# Official Journal C 337/26 S

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 337 |
| | |
| English edition | Information and Notices | Volume 5726 September 2014 |

ISSN 1977-091X

Official Journal

of the European Union

C 337

English edition

Information and Notices

Volume 5726 September 2014

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2014/C 337/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 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 337/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2014 to 31 August 2014(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 4 |
| 2014/C 337/03 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2014 to 31 August 2014(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 12 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2014/C 337/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 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 337/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2014 to 31 August 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)

4

2014/C 337/03

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2014 to 31 August 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)

12

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 26.9.2014 | EN | Official Journal of the European Union | C 337/1 |
| --- | --- | --- | --- |

26.9.2014

EN

Official Journal of the European Union

C 337/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 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 337/01

—   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 |
| --- | --- | --- | --- | --- |
| 11.7.2014 | Aclasta | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/05/308 | 20.8.2014 |

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

11.7.2014

Aclasta

Novartis Europharm Limited

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

EU/1/05/308

20.8.2014

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

| 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 |
| --- | --- | --- | --- | --- |
| 18.7.2014 | Revasc | Canyon Pharmaceuticals Ltd
  7th Floor, 52-54 Gracechurch Street, London EC3V 0EH, United Kingdom | EU/1/97/043 | 22.8.2014 |

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

18.7.2014

Revasc

Canyon Pharmaceuticals Ltd

7th Floor, 52-54 Gracechurch Street, London EC3V 0EH, United Kingdom

EU/1/97/043

22.8.2014

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 31.7.2014 | Versican Plus Pi/L4R | Canine parainfluenza type 2 virus
  Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089
  Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090
  Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091
  Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088
  Inactivated rabies virus, strain SAD Vnukovo-32 | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/173 | Lyophilisate and solvent for suspension for injection | QI07AJ | 4.8.2014 |

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

31.7.2014

Versican Plus Pi/L4R

Canine parainfluenza type 2 virus

Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089

Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090

Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091

Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088

Inactivated rabies virus, strain SAD Vnukovo-32

Zoetis Belgium S.A.

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

EU/2/14/173

Lyophilisate and solvent for suspension for injection

QI07AJ

4.8.2014

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 |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK — LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK — LONDON E14 5EU

---

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

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

---

| 26.9.2014 | EN | Official Journal of the European Union | C 337/4 |
| --- | --- | --- | --- |

26.9.2014

EN

Official Journal of the European Union

C 337/4

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2014 to 31 August 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 337/02

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 22.8.2014 | Daklinza | daclatasvir | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/14/939 | Film-coated tablet | J05AX | 26.8.2014 |
| 22.8.2014 | Vizamyl | flutemetamol (18F) | GE Healthcare Ltd
  Amersham Place Little Chalfont Buckinghamshire HP7 9NA UNITED KINGDOM | EU/1/14/941 | Solution for injection | V09AX04 | 26.8.2014 |
| 26.8.2014 | Velphoro | mixture of polynuclear iron (iii)-oxyhydroxide, sucrose and starches | Vifor Fresenius Medical Care Renal Pharma France
  7-13 boulevard Paul-Emile Victor, 92521 Neuilly-sur-Seine, France | EU/1/14/943 | Chewable tablet | V03AE05 | 28.8.2014 |

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

22.8.2014

Daklinza

daclatasvir

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/14/939

Film-coated tablet

J05AX

26.8.2014

22.8.2014

Vizamyl

flutemetamol (18F)

GE Healthcare Ltd

Amersham Place Little Chalfont Buckinghamshire HP7 9NA UNITED KINGDOM

EU/1/14/941

Solution for injection

V09AX04

26.8.2014

26.8.2014

Velphoro

mixture of polynuclear iron (iii)-oxyhydroxide, sucrose and starches

Vifor Fresenius Medical Care Renal Pharma France

7-13 boulevard Paul-Emile Victor, 92521 Neuilly-sur-Seine, France

EU/1/14/943

Chewable tablet

V03AE05

28.8.2014

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

| 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 |
| --- | --- | --- | --- | --- |
| 5.8.2014 | Folcepri | Endocyte Europe B.V.
  Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland | — | 7.8.2014 |
| 5.8.2014 | Neocepri | Endocyte Europe B.V.
  Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland | — | 7.8.2014 |
| 5.8.2014 | Reasanz | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | — | 20.8.2014 |
| 5.8.2014 | Vynfinit | Endocyte Europe B.V.
  Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland | — | 7.8.2014 |
| 19.8.2014 | Nerventra | Teva Pharma GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | — | 21.8.2014 |

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

5.8.2014

Folcepri

Endocyte Europe B.V.

Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland

—

7.8.2014

5.8.2014

Neocepri

Endocyte Europe B.V.

Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland

—

7.8.2014

5.8.2014

Reasanz

Novartis Europharm Limited

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

—

20.8.2014

5.8.2014

Vynfinit

Endocyte Europe B.V.

Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland

—

7.8.2014

19.8.2014

Nerventra

Teva Pharma GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

—

21.8.2014

—   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 |
| --- | --- | --- | --- | --- |
| 6.8.2014 | APTIVUS | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/05/315 | 8.8.2014 |
| 6.8.2014 | Eylea | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/12/797 | 8.8.2014 |
| 6.8.2014 | Fluenz Tetra | MedImmune, LLC
  Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland | EU/1/13/887 | 8.8.2014 |
| 6.8.2014 | IDflu | Sanofi Pasteur SA
  2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/08/507 | 8.8.2014 |
| 6.8.2014 | Intanza | Sanofi Pasteur MSD, SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/08/505 | 8.8.2014 |
| 6.8.2014 | Olazax Disperzi | Glenmark Pharmaceuticals s.r.o.
  City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika | EU/1/09/592 | 8.8.2014 |
| 6.8.2014 | Optaflu | Novartis Vaccines and Diagnostics GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/07/394 | 8.8.2014 |
| 6.8.2014 | Sprycel | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/363 | 8.8.2014 |
| 19.8.2014 | Aerius | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/160 | 21.8.2014 |
| 19.8.2014 | Azomyr | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/157 | 21.8.2014 |
| 19.8.2014 | Capecitabine SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/13/831 | 21.8.2014 |
| 19.8.2014 | Neoclarityn | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/161 | 21.8.2014 |
| 19.8.2014 | Olanzapine Glenmark | Glenmark Pharmaceuticals Europe Limited
  Laxmi House, 2B Draycott Avenue, Kenton, Harrow, Middlesex, HA3 0BU, United Kingdom | EU/1/09/587 | 21.8.2014 |
| 19.8.2014 | Olanzapine Glenmark Europe | Glenmark Pharmaceuticals Europe Limited
  Laxmi House, 2B Draycott Avenue, Kenton, Harrow, Middlesex, HA3 0BU, United Kingdom | EU/1/09/588 | 21.8.2014 |
| 19.8.2014 | Olanzapine Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/08/475 | 21.8.2014 |
| 19.8.2014 | Panretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/00/149 | 21.8.2014 |
| 19.8.2014 | Retacrit | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/07/431 | 21.8.2014 |
| 19.8.2014 | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621 | 21.8.2014 |
| 19.8.2014 | Rivastigmine 1 A Pharma | 1 A Pharma GmbH
  Keltenring 1 + 3, D-82041 Oberhaching, Deutschland | EU/1/09/585 | 21.8.2014 |
| 22.8.2014 | ADCETRIS | Takeda Pharma A/S
  Langebjerg 1, DK-4000 Roskilde, Danmark | EU/1/12/794 | 26.8.2014 |
| 22.8.2014 | Baraclude | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/343 | 26.8.2014 |
| 22.8.2014 | ChondroCelect | TiGenix NV
  Romeinse straat 12/2, B-3001 Leuven, België | EU/1/09/563 | 26.8.2014 |
| 22.8.2014 | Clopidogrel HCS | HCS bvba
  H. Kennisstraat 53, B-2650 Edegem, België | EU/1/10/651 | 27.8.2014 |
| 22.8.2014 | Corlentor | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes CEDEX, France | EU/1/05/317 | 26.8.2014 |
| 22.8.2014 | Dasselta | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/739 | 26.8.2014 |
| 22.8.2014 | Elonva | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/609 | 26.8.2014 |
| 22.8.2014 | Enyglid | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/580 | 26.8.2014 |
| 22.8.2014 | Imvanex | Bavarian Nordic A/S
  Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark | EU/1/13/855 | 26.8.2014 |
| 22.8.2014 | Isentress | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/436 | 26.8.2014 |
| 22.8.2014 | Olazax | Glenmark Pharmaceuticals s.r.o.
  Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | EU/1/09/597 | 26.8.2014 |
| 22.8.2014 | Procoralan | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes CEDEX, France | EU/1/05/316 | 26.8.2014 |
| 22.8.2014 | Repaglinide Krka | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/579 | 26.8.2014 |
| 22.8.2014 | Synagis | AbbVie Ltd
  Maidenhead, SL6 4XE, United Kingdom | EU/1/99/117 | 26.8.2014 |
| 22.8.2014 | Teysuno | Nordic Group B.V.
  Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland | EU/1/11/669 | 26.8.2014 |
| 22.8.2014 | Victrelis | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/704 | 26.8.2014 |
| 22.8.2014 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 26.8.2014 |
| 26.8.2014 | Aerinaze | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/399 | 28.8.2014 |
| 26.8.2014 | Arixtra | Aspen Pharma Trading Limited
  3016 Lake Drive Citywest Business Campus Dublin 24 Ireland | EU/1/02/206 | 28.8.2014 |
| 26.8.2014 | Avonex | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/97/033 | 28.8.2014 |
| 26.8.2014 | BeneFIX | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/97/047 | 28.8.2014 |
| 26.8.2014 | Betaferon | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/95/003 | 28.8.2014 |
| 26.8.2014 | Biopoin | Teva GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/565 | 28.8.2014 |
| 26.8.2014 | Busilvex | Pierre Fabre Médicament
  45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France | EU/1/03/254 | 28.8.2014 |
| 26.8.2014 | Ecalta | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/416 | 28.8.2014 |
| 26.8.2014 | Eylea | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/12/797 | 28.8.2014 |
| 26.8.2014 | Fareston | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/96/004 | 28.8.2014 |
| 26.8.2014 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 28.8.2014 |
| 26.8.2014 | MACI | Aastrom Biosciences DK ApS
  Oliefabriksvej 45, 2770 Kastrup, Danmark | EU/1/13/847 | 28.8.2014 |
| 26.8.2014 | Marixino | Consilient Health Ltd
  5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland | EU/1/13/820 | 28.8.2014 |
| 26.8.2014 | Nevirapine Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/598 | 28.8.2014 |
| 26.8.2014 | Ozurdex | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/10/638 | 28.8.2014 |
| 26.8.2014 | Prolia | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/10/618 | 28.8.2014 |
| 26.8.2014 | Rebif | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/98/063 | 28.8.2014 |
| 26.8.2014 | Scintimun | CIS bio international
  Boîte postale 32, F-91192 Gif-sur-Yvette, France | EU/1/09/602 | 28.8.2014 |
| 26.8.2014 | Temozolomide Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/606 | 28.8.2014 |
| 26.8.2014 | Xenical | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/98/071 | 28.8.2014 |
| 26.8.2014 | Zalasta | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/07/415 | 28.8.2014 |
| 27.8.2014 | Clopidogrel BGR | Laboratoires BIOGARAN
  15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France | EU/1/09/558 | 29.8.2014 |

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

6.8.2014

APTIVUS

Boehringer Ingelheim International GmbH

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

EU/1/05/315

8.8.2014

6.8.2014

Eylea

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/12/797

8.8.2014

6.8.2014

Fluenz Tetra

MedImmune, LLC

Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland

EU/1/13/887

8.8.2014

6.8.2014

IDflu

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/08/507

8.8.2014

6.8.2014

Intanza

Sanofi Pasteur MSD, SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/08/505

8.8.2014

6.8.2014

Olazax Disperzi

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika

EU/1/09/592

8.8.2014

6.8.2014

Optaflu

Novartis Vaccines and Diagnostics GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/07/394

8.8.2014

6.8.2014

Sprycel

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/363

8.8.2014

19.8.2014

Aerius

Merck Sharp & Dohme Limited

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

EU/1/00/160

21.8.2014

19.8.2014

Azomyr

Merck Sharp & Dohme Limited

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

EU/1/00/157

21.8.2014

19.8.2014

Capecitabine SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/13/831

21.8.2014

19.8.2014

Neoclarityn

Merck Sharp & Dohme Limited

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

EU/1/00/161

21.8.2014

19.8.2014

Olanzapine Glenmark

Glenmark Pharmaceuticals Europe Limited

Laxmi House, 2B Draycott Avenue, Kenton, Harrow, Middlesex, HA3 0BU, United Kingdom

EU/1/09/587

21.8.2014

19.8.2014

Olanzapine Glenmark Europe

Glenmark Pharmaceuticals Europe Limited

Laxmi House, 2B Draycott Avenue, Kenton, Harrow, Middlesex, HA3 0BU, United Kingdom

EU/1/09/588

21.8.2014

19.8.2014

Olanzapine Mylan

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/08/475

21.8.2014

19.8.2014

Panretin

Eisai Limited

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

EU/1/00/149

21.8.2014

19.8.2014

Retacrit

Hospira UK Limited

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

EU/1/07/431

21.8.2014

19.8.2014

Ristaben

Merck Sharp & Dohme Limited

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

EU/1/10/621

21.8.2014

19.8.2014

Rivastigmine 1 A Pharma

1 A Pharma GmbH

Keltenring 1 + 3, D-82041 Oberhaching, Deutschland

EU/1/09/585

21.8.2014

22.8.2014

ADCETRIS

Takeda Pharma A/S

Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/12/794

26.8.2014

22.8.2014

Baraclude

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/343

26.8.2014

22.8.2014

ChondroCelect

TiGenix NV

Romeinse straat 12/2, B-3001 Leuven, België

EU/1/09/563

26.8.2014

22.8.2014

Clopidogrel HCS

HCS bvba

H. Kennisstraat 53, B-2650 Edegem, België

EU/1/10/651

27.8.2014

22.8.2014

Corlentor

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/05/317

26.8.2014

22.8.2014

Dasselta

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/739

26.8.2014

22.8.2014

Elonva

Merck Sharp & Dohme Limited

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

EU/1/09/609

26.8.2014

22.8.2014

Enyglid

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/580

26.8.2014

22.8.2014

Imvanex

Bavarian Nordic A/S

Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark

EU/1/13/855

26.8.2014

22.8.2014

Isentress

Merck Sharp & Dohme Limited

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

EU/1/07/436

26.8.2014

22.8.2014

Olazax

Glenmark Pharmaceuticals s.r.o.

Hvězdova 1716/2b, 140 78 Praha 4, Česká republika

EU/1/09/597

26.8.2014

22.8.2014

Procoralan

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/05/316

26.8.2014

22.8.2014

Repaglinide Krka

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/579

26.8.2014

22.8.2014

Synagis

AbbVie Ltd

Maidenhead, SL6 4XE, United Kingdom

EU/1/99/117

26.8.2014

22.8.2014

Teysuno

Nordic Group B.V.

Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland

EU/1/11/669

26.8.2014

22.8.2014

Victrelis

Merck Sharp & Dohme Limited

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

EU/1/11/704

26.8.2014

22.8.2014

XALKORI

Pfizer Limited

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

EU/1/12/793

26.8.2014

26.8.2014

Aerinaze

Merck Sharp & Dohme Limited

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

EU/1/07/399

28.8.2014

26.8.2014

Arixtra

Aspen Pharma Trading Limited

3016 Lake Drive Citywest Business Campus Dublin 24 Ireland

EU/1/02/206

28.8.2014

26.8.2014

Avonex

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/97/033

28.8.2014

26.8.2014

BeneFIX

Pfizer Limited

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

EU/1/97/047

28.8.2014

26.8.2014

Betaferon

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/95/003

28.8.2014

26.8.2014

Biopoin

Teva GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/565

28.8.2014

26.8.2014

Busilvex

Pierre Fabre Médicament

45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France

EU/1/03/254

28.8.2014

26.8.2014

Ecalta

Pfizer Limited

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

EU/1/07/416

28.8.2014

26.8.2014

Eylea

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/12/797

28.8.2014

26.8.2014

Fareston

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/96/004

28.8.2014

26.8.2014

Imnovid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/13/850

28.8.2014

26.8.2014

MACI

Aastrom Biosciences DK ApS

Oliefabriksvej 45, 2770 Kastrup, Danmark

EU/1/13/847

28.8.2014

26.8.2014

Marixino

Consilient Health Ltd

5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

EU/1/13/820

28.8.2014

26.8.2014

Nevirapine Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/598

28.8.2014

26.8.2014

Ozurdex

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/10/638

28.8.2014

26.8.2014

Prolia

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618

28.8.2014

26.8.2014

Rebif

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/98/063

28.8.2014

26.8.2014

Scintimun

CIS bio international

Boîte postale 32, F-91192 Gif-sur-Yvette, France

EU/1/09/602

28.8.2014

26.8.2014

Temozolomide Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/606

28.8.2014

26.8.2014

Xenical

Roche Registration Limited

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

EU/1/98/071

28.8.2014

26.8.2014

Zalasta

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/07/415

28.8.2014

27.8.2014

Clopidogrel BGR

Laboratoires BIOGARAN

15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France

EU/1/09/558

29.8.2014

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

| 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 |
| --- | --- | --- | --- | --- |
| 19.8.2014 | Rivastigmine 3M Health Care Ltd. | 3M Health Care Limited
  1 Morley Street, Loughborough, Leicestershire, LE11 1EP United Kingdom | EU/1/14/911 | 21.8.2014 |
| 22.8.2014 | Vistide | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/97/037 | 26.8.2014 |

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

19.8.2014

Rivastigmine 3M Health Care Ltd.

