# Official Journal C 124/2012

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2012.124.eng |
| --- | --- |
| Official Journal
  of the European Union | C 124 |
| | |
| English edition | Information and Notices | Volume 5527 April 2012 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2012.124.eng

Official Journal

of the European Union

C 124

English edition

Information and Notices

Volume 5527 April 2012

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2012/C 124/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2012 to 31 March 2012(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2012/C 124/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2012 to 31 March 2012(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

2012/C 124/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2012 to 31 March 2012(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

2012/C 124/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2012 to 31 March 2012(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

| 27.4.2012 | EN | Official Journal of the European Union | C 124/1 |
| --- | --- | --- | --- |

27.4.2012

EN

Official Journal of the European Union

C 124/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2012 to 31 March 2012

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

2012/C 124/01

—   Issuing of a marketing authorization (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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.3.2012 | Mercaptopurine Nova Laboratories | Mercaptopurine | Nova Laboratories Limited |
| Martin House, Gloucester Crescent, |
| Wigston Leicester, |
| LE18 4YL, |
| United Kingdom |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

9.3.2012

Mercaptopurine Nova Laboratories

Mercaptopurine

Nova Laboratories Limited

Martin House, Gloucester Crescent,

Wigston Leicester,

LE18 4YL,

United Kingdom

EU/1/11/727/001

Oral suspension

L01BB02

13.3.2012

9.3.2012

Sepioglin

pioglitazone

| Vaia S.A. |
| --- |
| 1, 28 Octovriou str., |
| Ag. Varvara |
| 123 51, Athens, |
| Ελλάδα |

Vaia S.A.

1, 28 Octovriou str.,

Ag. Varvara

123 51, Athens,

Ελλάδα

EU/1/12/754/001-021

Tablet

A10BG03

13.3.2012

15.3.2012

Pioglitazone Actavis

pioglitazone

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

Actavis Group PTC ehf.

Reykjavíkurvegi 76 78,

220 Hafnarfjörður,

Iceland

EU/1/12/755/001-027

Tablet

A10BG03

20.3.2012

15.3.2012

Pioglitazone Actavis Group

pioglitazone

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

Actavis Group PTC ehf.

Reykjavíkurvegi 76 - 78,

220 Hafnarfjörður,

Iceland

EU/1/12/756/001-027

Tablet

A10BG03

20.3.2012

21.3.2012

Paglitaz

pioglitazone

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

KRKA, d. d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/11/721/001-021

Tablet

A10BG03

26.3.2012

21.3.2012

Pioglitazone Accord

pioglitazone

| Accord Healthcare Limited |
| --- |
| 5th Floor Charles House, 108/110 Finchley road, |
| London NW3 5JJ, |
| United Kingdom |

Accord Healthcare Limited

5th Floor Charles House, 108/110 Finchley road,

London NW3 5JJ,

United Kingdom

EU/1/11/722/001-030

Tablet

A10BG03

27.3.2012

26.3.2012

Pioglitazone Teva

pioglitazone

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/12/757/001-030

Tablet

A10BG03

29.3.2012

26.3.2012

Pioglitazone Teva Pharma

pioglitazone

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/12/758/001-030

Tablet

A10BG03

29.3.2012

—   Modification of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.3.2012 | ATryn | GTC Biotherapeutics UK Limited |
| 10 Norwich Street, |
| London |
| EC4A 1BD, |
| United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

2.3.2012

ATryn

GTC Biotherapeutics UK Limited

10 Norwich Street,

London

EC4A 1BD,

United Kingdom

EU/1/06/355/001-003

6.3.2012

2.3.2012

Daliresp

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, |
| D-78467 Konstanz, |
| Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2,

D-78467 Konstanz,

Deutschland

EU/1/11/668/001-003

6.3.2012

2.3.2012

Esbriet

| InterMune UK Ltd |
| --- |
| Euston Tower, Floor 32, 286 Euston Road, |
| London, |
| NW1 3DP, |
| United Kingdom |

InterMune UK Ltd

Euston Tower, Floor 32, 286 Euston Road,

London,

NW1 3DP,

United Kingdom

EU/1/11/667/001-004

6.3.2012

2.3.2012

Fampyra

| Biogen Idec Limited |
| --- |
| Innovation House, 70 Norden Road, Maidenhead, |
| Berkshire |
| SL6 4AY, |
| United Kingdom |

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead,

Berkshire

SL6 4AY,

United Kingdom

EU/1/11/699/001-004

6.3.2012

2.3.2012

Invirase

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

Roche Registration Limited

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/96/026/001-002

6.3.2012

2.3.2012

Leflunomide Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/11/675/001-010

6.3.2012

2.3.2012

Libertek

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, |
| D-78467 Konstanz, |
| Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2,

D-78467 Konstanz,

Deutschland

EU/1/11/666/001-003

6.3.2012

2.3.2012

NutropinAq

| Ipsen Pharma |
| --- |
| 65, quai Georges Gorse, |
| 92100 Boulogne-Billancourt, |
| France |

Ipsen Pharma

65, quai Georges Gorse,

92100 Boulogne-Billancourt,

France

EU/1/00/164/003-005

6.3.2012

2.3.2012

Ruconest

| Pharming Group N.V. |
| --- |
| Darwinweg 24, |
| NL-2333 CR Leiden, |
| Nederland |

Pharming Group N.V.

Darwinweg 24,

NL-2333 CR Leiden,

Nederland

EU/1/10/641/001

6.3.2012

2.3.2012

Tandemact

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, |
| London |
| WC2B 4AE, |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/06/366/005-022

6.3.2012

2.3.2012

Valtropin

| BioPartners GmbH |
| --- |
| Kaiserpassage 11 – |
| D-72764 Reutlingen, |
| Deutschland |

BioPartners GmbH

Kaiserpassage 11 –

D-72764 Reutlingen,

Deutschland

EU/1/06/335/001

6.3.2012

6.3.2012

Clopidogrel Acino

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/532/001-007

8.3.2012

6.3.2012

Repso

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/11/674/001-010

8.3.2012

6.3.2012

Rivastigmine Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/513/001-020

8.3.2012

6.3.2012

Topotecan Actavis

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegur 76-78, |
| 220 Hafnarfjordur, |
| Iceland |

Actavis Group PTC ehf

Reykjavikurvegur 76-78,

220 Hafnarfjordur,

Iceland

EU/1/09/536/001-004

8.3.2012

8.3.2012

Docetaxel Winthrop

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, |
| F-92165 Antony Cedex, |
| France |

Aventis Pharma S.A.

