(Invented) Name Strength Pharmaceutical Form. 3 mg/3 ml Solution for injection. Kytril 2 mg - Filmtabletten 2 mg Film-coated tablet Oral use

Transcription

1 ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 1

2 Austria Austria Bulgaria Bulgaria Czech Republic Czech Republic Roche Austria GmbH, Kytril 3 mg - Engelhorngasse 3, 1211 Wien Injektionslösung Austria Roche Austria GmbH, Engelhorngasse 3, 1211 Wien Austria Roche Bulgaria EOOD, 16 Bialo Pole Str Sofia Bulgaria Roche Bulgaria EOOD, 16 Bialo Pole Str Sofia Bulgaria Roche s.r.o., Dukelských hrdinů Praha 7 Czech Republic Roche s.r.o., Dukelských hrdinů Praha 7 Czech Republic 3 mg/3 ml Solution for Kytril 2 mg - Filmtabletten 2 mg Film-coated tablet Oral use Kytril solution injectable Kytril 3 mg/3 ml solution injectable Kytril 1 mg comprimés pelliculés 1 mg Solution for 3 mg Solution for Kytril 1 mg / ml Solution for /infusion Kytril 2 mg 2 mg Film-coated tablet Oral use Kytril inj./inf Solution for /infusion 3 ml 3 mg/3 ml 1 ml (1 mg/ ml) 3 ml (1 mg/ ml) 2

3 Estonia Estonia Roche Eesti OÜ Lõõtsa 2, Tallinn Estonia Roche Eesti OÜ Lõõtsa 2, Tallinn Estonia Roche Oy PL Espoo Roche Oy PL Espoo Roche Oy PL Espoo ROCHE 52 Boulevard du Parc NEUILLY SUR SEINE cedex ROCHE 52 Boulevard du Parc NEUILLY SUR SEINE cedex ROCHE 52 Boulevard du Parc NEUILLY SUR SEINE cedex Kytril 1mg/ml Concentrate for /infusion Kytril 1mg Film-coated tablet Oral use Kytril Kytril Solution for Kytril 3mg/3ml solution injectable pour voie intraveineuse Kytril 1mg/ comprimé pelliculé Kytril 2 mg comprimé pelliculé 3mg/3ml Solution for 2 mg Film-coated tablet Oral use 1mg/ml (1ml and 3ml) 5x1 ml and 5x3 ml 3mg/3ml 3

4 Roche Pharma AG Emil-Barell-Straße Grenzach-Wyhlen Roche Pharma AG Emil-Barell-Straße Grenzach-Wyhlen Roche Pharma AG Emil-Barell-Straße Grenzach-Wyhlen Greece Roche (Hellas ) A.E. Alamanas 4 & Delfon, Maroussi Greece Greece Roche (Hellas ) A.E. Alamanas 4 & Delfon, Maroussi Greece Greece Roche (Hellas ) A.E. Alamanas 4 & Delfon, Maroussi Greece Greece Roche (Hellas ) A.E. Alamanas 4 & Delfon, Maroussi Greece Hungary Roche (Hungary) Ltd H-2040 Budaörs Edison u. 1. Hungary Kevatril 1 mg Solution for Injektionslösung Kevatril Filmtabletten 2 mg 2 mg Film-coated tablet Oral use Kevatril 3 mg Solution for 3 mg/3 ml Injektionslösung Kytril 1mg Film-coated tablet Oral use Kytril 1mg/1ml Solution for Kytril 3mg/3ml Solution for Kytril 1 ml 3 ml 1mg/1ml 3mg/3ml 4

5 Hungary Ireland Ireland Ireland Ireland Roche (Hungary) Ltd H-2040 Budaörs Edison u. 1. Hungary Roche S.p.A. Piazza Durante Milano Roche S.p.A. Piazza Durante Milano Roche S.p.A. Piazza Durante Milano Kytril 3 mg/3 ml Solution for Kytril Tablets 1mg 1mg Film-coated tablet Oral use Kytril Tablets 2mg 2mg Film-coated tablet Oral use Kytril Ampoules concentrate for infusion or Kytril Infusion 3 mg/3 ml concentrate for infusion or 1mg/1ml 3mg/3ml Concentrate for infusion/ Concentrate for infusion/ Kytril 3 mg/3 ml Solution for Kytril Solution for Kytril 3 mg/5 ml Solution for 3 mg/3 ml 1ml contains 1mg granisetron (hydrochloride) 1mg contains 9mg sodium chloride = 3.54 mg sodium 3ml contains 3mg granisetron (hydrochloride) 3ml contains 27mg sodium chloride = mg sodium 3 mg/3 ml 3 mg/5 ml 5