3M Health Care Limited

1 Morley Street, Loughborough, Leicestershire, LE11 1EP United Kingdom

EU/1/14/911

21.8.2014

22.8.2014

Vistide

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/97/037

26.8.2014

—   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 |
| --- | --- | --- | --- | --- |
| 5.8.2014 | Activyl Tick Plus | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/11/137 | 7.8.2014 |
| 19.8.2014 | Zolvix | Novartis Healthcare A/S
  Edvard Thomsens Vej 14, DK-2300 København S, Danmark | EU/2/09/101 | 21.8.2014 |
| 26.8.2014 | Cortavance | VIRBAC S.A.
  1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France | EU/2/06/069 | 28.8.2014 |
| 26.8.2014 | Naxcel | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/05/053 | 28.8.2014 |
| 26.8.2014 | Procox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/11/123 | 28.8.2014 |
| 26.8.2014 | Slentrol | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/07/071 | 28.8.2014 |
| 26.8.2014 | Stronghold | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/99/014 | 28.8.2014 |
| 27.8.2014 | Convenia | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/06/059 | 29.8.2014 |

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

5.8.2014

Activyl Tick Plus

Intervet International B.V.

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

EU/2/11/137

7.8.2014

19.8.2014

Zolvix

Novartis Healthcare A/S

Edvard Thomsens Vej 14, DK-2300 København S, Danmark

EU/2/09/101

21.8.2014

26.8.2014

Cortavance

VIRBAC S.A.

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

EU/2/06/069

28.8.2014

26.8.2014

Naxcel

Zoetis Belgium S.A.

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

EU/2/05/053

28.8.2014

26.8.2014

Procox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/11/123

28.8.2014

26.8.2014

Slentrol

Zoetis Belgium S.A.

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

EU/2/07/071

28.8.2014

26.8.2014

Stronghold

Zoetis Belgium S.A.

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

EU/2/99/014

28.8.2014

27.8.2014

Convenia

Zoetis Belgium S.A.

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

EU/2/06/059

29.8.2014

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 |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK — LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK — LONDON E14 5EU

---

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

---

| 26.9.2014 | EN | Official Journal of the European Union | C 337/12 |
| --- | --- | --- | --- |

26.9.2014

EN

Official Journal of the European Union

C 337/12

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2014 to 31 August 2014

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

2014/C 337/03

—   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 |
| --- | --- | --- | --- | --- | --- |
| 19.8.2014 | Estradiol | See Annex I | See Annex I | See Annex I | 20.8.2014 |
| 6.8.2014 | Dexamed | See Annex II | See Annex II | See Annex II | 7.8.2014 |
| 26.8.2014 | Sandostatin LAR | See Annex III | See Annex III | See Annex III | 28.8.2014 |
| 26.8.2014 | Sandostatin | See Annex IV | See Annex IV | See Annex IV | 28.8.2014 |
| 6.8.2014 | Seroquel-Seroquel XR | See Annex V | See Annex V | See Annex V | 7.8.2014 |

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

19.8.2014

Estradiol

See Annex I

See Annex I

See Annex I

20.8.2014

6.8.2014

Dexamed

See Annex II

See Annex II

See Annex II

7.8.2014

26.8.2014

Sandostatin LAR

See Annex III

See Annex III

See Annex III

28.8.2014

26.8.2014

Sandostatin

See Annex IV

See Annex IV

See Annex IV

28.8.2014

6.8.2014

Seroquel-Seroquel XR

See Annex V

See Annex V

See Annex V

7.8.2014

---

(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, routes of administration, marketing authorisation holders in the Member States

0,01
  % w/w estradiol containing medicinal products for topical use

| Member State (in EEA) | Marketing authorisation holder | INN | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Pharmazeutische Fabrik Montavit GesmbH
  Salzbergstraße 96
  6067 Absam
  Austria | estradiol | Linoladiol Estradiol — Emulsion | 10 mg/100 g
  (0,01 %) | Vaginal emulsion | Cutaneous use, vaginal use |
| Austria | Pharmazeutische Fabrik Montavit GesmbH
  Salzbergstraße 96
  6067 Absam
  Austria | estradiol | Montadiol 0,01 % Creme | 10 mg/100 g
  (0,01 %) | Cream | Cutaneous use, vaginal use |
| Bulgaria | Dr. August Wolff GmbH&Co.
  KG Arzneimittel
  Sudbrackstrasse 56
  33611 Bielefeld
  Germany | estradiol | Linoladiol N | 10 mg/100 g
  (0,01 %) | Cream | Cutaneous use, vaginal use |
| Czech Republic | Dr. August Wolff GmbH&Co.
  KG Arzneimittel
  Sudbrackstrasse 56
  33611 Bielefeld
  Germany | estradiol | Linoladiol N | 10,33 mg/100 g
  (10 mg/100 g; 0,01 %) | Cream | Cutaneous use, vaginal use |
| Estonia | Dr. August Wolff GmbH&Co.
  KG Arzneimittel
  Sudbrackstrasse 56
  33611 Bielefeld
  Germany | estradiol | Linoladiol N | 10 mg/100 g
  (0,01 %) | Cream | Cutaneous use, vaginal use |
| Germany | Dr. August Wolff GmbH&Co.
  KG Arzneimittel
  Sudbrackstrasse 56
  33611 Bielefeld
  Germany | estradiol | Linoladiol N | 10 mg/100 g
  (0,01 %) | Cream | Topical use |
| Hungary | Dr. August Wolff GmbH&Co.
  KG Arzneimittel
  Sudbrackstrasse 56
  33611 Bielefeld
  Germany | estradiol | Linoladiol 0,1 mg/g gél | 0,1 mg/g | Cream | Cutaneous use, vaginal use |
| Latvia | Dr. August Wolff GmbH&Co.
  KG Arzneimittel
  Sudbrackstrasse 56
  33611 Bielefeld
  Germany | estradiol | Linoladiol N 0,1 mg/g vaginal cream | 10 mg/100 g
  (0,01 %) | Vaginal cream | Vaginal use, topical use |
| Lithuania | Dr. August Wolff GmbH&Co.
  KG Arzneimittel
  Sudbrackstrasse 56
  33611 Bielefeld
  Germany | estradiol | Linoladiol N | 10 mg/100 g
  (0,01 %) | Cream | Cutaneous use, vaginal use |
| Slovak Republic | Dr. August Wolff GmbH&Co.
  KG Arzneimittel
  Sudbrackstrasse 56
  33611 Bielefeld
  Germany | estradiol | Linoladiol N | 10 mg/100 g
  (0,01 %) | Cream | Cutaneous use |

Member State (in EEA)

Marketing authorisation holder

INN

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Pharmazeutische Fabrik Montavit GesmbH

Salzbergstraße 96

6067 Absam

Austria

estradiol

Linoladiol Estradiol — Emulsion

10 mg/100 g

(0,01 %)

Vaginal emulsion

Cutaneous use, vaginal use

Austria

Pharmazeutische Fabrik Montavit GesmbH

Salzbergstraße 96

6067 Absam

Austria

estradiol

Montadiol 0,01 % Creme

10 mg/100 g

(0,01 %)

Cream

Cutaneous use, vaginal use

Bulgaria

Dr. August Wolff GmbH&Co.

KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

estradiol

Linoladiol N

10 mg/100 g

(0,01 %)

Cream

Cutaneous use, vaginal use

Czech Republic

Dr. August Wolff GmbH&Co.

KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

estradiol

Linoladiol N

10,33 mg/100 g

(10 mg/100 g; 0,01 %)

Cream

Cutaneous use, vaginal use

Estonia

Dr. August Wolff GmbH&Co.

KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

estradiol

Linoladiol N

10 mg/100 g

(0,01 %)

Cream

Cutaneous use, vaginal use

Germany

Dr. August Wolff GmbH&Co.

KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

estradiol

Linoladiol N

10 mg/100 g

(0,01 %)

Cream

Topical use

Hungary

Dr. August Wolff GmbH&Co.

KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

estradiol

Linoladiol 0,1 mg/g gél

0,1 mg/g

Cream

Cutaneous use, vaginal use

Latvia

Dr. August Wolff GmbH&Co.

KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

estradiol

Linoladiol N 0,1 mg/g vaginal cream

10 mg/100 g

(0,01 %)

Vaginal cream

Vaginal use, topical use

Lithuania

Dr. August Wolff GmbH&Co.

KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

estradiol

Linoladiol N

10 mg/100 g

(0,01 %)

Cream

Cutaneous use, vaginal use

Slovak Republic

Dr. August Wolff GmbH&Co.

KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

estradiol

Linoladiol N

10 mg/100 g

(0,01 %)

Cream

Cutaneous use

0,005
  % w/w estradiol/0,4 % w/w prednisolone containing medicinal products for topical use

| Member State (in EEA) | Marketing authorisation holder | INN | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Estonia | Dr. August Wolff GmbH&Co.
  KG Arzneimittel
  Sudbrackstrasse 56
  33611 Bielefeld
  Germany | estradiol
  prednisolone | Linoladiol HN | 0,05 mg/g
  4 mg/g | Cream | Cutaneous use |
| Germany | Dr. August Wolff GmbH&Co.
  KG Arzneimittel
  Sudbrackstrasse 56
  33611 Bielefeld
  Germany | estradiol
  prednisolone | Linoladiol HN | 0,005 g/100 g (0,005 %) | Cream | Topical use |
| Latvia | Dr. August Wolff GmbH&Co.
  KG Arzneimittel
  Sudbrackstrasse 56
  33611 Bielefeld
  Germany | estradiol
  prednisolone | Linoladiol-HN 0,05 mg/4 mg/g cream | 0,05 mg/g
  4 mg/g | Cream | Cutaneous use |
| Lithuania | Dr. August Wolff GmbH&Co.
  KG Arzneimittel
  Sudbrackstrasse 56
  33611 Bielefeld
  Germany | estradiol
  prednisolone | Linoladiol HN | 0,05 mg/g
  4 mg/g | Cream | Cutaneous use |

Member State (in EEA)

Marketing authorisation holder

INN

Invented name

Strength

Pharmaceutical form

Route of administration

Estonia

Dr. August Wolff GmbH&Co.

KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

estradiol

prednisolone

Linoladiol HN

0,05 mg/g

4 mg/g

Cream

Cutaneous use

Germany

Dr. August Wolff GmbH&Co.

KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

estradiol

prednisolone

Linoladiol HN

0,005 g/100 g (0,005 %)

Cream

Topical use

Latvia

Dr. August Wolff GmbH&Co.

KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

estradiol

prednisolone

Linoladiol-HN 0,05 mg/4 mg/g cream

0,05 mg/g

4 mg/g

Cream

Cutaneous use

Lithuania

Dr. August Wolff GmbH&Co.

KG Arzneimittel

Sudbrackstrasse 56

33611 Bielefeld

Germany

estradiol

prednisolone

Linoladiol HN

0,05 mg/g

4 mg/g

Cream

Cutaneous use

---

ANNEX II

List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant in the Member States

| Member State EU/EEA | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Denmark | Kohne Pharma GmbH
  Schallbruch 1
  42781 Haan
  Germany | Dexamed | 5 mg | Tablet | Oral use |
| Finland | Kohne Pharma GmbH
  Schallbruch 1
  42781 Haan
  Germany | Attentin 5 mg | 5 mg | Tablet | Oral use |
| Ireland | Kohne Pharma GmbH
  Schallbruch 1
  42781 Haan
  Germany | Dexamed 5 mg tablets | 5 mg | Tablet | Oral use |
| Luxembourg | Kohne Pharma GmbH
  Schallbruch 1
  42781 Haan
  Germany | Attentin 5 mg | 5 mg | Tablet | Oral use |
| Norway | Kohne Pharma GmbH
  Schallbruch 1
  42781 Haan
  Germany | Attentin | 5 mg | Tablet | Oral use |
| Spain | Kohne Pharma GmbH
  Schallbruch 1
  42781 Haan
  Germany | Dexamed 5 mg comprimidos | 5 mg | Tablet | Oral use |
| Sweden | Kohne Pharma GmbH
  Schallbruch 1
  42781 Haan
  Germany | Attentin 5 mg | 5 mg | Tablet | Oral use |
| The Netherlands | Kohne Pharma GmbH
  Schallbruch 1
  42781 Haan
  Germany | Tentin 5 mg | 5 mg | Tablet | Oral use |
| United Kingdom | Kohne Pharma GmbH
  Schallbruch 1
  42781 Haan
  Germany | Dexamed 5 mg | 5 mg | Tablet | Oral use |

