mg/2ml Metoclopramida Medinfar 10mg Tablett Oral bruk Metoclopramida Medinfar 2,6mg/ml Munndråper, Oral bruk Metoclopramida Medinfar 1mg/ml Mikstur, Oral bruk METOCLOPRAMID LAROPHARM 10mg Tablett Oral bruk 29

30 Romania Romania S.C. SLAVIA PHARM S.R.L. B-dul Theodor Pallady nr. 44C Sector 3, Bucureşti România S.C. MEDUMAN S.A. Str. Aleea Eroilor nr. 28, Vişeu de Sus, Judeţul Maramureş România METOCLOPRAMID 10mg Tablett Oral bruk N - METOCLOPRAMID 10mg Tablett Oral bruk Romania S.C. ARENA GROUP S.A Str. Stefan Mihaileanu, nr.31 sector 2; Bucuresti România METOCLOPRAMID ARENA 10 mg 10mg Tablett Oral bruk Romania Romania Romania S.C. TERAPIA S.A. Str. Fabricii nr. 124 Cluj - Napoca România S.C. BIOFARM S.A. Str. Logofăt Tăutu, nr. 99 sector 3, Bucureşti Romania S.C. BIOFARM S.A. Str. Logofăt Tăutu, nr. 99 sector 3, Bucureşti Romania METOCLOPRAMID 10 mg 10mg Tablett Oral bruk METOCLOPRAMID BIOFARM 1mg/5ml 1mg/5ml Mikstur Oral bruk METOCLOPRAMID 7mg/ml Munndråper, Oral bruk 30

31 Romania S.C. TERAPIA S.A. Str. Fabricii nr. 124 Cluj - Napoca România METOCLOPRAMID 10 mg 10mg/2ml Romania Slovakia Slovakia Slovakia Slovakia Slovenia Accord Healthcar Ltd Sage House 319 Pinner Road North Harrow Middlesex HA1 4HF TEVA Pharmaceuticals Slovakia s.r.o. Teslova Bratislava Slovakia AWD. pharma GmbH & Co.KG Wasastr Radebeul Sandoz Pharmaceuticals d.d. Verovškova Ljubljana Slovenia Sandoz Pharmaceuticals d.d. Verovškova Ljubljana Slovenia Alkaloid-INT d.o.o. Ljubljana Slandrova ulica Ljubljana- Crnuce Slovenia Metoclopramid Accord 10 mg comprimate 10mg Tablett Oral bruk Cerucal 10mg Tablett Oral bruk Cerucal 10mg/2ml DEGAN 10 mg 10mg Tablett Oral bruk DEGAN 10 mg/2 ml 10mg/2ml Reglan 1 mg/1 ml peroralna raztopina 1mg/ml Mikstur, Oral bruk 31

32 Slovenia Spania Spania Spania Spania Alkaloid-INT d.o.o. Ljubljana Slandrova ulica Ljubljana- Crnuce Slovenia Sanofi Aventis, S.A. Josep Plá, Barcelona Spain Sanofi Aventis, S.A. Josep Plá, Barcelona Spain Sanofi Aventis, S.A. Josep Plá, Barcelona Spain Sanofi Aventis, S.A. Josep Plá, Barcelona Spain Reglan 10 mg tablete 10mg Tablett Oral bruk PRIMPERAN 10 mg/2 ml SOLUCION INYECTABLE PRIMPERAN 1mg/1ml SOLUCION ORAL PRIMPERAN 10 mg COMPRIMIDOS PRIMPERAN 260mg/100 ml GOTAS 10mg/2ml 1mg/ml Mikstur, Oral bruk 10mg Tablett Oral bruk 2,6mg/ml Munndråper, Oral bruk Spania Sanofi Aventis, S.A. Josep Plá, Barcelona Spain PRIMPERAN 100 mg/5 ml SOLUCION INYECTABLE 100mg/5ml Spania Kern Pharma, S.L. Venus, 72. Poligono Industrial Colon II Tarrasa Spain METOCLOPRAMIDA KERN PHARMA 1 mg/ml SOLUCION ORAL 1mg/ml Mikstur, Oral bruk 32