6 Latvia Latvia Luxembourg Luxembourg Roche S.p.A. Piazza Durante Milano Roche S.p.A. Piazza Durante Milano Roche Latvija SIA G. Astras 8b Riga, LV-1082 Latvia Roche Latvija SIA G. Astras 8b Riga, LV-1082 Latvia UAB Roche Lietuva J. Jasinskio 16b, LT Vilnius UAB Roche Lietuva J. Jasinskio 16b, LT Vilnius UAB Roche Lietuva J. Jasinskio 16b, LT Vilnius Kytril Kytril Kytril 1 mg film-coated tablets Solution for Kytril 1mg Film-coated tablet Oral use Kytril 1mg/ml Solution for /infusion Kytril 3mg/3ml Solution for /infusion Kytril solution injectable Kytril 3 mg/3 ml solution injectable 1 mg Solution for 3 mg Solution for 3 mg/3 ml 3 mg/3 ml 6

7 Luxembourg Malta Malta Kytril 1 mg comprimés pelliculés Roche Nederland B.V., Kytril i.v. 3 mg = 3 ml, Postbus 44, 3440 AA Woerden oplossing voor injectie Roche Nederland B.V., Kytril i.v. 1 mg = 1 ml, Postbus 44, 3440 AA Woerden oplossing voor injectie Roche Nederland B.V., Kytril 1 mg tabletten, Postbus 44, 3440 AA Woerden omhulde tabletten Roche Nederland B.V., Kytril 2 mg tabletten, Postbus 44, 3440 AA Woerden omhulde tabletten Roche Farmacêutica Química, Lda Estrada nacional 249-1, , Amadora Roche Farmacêutica Química, Lda Estrada nacional 249-1, , Amadora Kytril Tablets 1mg 1mg Film-coated tablet Oral use Kytril Injection 3mg/3ml 3mg/3ml Concentrate for infusion/ Solution for Solution for 2 mg Film-coated tablet Oral use Kytril 1ml contains 1mg granisetron (hydrochloride) 7

8 Romania Romania Slovak Republic Slovak Republic Slovak Republic Roche Farmacêutica Química, Lda Estrada nacional 249-1, , Amadora Roche Farmacêutica Química, Lda Estrada nacional 249-1, , Amadora Roche Romania SRL 9-9A Dimitrie Pompei Street, Building 19, Entrance B, 3rd Floor, Sector (District) 2, Bucharest Romania Roche Romania SRL 9-9A Dimitrie Pompei Street, Building 19, Entrance B, 3rd Floor, Sector (District) 2, Bucharest Romania Roche Slovensko s.r.o. Cintorínska 3/A Bratislava Slovak Republic Roche Slovensko s.r.o. Cintorínska 3/A Bratislava Slovak Republic F.Hoffmann-La Roche Ltd. Basel, Switzerland Roche farmacevtska družba d.o.o. Vodovodna cesta Ljubljana Kytril Solution for Kytril 3 mg/3 ml Solution for Kytril 1 mg Kytril 3mg/3ml Solution for Kytril 1 mg Kytril 2 mg 2 mg Film-coated tablet Oral use Kytril INJ/INF Concentrate for infusion/ Kytril 2 mg filmsko 2 mg Film-coated tablet Oral use obložene tablete 1 ml () 3 ml (3 mg/3 ml) 3mg/3ml (1mg/ml) 8

9 Roche farmacevtska družba d.o.o. Vodovodna cesta Ljubljana Roche farmacevtska družba d.o.o. Vodovodna cesta Ljubljana Roche Farma S.A. C/ Eucalipto Madrid Roche Farma S.A. C/ Eucalipto Madrid Roche Farma S.A. C/ Eucalipto Madrid Roche AB Box Stockholm Roche AB Box Stockholm Roche AB Box Stockholm Kytril raztopina za injiciranje Kytril 3 mg/3 ml raztopina za injiciranje Kytril 1 mg comprimidos recubiertos con película Kytril solución inyectable Kytril 3 mg/3 ml solución inyectable Solution for 3 mg/3 ml Solution for 1mg/1ml 3mg/3ml Solution for Solution for Kytril Kytril Solution for 5 x 1 ml 5 x 3 ml 9

10 AL7 1TW AL7 1TW AL7 1TW AL7 1TW Kytril Tablets 1mg 1mg Film-coated tablet Oral use Kytril Tablets 2mg 2mg Film-coated tablet Oral use Kytril Ampoule 1mg/1ml 1mg/1ml Concentrate for infusion/ Kytril Infusion 3mg/ml 3mg/3ml Concentrate for infusion/ 1ml contains 1mg granisetron (hydrochloride 1mg of granisetron per 1 ml solution 10