Member State EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Denmark

Kohne Pharma GmbH

Schallbruch 1

42781 Haan

Germany

Dexamed

5 mg

Tablet

Oral use

Finland

Kohne Pharma GmbH

Schallbruch 1

42781 Haan

Germany

Attentin 5 mg

5 mg

Tablet

Oral use

Ireland

Kohne Pharma GmbH

Schallbruch 1

42781 Haan

Germany

Dexamed 5 mg tablets

5 mg

Tablet

Oral use

Luxembourg

Kohne Pharma GmbH

Schallbruch 1

42781 Haan

Germany

Attentin 5 mg

5 mg

Tablet

Oral use

Norway

Kohne Pharma GmbH

Schallbruch 1

42781 Haan

Germany

Attentin

5 mg

Tablet

Oral use

Spain

Kohne Pharma GmbH

Schallbruch 1

42781 Haan

Germany

Dexamed 5 mg comprimidos

5 mg

Tablet

Oral use

Sweden

Kohne Pharma GmbH

Schallbruch 1

42781 Haan

Germany

Attentin 5 mg

5 mg

Tablet

Oral use

The Netherlands

Kohne Pharma GmbH

Schallbruch 1

42781 Haan

Germany

Tentin 5 mg

5 mg

Tablet

Oral use

United Kingdom

Kohne Pharma GmbH

Schallbruch 1

42781 Haan

Germany

Dexamed 5 mg

5 mg

Tablet

Oral use

---

ANNEX III

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

| Member State EU/EEA | Marketing authorisation holder | (Invented) Name | Strength | Pharmaceutical form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  1020 Wien
  Austria | Sandostatin LAR 10 mg — Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension | 10 mg | Powder and solvent for suspension for injection | Injection | 5 mg/ml |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  1020 Wien
  Austria | Sandostatin LAR 20 mg — Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension | 20 mg | Powder and solvent for suspension for injection | Injection | 10 mg/ml |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  1020 Wien
  Austria | Sandostatin LAR 30 mg — Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension | 30 mg | Powder and solvent for suspension for injection | Injection | 15 mg/ml |
| Belgium | N.V. Novartis Pharma S.A.
  Medialaan 40,
  1800 Vilvoorde
  Belgium | Sandostatine Long Acting Repeatable | 10 mg | Powder and solvent for suspension for injection | Injection | 4 mg/ml |
| Belgium | N.V. Novartis Pharma S.A.
  Medialaan 40,
  1800 Vilvoorde
  Belgium | Sandostatine Long Acting Repeatable | 20 mg | Powder and solvent for suspension for injection | Injection | 8 mg/ml |
| Belgium | N.V. Novartis Pharma S.A.
  Medialaan 40,
  1800 Vilvoorde
  Belgium | Sandostatine Long Acting Repeatable | 30 mg | Powder and solvent for suspension for injection | Injection | 12 mg/ml |
| Bulgaria | Novartis Pharma GmbH
  Roonstrasse 25, 90429
  Nuremberg
  Germany | Sandostatin LAR | 20 mg | Powder and solvent for suspension for injection | Injection | 10 mg/ml |
| Bulgaria | Novartis Pharma GmbH
  Roonstrasse 25, 90429
  Nuremberg
  Germany | Sandostatin LAR | 30 mg | Powder and solvent for suspension for injection | Injection | 15 mg/ml |
| Cyprus | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin LAR | 10 mg | Powder and solvent for suspension for injection | Injection | 4 mg/ml |
| Cyprus | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin LAR | 20 mg | Powder and solvent for suspension for injection | Injection | 8 mg/ml |
| Cyprus | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin LAR | 30 mg | Powder and solvent for suspension for injection | Injection | 12 mg/ml |
| Czech Republic | Novartis s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 — Nusle
  Czech Republic | Sandostatin LAR 20 MG | 20 mg | Powder and solvent for suspension for injection | Intramuscular use | 10 mg/ml |
| Czech Republic | Novartis s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 — Nusle
  Czech Republic | Sandostatin LAR 30 MG | 30 mg | Powder and solvent for suspension for injection | Intramuscular use | 15 mg/ml |
| Denmark | Novartis Healthcare A/S
  Edvard Thomsens Vej 14
  2300 Copenhagen S
  Denmark | Sandostatin LAR | 10 mg | Powder and solvent for suspension for injection | Injection | 4 mg/ml |
| Denmark | Novartis Healthcare A/S
  Edvard Thomsens Vej 14
  2300 Copenhagen S
  Denmark | Sandostatin LAR | 20 mg | Powder and solvent for suspension for injection | Injection | 8 mg/ml |
| Denmark | Novartis Healthcare A/S
  Edvard Thomsens Vej 14
  2300 Copenhagen S
  Denmark | Sandostatin LAR | 30 mg | Powder and solvent for suspension for injection | Injection | 12 mg/ml |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin LAR | 10 mg | Powder and solvent for suspension for injection | Intramuscular use | 5 mg/ml |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin LAR | 20 mg | Powder and solvent for suspension for injection | Intramuscular use | 10 mg/ml |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin LAR | 30 mg | Powder and solvent for suspension for injection | Intramuscular use | 15 mg/ml |
| Finland | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin LAR | 10 mg | Powder and solvent for suspension for injection | Intramuscular use | 5 mg/ml |
| Finland | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin LAR | 20 mg | Powder and solvent for suspension for injection | Intramuscular use | 10 mg/ml |
| Finland | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin LAR | 30 mg | Powder and solvent for suspension for injection | Intramuscular use | 15 mg/ml |
| France | Novartis Pharma S.A.S.
  2-4, rue Lionel Terray
  92500 RUEIL-MALMAISON,
  France | Sandostatine LP | 10 mg | Powder and solvent in prefilled syringe for prolonged-release suspension for injection (I.M) | Intramuscular use | 4 mg/ml |
| France | Novartis Pharma S.A.S.
  2-4, rue Lionel Terray
  92500 RUEIL-MALMAISON,
  France | Sandostatine LP | 20 mg | Powder and solvent in prefilled syringe for prolonged-release suspension for injection (I.M) | Intramuscular use | 8 mg/ml |
| France | Novartis Pharma S.A.S.
  2-4, rue Lionel Terray
  92500 RUEIL-MALMAISON,
  France | Sandostatine LP | 30 mg | Powder and solvent in prefilled syringe for prolonged-release suspension for injection (I.M) | Intramuscular use | 12 mg/ml |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin LAR — Monatsdepot 10 mg | 10 mg/2 ml | Powder and solvent for suspension for injection | Injection | 5 mg/ml |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin LAR- Monatsdepot 20 mg | 20 mg/2 ml | Powder and solvent for suspension for injection | Injection | 10 mg/ml |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin LAR- Monatsdepot 30 mg | 30 mg/2 ml | Powder and solvent for suspension for injection | Injection | 15 mg/ml |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  144 51 Athens
  Greece | Sandostatin LAR | 10 mg | Powder and solvent for suspension for injection | Intramuscular use | 4 mg/ml |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  144 51 Athens
  Greece | Sandostatin LAR | 20 mg | Powder and solvent for suspension for injection | Intramuscular use | 8 mg/ml |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  144 51 Athens
  Greece | Sandostatin LAR | 30 mg | Powder and solvent for suspension for injection | Intramuscular use | 12 mg/ml |
| Hungary | Novartis Hungária Kft.
  (Pharma részlege)
  Bartók Béla út 43-47
  1114 Budapest
  Hungary | Sandostatin LAR 10 mg por és oldószer szuszpenziós injekcióhoz | 10 mg | Powder and solvent for suspension for injection | Intramuscular use | 5 mg/ml |
| Hungary | Novartis Hungária Kft.
  (Pharma részlege)
  Bartók Béla út 43-47
  1114 Budapest
  Hungary | Sandostatin LAR 20 mg por és oldószer szuszpenziós injekcióhoz | 20 mg | Powder and solvent for suspension for injection | Intramuscular use | 10 mg/ml |
| Hungary | Novartis Hungária Kft.
  (Pharma részlege)
  Bartók Béla út 43-47
  1114 Budapest
  Hungary | Sandostatin LAR 30 mg por és oldószer szuszpenziós injekcióhoz | 30 mg | Powder and solvent for suspension for injection | Intramuscular use | 15 mg/ml |
| Iceland | Novartis Healthcare A/S
  Edvard Thomsens Vej 14
  2300 Copenhagen S
  Denmark | Sandostatin LAR | 10 mg | Powder and solvent for suspension for injection | Intramuscular use | 5 mg/ml |
| Iceland | Novartis Healthcare A/S
  Edvard Thomsens Vej 14
  2300 Copenhagen S
  Denmark | Sandostatin LAR | 20 mg | Powder and solvent for suspension for injection | Intramuscular use | 10 mg/ml |
| Iceland | Novartis Healthcare A/S
  Edvard Thomsens Vej 14
  2300 Copenhagen S
  Denmark | Sandostatin LAR | 30 mg | Powder and solvent for suspension for injection | Intramuscular use | 15 ml/mg |
| Ireland | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin LAR | 10 mg | Powder and solvent for suspension for injection | Injection | 5 ml/mg |
| Ireland | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin LAR | 20 mg | Powder and solvent for suspension for injection | Injection | 10 ml/mg |
| Ireland | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin LAR | 30 mg | Powder and solvent for suspension for injection | Injection | 15 ml/mg |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  21040 Origgio
  Italy | Sandostatina LAR | 10 mg | Powder and solvent for suspension for injection | Injection | 4 mg/ml |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  21040 Origgio
  Italy | Sandostatina LAR | 20 mg | Powder and solvent for suspension for injection | Injection | 8 mg/ml |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  21040 Origgio
  Italy | Sandostatina LAR | 30 mg | Powder and solvent for suspension for injection | Injection | 12 mg/ml |
| Latvia | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin LAR 10 mg pulveris un šķīdinātājs injekciju suspensijas pagatavošanai | 10 mg | Powder and solvent for suspension for injection | Injection | 5 mg/ml |
| Latvia | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin LAR 20 mg pulveris un šķīdinātājs injekciju suspensijas pagatavošanai | 20 mg | Powder and solvent for suspension for injection | Injection | 10 mg/ml |
| Latvia | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin LAR 30 mg pulveris un šķīdinātājs injekciju suspensijas pagatavošanai | 30 mg | Powder and solvent for suspension for injection | Injection | 15 mg/ml |
| Lithuania | Novartis Finland Oy
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin LAR | 10 mg | Powder and solvent for suspension for injection | Intramuscular use | 5 mg/ml;
  4 mg/ml |
| Lithuania | Novartis Finland Oy
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin LAR | 20 mg | Powder and solvent for suspension for injection | Intramuscular use | 10 mg/ml;
  8 mg/ml |
| Lithuania | Novartis Finland Oy
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin LAR | 30 mg | Powder and solvent for suspension for injection | Intramuscular use | 15 mg/ml;
  12 mg/ml |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D-90429 Nürnberg
  Germany | Sandostatin Long Acting Repeatable | 10 mg | Powder and solvent for suspension for injection | Injection | 5 mg/ml |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D-90429 Nürnberg
  Germany | Sandostatin Long Acting Repeatable | 20 mg | Powder and solvent for suspension for injection | Injection | 10 mg/ml |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D-90429 Nürnberg
  Germany | Sandostatin Long Acting Repeatable | 30 mg | Powder and solvent for suspension for injection | Injection | 15 mg/ml |
| Malta | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin LAR 10 mg Powder and solvent for suspension for injection | 10 mg | Powder and solvent for suspension for injection | Injection | 5 mg/ml |
| Malta | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin LAR 20 mg Powder and solvent for suspension for injection | 20 mg | Powder and solvent for suspension for injection | Injection | 10 mg/ml |
| Malta | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin LAR 30 mg Powder and solvent for suspension for injection | 30 mg | Powder and solvent for suspension for injection | Injection | 15 mg/ml |
| The Netherlands | Novartis Pharma B.V.
  Raapopseweg 1
  6824 DP Arnhem
  The Netherlands | Sandostatine LAR 10 mg, poeder en oplosmiddel voor suspensie voor injectie | 10 mg | Powder and solvent for suspension for injection | Injection | 5 mg/ml |
| The Netherlands | Novartis Pharma B.V.
  Raapopseweg 1
  6824 DP Arnhem
  The Netherlands | Sandostatine LAR 20 mg, poeder en oplosmiddel voor suspensie voor injectie | 20 mg | Powder and solvent for suspension for injection | Injection | 10 mg/ml |
| The Netherlands | Novartis Pharma B.V.
  Raapopseweg 1
  6824 DP Arnhem
  The Netherlands | Sandostatine LAR 30 mg, poeder en oplosmiddel voor suspensie voor injectie | 30 mg | Powder and solvent for suspension for injection | Injection | 15 mg/ml |
| Norway | Novartis Norge AS
  Postboks 4284 Nydalen,
  0401 Oslo
  Norway | Sandostatin LAR | 10 mg | Powder and solvent for suspension for injection | Injection | 5 mg/ml |
| Norway | Novartis Norge AS
  Postboks 4284 Nydalen,
  0401 Oslo
  Norway | Sandostatin LAR | 20 mg | Powder and solvent for suspension for injection | Injection | 10 mg/ml |
| Norway | Novartis Norge AS
  Postboks 4284 Nydalen,
  0401 Oslo
  Norway | Sandostatin LAR | 30 mg | Powder and solvent for suspension for injection | Injection | 15 mg/ml |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin LAR | 10 mg | Powder and solvent for suspension for injection | Injection | 5 mg/ml |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin LAR | 20 mg | Powder and solvent for suspension for injection | Injection | 10 mg/ml |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin LAR | 30 mg | Powder and solvent for suspension for injection | Injection | 15 mg/ml |
| Portugal | Novartis Farma — Produtos
  Farmacêuticos S.A.
  Av. Professor Doutor Cavaco Silva, 10 E
  Taguspark
  2740-255 Porto Salvo
  Portugal | Sandostatina LAR | 10 mg/2 ml | Powder and solvent for suspension for injection | Intramuscular use | 5 mg/ml |
| Portugal | Novartis Farma — Produtos
  Farmacêuticos S.A.
  Av. Professor Doutor Cavaco Silva, 10 E
  Taguspark
  2740-255 Porto Salvo
  Portugal | Sandostatina LAR | 20 mg/2 ml | Powder and solvent for suspension for injection | Intramuscular use | 10 mg/ml |
| Portugal | Novartis Farma — Produtos
  Farmacêuticos S.A.
  Av. Professor Doutor Cavaco Silva, 10 E
  Taguspark
  2740-255 Porto Salvo
  Portugal | Sandostatina LAR | 30 mg/2 ml | Powder and solvent for suspension for injection | Intramuscular use | 15 mg/ml |
| Romania | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin LAR 10 mg pulbere și solvent pentru suspensie injectabilă | 10 mg | Powder and solvent for suspension for injection | Injection | 5 mg/ml |
| Romania | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin LAR 20 mg pulbere și solvent pentru suspensie injectabilă | 20 mg | Powder and solvent for suspension for injection | Injection | 10 mg/ml |
| Romania | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin LAR 30 mg pulbere și solvent pentru suspensie injectabilă | 30 mg | Powder and solvent for suspension for injection | Injection | 15 mg/ml |
| Slovak Republic | Novartis s.r.o.
  Na Pankrá ci 1724/129
  140 00 Praha 4 — Nusle
  Czech Republic | Sandostatin LAR | 10 mg | Powder and solvent for suspension for injection | Injection | 5 mg/ml
  4 mg/ml |
| Slovak Republic | Novartis s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 — Nusle
  Czech Republic | Sandostatin LAR | 20 mg | Powder and solvent for suspension for injection | Injection | 10 mg/ml
  8 mg/ml |
| Slovak Republic | Novartis s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 — Nusle
  Czech Republic | Sandostatin LAR | 30 mg | Powder and solvent for suspension for injection | Injection | 15 mg/ml
  12 mg/ml |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin LAR 10 mg prašek in vehikel za suspenzijo za injiciranje | 10 mg | Powder and solvent for suspension for injection | Injection | 5 mg/ml |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin LAR 20 mg prašek in vehikel za suspenzijo za injiciranje | 20 mg | Powder and solvent for suspension for injection | Injection | 10 mg/ml |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin LAR 30 mg prašek in vehikel za suspenzijo za injiciranje | 30 mg | Powder and solvent for suspension for injection | Injection | 15 mg/ml |
| Spain | Novartis Farmacéutica S.A.
  Gran Via de les Corts
  Catalanes, 764
  08013 Barcelona
  Spain | Sandostatin LAR 10 mg polvo para suspensión inyectable | 10 mg | Powder and solvent for suspension for injection | Intramuscular use | 5 mg/ml |
| Spain | Novartis Farmacéutica S.A.
  Gran Via de les Corts
  Catalanes, 764
  08013 Barcelona
  Spain | Sandostatin LAR 20 mg polvo para suspensión inyectable | 20 mg | Powder and solvent for suspension for injection | Intramuscular use | 10 mg/ml |
| Spain | Novartis Farmacéutica S.A.
  Gran Via de les Corts
  Catalanes, 764
  08013 Barcelona
  Spain | Sandostatin LAR 30 mg polvo para suspensión inyectable | 30 mg | Powder and solvent for suspension for injection | Intramuscular use | 15 mg/ml |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B/Box 1150
  183 11 Täby
  Sweden | Sandostatin LAR | 10 mg | Powder and solvent for suspension for injection | Injection | 5 mg/ml |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B/Box 1150
  183 11 Täby
  Sweden | Sandostatin LAR | 20 mg | Powder and solvent for suspension for injection | Injection | 10 mg/ml |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B/Box 1150
  183 11 Täby
  Sweden | Sandostatin LAR | 30 mg | Powder and solvent for suspension for injection | Injection | 15 mg/ml |
| United Kingdom | Novartis Pharmaceuticals UK
  Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin LAR 10 mg powder and solvent for suspension for injection | 10 mg | Powder and solvent for suspension for injection | Injection | 5 mg/ml |
| United Kingdom | Novartis Pharmaceuticals UK
  Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin LAR 20 mg powder and solvent for suspension for injection | 20 mg | Powder and solvent for suspension for injection | Injection | 10 mg/ml |
| United Kingdom | Novartis Pharmaceuticals UK
  Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin LAR 30 mg powder and solvent for suspension for injection | 30 mg | Powder and solvent for suspension for injection | Injection | 15 mg/ml |

Member State EU/EEA

Marketing authorisation holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content (concentration)

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Sandostatin LAR 10 mg — Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension

10 mg

Powder and solvent for suspension for injection

Injection

5 mg/ml

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Sandostatin LAR 20 mg — Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension

20 mg

Powder and solvent for suspension for injection

Injection

10 mg/ml

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Sandostatin LAR 30 mg — Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension

30 mg

Powder and solvent for suspension for injection

Injection

15 mg/ml

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40,

1800 Vilvoorde

Belgium

Sandostatine Long Acting Repeatable

10 mg

Powder and solvent for suspension for injection

Injection

4 mg/ml

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40,

1800 Vilvoorde

Belgium

Sandostatine Long Acting Repeatable

20 mg

Powder and solvent for suspension for injection

Injection

8 mg/ml

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40,

1800 Vilvoorde

Belgium

Sandostatine Long Acting Repeatable

30 mg

Powder and solvent for suspension for injection

Injection

12 mg/ml

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25, 90429

Nuremberg

Germany

Sandostatin LAR

20 mg

Powder and solvent for suspension for injection

Injection

10 mg/ml

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25, 90429

Nuremberg

Germany

Sandostatin LAR

30 mg

Powder and solvent for suspension for injection

Injection

15 mg/ml

Cyprus

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin LAR

10 mg

Powder and solvent for suspension for injection

Injection

4 mg/ml

Cyprus

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin LAR

20 mg

Powder and solvent for suspension for injection

Injection

8 mg/ml

Cyprus

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin LAR

30 mg

Powder and solvent for suspension for injection

Injection

12 mg/ml

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 — Nusle

Czech Republic

Sandostatin LAR 20 MG

20 mg

Powder and solvent for suspension for injection

Intramuscular use

10 mg/ml

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 — Nusle

Czech Republic

Sandostatin LAR 30 MG

30 mg

Powder and solvent for suspension for injection

Intramuscular use

15 mg/ml

Denmark

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Sandostatin LAR

10 mg

Powder and solvent for suspension for injection

Injection

4 mg/ml

Denmark

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Sandostatin LAR

20 mg

Powder and solvent for suspension for injection

Injection

8 mg/ml

Denmark

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Sandostatin LAR

30 mg

Powder and solvent for suspension for injection

Injection

12 mg/ml

Estonia

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin LAR

10 mg

Powder and solvent for suspension for injection

Intramuscular use

5 mg/ml

Estonia

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin LAR

20 mg

Powder and solvent for suspension for injection

Intramuscular use

10 mg/ml

Estonia

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin LAR

30 mg

Powder and solvent for suspension for injection

Intramuscular use

15 mg/ml

Finland

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin LAR

10 mg

Powder and solvent for suspension for injection

Intramuscular use

5 mg/ml

Finland

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin LAR

20 mg

Powder and solvent for suspension for injection

Intramuscular use

10 mg/ml

Finland

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin LAR

30 mg

Powder and solvent for suspension for injection

Intramuscular use

15 mg/ml

France

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

Sandostatine LP

10 mg

Powder and solvent in prefilled syringe for prolonged-release suspension for injection (I.M)

Intramuscular use

4 mg/ml

France

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

Sandostatine LP

20 mg

Powder and solvent in prefilled syringe for prolonged-release suspension for injection (I.M)

Intramuscular use

8 mg/ml

France

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

Sandostatine LP

30 mg

Powder and solvent in prefilled syringe for prolonged-release suspension for injection (I.M)

Intramuscular use

12 mg/ml

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin LAR — Monatsdepot 10 mg

10 mg/2 ml

Powder and solvent for suspension for injection

Injection

5 mg/ml

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin LAR- Monatsdepot 20 mg

20 mg/2 ml

Powder and solvent for suspension for injection

Injection

10 mg/ml

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin LAR- Monatsdepot 30 mg

30 mg/2 ml

Powder and solvent for suspension for injection

Injection

15 mg/ml

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

Greece

Sandostatin LAR

10 mg

Powder and solvent for suspension for injection

Intramuscular use

4 mg/ml

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

Greece

Sandostatin LAR

20 mg

Powder and solvent for suspension for injection

Intramuscular use

8 mg/ml

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

Greece

Sandostatin LAR

30 mg

Powder and solvent for suspension for injection

Intramuscular use

12 mg/ml

Hungary

Novartis Hungária Kft.

