Vedlegg I. Liste over navn, legemiddelformer, legemiddelstyrker, administrasjonsmåte, innehavere av markedsføringstillatelsen i medlemslandene

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1 Vedlegg I Liste over navn, legemiddelformer, legemiddelstyrker, administrasjonsmåte, innehavere av n i medlemslandene 1

2 Østerrike G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria Zoldem 5 mg - Filmtabletten 5 mg tablett, filmdrasjert oral bruk Østerrike G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria Zoldem 10 mg - Filmtabletten Østerrike G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria Zolpidem G.L. 10 mg - Filmtabletten Østerrike Hexal Pharma GmbH, Stella-Klein- Löw-Weg 17, 1020 Wien, Austria Zolpidem "Hexal" - Filmtabletten Østerrike Meda Pharma GmbH, Guglgasse 15, 1110 Wien, Austria Edluar 5 mg Sublingualtabletten 5 mg sublingvaltablett sublingval bruk Østerrike Meda Pharma GmbH, Guglgasse 15, 1110 Wien, Austria Edluar 10 mg Sublingualtabletten 10 mg sublingvaltablett sublingval bruk 2

3 Østerrike ratiopharm Arzneimittel Vertriebs- GmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria Zolpidem "ratiopharm" 10 mg Filmtabletten Østerrike sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria Ivadal - Filmtabletten Østerrike STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Wien, Austria Mondeal 10 mg - Filmtabletten Belgia Belgia Belgia APOTEX NV Av. du Bourg. Etienne Demunter 5 box Jette Belgium APOTEX NV Av. du Bourg. Etienne Demunter 5 box Jette Belgium Eurogenerics S.A. Esplanade Heysel, b Bruxelles Belgium Zolpitop Zolpitop 5 mg tablett, filmdrasjert oral bruk Zolpidem EG 3

4 Belgia Belgia Belgia Belgia Belgia Eurogenerics S.A. Esplanade Heysel, b Bruxelles Belgium Ipca, Produtos Farmaceuticos, Unipessoal Lda Rua Chanceler-Mor 11 R/c Frt. Cacem Ipca, Produtos Farmaceuticos, Unipessoal Lda Rua Chanceler-Mor 11 R/c Frt. Cacem MEDA PHARMA Chaussee de la Hulpe Watermael-Boitsfort Belgium MEDA PHARMA Chaussee de la Hulpe Watermael-Boitsfort Belgium Zolpidem EG 10 mg brusetablett oral bruk Zolpidem IPCA 5 mg tablett, filmdrasjert oral bruk Zolpidem IPCA Zolpeduar 5 mg sublingvaltablett oral bruk Zolpeduar 10 mg sublingvaltablett oral bruk 4

5 Belgia Belgia Belgia Belgia Belgia Belgia MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium SANDOZ N.V. Telecom Gardens Medialaan ilvoorde Belgium SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan Diegem Belgium SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan Diegem Belgium TEVA PHARMA BELGIUM NV Laarstraat Wilrijk Belgium TEVA PHARMA BELGIUM NV Laarstraat Wilrijk Belgium Zolpidem Mylan Zolpidem Sandoz Stilnoct 10 mg tablett oral bruk Zolpidem Sanofi-Aventis Belgium Zolpidem Teva Zolpidem Ratiopharm 5

6 Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Adorma 5 mg tablett, filmdrasjert oral bruk Adorma Zolsana 5 mg tablett, filmdrasjert oral bruk Zolsana Edluar 5 mg sublingvaltablett sublingval bruk Edluar 10 mg sublingvaltablett sublingval bruk 6

7 Bulgaria Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd. Building Sofia Tower Sofia 1303 Bulgaria Stilnox Kroatia Alkaloid d.o.o., Ulica grada Vukovara 226 F, Zagreb, Croatia Lunata 5 mg filmom obložene tablete 5 mg tablett, filmdrasjert oral bruk Kroatia Alkaloid d.o.o., Ulica grada Vukovara 226 F, Zagreb, Croatia Lunata 10 mg filmom obložene tablete Kroatia Krka - farma d.o.o., Radnička cesta 48, Zagreb, Croatia Zolsana 5 mg filmom obložene tablete 5 mg tablett, filmdrasjert oral bruk Kroatia Krka - farma d.o.o., Radnička cesta 48, Zagreb, Croatia Zolsana 10 mg filmom obložene tablete Kroatia Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Croatia Zonadin 5 mg tablete 5 mg tablett, filmdrasjert oral bruk 7

8 Kroatia Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Croatia Zonadin 10 mg tablete Kroatia Sandoz d.o.o., Maksimirska 120, Zagreb, 1000, Croatia Sanval 5 mg filmom obložene tablete 5 mg tablett, filmdrasjert oral bruk Kroatia Sandoz d.o.o., Maksimirska 120, Zagreb, 1000, Croatia Sanval 10 mg filmom obložene tablete Kypros Tsjekkia Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14 Lefkosia 2015 Cyprus ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče Stilnox ADORMA 5 MG 5 mg tablett, filmdrasjert oral bruk Tsjekkia ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče ADORMA 10 MG 8

9 Tsjekkia Tsjekkia Tsjekkia Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Netherlands Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire - Potters Bar United Kingdom Krka, d.d., Novo mesto Šmarješka cesta Novo mesto APO-ZOLPIDEM 10 MG ZOLPIDEM MYLAN ZOLSANA 10 MG Tsjekkia MEDA Pharma s.r.o. Kodaňská 1441/ Prague 10 Czech Republic EDLUAR 5 MG SUBLINGVÁLNÍ TABLETY 5 mg sublingvaltablett sublingval bruk Tsjekkia MEDA Pharma s.r.o. Kodaňská 1441/ Prague 10 Czech Republic EDLUAR 10 MG SUBLINGVÁLNÍ TABLETY 10 mg sublingvaltablett sublingval bruk Tsjekkia Orion Corporation Orionintie 1/A FI Espoo Finland ZOLPIDEM ORION 10 MG 9