20 avenue Raymond Aron,

F-92165 Antony Cedex,

France

EU/1/07/384/003-005

12.3.2012

8.3.2012

Firazyr

| Shire Orphan Therapies GmbH |
| --- |
| Friedrichstrasse 149, |
| D-10117 Berlin, |
| Deutschland |

Shire Orphan Therapies GmbH

Friedrichstrasse 149,

D-10117 Berlin,

Deutschland

EU/1/08/461/001-002

12.3.2012

8.3.2012

Pritor

| Bayer Pharma AG |
| --- |
| 13342 Berlin, |
| Deutschland |

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/98/089/001-022

12.3.2012

8.3.2012

PritorPlus

| Bayer Pharma AG |
| --- |
| 13342 Berlin, |
| Deutschland |

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/02/215/001-021

12.3.2012

9.3.2012

Samsca

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House, Highbridge Business Park, Oxford Road, |
| Uxbridge, Middlesex |
| UB8 1HU, |
| United Kingdom |

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Business Park, Oxford Road,

Uxbridge, Middlesex

UB8 1HU,

United Kingdom

EU/1/09/539/001-004

13.3.2012

15.3.2012

Avamys

| Glaxo Group Ltd |
| --- |
| Greenford, Middlesex |
| UB6 0NN, |
| United Kingdom |

Glaxo Group Ltd

Greenford, Middlesex

UB6 0NN,

United Kingdom

EU/1/07/434/001-003

19.3.2012

15.3.2012

Carbaglu

| Orphan Europe |
| --- |
| Immeuble Le Wilson, |
| 70 Avenue du General de Gaulle, |
| 92800 Puteaux, |
| France |

Orphan Europe

Immeuble Le Wilson,

70 Avenue du General de Gaulle,

92800 Puteaux,

France

EU/1/02/246/001-003

19.3.2012

15.3.2012

Orencia

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, |
| Uxbridge |
| UB8 1DH, |
| United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road,

Uxbridge

UB8 1DH,

United Kingdom

EU/1/07/389/001-003

19.3.2012

15.3.2012

Prolia

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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/10/618/001-004

19.3.2012

15.3.2012

Toviaz

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

Pfizer Limited

Ramsgate Road, Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/1/07/386/001-018

19.3.2012

15.3.2012

Ventavis

| Bayer Pharma AG |
| --- |
| 13342 Berlin, |
| Deutschland |

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/03/255/001-008

19.3.2012

15.3.2012

Vizarsin

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

KRKA, d.d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/09/551/001-012

19.3.2012

19.3.2012

Afinitor

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/09/538/001-008

21.3.2012

19.3.2012

Arava

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, |
| Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/99/118/001-010

21.3.2012

19.3.2012

Avastin

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

Roche Registration Limited

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/04/300/001-002

22.3.2012

19.3.2012

Benlysta

| Glaxo Group Limited |
| --- |
| Glaxo Wellcome House, Berkely Avenue, Greenford, |
| Middlesex |
| UB6 0NN, |
| United Kingdom |

Glaxo Group Limited

Glaxo Wellcome House, Berkely Avenue, Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/11/700/001-002

21.3.2012

19.3.2012

Byetta

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

Eli Lilly Nederland B.V.

Grootslag 1-5,

3991 RA Houten,

Nederland

EU/1/06/362/001-004

22.3.2012

19.3.2012

Fasturtec

| Sanofi-Aventis |
| --- |
| 174, avenue de France, |
| F-75013 Paris, |
| France |

Sanofi-Aventis

174, avenue de France,

F-75013 Paris,

France

EU/1/00/170/001-002

21.3.2012

19.3.2012

Helixate NexGen

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, |
| Deutschland |

Bayer Schering Pharma AG

13342 Berlin,

Deutschland

EU/1/00/144/001-005

22.3.2012

19.3.2012

IDflu

| Sanofi Pasteur SA |
| --- |
| 2, avenue Pont Pasteur, |
| F-69007 Lyon, |
| France |

Sanofi Pasteur SA

2, avenue Pont Pasteur,

F-69007 Lyon,

France

EU/1/08/507/001-006

22.3.2012

19.3.2012

Incivo

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

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/11/720/001-002

21.3.2012

19.3.2012

Intanza

| Sanofi Pasteur MSD SNC |
| --- |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Sanofi Pasteur MSD SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/08/505/001-006

21.3.2012

19.3.2012

Intelence

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

Janssen-Cilag International NV

Turnhoutseweg, 30 –

2340 Beerse –

België

EU/1/08/468/001-002

21.3.2012

19.3.2012

Isentress

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

Merck Sharp & Dohme Limited

Hertford Road,

Hoddesdon, Hertfordshire

EN11 9BU,

United Kingdom

EU/1/07/436/001-002

21.3.2012

19.3.2012

Kogenate Bayer

| Bayer Pharma AG |
| --- |
| 13342 Berlin, |
| Deutschland |

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/00/143/004-013

22.3.2012

19.3.2012

Leflunomide Winthrop

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, |
| Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/09/604/001-010

21.3.2012

19.3.2012

Levitra

| Bayer Pharma AG |
| --- |
| 13342 Berlin, |
| Deutschland |

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/03/248/001-023

21.3.2012

19.3.2012

Norvir

| Abbott Laboratories Ltd |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, |
| Maidenhead, Berkshire |
| SL6 4XE, |
| United Kingdom |

Abbott Laboratories Ltd

Abbott House, Vanwall Business Park, Vanwall Road,

Maidenhead, Berkshire

SL6 4XE,

United Kingdom

EU/1/96/016/001

EU/1/96/016/003-008

21.3.2012

19.3.2012

PegIntron

| Schering Plough Europe |
| --- |
| Clos du Lynx 5, |
| 1200 Bruxelles, |
| Belgique – |

Schering Plough Europe

Clos du Lynx 5,

1200 Bruxelles,

Belgique –

| Lynx Binnenhof 5, |
| --- |
| 1200 Brussel, |
| België |

Lynx Binnenhof 5,

1200 Brussel,

België

EU/1/00/131/001-050

21.3.2012

19.3.2012

Prevenar 13

| Wyeth-Lederle Vaccines S.A. |
| --- |
| Pleinlaan 17 Boulevard de la Plaine, |
| 1050 Brussel - Bruxelles, |
| Belgïe-Belgique |

Wyeth-Lederle Vaccines S.A.

Pleinlaan 17 Boulevard de la Plaine,

1050 Brussel - Bruxelles,

Belgïe-Belgique

EU/1/09/590/001-006

22.3.2012

19.3.2012

Privigen

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Strasse 76, |
| 35041 Marburg, |
| Deutschland |

CSL Behring GmbH

Emil-von-Behring-Strasse 76,

35041 Marburg,

Deutschland

EU/1/08/446/001-006

21.3.2012

19.3.2012

ProQuad

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/05/323/001-013

21.3.2012

19.3.2012

Ranexa

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1, Avenue de la Gare, |
| L-1611 Luxembourg, |
| Luxembourg |

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare,

L-1611 Luxembourg,

Luxembourg

EU/1/08/462/001-012

22.3.2012

19.3.2012

Refludan

| Celgene Europe Ltd |
| --- |
| 1 Longwalk Road, Stockley Park, |
| Uxbridge, |
| UB11 1DB, |
| United Kingdom |

Celgene Europe Ltd

1 Longwalk Road, Stockley Park,

Uxbridge,

UB11 1DB,

United Kingdom

EU/1/97/035/001-004

21.3.2012

19.3.2012

Remicade

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

Janssen Biologics B.V.

