# Official Journal C 243/25 J

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 243 |
| | |
| English edition | Information and Notices | Volume 5725 July 2014 |

ISSN 1977-091X

Official Journal

of the European Union

C 243

English edition

Information and Notices

Volume 5725 July 2014

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2014/C 243/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2014 to 30 June 2014(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2014/C 243/02 | 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) | 11 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2014/C 243/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2014 to 30 June 2014(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2014/C 243/02

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)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

11

| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 25.7.2014 | EN | Official Journal of the European Union | C 243/1 |
| --- | --- | --- | --- |

25.7.2014

EN

Official Journal of the European Union

C 243/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2014 to 30 June 2014

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

2014/C 243/01

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 30.6.2014 | Mekinist | trametinib | Glaxo Group Ltd |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

30.6.2014

Mekinist

trametinib

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/14/931

Film-coated tablet

L01XE25

2.7.2014

—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.6.2014 | Adasuve | Alexza UK Ltd. |
| 10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

3.6.2014

Adasuve

Alexza UK Ltd.

10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom

EU/1/13/823

5.6.2014

3.6.2014

Clopidogrel Krka d.d.

| Krka, d. d., Novo Mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

5.6.2014

3.6.2014

Docetaxel Mylan

| Mylan S.A.S |
| --- |
| 117 allée des Parcs, F-69800 Saint Priest, France |

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/11/748

5.6.2014

3.6.2014

Docetaxel Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/611

6.6.2014

3.6.2014

Efficib

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/457

5.6.2014

3.6.2014

Ibandronic acid Sandoz

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland

EU/1/11/685

5.6.2014

3.6.2014

Janumet

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/455

5.6.2014

3.6.2014

Kepivance

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| SE-112 76, Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

SE-112 76, Stockholm, Sverige

EU/1/05/314

5.6.2014

3.6.2014

Kiovig

| Baxter AG |
| --- |
| Industriestraße 67, A-1221 Wien, Österreich |

Baxter AG

Industriestraße 67, A-1221 Wien, Österreich

EU/1/05/329

5.6.2014

3.6.2014

Lysodren

| Laboratoire HRA Pharma |
| --- |
| 15 rue Béranger, F-75003 Paris, France |

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/04/273

5.6.2014

3.6.2014

Macugen

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/05/325

5.6.2014

3.6.2014

Memantine LEK

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/13/826

5.6.2014

3.6.2014

Nevanac

| Alcon Laboratories (UK) Ltd. |
| --- |
| Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |

Alcon Laboratories (UK) Ltd.

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

EU/1/07/433

5.6.2014

3.6.2014

Pradaxa

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

5.6.2014

3.6.2014

Prolia

| Amgen Europe B.V. |
| --- |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618

5.6.2014

3.6.2014

Ristfor

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/620

5.6.2014

3.6.2014

Velmetia

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/456

5.6.2014

3.6.2014

Yondelis

| Pharma Mar S.A. |
| --- |
| Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España |

Pharma Mar S.A.

Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España

EU/1/07/417

5.6.2014

6.6.2014

Champix

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/06/360

11.6.2014

6.6.2014

Edarbi

| Takeda Pharma A/S |
| --- |
| Dybendal Alle 10, 2630 Taastrup, Danmark |

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/11/734

11.6.2014

6.6.2014

Gardasil

| Sanofi Pasteur MSD, SNC |
| --- |
| 162 avenue Jean Jaurès, 69007 Lyon, France |

Sanofi Pasteur MSD, SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

12.6.2014

6.6.2014

Resolor

| Shire Pharmaceuticals Ireland Limited |
| --- |
| 5 River Walk, Citywest Business Campus, Dublin 24, Ireland |

Shire Pharmaceuticals Ireland Limited

5 River Walk, Citywest Business Campus, Dublin 24, Ireland

EU/1/09/581

11.6.2014

6.6.2014

Silgard

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/358

13.6.2014

6.6.2014

Telmisartan Teva Pharma

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/11/719

12.6.2014

6.6.2014

Topotecan Actavis

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland |

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/09/536

11.6.2014

6.6.2014

Zutectra

| Biotest Pharma GmbH |
| --- |
| Landsteinerstrasse 5, D-63303 Dreieich, Deutschland |

Biotest Pharma GmbH

Landsteinerstrasse 5, D-63303 Dreieich, Deutschland

EU/1/09/600

11.6.2014

12.6.2014

Imatinib Actavis

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland |

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/13/825

16.6.2014

19.6.2014

Celvapan

| Baxter AG |
| --- |
| Industriestraße 67, A-1221 Wien, Österreich |

Baxter AG

Industriestraße 67, A-1221 Wien, Österreich

EU/1/08/506

23.6.2014

19.6.2014

Enurev Breezhaler

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/12/789

23.6.2014

19.6.2014

Erivedge

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/13/848

23.6.2014

19.6.2014

GILENYA

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/677

23.6.2014

19.6.2014

Ilaris

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/564

23.6.2014

19.6.2014

Incivo

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/720

23.6.2014

19.6.2014

Javlor

| Pierre Fabre Médicament |
| --- |
| 45, place Abel Gance, F-92100 Boulogne, France |