10 Tsjekkia Tsjekkia Tsjekkia Tsjekkia Tsjekkia ratiopharm GmbH Graf Arco Strasse 3 D Ulm SANDOZ s.r.o. U nákladového nádraží 3265/ Prague 3 Czech Republic sanofi-aventis, s.r.o. Evropská 846/176a Prague 6 - Vokovice Czech Republic SVUS Pharma a.s., Smetanovo nábřeží 1238/20a Hradec Králové Czech Republic Takeda GmbH Byk-Gulden-Str Konstanz ZOLPIDEM-RATIOPHARM 10 MG SANVAL 10 MG STILNOX ZOLPINOX HYPNOGEN Tsjekkia Vitabalans Oy Varastokatu Hämeenlinna Finland ZOLPIDEM VITABALANS 10 MG POTAHOVANÉ TABLETY 10

11 Danmark Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Zolpidem "Actavis" Danmark Danmark Danmark Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire - Potters Bar United Kingdom HEXAL A/S, Kanalholmen 8-12, DK Hvodovre, Denmark Zolpidem "Actavis" 5 mg tablett, filmdrasjert oral bruk Zolpidem "Generics" Zolpidem "Hexal" Danmark Meda AS, Solvang 8, DK-3450 Allerød, Denmark Edluar 5 mg sublingvaltablett sublingval bruk Danmark Meda AS, Solvang 8, DK-3450 Allerød, Denmark Edluar 10 mg sublingvaltablett sublingval bruk 11

12 Danmark PharmaCoDane ApS, Marielundvej 46 A, DK-2730 Herlev, Denmark Zonoct Danmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark Stilnoct Danmark Synthon BV, Microweg 22, NL-6545 CM Nijmegen, Zolpidem "Genthon" 5 mg tablett, filmdrasjert oral bruk Danmark Synthon BV, Microweg 22, NL-6545 CM Nijmegen, Zolpidem "Genthon" Danmark Estland Vitabalans Oy Varastokatu Hämeenlinna Finland Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Zolpidem "Vitabalans" ZOLSANA 5 mg tablett oral bruk 12

13 Estland Estland Estland Estland Estland Estland Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Sandoz d.d. Verovškova 57, 1000 Ljubljana, Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/ Tallinn Estonia Takeda GmbH 2 Byk-Gulden Strasse Konstanz ZOLSANA 10 mg tablett oral bruk EDLUAR 5 mg sublingvaltablett oral bruk EDLUAR 10 mg sublingvaltablett oral bruk ZOLPIDEM SANDOZ 10 MG 10 mg tablett oral bruk STILNOX 10 mg tablett oral bruk HYPNOGEN 10 mg tablett oral bruk 13

14 Estland Finland Finland Finland Finland Finland Vitabalans Oy Varastokatu Hämeenlinna Finland Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Hexal A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Denmark Meda Oy Vaisalantie Espoo Finland Meda Oy Vaisalantie Espoo Finland ZOLPIDEM VITABALANS 10MG 10 mg tablett oral bruk Stella 5 mg tablett, filmdrasjert oral bruk Stella Zolpidem Hexal Edluar 5 mg sublingvaltablett sublingval bruk Edluar 10 mg sublingvaltablett sublingval bruk 14

15 Finland Finland Finland Finland Frankrike Frankrike Orion Corporation Orionintie 1/A FI Espoo Finland ratiopharm GmbH Graf Arco Strasse 3 D Ulm Sanofi Oy Huopalahdentie 24 P.O.Box Helsinki Finland Vitabalans Oy Varastokatu Hämeenlinna Finland LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf Villebon Sur Yvette France Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Somnor Zolpidem-Ratiopharm Stilnoct Zolpidem Vitabalans ZOLPIDEM ALTER ZOLPIDEM ACTAVIS 10 MG tablett, filmdrasjert oral bruk 15

16 Frankrike ARROW GENERIQUES 26, avenue Tony Garnier Lyon France ZOLPIDEM ARROW Frankrike Frankrike BIOGARAN 15, boulevard Charles de Gaulle Colombes FRANCE BIOGARAN 15, boulevard Charles de Gaulle Colombes FRANCE ZOLPIDEM ALMUS ZOLPIDEM BIOGARAN Frankrike CRISTERS 22 quai Gallieni Suresnes France ZOLPIDEM CRISTERS Frankrike CTRS Route de la Ganne Saint Benoit du Sault France ZOLPIDEM CTRS Frankrike EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou Boulogne Billancourt Cedex France ZOLPIDEM EG 16

17 Frankrike Frankrike Frankrike Frankrike Frankrike Frankrike EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou Boulogne Billancourt Cedex France Genfarma B.V. Postbus GB Zaandam Kiron Pharmaceutica BV Groesbeekseweg 11 Nijmegen, 6524 CK MEDA PHARMA 25, boulevard de l'amiral Bruix Paris FRANCE MEDA PHARMA 25, boulevard de l'amiral Bruix Paris FRANCE MYLAN SAS 117, allée des Parcs Saint-Priest France ZOLPIDEM EG 10 mg tablett, drasjert oral bruk ZOLPIDEM RATIOPHARM 10 mg tablett, drasjert oral bruk ZOLPIDEM KIRION 5 mg tablett, filmdrasjert oral bruk EDLUAR 5 mg sublingvaltablett oral bruk EDLUAR 10 mg sublingvaltablett oral bruk ZOLPIDEM MYLAN 17

18 Frankrike Frankrike PHARMACHEMIE BV Swensweg 5 - Haarlem PO Box RN Haarlem PAYS-BAS RANBAXY PHARMACIE GENERIQUES Quai Dion Bouton Puteaux FRANCE ZOLPIDEM TEVA 10 mg tablett, drasjert oral bruk ZOLPIDEM RPG Frankrike RATIOPHARM GMBH Graf Arco Strasse Ulm ALLEMAGNE ZOLPIDEM RATIOPHARM Frankrike SANDOZ 49, avenue Georges Pompidou Levallois-Perret France ZOLPIDEM GNR Frankrike SANDOZ 49, avenue Georges Pompidou Levallois-Perret France ZOLPIDEM GENERES Frankrike SANDOZ 49, avenue Georges Pompidou Levallois-Perret France ZOLPIDEM SANDOZ Frankrike SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland Paris France STILNOX 18