Einsteinweg 101,

2333 CB Leiden,

Nederland

EU/1/99/116/001-005

22.3.2012

19.3.2012

Resolor

| Shire-Movetis NV |
| --- |
| Veedjik 58, |
| B-2300 Turnhout, |
| België |

Shire-Movetis NV

Veedjik 58,

B-2300 Turnhout,

België

EU/1/09/581/001-008

21.3.2012

19.3.2012

Tasmar

| Meda AB |
| --- |
| Pipers väg 2A, |
| 170 09 Solna, |
| Sverige |

Meda AB

Pipers väg 2A,

170 09 Solna,

Sverige

EU/1/97/044/001-009

21.3.2012

19.3.2012

Vimpat

| UCB Pharma SA. |
| --- |
| Allée de la Recherche 60, |
| 1070 Bruxelles, |
| Belgique/ |

UCB Pharma SA.

Allée de la Recherche 60,

1070 Bruxelles,

Belgique/

| Researchdreef, 60, |
| --- |
| 1070 Brussel, |
| België |

Researchdreef, 60,

1070 Brussel,

België

EU/1/08/470/001-013

EU/1/08/470/016-017

22.3.2012

19.3.2012

Votrient

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, |
| Greenford, Middlesex |
| UB6 0NN, |
| United Kingdom |

Glaxo Group Limited

Berkeley Avenue,

Greenford, Middlesex

UB6 0NN,

United Kingdom

EU/1/10/628/001-004

22.3.2012

21.3.2012

Atriance

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, |
| Greenford, Middlesex |
| UB6 0NN, |
| United Kingdom |

Glaxo Group Limited

Berkeley Avenue,

Greenford, Middlesex

UB6 0NN,

United Kingdom

EU/1/07/403/001

26.3.2012

21.3.2012

Champix

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, |
| Kent |
| CT 13 9NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/06/360/001-013

26.3.2012

21.3.2012

Clopidogrel Krka d.d.

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

KRKA, d.d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/09/562/001-009

26.3.2012

21.3.2012

Foclivia

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

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/09/577/001-004

26.3.2012

21.3.2012

Integrilin

| Glaxo Group Ltd |
| --- |
| Greenford, Middlesex, |
| UB6 ONN, |
| United Kingdom |

Glaxo Group Ltd

Greenford, Middlesex,

UB6 ONN,

United Kingdom

EU/1/99/109/001-002

23.3.2012

21.3.2012

Rapiscan

| Rapidscan Pharma Solutions EU Ltd. |
| --- |
| Regent's Place, 338 Euston Road, |
| London |
| NW1 3BT, |
| UK |

Rapidscan Pharma Solutions EU Ltd.

Regent's Place, 338 Euston Road,

London

NW1 3BT,

UK

EU/1/10/643/001

23.3.2012

21.3.2012

Revatio

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

Pfizer Limited

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

EU/1/05/318/001-003

26.3.2012

21.3.2012

Thymanax

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

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow,

Ireland

EU/1/08/498/001-008

26.3.2012

21.3.2012

VELCADE

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

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/04/274/001-002

26.3.2012

21.3.2012

Victrelis

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

Merck Sharp & Dohme Limited

Hertford Road,

Hodderson, Hertfordshire

EN11 9BU,

United Kingdom

EU/1/11/704/001-002

23.3.2012

21.3.2012

Volibris

| Glaxo Group Ltd |
| --- |
| Greenford, |
| Middlesex |
| UB6 0NN, |
| United Kingdom |

Glaxo Group Ltd

Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/08/451/001-004

26.3.2012

21.3.2012

Xgeva

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

Amgen Europe B.V.

Minervum 7061,

4817 ZK Breda,

Nederland

EU/1/11/703/001-003

23.3.2012

21.3.2012

Zostavax

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/341/001-013

23.3.2012

26.3.2012

Azilect

| Teva Pharma GmbH |
| --- |
| Graf-Arco-Str. 3, |
| 89079 Ulm, |
| Deutschland |

Teva Pharma GmbH

Graf-Arco-Str. 3,

89079 Ulm,

Deutschland

EU/1/04/304/001-007

28.3.2012

26.3.2012

Eurartesim

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A |
| --- |
| Viale Shakespeare 47, |
| 00144 Rome, |
| Italia |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare 47,

00144 Rome,

Italia

EU/1/11/716/001-005

28.3.2012

26.3.2012

Neupro

| Schwarz Pharma Ltd |
| --- |
| Shannon, Industrial Estate, |
| Co.Clare, |
| Ireland |

Schwarz Pharma Ltd

Shannon, Industrial Estate,

Co.Clare,

Ireland

EU/1/05/331/001-055

28.3.2012

26.3.2012

Nimvastid

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

KRKA, d.d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/09/525/001-050

28.3.2012

26.3.2012

Pandemic influenza vaccine H5N1 BAXTER

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

Baxter AG

Industriestraße 67,

A – 1221 Wien,

Österreich

EU/1/09/571/001-002

28.3.2012

26.3.2012

PegIntron

| Schering Plough Europe |
| --- |
| Clos du Lynx 5, |
| 1200 Bruxelles, |
| Belgique – |

Schering Plough Europe

Clos du Lynx 5,

1200 Bruxelles,

Belgique –

| Lynx Binnenhof 5, |
| --- |
| 1200 Brussel, |
| België |

Lynx Binnenhof 5,

1200 Brussel,

België

EU/1/00/131/001-050

28.3.2012

26.3.2012

Plenadren

| DuoCort Pharma AB |
| --- |
| Kullagatan 8-10, |
| S-252 20 Helsingborg, |
| Sverige |

DuoCort Pharma AB

Kullagatan 8-10,

S-252 20 Helsingborg,

Sverige

EU/1/11/715/001-002

28.3.2012

26.3.2012

Valdoxan

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

Les Laboratoires Servier

50 rue Carnot,

92284 Suresnes, Cedex,

France

EU/1/08/499/001-008

28.3.2012

26.3.2012

ViraferonPeg

| Schering Plough Europe |
| --- |
| Clos du Lynx 5, |
| 1200 Bruxelles, |
| Belgique – |

Schering Plough Europe

Clos du Lynx 5,

1200 Bruxelles,

Belgique –

| Lynx Binnenhof 5, |
| --- |
| 1200 Brussel, |
| België |

Lynx Binnenhof 5,

1200 Brussel,

België

EU/1/00/132/001-050

28.3.2012

26.3.2012

VPRIV

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

Shire Pharmaceuticals Ireland Limited

5 Riverside Walk, Citywest Business Campus,

Dublin 24,

Ireland

EU/1/10/646/001-006

28.3.2012

—   Withdrawal of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 15.3.2012 | Livensa | Warner Chilcott Deutschland Gmbh |
| Dr.-Otto-Röhm-Strasse 2-4, |
| 64331 Weiterstadt, |
| Deutschland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

15.3.2012

Livensa

Warner Chilcott Deutschland Gmbh

Dr.-Otto-Röhm-Strasse 2-4,

64331 Weiterstadt,

Deutschland

EU/1/06/351/001-003

19.3.2012

—   Suspension of a marketing authorization (Article 20 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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.3.2012 | Omnitrope | Sandoz GmbH |
| Biochemiestrasse 10, |
| 6250 Kundl, |
| Österreich |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

2.3.2012

Omnitrope

Sandoz GmbH

Biochemiestrasse 10,

6250 Kundl,

Österreich

EU/1/06/332/001-012

6.3.2012

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

| Date of the Décision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.3.2012 | Zulvac 1+8 Bovis | — | Pfizer Limited |
| Ramsgate Road, Sandwich, |
| Kent |
| CT13 9NJ |
| United Kingdom |