(Pharma részlege)

Bartók Béla út 43-47

1114 Budapest

Hungary

Sandostatin LAR 10 mg por és oldószer szuszpenziós injekcióhoz

10 mg

Powder and solvent for suspension for injection

Intramuscular use

5 mg/ml

Hungary

Novartis Hungária Kft.

(Pharma részlege)

Bartók Béla út 43-47

1114 Budapest

Hungary

Sandostatin LAR 20 mg por és oldószer szuszpenziós injekcióhoz

20 mg

Powder and solvent for suspension for injection

Intramuscular use

10 mg/ml

Hungary

Novartis Hungária Kft.

(Pharma részlege)

Bartók Béla út 43-47

1114 Budapest

Hungary

Sandostatin LAR 30 mg por és oldószer szuszpenziós injekcióhoz

30 mg

Powder and solvent for suspension for injection

Intramuscular use

15 mg/ml

Iceland

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Sandostatin LAR

10 mg

Powder and solvent for suspension for injection

Intramuscular use

5 mg/ml

Iceland

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Sandostatin LAR

20 mg

Powder and solvent for suspension for injection

Intramuscular use

10 mg/ml

Iceland

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Sandostatin LAR

30 mg

Powder and solvent for suspension for injection

Intramuscular use

15 ml/mg

Ireland

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin LAR

10 mg

Powder and solvent for suspension for injection

Injection

5 ml/mg

Ireland

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin LAR

20 mg

Powder and solvent for suspension for injection

Injection

10 ml/mg

Ireland

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin LAR

30 mg

Powder and solvent for suspension for injection

Injection

15 ml/mg

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio

Italy

Sandostatina LAR

10 mg

Powder and solvent for suspension for injection

Injection

4 mg/ml

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio

Italy

Sandostatina LAR

20 mg

Powder and solvent for suspension for injection

Injection

8 mg/ml

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio

Italy

Sandostatina LAR

30 mg

Powder and solvent for suspension for injection

Injection

12 mg/ml

Latvia

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin LAR 10 mg pulveris un šķīdinātājs injekciju suspensijas pagatavošanai

10 mg

Powder and solvent for suspension for injection

Injection

5 mg/ml

Latvia

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin LAR 20 mg pulveris un šķīdinātājs injekciju suspensijas pagatavošanai

20 mg

Powder and solvent for suspension for injection

Injection

10 mg/ml

Latvia

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin LAR 30 mg pulveris un šķīdinātājs injekciju suspensijas pagatavošanai

30 mg

Powder and solvent for suspension for injection

Injection

15 mg/ml

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin LAR

10 mg

Powder and solvent for suspension for injection

Intramuscular use

5 mg/ml;

4 mg/ml

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin LAR

20 mg

Powder and solvent for suspension for injection

Intramuscular use

10 mg/ml;

8 mg/ml

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin LAR

30 mg

Powder and solvent for suspension for injection

Intramuscular use

15 mg/ml;

12 mg/ml

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandostatin Long Acting Repeatable

10 mg

Powder and solvent for suspension for injection

Injection

5 mg/ml

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandostatin Long Acting Repeatable

20 mg

Powder and solvent for suspension for injection

Injection

10 mg/ml

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandostatin Long Acting Repeatable

30 mg

Powder and solvent for suspension for injection

Injection

15 mg/ml

Malta

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin LAR 10 mg Powder and solvent for suspension for injection

10 mg

Powder and solvent for suspension for injection

Injection

5 mg/ml

Malta

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin LAR 20 mg Powder and solvent for suspension for injection

20 mg

Powder and solvent for suspension for injection

Injection

10 mg/ml

Malta

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin LAR 30 mg Powder and solvent for suspension for injection

30 mg

Powder and solvent for suspension for injection

Injection

15 mg/ml

The Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Sandostatine LAR 10 mg, poeder en oplosmiddel voor suspensie voor injectie

10 mg

Powder and solvent for suspension for injection

Injection

5 mg/ml

The Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Sandostatine LAR 20 mg, poeder en oplosmiddel voor suspensie voor injectie

20 mg

Powder and solvent for suspension for injection

Injection

10 mg/ml

The Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Sandostatine LAR 30 mg, poeder en oplosmiddel voor suspensie voor injectie

30 mg

Powder and solvent for suspension for injection

Injection

15 mg/ml

Norway

Novartis Norge AS

Postboks 4284 Nydalen,

0401 Oslo

Norway

Sandostatin LAR

10 mg

Powder and solvent for suspension for injection

Injection

5 mg/ml

Norway

Novartis Norge AS

Postboks 4284 Nydalen,

0401 Oslo

Norway

Sandostatin LAR

20 mg

Powder and solvent for suspension for injection

Injection

10 mg/ml

Norway

Novartis Norge AS

Postboks 4284 Nydalen,

0401 Oslo

Norway

Sandostatin LAR

30 mg

Powder and solvent for suspension for injection

Injection

15 mg/ml

Poland

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin LAR

10 mg

Powder and solvent for suspension for injection

Injection

5 mg/ml

Poland

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin LAR

20 mg

Powder and solvent for suspension for injection

Injection

10 mg/ml

Poland

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin LAR

30 mg

Powder and solvent for suspension for injection

Injection

15 mg/ml

Portugal

Novartis Farma — Produtos

Farmacêuticos S.A.

Av. Professor Doutor Cavaco Silva, 10 E

Taguspark

2740-255 Porto Salvo

Portugal

Sandostatina LAR

10 mg/2 ml

Powder and solvent for suspension for injection

Intramuscular use

5 mg/ml

Portugal

Novartis Farma — Produtos

Farmacêuticos S.A.

Av. Professor Doutor Cavaco Silva, 10 E

Taguspark

2740-255 Porto Salvo

Portugal

Sandostatina LAR

20 mg/2 ml

Powder and solvent for suspension for injection

Intramuscular use

10 mg/ml

Portugal

Novartis Farma — Produtos

Farmacêuticos S.A.

Av. Professor Doutor Cavaco Silva, 10 E

Taguspark

2740-255 Porto Salvo

Portugal

Sandostatina LAR

30 mg/2 ml

Powder and solvent for suspension for injection

Intramuscular use

15 mg/ml

Romania

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin LAR 10 mg pulbere și solvent pentru suspensie injectabilă

10 mg

Powder and solvent for suspension for injection

Injection

5 mg/ml

Romania

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin LAR 20 mg pulbere și solvent pentru suspensie injectabilă

20 mg

Powder and solvent for suspension for injection

Injection

10 mg/ml

Romania

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin LAR 30 mg pulbere și solvent pentru suspensie injectabilă

30 mg

Powder and solvent for suspension for injection

Injection

15 mg/ml

Slovak Republic

Novartis s.r.o.

Na Pankrá ci 1724/129

140 00 Praha 4 — Nusle

Czech Republic

Sandostatin LAR

10 mg

Powder and solvent for suspension for injection

Injection

5 mg/ml

4 mg/ml

Slovak Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 — Nusle

Czech Republic

Sandostatin LAR

20 mg

Powder and solvent for suspension for injection

Injection

10 mg/ml

8 mg/ml

Slovak Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 — Nusle

Czech Republic

Sandostatin LAR

30 mg

Powder and solvent for suspension for injection

Injection

15 mg/ml

12 mg/ml

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin LAR 10 mg prašek in vehikel za suspenzijo za injiciranje

10 mg

Powder and solvent for suspension for injection

Injection

5 mg/ml

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin LAR 20 mg prašek in vehikel za suspenzijo za injiciranje

20 mg

Powder and solvent for suspension for injection

Injection

10 mg/ml

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin LAR 30 mg prašek in vehikel za suspenzijo za injiciranje

30 mg

Powder and solvent for suspension for injection

Injection

15 mg/ml

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts

Catalanes, 764

08013 Barcelona

Spain

Sandostatin LAR 10 mg polvo para suspensión inyectable

10 mg

Powder and solvent for suspension for injection

Intramuscular use

5 mg/ml

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts

Catalanes, 764

08013 Barcelona

Spain

Sandostatin LAR 20 mg polvo para suspensión inyectable

20 mg

Powder and solvent for suspension for injection

Intramuscular use

10 mg/ml

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts

Catalanes, 764

08013 Barcelona

Spain

Sandostatin LAR 30 mg polvo para suspensión inyectable

30 mg

Powder and solvent for suspension for injection

Intramuscular use

15 mg/ml

Sweden

Novartis Sverige AB

Kemistvägen 1B/Box 1150

183 11 Täby

Sweden

Sandostatin LAR

10 mg

Powder and solvent for suspension for injection

Injection

5 mg/ml

Sweden

Novartis Sverige AB

Kemistvägen 1B/Box 1150

183 11 Täby

Sweden

Sandostatin LAR

20 mg

Powder and solvent for suspension for injection

Injection

10 mg/ml

Sweden

Novartis Sverige AB

Kemistvägen 1B/Box 1150

183 11 Täby

Sweden

Sandostatin LAR

30 mg

Powder and solvent for suspension for injection

Injection

15 mg/ml

United Kingdom

Novartis Pharmaceuticals UK

Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin LAR 10 mg powder and solvent for suspension for injection

10 mg

Powder and solvent for suspension for injection

Injection

5 mg/ml

United Kingdom

Novartis Pharmaceuticals UK

Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin LAR 20 mg powder and solvent for suspension for injection

20 mg

Powder and solvent for suspension for injection

Injection

10 mg/ml

United Kingdom

Novartis Pharmaceuticals UK

Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin LAR 30 mg powder and solvent for suspension for injection

30 mg

Powder and solvent for suspension for injection

Injection

15 mg/ml

---

ANNEX IV

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

| Member State EU/EEA | Marketing authorisation holder | (Invented) Name | Strength | Pharmaceutical form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  1020 Wien
  Austria | Sandostatin 0,05 mg/ml — Ampullen | 0,05 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,05 mg/ml |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  1020 Wien
  Austria | Sandostatin 0,1 mg/ml — Ampullen | 0,1 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,1 mg/ml |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  1020 Wien
  Austria | Sandostatin 0,5 mg/ml — Ampullen | 0,5 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,5 mg/ml |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  1020 Wien
  Austria | Sandostatin 0,2 mg/ml — Durchstechflasche | 0,2 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,2 mg/ml |
| Belgium | N.V. Novartis Pharma S.A.
  Medialaan 40,
  1800 Vilvoorde
  Belgium | Sandostatine | 0,1 mg/ml | Solution for injection | Injection or infusion | 0,1 mg/ml |
| Belgium | N.V. Novartis Pharma S.A.
  Medialaan 40,
  1800 Vilvoorde
  Belgium | Sandostatine | 0,5 mg/ml | Solution for injection | Injection or infusion | 0,5 mg/ml |
| Bulgaria | Novartis Pharma GmbH
  Roonstrasse 25, 90429
  Nuremberg
  Germany | Sandostatin | 0,1 mg/ml | Solution for injection | Subcutaneous use or intravenous use | 0,1 mg/ml |
| Cyprus | Novartis Pharmaceuticals UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin | 0,05 mg/ml | Solution for injection | Injection | 0,05 mg/ml |
| Cyprus | Novartis Pharmaceuticals UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin | 0,1 mg/ml | Solution for injection | Injection | 0,1 mg/ml |
| Czech Republic | Novartis s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 — Nusle
  Czech Republic | Sandostatin 0,05 mg/ml | 0,05 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use or intravenous use | 0,05 mg/ml |
| Czech Republic | Novartis s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 — Nusle
  Czech Republic | Sandostatin 0,1 mg/ml | 0,1 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use or intravenous use | 0,1 mg/ml |
| Czech Republic | Novartis s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 — Nusle
  Czech Republic | Sandostatin 0,5 mg/ml | 0,5 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use or intravenous use | 0,5 mg/ml |
| Czech Republic | Novartis s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 — Nusle
  Czech Republic | Sandostatin 0,2 mg/ml | 0,2 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use or intravenous use | 0,2 mg/ml |
| Denmark | Novartis Healthcare A/S
  Edvard Thomsens Vej 14
  2300 Copenhagen S
  Denmark | Sandostatin | 0,05 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,05 mg/ml |
| Denmark | Novartis Healthcare A/S
  Edvard Thomsens Vej 14
  2300 Copenhagen S
  Denmark | Sandostatin | 0,1 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,1 mg/ml |
| Denmark | Novartis Healthcare A/S
  Edvard Thomsens Vej 14
  2300 Copenhagen S
  Denmark | Sandostatin | 1 mg/5 ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 1 mg/5 ml |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin | 0,1 mg/ml | Solution for injection | Subcutaneous use | 0,1 mg/ml |
| Finland | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin | 0,05 mg/ml | Solution for injection | Subcutaneous use or intravenous use | 0,05 mg/ml |
| Finland | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin | 0,1 mg/ml | Solution for injection | Subcutaneous use or intravenous use | 0,1 mg/ml |
| Finland | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin | 0,5 mg/ml | Solution for injection | Subcutaneous use or intravenous use | 0,5 mg/ml |
| France | Novartis Pharma S.A.S.
  2-4, rue Lionel Terray
  92500 RUEIL-MALMAISON,
  France | Sandostatine | 0,05 mg/1ml | Solution for injection | Subcutaneous use or intravenous use | 0,05 mg/ml |
| France | Novartis Pharma S.A.S.
  2-4, rue Lionel Terray
  92500 RUEIL-MALMAISON,
  France | Sandostatine | 0,1 mg/1ml | Solution for injection | Subcutaneous use or intravenous use | 0,1 mg/ml |
| France | Novartis Pharma S.A.S.
  2-4, rue Lionel Terray
  92500 RUEIL-MALMAISON,
  France | Sandostatine | 0,5 mg/1ml | Solution for injection | Subcutaneous use or intravenous use | 0,5 mg/ml |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin 50 ug | 0,05 mg/ml | Solution for injection | Injection | 0,05 mg/ml |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin 100 ug | 0,1 mg/ml | Solution for injection | Injection | 0,1 mg/ml |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin 500 ug | 0,5 mg/1ml | Solution for injection | Injection | 0,5 mg/1ml |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin 1000 ug | 1 mg/5 ml | Solution for injection | Injection | 1 mg/5 ml |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  144 51 Athens
  Greece | Sandostatin | 0,1 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use or intravenous use | 0,1 mg/ml |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  144 51 Athens
  Greece | Sandostatin | 0,5 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use or intravenous use | 0,5 mg/ml |
| Hungary | Novartis Hungária Kft.
  (Pharma részlege)
  Bartók Béla út 43-47
  1114 Budapest
  Hungary | Sandostatin 0,1 mg/ml oldatos injekció | 0,1 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use or intravenous use | 0,1 mg/ml |
| Hungary | Novartis Hungária Kft.
  (Pharma részlege)
  Bartók Béla út 43-47
  1114 Budapest
  Hungary | Sandostatin 0,2 mg/ml oldatos injekció | 0,2 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use or intravenous use | 0,2 mg/ml |
| Iceland | Novartis Healthcare A/S
  Edvard Thomsens Vej 14
  2300 Copenhagen S
  Denmark | Sandostatin | 50 mcg/ml | Solution for injection | Subcutaneous use or intravenous use | 50 mcg/ml |
| Iceland | Novartis Healthcare A/S
  Edvard Thomsens Vej 14
  2300 Copenhagen S
  Denmark | Sandostatin | 100 mcg/ml | Solution for injection | Subcutaneous use or intravenous use | 100 mcg/ml |
| Iceland | Novartis Healthcare A/S
  Edvard Thomsens Vej 14
  2300 Copenhagen S
  Denmark | Sandostatin | 200 mcg/ml | Solution for injection | Subcutaneous use or intravenous use | 200 mcg/ml |
| Ireland | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin | 50 mcg/ml | Solution for s.c. or i.v. injection | Injection or infusion | 50 mcg/ml |
| Ireland | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin | 100 mcg/ml | Solution for s.c. injection or concentrate for solution for i.v. injection | Injection or infusion | 100 mcg/ml |
| Ireland | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin | 500 mcg/ml | Solution for s.c. injection or concentrate for solution for i.v. injection or concentrate for solution for i.v. infusion | Injection or infusion | 500 mcg/ml |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  21040 Origgio
  Italy | Sandostatina | 0,05 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,05 mg/ml |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  21040 Origgio
  Italy | Sandostatina | 0,1 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,1 mg/ml |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  21040 Origgio
  Italy | Sandostatina | 0,5 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,5 mg/ml |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  21040 Origgio
  Italy | Sandostatina | 1 mg/5 ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 1 mg/5 ml |
| Latvia | Novartis Finland OY
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin 0,1 mg/ml šķīdums injekcijām | 0,1 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,1 mg/ml |
| Lithuania | Novartis Finland Oy
  Metsänneidonkuja 10
  02130 Espoo
  Finland | Sandostatin | 0,1 mg/ml | Solution for injection | Subcutaneous use or intravenous use | 0,1 mg/ml |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin 50 ug | 0 ,05 mg/ml | Solution for injection | Injection | 0,05 mg/ml |
| Luxembourg | N.V. Novartis Pharma S.A.
  Medialaan 40,
  1800 Vilvoorde
  Belgium | Sandostatine | 0,1 mg/ml | Solution for injection | Injection | 0,1 mg/ml |
| Luxembourg | N.V. Novartis Pharma S.A.
  Medialaan 40,
  1800 Vilvoorde
  Belgium | Sandostatine | 0,5 mg/ml | Solution for injection | Injection | 0,5 mg/ml |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin 1000 ug | 1 mg/5 ml | Solution for injection | Injection | 1 mg/5 ml |
| Malta | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin 0,5 mg/1 ml ampoules | 0,5 mg/ml | Solution for injection (s.c) or concentrate for solution for infusion (i.v.infusion) | Injection or infusion | 0,5 mg/ml |
| Malta | Novartis Pharmaceuticals
  UNITED KINGDOM Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin multidose vials 1 mg/5 ml (0,2 mg/ml) | 0,2 mg/ml | Solution for injection (s.c.) or concentrate for solution for infusion (i.v. infusion) | Injection or infusion | 0,2 mg/ml |
| The Netherlands | Novartis Pharma B.V.
  Raapopseweg 1
  6824 DP Arnhem
  The Netherlands | Sandostatine 0,05 mg/ml, injectievloeistof 1 ml | 0,05 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,05 mg/ml |
| The Netherlands | Novartis Pharma B.V.
  Raapopseweg 1
  6824 DP Arnhem
  The Netherlands | Sandostatine 0,1 mg/ml, injectievloeistof 1 ml | 0,1 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,1 mg/ml |
| The Netherlands | Novartis Pharma B.V.
  Raapopseweg 1
  6824 DP Arnhem
  The Netherlands | Sandostatine 0,5 mg/ml, oplossing voor injectie 1 ml | 0,5 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,5 mg/ml |
| The Netherlands | Novartis Pharma B.V.
  Raapopseweg 1
  6824 DP Arnhem
  The Netherlands | Sandostatine 0,2 mg/ml, injectievloeistof 5 ml | 0,2 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,2 mg/ml |
| Norway | Novartis Norge AS
  Postboks 4284 Nydalen,
  0401 Oslo
  Norway | Sandostatin | 0,05 mg/ml | Solution for injection | Injection or infusion | 0,05 mg/ml |
| Norway | Novartis Norge AS
  Postboks 4284 Nydalen,
  0401 Oslo
  Norway | Sandostatin | 0,1 mg/ml | Solution for injection | Injection or infusion | 0,1 mg/ml |
| Norway | Novartis Norge AS
  Postboks 4284 Nydalen,
  0401 Oslo
  Norway | Sandostatin | 0,2 mg/ml | Solution for injection | Injection or infusion | 0,2 mg/ml |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin | 50 mcg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 50 mcg/ml |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin | 100 mcg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 100 mcg/ml |
| Portugal | Novartis Farma — Produtos
  Farmacêuticos S.A.
  Av. Professor Doutor Cavaco Silva, 10 E
  Taguspark
  2740-255 Porto Salvo
  Portugal | Sandostatina | 0,05 mg/ml | Solution for injection | Subcutaneous use Intravenous use | 0,05 mg/ml |
| Portugal | Novartis Farma — Produtos
  Farmacêuticos S.A.
  Av. Professor Doutor Cavaco Silva, 10 E
  Taguspark
  2740-255 Porto Salvo
  Portugal | Sandostatina | 0,1 mg/ml | Solution for injection | Subcutaneous use Intravenous use | 0,1 mg/ml |
| Portugal | Novartis Farma — Produtos
  Farmacêuticos S.A.
  Av. Professor Doutor Cavaco Silva, 10 E
  Taguspark
  2740-255 Porto Salvo
  Portugal | Sandostatina | 0,5 mg/ml | Solution for injection | Subcutaneous use Intravenous use | 0,5 mg/ml |
| Portugal | Novartis Farma — Produtos
  Farmacêuticos S.A.
  Avenida Professor Doutor Cavaco Silva, n.o 10E
  Taguspark
  2740-255 Porto Salvo
  Portugal | Sandostatina | 0,2 mg/ml | Solution for injection | Subcutaneous use Intravenous use | 0,2 mg/ml |
| Romania | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | SANDOSTATIN 0,1 mg/ml soluţie injectabilă | 0,1 mg/ml | Solution for injection | Subcutaneous use Intravenous use | 0,1 mg/ml |
| Slovak Republic | Novartis s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 — Nusle
  Czech Republic | Sandostatin | 0,05 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,05 mg/ml |
| Slovak Republic | Novartis s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 — Nusle
  Czech Republic | Sandostatin | 0,1 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,1 mg/ml |
| Slovak Republic | Novartis s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 — Nusle
  Czech Republic | Sandostatin | 0,5 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,5 mg/ml |
| Slovak Republic | Novartis s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 — NusleCzech Republic | Sandostatin | 1 mg/5 ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 1 mg/5 ml |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin 0,05 mg/ml raztopina za injiciranje/infundiranje | 0,05 mg/ml | Solution for injection or infusion | Injection or infusion | 0,05 mg/ml |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin 0,1 mg/ml raztopina za injiciranje/infundiranje | 0,1 mg/ml | Solution for injection or infusion | Injection or infusion | 0,1 mg/ml |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg
  Germany | Sandostatin 0,5 mg/ml raztopina za injiciranje/infundiranje | 0,5 mg/ml | Solution for injection or infusion | Injection or infusion | 0,5 mg/ml |
| Spain | Novartis Farmacéutica S.A.
  Gran Via de les Corts
  Catalanes, 764
  08013 Barcelona
  Spain | Sandostatin 50 microgramos/ml solución inyectable | 0,05 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use Intravenous use | 0,05 mg/ml |
| Spain | Novartis Farmacéutica S.A.
  Gran Via de les Corts
  Catalanes, 764
  08013 Barcelona
  Spain | Sandostatin 100 microgramos/ml solución inyectable | 0,1 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use Intravenous use | 0,1 mg/ml |
| Spain | Novartis Farmacéutica S.A.
  Gran Via de les Corts
  Catalanes, 764
  08013 Barcelona
  Spain | Sandostatin 200 microgramos/ml solución inyectable | 0,2 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use Intravenous use | 0,2 mg/ml |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B/Box 1150
  183 11 Täby
  Sweden | Sandostatin | 0,05 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,05 mg/ml |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B/Box 1150
  183 11 Täby
  Sweden | Sandostatin | 0,1 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,1 mg/ml |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B/Box 1150
  183 11 Täby
  Sweden | Sandostatin | 0,5 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,5 mg/ml |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B/Box 1150
  183 11 Täby
  Sweden | Sandostatin | 0,2 mg/ml | Solution for injection or concentrate for solution for infusion | Injection or infusion | 0,2 mg/ml |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin ampoules 50 mcg/ml solution for injection or concentrate for solution for infusion | 0,05 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use Intravenous use | 0,05 mg/ml |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin ampoules 100 mcg/ml solution for injection or concentrate for solution for infusion | 0,1 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use Intravenous use | 0,1 mg/ml |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin ampoules 500 mcg/ml solution for injection or concentrate for solution for infusion | 0,5 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use Intravenous use | 0,5 mg/ml |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Sandostatin multidose vial 1 mg/5ml solution for injection or concentrate for solution for infusion | 0,2 mg/ml | Solution for injection or concentrate for solution for infusion | Subcutaneous use Intravenous use | 0,2 mg/ml |