19 Frankrike SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland Paris France ZOLPIDEM ZENTIVA Frankrike Synthon BV, Microweg 22, NL-6545 CM Nijmegen, ZOLPIDEM BAYER Frankrike Synthon BV, Microweg 22, NL-6545 CM Nijmegen, ZOLPIDEM BAYER 5 mg tablett, filmdrasjert oral bruk Frankrike Frankrike TEVA SANTE 110, Esplanade du Général de Gaulle Paris La Défense Cedex FRANCE ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d Activités des Peupliers Nanterre FRANCE ZOLPIDEM TEVA ZOLPIDEM ZYDUS Tyskland 1 A Pharma Keltenring Oberhaching Zolpidem 10-1A-Pharma 19

20 Tyskland AbZ-Pharma GmbH Graf-Arco-Str Ulm Zolpidem AbZ 10 mg Filmtabletten Tyskland Actavis Deutschland GmbH & Co.KG Willy-Brandt-Allee München Zolpidem-Actavis 10 mg Filmtabletten Tyskland Tyskland Tyskland Tyskland Tyskland Aliud Pharma GmbH Gottlieb-Daimler-Str Laichingen Aliud Pharma GmbH Gottlieb-Daimler-Str Laichingen Aristo Pharma GmbH Wallenroder Str Berlin AbZ-Pharma GmbH Graf-Arco-Str Ulm AbZ-Pharma GmbH Graf-Arco-Str Ulm Zolpidem AL 10 mg Filmtabletten Zolpidem AL 5 mg Filmtabletten 5 mg tablett, filmdrasjert oral bruk Zolpidem Aristo 10 mg Filmtabletten Zolpidem-CT 10 mg Filmtabletten Zolpidem-CT 5 mg Filmtabletten 5 mg tablett, filmdrasjert oral bruk 20

21 Tyskland Tyskland Tyskland Tyskland Tyskland Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str Sankt Augustin Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Hexal Aktiengesellschaft Industriestr Holzkirchen IPCA - Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote Lj Esq Povoa de Santa Iria Zolpidem real 10 mg Filmtabletten Zolpidem Heumann 10 mg Filmtabletten Zolpidem Heumann 5 mg 5 mg tablett, filmdrasjert oral bruk Filmtabletten Zolpidem Hexal 10 mg Filmtabletten Zolpidem IPCA 10 mg Filmtabletten 21

22 Tyskland IPCA - Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote Lj Esq Povoa de Santa Iria Zolpidem IPCA 5 mg Filmtabletten 5 mg tablett, filmdrasjert oral bruk Tyskland Tyskland Juta Pharma GmbH Gutenbergstr Flensburg Krewel Meuselbach GmbH Krewelstr Eitorf Zolpi-Q 10 mg Filmtabletten Zolpinox 10 mg Tyskland Tyskland Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Edluar 10 mg Sublingualtabletten 10 mg sublingvaltablett oral bruk Edluar 5 mg Sublingualtabletten 5 mg sublingvaltablett oral bruk 22

23 Tyskland Tyskland Mylan dura GmbH Wittichstr Darmstadt neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str Langenfeld Zolpidem dura 10 mg Filmtabletten Zolpidem-neuraxpharm 10 mg Filmtabletten Tyskland neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str Langenfeld Zolpidem-neuraxpharm 5 mg Filmtabletten 5 mg tablett, filmdrasjert oral bruk Tyskland ratiopharm GmbH Graf Arco Strasse 3 D Ulm Zolpidem-ratiopharm 10 mg Filmtabletten Tyskland ratiopharm GmbH Graf Arco Strasse 3 D Ulm Zolpidem-ratiopharm 5 mg Filmtabletten 5 mg tablett, filmdrasjert oral bruk Tyskland Sandoz Pharmaceuticals GmbH Raiffeisenstr Holzkirchen Zolpidem Sandoz 10 mg Filmtabletten 23

24 Tyskland Tyskland Tyskland Tyskland Tyskland Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K Frankfurt am Main Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K Frankfurt am Main Stadapharm GmbH Stadastr Bad Vilbel Stadapharm GmbH Stadastr Bad Vilbel TAD Pharma GmbH Heinz-Lohmann-Str Cuxhaven Bikalm Stilnox Zolpidem STADA 10 mg Filmtabletten Zolpidem STADA 5 mg Filmtabletten 5 mg tablett, filmdrasjert oral bruk Zolpidem TAD 10 mg Tyskland Vitabalans Oy Varastokatu Hämeenlinna Finland Zolpidem Vitabalans 10 mg Filmtabletten 24

25 Tyskland Hellas Hellas Hellas Hellas Ungarn Winthrop Arzneimittel GmbH Brüningstr Frankfurt am Main IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES ABEE, INTERMED ABEE, Kalyftaki 27, Kifissia Greece ITF HELLAS S.A. Areos 103 and Ag. Triados 36, Palaio Faliro Greece ITF PHARMA KERESKEDELMI ES SZOLGALTATO KFT, BUDAPEST, HUNGAR H-1056, Budapest Duna u.1 Hungary SANOFI-AVENTIS AEBE 348 SYNGROU AVENUE, BUILDING A, KALLITHEA Greece EGIS Gyógyszergyár Nyrt. Keresztúri út Budapest 1106 Hungary Zolpi-Lich 10 mg Filmtabletten HYPNONORM ONIRIA 10 mg/ml dråper, oppløsning oral bruk KALINICTA 10 mg/ml dråper, oppløsning oral bruk STILNOX PIDEZOL 10 mg filmtabletta 25