Date of the Décision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

8.3.2012

Zulvac 1+8 Bovis

—

Pfizer Limited

Ramsgate Road, Sandwich,

Kent

CT13 9NJ

United Kingdom

EU/2/12/139/001-003

Suspension for injection

QI02AA08

12.3.2012

—   Modification of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.3.2012 | Easotic | VIRBAC S.A |
| 1ère Avenue 2065 m L.I.D. – |
| 06516 Carros – |
| France |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

2.3.2012

Easotic

VIRBAC S.A

1ère Avenue 2065 m L.I.D. –

06516 Carros –

France

EU/2/08/085/001-006

6.3.2012

2.3.2012

Flexicam

| Dechra Veterinary Products A/S |
| --- |
| Mekuvej 9, |
| 7171 Uldum, |
| Danmark |

Dechra Veterinary Products A/S

Mekuvej 9,

7171 Uldum,

Danmark

EU/2/06/058/004

6.3.2012

9.3.2012

Purevax Rabies

| MERIAL |
| --- |
| 29 avenue Tony Garnier, |
| 69007 LYON, |
| France |

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/117/001-003

13.3.2012

15.3.2012

BTVPUR AlSap 8

| MERIAL |
| --- |
| 29 avenue Tony Garnier, |
| 69007 LYON, |
| France |

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/09/094/001-004

19.3.2012

15.3.2012

Masivet

| AB Science S.A. |
| --- |
| 3 avenue George V, |
| 75008 Paris, |
| France |

AB Science S.A.

3 avenue George V,

75008 Paris,

France

EU/2/08/087/001-003

19.3.2012

15.3.2012

Recuvyra

| Nexcyon Pharmaceuticals Ltd. |
| --- |
| Bank Barn, How Mill, |
| Brampton, Cumbria |
| CA8 9JY, |
| United Kingdom |

Nexcyon Pharmaceuticals Ltd.

Bank Barn, How Mill,

Brampton, Cumbria

CA8 9JY,

United Kingdom

EU/2/11/127/001

20.3.2012

26.3.2012

Aivlosin

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road New Malden |
| Surrey |
| KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road New Malden

Surrey

KT3 4QS

United Kingdom

EU/2/04/044/001-013

28.3.2012

—   Withdrawal of a marketing authorization (Article 38 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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 19.3.2012 | Gonazon | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

19.3.2012

Gonazon

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/03/040/001-002

22.3.2012

19.3.2012

Zubrin

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/00/028/002-008

22.3.2012

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

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

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK - LONDON E14 4H

---

(1)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 136, 30.4.2004, p. 1.

---

| 27.4.2012 | EN | Official Journal of the European Union | C 124/12 |
| --- | --- | --- | --- |

27.4.2012

EN

Official Journal of the European Union

C 124/12

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2012 to 31 March 2012

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

2012/C 124/02

—   Refusal of modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 6.3.2012 | Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and ass. names | See Annex I | See Annex I | 7.3.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

6.3.2012

Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and ass. names

See Annex I

See Annex I

7.3.2012

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  EU/EEA | Marketing authorisaton holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Novo Nordisk Pharma GmbH |
| Opernring 3-5 |
| 1010 Wien |
| Austria |

Member State

EU/EEA

Marketing authorisaton holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin SimpleXx 5 mg/1,5 ml - Injektionslösung

5 mg/1,5 mL

solution for injection

subcutaneous use

Austria

| Novo Nordisk Pharma GmbH |
| --- |
| Opernring 3-5 |
| 1010 Wien |
| Austria |

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin SimpleXx 10 mg/1,5 ml - Injektionslösung

10 mg/1,5 mL

solution for injection

subcutaneous use

Austria

| Novo Nordisk Pharma GmbH |
| --- |
| Opernring 3-5 |
| 1010 Wien |
| Austria |

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin SimpleXx 15 mg/1,5 ml - Injektionslösung

15 mg/1,5 mL

solution for injection

subcutaneous use

Austria

| Novo Nordisk Pharma GmbH |
| --- |
| Opernring 3-5 |
| 1010 Wien |
| Austria |

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin NordiFlex 5 mg/1,5 ml - Injektionslösung in einem Fertigpen

5 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Austria

| Novo Nordisk Pharma GmbH |
| --- |
| Opernring 3-5 |
| 1010 Wien |
| Austria |

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin NordiFlex 10 mg/1,5 ml - Injektionslösung in einem Fertigpen

10 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Austria

| Novo Nordisk Pharma GmbH |
| --- |
| Opernring 3-5 |
| 1010 Wien |
| Austria |

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin NordiFlex 15 mg/1,5 ml - Injektionslösung in einem Fertigpen

15 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Austria

| Novo Nordisk Pharma GmbH |
| --- |
| Opernring 3-5 |
| 1010 Wien |
| Austria |

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin FlexPro 5 mg/1,5 ml - Injektionslösung in einem Fertigpen

5 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Austria

| Novo Nordisk Pharma GmbH |
| --- |
| Opernring 3-5 |
| 1010 Wien |
| Austria |

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin FlexPro 10 mg/1,5 ml - Injektionslösung in einem Fertigpen

10 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Austria

| Novo Nordisk Pharma GmbH |
| --- |
| Opernring 3-5 |
| 1010 Wien |
| Austria |

Novo Nordisk Pharma GmbH

Opernring 3-5

1010 Wien

Austria

Norditropin FlexPro 15 mg/1,5 ml - Injektionslösung in einem Fertigpen

15 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Belgium

| NOVO NORDISK PHARMA SA |
| --- |
| Boulevard international 55 |
| 1070 Brussels |
| Belgium |

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Simplexx

5 mg/1,5 mL

solution for injection

subcutaneous use

Belgium

| NOVO NORDISK PHARMA SA |
| --- |
| Boulevard international 55 |
| 1070 Brussels |
| Belgium |

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Simplexx

10 mg/1,5 mL

solution for injection

subcutaneous use

Belgium

| NOVO NORDISK PHARMA SA |
| --- |
| Boulevard international 55 |
| 1070 Brussels |
| Belgium |

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Simplexx

15 mg/1,5 ml

solution for injection

subcutaneous use

Belgium

| NOVO NORDISK PHARMA SA |
| --- |
| Boulevard international 55 |
| 1070 Brussels |
| Belgium |

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Nordiflex

5 mg/1,5 mL

solution for injection

subcutaneous use

Belgium

| NOVO NORDISK PHARMA SA |
| --- |
| Boulevard international 55 |
| 1070 Brussels |
| Belgium |

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Nordiflex

10 mg/1,5 mL

solution for injection

subcutaneous use

Belgium

| NOVO NORDISK PHARMA SA |
| --- |
| Boulevard international 55 |
| 1070 Brussels |
| Belgium |

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Nordiflex

15 mg/1,5 mL

solution for injection

subcutaneous use

Belgium

| NOVO NORDISK PHARMA SA |
| --- |
| Boulevard international 55 |
| 1070 Brussels |
| Belgium |

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Flexpro

5 mg/1,5 mL

solution for injection

subcutaneous use

Belgium

| NOVO NORDISK PHARMA SA |
| --- |
| Boulevard international 55 |
| 1070 Brussels |
| Belgium |