Member State EU/EEA

Marketing authorisation holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content (concentration)

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Sandostatin 0,05 mg/ml — Ampullen

0,05 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,05 mg/ml

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Sandostatin 0,1 mg/ml — Ampullen

0,1 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,1 mg/ml

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Sandostatin 0,5 mg/ml — Ampullen

0,5 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,5 mg/ml

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

1020 Wien

Austria

Sandostatin 0,2 mg/ml — Durchstechflasche

0,2 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,2 mg/ml

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40,

1800 Vilvoorde

Belgium

Sandostatine

0,1 mg/ml

Solution for injection

Injection or infusion

0,1 mg/ml

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40,

1800 Vilvoorde

Belgium

Sandostatine

0,5 mg/ml

Solution for injection

Injection or infusion

0,5 mg/ml

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25, 90429

Nuremberg

Germany

Sandostatin

0,1 mg/ml

Solution for injection

Subcutaneous use or intravenous use

0,1 mg/ml

Cyprus

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin

0,05 mg/ml

Solution for injection

Injection

0,05 mg/ml

Cyprus

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin

0,1 mg/ml

Solution for injection

Injection

0,1 mg/ml

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 — Nusle

Czech Republic

Sandostatin 0,05 mg/ml

0,05 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use or intravenous use

0,05 mg/ml

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 — Nusle

Czech Republic

Sandostatin 0,1 mg/ml

0,1 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use or intravenous use

0,1 mg/ml

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 — Nusle

Czech Republic

Sandostatin 0,5 mg/ml

0,5 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use or intravenous use

0,5 mg/ml

Czech Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 — Nusle

Czech Republic

Sandostatin 0,2 mg/ml

0,2 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use or intravenous use

0,2 mg/ml

Denmark

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Sandostatin

0,05 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,05 mg/ml

Denmark

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Sandostatin

0,1 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,1 mg/ml

Denmark

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Sandostatin

1 mg/5 ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

1 mg/5 ml

Estonia

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin

0,1 mg/ml

Solution for injection

Subcutaneous use

0,1 mg/ml

Finland

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin

0,05 mg/ml

Solution for injection

Subcutaneous use or intravenous use

0,05 mg/ml

Finland

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin

0,1 mg/ml

Solution for injection

Subcutaneous use or intravenous use

0,1 mg/ml

Finland

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin

0,5 mg/ml

Solution for injection

Subcutaneous use or intravenous use

0,5 mg/ml

France

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

Sandostatine

0,05 mg/1ml

Solution for injection

Subcutaneous use or intravenous use

0,05 mg/ml

France

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

Sandostatine

0,1 mg/1ml

Solution for injection

Subcutaneous use or intravenous use

0,1 mg/ml

France

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

Sandostatine

0,5 mg/1ml

Solution for injection

Subcutaneous use or intravenous use

0,5 mg/ml

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin 50 ug

0,05 mg/ml

Solution for injection

Injection

0,05 mg/ml

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin 100 ug

0,1 mg/ml

Solution for injection

Injection

0,1 mg/ml

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin 500 ug

0,5 mg/1ml

Solution for injection

Injection

0,5 mg/1ml

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin 1000 ug

1 mg/5 ml

Solution for injection

Injection

1 mg/5 ml

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

Greece

Sandostatin

0,1 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use or intravenous use

0,1 mg/ml

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

144 51 Athens

Greece

Sandostatin

0,5 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use or intravenous use

0,5 mg/ml

Hungary

Novartis Hungária Kft.

(Pharma részlege)

Bartók Béla út 43-47

1114 Budapest

Hungary

Sandostatin 0,1 mg/ml oldatos injekció

0,1 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use or intravenous use

0,1 mg/ml

Hungary

Novartis Hungária Kft.

(Pharma részlege)

Bartók Béla út 43-47

1114 Budapest

Hungary

Sandostatin 0,2 mg/ml oldatos injekció

0,2 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use or intravenous use

0,2 mg/ml

Iceland

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Sandostatin

50 mcg/ml

Solution for injection

Subcutaneous use or intravenous use

50 mcg/ml

Iceland

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Sandostatin

100 mcg/ml

Solution for injection

Subcutaneous use or intravenous use

100 mcg/ml

Iceland

Novartis Healthcare A/S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Sandostatin

200 mcg/ml

Solution for injection

Subcutaneous use or intravenous use

200 mcg/ml

Ireland

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin

50 mcg/ml

Solution for s.c. or i.v. injection

Injection or infusion

50 mcg/ml

Ireland

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin

100 mcg/ml

Solution for s.c. injection or concentrate for solution for i.v. injection

Injection or infusion

100 mcg/ml

Ireland

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin

500 mcg/ml

Solution for s.c. injection or concentrate for solution for i.v. injection or concentrate for solution for i.v. infusion

Injection or infusion

500 mcg/ml

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio

Italy

Sandostatina

0,05 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,05 mg/ml

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio

Italy

Sandostatina

0,1 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,1 mg/ml

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio

Italy

Sandostatina

0,5 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,5 mg/ml

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

21040 Origgio

Italy

Sandostatina

1 mg/5 ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

1 mg/5 ml

Latvia

Novartis Finland OY

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin 0,1 mg/ml šķīdums injekcijām

0,1 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,1 mg/ml

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

02130 Espoo

Finland

Sandostatin

0,1 mg/ml

Solution for injection

Subcutaneous use or intravenous use

0,1 mg/ml

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin 50 ug

0 ,05 mg/ml

Solution for injection

Injection

0,05 mg/ml

Luxembourg

N.V. Novartis Pharma S.A.

Medialaan 40,

1800 Vilvoorde

Belgium

Sandostatine

0,1 mg/ml

Solution for injection

Injection

0,1 mg/ml

Luxembourg

N.V. Novartis Pharma S.A.

Medialaan 40,

1800 Vilvoorde

Belgium

Sandostatine

0,5 mg/ml

Solution for injection

Injection

0,5 mg/ml

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin 1000 ug

1 mg/5 ml

Solution for injection

Injection

1 mg/5 ml

Malta

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin 0,5 mg/1 ml ampoules

0,5 mg/ml

Solution for injection (s.c) or concentrate for solution for infusion (i.v.infusion)

Injection or infusion

0,5 mg/ml

Malta

Novartis Pharmaceuticals

UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin multidose vials 1 mg/5 ml (0,2 mg/ml)

0,2 mg/ml

Solution for injection (s.c.) or concentrate for solution for infusion (i.v. infusion)

Injection or infusion

0,2 mg/ml

The Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Sandostatine 0,05 mg/ml, injectievloeistof 1 ml

0,05 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,05 mg/ml

The Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Sandostatine 0,1 mg/ml, injectievloeistof 1 ml

0,1 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,1 mg/ml

The Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Sandostatine 0,5 mg/ml, oplossing voor injectie 1 ml

0,5 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,5 mg/ml

The Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Sandostatine 0,2 mg/ml, injectievloeistof 5 ml

0,2 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,2 mg/ml

Norway

Novartis Norge AS

Postboks 4284 Nydalen,

0401 Oslo

Norway

Sandostatin

0,05 mg/ml

Solution for injection

Injection or infusion

0,05 mg/ml

Norway

Novartis Norge AS

Postboks 4284 Nydalen,

0401 Oslo

Norway

Sandostatin

0,1 mg/ml

Solution for injection

Injection or infusion

0,1 mg/ml

Norway

Novartis Norge AS

Postboks 4284 Nydalen,

0401 Oslo

Norway

Sandostatin

0,2 mg/ml

Solution for injection

Injection or infusion

0,2 mg/ml

Poland

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin

50 mcg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

50 mcg/ml

Poland

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin

100 mcg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

100 mcg/ml

Portugal

Novartis Farma — Produtos

Farmacêuticos S.A.

Av. Professor Doutor Cavaco Silva, 10 E

Taguspark

2740-255 Porto Salvo

Portugal

Sandostatina

0,05 mg/ml

Solution for injection

Subcutaneous use Intravenous use

0,05 mg/ml

Portugal

Novartis Farma — Produtos

Farmacêuticos S.A.

Av. Professor Doutor Cavaco Silva, 10 E

Taguspark

2740-255 Porto Salvo

Portugal

Sandostatina

0,1 mg/ml

Solution for injection

Subcutaneous use Intravenous use

0,1 mg/ml

Portugal

Novartis Farma — Produtos

Farmacêuticos S.A.

Av. Professor Doutor Cavaco Silva, 10 E

Taguspark

2740-255 Porto Salvo

Portugal

Sandostatina

0,5 mg/ml

Solution for injection

Subcutaneous use Intravenous use

0,5 mg/ml

Portugal

Novartis Farma — Produtos

Farmacêuticos S.A.