26 Ungarn Ungarn ExtractumPharma zrt. Megyeri út 64. Budapest 1044 Hungary Generics (UK) Ltd. Albany Gate, Darkes Lane, Potters bar Herts EN61AG United Kingdom ZOLEP 10 mg filmtabletta SOMNOGEN 10 mg filmtabletta Ungarn ITF Pharma Kft Duna u. 1. Budapest 1056 Hungary ONIRIA 10 mg/ml belsőleges oldatos cseppek 10 mg/ml dråper, oppløsning oral bruk Ungarn Krka d.d. Novo Mesto Smarjeska cesta 6. Novo Mesto 8501 ZOLSANA 5 mg filmtabletta 5 mg tablett, filmdrasjert oral bruk Ungarn Krka d.d. Novo Mesto Smarjeska cesta 6. Novo Mesto 8501 ZOLSANA 10 mg filmtabletta Ungarn LEK Pharmaceuticals d.d. Verovskova 57 Ljubljana SANVAL 5 mg filmtabletta 5 mg tablett, filmdrasjert oral bruk 26

27 Ungarn Ungarn LEK Pharmaceuticals d.d. Verovskova 57 Ljubljana Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary SANVAL 10 mg filmtabletta EDLUAR 5 mg nyelvalatti tabletta 5 mg sublingvaltablett sublingval bruk Ungarn Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary EDLUAR 10 mg nyelvalatti tabletta 10 mg sublingvaltablett sublingval bruk Ungarn Ungarn Sanofi-Aventis Magyarország Zrt Tó u. 1-5 Budapest 1045 Hungary Teva Magyarország Zrt Repülőtéri út 5. Gödöllő 2100 Hungary STILNOX 10 mg filmtabletta ZOLPIDEM-RATIOPHARM 10 mg filmtabletta Ungarn Vitabalans Oy Varastokatu 8. Hämeenlinna Finland ZOLPIDEM VITABALANS 10 mg filmtabletta 27

28 Ungarn Vulm CZ a.s. Olivova 1888 Ricany Czech Republic INSOM 10 mg pezsgőtabletta 10 mg brusetablett oral bruk Ungarn Zentiva k.s. Dolny Mecholupy, U kabelovny 130 Prague Czech Republic HYPNOGEN 10 mg filmtabletta Ísland LYFIS ehf., Grensásvegur 22, 108 Reykjavík, Iceland Zolpidem LYFIS Ísland Meda AB, Pipers väg 2A, Box 906, SE , Sweden Edluar 5 mg sublingvaltablett oral bruk Ísland Meda AB, Pipers väg 2A, Box 906, SE , Sweden Edluar 10 mg sublingvaltablett oral bruk Ísland Mylan AB, Ynglingagatan 14, Stockholm, Sweden. Zolpidem Mylan 28

29 Ísland Sanofi Aventis Norge Stranden 15, 1366 Lysaker, Norway Stilnoct 5 mg tablett, filmdrasjert oral bruk Ísland Sanofi Aventis Norge Stranden 15, 1366 Lysaker, Norway Stilnoct Irland Irland Irland Irland Clonmel Healthcare Ltd Waterford Road Clonmel Co. Tipperary Ireland Clonmel Healthcare Ltd Waterford Road Clonmel Co. Tipperary Ireland McDermott Laboratories Ltd t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland Meda Health Sales Ireland Limited Unit 34/35 Block A Dunboyne Business Park Dunboyne Co Meath Ireland Nytamel 5 mg Film-coated Tablets 5 mg tablett, filmdrasjert oral bruk Nytamel 10 mg Film-coated Tablets. Zoldem 10 mg film coated tablets Edluar 5 mg sublingual tablets 5 mg sublingvaltablett oral bruk 29

30 Irland Irland Irland Meda Health Sales Ireland Limited Unit 34/35 Block A Dunboyne Business Park Dunboyne Co Meath Ireland Rowex Ltd, Bantry, Co. Cork, Ireland Sanofi-Aventis Ireland Limited T/A Sanofi, Citywest Business Campus, Dublin 24, Ireland Edluar 10 mg sublingual tablets 10 mg sublingvaltablett oral bruk Zolnod 10mg film-coated tablets Stilnoct 5mg Film-coated Tablets 5 mg tablett, filmdrasjert oral bruk Irland Sanofi-Aventis Ireland Limited T/A Sanofi, Citywest Business Campus, Dublin 24, Ireland Stilnoct 10mg Film-coated Tablets Irland Teva Pharma B. V. Computerweg DR Utrecht Irland Teva Pharma B. V. Computerweg DR Utrecht Zolpidem Tartrate Teva 5 mg Filmcoated Tablets Zolpidem Tartrate Teva 10 mg Filmcoated Tablets 5 mg tablett, filmdrasjert oral bruk 30

31 Italia Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland ZOLPIDEM ACTAVIS Italia Doc Generici S.r.l. Turati 40, Milano Italy ZOLPIDEM DOC GENERICI 5 mg tablett, filmdrasjert oral bruk Italia Doc Generici S.r.l. Turati 40, Milano Italy ZOLPIDEM DOC GENERICI Italia EG S.p.a. Via Scarlatti, 31, Milano Italy ZOLPIDEM EG Italia Italia FIDIA Farmaceutici S.p.a. Via Ponte della Fabbrica, 3/a, Abano Terme, Padova Italy HEXAL S.p.a. Largo Umberto Boccioni Origgio Varese Italy OPSYCON ZOLPIDEM HEXAL 31

32 Italia IPCA - Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote Lj Esq Povoa de Santa Iria ZOLPIDEM IPCA 5 mg tablett, filmdrasjert oral bruk Italia Italia IPCA - Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote Lj Esq Povoa de Santa Iria ITALFARMACO S.p.A. Viale Fulvio Testi 330, Milano, Italy ZOLPIDEM IPCA SONIREM 10 mg/ml dråper, oppløsning oral bruk Italia LIFEPHARMA S.P.A. Via dei Lavoratori 54, Cinisello Balsamo, Milano - Italy ZOLPREM 10 mg/ml dråper, oppløsning oral bruk Italia MEDA PHARMA S.P.A., Viale brenta 18, Milano - Italy ZOLPEDUAR 5 mg sublingvaltablett oral bruk 32