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Flexpro

10 mg/1,5 mL

solution for injection

subcutaneous use

Belgium

| NOVO NORDISK PHARMA SA |
| --- |
| Boulevard international 55 |
| 1070 Brussels |
| Belgium |

NOVO NORDISK PHARMA SA

Boulevard international 55

1070 Brussels

Belgium

Norditropin Flexpro

15 mg/1,5 mL

solution for injection

subcutaneous use

Bulgaria

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

5 mg/1,5 mL

solution for injection

subcutaneous use

Cyprus

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SIMPLEXx SOLUTION FOR INJECTION 5 MG/1,5 ML

5 mg/1,5 mL

solution for injection

subcutaneous use

Cyprus

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SIMPLEXx SOLUTION FOR INJECTION 10 MG/1,5 ML

10 mg/1,5 mL

solution for injection

subcutaneous use

Cyprus

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SIMPLEXx SOLUTION FOR INJECTION 15 MG/1,5 ML

15 mg/1,5 mL

solution for injection

subcutaneous use

Cyprus

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN FLEXPRO SOLUTION FOR INJECTION 5 mg/1,5 ml

5 mg/1,5 mL

solution for injection

subcutaneous use

Cyprus

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN FLEXPRO SOLUTION FOR INJECTION 10 mg/1,5 ml

10 mg/1,5 mL

solution for injection

subcutaneous use

Cyprus

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN FLEXPRO SOLUTION FOR INJECTION 15 mg/1,5 ml

15 mg/1,5 mL

solution for injection

subcutaneous use

Czech Republic

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx 5 mg/1,5 ml

5 mg/1,5 mL

solution for injection

subcutaneous use

Czech Republic

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx 10 mg/1,5 ml

10 mg/1,5 mL

solution for injection

subcutaneous use

Czech Republic

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx 15 mg/1,5 ml

15 mg/1,5 mL

solution for injection

subcutaneous use

Czech Republic

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro 5 mg/1,5 ml

5 mg/1,5 mL

solution for injection

subcutaneous use

Czech Republic

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro 10 mg/1,5 ml

10 mg/1,5 mL

solution for injection

subcutaneous use

Czech Republic

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro 15 mg/1,5 ml

15 mg/1,5 mL

solution for injection

subcutaneous use

Denmark

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

5 mg/1,5 mL

solution for injection

subcutaneous use

Denmark

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

10 mg/1,5 mL

solution for injection

subcutaneous use

Denmark

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

15 mg/1,5 mL

solution for injection

subcutaneous use

Denmark

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin NordiFlex

5 mg/1,5 mL

solution for injection, prefilled pen

subcutaneous use

Denmark

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin NordiFlex

10 mg/1,5 mL

solution for injection, prefilled pen

subcutaneous use

Denmark

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin NordiFlex

15 mg/1,5 mL

solution for injection, prefilled pen

subcutaneous use

Denmark

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin Flexpro

5 mg/1,5 mL

solution for injection, prefilled pen

subcutaneous use

Denmark

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin Flexpro

10 mg/1,5 mL

solution for injection, prefilled pen

subcutaneous use

Denmark

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin Flexpro

15 mg/1,5 mL

solution for injection, prefilled pen

subcutaneous use

Finland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin Simplexx

5 mg/1,5 mL

solution for injection

subcutaneous use

Finland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin Simplexx

10 mg/1,5 mL

solution for injection

subcutaneous use

Finland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin Simplexx

15 mg/1,5 mL

solution for injection

subcutaneous use

Finland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin Nordiflex

5 mg/1,5 mL

solution for injection in pre-filled pen

subcutaneous use

Finland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin Nordiflex

10 mg/1,5 mL

solution for injection in pre-filled pen

subcutaneous use

Finland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin Nordiflex

15 mg/1,5 mL

solution for injection in pre-filled pen

subcutaneous use

Finland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin Flexpro

5 mg/1,5 mL

solution for injection in pre-filled pen

subcutaneous use

Finland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin Flexpro

10 mg/1,5 mL

solution for injection in pre-filled pen

subcutaneous use

Finland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin Flexpro

15 mg/1,5 mL

solution for injection in pre-filled pen

subcutaneous use

France

| Novo Nordisk, Coeur Défense – |
| --- |
| 100, avenue du Général de Gaulle – |
| 92400 Courbevoie |
| France |

Novo Nordisk, Coeur Défense –

100, avenue du Général de Gaulle –

92400 Courbevoie

France

NORDITROPINE SIMPLEXX 5 mg/1,5 ml, solution injectable

5 mg/1,5 mL

solution for injection

subcutaneous use

France

| Novo Nordisk, Coeur Défense – |
| --- |
| 100, avenue du Général de Gaulle – |
| 92400 Courbevoie |
| France |

Novo Nordisk, Coeur Défense –

100, avenue du Général de Gaulle –

92400 Courbevoie

France

NORDITROPINE SIMPLEXX 10 mg/1,5 ml, solution injectable

10 mg/1,5 mL

solution for injection

subcutaneous use

France

| Novo Nordisk, Coeur Défense – |
| --- |
| 100, avenue du Général de Gaulle – |
| 92400 Courbevoie |
| France |

Novo Nordisk, Coeur Défense –

100, avenue du Général de Gaulle –

92400 Courbevoie

France

NORDITROPINE SIMPLEXX 15 mg/1,5 ml, solution injectable

15 mg/1,5 mL

solutrion for injection

subcutaneous use

France

| Novo Nordisk, Coeur Défense – |
| --- |
| 100, avenue du Général de Gaulle – |
| 92400 Courbevoie |
| France |

Novo Nordisk, Coeur Défense –

100, avenue du Général de Gaulle –

92400 Courbevoie

France

NORDITROPINE NORDIFLEX 5 mg/1,5 ml, solution injectable en stylo prérempli

5 mg/1,5 mL

solution for injection in pre-filled pen

subcutaneous use

France

| Novo Nordisk, Coeur Défense – |
| --- |
| 100, avenue du Général de Gaulle – |
| 92400 Courbevoie |
| France |

Novo Nordisk, Coeur Défense –

100, avenue du Général de Gaulle –

92400 Courbevoie

France

NORDITROPINE NORDIFLEX 10 mg/1,5 ml, solution injectable en stylo prérempli

10 mg/1,5 mL

solution for injection in pre-filled pen

subcutaneous use

France

| Novo Nordisk, Coeur Défense – |
| --- |
| 100, avenue du Général de Gaulle – |
| 92400 Courbevoie |
| France |

Novo Nordisk, Coeur Défense –

100, avenue du Général de Gaulle –

92400 Courbevoie

France

NORDITROPINE NORDIFLEX 15 mg/1,5 ml, solution injectable en stylo prérempli

15 mg/1,5 mL

solution for injection in pre-filled pen

subcutaneous use

France

| Novo Nordisk, Coeur Défense – |
| --- |
| 100, avenue du Général de Gaulle – |
| 92400 Courbevoie |
| France |