Avenida Professor Doutor Cavaco Silva, n.o 10E

Taguspark

2740-255 Porto Salvo

Portugal

Sandostatina

0,2 mg/ml

Solution for injection

Subcutaneous use Intravenous use

0,2 mg/ml

Romania

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

SANDOSTATIN 0,1 mg/ml soluţie injectabilă

0,1 mg/ml

Solution for injection

Subcutaneous use Intravenous use

0,1 mg/ml

Slovak Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 — Nusle

Czech Republic

Sandostatin

0,05 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,05 mg/ml

Slovak Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 — Nusle

Czech Republic

Sandostatin

0,1 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,1 mg/ml

Slovak Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 — Nusle

Czech Republic

Sandostatin

0,5 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,5 mg/ml

Slovak Republic

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 — NusleCzech Republic

Sandostatin

1 mg/5 ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

1 mg/5 ml

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin 0,05 mg/ml raztopina za injiciranje/infundiranje

0,05 mg/ml

Solution for injection or infusion

Injection or infusion

0,05 mg/ml

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin 0,1 mg/ml raztopina za injiciranje/infundiranje

0,1 mg/ml

Solution for injection or infusion

Injection or infusion

0,1 mg/ml

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Sandostatin 0,5 mg/ml raztopina za injiciranje/infundiranje

0,5 mg/ml

Solution for injection or infusion

Injection or infusion

0,5 mg/ml

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts

Catalanes, 764

08013 Barcelona

Spain

Sandostatin 50 microgramos/ml solución inyectable

0,05 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use Intravenous use

0,05 mg/ml

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts

Catalanes, 764

08013 Barcelona

Spain

Sandostatin 100 microgramos/ml solución inyectable

0,1 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use Intravenous use

0,1 mg/ml

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts

Catalanes, 764

08013 Barcelona

Spain

Sandostatin 200 microgramos/ml solución inyectable

0,2 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use Intravenous use

0,2 mg/ml

Sweden

Novartis Sverige AB

Kemistvägen 1B/Box 1150

183 11 Täby

Sweden

Sandostatin

0,05 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,05 mg/ml

Sweden

Novartis Sverige AB

Kemistvägen 1B/Box 1150

183 11 Täby

Sweden

Sandostatin

0,1 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,1 mg/ml

Sweden

Novartis Sverige AB

Kemistvägen 1B/Box 1150

183 11 Täby

Sweden

Sandostatin

0,5 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,5 mg/ml

Sweden

Novartis Sverige AB

Kemistvägen 1B/Box 1150

183 11 Täby

Sweden

Sandostatin

0,2 mg/ml

Solution for injection or concentrate for solution for infusion

Injection or infusion

0,2 mg/ml

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin ampoules 50 mcg/ml solution for injection or concentrate for solution for infusion

0,05 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use Intravenous use

0,05 mg/ml

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin ampoules 100 mcg/ml solution for injection or concentrate for solution for infusion

0,1 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use Intravenous use

0,1 mg/ml

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin ampoules 500 mcg/ml solution for injection or concentrate for solution for infusion

0,5 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use Intravenous use

0,5 mg/ml

United Kingdom

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandostatin multidose vial 1 mg/5ml solution for injection or concentrate for solution for infusion

0,2 mg/ml

Solution for injection or concentrate for solution for infusion

Subcutaneous use Intravenous use

0,2 mg/ml

---

ANNEX V

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States

| Member State in EEA | Marketing authorisation holder | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | SEROQUEL 25 mg Filmtabletten | 25 mg | Film-coated Tablets | Oral use |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | SEROQUEL 100 mg Filmtabletten | 100 mg | Film-coated Tablets | Oral use |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | SEROQUEL 150 mg Filmtabletten | 150 mg | Film-coated Tablets | Oral use |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | SEROQUEL 200 mg Filmtabletten | 200 mg | Film-coated Tablets | Oral use |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | SEROQUEL 300 mg Filmtabletten | 300 mg | Film-coated Tablets | Oral use |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | SEROQUEL 4-Day Starter Pack | 25 mg Filmtabletten + 100 mg
  Filmtabletten + 200 mg
  Filmtabletten | Film-coated Tablets | Oral use |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | SEROQUEL XR 50 mg Retardtabletten | 50 mg | Prolonged-release tablets | Oral use |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | SEROQUEL XR 150 mg Retardtabletten | 150 mg | Prolonged-release tablets | Oral use |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | SEROQUEL XR 200 mg Retardtabletten | 200 mg | Prolonged-release tablets | Oral use |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | SEROQUEL XR 300 mg Retardtabletten | 300 mg | Prolonged-release tablets | Oral use |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | SEROQUEL XR 400 mg Retardtabletten | 400 mg | Prolonged-release tablets | Oral use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL | 25 mg | Film-coated Tablets | Oral use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL | 150 mg | Film-coated Tablets | Oral use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL | 300 mg | Film-coated Tablets | Oral use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL Starter Pack | 25 mg + 100 mg | Film-coated Tablets | Oral use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL 4-Day Starter Pack | 25 mg + 100 mg + 200 mg | Film-coated Tablets | Oral use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL XR | 50 mg | Prolonged-release tablets | Oral use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL XR | 150 mg | Prolonged-release tablets | Oral use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL XR | 200 mg | Prolonged-release tablets | Oral use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL XR | 300 mg | Prolonged-release tablets | Oral use |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL XR | 400 mg | Prolonged-release tablets | Oral use |
| Cyprus | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL | 25 mg | Film-coated Tablets | Oral use |
| Cyprus | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Cyprus | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Cyprus | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 50 mg | Prolonged-release tablets | Oral use |
| Cyprus | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 150 mg | Prolonged-release tablets | Oral use |
| Cyprus | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 200 mg | Prolonged-release tablets | Oral use |
| Cyprus | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 300 mg | Prolonged-release tablets | Oral use |
| Cyprus | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 400 mg | Prolonged-release tablets | Oral use |
| Czech Republic | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL PROLONG 200 mg tablety s prodlouženým uvolňováním | 200 mg | Prolonged-release tablets | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S
  Denmark | SEROQUEL | 25 mg | Film-coated Tablets | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S
  Denmark | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S
  Denmark | SEROQUEL | 150 mg | Film-coated Tablets | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S
  Denmark | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S
  Denmark | SEROQUEL | 300 mg | Film-coated Tablets | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S
  Denmark | SEROQUEL 4-Day Starter Pack | 25 mg + 100 mg + 200 mg | Film-coated Tablets | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S
  Denmark | SEROQUEL PROLONG | 50 mg | Prolonged-release tablets | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S
  Denmark | SEROQUEL PROLONG | 150 mg | Prolonged-release tablets | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S
  Denmark | SEROQUEL PROLONG | 200 mg | Prolonged-release tablets | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S
  Denmark | SEROQUEL PROLONG | 300 mg | Prolonged-release tablets | Oral use |
| Denmark | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S
  Denmark | SEROQUEL PROLONG | 400 mg | Prolonged-release tablets | Oral use |
| Estonia | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Estonia | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Estonia | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 300 mg | Prolonged-release tablets | Oral use |
| Estonia | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 400 mg | Prolonged-release tablets | Oral use |
| Finland | AstraZeneca Oy
  Luomanportti 3
  02200 Espoo
  Finland | SEROQUEL | 25 mg | Film-coated Tablets | Oral use |
| Finland | AstraZeneca Oy
  Luomanportti 3
  02200 Espoo
  Finland | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Finland | AstraZeneca Oy
  Luomanportti 3
  02200 Espoo
  Finland | SEROQUEL | 150 mg | Film-coated Tablets | Oral use |
| Finland | AstraZeneca Oy
  Luomanportti 3
  02200 Espoo
  Finland | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Finland | AstraZeneca Oy
  Luomanportti 3
  02200 Espoo
  Finland | SEROQUEL | 300 mg | Film-coated Tablets | Oral use |
| Finland | AstraZeneca Oy
  Luomanportti 3
  02200 Espoo
  Finland | SEROQUEL PROLONG | 50 mg | Prolonged-release tablets | Oral use |
| Finland | AstraZeneca Oy
  Luomanportti 3
  02200 Espoo
  Finland | SEROQUEL PROLONG | 150 mg | Prolonged-release tablets | Oral use |
| Finland | AstraZeneca Oy
  Luomanportti 3
  02200 Espoo
  Finland | SEROQUEL PROLONG | 200 mg | Prolonged-release tablets | Oral use |
| Finland | AstraZeneca Oy
  Luomanportti 3
  02200 Espoo
  Finland | SEROQUEL PROLONG | 300 mg | Prolonged-release tablets | Oral use |
| Finland | AstraZeneca Oy
  Luomanportti 3
  02200 Espoo
  Finland | SEROQUEL PROLONG | 400 mg | Prolonged-release tablets | Oral use |
| France | AstraZeneca
  1, Place Renault
  92844 RUEIL-MALMAISON Cedex
  France | XEROQUEL LP | 50 mg | Prolonged-release tablets | Oral use |
| France | AstraZeneca
  1, Place Renault
  92844 RUEIL-MALMAISON Cedex
  France | XEROQUEL LP | 150 mg | Prolonged-release tablets | Oral use |
| France | AstraZeneca
  1, Place Renault
  92844 RUEIL-MALMAISON Cedex
  France | XEROQUEL LP | 200 mg | Prolonged-release tablets | Oral use |
| France | AstraZeneca
  1, Place Renault
  92844 RUEIL-MALMAISON Cedex
  France | XEROQUEL LP | 300 mg | Prolonged-release tablets | Oral use |
| France | AstraZeneca
  1, Place Renault
  92844 RUEIL-MALMAISON Cedex
  France | XEROQUEL LP | 400 mg | Prolonged-release tablets | Oral use |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | SEROQUEL 25 mg Filmtabletten | 25 mg | Film-coated Tablets | Oral use |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | SEROQUEL 100 mg Filmtabletten | 100 mg | Film-coated Tablets | Oral use |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | SEROQUEL 200 mg Filmtabletten | 200 mg | Film-coated Tablets | Oral use |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | SEROQUEL 300 mg Filmtabletten | 300 mg | Film-coated Tablets | Oral use |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | SEROQUEL PROLONG 50 mg Retardtabletten | 50 mg | Prolonged-release tablets | Oral use |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | SEROQUEL PROLONG 150 mg Retardtabletten | 150 mg | Prolonged-release tablets | Oral use |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | SEROQUEL PROLONG 200 mg Retardtabletten | 200 mg | Prolonged-release tablets | Oral use |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | SEROQUEL PROLONG 300 mg Retardtabletten | 300 mg | Prolonged-release tablets | Oral use |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | SEROQUEL PROLONG 400 mg Retardtabletten | 400 mg | Prolonged-release tablets | Oral use |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens, Greece | SEROQUEL | 25 mg | Film-coated Tablets | Oral use |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens, Greece | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens, Greece | SEROQUEL | 150 mg | Film-coated Tablets | Oral use |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens, Greece | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens, Greece | SEROQUEL | 300 mg | Film-coated Tablets | Oral use |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens, Greece | SEROQUEL 3-Day Starter Pack | 25 mg + 100 mg | Film-coated Tablets | Oral use |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens, Greece | SEROQUEL 4-Day Starter Pack | 25 mg + 100 mg + 200 mg | Film-coated Tablets | Oral use |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens, Greece | SEROQUEL XR | 50 mg | Prolonged-release tablets | Oral use |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens, Greece | SEROQUEL XR | 150 mg | Prolonged-release tablets | Oral use |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens, Greece | SEROQUEL XR | 200 mg | Prolonged-release tablets | Oral use |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens, Greece | SEROQUEL XR | 300 mg | Prolonged-release tablets | Oral use |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi
  Athens, Greece | SEROQUEL XR | 400 mg | Prolonged-release tablets | Oral use |
| Hungary | AstraZeneca Kft.
  1113 Budapest
  Bocskai út 134-146.
  Hungary | SEROQUEL XR | 50 mg | Prolonged-release tablets | Oral use |
| Hungary | AstraZeneca Kft.
  1113 Budapest
  Bocskai út 134-146.
  Hungary | SEROQUEL XR | 150 mg | Prolonged-release tablets | Oral use |
| Hungary | AstraZeneca Kft.
  1113 Budapest
  Bocskai út 134-146.
  Hungary | SEROQUEL XR | 200 mg | Prolonged-release tablets | Oral use |
| Hungary | AstraZeneca Kft.
  1113 Budapest
  Bocskai út 134-146.
  Hungary | SEROQUEL XR | 300 mg | Prolonged-release tablets | Oral use |
| Hungary | AstraZeneca Kft.
  1113 Budapest
  Bocskai út 134-146.
  Hungary | SEROQUEL XR | 400 mg | Prolonged-release tablets | Oral use |
| Iceland | AstraZeneca AB
  151 85 Södertälje
  Sweden | SEROQUEL | 25 mg | Film-coated Tablets | Oral use |
| Iceland | AstraZeneca AB
  151 85 Södertälje
  Sweden | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Iceland | AstraZeneca AB
  151 85 Södertälje
  Sweden | SEROQUEL | 150 mg | Film-coated Tablets | Oral use |
| Iceland | AstraZeneca AB
  151 85 Södertälje
  Sweden | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Iceland | AstraZeneca AB
  151 85 Södertälje
  Sweden | SEROQUEL | 300 mg | Film-coated Tablets | Oral use |
| Iceland | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S,
  Denmark | SEROQUEL PROLONG | 50 mg | Prolonged-release tablets | Oral use |
| Iceland | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S,
  Denmark | SEROQUEL PROLONG | 150 mg | Prolonged-release tablets | Oral use |
| Iceland | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S,
  Denmark | SEROQUEL PROLONG | 200 mg | Prolonged-release tablets | Oral use |
| Iceland | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S,
  Denmark | SEROQUEL PROLONG | 300 mg | Prolonged-release tablets | Oral use |
| Iceland | AstraZeneca A/S
  Arne Jacobsens Allé 13
  2300 Copenhagen S,
  Denmark | SEROQUEL PROLONG | 400 mg | Prolonged-release tablets | Oral use |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL | 25 mg | Film-coated Tablets | Oral use |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL | 300 mg | Film-coated Tablets | Oral use |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL XR | 50 mg | Prolonged-release tablets | Oral use |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL XR | 150 mg | Prolonged-release tablets | Oral use |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL XR | 200 mg | Prolonged-release tablets | Oral use |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL XR | 300 mg | Prolonged-release tablets | Oral use |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL XR | 400 mg | Prolonged-release tablets | Oral use |
| Italy | AstraZeneca S.p.A.
  Palazzo Volta
  Via F. Sforza
  20080 — Basiglio (Milano)
  Italy | SEROQUEL 25 mg compresse rivestite con film | 25 mg | Film-coated Tablets | Oral use |
| Italy | AstraZeneca S.p.A.
  Palazzo Volta
  Via F. Sforza
  20080 — Basiglio (Milano)
  Italy | SEROQUEL 100 mg compresse rivestite con film | 100 mg | Film-coated Tablets | Oral use |
| Italy | AstraZeneca S.p.A.
  Palazzo Volta
  Via F. Sforza
  20080 — Basiglio (Milano)
  Italy | SEROQUEL 150 mg compresse rivestite con film | 150 mg | Film-coated Tablets | Oral use |
| Italy | AstraZeneca S.p.A.
  Palazzo Volta
  Via F. Sforza
  20080 — Basiglio (Milano)
  Italy | SEROQUEL 200 mg compresse rivestite con film | 200 mg | Film-coated Tablets | Oral use |
| Italy | AstraZeneca S.p.A.
  Palazzo Volta
  Via F. Sforza
  20080 — Basiglio (Milano)
  Italy | SEROQUEL 300 mg compresse rivestite con film | 300 mg | Film-coated Tablets | Oral use |
| Italy | AstraZeneca S.p.A.
  Palazzo Volta
  Via F. Sforza
  20080 — Basiglio (Milano)
  Italy | SEROQUEL | 25 mg + 100 mg
  +200 mg (Confezione Starter) | Film-coated Tablets | Oral use |
| Italy | AstraZeneca S.p.A.
  Palazzo Volta
  Via F. Sforza
  20080 — Basiglio (Milano)
  Italy | SEROQUEL | 50 mg | Prolonged-release tablets | Oral use |
| Italy | AstraZeneca S.p.A.
  Palazzo Volta
  Via F. Sforza
  20080 — Basiglio (Milano)
  Italy | SEROQUEL | 150 mg | Prolonged-release tablets | Oral use |
| Italy | AstraZeneca S.p.A.
  Palazzo Volta
  Via F. Sforza
  20080 — Basiglio (Milano)
  Italy | SEROQUEL | 200 mg | Prolonged-release tablets | Oral use |
| Italy | AstraZeneca S.p.A.
  Palazzo Volta
  Via F. Sforza
  20080 — Basiglio (Milano)
  Italy | SEROQUEL | 300 mg | Prolonged-release tablets | Oral use |
| Italy | AstraZeneca S.p.A.
  Palazzo Volta
  Via F. Sforza
  20080 — Basiglio (Milano)
  Italy | SEROQUEL | 400 mg | Prolonged-release tablets | Oral use |
| Latvia | AstraZeneca UK Limited,
  2 Kingdom Street,
  London W2 6BD
  United Kingdom | SEROQUEL 100 mg apvalkotās tabletes | 100 mg | Film-coated tablets | Oral use |
| Latvia | AstraZeneca UK Limited,
  2 Kingdom Street,
  London W2 6BD
  United Kingdom | SEROQUEL 200 mg apvalkotās tabletes | 200 mg | Film-coated tablets | Oral use |
| Latvia | AstraZeneca UK Limited,
  2 Kingdom Street,
  London W2 6BD
  United Kingdom | SEROQUEL XR 50 mg ilgstošās darbības apvalkotās tabletes | 50 mg | Prolonged-release tablets | Oral use |
| Latvia | AstraZeneca UK Limited,
  2 Kingdom Street,
  London W2 6BD
  United Kingdom | SEROQUEL XR 150 mg ilgstošās darbības apvalkotās tabletes | 150 mg | Prolonged-release tablets | Oral use |
| Latvia | AstraZeneca UK Limited,
  2 Kingdom Street,
  London W2 6BD
  United Kingdom | SEROQUEL XR 300 mg ilgstošās darbības apvalkotās tabletes | 300 mg | Prolonged-release tablets | Oral use |
| Latvia | AstraZeneca UK Limited,
  2 Kingdom Street,
  London W2 6BD
  United Kingdom | SEROQUEL XR 400 mg ilgstošās darbības apvalkotās tabletes | 400 mg | Prolonged-release tablets | Oral use |
| Lithuania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL | 25 mg | Film-coated Tablets | Oral use |
| Lithuania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Lithuania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Lithuania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 50 mg | Prolonged-release tablets | Oral use |
| Lithuania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 150 mg | Prolonged-release tablets | Oral use |
| Lithuania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 200 mg | Prolonged-release tablets | Oral use |
| Lithuania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 300 mg | Prolonged-release tablets | Oral use |
| Lithuania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 400 mg | Prolonged-release tablets | Oral use |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL | 25 mg | Film-coated Tablets | Oral use |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL | 150 mg | Film-coated Tablets | Oral use |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL | 300 mg | Film-coated Tablets | Oral use |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL Starter Pack | 25 mg + 100 mg | Film-coated Tablets | Oral use |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL 4-Day Starter Pack | 25 mg + 100 mg + 200 mg | Film-coated Tablets | Oral use |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL XR | 50 mg | Prolonged-release tablets | Oral use |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL XR | 150 mg | Prolonged-release tablets | Oral use |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL XR | 200 mg | Prolonged-release tablets | Oral use |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL XR | 300 mg | Prolonged-release tablets | Oral use |
| Malta | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  B-1180 Brussel, Belgium | SEROQUEL XR | 400 mg | Prolonged-release tablets | Oral use |
| Malta | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL | 25 mg | Film-coated Tablets | Oral use |
| Malta | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Malta | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Malta | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 50 mg | Prolonged-release tablets | Oral use |
| Malta | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 150 mg | Prolonged-release tablets | Oral use |
| Malta | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 200 mg | Prolonged-release tablets | Oral use |
| Malta | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 300 mg | Prolonged-release tablets | Oral use |
| Netherlands | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 400 mg | Prolonged-release tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | SEROQUEL-25 | 25 mg | Film-coated Tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | SEROQUEL-100 | 100 mg | Film-coated Tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | SEROQUEL-150 | 150 mg | Film-coated Tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | SEROQUEL-200 | 200 mg | Film-coated Tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | SEROQUEL-300 | 300 mg | Film-coated Tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | SEROQUEL
  4-daagse startverpakking | 6 x 25 mg + 3x 100 mg + 1 x 200 mg | Film-coated Tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | SEROQUEL XR 50 mg | 50 mg | Prolonged-release tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | SEROQUEL XR 150 mg | 150 mg | Prolonged-release tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | SEROQUEL XR 200 mg | 200 mg | Prolonged-release tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | SEROQUEL XR 300 mg | 300 mg | Prolonged-release tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | SEROQUEL XR 400 mg | 400 mg | Prolonged-release tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | Quetiapine XR AstraZeneca 50 mg | 50 mg | Prolonged-release tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | Quetiapine XR AstraZeneca 150 mg | 150 mg | Prolonged-release tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | Quetiapine XR AstraZeneca 200 mg | 200 mg | Prolonged-release tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | Quetiapine XR AstraZeneca 300 mg | 300 mg | Prolonged-release tablets | Oral use |
| Netherlands | AstraZeneca BV
  Louis Pasteurlaan 5
  2719 EE Zoetermeer
  The Netherlands | Quetiapine XR AstraZeneca 400 mg | 400 mg | Prolonged-release tablets | Oral use |
| Norway | AstraZeneca AS
  Postboks 6050
  Etterstad
  0601 OSLO, Norway | SEROQUEL | 25 mg | Film-coated Tablets | Oral use |
| Norway | AstraZeneca AS
  Postboks 6050
  Etterstad
  0601 OSLO, Norway | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Norway | AstraZeneca AS
  Postboks 6050
  Etterstad
  0601 OSLO, Norway | SEROQUEL | 150 mg | Film-coated Tablets | Oral use |
| Norway | AstraZeneca AS
  Postboks 6050
  Etterstad
  0601 OSLO, Norway | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Norway | AstraZeneca AS
  Postboks 6050
  Etterstad
  0601 OSLO, Norway | SEROQUEL | 300 mg | Film-coated Tablets | Oral use |
| Norway | AstraZeneca AS
  Postboks 6050
  Etterstad
  0601 OSLO, Norway | SEROQUEL DEPOT | 50 mg | Prolonged-release tablets | Oral use |
| Norway | AstraZeneca AS
  Postboks 6050
  Etterstad
  0601 OSLO, Norway | SEROQUEL DEPOT | 150 mg | Prolonged-release tablets | Oral use |
| Norway | AstraZeneca AS
  Postboks 6050
  Etterstad
  0601 OSLO, Norway | SEROQUEL DEPOT | 200 mg | Prolonged-release tablets | Oral use |
| Norway | AstraZeneca AS
  Postboks 6050
  Etterstad
  0601 OSLO, Norway | SEROQUEL DEPOT | 300 mg | Prolonged-release tablets | Oral use |
| Norway | AstraZeneca AS
  Postboks 6050
  Etterstad
  0601 OSLO, Norway | SEROQUEL DEPOT | 400 mg | Prolonged-release tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | SEROQUEL | 25 mg | Film-coated Tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | SEROQUEL | 150 mg | Film-coated Tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | SEROQUEL | 300 mg | Film-coated Tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | SEROQUEL | 25 mg +
  100 mg + | Film-coated Tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | SEROQUEL | 25 mg +
  100 mg +
  200 mg | Film-coated Tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | SEROQUEL SR | 50 mg | Prolonged-release tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | SEROQUEL SR | 150 mg | Prolonged-release tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | SEROQUEL SR | 200 mg | Prolonged-release tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | SEROQUEL SR | 300 mg | Prolonged-release tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | SEROQUEL SR | 400 mg | Prolonged-release tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | ALZEN SR | 150 mg | Prolonged-release tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | ALZEN SR | 50 mg | Prolonged-release tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | ALZEN SR | 200 mg | Prolonged-release tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | ALZEN SR | 300 mg | Prolonged-release tablets | Oral use |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Queluz de Baixo
  2730-097 Barcarena, Portugal | ALZEN SR | 400 mg | Prolonged-release tablets | Oral use |
| Romania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| Romania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| Romania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 50 mg | Prolonged-release tablets | Oral use |
| Romania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 150 mg | Prolonged-release tablets | Oral use |
| Romania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 200 mg | Prolonged-release tablets | Oral use |
| Romania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 300 mg | Prolonged-release tablets | Oral use |
| Romania | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 400 mg | Prolonged-release tablets | Oral use |
| Slovak Republic | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 50 mg | Prolonged-release tablets | Oral use |
| Slovak Republic | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 200 mg | Prolonged-release tablets | Oral use |
| Slovak Republic | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 300 mg | Prolonged-release tablets | Oral use |
| Slovak Republic | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL XR | 400 mg | Prolonged-release tablets | Oral use |
| Slovenia | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL 25 mg filmsko obložene tablete | 25 mg | Film-coated Tablets | Oral use |
| Slovenia | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL 100 mg filmsko obložene tablete | 100 mg | Film-coated Tablets | Oral use |
| Slovenia | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL 200 mg filmsko obložene tablete | 200 mg | Film-coated Tablets | Oral use |
| Slovenia | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL 300 mg filmsko obložene tablete | 300 mg | Film-coated Tablets | Oral use |
| Slovenia | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL SR 50 mg tablete s podaljšanim sproščanjem | 50 mg | Prolonged-release tablets | Oral use |
| Slovenia | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | Seroquel SR 150 mg tablete s podaljšanim sproščanjem | 150 mg | Prolonged-release tablets | Oral use |
| Slovenia | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL SR 200 mg tablete s podaljšanim sproščanjem | 200 mg | Prolonged-release tablets | Oral use |
| Slovenia | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL SR 300 mg tablete s podaljšanim sproščanjem | 300 mg | Prolonged-release tablets | Oral use |
| Slovenia | AstraZeneca UK Limited
  2 Kingdom Street
  London W2 6BD
  United Kingdom | SEROQUEL SR 400 mg tablete s podaljšanim sproščanjem | 400 mg | Prolonged-release tablets | Oral use |
| Spain | AstraZeneca Farmacéutica Spain, S.A.
  C/Serrano Galvache,
  56 Edificio Roble
  28033 Madrid, Spain | SEROQUEL 25 mg comprimidos recubiertos con película | 25 mg | Film-coated Tablets | Oral use |
| Spain | AstraZeneca Farmacéutica Spain, S.A.
  C/Serrano Galvache,
  56 Edificio Roble
  28033 Madrid, Spain | SEROQUEL 100 mg comprimidos recubiertos con película | 100 mg | Film-coated Tablets | Oral use |
| Spain | AstraZeneca Farmacéutica Spain, S.A.
  C/Serrano Galvache,
  56 Edificio Roble
  28033 Madrid, Spain | SEROQUEL 200 mg comprimidos recubiertos con película | 200 mg | Film-coated Tablets | Oral use |
| Spain | AstraZeneca Farmacéutica Spain, S.A.
  C/Serrano Galvache,
  56 Edificio Roble
  28033 Madrid, Spain | SEROQUEL 300 mg comprimidos recubiertos con película | 300 mg | Film-coated Tablets | Oral use |
| Spain | AstraZeneca Farmacéutica Spain, S.A.
  C/Serrano Galvache,
  56 Edificio Roble
  28033 Madrid, Spain | SEROQUEL PROLONG 50 mg
  Comprimidos de liberación prolongada | 50 mg | Prolonged-release tablets | Oral use |
| Spain | AstraZeneca Farmacéutica Spain, S.A.
  C/Serrano Galvache,
  56 Edificio Roble
  28033 Madrid, Spain | SEROQUEL PROLONG 150 mg
  Comprimidos de liberación prolongada | 150 mg | Prolonged-release tablets | Oral use |
| Spain | AstraZeneca Farmacéutica Spain, S.A.
  C/Serrano Galvache,
  56 Edificio Roble
  28033 Madrid, Spain | SEROQUEL PROLONG 200 mg
  Comprimidos de liberación prolongada | 200 mg | Prolonged-release tablets | Oral use |
| Spain | AstraZeneca Farmacéutica Spain, S.A.
  C/Serrano Galvache,
  56 Edificio Roble
  28033 Madrid, Spain | SEROQUEL PROLONG 300 mg
  Comprimidos de liberación prolongada | 300 mg | Prolonged-release tablets | Oral use |
| Spain | AstraZeneca Farmacéutica Spain, S.A.
  C/Serrano Galvache,
  56 Edificio Roble
  28033 Madrid, Spain | SEROQUEL PROLONG 400 mg
  Comprimidos de liberación prolongada | 400 mg | Prolonged-release tablets | Oral use |
| Sweden | AstraZeneca AB
  151 85 Södertälje
  Sweden | Seroquel | 25 mg | Film-coated Tablets | Oral use |
| Sweden | AstraZeneca AB
  151 85 Södertälje
  Sweden | Seroquel | 100 mg | Film-coated Tablets | Oral use |
| Sweden | AstraZeneca AB
  151 85 Södertälje
  Sweden | Seroquel | 150 mg | Film-coated Tablets | Oral use |
| Sweden | AstraZeneca AB
  151 85 Södertälje
  Sweden | Seroquel | 200 mg | Film-coated Tablets | Oral use |
| Sweden | AstraZeneca AB
  151 85 Södertälje
  Sweden | Seroquel | 300 mg | Film-coated Tablets | Oral use |
| Sweden | AstraZeneca AB
  151 85 Södertälje
  Sweden | Seroquel Depot | 50 mg | Prolonged-release tablets | Oral use |
| Sweden | AstraZeneca AB
  151 85 Södertälje
  Sweden | Seroquel Depot | 150 mg | Prolonged-release tablets | Oral use |
| Sweden | AstraZeneca AB
  151 85 Södertälje
  Sweden | Seroquel Depot | 200 mg | Prolonged-release tablets | Oral use |
| Sweden | AstraZeneca AB
  151 85 Södertälje
  Sweden | Seroquel Depot | 300 mg | Prolonged-release tablets | Oral use |
| Sweden | AstraZeneca AB
  151 85 Södertälje
  Sweden | Seroquel Depot | 400 mg | Prolonged-release tablets | Oral use |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL | 25 mg | Film-coated Tablets | Oral use |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL | 100 mg | Film-coated Tablets | Oral use |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL | 150 mg | Film-coated Tablets | Oral use |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL | 200 mg | Film-coated Tablets | Oral use |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL | 300 mg | Film-coated Tablets | Oral use |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL XL | 50 mg | Prolonged-release tablets | Oral use |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL XL | 150 mg | Prolonged-release tablets | Oral use |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL XL | 200 mg | Prolonged-release tablets | Oral use |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL XL | 300 mg | Prolonged-release tablets | Oral use |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | SEROQUEL XL | 400 mg | Prolonged-release tablets | Oral use |