33 Italia MEDA PHARMA S.P.A., Viale brenta 18, Milano - Italy ZOLPEDUAR 10 mg sublingvaltablett oral bruk Italia Italia Italia Ratiopharm GmbH Graf Arco Strasse 3 D Ulm Sandoz S.p.a. Largo Umberto Boccioni, 1, Origgio, Varese Italy Sanofi-aventis SpA, Viale Bodio 37/b, Milano Italy ZOLPIDEM RATIOPHARM ZOLPIDEM SANDOZ STILNOX Italia Sanofi-aventis SpA, Viale Bodio 37/b, Milano Italy NOTTEM Italia Teva Italia S.r.l. - via Messina Milano Italy ZOLPIDEM TEVA 33

34 Italia ZENTIVA ITALIA S.R.L. - Viale Bodio 37/b, Milano Italy ZOLPIDEM ZENTIVA Latvia Latvia Latvia Latvia Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Zolsana 5 mg coated tablets 5 mg tablett, drasjert oral bruk Zolsana 10 mg coated tablets 10 mg tablett, drasjert oral bruk Edluar 5 mg sublingual tablets 5 mg sublingvaltablett sublingval bruk Edluar 10 mg sublingual tablets 10 mg sublingvaltablett sublingval bruk Latvia Sandoz d.d. Verovškova 57, 1000 Ljubljana, Zolpidem Sandoz 10 mg film-coated tablets 34

35 Latvia sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia Stilnox 10 mg film-coated tablets Latvia Vitabalans Oy Varastokatu Hämeenlinna Finland Zolpidem Vitabalans 10 mg filmcoated tablets Latvia Zentiva, k.s. U kabelovny 130 Prague 10, Dolni Mecholupy Czech Republic Hypnogen 10 mg film-coated tablets Litauen Litauen Litauen Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Sandoz d.d. Verovškova 57, 1000 Ljubljana, Zolsana Zolsana 5 mg tablett, filmdrasjert oral bruk Zolpidem Sandoz 35

36 Litauen UAB SANOFI-AVENTIS LIETUVA A. Juozapavičiaus 6/2 g. LT Vilnius Lithuania Stilnox Litauen Litauen Luxemburg Luxemburg Luxemburg Vitabalans Oy Varastokatu Hämeenlinna Finland Zentiva, k.s. U kabelovny 130 Prague 10, Dolni Mecholupy Czech Republic MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium SANOFI BELGIUM Airport Plaza, Montreal Building, Leonardo Da Vincilaan Diegem Belgium Eurogenerics S.A. Esplanade Heysel, b Bruxelles Belgium Zolpidem Vitabalans HYPNOGEN Dodorest 10 mg tablett, drasjert oral bruk Stilnoct 10 mg tablett, drasjert oral bruk Zolpidem EG cpr.eff. 10 mg brusetablett oral bruk 36

37 Luxemburg Luxemburg Luxemburg Luxemburg Luxemburg Eurogenerics S.A. Esplanade Heysel, b Bruxelles Belgium Genthon BV Microweg, Nijmegen Genthon BV Microweg, Nijmegen Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Zolpidem EG cpr.pellic. 10 mg tablett, drasjert oral bruk Zolpidem Genthion 10 mg tablett, drasjert oral bruk Zolpidem Genthion 5 mg tablett, drasjert oral bruk Zolpitop 10 mg tablett, drasjert oral bruk Zolpitop 5 mg tablett, drasjert oral bruk Luxemburg MEDA PHARMA Chaussee de la Hulpe Watermael-Boitsfort Belgium Zolpeduar 10 mg sublingvaltablett sublingval bruk 37

38 Luxemburg Malta Malta Norge MEDA PHARMA Chaussee de la Hulpe Watermael-Boitsfort Belgium Sanofi Malta Ltd. St. Julian s Rd. San Gwann SGN 2805 Malta Pharma MT 103, Stuart Street, Gzira, Malta Sanofi Aventis Norge Stranden 15, 1366 Lysaker, Norway Zolpeduar 5 mg sublingvaltablett sublingval bruk Stilnox Nytamel Stilnoct 5 mg tablett, filmdrasjert oral bruk Norge Sanofi Aventis Norge Stranden 15, 1366 Lysaker, Norway Stilnoct Norge Actavis Norway AS, P.O.BOX 409, 0213 Skoyen, OSLO, Norway Zolpidem Actavis 5 mg tablett, filmdrasjert oral bruk 38

39 Norge Actavis Norway AS, P.O.BOX 409, 0213 Skoyen, OSLO, Norway Zolpidem Actavis Norge Meda Norge, P.O.BOX 194, 1371 ASKER, Norway Edluar 5 mg sublingvaltablett oral bruk Norge Meda Norge, P.O.BOX 194, 1371 ASKER, Norway Edluar 10 mg sublingvaltablett oral bruk Norge Polen Polen Vitabalans Oy Varastokatu Hämeenlinna Finland Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Zolpidem Vitabalans Noxizol Apo-Zolpin 39

40 Polen Polen Polen Polen Polen Farma-Projekt Sp. z o.o. ul. Józefińska Kraków Poland Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire - Potters Bar United Kingdom Ipca, Produtos Farmaceuticos, Unipessoal Lda Rua Chanceler-Mor 11 R/c Frt. Cacem Ipca, Produtos Farmaceuticos, Unipessoal Lda Rua Chanceler-Mor 11 R/c Frt. Cacem Italfarmaco S.p.A. Viale Fulvio Milano Italy Xentic ZolpiGen Zolpidem IPCA 5 mg tablett, filmdrasjert oral bruk Zolpidem IPCA Sonirem 10 mg/ml dråper, oppløsning oral bruk 40

41 Polen Polen Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Zolsana Edluar 5 mg sublingvaltablett oral bruk Polen Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Edluar 10 mg sublingvaltablett oral bruk Polen Polen Orion Corporation Orionintie 1/A FI Espoo Finland Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J. Piłsudskiego Pabianice Poland Onirex Polsen 41

42 Polen Polen Polen Polen Polen Polen Pfizer Europe MA EEIG Ramsgate Road Kent, Sandwich CT13 9 NJ United Kingdom Polfarmex S.A. Józefów Kutno Poland Sandoz GmbH ul. Biochemiestrasse 10 Kundli 6250 Austria Sanofi-Aventis France 1-13 boulevard Romain Rolland Paris France Vitabalans Oy Varastokatu Hämeenlinna Finland VULM CZ, a.s. Olivova 1888 Ricany Czech Republic Zolpidem Pfizer Nasen Sanval Stilnox Zolpidem Vitabalans Insom 10 mg brusetablett oral bruk 42