Novo Nordisk, Coeur Défense –

100, avenue du Général de Gaulle –

92400 Courbevoie

France

NORDITROPINE FLEXPRO 5 mg/1,5 ml, solution injectable en stylo prérempli

5 mg/1,5 mL

solution for injection in pre-filled pen

subcutaneous use

France

| Novo Nordisk, Coeur Défense – |
| --- |
| 100, avenue du Général de Gaulle – |
| 92400 Courbevoie |
| France |

Novo Nordisk, Coeur Défense –

100, avenue du Général de Gaulle –

92400 Courbevoie

France

NORDITROPINE FLEXPRO 10 mg/1,5 ml, solution injectable en stylo prérempli

10 mg/1,5 mL

solution for injection in pre-filled pen

subcutaneous use

France

| Novo Nordisk, Coeur Défense – |
| --- |
| 100, avenue du Général de Gaulle – |
| 92400 Courbevoie |
| France |

Novo Nordisk, Coeur Défense –

100, avenue du Général de Gaulle –

92400 Courbevoie

France

NORDITROPINE FLEXPRO 15 mg/1,5 ml, solution injectable en stylo prérempli

15 mg/1,5 mL

solution for injection in pre-filled pen

subcutaneous use

Germany

| Novo Nordisk Pharma GmbH |
| --- |
| Brucknerstr. 1 |
| D-55127 Mainz |
| Germany |

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Germany

Norditropin Simplexx 5 mg/1,5 ml Injektionslösung

5 mg/1,5 mL

solution for injection

subcutaneous use

Germany

| Novo Nordisk Pharma GmbH |
| --- |
| Brucknerstr. 1 |
| D-55127 Mainz |
| Germany |

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Germany

Norditropin Simplexx 10 mg/1,5 ml Injektionslösung

10 mg/1,5 mL

solution for injection

subcutaneous use

Germany

| Novo Nordisk Pharma GmbH |
| --- |
| Brucknerstr. 1 |
| D-55127 Mainz |
| Germany |

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Germany

Norditropin Simplexx 15 mg/1,5 ml Injektionslösung

15 mg/1,5 mL

solution for injection

subcutaneous use

Germany

| Novo Nordisk Pharma GmbH |
| --- |
| Brucknerstr. 1 |
| D-55127 Mainz |
| Germany |

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Germany

Norditropin NordiFlex 5 mg/1,5 ml Injektionslöung in einem Fertigpen

5 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Germany

| Novo Nordisk Pharma GmbH |
| --- |
| Brucknerstr. 1 |
| D-55127 Mainz |
| Germany |

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Germany

Norditropin NordiFlex 10 mg/1,5 ml Injektionslöung in einem Fertigpen

10 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Germany

| Novo Nordisk Pharma GmbH |
| --- |
| Brucknerstr. 1 |
| D-55127 Mainz |
| Germany |

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Germany

Norditropin NordiFlex 15 mg/1,5 ml Injektionslöung in einem Fertigpen

15 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Germany

| Novo Nordisk Pharma GmbH |
| --- |
| Brucknerstr. 1 |
| D-55127 Mainz |
| Germany |

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Germany

Norditropin FlexPro 5 mg/1,5 ml Injektionslösung in einem Fertigpen

5 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Germany

| Novo Nordisk Pharma GmbH |
| --- |
| Brucknerstr. 1 |
| D-55127 Mainz |
| Germany |

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Germany

Norditropin FlexPro 10 mg/1,5 ml Injektionslösung in einem Fertigpen

10 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Germany

| Novo Nordisk Pharma GmbH |
| --- |
| Brucknerstr. 1 |
| D-55127 Mainz |
| Germany |

Novo Nordisk Pharma GmbH

Brucknerstr. 1

D-55127 Mainz

Germany

Norditropin FlexPro 15 mg/1,5 ml Injektionslösung in einem Fertigpen

15 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Greece

| Novo Nordisk Hellas Ltd. |
| --- |
| A. Panagouli 80 & Aghias Triados 65. |
| 153 43 Aghia Paraskevi, |
| Athens |
| Greece |

Novo Nordisk Hellas Ltd.

A. Panagouli 80 & Aghias Triados 65.

153 43 Aghia Paraskevi,

Athens

Greece

Norditropin SimpleXx 5 mg/1,5 mL cartridge

5 mg/1,5 mL

solution for injection

subcutaneous use

Greece

| Novo Nordisk Hellas Ltd. |
| --- |
| A. Panagouli 80 & Aghias Triados 65. |
| 153 43 Aghia Paraskevi, |
| Athens |
| Greece |

Novo Nordisk Hellas Ltd.

A. Panagouli 80 & Aghias Triados 65.

153 43 Aghia Paraskevi,

Athens

Greece

Norditropin SimpleXx 10 mg/1,5 mL cartridge

10 mg/1,5 mL

solution for injection

subcutaneous use

Greece

| Novo Nordisk Hellas Ltd. |
| --- |
| A. Panagouli 80 & Aghias Triados 65. |
| 153 43 Aghia Paraskevi, |
| Athens |
| Greece |

Novo Nordisk Hellas Ltd.

A. Panagouli 80 & Aghias Triados 65.

153 43 Aghia Paraskevi,

Athens

Greece

Norditropin SimpleXx 15 mg/1,5 mL cartridge

15 mg/1,5 mL

solution for injection

subcutaneous use

Greece

| Novo Nordisk Hellas Ltd. |
| --- |
| A. Panagouli 80 & Aghias Triados 65. |
| 153 43 Aghia Paraskevi, |
| Athens |
| Greece |

Novo Nordisk Hellas Ltd.

A. Panagouli 80 & Aghias Triados 65.

153 43 Aghia Paraskevi,

Athens

Greece

Norditropin FlexPro 5 mg/1,5 mL

5 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Greece

| Novo Nordisk Hellas Ltd. |
| --- |
| A. Panagouli 80 & Aghias Triados 65. |
| 153 43 Aghia Paraskevi, |
| Athens |
| Greece |

Novo Nordisk Hellas Ltd.

A. Panagouli 80 & Aghias Triados 65.

153 43 Aghia Paraskevi,

Athens

Greece

Norditropin FlexPro 10 mg/1,5 mL

10 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Greece

| Novo Nordisk Hellas Ltd. |
| --- |
| A. Panagouli 80 & Aghias Triados 65. |
| 153 43 Aghia Paraskevi, |
| Athens |
| Greece |

Novo Nordisk Hellas Ltd.

