Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2014 to 30 June 2014 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2014-07-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014243EN.01001101.xml










25.7.2014   


EN


Official Journal of the European Union


C 243/11





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2014 to 30 June 2014
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
2014/C 243/02
—   Issuing, maintenance or modification of a national marketing authorisation











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




23.6.2014


Zolpidem


See Annex I


See Annex I


See Annex I


24.6.2014




30.6.2014


Crestor


See Annex II


See Annex II


See Annex II


1.7.2014






(1)  OJ L 311, 28.11.01, p. 67.


(2)  OJ L 311, 28.11.01, p. 1.



Annex I
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States










Member State in EEA


Marketing authorisation holder


Product name


Strength


Pharmaceutical form


Route of administration




Austria


G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria


Zoldem 5 mg — Filmtabletten


5 mg


film-coated tablet


oral use




Austria


G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria


Zoldem 10 mg — Filmtabletten


10 mg


film-coated tablet


oral use




Austria


G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria


Zolpidem G.L. 10 mg — Filmtabletten


10 mg


film-coated tablet


oral use




Austria


Hexal Pharma GmbH, Stella-Klein-Löw-Weg 17, 1020 Wien, Austria


Zolpidem ‘Hexal’ — Filmtabletten


10 mg


film-coated tablet


oral use




Austria


Meda Pharma GmbH, Guglgasse 15, 1110 Wien, Austria


Edluar 5 mg Sublingualtabletten


5 mg


sublingual tablet


sublingual use




Austria


Meda Pharma GmbH, Guglgasse 15, 1110 Wien, Austria


Edluar 10 mg Sublingualtabletten


10 mg


sublingual tablet


sublingual use




Austria


ratiopharm Arzneimittel Vertriebs-GmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria


Zolpidem ‘ratiopharm’ 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Austria


sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria


Ivadal — Filmtabletten


10 mg


film-coated tablet


oral use




Austria


STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Wien, Austria


Mondeal 10 mg — Filmtabletten


10 mg


film-coated tablet


oral use




Belgium


APOTEX NV
Av. du Bourg. Etienne Demunter 5 box 8
1090 Jette
Belgium


Zolpitop


10 mg


film-coated tablet


oral use




Belgium


APOTEX NV
Av. du Bourg. Etienne Demunter 5 box 8
1090 Jette
Belgium


Zolpitop


5 mg


film-coated tablet


oral use




Belgium


Eurogenerics S.A.
Esplanade Heysel, b22
1020 Bruxelles
Belgium


Zolpidem EG


10 mg


film-coated tablet


oral use




Belgium


Eurogenerics S.A.
Esplanade Heysel, b22
1020 Bruxelles
Belgium


Zolpidem EG


10 mg


effervescent tablet


oral use




Belgium


Ipca, Produtos Farmaceuticos, Unipessoal Lda
Rua Chanceler-Mor 11 R/c Frt.
Cacem
2735-615
Portugal


Zolpidem IPCA


5 mg


film-coated tablet


oral use




Belgium


Ipca, Produtos Farmaceuticos, Unipessoal Lda
Rua Chanceler-Mor 11 R/c Frt.
Cacem
2735-615
Portugal


Zolpidem IPCA


10 mg


film-coated tablet


oral use




Belgium


MEDA PHARMA
Chaussee de la Hulpe 166
1170 Watermael-Boitsfort
Belgium


Zolpeduar


5 mg


sublingual tablet


oral use




Belgium


MEDA PHARMA
Chaussee de la Hulpe 166
1170 Watermael-Boitsfort
Belgium


Zolpeduar


10 mg


sublingual tablet


oral use




Belgium


MYLAN BVBA/SPRL
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Zolpidem Mylan


10 mg


film-coated tablet


oral use




Belgium


SANDOZ N.V.
Telecom Gardens
Medialaan 40
1800 1800ilvoorde
Belgium


Zolpidem Sandoz


10 mg


film-coated tablet


oral use




Belgium


SANOFI BELGIUM
Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19
1831 Diegem
Belgium


Stilnoct


10 mg


tablet


oral use




Belgium


SANOFI BELGIUM
Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19
1831 Diegem
Belgium


Zolpidem Sanofi-Aventis Belgium


10 mg


film-coated tablet


oral use




Belgium


TEVA PHARMA BELGIUM NV
Laarstraat 16
2610 Wilrijk
Belgium


Zolpidem Teva


10 mg


film-coated tablet


oral use




Belgium


TEVA PHARMA BELGIUM NV
Laarstraat 16
2610 Wilrijk
Belgium


Zolpidem Ratiopharm


10 mg


film-coated tablet


oral use




Bulgaria


ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče Slovenia


Adorma


5 mg


film-coated tablet


oral use




Bulgaria


ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče Slovenia


Adorma


10 mg


film-coated tablet


oral use




Bulgaria


Krka, d.d., Novo mesto
Šmarješka cesta 6
8000 Novo mesto
Slovenia


Zolsana


5 mg


film-coated tablet


oral use




Bulgaria


Krka, d.d., Novo mesto
Šmarješka cesta 6
8000 Novo mesto
Slovenia


Zolsana


10 mg


film-coated tablet


oral use




Bulgaria


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


Edluar


5 mg


sublingual tablet


sublingual use




Bulgaria


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


Edluar


10 mg


sublingual tablet


sublingual use




Bulgaria


Sanofi-Aventis Bulgaria EOOD,
103 Alexander Stamboliiski Blvd. Building Sofia Tower
Sofia 1303
Bulgaria


Stilnox


10 mg


film-coated tablet


oral use




Croatia


Alkaloid d.o.o., Ulica grada Vukovara 226 F, Zagreb, Croatia


Lunata 5 mg filmom obložene tablete


5 mg


film-coated tablet


oral use




Croatia


Alkaloid d.o.o., Ulica grada Vukovara 226 F, Zagreb, Croatia


Lunata 10 mg filmom obložene tablete


10 mg


film-coated tablet


oral use




Croatia


Krka — farma d.o.o., Radnička cesta 48, Zagreb, Croatia


Zolsana 5 mg filmom obložene tablete


5 mg


film-coated tablet


oral use




Croatia


Krka — farma d.o.o., Radnička cesta 48, Zagreb, Croatia


Zolsana 10 mg filmom obložene tablete


10 mg


film-coated tablet


oral use




Croatia


Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Croatia


Zonadin 5 mg tablete


5 mg


film-coated tablet


oral use




Croatia


Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Croatia


Zonadin 10 mg tablete


10 mg


film-coated tablet


oral use




Croatia


Sandoz d.o.o., Maksimirska 120, Zagreb, 1000, Croatia


Sanval 5 mg filmom obložene tablete


5 mg


film-coated tablet


oral use




Croatia


Sandoz d.o.o., Maksimirska 120, Zagreb, 1000, Croatia


Sanval 10 mg filmom obložene tablete


10 mg


film-coated tablet


oral use




Cyprus


Sanofi-Aventis Cyprus Ltd
Charalambou Mouskou 14
Lefkosia 2015 Cyprus


Stilnox


10 mg


film-coated tablet


oral use




Czech Republic


ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče Slovenia


ADORMA 5 MG


5 mg


film-coated tablet


oral use




Czech Republic


ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče Slovenia


ADORMA 10 MG


10 mg


film-coated tablet


oral use




Czech Republic


Apotex Europe B.V.
Darwinweg 20
NL 2333 CR Leiden
Netherlands


APO-ZOLPIDEM 10 MG


10 mg


film-coated tablet


oral use




Czech Republic


Generics [UK] Ltd.
Station Close
EN6 1TL Hertfordshire — Potters Bar
United Kingdom


ZOLPIDEM MYLAN


10 mg


film-coated tablet


oral use




Czech Republic


Krka, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia


ZOLSANA 10 MG


10 mg


film-coated tablet


oral use




Czech Republic


MEDA Pharma s.r.o.
Kodaňská 1441/46
110 00 Prague 10
Czech Republic


EDLUAR 5 MG SUBLINGVÁLNÍ TABLETY


5 mg


sublingual tablet


sublingual use




Czech Republic


MEDA Pharma s.r.o.
Kodaňská 1441/46
110 00 Prague 10
Czech Republic


EDLUAR 10 MG SUBLINGVÁLNÍ TABLETY


10 mg


sublingual tablet


sublingual use




Czech Republic


Orion Corporation
Orionintie 1/A
FI-02200 Espoo
Finland


ZOLPIDEM ORION 10 MG


10 mg


film-coated tablet


oral use




Czech Republic


ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany


ZOLPIDEM-RATIOPHARM 10 MG


10 mg


film-coated tablet


oral use




Czech Republic


SANDOZ s.r.o.
U nákladového nádraží 3265/10
130 00 Prague 3
Czech Republic


SANVAL 10 MG


10 mg


film-coated tablet


oral use




Czech Republic


sanofi-aventis, s.r.o.
Evropská 846/176a
160 00 Prague 6 — Vokovice
Czech Republic


STILNOX


10 mg


film-coated tablet


oral use




Czech Republic


SVUS Pharma a.s., Smetanovo nábřeží 1238/20a
500 02 Hradec Králové Czech Republic


ZOLPINOX


10 mg


film-coated tablet


oral use




Czech Republic


Takeda GmbH
Byk-Gulden-Str. 2
78467 Konstanz
Germany


HYPNOGEN


10 mg


film-coated tablet


oral use




Czech Republic


Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland


ZOLPIDEM VITABALANS 10 MG POTAHOVANÉ TABLETY


10 mg


film-coated tablet


oral use




Denmark


Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjördur
Iceland


Zolpidem ‘Actavis’


10 mg


film-coated tablet


oral use




Denmark


Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjördur
Iceland


Zolpidem ‘Actavis’


5 mg


film-coated tablet


oral use




Denmark


Generics [UK] Ltd.
Station Close
EN6 1TL Hertfordshire — Potters Bar
United Kingdom


Zolpidem ‘Generics’


10 mg


film-coated tablet


oral use




Denmark


HEXAL A/S, Kanalholmen 8-12, DK-2650 Hvodovre, Denmark


Zolpidem ‘Hexal’


10 mg


film-coated tablet


oral use




Denmark


Meda AS, Solvang 8, DK-3450 Allerød, Denmark


Edluar


5 mg


sublingual tablet


sublingual use




Denmark


Meda AS, Solvang 8, DK-3450 Allerød, Denmark


Edluar


10 mg


sublingual tablet


sublingual use




Denmark


PharmaCoDane ApS, Marielundvej 46 A, DK-2730 Herlev, Denmark


Zonoct


10 mg


film-coated tablet


oral use




Denmark


sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark


Stilnoct


10 mg


film-coated tablet


oral use




Denmark


Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands


Zolpidem ‘Genthon’


5 mg


film-coated tablet


oral use




Denmark


Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands


Zolpidem ‘Genthon’


10 mg


film-coated tablet


oral use




Denmark


Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland


Zolpidem ‘Vitabalans’


