INN Invented name Strengths Pharmaceutic al forms BEROTEC 0,5MG/10 ML. Partusisten intrapartal
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1 Annex I List of the names, pharmaceutical, strengths of the medicinal products, routes of, marketing authorisation s in the Member States 1
2 State (in INN Invented name Strengths Pharmaceutic al SCS Boehringer Ingelheim SA Avenue Ariane 16 B-1200 Woluwe-Saint- Lambert fenoterol BEROTEC 0,5MG/10 ML 0.5mg/10ml Germany Boehringer Ingelheim Pharma GmbH & Co. KG Binger Str Ingelheim Germany fenoterol Partusisten intrapartal 0.025mg/ml Concentrate for solution for Germany Boehringer Ingelheim Pharma GmbH & Co. KG Binger Str Ingelheim Germany fenoterol Partusisten 0.5mg/10ml Concentrate for solution for Germany Boehringer Ingelheim Pharma GmbH & Co. KG Binger Str Ingelheim Germany fenoterol Partusisten 5mg Tablet Oral use Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater Warszawa fenoterol Fenoterol Teva 0.05mg/ml 2
3 State INN Invented name Strengths Pharmaceutic (in al Pharmaceuticals S.A. ul. Grunwaldzka Poznań fenoterol Fenoterol GSK 5mg Tablet Oral use The Boehringer Ingelheim B.V. fenoterol Partusisten, 0.05mg/ml Concentrate for Netherlands Comeniusstraat 6 concentraat voor solution for 1817 MS Alkmaar oplossing voor The Netherlands intraveneuze infusie 50 microgram/ml Member State (in Takeda GmbH hexoprenaline Gynipral 25 μg mg/5m Concentrate for Konzentrat zur l solution for Infusionsbereitun g Takeda GmbH hexoprenaline Gynipral 10 μg / 0.01mg/2ml 2 ml - Ampullen / 3
4 State (in Bulgaria Bulgaria Czech Republic Czech Republic Czech Republic Estonia NYCOMED GmbH NYCOMED GmbH Takeda GmbH Takeda GmbH Takeda GmbH NYCOMED GmbH hexoprenaline Gynipral 0.005mg/ml hexoprenaline Gynipral 0.5mg Tablet Oral use hexoprenaline GYNIPRAL 0,5 0.5mg Tablet Oral use MG hexoprenaline GYNIPRAL mg/ml MCG/2 ML / hexoprenaline GYNIPRAL mg/5m Concentrate for MCG l solution for KONCENTRÁT PRO PŘÍPRAVU INFÚZE hexoprenaline GYNIPRAL 0.5mg Tablet Oral use 4
5 State (in Lithuania Lithuania Lithuania Romania Romania NYCOMED GmbH NYCOMED GmbH NYCOMED GmbH NYCOMED GmbH NYCOMED GmbH hexoprenaline Gynipral 0.5mg Tablet Oral use hexoprenaline Gynipral 0.025mg/5m Concentrate for l solution for / hexoprenaline Gynipral 0.01mg/2ml / hexoprenaline GYNIPRAL 0,5 0.5mg Tablet Oral use mg, hexoprenaline GYNIPRAL mg/2ml Parenteral use μg/2 ml 5
6 Portugal Istituto Luso Farmaco d'italia SpA Via W. Tobagi Peschiera Borromeo (MI) Istituto Luso Farmaco d'italia SpA Via W. Tobagi Peschiera Borromeo (MI) Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan Amoreiras Torre 3-12, Portugal isoxsuprine VASOSUPRINA ILFI 10mg/2ml Intramuscular use, intravenous use isoxsuprine VASOSUPRINA 30mg Modified-release Oral use RETARD tablet isoxsuprine Dilum Retard 30mg Prolonged-release Oral use tablet Member EUMEDICA N.V. Av. Winston Churchill 67 B-1180 Bruxelles ritodrine PRE-PAR 10 MG 10mg Tablet Oral use 6
7 Greece Greece EUMEDICA N.V. Av. Winston Churchill 67 B-1180 Bruxelles Galenica SA 4, Eleftherias Street Kifisia Greece Galenica SA 4, Eleftherias Street Kifisia Greece Istituto Luso Farmaco d'italia SpA Via W. Tobagi Peschiera Borromeo (MI) Istituto Luso Farmaco d'italia SpA Via W. Tobagi Peschiera Borromeo (MI) ritodrine PRE-PAR 50MG/5ML 50mg/5ml ritodrine YUTOPAR 10mg Tablet Oral use ritodrine YUTOPAR 50mg/5ml ; Injection Intramuscular use ritodrine MIOLENE 10mg/2ml Intramuscular use Injection ritodrine MIOLENE 10mg Tablet Oral use 7