A. Panagouli 80 & Aghias Triados 65.

153 43 Aghia Paraskevi,

Athens

Greece

Norditropin FlexPro 15 mg/1,5 mL

15 mg/1,5 mL

solution for injection, in pre-filled pen

subcutaneous use

Hungary

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SimpleXx 5 mg/1,5 ml oldatos injekció

5 mg/1,5 mL

solution for injection

subcutaneous use

Hungary

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SimpleXx 10 mg/1,5 ml oldatos injekció

10 mg/1,5 mL

solution for injection

subcutaneous use

Hungary

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SimpleXx 15 mg/1,5 ml oldatos injekció

15 mg/1,5 mL

solution for injection

subcutaneous use

Hungary

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN FlexPro 5 mg/1,5 ml oldatos injekció előretöltött injekciós tollban

5 mg/1,5 mL

solution for injection (in prefilled pen)

subcutaneous use

Hungary

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN FlexPro 10 mg/1,5 ml oldatos injekció előretöltött injekciós tollban

10 mg/1,5 mL

solution for injection (in prefilled pen)

subcutaneous use

Hungary

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN FlexPro 15 mg/1,5 ml oldatos injekció előretöltött injekciós tollban

15 mg/1,5 mL

solution for injection (in prefilled pen)

subcutaneous use

Ireland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx 5 mg/1,5 ml, solution for injection, in pre-filled pen

5 mg/1,5 mL

solution for injection

subcutaneous use

Ireland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx 10 mg/1,5 ml, solution for injection, in pre-filled pen

10 mg/1,5 mL

solution for injection

subcutaneous use

Ireland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx 15 mg/1,5 ml, solution for injection, in pre-filled pen

15 mg/1,5 mL

solution for injection

subcutaneous use

Ireland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin NordiFlex 5 mg/1,5 ml, solution for injection, in pre-filled pen

5 mg/1,5 mL

solution for injection

subcutaneous use

Ireland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin NordiFlex 10 mg/1,5 ml, solution for injection, in pre-filled pen

10 mg/1,5 mL

solution for injection

subcutaneous use

Ireland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin NordiFlex 15 mg/1,5 ml, solution for injection, in pre-filled pen

15 mg/1,5 ml

solution for injection

subcutaneous use

Ireland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro 5 mg/1,5 ml Solution for Injection, Pre-filled Pen

5 mg/1,5 ml

solution for injection

subcutaneous use

Ireland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro 10 mg/1,5 ml Solution for Injection, Pre-filled Pen

10 mg/1,5 ml

solution for injection

subcutaneous use

Ireland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro 15 mg/1,5 ml, solution for injection, pre-filled pen

15 mg/1,5 ml

solution for injection

subcutaneous use

Italy

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SIMPLEXX

5 mg/1,5 ml

solution for injection

subcutaneous use

Italy

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SIMPLEXX

10 mg/1,5 ml

solution for injection

subcutaneous use

Italy

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SIMPLEXX

15 mg/1,5 ml

solution for injection

subcutaneous use

Italy

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN NORDIFLEX

5 mg/1,5 ml

solution for injection in pre-filled syringe

subcutaneous use

Italy

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN NORDIFLEX

10 mg/1,5 ml

solution for injection in pre-filled syringe

subcutaneous use

Italy

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN NORDIFLEX

15 mg/1,5 ml

solution for injection in pre-filled syringe

subcutaneous use

Italy

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN FLEXPRO

5 mg/1,5 ml

solution for injection in pre-filled pen

subcutaneous use

Italy

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN FLEXPRO

10 mg/1,5 ml

solution for injection in pre-filled pen

subcutaneous use

Italy

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN FLEXPRO

15 mg/1,5 ml

solution for injection in pre-filled pen

subcutaneous use

Lithuania

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin Simplexx

10 mg/1,5 ml

solution for injection

subcutaneous use

Lithuania

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

5 mg/1,5 ml

solution for injection

subcutaneous use

Lithuania

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro

10 mg/1,5 ml

solution for injection in pre-filled pen

subcutaneous use

Lithuania

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro

5 mg/1,5 ml

solution for injection in pre-filled pen

subcutaneous use

Luxembourg

| Novo Nordisk Pharma |
| --- |
| Riverside Business Park |
| B-1070 Bruxelles |
| Belgium |

Novo Nordisk Pharma

Riverside Business Park

B-1070 Bruxelles

Belgium

Norditropin Simplexx

5 mg/1,5 mL

solution for injection

subcutaneous use

Luxembourg

| Novo Nordisk Pharma |
| --- |
| Riverside Business Park |
| B-1070 Bruxelles |
| Belgium |

Novo Nordisk Pharma

Riverside Business Park

B-1070 Bruxelles

Belgium

Norditropin Simplexx

10 mg/1,5 mL

solution for injection

subcutaneous use

Luxembourg

| Novo Nordisk Pharma |
| --- |
| Riverside Business Park |
| B-1070 Bruxelles |
| Belgium |

Novo Nordisk Pharma

Riverside Business Park

B-1070 Bruxelles

Belgium

Norditropin Simplexx

15 mg/1,5 mL

solution for injection

subcutaneous use

Luxembourg

| Novo Nordisk Pharma |
| --- |
| Riverside Business Park |
| B-1070 Bruxelles |
| Belgium |

Novo Nordisk Pharma

Riverside Business Park

B-1070 Bruxelles

Belgium

Norditropin Nordiflex

5 mg/1,5 mL

solution for injection

subcutaneous use

Luxembourg

| Novo Nordisk Pharma |
| --- |
| Riverside Business Park |
| B-1070 Bruxelles |
| Belgium |

Novo Nordisk Pharma

Riverside Business Park

B-1070 Bruxelles

Belgium

Norditropin Nordiflex

10 mg/1,5 mL

solution for injection

subcutaneous use

Luxembourg

| Novo Nordisk Pharma |
| --- |
| Riverside Business Park |
| B-1070 Bruxelles |
| Belgium |

Novo Nordisk Pharma

Riverside Business Park

B-1070 Bruxelles

Belgium

Norditropin Nordiflex

15 mg/1,5 mL

solution for injection

subcutaneous use

Malta

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

5 mg/1,5 mL

solution for injeciton

subcutaneous use

Malta

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

10 mg/1,5 mL

solution for injeciton

subcutaneous use

Malta

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro

5 mg/1,5 ml

solution for injection, in a pre-filled pen

subcutaneous use

Malta

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro

10 mg/1,5 ml

solution for injection, in a pre-filled pen

subcutaneous use

The Netherlands

| Novo Nordisk B.V. |
| --- |
| Flemingweg 18, |
| 2408 AV ALPHEN A/D RIJN |
| The Netherlands |

Novo Nordisk B.V.

Flemingweg 18,

2408 AV ALPHEN A/D RIJN

The Netherlands

Norditropin SimpleXx

5 mg/1,5 mL

solution for injection (oplossing voor injectie)

subcutaneous use

The Netherlands

| Novo Nordisk B.V. |
| --- |
| Flemingweg 18, |
| 2408 AV ALPHEN A/D RIJN |
| The Netherlands |

Novo Nordisk B.V.

Flemingweg 18,

2408 AV ALPHEN A/D RIJN

The Netherlands

Norditropin SimpleXx

10 mg/1,5 mL

solution for injection (oplossing voor injectie)

subcutaneous use

The Netherlands

| Novo Nordisk B.V. |
| --- |
| Flemingweg 18, |
| 2408 AV ALPHEN A/D RIJN |
| The Netherlands |

Novo Nordisk B.V.

Flemingweg 18,

2408 AV ALPHEN A/D RIJN

The Netherlands

Norditropin SimpleXx

15 mg/1,5 mL

solution for injection (oplossing voor injectie)

subcutaneous use

The Netherlands

| Novo Nordisk B.V. |
| --- |
| Flemingweg 18, |
| 2408 AV ALPHEN A/D RIJN |
| The Netherlands |

Novo Nordisk B.V.