10 mg


film-coated tablet


oral use




Estonia


Krka, d.d., Novo mesto
Šmarješka cesta 6
8000 Novo mesto
Slovenia


ZOLSANA


5 mg


tablet


oral use




Estonia


Krka, d.d., Novo mesto
Šmarješka cesta 6
8000 Novo mesto
Slovenia


ZOLSANA


10 mg


tablet


oral use




Estonia


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


EDLUAR


5 mg


sublingual tablet


oral use




Estonia


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


EDLUAR


10 mg


sublingual tablet


oral use




Estonia


Sandoz d.d.
Verovškova 57,
1000 Ljubljana,
Slovenia


ZOLPIDEM SANDOZ 10 MG


10 mg


tablet


oral use




Estonia


Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2
11317 Tallinn
Estonia


STILNOX


10 mg


tablet


oral use




Estonia


Takeda GmbH 2 Byk-Gulden Strasse
78467 Konstanz Germany


HYPNOGEN


10 mg


tablet


oral use




Estonia


Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland


ZOLPIDEM VITABALANS 10 MG


10 mg


tablet


oral use




Finland


Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjördur
Iceland


Stella


5 mg


film-coated tablet


oral use




Finland


Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjördur
Iceland


Stella


10 mg


film-coated tablet


oral use




Finland


Hexal A/S
Edvard Thomsens Vej 14
DK-2300 Köpenhamn S
Denmark


Zolpidem Hexal


10 mg


film-coated tablet


oral use




Finland


Meda Oy
Vaisalantie 4
02130 Espoo
Finland


Edluar


5 mg


sublingual tablet


sublingual use




Finland


Meda Oy
Vaisalantie 4
02130 Espoo
Finland


Edluar


10 mg


sublingual tablet


sublingual use




Finland


Orion Corporation
Orionintie 1/A
FI-02200 Espoo
Finland


Somnor


10 mg


film-coated tablet


oral use




Finland


ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany


Zolpidem-Ratiopharm


10 mg


film-coated tablet


oral use




Finland


Sanofi Oy
Huopalahdentie 24
P.O.Box 22
00350 Helsinki
Finland


Stilnoct


10 mg


film-coated tablet


oral use




Finland


Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland


Zolpidem Vitabalans


10 mg


film-coated tablet


oral use




France


LABORATOIRES ALTER
3, avenue de la Baltique
ZI de Courtaboeuf
91140 Villebon Sur Yvette France


ZOLPIDEM ALTER


10 mg


film-coated tablet


oral use




France


Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjördur
Iceland


ZOLPIDEM ACTAVIS


10 MG


film-coated tablet


oral use




France


ARROW GENERIQUES
26, avenue Tony Garnier
69007 Lyon France


ZOLPIDEM ARROW


10 mg


film-coated tablet


oral use




France


BIOGARAN
15, boulevard Charles de Gaulle
92700 Colombes FRANCE


ZOLPIDEM ALMUS


10 mg


film-coated tablet


oral use




France


BIOGARAN
15, boulevard Charles de Gaulle
92700 Colombes FRANCE


ZOLPIDEM BIOGARAN


10 mg


film-coated tablet


oral use




France


CRISTERS
22 quai Gallieni
92150 Suresnes France


ZOLPIDEM CRISTERS


10 mg


film-coated tablet


oral use




France


CTRS
Route de la Ganne
36170 Saint Benoit du Sault France


ZOLPIDEM CTRS


10 mg


film-coated tablet


oral use




France


EG LABO — LABORATOIRES EUROGENERICS
‘Le Quintet’ — bâtiment A
12, rue Danjou
92517 Boulogne Billancourt Cedex France


ZOLPIDEM EG


10 mg


film-coated tablet


oral use




France


EG LABO — LABORATOIRES EUROGENERICS
‘Le Quintet’ — bâtiment A
12, rue Danjou
92517 Boulogne Billancourt Cedex France


ZOLPIDEM EG


10 mg


coated tablet


oral use




France


Genfarma B.V.
Postbus 2062
1500 GB Zaandam
The Netherlands


ZOLPIDEM RATIOPHARM


10 mg


coated tablet


oral use




France


Kiron Pharmaceutica BV
Groesbeekseweg 11 Nijmegen, 6524 CK
The Netherlands


ZOLPIDEM KIRION


5 mg


film-coated tablet


oral use




France


MEDA PHARMA
25, boulevard de l'Amiral Bruix
75016 Paris
FRANCE


EDLUAR


5 mg


sublingual tablet


oral use




France


MEDA PHARMA
25, boulevard de l'Amiral Bruix
75016 Paris
FRANCE


EDLUAR


10 mg


sublingual tablet


oral use




France


MYLAN SAS
117, allée des Parcs
69800 Saint-Priest
France


ZOLPIDEM MYLAN


10 mg


film-coated tablet


oral use




France


PHARMACHEMIE BV
Swensweg 5 — Haarlem
PO Box 552
2003 RN Haarlem PAYS-BAS
The Netherlands


ZOLPIDEM TEVA


10 mg


coated tablet


oral use




France


RANBAXY PHARMACIE GENERIQUES
11-15 Quai Dion Bouton
92800 Puteaux FRANCE


ZOLPIDEM RPG


10 mg


film-coated tablet


oral use




France


RATIOPHARM GMBH
Graf Arco Strasse 3
89079 Ulm ALLEMAGNE


ZOLPIDEM RATIOPHARM


10 mg


film-coated tablet


oral use




France


SANDOZ
49, avenue Georges Pompidou
92300 Levallois-Perret France


ZOLPIDEM GNR


10 mg


film-coated tablet


oral use




France


SANDOZ
49, avenue Georges Pompidou
92300 Levallois-Perret France


ZOLPIDEM GENERES


10 mg


film-coated tablet


oral use




France


SANDOZ
49, avenue Georges Pompidou
92300 Levallois-Perret France


ZOLPIDEM SANDOZ


10 mg


film-coated tablet


oral use




France


SANOFI AVENTIS FRANCE
1-13, boulevard Romain Rolland
75014 Paris
France


STILNOX


10 mg


film-coated tablet


oral use




France


SANOFI AVENTIS FRANCE
1-13, boulevard Romain Rolland
75014 Paris France


ZOLPIDEM ZENTIVA


10 mg


film-coated tablet


oral use




France


Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands


ZOLPIDEM BAYER


10 mg


film-coated tablet


oral use




France


Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands


ZOLPIDEM BAYER


5 mg


film-coated tablet


oral use




France


TEVA SANTE
110, Esplanade du Général de Gaulle
92931 Paris La Défense Cedex FRANCE


ZOLPIDEM TEVA


10 mg


film-coated tablet


oral use




France


ZYDUS FRANCE
25, rue des Peupliers
ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers
92000 Nanterre FRANCE


ZOLPIDEM ZYDUS


10 mg


film-coated tablet


oral use




Germany


1 A Pharma
Keltenring 1 + 3
82041 Oberhaching
Germany


Zolpidem 10 — 1A-Pharma


10 mg


film-coated tablet


oral use




Germany


AbZ-Pharma GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany


Zolpidem AbZ 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


Actavis Deutschland GmbH & Co. KG
Willy-Brandt-Allee 2
81829 München
Germany


Zolpidem-Actavis 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


Aliud Pharma GmbH
Gottlieb-Daimler-Str. 19
89150 Laichingen
Germany


Zolpidem AL 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


Aliud Pharma GmbH
Gottlieb-Daimler-Str. 19
89150 Laichingen
Germany


Zolpidem AL 5 mg Filmtabletten


5 mg


film-coated tablet


oral use




Germany


Aristo Pharma GmbH
Wallenroder Str. 8-10
13435 Berlin
Germany


Zolpidem Aristo 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


AbZ-Pharma GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany


Zolpidem-CT 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


AbZ-Pharma GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany


Zolpidem-CT 5 mg Filmtabletten


5 mg


film-coated tablet


oral use




Germany


Dolorgiet GmbH & Co. KG
Otto-von-Guericke-Str. 1
53757 Sankt Augustin
Germany


Zolpidem real 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany


Zolpidem Heumann 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany


Zolpidem Heumann 5 mg Filmtabletten


5 mg


film-coated tablet


oral use




Germany


Hexal Aktiengesellschaft
Industriestr. 25
83607 Holzkirchen
Germany


Zolpidem Hexal 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


IPCA — Produtos Farmacêuticos Unipessoal, Lda.
Rua José Nogueira Vaz, Lote 104 — Lj Esq
2625-099 Povoa de Santa Iria
Portugal


Zolpidem IPCA 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


IPCA — Produtos Farmacêuticos Unipessoal, Lda.
Rua José Nogueira Vaz, Lote 104 — Lj Esq
2625-099 Povoa de Santa Iria
Portugal


Zolpidem IPCA 5 mg Filmtabletten


5 mg


film-coated tablet


oral use




Germany


Juta Pharma GmbH
Gutenbergstr. 13
24941 Flensburg
Germany


Zolpi-Q 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


Krewel Meuselbach GmbH
Krewelstr. 2
53783 Eitorf
Germany


Zolpinox 10 mg


10 mg


film-coated tablet


oral use




Germany


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


Edluar 10 mg Sublingualtabletten


10 mg


sublingual tablet


oral use




Germany


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


Edluar 5 mg Sublingualtabletten


5 mg


sublingual tablet


oral use




Germany


Mylan dura GmbH
Wittichstr. 6
64295 Darmstadt
Germany


Zolpidem dura 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Str. 23
40764 Langenfeld
Germany


Zolpidem-neuraxpharm 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Str. 23
40764 Langenfeld
Germany


Zolpidem-neuraxpharm 5 mg Filmtabletten


5 mg


film-coated tablet


oral use




Germany


ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany


Zolpidem-ratiopharm 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany


Zolpidem-ratiopharm 5 mg Filmtabletten


5 mg


film-coated tablet


oral use




Germany


Sandoz Pharmaceuticals GmbH
Raiffeisenstr. 11
83607 Holzkirchen
Germany


Zolpidem Sandoz 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst, Gebäude K703
65926 Frankfurt am Main
Germany


Bikalm


10 mg


film-coated tablet


oral use




Germany


Sanofi-Aventis Deutschland GmbH
Industriepark Höchst, Gebäude K703
65926 Frankfurt am Main
Germany


Stilnox


10 mg


film-coated tablet


oral use




Germany


Stadapharm GmbH
Stadastr. 2-18
61118 Bad Vilbel
Germany


Zolpidem STADA 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


Stadapharm GmbH
Stadastr. 2-18
61118 Bad Vilbel
Germany


Zolpidem STADA 5 mg Filmtabletten


5 mg


film-coated tablet


oral use




Germany


TAD Pharma GmbH
Heinz-Lohmann-Str. 5
27472 Cuxhaven
Germany


Zolpidem TAD 10 mg


10 mg


film-coated tablet


oral use




Germany


Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland


Zolpidem Vitabalans 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Germany


Winthrop Arzneimittel GmbH
Brüningstr. 50
65926 Frankfurt am Main
Germany


Zolpi-Lich 10 mg Filmtabletten


10 mg


film-coated tablet


oral use




Greece


IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES ABEE, INTERMED ABEE,
Kalyftaki 27, Kifissia 14564
Greece


HYPNONORM


10 mg


film-coated tablet


oral use




Greece


ITF HELLAS S.A.
Areos 103 and Ag. Triados 36, Palaio Faliro 17562
Greece


ONIRIA


10 mg/ml


oral drops, solution


oral use




Greece


ITF PHARMA KERESKEDELMI ES SZOLGALTATO KFT, BUDAPEST, HUNGAR
H-1056, Budapest
Duna u.1
Hungary