8 Luxembourg Luxembourg Spain Spain Istituto Luso Farmaco d'italia SpA Via W. Tobagi Peschiera Borromeo (MI) Eumedica S.A. Av. Winston Churchill 67 B-1180 Bruxelles Eumedica S.A. Av. Winston Churchill 67 B-1180 Bruxelles Laboratorio Reig Jofre SA. Gran Capita 10 Sant Joan Despi Barcelona Spain Laboratorio Reig Jofre SA. Gran Capita 10 Sant Joan Despi Barcelona Spain ritodrine MIOLENE 50mg/5ml ritodrine Pre-Par comprimés 10mg Tablet ritodrine Pre-Par solution 50mg/5ml injectable / ritodrine PRE-PAR AMPOLLAS 10mg/ml ; Intramuscular use ritodrine PRE-PAR 10 mg 10mg Tablet Oral use COMPRIMIDOS 8
9 Cyprus Pharmaceuticals S.A./N.V. Site Apollo, B-1300 Wavre Pharmaceuticals S.A./N.V. Site Apollo, B-1300 Wavre Pharmaceuticals S.A./N.V. Site Apollo, B-1300 Wavre Pharmaceuticals S.A./N.V. Site Apollo, B-1300 Wavre Remedica Ltd Aharnon Street Industrial Estate 3508 Lemesos Cyprus salbutamol VENTOLIN POUR PERFUSION I.V. 5mg salbutamol VENTOLIN I.M.-S.C. 0.5mg Intramuscular use, Subcutaneous use salbutamol VENTOLIN 4MG 4mg Oral solution Oral use salbutamol VENTOLIN 2 MG 2mg Oral solution Oral use salbutamol SALBUTAMOL 4mg Tablet Oral use tablets 4 mg 9
10 Denmark Denmark Pharma A/S Nykær 68 DK-2605 Brøndby Denmark Pharma A/S Nykær 68 DK-2605 Brøndby Denmark Laboratoire 100, route de Versailles Marly-le-Roi Cedex Laboratoire 100, route de Versailles Marly-le-Roi Cedex Laboratoire 100, route de Versailles Marly-le-Roi Cedex salbutamol Ventoline 0.5mg/ml Intramuscular use, Subcutaneous use salbutamol Ventoline 1mg/ml Concentrate for salbutamol SALBUMOL 0.5mg/ml, 0,5 mg/1 ml, Intramuscular use, solution for Subcutaneous use salbutamol SALBUMOL 1 mg, 1mg Suppository Rectal use suppository salbutamol SALBUMOL 2 mg 2mg Tablet Oral use tablet 10
11 Laboratoire 100, route de Versailles Marly-le-Roi Cedex MYLAN SAS 117, allée des Parcs Saint-Priest Laboratoire Renaudin Z A. Errobi Itxassou Cambo les Bains salbutamol salbutamol salbutamol SALBUMOL FORT 5 mg / 5 ml solution for SALBUTAMOL MYLAN 5 mg/5 ml, solution for SALBUTAMOL RENAUDIN 5 mg/5 ml, 5mg/5ml 5mg/5ml 5mg/5ml Ireland Ireland (Ireland) Limited Stonemasons Way Rathfarnham Dublin 16 Ireland (Ireland) Limited Stonemasons Way Rathfarnham Dublin 16 Ireland salbutamol Ventolin 500 micrograms/ml Injection salbutamol Ventolin 1mg/ml Concentrate for Intravenous Infusion 0.5mg/ml 1mg/ml Injection Concentrate for solution for intravenous Subcutaneous, intramuscular, intravenous 11
12 Lithuania Lithuania Luxembourg Luxembourg Luxembourg Warszawskie Zakłady Farmaceutyczne Polfa S.A. ul. Karolkowa 22/ Warszawa Warszawskie Zakłady Farmaceutyczne Polfa S.A. ul. Karolkowa 22/ Warszawa Pharmaceuticals S.A./N.V. Site Apollo, B-1300 wavre Pharmaceuticals S.A./N.V. Site Apollo, B-1300 wavre Pharmaceuticals S.A./N.V. Site Apollo, B-1300 wavre salbutamol SALBUTAMOL WZF Polfa 2mg Tablet Oral use salbutamol SALBUTAMOL WZF 4mg Tablet Oral use Polfa salbutamol Ventolin comprimés 2mg Tablet Oral use salbutamol Ventolin comprimés 4mg Tablet Oral use salbutamol Ventolin solution 0.5mg/ml injectable 12
13 Luxembourg Portugal Pharmaceuticals S.A./N.V. Site Apollo, B-1300 wavre Warszawskie Zakłady Farmaceutyczne Polfa S.A. ul. Karolkowa 22/ Warszawa Warszawskie Zakłady Farmaceutyczne Polfa S.A. ul. Karolkowa 22/ Warszawa Warszawskie Zakłady Farmaceutyczne Polfa S.A. ul. Karolkowa 22/ Warszawa Glaxo Wellcome Farmacêutica, Lda. Rua Dr. António Loureiro Borges, 3 - Arquiparque - Miraflores Algés, Lisbon Portugal salbutamol Ventolin solution à diluer pour perfusion 5mg/5ml salbutamol Salbutamol WZF 0.5mg/ml, Injection Intramuscular use, Subcutaneous use salbutamol Salbutamol WZF 2mg Tablet Oral use salbutamol Salbutamol WZF 4mg Tablet Oral use salbutamol ventilan 4mg Tablet Oral use 13