Pierre Fabre Médicament

45, place Abel Gance, F-92100 Boulogne, France

EU/1/09/550

23.6.2014

19.6.2014

Osseor

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France |

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/04/287

23.6.2014

19.6.2014

Ozurdex

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road, Westport, County Mayo, Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/10/638

23.6.2014

19.6.2014

Protelos

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France |

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/04/288

23.6.2014

19.6.2014

Remicade

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, NL-2333 CB Leiden, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/99/116

23.6.2014

19.6.2014

Repaglinide Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/530

23.6.2014

19.6.2014

Samsca

| Otsuka Pharmaceutical Europe Ltd. |
| --- |
| Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/09/539

23.6.2014

19.6.2014

Seebri Breezhaler

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/12/788

23.6.2014

19.6.2014

Simponi

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, NL-2333 CB Leiden, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/09/546

23.6.2014

19.6.2014

Topotecan Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/552

23.6.2014

19.6.2014

Tovanor Breezhaler

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/12/790

23.6.2014

19.6.2014

Valdoxan

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France |

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/08/499

23.6.2014

19.6.2014

Votubia

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/710

23.6.2014

23.6.2014

Angiox

| The Medicines Company UK Ltd |
| --- |
| 115 L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom |

The Medicines Company UK Ltd

115 L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom

EU/1/04/289

25.6.2014

23.6.2014

Bosulif

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/13/818

25.6.2014

23.6.2014

Brilique

| AstraZeneca AB |
| --- |
| SE-151 85 Södertälje, Sverige |

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/10/655

25.6.2014

23.6.2014

Diacomit

| Biocodex |
| --- |
| 7 avenue Gallieni, F-94250 Gentilly, France |

Biocodex

7 avenue Gallieni, F-94250 Gentilly, France

EU/1/06/367

25.6.2014

23.6.2014

Prevenar 13

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/09/590

25.6.2014

23.6.2014

Thymanax

| Servier (Ireland) Industries Limited |
| --- |
| Gorey Road, Arklow, Co. Wicklow, Ireland |

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

25.6.2014

23.6.2014

Vfend

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/02/212

25.6.2014

23.6.2014

Yondelis

| Pharma Mar S.A. |
| --- |
| Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España |

Pharma Mar S.A.

Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España

EU/1/07/417

25.6.2014

23.6.2014

Zeffix

| Glaxo Group Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/99/114

25.6.2014

27.6.2014

Amyvid

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, NL-3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/12/805

1.7.2014

27.6.2014

Cayston

| Gilead Sciences International Limited |
| --- |
| Granta Park, Abington, Cambridge CB21 6GT, United Kingdom |

Gilead Sciences International Limited

Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543

1.7.2014

27.6.2014

Circadin

| RAD Neurim Pharmaceuticals EEC Limited |
| --- |
| One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom |

RAD Neurim Pharmaceuticals EEC Limited

One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom

EU/1/07/392

1.7.2014

27.6.2014

Esbriet

| InterMune UK Limited |
| --- |
| Grove House, 2nd Floor, 248A Marylebone Road, London NW1 6JZ, United Kingdom |

InterMune UK Limited

Grove House, 2nd Floor, 248A Marylebone Road, London NW1 6JZ, United Kingdom

EU/1/11/667

1.7.2014

27.6.2014

Foclivia

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, 53100 Siena, Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/09/577

1.7.2014

27.6.2014

HALAVEN

| Eisai Europe Limited |
| --- |
| European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom |

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

EU/1/11/678

1.7.2014

27.6.2014

Ibandronic Acid Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/10/642

2.7.2014

27.6.2014

Kineret

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| SE-112 76, Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

SE-112 76, Stockholm, Sverige

EU/1/02/203

1.7.2014

27.6.2014

Orfadin

| Swedish Orphan Biovitrum International AB |
| --- |
| SE-112 76, Stockholm, Sverige |

Swedish Orphan Biovitrum International AB

SE-112 76, Stockholm, Sverige

EU/1/04/303

1.7.2014

27.6.2014

Rasilamlo

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/686

9.7.2014

27.6.2014

Rasilez

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/405

9.7.2014

27.6.2014

Rasilez HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/491

9.7.2014

27.6.2014

Topotecan Hospira

| Hospira UK Limited |
| --- |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/633

1.7.2014

27.6.2014

Xyrem

| UCB Pharma Ltd. |
| --- |
| 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom |

UCB Pharma Ltd.

208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom

EU/1/05/312

1.7.2014

27.6.2014

ZALTRAP

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/814

1.7.2014

27.6.2014

Zoledronic acid Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/12/771

2.7.2014

30.6.2014

Arzerra

| Glaxo Group Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/10/625

2.7.2014

30.6.2014

Avastin

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300

2.7.2014

30.6.2014

Exforge HCT

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/569

9.7.2014

30.6.2014

Perjeta

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/13/813

2.7.2014

—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2)): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.6.2014 | Vectra Felis | dinotefuran, pyriproxyfen | CEVA SANTE ANIMALE |
| 10 avenue de la Ballastière, F-33500 Libourne, France |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

6.6.2014

Vectra Felis

dinotefuran, pyriproxyfen

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

EU/2/14/165

Spot-on solution

QP53AX73

11.6.2014

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.6.2014 | Activyl | Intervet International B.V. |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

3.6.2014

Activyl

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/10/118

5.6.2014

6.6.2014

Cerenia

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/06/062

11.6.2014

6.6.2014

Leucofeligen FeLV/RCP

| Virbac |
| --- |
| 1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France |

Virbac

1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France

EU/2/09/097

11.6.2014

6.6.2014

Melovem

| Dopharma Research B.V. |
| --- |
| Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland |

Dopharma Research B.V.

Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland

EU/2/09/098

11.6.2014

6.6.2014

Metacam

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/97/004

11.6.2014

6.6.2014

Suvaxyn PCV

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/099

11.6.2014

12.6.2014

Leucogen

| Virbac |
| --- |
| 1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France |

Virbac

1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France

EU/2/09/096

16.6.2014

19.6.2014

Locatim

| Biokema Anstalt |
| --- |
| Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein |

Biokema Anstalt

Pflugstrasse 12, 9490 Vaduz, Fürstentum Liechtenstein

EU/2/99/011

23.6.2014

19.6.2014

Previcox

| Merial |
| --- |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/04/045

23.6.2014

23.6.2014

Econor

| Novartis Tiergesundheit GmbH |
| --- |
| Zielstattstrasse 40, D-81379 München, Deutschland |

Novartis Tiergesundheit GmbH

Zielstattstrasse 40, D-81379 München, Deutschland

EU/2/98/010

25.6.2014

27.6.2014

Hiprabovis IBR Marker Live

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, E-17170- Amer (Girona), España |

Laboratorios Hipra, S.A.

Avda. La Selva, 135, E-17170- Amer (Girona), España

EU/2/10/114

1.7.2014

27.6.2014

Zulvac 8 Bovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/105

1.7.2014

27.6.2014

Zulvac 8 Ovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/104

1.7.2014

30.6.2014

TruScient

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/11/136

2.7.2014

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK — LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK — LONDON E14 4H

---

(1)  OJ L 136, 30.4.04, p. 1.

(2)  OJ L 136, 30.4.04, p. 1.

---

| 25.7.2014 | EN | Official Journal of the European Union | C 243/11 |
| --- | --- | --- | --- |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Crestor

5 mg

Film coated tablets

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Itsehallintokuja 4 |
| 02600 Espoo |
| Finland |

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Crestor

10 mg

Film coated tablets

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Itsehallintokuja 4 |
| 02600 Espoo |
| Finland |

AstraZeneca Oy

Itsehallintokuja 4

02600 Espoo

Finland

Crestor

20 mg

Film coated tablets

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Itsehallintokuja 4 |
| 02600 Espoo |
| 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 |

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 |

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 |

AstraZeneca

1, Place Renault

92844 Rueil-Malmaison Cedex,

France

Crestor

20 mg

Film coated tablets

Oral use

Germany

| AstraZeneca GmbH, |
| --- |
| 22876 Wedel, |
| Germany |

AstraZeneca GmbH,

22876 Wedel,

Germany

CRESTOR 5 mg Filmtabletten

5 mg

Film coated tablets

Oral use

Germany

| AstraZeneca GmbH, |
| --- |
| 22876 Wedel, |
| Germany |

AstraZeneca GmbH,

22876 Wedel,

Germany

CRESTOR 10 mg Filmtabletten

10 mg

Film coated tablets

Oral use

Germany

| AstraZeneca GmbH, |
| --- |
| 22876 Wedel, |
| Germany |

AstraZeneca GmbH,

22876 Wedel,

Germany

CRESTOR 20 mg Filmtabletten

20 mg

Film coated tablets

Oral use

Germany

| AstraZeneca GmbH, |
| --- |
| 22876 Wedel, |
| 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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

AstraZeneca AS

Postboks 6050,

Etterstad

0601 Oslo

Norway

Crestor

40 mg

Film coated tablets

Oral use

Poland

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, |
| Sweden |

AstraZeneca AB,

S-151 85 Södertälje,

Sweden

Crestor

5 mg

Film coated tablets

Oral use

Poland

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, |
| Sweden |

AstraZeneca AB,

S-151 85 Södertälje,

Sweden

Crestor

10 mg

Film coated tablets

Oral use

Poland

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, |
| Sweden |

AstraZeneca AB,

S-151 85 Södertälje,

Sweden

Crestor

20 mg

Film coated tablets

Oral use

Poland

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, |
| Sweden |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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. |

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. |

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. |

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. |

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. |

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. |

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. |

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. |

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 |

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Crestor

5 mg

Film coated tablets

Oral use

Sweden

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje |
| Sweden |

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Crestor

10 mg

Film coated tablets

Oral use

Sweden

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje |
| Sweden |

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Crestor

20 mg

Film coated tablets

Oral use

Sweden

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje |
| 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 |

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 |

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 |

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 |

AstraZeneca UK Limited,

600 Capability Green,

Luton, LU1 3LU,

United Kingdom

Crestor

40 mg

Film coated tablets

Oral use

---