KALINICTA


10 mg/ml


oral drops, solution


oral use




Greece


SANOFI-AVENTIS AEBE
348 SYNGROU AVENUE, BUILDING A, KALLITHEA 17674
Greece


STILNOX


10 mg


film-coated tablet


oral use




Hungary


EGIS Gyógyszergyár Nyrt. Keresztúri út 30-38.
Budapest
1106
Hungary


PIDEZOL 10 mg filmtabletta


10 mg


film-coated tablet


oral use




Hungary


ExtractumPharma zRt.
Megyeri út 64.
Budapest
1044
Hungary


ZOLEP 10 mg filmtabletta


10 mg


film-coated tablet


oral use




Hungary


Generics (UK) Ltd.
Albany Gate, Darkes Lane, Potters bar Herts EN61AG
United Kingdom


SOMNOGEN 10 mg filmtabletta


10 mg


film-coated tablet


oral use




Hungary


ITF Pharma Kft Duna u. 1. Budapest 1056 Hungary


ONIRIA 10 mg/ml belsőleges oldatos cseppek


10 mg/ml


oral drops, solution


oral use




Hungary


Krka d.d. Novo Mesto Smarjeska cesta 6. Novo Mesto 8501 Slovenia


ZOLSANA 5 mg filmtabletta


5 mg


film-coated tablet


oral use




Hungary


Krka d.d. Novo Mesto Smarjeska cesta 6. Novo Mesto 8501 Slovenia


ZOLSANA 10 mg filmtabletta


10 mg


film-coated tablet


oral use




Hungary


LEK Pharmaceuticals d.d. Verovskova 57
Ljubljana
Slovenia


SANVAL 5 mg filmtabletta


5 mg


film-coated tablet


oral use




Hungary


LEK Pharmaceuticals d.d. Verovskova 57
Ljubljana
Slovenia


SANVAL 10 mg filmtabletta


10 mg


film-coated tablet


oral use




Hungary


Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary


EDLUAR 5 mg nyelvalatti tabletta


5 mg


sublingual tablet


sublingual use




Hungary


Meda Pharma Hungary Kft Váci út 91. Budapest 1139 Hungary


EDLUAR 10 mg nyelvalatti tabletta


10 mg


sublingual tablet


sublingual use




Hungary


Sanofi-Aventis Magyarország Zrt
Tó u. 1-5
Budapest
1045
Hungary


STILNOX 10 mg filmtabletta


10 mg


film-coated tablet


oral use




Hungary


Teva Magyarország Zrt
Repülőtéri út 5.
Gödöllő 2100
Hungary


ZOLPIDEM-RATIOPHARM 10 mg filmtabletta


10 mg


film-coated tablet


oral use




Hungary


Vitabalans Oy Varastokatu 8. Hämeenlinna 13500
Finland


ZOLPIDEM VITABALANS 10 mg filmtabletta


10 mg


film-coated tablet


oral use




Hungary


Vulm CZ a.s.
Olivova 1888
Ricany 25101 Czech Republic


INSOM 10 mg pezsgőtabletta


10 mg


effervescent tablet


oral use




Hungary


Zentiva k.s.
Dolny Mecholupy,
U kabelovny 130
Prague 10. 10237
Czech Republic


HYPNOGEN 10 mg filmtabletta


10 mg


film-coated tablet


oral use




Iceland


LYFIS ehf., Grensásvegur 22, 108 Reykjavík, Iceland


Zolpidem LYFIS


10 mg


film-coated tablet


oral use




Iceland


Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden


Edluar


5 mg


sublingual tablet


oral use




Iceland


Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden


Edluar


10 mg


sublingual tablet


oral use




Iceland


Mylan AB, Ynglingagatan 14, 10435 Stockholm, Sweden.


Zolpidem Mylan


10 mg


film-coated tablet


oral use




Iceland


Sanofi Aventis Norge
Strandveien 15,
1366 Lysaker, Norway


Stilnoct


5 mg


film-coated tablet


oral use




Iceland


Sanofi Aventis Norge
Strandveien 15,
1366 Lysaker, Norway


Stilnoct


10 mg


film-coated tablet


oral use




Ireland


Clonmel Healthcare Ltd
Waterford Road
Clonmel
Co. Tipperary
Ireland


Nytamel 5 mg Film-coated Tablets


5 mg


film-coated tablet


oral use




Ireland


Clonmel Healthcare Ltd
Waterford Road
Clonmel
Co. Tipperary
Ireland


Nytamel 10 mg Film-coated Tablets.


10 mg


film-coated tablet


oral use




Ireland


McDermott Laboratories Ltd t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland


Zoldem 10 mg film-coated tablets


10 mg


film-coated tablet


oral use




Ireland


Meda Health Sales Ireland Limited
Unit 34/35 Block A
Dunboyne Business Park
Dunboyne
Co Meath
Ireland


Edluar 5 mg sublingual tablets


5 mg


sublingual tablet


oral use




Ireland


Meda Health Sales Ireland Limited
Unit 34/35 Block A
Dunboyne Business Park
Dunboyne
Co Meath
Ireland


Edluar 10 mg sublingual tablets


10 mg


sublingual tablet


oral use




Ireland


Rowex Ltd,
Bantry,
Co. Cork,
Ireland


Zolnod 10 mg film-coated tablets


10 mg


film-coated tablet


oral use




Ireland


Sanofi-Aventis Ireland Limited T/A Sanofi, Citywest Business Campus, Dublin 24, Ireland


Stilnoct 5 mg Film-coated Tablets


5 mg


film-coated tablet


oral use




Ireland


Sanofi-Aventis Ireland Limited T/A Sanofi, Citywest Business Campus, Dublin 24, Ireland


Stilnoct 10 mg Film-coated Tablets


10 mg


film-coated tablet


oral use




Ireland


Teva Pharma B. V.
Computerweg 10
3542 DR Utrecht
The Netherlands


Zolpidem Tartrate Teva 5 mg Film-coated Tablets


5 mg


film-coated tablet


oral use




Ireland


Teva Pharma B. V.
Computerweg 10
3542 DR Utrecht
The Netherlands


Zolpidem Tartrate Teva 10 mg Film-coated Tablets


10 mg


film-coated tablet


oral use




Italy


Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjördur
Iceland


ZOLPIDEM ACTAVIS


10 mg


film-coated tablet


oral use




Italy


Doc Generici S.r.l.
Turati 40, Milano — 20121 Italy


ZOLPIDEM DOC GENERICI


5 mg


film-coated tablet


oral use




Italy


Doc Generici S.r.l.
Turati 40, Milano — 20121 Italy


ZOLPIDEM DOC GENERICI


10 mg


film-coated tablet


oral use




Italy


EG S.p.a. Via Scarlatti, 31, Milano — 20124 Italy


ZOLPIDEM EG


10 mg


film-coated tablet


oral use




Italy


FIDIA Farmaceutici S.p.a.
Via Ponte della Fabbrica, 3/a, Abano Terme, Padova — 35031 Italy


OPSYCON


10 mg


film-coated tablet


oral use




Italy


HEXAL S.p.a.
Largo Umberto Boccioni 1
21040 Origgio
Varese
Italy


ZOLPIDEM HEXAL


10 mg


film-coated tablet


oral use




Italy


IPCA — Produtos Farmacêuticos Unipessoal, Lda.
Rua José Nogueira Vaz, Lote 104 — Lj Esq
2625-099 Povoa de Santa Iria
Portugal


ZOLPIDEM IPCA


5 mg


film-coated tablet


oral use




Italy


IPCA — Produtos Farmacêuticos Unipessoal, Lda.
Rua José Nogueira Vaz, Lote 104 — Lj Esq
2625-099 Povoa de Santa Iria
Portugal


ZOLPIDEM IPCA


10 mg


film-coated tablet


oral use




Italy


ITALFARMACO S.p.A.
Viale Fulvio Testi 330,
20126 Milano, Italy


SONIREM


10 mg/ml


oral drops, solution


oral use




Italy


LIFEPHARMA S.P.A. Via dei Lavoratori 54, 20092 Cinisello Balsamo, Milano — Italy


ZOLPREM


10 mg/ml


oral drops, solution


oral use




Italy


MEDA PHARMA S.P.A., Viale brenta 18, 20139 Milano — Italy


ZOLPEDUAR


5 mg


sublingual tablet


oral use




Italy


MEDA PHARMA S.P.A., Viale brenta 18, 20139 Milano — Italy


ZOLPEDUAR


10 mg


sublingual tablet


oral use




Italy


Ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany


ZOLPIDEM RATIOPHARM


10 mg


film-coated tablet


oral use




Italy


Sandoz S.p.a.
Largo Umberto Boccioni, 1,
Origgio, Varese — 21040
Italy


ZOLPIDEM SANDOZ


10 mg


film-coated tablet


oral use




Italy


Sanofi-aventis SpA, Viale Bodio 37/b, 20158 Milano Italy


STILNOX


10 mg


film-coated tablet


oral use




Italy


Sanofi-aventis SpA, Viale Bodio 37/b, 20158 Milano Italy


NOTTEM


10 mg


film-coated tablet


oral use




Italy


Teva Italia S.r.l. — via Messina 38 — 20154 Milano Italy


ZOLPIDEM TEVA


10 mg


film-coated tablet


oral use




Italy


ZENTIVA ITALIA S.R.L. — Viale Bodio 37/b, 20158 Milano Italy


ZOLPIDEM ZENTIVA


10 mg


film-coated tablet


oral use




Latvia


Krka, d.d., Novo mesto
Šmarješka cesta 6
8000 Novo mesto
Slovenia


Zolsana 5 mg coated tablets


5 mg


coated tablet


oral use




Latvia


Krka, d.d., Novo mesto
Šmarješka cesta 6
8000 Novo mesto
Slovenia


Zolsana 10 mg coated tablets


10 mg


coated tablet


oral use




Latvia


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


Edluar 5 mg sublingual tablets


5 mg


sublingual tablet


sublingual use




Latvia


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


Edluar 10 mg sublingual tablets


10 mg


sublingual tablet


sublingual use




Latvia


Sandoz d.d.
Verovškova 57,
1000 Ljubljana,
Slovenia


Zolpidem Sandoz 10 mg film-coated tablets


10 mg


film-coated tablet


oral use




Latvia


sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia


Stilnox 10 mg film-coated tablets


10 mg


film-coated tablet


oral use




Latvia


Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland


Zolpidem Vitabalans 10 mg film-coated tablets


10 mg


film-coated tablet


oral use




Latvia


Zentiva, k.s.
U kabelovny 130
Prague 10, Dolni Mecholupy
10237
Czech Republic


Hypnogen 10 mg film-coated tablets


10 mg


film-coated tablet


oral use




Lithuania


Krka, d.d., Novo mesto
Šmarješka cesta 6
8000 Novo mesto
Slovenia


Zolsana


10 mg


film-coated tablet


oral use




Lithuania


Krka, d.d., Novo mesto
Šmarješka cesta 6
8000 Novo mesto
Slovenia


Zolsana


5 mg


film-coated tablet


oral use




Lithuania


Sandoz d.d.
Verovškova 57,
1000 Ljubljana,
Slovenia


Zolpidem Sandoz


10 mg


film-coated tablet


oral use




Lithuania


UAB ‘SANOFI-AVENTIS LIETUVA’
A. Juozapavičiaus 6/2 g.
LT-09310 Vilnius
Lithuania


Stilnox


10 mg


film-coated tablet


oral use




Lithuania


Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland


Zolpidem Vitabalans


10 mg


film-coated tablet


oral use




Lithuania


Zentiva, k.s.
U kabelovny 130
Prague 10, Dolni Mecholupy
10237
Czech Republic


HYPNOGEN


10 mg


film-coated tablet


oral use




Luxembourg


MYLAN BVBA/SPRL
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Dodorest


10 mg


coated tablet


oral use




Luxembourg


SANOFI BELGIUM
Airport Plaza, Montreal Building, Leonardo Da Vincilaan 19
1831 Diegem
Belgium


Stilnoct


10 mg


coated tablet


oral use




Luxembourg


Eurogenerics S.A.
Esplanade Heysel, b22
1020 Bruxelles
Belgium


Zolpidem EG cpr.eff.