43 Polen Polen Zakłady Farmaceutyczne POLPHARMA S.A. Pelplińska Starogard Gdański Poland Zentiva, k.s. U kabelovny 130 Prague 10, Dolni Mecholupy Czech Republic Actavis A/S Sucursal Rua Virgílio Correia, 11 - A Lisboa Aurobindo Pharma (), Unipessoal Lda. Av. do Forte, nº 3 - Parque Suécia, Edifício. IV, 2º Carnaxide Aurobindo Pharma (), Unipessoal Lda. Av. do Forte, nº 3 - Parque Suécia, Edifício. IV, 2º Carnaxide Zolpic Hypnogen Zolpidem Actavis Zolpidem Aurobindo 5 mg tablett, filmdrasjert oral bruk Zolpidem Aurobindo 43

44 Cinfa, Lda. Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark Carnaxide Zolpidem Cinfa 10 mg Comprimidos Generis Farmacêutica, S.A. Rua João de Deus, Amadora Zolpidem Generis 5 mg Comprimidos Revestidos 5 mg tablett, filmdrasjert oral bruk Generis Farmacêutica, S.A. Rua João de Deus, Amadora Zolpidem Generis 10 mg Comprimidos Revestidos Genthon GmbH Groesbeeker Weg, 1 D Kranenburg Zolpidem 5 mg Comprimidos Revestidos 5 mg tablett, filmdrasjert oral bruk IPCA - Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote Lj Esq Povoa de Santa Iria Zolpidem IPCA 5 mg tablett, filmdrasjert oral bruk 44

45 IPCA - Produtos Farmacêuticos Unipessoal, Lda. Rua José Nogueira Vaz, Lote Lj Esq Povoa de Santa Iria Zolpidem IPCA Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, Campo de Besteiros Zolpidem Labesfal Laboratórios Azevedos - Indústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide Amadora Meda Pharma - Produtos Farmacêuticos, S.A. Rua do Centro Cultural, Lisboa Meda Pharma - Produtos Farmacêuticos, S.A. Rua do Centro Cultural, Lisboa Cymerion Edluar 5 mg sublingvaltablett sublingval bruk Edluar 10 mg sublingvaltablett sublingval bruk 45

46 Mylan, Lda. Parque Expo, Edifício Atlantis, Avenida D. João II, Lote C e Lisboa Zolpidem Mylan Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso Porto Salvo Zolpidem Ratiopharm 10 mg Comprimidos Revestidos Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2º - Escritório Sintra Zolpidem Sandoz Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7, 3º Piso Porto Salvo Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras Lisboa Stilnox Zolpidem Wynn 46

47 Romania Romania Romania ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče ITALFARMACO S.p.A. Viale Fulvio Testi 330, Milano, Italia ZADOBRA 5 mg 5 mg tablett, filmdrasjert oral bruk ZADOBRA 10 mg ONIRIA 10 mg/ml 10 mg/ml dråper, oppløsning oral bruk Romania Romania Romania Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Krka, d.d., Novo mesto Šmarješka cesta Novo mesto LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B Sector 3, Bucureşti, România ZOLSANA 5 mg 5 mg tablett, filmdrasjert oral bruk ZOLSANA 10 mg ZOLPIDEM 10 mg 47

48 Romania Romania Romania Romania LEK farmacevtska družba d.d. Verovškova Ljubljana Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h S.C. ANTIBIOTICE S.A., Str. Valea Lupului nr.1, Iaşi, România SANVAL 10 mg EDLUAR 5 mg 5 mg sublingvaltablett oral bruk EDLUAR 10 mg 10 mg sublingvaltablett oral bruk ZOLPIDEM ATB 10 mg Romania SANOFI-AVENTIS ROMÂNIA S.R.L. Str. Izvor, Nr. 80, Et Sector 5, Bucureşti, România STILNOX 10 mg Slovakia ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče ADORMA 5 mg filmom obalené tablety 5 mg tablett, filmdrasjert oral bruk 48

49 Slovakia ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče ADORMA 10 mg filmom obalené tablety Slovakia Slovakia Slovakia Slovakia Slovakia Generics [UK] Ltd. Station Close EN6 1TL Hertfordshire - Potters Bar United Kingdom Orion Corporation Orionintie 1/A FI Espoo Finland Sandoz d.d. Verovškova 57, 1000 Ljubljana, Sandoz d.d. Verovškova 57, 1000 Ljubljana, sanofi-aventis Slovakia s.r.o. Einsteinova Bratislava Slovak Republic Zolpidem Mylan 10 mg Zolpidem Orion 10 mg SANVAL 5 mg 5 mg tablett, filmdrasjert oral bruk SANVAL 10 mg STILNOX 49

50 Slovakia Slovakia SVUS Pharma a.s., Smetanovo nábřeží 1238/20a Hradec Králové Czech Republic Takeda GmbH 2 Byk-Gulden Strasse Konstanz ZOLPINOX HYPNOGEN Slovakia Vitabalans Oy Varastokatu Hämeenlinna Finland Zolpidem Vitabalans 10 mg filmom obalené tablety ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče Perluna 10 mg filmsko obožene tablete ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče Perluna 5 mg filmsko obožene tablete 5 mg tablett, filmdrasjert oral bruk Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Zolsana 10 mg filmsko obložene tablete 50

51 Krka, d.d., Novo mesto Šmarješka cesta Novo mesto Zolsana 5 mg filmsko obložene tablete 5 mg tablett, filmdrasjert oral bruk LEK farmacevtska družba d.d. Verovškova Ljubljana Sanval 10 mg filmsko obožene tablete LEK farmacevtska družba d.d. Verovškova Ljubljana Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Meda Pharma GmbH & Co. KG Benzstrasse 1 Bad Homburg v.d.h Sanval 5 mg filmsko obložene tablete 5 mg tablett, filmdrasjert oral bruk Edluar 10 mg podjezične tablete 10 mg sublingvaltablett sublingval bruk Edluar 5 mg podjezične tablete 5 mg sublingvaltablett sublingval bruk Vitabalans Oy Varastokatu Hämeenlinna Finland Zolpidem Vitabalans 10 mg filmsko obložene tablete 51