Member State in EEA

Marketing authorisation holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

SEROQUEL 25 mg Filmtabletten

25 mg

Film-coated Tablets

Oral use

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

SEROQUEL 100 mg Filmtabletten

100 mg

Film-coated Tablets

Oral use

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

SEROQUEL 150 mg Filmtabletten

150 mg

Film-coated Tablets

Oral use

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

SEROQUEL 200 mg Filmtabletten

200 mg

Film-coated Tablets

Oral use

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

SEROQUEL 300 mg Filmtabletten

300 mg

Film-coated Tablets

Oral use

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

SEROQUEL 4-Day Starter Pack

25 mg Filmtabletten + 100 mg

Filmtabletten + 200 mg

Filmtabletten

Film-coated Tablets

Oral use

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

SEROQUEL XR 50 mg Retardtabletten

50 mg

Prolonged-release tablets

Oral use

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

SEROQUEL XR 150 mg Retardtabletten

150 mg

Prolonged-release tablets

Oral use

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

SEROQUEL XR 200 mg Retardtabletten

200 mg

Prolonged-release tablets

Oral use

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

SEROQUEL XR 300 mg Retardtabletten

300 mg

Prolonged-release tablets

Oral use

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

SEROQUEL XR 400 mg Retardtabletten

400 mg

Prolonged-release tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL

25 mg

Film-coated Tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL

150 mg

Film-coated Tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL

300 mg

Film-coated Tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL Starter Pack

25 mg + 100 mg

Film-coated Tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL 4-Day Starter Pack

25 mg + 100 mg + 200 mg

Film-coated Tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL XR

50 mg

Prolonged-release tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL XR

150 mg

Prolonged-release tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL XR

200 mg

Prolonged-release tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL XR

300 mg

Prolonged-release tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL XR

400 mg

Prolonged-release tablets

Oral use

Cyprus

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL

25 mg

Film-coated Tablets

Oral use

Cyprus

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Cyprus

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Cyprus

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

50 mg

Prolonged-release tablets

Oral use

Cyprus

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

150 mg

Prolonged-release tablets

Oral use

Cyprus

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

200 mg

Prolonged-release tablets

Oral use

Cyprus

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

300 mg

Prolonged-release tablets

Oral use

Cyprus

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

400 mg

Prolonged-release tablets

Oral use

Czech Republic

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL PROLONG 200 mg tablety s prodlouženým uvolňováním

200 mg

Prolonged-release tablets

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S

Denmark

SEROQUEL

25 mg

Film-coated Tablets

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S

Denmark

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S

Denmark

SEROQUEL

150 mg

Film-coated Tablets

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S

Denmark

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S

Denmark

SEROQUEL

300 mg

Film-coated Tablets

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S

Denmark

SEROQUEL 4-Day Starter Pack

25 mg + 100 mg + 200 mg

Film-coated Tablets

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S

Denmark

SEROQUEL PROLONG

50 mg

Prolonged-release tablets

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S

Denmark

SEROQUEL PROLONG

150 mg

Prolonged-release tablets

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S

Denmark

SEROQUEL PROLONG

200 mg

Prolonged-release tablets

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S

Denmark

SEROQUEL PROLONG

300 mg

Prolonged-release tablets

Oral use

Denmark

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S

Denmark

SEROQUEL PROLONG

400 mg

Prolonged-release tablets

Oral use

Estonia

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Estonia

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Estonia

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

300 mg

Prolonged-release tablets

Oral use

Estonia

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

400 mg

Prolonged-release tablets

Oral use

Finland

AstraZeneca Oy

Luomanportti 3

02200 Espoo

Finland

SEROQUEL

25 mg

Film-coated Tablets

Oral use

Finland

AstraZeneca Oy

Luomanportti 3

02200 Espoo

Finland

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Finland

AstraZeneca Oy

Luomanportti 3

02200 Espoo

Finland

SEROQUEL

150 mg

Film-coated Tablets

Oral use

Finland

AstraZeneca Oy

Luomanportti 3

02200 Espoo

Finland

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Finland

AstraZeneca Oy

Luomanportti 3

02200 Espoo

Finland

SEROQUEL

300 mg

Film-coated Tablets

Oral use

Finland

AstraZeneca Oy

Luomanportti 3

02200 Espoo

Finland

SEROQUEL PROLONG

50 mg

Prolonged-release tablets

Oral use

Finland

AstraZeneca Oy

Luomanportti 3

02200 Espoo

Finland

SEROQUEL PROLONG

150 mg

Prolonged-release tablets

Oral use

Finland

AstraZeneca Oy

Luomanportti 3

02200 Espoo

Finland

SEROQUEL PROLONG

200 mg

Prolonged-release tablets

Oral use

Finland

AstraZeneca Oy

Luomanportti 3

02200 Espoo

Finland

SEROQUEL PROLONG

300 mg

Prolonged-release tablets

Oral use

Finland

AstraZeneca Oy

Luomanportti 3

02200 Espoo

Finland

SEROQUEL PROLONG

400 mg

Prolonged-release tablets

Oral use

France

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cedex

France

XEROQUEL LP

50 mg

Prolonged-release tablets

Oral use

France

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cedex

France

XEROQUEL LP

150 mg

Prolonged-release tablets

Oral use

France

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cedex

France

XEROQUEL LP

200 mg

Prolonged-release tablets

Oral use

France

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cedex

France

XEROQUEL LP

300 mg

Prolonged-release tablets

Oral use

France

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cedex

France

XEROQUEL LP

400 mg

Prolonged-release tablets

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

SEROQUEL 25 mg Filmtabletten

25 mg

Film-coated Tablets

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

SEROQUEL 100 mg Filmtabletten

100 mg

Film-coated Tablets

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

SEROQUEL 200 mg Filmtabletten

200 mg

Film-coated Tablets

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

SEROQUEL 300 mg Filmtabletten

300 mg

Film-coated Tablets

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

SEROQUEL PROLONG 50 mg Retardtabletten

50 mg

Prolonged-release tablets

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

SEROQUEL PROLONG 150 mg Retardtabletten

150 mg

Prolonged-release tablets

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

SEROQUEL PROLONG 200 mg Retardtabletten

200 mg

Prolonged-release tablets

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

SEROQUEL PROLONG 300 mg Retardtabletten

300 mg

Prolonged-release tablets

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

SEROQUEL PROLONG 400 mg Retardtabletten

400 mg

Prolonged-release tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens, Greece

SEROQUEL

25 mg

Film-coated Tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens, Greece

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens, Greece

SEROQUEL

150 mg

Film-coated Tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens, Greece

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens, Greece

SEROQUEL

300 mg

Film-coated Tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens, Greece

SEROQUEL 3-Day Starter Pack

25 mg + 100 mg

Film-coated Tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens, Greece

SEROQUEL 4-Day Starter Pack

25 mg + 100 mg + 200 mg

Film-coated Tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens, Greece

SEROQUEL XR

50 mg

Prolonged-release tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens, Greece

SEROQUEL XR

150 mg

Prolonged-release tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens, Greece

SEROQUEL XR

200 mg

Prolonged-release tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens, Greece

SEROQUEL XR

300 mg

Prolonged-release tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens, Greece

SEROQUEL XR

400 mg

Prolonged-release tablets

Oral use

Hungary

AstraZeneca Kft.