10 mg


effervescent tablet


oral use




Luxembourg


Eurogenerics S.A.
Esplanade Heysel, b22
1020 Bruxelles
Belgium


Zolpidem EG cpr.pellic.


10 mg


coated tablet


oral use




Luxembourg


Genthon BV
Microweg, 22
6545 Nijmegen
The Netherlands


Zolpidem Genthion


10 mg


coated tablet


oral use




Luxembourg


Genthon BV
Microweg, 22
6545 Nijmegen
The Netherlands


Zolpidem Genthion


5 mg


coated tablet


oral use




Luxembourg


Apotex Europe B.V.
Darwinweg 20
NL 2333 CR Leiden
The Netherlands


Zolpitop


10 mg


coated tablet


oral use




Luxembourg


Apotex Europe B.V.
Darwinweg 20
NL 2333 CR Leiden
The Netherlands


Zolpitop


5 mg


coated tablet


oral use




Luxembourg


MEDA PHARMA
Chaussee de la Hulpe 166
1170 Watermael-Boitsfort
Belgium


Zolpeduar


10 mg


sublingual tablet


sublingual use




Luxembourg


MEDA PHARMA
Chaussee de la Hulpe 166
1170 Watermael-Boitsfort
Belgium


Zolpeduar


5 mg


sublingual tablet


sublingual use




Malta


Sanofi Malta Ltd.
St. Julian’s Rd.
San Gwann SGN 2805
Malta


Stilnox


10 mg


film-coated tablet


oral use




Malta


Pharma MT
103, Stuart Street,
Gzira,
Malta


Nytamel


10 mg


film-coated tablet


oral use




Norway


Sanofi Aventis Norge
Strandveien 15,
1366 Lysaker, Norway


Stilnoct


5 mg


film-coated tablet


oral use




Norway


Sanofi Aventis Norge
Strandveien 15,
1366 Lysaker, Norway


Stilnoct


10 mg


film-coated tablet


oral use




Norway


Actavis Norway AS, P.O.BOX 409, 0213 Skoyen, OSLO, Norway


Zolpidem Actavis


5 mg


film-coated tablet


oral use




Norway


Actavis Norway AS, P.O.BOX 409, 0213 Skoyen, OSLO, Norway


Zolpidem Actavis


10 mg


film-coated tablet


oral use




Norway


Meda Norge, P.O.BOX 194, 1371 ASKER, Norway


Edluar


5 mg


sublingual tablet


oral use




Norway


Meda Norge, P.O.BOX 194, 1371 ASKER, Norway


Edluar


10 mg


sublingual tablet


oral use




Norway


Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland


Zolpidem Vitabalans


10 mg


film-coated tablet


oral use




Poland


Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjördur
Iceland


Noxizol


10 mg


film-coated tablet


oral use




Poland


Apotex Europe B.V.
Darwinweg 20
NL 2333 CR Leiden
The Netherlands


Apo-Zolpin


10 mg


film-coated tablet


oral use




Poland


Farma-Projekt Sp. z o.o.
ul. Józefińska 2
30-529 Kraków
Poland


Xentic


10 mg


film-coated tablet


oral use




Poland


Generics [UK] Ltd.
Station Close
EN6 1TL Hertfordshire — Potters Bar
United Kingdom


ZolpiGen


10 mg


film-coated tablet


oral use




Poland


Ipca, Produtos Farmaceuticos, Unipessoal Lda
Rua Chanceler-Mor 11 R/c Frt.
Cacem
2735-615
Portugal


Zolpidem IPCA


5 mg


film-coated tablet


oral use




Poland


Ipca, Produtos Farmaceuticos, Unipessoal Lda
Rua Chanceler-Mor 11 R/c Frt.
Cacem
2735-615
Portugal


Zolpidem IPCA


10 mg


film-coated tablet


oral use




Poland


Italfarmaco S.p.A.
Viale Fulvio 330
20126 Milano
Italy


Sonirem


10 mg/ml


oral drops, solution


oral use




Poland


Krka, d.d., Novo mesto
Šmarješka cesta 6
8000 Novo mesto
Slovenia


Zolsana


10 mg


film-coated tablet


oral use




Poland


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


Edluar


5 mg


sublingual tablet


oral use




Poland


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


Edluar


10 mg


sublingual tablet


oral use




Poland


Orion Corporation
Orionintie 1/A
FI-02200 Espoo
Finland


Onirex


10 mg


film-coated tablet


oral use




Poland


Pabianickie Zakłady Farmaceutyczne Polfa S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Poland


Polsen


10 mg


film-coated tablet


oral use




Poland


Pfizer Europe MA EEIG
Ramsgate Road
Kent, Sandwich
CT13 9 NJ
United Kingdom


Zolpidem Pfizer


10 mg


film-coated tablet


oral use




Poland


Polfarmex S.A.
Józefów 9
99-300 Kutno
Poland


Nasen


10 mg


film-coated tablet


oral use




Poland


Sandoz GmbH
ul. Biochemiestrasse 10
Kundli
6250
Austria


Sanval


10 mg


film-coated tablet


oral use




Poland


Sanofi-Aventis France
1-13 boulevard Romain Rolland
75014 Paris
France


Stilnox


10 mg


film-coated tablet


oral use




Poland


Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland


Zolpidem Vitabalans


10 mg


film-coated tablet


oral use




Poland


VULM CZ, a.s.
Olivova 1888
Ricany
251 01
Czech Republic


Insom


10 mg


effervescent tablet


oral use




Poland


Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19
83-200 Starogard Gdański
Poland


Zolpic


10 mg


film-coated tablet


oral use




Poland


Zentiva, k.s.
U kabelovny 130
Prague 10, Dolni Mecholupy
10237
Czech Republic


Hypnogen


10 mg


film-coated tablet


oral use




Portugal


Actavis A/S Sucursal
Rua Virgílio Correia, 11 — A
1600-219 Lisboa
Portugal


Zolpidem Actavis


10 mg


film-coated tablet


oral use




Portugal


Aurobindo Pharma (Portugal), Unipessoal Lda.
Av. do Forte, no 3 — Parque Suécia, Edifício. IV, 2o

2794-038 Carnaxide
Portugal


Zolpidem Aurobindo


5 mg


film-coated tablet


oral use




Portugal


Aurobindo Pharma (Portugal), Unipessoal Lda.
Av. do Forte, no 3 — Parque Suécia, Edifício. IV, 2o

2794-038 Carnaxide
Portugal


Zolpidem Aurobindo


10 mg


film-coated tablet


oral use




Portugal


Cinfa Portugal, Lda.
Av. Tomás Ribeiro, 43 — Bloco 2, 3o F — Edifício Neopark
2790-221 Carnaxide
Portugal


Zolpidem Cinfa 10 mg Comprimidos


10 mg


film-coated tablet


oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Zolpidem Generis 5 mg Comprimidos Revestidos


5 mg


film-coated tablet


oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Zolpidem Generis 10 mg Comprimidos Revestidos


10 mg


film-coated tablet


oral use




Portugal


Genthon GmbH
Groesbeeker Weg, 1
D-47559 Kranenburg
Germany


Zolpidem 5 mg Comprimidos Revestidos


5 mg


film-coated tablet


oral use




Portugal


IPCA — Produtos Farmacêuticos Unipessoal, Lda.
Rua José Nogueira Vaz, Lote 104 — Lj Esq
2625-099 Povoa de Santa Iria
Portugal


Zolpidem IPCA


5 mg


film-coated tablet


oral use




Portugal


IPCA — Produtos Farmacêuticos Unipessoal, Lda.
Rua José Nogueira Vaz, Lote 104 — Lj Esq
2625-099 Povoa de Santa Iria
Portugal


Zolpidem IPCA


10 mg


film-coated tablet


oral use




Portugal


Labesfal Genéricos, S.A
Avenida Dr. Afonso Costa, 1370
3465-051 Campo de Besteiros
Portugal


Zolpidem Labesfal


10 mg


film-coated tablet


oral use




Portugal


Laboratórios Azevedos — Indústria Farmacêutica, S.A.
Edifícios Azevedos — Estrada Nacional 117-2, Alfragide
2614-504 Amadora
Portugal


Cymerion


10 mg


film-coated tablet


oral use




Portugal


Meda Pharma — Produtos Farmacêuticos, S.A.
Rua do Centro Cultural, 13
1749-066 Lisboa
Portugal


Edluar


5 mg


sublingual tablet


sublingual use




Portugal


Meda Pharma — Produtos Farmacêuticos, S.A.
Rua do Centro Cultural, 13
1749-066 Lisboa
Portugal


Edluar


10 mg


sublingual tablet


sublingual use




Portugal


Mylan, Lda.
Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C — 7.3 e 7.4
1990-095 Lisboa
Portugal


Zolpidem Mylan


10 mg


film-coated tablet


oral use




Portugal


Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.
Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo
Portugal


Zolpidem Ratiopharm 10 mg Comprimidos Revestidos


10 mg


film-coated tablet


oral use




Portugal


Sandoz Farmacêutica, Lda.
Alameda da Beloura, Edifício 1, 2o — Escritório 15
2710-693 Sintra
Portugal


Zolpidem Sandoz


10 mg


film-coated tablet


oral use




Portugal


Sanofi — Produtos Farmacêuticos, Lda.
Empreendimento Lagoas Park Edifício 7, 3o Piso
2740-244 Porto Salvo
Portugal


Stilnox


10 mg


film-coated tablet


oral use




Portugal


Wynn Industrial Pharma, S.A.
Rua Tierno Galvan, Torre 3, 16o Piso, Amoreiras
1070-274 Lisboa
Portugal