33 Spania Spania Sverige Sverige Sverige Storbritannia Pensa Pharma, S.A.U Jorge Comín (médico pediatra) Valencia Spain Accord Healthcare, S.L.U. Moll de Barcelona s/n World Trade Centre Edifici Est 6ª planta Barcelona Spain sanofi-aventis AB Box Bromma Sweden sanofi-aventis AB Box Bromma Sweden sanofi-aventis AB Box Bromma Sweden Actavis UK Limited Whiddon Valley Barnstaple North evon EX32 8NS METOCLOPRAMIDA PENSA 1 mg/ml SOLUCION ORAL METOCLOPRAMIDA ACCORD 10 mg COMPRIMIDOS 1mg/ml Mikstur, Oral bruk 10mg Tablett Oral bruk Primperan 10mg Tablett Oral bruk Primperan 10mg/2ml Primperan 20mg Stikkpille Rektal bruk Metoclopramide Tablets BP 10mg 10mg Tablett Oral bruk Storbritannia Amdipharm plc Regency House Miles Gray Road, Basildon Essex SS14 3AF Maxolon SR 15mg Kapsler med modifisert frisetting, hard Oral bruk 33

34 Storbritannia Storbritannia Storbritannia Storbritannia Storbritannia Storbritannia Storbritannia Amdipharm plc Regency House Miles Gray Road, Basildon Essex SS14 3AF Amdipharm plc Regency House Miles Gray Road, Basildon Essex SS14 3AF Amdipharm plc Regency House Miles Gray Road, Basildon Essex SS14 3AF Chelonia Healthcare Limited Boumpoulinas 11, 3rd Floor Nicosia, CY-1060 Cyprus Crescent Pharma Limited Units 3 & 4 Quidhampton Business Units Polhampton Lane, Overton Hampshire RG25 3ED Ennogen Limited 78 York Street London W1H 1DP Ennogen Limited 78 York Street London W1H 1DP Maxolon Tablets 10mg 10mg Tablett Oral bruk Maxolon Injection 5mg/ml 0.5% w/v Maxolon High Dose 100mg/20ml 0.5% w/v Metoclopramide 10mg Tablets 10mg Tablett Oral bruk Metoclopramide 10mg Tablets 10mg Tablett Oral bruk Metoclopramide 10mg Tablets 10mg Tablett Oral bruk Metoclopramide 5mg/ml Injection 0.5% w/v 34

35 Storbritannia Storbritannia Storbritannia Storbritannia Storbritannia Generics () Limited Station Close, Potters Bar Hertfordshire EN6 1TL Hameln Pharmaceuticals Limited Nexus, Gloucester Business Park Gloucester GL3 4AG Metwest Pharmaceuticals Limited 15 Runnelfield Harrow on the Hill Middlesex HA1 3NY Pharmvit Limited 177 Bilton Road, Perivale Middlesex UB6 7HQ Rosemont Pharmaceuticals Limited Rosemont House Yorkdale Industrial Park Braithwaite Street Leeds, W Yorkshire LS11 9XE Metoclopramide Tablets 10mg 10mg Tablett Oral bruk Metoclopramide Injection BP 5mg/ml 0.526% w/v Metoclopramide 10mg Tablets 10mg Tablett Oral bruk Metoclopramide Tablets BP 10mg Metoclopramide Hydrochloride 5mg/5ml Oral Solution 10mg Tablett Oral bruk 5mg/5ml Mikstur, Oral bruk 35

36 Storbritannia Storbritannia Storbritannia Storbritannia Rosemont Pharmaceuticals Limited Rosemont House Yorkdale Industrial Park Braithwaite Street Leeds, W Yorkshire LS11 9XE Teva Limted Brampton Road Hampden Park, Eastbourne East Sussex BN22 9AG Accord Healthcare Ltd Sage House 319 Pinner Road North Harrow Middlesex HA1 4HF Mercury Pharma International Limited 4045 Kingswood Raod City West Business Park County Dublin Ireland Maxolon Paediatric Liquid 5mg/5ml Mikstur, Oral bruk Primperan; Metoclopramide Tablets BP 10mg Metoclopramide Hydrochloride 10 mg tablets Metoclopramide 5mg/ml solution for injection 10mg Tablett Oral bruk 10mg Tablett Oral bruk 5mg/ml 36