1113 Budapest

Bocskai út 134-146.

Hungary

SEROQUEL XR

50 mg

Prolonged-release tablets

Oral use

Hungary

AstraZeneca Kft.

1113 Budapest

Bocskai út 134-146.

Hungary

SEROQUEL XR

150 mg

Prolonged-release tablets

Oral use

Hungary

AstraZeneca Kft.

1113 Budapest

Bocskai út 134-146.

Hungary

SEROQUEL XR

200 mg

Prolonged-release tablets

Oral use

Hungary

AstraZeneca Kft.

1113 Budapest

Bocskai út 134-146.

Hungary

SEROQUEL XR

300 mg

Prolonged-release tablets

Oral use

Hungary

AstraZeneca Kft.

1113 Budapest

Bocskai út 134-146.

Hungary

SEROQUEL XR

400 mg

Prolonged-release tablets

Oral use

Iceland

AstraZeneca AB

151 85 Södertälje

Sweden

SEROQUEL

25 mg

Film-coated Tablets

Oral use

Iceland

AstraZeneca AB

151 85 Södertälje

Sweden

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Iceland

AstraZeneca AB

151 85 Södertälje

Sweden

SEROQUEL

150 mg

Film-coated Tablets

Oral use

Iceland

AstraZeneca AB

151 85 Södertälje

Sweden

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Iceland

AstraZeneca AB

151 85 Södertälje

Sweden

SEROQUEL

300 mg

Film-coated Tablets

Oral use

Iceland

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S,

Denmark

SEROQUEL PROLONG

50 mg

Prolonged-release tablets

Oral use

Iceland

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S,

Denmark

SEROQUEL PROLONG

150 mg

Prolonged-release tablets

Oral use

Iceland

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S,

Denmark

SEROQUEL PROLONG

200 mg

Prolonged-release tablets

Oral use

Iceland

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S,

Denmark

SEROQUEL PROLONG

300 mg

Prolonged-release tablets

Oral use

Iceland

AstraZeneca A/S

Arne Jacobsens Allé 13

2300 Copenhagen S,

Denmark

SEROQUEL PROLONG

400 mg

Prolonged-release tablets

Oral use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL

25 mg

Film-coated Tablets

Oral use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL

300 mg

Film-coated Tablets

Oral use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL XR

50 mg

Prolonged-release tablets

Oral use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL XR

150 mg

Prolonged-release tablets

Oral use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL XR

200 mg

Prolonged-release tablets

Oral use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL XR

300 mg

Prolonged-release tablets

Oral use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL XR

400 mg

Prolonged-release tablets

Oral use

Italy

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 — Basiglio (Milano)

Italy

SEROQUEL 25 mg compresse rivestite con film

25 mg

Film-coated Tablets

Oral use

Italy

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 — Basiglio (Milano)

Italy

SEROQUEL 100 mg compresse rivestite con film

100 mg

Film-coated Tablets

Oral use

Italy

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 — Basiglio (Milano)

Italy

SEROQUEL 150 mg compresse rivestite con film

150 mg

Film-coated Tablets

Oral use

Italy

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 — Basiglio (Milano)

Italy

SEROQUEL 200 mg compresse rivestite con film

200 mg

Film-coated Tablets

Oral use

Italy

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 — Basiglio (Milano)

Italy

SEROQUEL 300 mg compresse rivestite con film

300 mg

Film-coated Tablets

Oral use

Italy

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 — Basiglio (Milano)

Italy

SEROQUEL

25 mg + 100 mg

+200 mg (Confezione Starter)

Film-coated Tablets

Oral use

Italy

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 — Basiglio (Milano)

Italy

SEROQUEL

50 mg

Prolonged-release tablets

Oral use

Italy

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 — Basiglio (Milano)

Italy

SEROQUEL

150 mg

Prolonged-release tablets

Oral use

Italy

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 — Basiglio (Milano)

Italy

SEROQUEL

200 mg

Prolonged-release tablets

Oral use

Italy

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 — Basiglio (Milano)

Italy

SEROQUEL

300 mg

Prolonged-release tablets

Oral use

Italy

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 — Basiglio (Milano)

Italy

SEROQUEL

400 mg

Prolonged-release tablets

Oral use

Latvia

AstraZeneca UK Limited,

2 Kingdom Street,

London W2 6BD

United Kingdom

SEROQUEL 100 mg apvalkotās tabletes

100 mg

Film-coated tablets

Oral use

Latvia

AstraZeneca UK Limited,

2 Kingdom Street,

London W2 6BD

United Kingdom

SEROQUEL 200 mg apvalkotās tabletes

200 mg

Film-coated tablets

Oral use

Latvia

AstraZeneca UK Limited,

2 Kingdom Street,

London W2 6BD

United Kingdom

SEROQUEL XR 50 mg ilgstošās darbības apvalkotās tabletes

50 mg

Prolonged-release tablets

Oral use

Latvia

AstraZeneca UK Limited,

2 Kingdom Street,

London W2 6BD

United Kingdom

SEROQUEL XR 150 mg ilgstošās darbības apvalkotās tabletes

150 mg

Prolonged-release tablets

Oral use

Latvia

AstraZeneca UK Limited,

2 Kingdom Street,

London W2 6BD

United Kingdom

SEROQUEL XR 300 mg ilgstošās darbības apvalkotās tabletes

300 mg

Prolonged-release tablets

Oral use

Latvia

AstraZeneca UK Limited,

2 Kingdom Street,

London W2 6BD

United Kingdom

SEROQUEL XR 400 mg ilgstošās darbības apvalkotās tabletes

400 mg

Prolonged-release tablets

Oral use

Lithuania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL

25 mg

Film-coated Tablets

Oral use

Lithuania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Lithuania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Lithuania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

50 mg

Prolonged-release tablets

Oral use

Lithuania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

150 mg

Prolonged-release tablets

Oral use

Lithuania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

200 mg

Prolonged-release tablets

Oral use

Lithuania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

300 mg

Prolonged-release tablets

Oral use

Lithuania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

400 mg

Prolonged-release tablets

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL

25 mg

Film-coated Tablets

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL

150 mg

Film-coated Tablets

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL

300 mg

Film-coated Tablets

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL Starter Pack

25 mg + 100 mg

Film-coated Tablets

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL 4-Day Starter Pack

25 mg + 100 mg + 200 mg

Film-coated Tablets

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL XR

50 mg

Prolonged-release tablets

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL XR

150 mg

Prolonged-release tablets

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL XR

200 mg

Prolonged-release tablets

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL XR

300 mg

Prolonged-release tablets

Oral use

Malta

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel, Belgium

SEROQUEL XR

400 mg

Prolonged-release tablets

Oral use

Malta

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL

25 mg

Film-coated Tablets

Oral use

Malta

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Malta

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Malta

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

50 mg

Prolonged-release tablets

Oral use

Malta

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

150 mg

Prolonged-release tablets

Oral use

Malta

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

200 mg

Prolonged-release tablets

Oral use

Malta

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

300 mg

Prolonged-release tablets

Oral use

Netherlands

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

400 mg

Prolonged-release tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

SEROQUEL-25

25 mg

Film-coated Tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

SEROQUEL-100

100 mg

Film-coated Tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

SEROQUEL-150

150 mg

Film-coated Tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

SEROQUEL-200

200 mg

Film-coated Tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

SEROQUEL-300

300 mg

Film-coated Tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

SEROQUEL

4-daagse startverpakking

6 x 25 mg + 3x 100 mg + 1 x 200 mg

Film-coated Tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

SEROQUEL XR 50 mg

50 mg

Prolonged-release tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

SEROQUEL XR 150 mg

150 mg

Prolonged-release tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

SEROQUEL XR 200 mg

200 mg

Prolonged-release tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

SEROQUEL XR 300 mg

300 mg

Prolonged-release tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

SEROQUEL XR 400 mg

400 mg

Prolonged-release tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Quetiapine XR AstraZeneca 50 mg

50 mg

Prolonged-release tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Quetiapine XR AstraZeneca 150 mg

150 mg

Prolonged-release tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Quetiapine XR AstraZeneca 200 mg

200 mg

Prolonged-release tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Quetiapine XR AstraZeneca 300 mg

300 mg

Prolonged-release tablets

Oral use

Netherlands

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Quetiapine XR AstraZeneca 400 mg

400 mg

Prolonged-release tablets

Oral use

Norway

AstraZeneca AS

Postboks 6050

Etterstad

0601 OSLO, Norway

SEROQUEL

25 mg

Film-coated Tablets

Oral use

Norway

AstraZeneca AS

Postboks 6050

Etterstad

0601 OSLO, Norway

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Norway

AstraZeneca AS

Postboks 6050

Etterstad

0601 OSLO, Norway

SEROQUEL

150 mg

Film-coated Tablets

Oral use

Norway

AstraZeneca AS

Postboks 6050

Etterstad

0601 OSLO, Norway

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Norway

AstraZeneca AS

Postboks 6050

Etterstad

0601 OSLO, Norway

SEROQUEL

300 mg

Film-coated Tablets

Oral use

Norway

AstraZeneca AS

Postboks 6050

Etterstad

0601 OSLO, Norway

SEROQUEL DEPOT

50 mg

Prolonged-release tablets

Oral use

Norway

AstraZeneca AS

Postboks 6050

Etterstad

0601 OSLO, Norway

SEROQUEL DEPOT

150 mg

Prolonged-release tablets

Oral use

Norway

AstraZeneca AS

Postboks 6050

Etterstad

0601 OSLO, Norway

SEROQUEL DEPOT

200 mg

Prolonged-release tablets

Oral use

Norway

AstraZeneca AS

Postboks 6050

Etterstad

0601 OSLO, Norway

SEROQUEL DEPOT

300 mg

Prolonged-release tablets

Oral use

Norway

AstraZeneca AS

Postboks 6050

Etterstad

0601 OSLO, Norway

SEROQUEL DEPOT

400 mg

Prolonged-release tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

SEROQUEL

25 mg

Film-coated Tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

SEROQUEL

150 mg

Film-coated Tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

SEROQUEL

300 mg

Film-coated Tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

SEROQUEL

25 mg +

100 mg +

Film-coated Tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

SEROQUEL

25 mg +

100 mg +

200 mg

Film-coated Tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

SEROQUEL SR

50 mg

Prolonged-release tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

SEROQUEL SR

150 mg

Prolonged-release tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

SEROQUEL SR

200 mg

Prolonged-release tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

SEROQUEL SR

300 mg

Prolonged-release tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

SEROQUEL SR

400 mg

Prolonged-release tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

ALZEN SR

150 mg

Prolonged-release tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

ALZEN SR

50 mg

Prolonged-release tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

ALZEN SR

200 mg

Prolonged-release tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

ALZEN SR

300 mg

Prolonged-release tablets

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo

2730-097 Barcarena, Portugal

ALZEN SR

400 mg

Prolonged-release tablets

Oral use

Romania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL

100 mg

Film-coated Tablets

Oral use

Romania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL

200 mg

Film-coated Tablets

Oral use

Romania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

50 mg

Prolonged-release tablets

Oral use

Romania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

150 mg

Prolonged-release tablets

Oral use

Romania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

200 mg

Prolonged-release tablets

Oral use

Romania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

300 mg

Prolonged-release tablets

Oral use

Romania

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

400 mg

Prolonged-release tablets

Oral use

Slovak Republic

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

50 mg

Prolonged-release tablets

Oral use

Slovak Republic

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

200 mg

Prolonged-release tablets

Oral use

Slovak Republic

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

300 mg

Prolonged-release tablets

Oral use

Slovak Republic

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL XR

400 mg

Prolonged-release tablets

Oral use

Slovenia

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL 25 mg filmsko obložene tablete

25 mg

Film-coated Tablets

Oral use

Slovenia

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL 100 mg filmsko obložene tablete

100 mg

Film-coated Tablets

Oral use

Slovenia

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL 200 mg filmsko obložene tablete

200 mg

Film-coated Tablets

Oral use

Slovenia

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL 300 mg filmsko obložene tablete

300 mg

Film-coated Tablets

Oral use

Slovenia

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL SR 50 mg tablete s podaljšanim sproščanjem

50 mg

Prolonged-release tablets

Oral use

Slovenia

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Seroquel SR 150 mg tablete s podaljšanim sproščanjem

150 mg

Prolonged-release tablets

Oral use

Slovenia

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL SR 200 mg tablete s podaljšanim sproščanjem

200 mg

Prolonged-release tablets

Oral use

Slovenia

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL SR 300 mg tablete s podaljšanim sproščanjem

300 mg

Prolonged-release tablets

Oral use

Slovenia

AstraZeneca UK Limited

2 Kingdom Street

London W2 6BD

United Kingdom

SEROQUEL SR 400 mg tablete s podaljšanim sproščanjem

400 mg

Prolonged-release tablets

Oral use

Spain

AstraZeneca Farmacéutica Spain, S.A.

C/Serrano Galvache,

56 Edificio Roble

28033 Madrid, Spain

SEROQUEL 25 mg comprimidos recubiertos con película

25 mg

Film-coated Tablets

Oral use

Spain

AstraZeneca Farmacéutica Spain, S.A.

C/Serrano Galvache,

56 Edificio Roble

28033 Madrid, Spain

SEROQUEL 100 mg comprimidos recubiertos con película

100 mg

Film-coated Tablets

Oral use

Spain

AstraZeneca Farmacéutica Spain, S.A.

C/Serrano Galvache,

56 Edificio Roble

28033 Madrid, Spain

SEROQUEL 200 mg comprimidos recubiertos con película

200 mg

Film-coated Tablets

Oral use

Spain

AstraZeneca Farmacéutica Spain, S.A.

C/Serrano Galvache,

56 Edificio Roble

28033 Madrid, Spain

SEROQUEL 300 mg comprimidos recubiertos con película

300 mg

Film-coated Tablets

Oral use

Spain

AstraZeneca Farmacéutica Spain, S.A.

C/Serrano Galvache,

56 Edificio Roble

28033 Madrid, Spain

SEROQUEL PROLONG 50 mg

Comprimidos de liberación prolongada

50 mg

Prolonged-release tablets

Oral use

Spain

AstraZeneca Farmacéutica Spain, S.A.

C/Serrano Galvache,

56 Edificio Roble

28033 Madrid, Spain

SEROQUEL PROLONG 150 mg

Comprimidos de liberación prolongada

150 mg

Prolonged-release tablets

Oral use

Spain

AstraZeneca Farmacéutica Spain, S.A.

C/Serrano Galvache,

56 Edificio Roble

28033 Madrid, Spain

SEROQUEL PROLONG 200 mg

Comprimidos de liberación prolongada

200 mg

Prolonged-release tablets

Oral use

Spain

AstraZeneca Farmacéutica Spain, S.A.

C/Serrano Galvache,

56 Edificio Roble

28033 Madrid, Spain

SEROQUEL PROLONG 300 mg

Comprimidos de liberación prolongada

300 mg

Prolonged-release tablets

Oral use

Spain

AstraZeneca Farmacéutica Spain, S.A.

C/Serrano Galvache,

56 Edificio Roble

28033 Madrid, Spain

SEROQUEL PROLONG 400 mg

Comprimidos de liberación prolongada

400 mg

Prolonged-release tablets

Oral use

Sweden

AstraZeneca AB

151 85 Södertälje

Sweden

Seroquel

25 mg

Film-coated Tablets

Oral use

Sweden

AstraZeneca AB

151 85 Södertälje

Sweden

Seroquel

100 mg

Film-coated Tablets

Oral use

Sweden

AstraZeneca AB

151 85 Södertälje

Sweden

Seroquel

150 mg

Film-coated Tablets

Oral use

Sweden

AstraZeneca AB

151 85 Södertälje

Sweden

Seroquel

200 mg

Film-coated Tablets

Oral use

Sweden

AstraZeneca AB

151 85 Södertälje

Sweden

Seroquel

300 mg

Film-coated Tablets

Oral use

Sweden

AstraZeneca AB

151 85 Södertälje

Sweden

Seroquel Depot

50 mg

Prolonged-release tablets

Oral use

Sweden

AstraZeneca AB

151 85 Södertälje

Sweden

Seroquel Depot

150 mg

Prolonged-release tablets

Oral use

Sweden

AstraZeneca AB

151 85 Södertälje

Sweden

Seroquel Depot

200 mg

Prolonged-release tablets

Oral use

Sweden

AstraZeneca AB

151 85 Södertälje

Sweden

Seroquel Depot

300 mg

Prolonged-release tablets

Oral use

Sweden

AstraZeneca AB

151 85 Södertälje

Sweden

Seroquel Depot

400 mg

Prolonged-release tablets

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL

25 mg

Film-coated Tablets

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL

100 mg

Film-coated Tablets

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL

150 mg

Film-coated Tablets

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL

200 mg

Film-coated Tablets

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL

300 mg

Film-coated Tablets

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL XL

50 mg

Prolonged-release tablets

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL XL

150 mg

Prolonged-release tablets

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL XL

200 mg

Prolonged-release tablets

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL XL

300 mg

Prolonged-release tablets

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

SEROQUEL XL

400 mg

Prolonged-release tablets

Oral use

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