Zolpidem Wynn


10 mg


film-coated tablet


oral use




Romania


ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče Slovenia


ZADOBRA 5 mg


5 mg


film-coated tablet


oral use




Romania


ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče Slovenia


ZADOBRA 10 mg


10 mg


film-coated tablet


oral use




Romania


ITALFARMACO S.p.A.
Viale Fulvio Testi 330, 20126 Milano, Italia


ONIRIA 10 mg/ml


10 mg/ml


oral drops, solution


oral use




Romania


Krka, d.d., Novo mesto
Šmarješka cesta 6
8000 Novo mesto
Slovenia


ZOLSANA 5 mg


5 mg


film-coated tablet


oral use




Romania


Krka, d.d., Novo mesto
Šmarješka cesta 6
8000 Novo mesto
Slovenia


ZOLSANA 10 mg


10 mg


film-coated tablet


oral use




Romania


LABORMED PHARMA S.A.
B-dul Theodor Pallady nr. 44B
Sector 3, Bucureşti, România


ZOLPIDEM 10 mg


10 mg


film-coated tablet


oral use




Romania


LEK farmacevtska družba d.d. Verovškova 57
1526 Ljubljana
Slovenia


SANVAL 10 mg


10 mg


film-coated tablet


oral use




Romania


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


EDLUAR 5 mg


5 mg


sublingual tablet


oral use




Romania


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


EDLUAR 10 mg


10 mg


sublingual tablet


oral use




Romania


S.C. ANTIBIOTICE S.A.,
Str. Valea Lupului nr.1, Iaşi, România


ZOLPIDEM ATB 10 mg


10 mg


film-coated tablet


oral use




Romania


SANOFI-AVENTIS ROMÂNIA S.R.L.
Str. Izvor, Nr. 80, Et. 6-11
Sector 5, Bucureşti, România


STILNOX 10 mg


10 mg


film-coated tablet


oral use




Slovak Republic


ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče Slovenia


ADORMA 5 mg filmom obalené tablety


5 mg


film-coated tablet


oral use




Slovak Republic


ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče Slovenia


ADORMA 10 mg filmom obalené tablety


10 mg


film-coated tablet


oral use




Slovak Republic


Generics [UK] Ltd.
Station Close
EN6 1TL Hertfordshire — Potters Bar
United Kingdom


Zolpidem Mylan 10 mg


10 mg


film-coated tablet


oral use




Slovak Republic


Orion Corporation
Orionintie 1/A
FI-02200 Espoo
Finland


Zolpidem Orion 10 mg


10 mg


film-coated tablet


oral use




Slovak Republic


Sandoz d.d.
Verovškova 57,
1000 Ljubljana,
Slovenia


SANVAL 5 mg


5 mg


film-coated tablet


oral use




Slovak Republic


Sandoz d.d.
Verovškova 57,
1000 Ljubljana,
Slovenia


SANVAL 10 mg


10 mg


film-coated tablet


oral use




Slovak Republic


sanofi-aventis Slovakia s.r.o. Einsteinova 24
85101 Bratislava
Slovak Republic


STILNOX


10 mg


film-coated tablet


oral use




Slovak Republic


SVUS Pharma a.s., Smetanovo nábřeží 1238/20a
500 02 Hradec Králové Czech Republic


ZOLPINOX


10 mg


film-coated tablet


oral use




Slovak Republic


Takeda GmbH 2 Byk-Gulden Strasse
78467 Konstanz Germany


HYPNOGEN


10 mg


film-coated tablet


oral use




Slovak Republic


Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland


Zolpidem Vitabalans 10 mg filmom obalené tablety


10 mg


film-coated tablet


oral use




Slovenia


ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče Slovenia


Perluna 10 mg filmsko obožene tablete


10 mg


film-coated tablet


oral use




Slovenia


ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče Slovenia


Perluna 5 mg filmsko obožene tablete


5 mg


film-coated tablet


oral use




Slovenia


Krka, d.d., Novo mesto
Šmarješka cesta 6
8000 Novo mesto
Slovenia


Zolsana 10 mg filmsko obložene tablete


10 mg


film-coated tablet


oral use




Slovenia


Krka, d.d., Novo mesto
Šmarješka cesta 6
8000 Novo mesto
Slovenia


Zolsana 5 mg filmsko obložene tablete


5 mg


film-coated tablet


oral use




Slovenia


LEK farmacevtska družba d.d. Verovškova 57
1526 Ljubljana
Slovenia


Sanval 10 mg filmsko obožene tablete


10 mg


film-coated tablet


oral use




Slovenia


LEK farmacevtska družba d.d. Verovškova 57
1526 Ljubljana
Slovenia


Sanval 5 mg filmsko obložene tablete


5 mg


film-coated tablet


oral use




Slovenia


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


Edluar 10 mg podjezične tablete


10 mg


sublingual tablet


sublingual use




Slovenia


Meda Pharma GmbH & Co. KG
Benzstrasse 1
Bad Homburg v.d.H
61352
Germany


Edluar 5 mg podjezične tablete


5 mg


sublingual tablet


sublingual use




Slovenia


Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland


Zolpidem Vitabalans 10 mg filmsko obložene tablete


10 mg


film-coated tablet


oral use




Spain


ANGELINI FARMACEUTICA, S.A. Osi, 7-9 Barcelona. 08034. SPAIN


DALPARAN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA


10 mg


film-coated tablet


oral use




Spain


Apotex Europe B.V.
Darwinweg 20
NL 2333 CR Leiden
The Netherlands


ZOLPIDEM APOTEX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


10 mg


film-coated tablet


oral use




Spain


BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 — Area B, Aravaca (Madrid). 28023. SPAIN


ZOLPIDEM BEXALABS 10 mg COMPRIMIDOS CON CUBIERTOS CON PELICULA EFG


10 mg


film-coated tablet


oral use




Spain


BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 — Area B, Aravaca (Madrid). 28023. SPAIN


ZOLPIDEM BEXAL 10 mg COMPRIMIDOS RECUBIERTOS EFG


10 mg


film-coated tablet


oral use




Spain


FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid). 28108. SPAIN


ZOLPIDEM FARMALIDER 10 mg COMPRIMIDOS RECUBIERTOS EFG


10 mg


film-coated tablet


oral use




Spain


GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN


ZOLPIDEM DESGEN 5 mg COMPRIMIDOS EFG


5 mg


tablet


oral use




Spain


GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN


ZOLPIDEM DESGEN 10 mg COMPRIMIDOS EFG


10 mg


tablet


oral use




Spain


GERMED FARMACEUTICA S.L. Chile, 8 — 2a planta. Oficina 203, Las Matas (Madrid). 28290. SPAIN


ZOLPIDEM EDIGEN 10 mg COMPRIMIDOS RECUBIERTOS EFG


10 mg


film-coated tablet


oral use




Spain


LABORATORIO STADA, S.L. Frederic Mompou, 5 , Sant Just Desvern (Barcelona). 08960
SPAIN


ZOLPIDEM STADA 10 mg COMPRIMIDOS RECUBIERTOS EFG


10 mg


film-coated tablet


oral use




Spain


LABORATORIOS CINFA, S.A. Olaz-Chipi, 10. Poligono Industrial Areta .Huarte-Pamplona (Navarra)
31620
SPAIN


ZOLPIDEM CINFA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


10 mg


film-coated tablet


oral use




Spain


LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid). 28760. SPAIN


ZOLPIDEM NORMON 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


10 mg


film-coated tablet


oral use




Spain


MEDA PHARMA S.A.U Avda. de Castilla, 2. Edif. Berlin. 2a planta. Parque Empresarial San Fernando, San Fernando de Henares (Madrid).28830. SPAIN


EDLUAR 10 MG COMPRIMIDOS SUBLINGUALES


10 mg


sublingual tablet


oral use




Spain


MEDA PHARMA S.A.U Avda. de Castilla, 2. Edif. Berlin. 2a planta. Parque Empresarial San Fernando, San Fernando de Henares (Madrid).28830. SPAIN


EDLUAR 5 MG COMPRIMIDOS SUBLINGUALES


5 mg


sublingual tablet


oral use




Spain


MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5o Planta, Barcelona. 08038. SPAIN


ZOLPIDEM MYLAN 10 mg COMPRIMIDOS RECUBIERTOS EFG


10 mg


film-coated tablet


oral use




Spain


PHARMAGENUS, S.A. Avda. Camí Real, 51-57 Palau-solita i Plegamans (Barcelona). 08184. SPAIN


ZOLPIDEM PHARMAGENUS 5 mg COMPRIMIDOS


5 mg


tablet


oral use




Spain


PHARMAGENUS, S.A. Avda. Camí Real, 51-57 Palau-solita i Plegamans (Barcelona). 08184. SPAIN


ZOLPIDEM PHARMAGENUS 10 mg COMPRIMIDOS EFG


10 mg


tablet


oral use




Spain


RATIOPHARM ESPAÑA, S.A. C/Anabel Segura 11, Edificio Albatros B 1a Planta, Alcobendas, Madrid. 28108. SPAIN


ZOLPIDEM RATIOPHARM 10 mg COMPRIMIDOS RECUBIERTOS EFG


10 mg


film-coated tablet


oral use




Spain


RATIOPHARM ESPAÑA, S.A. C/Anabel Segura 11, Edificio Albatros B 1a Planta, Alcobendas, Madrid. 28108. SPAIN


ZOLPIDEM TEVAGEN 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


10 mg


film-coated tablet


oral use




Spain


RATIOPHARM ESPAÑA, S.A. C/Anabel Segura 11, Edificio Albatros B 1a Planta, Alcobendas, Madrid. 28108. SPAIN


ZOLPIDEM TEVAGEN 5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA


5 mg


film-coated tablet


oral use




Spain


SANDOZ FARMACÉUTICA, S.A.
Avda. Osa Mayor, 4
28023 Aravaca (Madrid)
Spain


ZOLPIDEM SANDOZ 10 mg COMPRIMIDOS EFG


10 mg


tablet


oral use




Spain


SANOFI AVENTIS, S.A.
Josep Plá, 2,
Barcelona. 08019
SPAIN


STILNOX 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA


10 mg


film-coated tablet


oral use




Spain


TEVA GENERICOS ESPAÑOLA S.L.U. C/Anabel Segura, 11 Edificio Albatros B, 1 planta Alcobendas (Madrid). 28108. SPAIN