52 Spania ANGELINI FARMACEUTICA, S.A. Osi, 7-9 Barcelona SPAIN DALPARAN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA Spania Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden ZOLPIDEM APOTEX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG Spania BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 - Area B, Aravaca (Madrid) SPAIN ZOLPIDEM BEXALABS 10 mg COMPRIMIDOS CON CUBIERTOS CON PELICULA EFG Spania BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 - Area B, Aravaca (Madrid) SPAIN ZOLPIDEM BEXAL 10 mg COMPRIMIDOS RECUBIERTOS EFG Spania FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid) SPAIN ZOLPIDEM FARMALIDER 10 mg COMPRIMIDOS RECUBIERTOS EFG Spania GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico Paterna (Valencia) SPAIN ZOLPIDEM DESGEN 5 mg COMPRIMIDOS EFG 5 mg tablett oral bruk 52

53 Spania GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico Paterna (Valencia) SPAIN ZOLPIDEM DESGEN 10 mg COMPRIMIDOS EFG 10 mg tablett oral bruk Spania GERMED FARMACEUTICA S.L. Chile, 8-2ª planta. Oficina 203, Las Matas (Madrid) SPAIN ZOLPIDEM EDIGEN 10 mg COMPRIMIDOS RECUBIERTOS EFG Spania LABORATORIO STADA, S.L. Frederic Mompou, 5, Sant Just Desvern (Barcelona) SPAIN ZOLPIDEM STADA 10 mg COMPRIMIDOS RECUBIERTOS EFG Spania LABORATORIOS CINFA, S.A. Olaz- Chipi, 10. Poligono Industrial Areta.Huarte-Pamplona (Navarra) SPAIN ZOLPIDEM CINFA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG Spania LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid) SPAIN ZOLPIDEM NORMON 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG Spania MEDA PHARMA S.A.U Avda. de Castilla, 2. Edif. Berlin. 2ª planta. Parque Empresarial San Fernando, San Fernando de Henares (Madrid) SPAIN EDLUAR 10 MG COMPRIMIDOS SUBLINGUALES 10 mg sublingvaltablett oral bruk 53

54 Spania MEDA PHARMA S.A.U Avda. de Castilla, 2. Edif. Berlin. 2ª planta. Parque Empresarial San Fernando, San Fernando de Henares (Madrid) SPAIN EDLUAR 5 MG COMPRIMIDOS SUBLINGUALES 5 mg sublingvaltablett oral bruk Spania MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5º Planta, Barcelona SPAIN ZOLPIDEM MYLAN 10 mg COMPRIMIDOS RECUBIERTOS EFG Spania PHARMAGENUS, S.A. Avda. Camí Real, Palau-solita i Plegamans (Barcelona) SPAIN Spania PHARMAGENUS, S.A. Avda. Camí Real, Palau-solita i Plegamans (Barcelona) SPAIN Spania RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas, Madrid SPAIN Spania RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas, Madrid SPAIN ZOLPIDEM PHARMAGENUS 5 mg COMPRIMIDOS ZOLPIDEM PHARMAGENUS 10 mg COMPRIMIDOS EFG ZOLPIDEM RATIOPHARM 10 mg COMPRIMIDOS RECUBIERTOS EFG ZOLPIDEM TEVAGEN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG 5 mg tablett oral bruk 10 mg tablett oral bruk 54

55 Spania RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas, Madrid SPAIN ZOLPIDEM TEVAGEN 5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA 5 mg tablett, filmdrasjert oral bruk Spania SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor, Aravaca (Madrid) Spain ZOLPIDEM SANDOZ 10 mg COMPRIMIDOS EFG 10 mg tablett oral bruk Spania SANOFI AVENTIS, S.A. Josep Plá, 2, Barcelona SPAIN STILNOX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA Spania TEVA GENERICOS ESPAÑOLA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B, 1 planta Alcobendas (Madrid) SPAIN ZOLPIDEM TEVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG Spania Zentiva, k.s. U kabelovny 130 Prague 10, Dolni Mecholupy Czech Republic ZOLPIDEM ZENTIVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG Sverige Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Zolpidem Actavis 5 mg tablett, filmdrasjert oral bruk 55

56 Sverige Sverige Sverige Sverige Actavis Group PTC ehf. Reykjavikurvegur IS-220 Hafnarfjördur Iceland Hexal A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Denmark Ranbaxy (UK) Ltd, Building 4 Chiswick Park London W4 5YE United Kingdom Ranbaxy (UK) Ltd, Building 4 Chiswick Park London W4 5YE United Kingdom Zolpidem Actavis Zolpidem HEXAL Zolpidem Ranbaxy 5 mg tablett, filmdrasjert oral bruk Zolpidem Ranbaxy Sverige Meda AB, Pipers väg 2A, Box 906, SE , Sweden Edluar 5 mg sublingvaltablett oral bruk Sverige Meda AB, Pipers väg 2A, Box 906, SE , Sweden Edluar 10 mg sublingvaltablett oral bruk 56

57 Sverige Sverige Sverige Sverige Sverige Sverige Mylan AB Box Stockholm Sweden Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark ratiopharm GmbH Graf Arco Strasse 3 D Ulm ratiopharm GmbH Graf Arco Strasse 3 D Ulm Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Denmark Zolpidem Mylan Zolpidem Orifarm 5 mg tablett, filmdrasjert oral bruk Zolpidem Orifarm Zolpidem ratiopharm 5 mg tablett, filmdrasjert oral bruk Zolpidem ratiopharm Zolpidem Sandoz 5 mg tablett, filmdrasjert oral bruk 57