14 Portugal Portugal Romania Slovak Republic Glaxo Wellcome Farmacêutica, Lda. Rua Dr. António Loureiro Borges, 3 - Arquiparque - Miraflores Algés, Lisbon Portugal Glaxo Wellcome Farmacêutica, Lda. Rua Dr. António Loureiro Borges, 3 - Arquiparque - Miraflores Algés, Lisbon Portugal GLAXO WELLCOME UK Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN Warszawskie Zakłady Farmaceutyczne Polfa S.A. ul. Karolkowa 22/ Warszawa salbutamol ventilan 5mg/5ml salbutamol ventilan 0.5mg/ml, Injection Subcutaneous use Intramuscular use salbutamol VENTOLIN, 0.5mg/ml Parenteral use soluţie injectabilă, 0,5 mg/ml salbutamol Salbutamol WZF 2mg Tablet Oral use Polfa 2 mg 14
15 Slovak Republic Slovenia United Kingdom United Kingdom Warszawskie Zakłady Farmaceutyczne Polfa S.A. ul. Karolkowa 22/ Warszawa GSK d.o.o. Cvetkova ulica Ljubljana Slovenija Actavis UK Limited Whiddon Valley Barnstaple North Devon EX32 8NS Actavis UK Limited Whiddon Valley Barnstaple North Devon EX32 8NS salbutamol salbutamol salbutamol salbutamol Salbutamol WZF Polfa 4 mg Ventolin 2 mg tablete Salbutamol Tablets BP 2mg Salbutamol Tablets BP 4mg 4mg Tablet Oral use 2mg Tablet Oral use 2mg Tablet Oral use 4mg Tablet Oral use United Kingdom Teva UK Limited Bampton Road Hampden Park Eastbourne East Sussex BN22 9AG salbutamol Asmaven 2 / Salbutamol Tablets BP 2mg 2mg Tablet Oral use 15
16 United Kingdom United Kingdom Teva UK Limited Bampton Road Hampden Park Eastbourne East Sussex BN22 9AG Glaxo Wellcome UK Limited Stockley Park West Uxbridge Middlesex UB11 1BT salbutamol Asmaven 4 / Salbutamol Tablets BP 4mg salbutamol Ventolin Solution for Intravenous Infusion 4mg Tablet Oral use 1mg/ml, Subcutaneous use Member State (in Marketing authorisation Cyprus AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A-1037 Vienna Medochemie Ltd 1-10 Constantinoupoleos Street 3505 Lemesos Cyprus terbutaline Bricanyl 0,5 mg - Ampullen terbutaline ATALINE tablets 2.5 mg 0.5mg/ml Subcutaneous use, 2.5mg Tablet Oral use 16
17 Marketing State authorisation (in Cyprus Hungary Ireland Norway Norway Medochemie Ltd 1-10 Constantinoupoleos Street 3505 Lemesos Cyprus AstraZeneca 1, place Renault Rueil Malmaison Cedex AstraZeneca Kft. Bocskai út Budapest 1113 Hungary AstraZeneca UK Limited 600 Capability Green Luton, LU1 3LU AstraZeneca AS Innspurten Oslo Norway AstraZeneca AS Innspurten Oslo Norway terbutaline ATALINE syrup 1.5 mg/5ml 1.5mg/5ml Syrup Oral use terbutaline BRICANYL mg/ml, mg/1 ml Subcutaneous use terbutaline Bricanyl 0,5 mg/ml 0.5mg/ml oldatos injekció or terbutaline Bricanyl mg/ml Subcutaneous, micrograms/ml or intramuscular, solution for intravenous or terbutaline Bricanyl 0.5mg/ml Parenteral use terbutaline Bricanyl 0.3mg/ml Oral solution Oral use 17
18 State (in Marketing authorisation Norway Norway Sweden Sweden United Kingdom United Kingdom United Kingdom AstraZeneca AS Innspurten Oslo Norway AstraZeneca AS Innspurten Oslo Norway AstraZeneca AB SE Södertälje Sweden AstraZeneca AB SE Södertälje Sweden AstraZeneca UK Limited 600 Capability Green Luton, LU1 3LU AstraZeneca UK Limited 600 Capability Green Luton, LU1 3LU AstraZeneca UK Limited 600 Capability Green Luton, LU1 3LU terbutaline Bricanyl 5mg Film- coated tablet Oral use terbutaline Bricanyl Depot 7.5mg Prolonged- release Oral use tablet terbutaline Bricanyl 0.5mg/ml Concentrate for solution for terbutaline Bricanyl 0.3mg/ml Oral solution Oral use terbutaline Bricanyl Injection 0.5mg/ml, Intramuscular use, Subcutaneous use terbutaline Bricanyl Tablets 5mg Tablet Oral use 5mg terbutaline Bricanyl Syrup 0.3mg/ml Oral solution Oral use 18
Name. Priligy 30 mg Filmtabletten. Priligy 60 mg Filmtabletten. Priligy 30 mg filmomhulde tablet. Priligy 60 mg filmomhulde tablet
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