ZOLPIDEM TEVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


10 mg


film-coated tablet


oral use




Spain


Zentiva, k.s.
U kabelovny 130
Prague 10, Dolni Mecholupy
10237
Czech Republic


ZOLPIDEM ZENTIVA 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


10 mg


film-coated tablet


oral use




Sweden


Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjördur
Iceland


Zolpidem Actavis


5 mg


film-coated tablet


oral use




Sweden


Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjördur
Iceland


Zolpidem Actavis


10 mg


film-coated tablet


oral use




Sweden


Hexal A/S
Edvard Thomsens Vej 14
DK-2300 Köpenhamn S
Denmark


Zolpidem HEXAL


10 mg


film-coated tablet


oral use




Sweden


Ranbaxy (UK) Ltd,
Building 4
Chiswick Park
London W4 5YE
United Kingdom


Zolpidem Ranbaxy


5 mg


film-coated tablet


oral use




Sweden


Ranbaxy (UK) Ltd,
Building 4
Chiswick Park
London W4 5YE
United Kingdom


Zolpidem Ranbaxy


10 mg


film-coated tablet


oral use




Sweden


Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden


Edluar


5 mg


sublingual tablet


oral use




Sweden


Meda AB, Pipers väg 2A, Box 906, SE-170 09, Sweden


Edluar


10 mg


sublingual tablet


oral use




Sweden


Mylan AB
Box 23033
104 35 Stockholm
Sweden


Zolpidem Mylan


10 mg


film-coated tablet


oral use




Sweden


Orifarm Generics A/S
Energivej 15 POB 69
DK-5260 Odense S
Denmark


Zolpidem Orifarm


5 mg


film-coated tablet


oral use




Sweden


Orifarm Generics A/S
Energivej 15 POB 69
DK-5260 Odense S
Denmark


Zolpidem Orifarm


10 mg


film-coated tablet


oral use




Sweden


ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany


Zolpidem ratiopharm


5 mg


film-coated tablet


oral use




Sweden


ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany


Zolpidem ratiopharm


10 mg


film-coated tablet


oral use




Sweden


Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 Köpenhamn S
Denmark


Zolpidem Sandoz


5 mg


film-coated tablet


oral use




Sweden


Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 Köpenhamn S
Denmark


Zolpidem Sandoz


10 mg


film-coated tablet


oral use




Sweden


sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden


Stilnoct


5 mg


film-coated tablet


oral use




Sweden


sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden


Stilnoct


10 mg


film-coated tablet


oral use




Sweden


STADA Arzneimittel AG
Stadastrasse 2-18
DE-61118 Bad Vilbel
Germany


Zolpidem STADA


5 mg


film-coated tablet


oral use




Sweden


STADA Arzneimittel AG
Stadastrasse 2-18
DE-61118 Bad Vilbel
Germany


Zolpidem STADA


10 mg


film-coated tablet


oral use




Sweden


Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands


Zolpidem Genthon


5 mg


film-coated tablet


oral use




Sweden


Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands


Zolpidem Genthon


10 mg


film-coated tablet


oral use




Sweden


Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland


Zolpidem Vitabalans


10 mg


film-coated tablet


oral use




The Netherlands


Actavis B.V.
Baarnsche Dijk 1
3741 LN BAARN
The Netherlands


Zolpidemtartaat Actavis 5 mg, tabletten


5 mg


tablet


oral use




The Netherlands


Actavis B.V.
Baarnsche Dijk 1
3741 LN BAARN
The Netherlands


Zolpidemtartraat Actavis 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


ADOH B.V.
Godfried Bomansstraat 31
6543 JA NIJMEGEN
The Netherlands


Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten


10 mg


effervescent tablet


oral use




The Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands


Zolpidemtartraat 5 mg PCH, filmomhulde tabletten


5 mg


film-coated tablet


oral use




The Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands


Zolpidemtartraat 10 mg PCH, filmomhulde tabletten


10 mg


film-coated tablet


oral use




The Netherlands


ratiopharm Nederland B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands


Zolpidemtartraat ratiopharm 5 mg, tabletten


5 mg


tablet


oral use




The Netherlands


ratiopharm Nederland B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands


Zolpidemtartraat ratiopharm 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


ratiopharm Nederland B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands


Zolpidemtartraat ratiopharm 5 mg, filmomhulde tabletten


5 mg


film-coated tablet


oral use




The Netherlands


ratiopharm Nederland B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands


Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten


10 mg


film-coated tablet


oral use




The Netherlands


ratiopharm Nederland B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands


Zolpidemtartraat ratiopharm 10 mg, filmomhulde tabletten


10 mg


film-coated tablet


oral use




The Netherlands


Sandoz B.V.
Veluwezoom 22
1327 AH ALMERE
The Netherlands


Zolpidemtartraat Sandoz 10 mg, filmomhulde tabletten


10 mg


film-coated tablet


oral use




The Netherlands


Sandoz B.V.
Veluwezoom 22
1327 AH ALMERE
The Netherlands


Zolpidemtartraat Sandoz 5, filmomhulde tabletten 5 mg


5 mg


film-coated tablet


oral use




The Netherlands


Sandoz B.V.
Veluwezoom 22
1327 AH ALMERE
The Netherlands


Zolpidemtartraat Sandoz 10, filmomhulde tabletten 10 mg


10 mg


film-coated tablet


oral use




The Netherlands


Synthon B.V.
Microweg 22
6545 CM NIJMEGEN
The Netherlands


Zolpidemtartraat 5 mg, filmomhulde tabletten


5 mg


film-coated tablet


oral use




The Netherlands


Synthon B.V.
Microweg 22
6545 CM NIJMEGEN
The Netherlands


Zolpidemtartraat 10 mg, filmomhulde tabletten


10 mg


film-coated tablet


oral use




The Netherlands


Synthon B.V.
Microweg 22
6545 CM NIJMEGEN
The Netherlands


Zolpidemtartraat 5 mg, filmomhulde tabletten


5 mg


film-coated tablet


oral use




The Netherlands


Synthon B.V.
Microweg 22
6545 CM NIJMEGEN
The Netherlands


Zolpidemtartraat 10 mg, filmomhulde tabletten


10 mg


film-coated tablet


oral use




The Netherlands


Synthon B.V.
Microweg 22
6545 CM NIJMEGEN
The Netherlands


Zolpidemtartraat 5 mg, filmomhulde tabletten


5 mg


film-coated tablet


oral use




The Netherlands


Synthon B.V.
Microweg 22
6545 CM NIJMEGEN
The Netherlands


Zolpidemtartraat 10 mg, filmomhulde tabletten


10 mg


film-coated tablet


oral use




The Netherlands


ADOH B.V.
Godfried Bomansstraat 31
6543 JA NIJMEGEN
The Netherlands


Zolpidemtartraat ADOH 10 mg, bruistabletten


10 mg


effervescent tablet


oral use




The Netherlands


Apotex Europe B.V.
Darwinweg 20
NL 2333 CR Leiden
The Netherlands


Zolpidemtartraat Apotex 5 mg, filmomhulde tabletten


5 mg


film-coated tablet


oral use




The Netherlands


Apotex Europe B.V.
Darwinweg 20
NL 2333 CR Leiden
The Netherlands


Zolpidemtartraat Apotex 10 mg, filmomhulde tabletten


10 mg


film-coated tablet


oral use




The Netherlands


Centrafarm B.V.
Nieuwe Donk 3
4879 AC ETTEN LEUR
The Netherlands


Zolpidemtartraat CF 5 mg, film-omhulde tabletten


5 mg


film-coated tablet


oral use




The Netherlands


Centrafarm B.V.
Nieuwe Donk 3
4879 AC ETTEN LEUR
The Netherlands


Zolpidemtartraat CF 10 mg, film-omhulde tabletten


10 mg


film-coated tablet


oral use




The Netherlands


Eurogenerics S.A.
Esplanade Heysel, b22
1020 Bruxelles
Belgium


Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten


10 mg


effervescent tablet


oral use




The Netherlands


FIDIA Farmaceutici S.p.a.
Via Ponte della Fabbrica, 3/a, Abano Terme, Padova — 35031 Italy


Zolpidemtartraat 10 mg, filmomhulde tabletten


10 mg


film-coated tablet


oral use




The Netherlands


Genthon BV
Microweg, 22
6545 Nijmegen
The Netherlands


Zolpidemtartraat 5 mg, filmomhulde tabletten


5 mg


film-coated tablet


oral use




The Netherlands


Genthon BV
Microweg, 22
6545 Nijmegen
The Netherlands


Zolpidemtartraat 10 mg, filmomhulde tabletten


10 mg


film-coated tablet


oral use




The Netherlands


Meda Pharma B.V.
Krijgsman 20
1186 DM AMSTELVEEN
The Netherlands


Edluar 5 mg, tablet voor sublinguaal gebruik


5 mg


sublingual tablet


sublingual use




The Netherlands


Meda Pharma B.V.
Krijgsman 20
1186 DM AMSTELVEEN
The Netherlands


Edluar 10 mg, tablet voor sublinguaal gebruik


10 mg


sublingual tablet


sublingual use




The Netherlands


Mylan B.V.
Dieselweg 25
3752 LB BUNSCHOTEN
The Netherlands


Zolpidemtartraat Mylan 10 mg, filmomhulde tabletten


10 mg


film-coated tablet


oral use




The Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands


Zolpidemtartraat 5 PCH, filmomhulde tabletten 5 mg


5 mg


film-coated tablet


oral use




The Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands


Zolpidemtartraat 10 PCH, filmomhulde tabletten 10 mg


10 mg


film-coated tablet


oral use




The Netherlands


Sanofi-Aventis Netherlands B.V.
Kampenringweg 45 D-E
2803 PE GOUDA
The Netherlands


Stilnoct, tabletten 10 mg


10 mg


tablet


oral use




The Netherlands


STADA Arzneimittel AG
Stadastrasse 2-18
DE-61118 Bad Vilbel
Germany


Zolpidemtartraat Stada 5 mg, filmomhulde tabletten


5 mg


film-coated tablet


oral use




The Netherlands


STADA Arzneimittel AG
Stadastrasse 2-18
DE-61118 Bad Vilbel
Germany


Zolpidemtartraat Stada 10 mg, filmomhulde tabletten


10 mg


film-coated tablet


oral use




The Netherlands


Synthon B.V.
Microweg 22
6545 CM NIJMEGEN
The Netherlands


Zolpidemtartraat 10 mg, filmomhulde tabletten


10 mg


film-coated tablet


oral use




United Kingdom


Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon EX32 8NS
United Kingdom


Zolpidem Tartrate 5 mg tablets


5 mg


film-coated tablet


oral use




United Kingdom


Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon EX32 8NS
United Kingdom


Zolpidem Tartrate 10 mg tablets


10 mg


film-coated tablet


oral use




United Kingdom


ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče Slovenia


Zolpidem Tartrate 5 mg film-coated tablets


5 mg


film-coated tablet


oral use




United Kingdom


ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče Slovenia


Zolpidem Tartrate 10 mg film-coated tablets


10 mg


film-coated tablet


oral use




United Kingdom


Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY
United Kingdom


Stilnoct 5 mg fiilm-coated tablets


5 mg


coated tablet


oral use




United Kingdom


Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY
United Kingdom


Stilnoct 10 mg film-coated tablets


10 mg


coated tablet


oral use




United Kingdom


Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG
United Kingdom


Zolpidem Tartrate 5 mg film-coated tablets


5 mg


film-coated tablet


oral use




United Kingdom


Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG
United Kingdom


Zolpidem Tartrate 10 mg film-coated tablets


10 mg


film-coated tablet


oral use




United Kingdom


Generics [UK] Ltd.
Station Close
EN6 1TL Hertfordshire — Potters Bar
United Kingdom