58 Sverige Sverige Sverige Sverige Sverige Sverige Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Denmark sanofi-aventis AB Box Bromma Sweden sanofi-aventis AB Box Bromma Sweden STADA Arzneimittel AG Stadastrasse 2-18 DE Bad Vilbel STADA Arzneimittel AG Stadastrasse 2-18 DE Bad Vilbel Synthon BV, Microweg 22, NL-6545 CM Nijmegen, Zolpidem Sandoz Stilnoct 5 mg tablett, filmdrasjert oral bruk Stilnoct Zolpidem STADA 5 mg tablett, filmdrasjert oral bruk Zolpidem STADA Zolpidem Genthon 5 mg tablett, filmdrasjert oral bruk 58

59 Sverige Synthon BV, Microweg 22, NL-6545 CM Nijmegen, Zolpidem Genthon Sverige Vitabalans Oy Varastokatu Hämeenlinna Finland Zolpidem Vitabalans Actavis B.V. Baarnsche Dijk LN BAARN Zolpidemtartaat Actavis 5 mg, tabletten 5 mg tablett oral bruk Actavis B.V. Baarnsche Dijk LN BAARN Zolpidemtartraat Actavis 10 mg, tabletten 10 mg tablett oral bruk ADOH B.V. Godfried Bomansstraat JA NIJMEGEN Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten 10 mg brusetablett oral bruk Pharmachemie B.V. Swensweg GA HAARLEM Zolpidemtartraat 5 mg PCH, filmomhulde tabletten 5 mg tablett, filmdrasjert oral bruk 59

60 Pharmachemie B.V. Swensweg GA HAARLEM Zolpidemtartraat 10 mg PCH, filmomhulde tabletten ratiopharm B.V. Swensweg GA HAARLEM Zolpidemtartraat ratiopharm 5 mg, tabletten 5 mg tablett oral bruk ratiopharm B.V. Swensweg GA HAARLEM Zolpidemtartraat ratiopharm 10 mg, tabletten 10 mg tablett oral bruk ratiopharm B.V. Swensweg GA HAARLEM Zolpidemtartraat ratiopharm 5 mg, filmomhulde tabletten 5 mg tablett, filmdrasjert oral bruk ratiopharm B.V. Swensweg GA HAARLEM Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten ratiopharm B.V. Swensweg GA HAARLEM Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten 60

61 Sandoz B.V. Veluwezoom AH ALMERE Zolpidemtartraat Sandoz 10 mg, filmomhulde tabletten Sandoz B.V. Veluwezoom AH ALMERE Zolpidemtartraat Sandoz 5, filmomhulde tabletten 5 mg 5 mg tablett, filmdrasjert oral bruk Sandoz B.V. Veluwezoom AH ALMERE Zolpidemtartraat Sandoz 10,filmomhulde tabletten 10 mg Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 5 mg, filmomhulde tabletten 5 mg tablett, filmdrasjert oral bruk Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 10 mg, filmomhulde tabletten Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 5 mg, filmomhulde tabletten 5 mg tablett, filmdrasjert oral bruk 61

62 Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 10 mg, filmomhulde tabletten Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 5 mg, filmomhulde tabletten 5 mg tablett, filmdrasjert oral bruk Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 10 mg, filmomhulde tabletten ADOH B.V. Godfried Bomansstraat JA NIJMEGEN Zolpidemtartraat ADOH 10 mg, bruistabletten 10 mg brusetablett oral bruk Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Zolpidemtartraat Apotex 5 mg, filmomhulde tabletten 5 mg tablett, filmdrasjert oral bruk Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Zolpidemtartraat Apotex 10 mg, filmomhulde tabletten 62

63 Centrafarm B.V. Nieuwe Donk AC ETTEN LEUR Zolpidemtartraat CF 5 mg, filmomhulde tabletten 5 mg tablett, filmdrasjert oral bruk Centrafarm B.V. Nieuwe Donk AC ETTEN LEUR Zolpidemtartraat CF 10 mg, filmomhulde tabletten Eurogenerics S.A. Esplanade Heysel, b Bruxelles Belgium Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten 10 mg brusetablett oral bruk FIDIA Farmaceutici S.p.a. Via Ponte della Fabbrica, 3/a, Abano Terme, Padova Italy Zolpidemtartraat 10 mg, filmomhulde tabletten Genthon BV Microweg, Nijmegen Zolpidemtartraat 5 mg, filmomhulde tabletten 5 mg tablett, filmdrasjert oral bruk Genthon BV Microweg, Nijmegen Zolpidemtartraat 10 mg, filmomhulde tabletten 63

64 Meda Pharma B.V. Krijgsman DM AMSTELVEEN Edluar 5 mg, tablet voor sublinguaal gebruik 5 mg sublingvaltablett sublingval bruk Meda Pharma B.V. Krijgsman DM AMSTELVEEN Edluar 10 mg, tablet voor sublinguaal gebruik 10 mg sublingvaltablett sublingval bruk Mylan B.V. Dieselweg LB BUNSCHOTEN Zolpidemtartraat Mylan 10 mg, filmomhulde tabletten Pharmachemie B.V. Swensweg GA HAARLEM Zolpidemtartraat 5 PCH, filmomhulde tabletten 5 mg 5 mg tablett, filmdrasjert oral bruk Pharmachemie B.V. Swensweg GA HAARLEM Zolpidemtartraat 10 PCH, filmomhulde tabletten 10 mg Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA Stilnoct, tabletten 10 mg 10 mg tablett oral bruk 64

65 STADA Arzneimittel AG Stadastrasse 2-18 DE Bad Vilbel Zolpidemtartraat Stada 5 mg, filmomhulde tabletten 5 mg tablett, filmdrasjert oral bruk STADA Arzneimittel AG Stadastrasse 2-18 DE Bad Vilbel Zolpidemtartraat Stada 10 mg, filmomhulde tabletten Synthon B.V. Microweg CM NIJMEGEN Zolpidemtartraat 10 mg, filmomhulde tabletten Storbritannia Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom Zolpidem Tartrate 5mg tablets 5 mg tablett, filmdrasjert oral bruk Storbritannia Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom Zolpidem Tartrate 10mg tablets Storbritannia ALKALOID-INT d.o.o. Šlandrova ulica Ljubljana-Črnuče Zolpidem Tartrate 5mg film-coated tablets 5 mg tablett, filmdrasjert oral bruk 65

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