Zolpidem 10 mg film-coated tablets


10 mg


film-coated tablet


oral use




United Kingdom


Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU
United Kingdom


Edluar 5 mg sublingual tablets


5 mg


sublingual tablet


oral use




United Kingdom


Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU
United Kingdom


Edluar 10 mg sublingual tablets


10 mg


sublingual tablet


oral use




United Kingdom


Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland


Zolpidem Tartrate 5 mg film-coated tablets


5 mg


film-coated tablet


oral use




United Kingdom


Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland


Zolpidem Tartrate 10 mg film-coated tablets


10 mg


film-coated tablet


oral use




United Kingdom


ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany


Zolpidem Tartrate 5 mg film-coated tablets


5 mg


film-coated tablet


oral use




United Kingdom


ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany


Zolpidem Tartrate 10 mg film-coated tablets


10 mg


film-coated tablet


oral use




United Kingdom


Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
United Kingdom


Zolpidem Tartrate 10 mg tablets


10 mg


film-coated tablet


oral use




United Kingdom


Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG
United Kingdom


Zolpidem Tartrate 5 mg, film-coated tablets


5 mg


film-coated tablet


oral use




United Kingdom


Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG
United Kingdom


Zolpidem Tartrate 10 mg, film-coated tablets


10 mg


film-coated tablet


oral use




United Kingdom


Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET
United Kingdom


Zolpidem 10 mg film-coated tablets


10 mg


film-coated tablet


oral use




United Kingdom


Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS
United Kingdom


Zolpidem Tartrate 5 mg tablets


5 mg


film-coated tablet


oral use




United Kingdom


Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS
United Kingdom


Zolpidem Tartrate 10 mg tablets


10 mg


film-coated tablet


oral use







ANNEX II
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration and marketing authorisation holders in the Member States










Member State EU/EEA


Marketing authorisation holder
company name, address


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Austria







AstraZeneca Österreich GmbH,




Schwarzenbergplatz 7,




A-1037 Wien,




Austria






Crestor 5 mg — Filmtabletten


5 mg


Film coated tablets


Oral use




Austria







AstraZeneca Österreich GmbH,




Schwarzenbergplatz 7,




A-1037 Wien,




Austria






Crestor 10 mg — Filmtabletten


10 mg


Film coated tablets


Oral use




Austria







AstraZeneca Österreich GmbH,




Schwarzenbergplatz 7,




A-1037 Wien,




Austria






Crestor 20 mg — Filmtabletten


20 mg


Film coated tablets


Oral use




Austria







AstraZeneca Österreich GmbH,




Schwarzenbergplatz 7,




A-1037 Wien,




Austria






Crestor 40 mg — Filmtabletten


40 mg


Film coated tablets


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels,




Belgium






Crestor


5 mg


Film coated tablets


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels,




Belgium






Crestor


10 mg


Film coated tablets


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels,




Belgium






Crestor


20 mg


Film coated tablets


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels,




Belgium






Crestor


40 mg


Film coated tablets


Oral use




Bulgaria







AstraZeneca




Pharmaceuticals AB,




S-151 85 Södertälje,




Sweden






Crestor


5 mg


Film coated tablets


Oral use




Bulgaria







AstraZeneca




Pharmaceuticals AB,




S-151 85 Södertälje,




Sweden






Crestor


10 mg


Film coated tablets


Oral use




Bulgaria







AstraZeneca




Pharmaceuticals AB,




S-151 85 Södertälje,




Sweden






Crestor


20 mg


Film coated tablets


Oral use




Croatia







AstraZeneca d.o.o.




Radnička cesta 80




10000 Zagreb




Croatia






Crestor 5 mg filmom obložene tablete


5 mg


Film coated tablets


Oral use




Croatia







AstraZeneca d.o.o.




Radnička cesta 80




10000 Zagreb




Croatia






Crestor 10 mg filmom obložene tablete


10 mg


Film coated tablets


Oral use




Croatia







AstraZeneca d.o.o.




Radnička cesta 80




10000 Zagreb




Croatia






Crestor 20 mg filmom obložene tablete


20 mg


Film coated tablets


Oral use




Croatia







AstraZeneca d.o.o.




Radnička cesta 80




10000 Zagreb




Croatia






Crestor 40 mg filmom obložene tablete


40 mg


Film coated tablets


Oral use




Cyprus







AstraZeneca UK Limited,




2 Kingdom Street,




London W2 6BD,




United Kingdom






Crestor


5 mg


Film coated tablets


Oral use




Cyprus







AstraZeneca UK Limited,




2 Kingdom Street,




London W2 6BD,




United Kingdom






Crestor


10 mg


Film coated tablets


Oral use




Cyprus







AstraZeneca UK Limited,




2 Kingdom Street,




London W2 6BD,




United Kingdom






Crestor


20 mg


Film coated tablets


Oral use




Cyprus







AstraZeneca UK Limited,




2 Kingdom Street,




London W2 6BD,




United Kingdom






Crestor


40 mg


Film coated tablets


Oral use




Czech Republic







AstraZeneca UK Limited,




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor 5 mg


5 mg


Film coated tablets


Oral use




Czech Republic







AstraZeneca UK Limited,




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor 10 mg


10 mg


Film coated tablets


Oral use




Czech Republic







AstraZeneca UK Limited,




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor 20 mg


20 mg


Film coated tablets


Oral use




Czech Republic







AstraZeneca UK Limited,




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor 40 mg


40 mg


Film coated tablets


Oral use




Denmark







AstraZeneca A/S




Arne Jacobsens Allé 13




2300 København S




Denmark






Crestor


5 mg


Film coated tablets


Oral use




Denmark







AstraZeneca A/S




Arne Jacobsens Allé 13




2300 København S




Denmark






Crestor


10 mg


Film coated tablets


Oral use




Denmark







AstraZeneca A/S




Arne Jacobsens Allé 13




2300 København S




Denmark






Crestor


20 mg


Film coated tablets


Oral use




Denmark







AstraZeneca A/S




Arne Jacobsens Allé 13




2300 København S




Denmark






Crestor


40 mg


Film coated tablets


Oral use




Estonia







AstraZeneca UK Ltd.




2 Kingdom Street,




London W2 6BD,




United Kingdom






Crestor


5 mg


Film coated tablets


Oral use




Estonia







AstraZeneca UK Ltd.




2 Kingdom Street,




London W2 6BD,




United Kingdom






Crestor


10 mg


Film coated tablets


Oral use




Estonia







AstraZeneca UK Ltd.




2 Kingdom Street,




London W2 6BD,




United Kingdom






Crestor


20 mg


Film coated tablets


Oral use




Finland







AstraZeneca Oy




Itsehallintokuja 4




02600 Espoo




Finland






Crestor


5 mg


Film coated tablets


Oral use




Finland







AstraZeneca Oy




Itsehallintokuja 4




02600 Espoo




Finland






Crestor


10 mg


Film coated tablets


Oral use




Finland







AstraZeneca Oy




Itsehallintokuja 4




02600 Espoo




Finland






Crestor


20 mg


Film coated tablets


Oral use




Finland







AstraZeneca Oy




Itsehallintokuja 4




02600 Espoo




Finland






Crestor


40 mg


Film coated tablets


Oral use




France







AstraZeneca




1, Place Renault




92844 Rueil-Malmaison Cedex,




France






Crestor


5 mg


Film coated tablets


Oral use




France







AstraZeneca




1, Place Renault




92844 Rueil-Malmaison Cedex,




France






Crestor


10 mg


Film coated tablets


Oral use




France







AstraZeneca




1, Place Renault




92844 Rueil-Malmaison Cedex,




France






Crestor


20 mg


Film coated tablets


Oral use




Germany







AstraZeneca GmbH,




22876 Wedel,




Germany






CRESTOR 5 mg Filmtabletten


5 mg


Film coated tablets


Oral use




Germany







AstraZeneca GmbH,




22876 Wedel,




Germany






CRESTOR 10 mg Filmtabletten


10 mg


Film coated tablets


Oral use




Germany







AstraZeneca GmbH,




22876 Wedel,




Germany






CRESTOR 20 mg Filmtabletten


20 mg


Film coated tablets


Oral use




Germany







AstraZeneca GmbH,




22876 Wedel,




Germany






CRESTOR 40 mg Filmtabletten


40 mg


Film coated tablets


Oral use




Greece







AstraZeneca SA




4 Theotokopoulou & Astronafton str




151 25 Maroussi, Athens




Greece






Crestor


5 mg


Film coated tablets


Oral use




Greece







AstraZeneca SA




4 Theotokopoulou & Astronafton str




151 25 Maroussi, Athens




Greece






Crestor


10 mg


Film coated tablets


Oral use




Greece







AstraZeneca SA




4 Theotokopoulou & Astronafton str




151 25 Maroussi, Athens




Greece






Crestor


20 mg


Film coated tablets


Oral use




Greece







AstraZeneca SA




4 Theotokopoulou & Astronafton str




151 25 Maroussi, Athens




Greece






Crestor


40 mg


Film coated tablets


Oral use




Hungary







AstraZeneca Kft.,




1113 Budapest,




Bocskai út 134-146.,




Hungary






Crestor 5 mg filmtabletta


5 mg


Film coated tablets


Oral use




Hungary







AstraZeneca Kft.,




1113 Budapest,




Bocskai út 134-146.,




Hungary






Crestor 10 mg filmtabletta


10 mg


Film coated tablets


Oral use




Hungary







AstraZeneca Kft.,




1113 Budapest,




Bocskai út 134-146.,




Hungary






Crestor 20 mg filmtabletta


20 mg


Film coated tablets


Oral use




Iceland







AstraZeneca A/S




Arne Jacobsens Allé 13




2300 København S




Denmark






Crestor


5 mg


Film coated tablets


Oral use




Iceland







AstraZeneca A/S




Arne Jacobsens Allé 13




2300 København S




Denmark






Crestor


10 mg


Film coated tablets


Oral use




Iceland







AstraZeneca A/S




Arne Jacobsens Allé 13




2300 København S




Denmark






Crestor


20 mg


Film coated tablets


Oral use




Iceland







AstraZeneca A/S




Arne Jacobsens Allé 13




2300 København S




Denmark






Crestor


40 mg


Film coated tablets


Oral use




Ireland







AstraZeneca UK Limited,




600 Capability Green,




Luton, LU1 3LU,




United Kingdom






Crestor


5 mg


Film coated tablets


Oral use




Ireland







AstraZeneca UK Limited,




600 Capability Green,




Luton, LU1 3LU,




United Kingdom






Crestor


10 mg


Film coated tablets


Oral use




Ireland







AstraZeneca UK Limited,




600 Capability Green,




Luton, LU1 3LU,




United Kingdom






Crestor


20 mg


Film coated tablets


Oral use




Ireland







AstraZeneca UK Limited,




600 Capability Green,




Luton, LU1 3LU,




United Kingdom






Crestor


40 mg


Film coated tablets


Oral use




Italy







AstraZeneca S.p.A.




Palazzo Volta, Via F. Sforza




20080 Basiglio (MI),




Italy






Crestor


5 mg


Film coated tablets


Oral use




Italy







AstraZeneca S.p.A.




Palazzo Volta, Via F. Sforza




20080 Basiglio (MI),




Italy






Crestor


10 mg


Film coated tablets


Oral use




Italy







AstraZeneca S.p.A.




Palazzo Volta, Via F. Sforza




20080 Basiglio (MI),




Italy






Crestor


20 mg


Film coated tablets


Oral use




Italy







AstraZeneca S.p.A.




Palazzo Volta, Via F. Sforza




20080 Basiglio (MI),




Italy






Crestor


40 mg


Film coated tablets


Oral use




Italy







AstraZeneca S.p.A.




Palazzo Volta, Via F. Sforza




20080 Basiglio (MI),




Italy






Cirantan


5 mg


Film coated tablets


Oral use




Italy







AstraZeneca S.p.A.




Palazzo Volta, Via F. Sforza




20080 Basiglio (MI),




Italy






Cirantan


10 mg


Film coated tablets


Oral use




Italy







AstraZeneca S.p.A.




Palazzo Volta, Via F. Sforza




20080 Basiglio (MI),




Italy






Cirantan


20 mg


Film coated tablets


Oral use




Italy







AstraZeneca S.p.A.




Palazzo Volta, Via F. Sforza




20080 Basiglio (MI),




Italy






Cirantan


40 mg


Film coated tablets


Oral use




Italy







AstraZeneca S.p.A.




Palazzo Volta, Via F. Sforza




20080 Basiglio (MI),




Italy






Provisacor


5 mg


Film coated tablets


Oral use




Italy







AstraZeneca S.p.A.




Palazzo Volta, Via F. Sforza




20080 Basiglio (MI),




Italy






Provisacor


10 mg


Film coated tablets


Oral use




Italy







AstraZeneca S.p.A.




Palazzo Volta, Via F. Sforza




20080 Basiglio (MI),




Italy






Provisacor


20 mg


Film coated tablets


Oral use




Italy







AstraZeneca S.p.A.




Palazzo Volta, Via F. Sforza




20080 Basiglio (MI),




Italy






Provisacor


40 mg


Film coated tablets


Oral use




Italy







Simesa S.P.A.




Palazzo Galileo, Via F. Sforza,




20080 Basiglio (MI),




Italy






Simestat


5 mg


Film coated tablets


Oral use




Italy







Simesa S.P.A.




Palazzo Galileo, Via F. Sforza,




20080 Basiglio (MI),




Italy






Simestat


10 mg


Film coated tablets


Oral use




Italy







Simesa S.P.A.




Palazzo Galileo, Via F. Sforza,




20080 Basiglio (MI),




Italy






Simestat


20 mg


Film coated tablets


Oral use




Italy







Simesa S.P.A.




Palazzo Galileo, Via F. Sforza,




20080 Basiglio (MI),




Italy






Simestat


40 mg


Film coated tablets


Oral use




Latvia







AstraZeneca UK Limited




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor 5 mg apvalkotās tabletes


5 mg


Film coated tablets


Oral use




Latvia







AstraZeneca UK Limited




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor 10 mg apvalkotās tabletes


10 mg


Film coated tablets


Oral use




Latvia







AstraZeneca UK Limited




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor 20 mg apvalkotās tabletes


20 mg


Film coated tablets


Oral use




Latvia







AstraZeneca UK Limited




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor 40 mg apvalkotās tabletes


40 mg


Film coated tablets


Oral use




Lithuania







AstraZeneca UK Limited




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor


5 mg


Film coated tablets


Oral use




Lithuania







AstraZeneca UK Limited




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor


10 mg


Film coated tablets


Oral use




Lithuania







AstraZeneca UK Limited




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor


20 mg


Film coated tablets


Oral use




Lithuania







AstraZeneca UK Limited




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor


40 mg


Film coated tablets


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels,




Belgium






Crestor


5 mg


Film coated tablets


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels,




Belgium






Crestor


10 mg


Film coated tablets


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels,




Belgium






Crestor


20 mg


Film coated tablets


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels,




Belgium






Crestor


40 mg


Film coated tablets


Oral use




Malta







AstraZeneca UK Limited




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor


5 mg


Film coated tablets


Oral use




Malta







AstraZeneca UK Limited




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor


10 mg


Film coated tablets


Oral use




Malta







AstraZeneca UK Limited




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor


20 mg


Film coated tablets


Oral use




Malta







AstraZeneca UK Limited




2 Kingdom Street




London W2 6BD




United Kingdom






Crestor


40 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Crestor


5 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Crestor


10 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Crestor


20 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Crestor


40 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Cirantan


5 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Cirantan


10 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Cirantan


20 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Cirantan


40 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Provisacor


5 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Provisacor


10 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Provisacor


20 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Provisacor


40 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Rosuvastatin AstraZeneca


5 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Rosuvastatin AstraZeneca


10 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Rosuvastatin AstraZeneca


20 mg


Film coated tablets


Oral use




The Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Rosuvastatin AstraZeneca


40 mg


Film coated tablets


Oral use




Norway







AstraZeneca AS




Postboks 6050,




Etterstad




0601 Oslo




Norway






Crestor


5 mg


Film coated tablets


Oral use




Norway







AstraZeneca AS




Postboks 6050,




Etterstad




0601 Oslo




Norway






Crestor


10 mg


Film coated tablets


Oral use




Norway







AstraZeneca AS




Postboks 6050,




Etterstad




0601 Oslo




Norway






Crestor


20 mg


Film coated tablets


Oral use




Norway







AstraZeneca AS




Postboks 6050,




Etterstad




0601 Oslo




Norway






Crestor


40 mg


Film coated tablets


Oral use




Poland







AstraZeneca AB,




S-151 85 Södertälje,




Sweden






Crestor


5 mg


Film coated tablets


Oral use




Poland







AstraZeneca AB,




S-151 85 Södertälje,




Sweden






Crestor


10 mg


Film coated tablets


Oral use




Poland







AstraZeneca AB,




S-151 85 Södertälje,




Sweden






Crestor


20 mg


Film coated tablets


Oral use




Poland







AstraZeneca AB,




S-151 85 Södertälje,




Sweden






Crestor


40 mg


Film coated tablets


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7




Queluz de Baixo




2730-097 Barcarena




Portugal






Crestor 5 mg


5 mg


Film coated tablets


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7




Queluz de Baixo




2730-097 Barcarena




Portugal






Crestor 10 mg


10 mg


Film coated tablets


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7




Queluz de Baixo




2730-097 Barcarena




Portugal






Crestor 20 mg


20 mg


Film coated tablets


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7




Queluz de Baixo




2730-097 Barcarena




Portugal






Crestor 40 mg


40 mg


Film coated tablets


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7,




Queluz de Baixo




2730-097 Barcarena




Portugal






Visacor 5 mg


5 mg


Film coated tablets


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7,




Queluz de Baixo




2730-097 Barcarena




Portugal






Visacor 10 mg


10 mg


Film coated tablets


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7,




Queluz de Baixo




2730-097 Barcarena




Portugal






Visacor 20 mg


20 mg


Film coated tablets


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7,




Queluz de Baixo




2730-097 Barcarena




Portugal






Visacor 40 mg


40 mg


Film coated tablets


Oral use




Romania







AstraZeneca UK Limited




2 Kingdom Street,




London W2 6BD,




United Kingdom






Crestor 5 mg comprimate filmate


5 mg


Film coated tablets


Oral use




Romania







AstraZeneca UK Limited




2 Kingdom Street,




London W2 6BD,




United Kingdom






Crestor 10 mg comprimate filmate


10 mg


Film coated tablets


Oral use




Romania







AstraZeneca UK Limited




2 Kingdom Street,




London W2 6BD,




United Kingdom






Crestor 20 mg comprimate filmate


20 mg


Film coated tablets


Oral use




Romania







AstraZeneca UK Limited




2 Kingdom Street,




London W2 6BD,




United Kingdom






Crestor 40 mg comprimate filmate


40 mg


Film coated tablets


Oral use




Slovak Republic







AstraZeneca UK Ltd




2 Kingdom Street




London, W2 6BD,




United Kingdom






CRESTOR 5 mg


5 mg


Film coated tablets


Oral use




Slovak Republic







AstraZeneca UK Ltd




2 Kingdom Street




London, W2 6BD,




United Kingdom






CRESTOR 10 mg


10 mg


Film coated tablets


Oral use




Slovak Republic







AstraZeneca UK Ltd




2 Kingdom Street




London, W2 6BD,




United Kingdom






CRESTOR 20 mg


20 mg


Film coated tablets


Oral use




Slovak Republic







AstraZeneca UK Ltd




2 Kingdom Street




London, W2 6BD,




United Kingdom






CRESTOR 40 mg


40mg


Film coated tablets


Oral use




Slovenia







AstraZeneca UK Limited




2 Kingdom Street




London, W2 6BD,




United Kingdom






Crestor 5 mg filmsko obložene tablete


5 mg


Film coated tablets


Oral use




Slovenia







AstraZeneca UK Limited




2 Kingdom Street




London, W2 6BD,




United Kingdom






Crestor 10 mg filmsko obložene tablete


10 mg


Film coated tablets


Oral use




Slovenia







AstraZeneca UK Limited




2 Kingdom Street




London, W2 6BD,




United Kingdom






Crestor 20 mg filmsko obložene tablete


20 mg


Film coated tablets


Oral use




Slovenia







AstraZeneca UK Limited




2 Kingdom Street




London, W2 6BD,




United Kingdom






Crestor 40 mg filmsko obložene tablete


40 mg


Film coated tablets


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/Serrano Galvache 56,




28033 Madrid,




Spain.






Crestor 5 mg comprimidos recubiertos con película


5 mg


Film coated tablets


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/Serrano Galvache 56,




28033 Madrid,




Spain.






Crestor 10 mg comprimidos recubiertos con película


10 mg


Film coated tablets


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/Serrano Galvache 56,




28033 Madrid,




Spain.






Crestor 20 mg comprimidos recubiertos con película


20 mg


Film coated tablets


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/Serrano Galvache 56,




28033 Madrid,




Spain.






Crestor 40 mg comprimidos recubiertos con película


40 mg


Film coated tablets


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/Serrano Galvache 56,




28033 Madrid,




Spain.






Provisacor 5 mg comprimidos recubiertos con película


5 mg


Film coated tablets


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/Serrano Galvache 56,




28033 Madrid,




Spain.






Provisacor 10 mg comprimidos recubiertos con película


10 mg


Film coated tablets


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/Serrano Galvache 56,




28033 Madrid,




Spain.






Provisacor 20 mg comprimidos recubiertos con película


20 mg


Film coated tablets


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/Serrano Galvache 56,




28033 Madrid,




Spain.






Provisacor 40 mg comprimidos recubiertos con película


40 mg


Film coated tablets


Oral use




Sweden







AstraZeneca AB,




S-151 85 Södertälje




Sweden






Crestor


5 mg


Film coated tablets


Oral use




Sweden







AstraZeneca AB,




S-151 85 Södertälje




Sweden






Crestor


10 mg


Film coated tablets


Oral use




Sweden







AstraZeneca AB,




S-151 85 Södertälje




Sweden






Crestor


20 mg


Film coated tablets


Oral use




Sweden







AstraZeneca AB,




S-151 85 Södertälje




Sweden






Crestor


40 mg


Film coated tablets


Oral use




United Kingdom







AstraZeneca UK Limited,




600 Capability Green,




Luton, LU1 3LU,




United Kingdom






Crestor


5 mg


Film coated tablets


Oral use




United Kingdom







AstraZeneca UK Limited,




600 Capability Green,




Luton, LU1 3LU,




United Kingdom






Crestor


10 mg


Film coated tablets


Oral use




United Kingdom







AstraZeneca UK Limited,




600 Capability Green,




Luton, LU1 3LU,




United Kingdom






Crestor


20 mg


Film coated tablets


Oral use




United Kingdom







AstraZeneca UK Limited,




600 Capability Green,




Luton, LU1 3LU,




United Kingdom






Crestor


40 mg


Film coated tablets


Oral use