Flemingweg 18,

2408 AV ALPHEN A/D RIJN

The Netherlands

Norditropin FlexPro

5 mg/1,5 mL

solution for injection in pre-filled syringe (oplossing voor injectie in een voorgevulde) pen

subcutaneous use

The Netherlands

| Novo Nordisk B.V. |
| --- |
| Flemingweg 18, |
| 2408 AV ALPHEN A/D RIJN |
| The Netherlands |

Novo Nordisk B.V.

Flemingweg 18,

2408 AV ALPHEN A/D RIJN

The Netherlands

Norditropin FlexPro

10 mg/1,5 mL

solution for injection in pre-filled syringe (oplossing voor injectie in een voorgevulde) pen

subcutaneous use

The Netherlands

| Novo Nordisk B.V. |
| --- |
| Flemingweg 18, |
| 2408 AV ALPHEN A/D RIJN |
| The Netherlands |

Novo Nordisk B.V.

Flemingweg 18,

2408 AV ALPHEN A/D RIJN

The Netherlands

Norditropin FlexPro

15 mg/1,5 mL

solution for injection in pre-filled syringe (oplossing voor injectie in een voorgevulde) pen

subcutaneous use

Poland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

5 mg/1,5 mL

solution for injection

subcutaneous use

Poland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

10 mg/1,5 mL

solution for injection

subcutaneous use

Poland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro

5 mg/1,5 mL

solution for injection in pre-filled pen

subcutaneous use

Portugal

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

5 mg/1,5 ml

solution for injection

subcutaneous use

Portugal

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

10 mg/1,5 ml

solution for injection

subcutaneous use

Portugal

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

15 mg/1,5 ml

solution for injection

subcutaneous use

Portugal

| Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda. Quinta da Fonte – |
| --- |
| Edifício D. José - Piso 1, |
| 2780-730 Paço d’ Arcos |
| Portugal |

Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda. Quinta da Fonte –

Edifício D. José - Piso 1,

2780-730 Paço d’ Arcos

Portugal

Norditropin Nordiflex

5 mg/1,5 ml

solution for injection

subcutaneous use

Portugal

| Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda. Quinta da Fonte – |
| --- |
| Edifício D. José - Piso 1, |
| 2780-730 Paço d’ Arcos |
| Portugal |

Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda. Quinta da Fonte –

Edifício D. José - Piso 1,

2780-730 Paço d’ Arcos

Portugal

Norditropin Nordiflex

10 mg/1,5 ml

solution for injection

subcutaneous use

Portugal

| Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda. Quinta da Fonte – |
| --- |
| Edifício D. José - Piso 1, |
| 2780-730 Paço d’ Arcos |
| Portugal |

Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda. Quinta da Fonte –

Edifício D. José - Piso 1,

2780-730 Paço d’ Arcos

Portugal

Norditropin Nordiflex

15 mg/1,5 ml

solution for injection

subcutaneous use

Portugal

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro

5 mg/1,5 ml

solution for injection in pre-filled pen

subcutaneous use

Portugal

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro

10 mg/1,5 ml

solution for injection in pre-filled pen

subcutaneous use

Portugal

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro

15 mg/1,5 ml

solution for injection in pre-filled pen

subcutaneous use

Romania

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

5 mg/1,5 ml

solution for injection

subcutaneous use

Romania

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

10 mg/1,5 ml

solution for injection

subcutaneous use

Romania

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro

5 mg/1,5 ml

solution for injection in pre-filled pen

subcutaneous use

Romania

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro

10 mg/1,5 ml

solution for injection in pre-filled pen

subcutaneous use

Slovakia

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

5 mg/1,5 mL

solution for injection

subcutaneous use

Slovakia

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx

10 mg/1,5 mL

solution for injection

subcutaneous use

Slovakia

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro

5 mg/1,5 mL

solution for injection

subcutaneous use

Slovakia

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro

10 mg/1,5 mL

solution for injection

subcutaneous use

Slovenia

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx 5 mg/1,5 ml raztopina za injiciranje v injekcijskem vložku

5 mg/1,5 mL

solution for injection

subcutaneous use

Slovenia

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx 10 mg/1,5 ml raztopina za injiciranje v injekcijskem vložku

10 mg/1,5 mL

solution for injection

subcutaneous use

Slovenia

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin SimpleXx 15 mg/1,5 ml raztopina za injiciranje v injekcijskem vložku

15 mg/1,5 mL

solution for injection

subcutaneous use

Slovenia

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro 5 mg/1,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku

5 mg/1,5 mL

solution for injection in pre-filed pen

subcutaneous use

Slovenia

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro 10 mg/1,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku

10 mg/1,5 mL

solution for injection in pre-filed pen

subcutaneous use

Slovenia

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin FlexPro 15 mg/1,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku

15 mg/1,5 mL

solution for injection in pre-filed pen

subcutaneous use

Spain

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SIMPLEXx 5 mg/1,5 ml solución inyectable

5 mg/1,5 mL

solution for injection

subcutaneous use

Spain

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SIMPLEXx 10 mg/1,5 ml solución inyectable

10 mg/1,5 mL

solution for injection

subcutaneous use

Spain

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN SIMPLEXx 15 mg/1,5 ml solución inyectable

15 mg/1,5 mL

solution for injection

subcutaneous use

Spain

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN NORDIFLEX 5 mg/1,5 ml solución inyectable

5 mg/1,5 mL

solution for injection

subcutaneous use

Spain

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN NORDIFLEX 10 mg/1,5 ml solución inyectable

10 mg/1,5 mL

solution for injection

subcutaneous use

Spain

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN NORDIFLEX 15 mg/1,5 ml solución inyectable

15 mg/1,5 mL

solution for injection

subcutaneous use

Spain

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN FLEXPRO 5 mg/1,5 ml

5 mg/1,5 ml

solution for injection

subcutaneous use

Spain

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN FLEXPRO 10 mg/1,5 ml

10 mg/1,5 ml

solution for injection

subcutaneous use

Spain

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

NORDITROPIN FLEXPRO 15 mg/1,5 ml

15 mg/1,5 ml

solution for injection

subcutaneous use

Sweden

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin® SimpleXx®

5 mg/1,5 ml

solution for injection

subcutaneous use

Sweden

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin® SimpleXx®

10 mg/1,5 ml

solution for injection

subcutaneous use

Sweden

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin® SimpleXx®

15 mg/1,5 ml

solution for injection

subcutaneous use

Sweden

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin NordiFlex®

5 mg/1,5 ml

solution for injection, pre-filled pen

subcutaneous use

Sweden

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin NordiFlex®

10 mg/1,5 ml

solution for injection, pre-filled pen

subcutaneous use

Sweden

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Norditropin NordiFlex®

15 mg/1,5 ml

solution for injection, pre-filled pen

subcutaneous use

Sweden

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Somatropin Novo Nordisk

5 mg/1,5 ml

solution for injection, pre-filled pen

subcutaneous use

Sweden

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Somatropin Novo Nordisk

10 mg/1,5 ml

solution for injection, pre-filled pen

subcutaneous use

Sweden

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsvaerd |
| Denmark |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Somatropin Novo Nordisk

15 mg/1,5 ml

solution for injection, pre-filled pen

subcutaneous use

United Kingdom

| Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, |
| --- |
| West Sussex |
| RH11 9RT |
| United Kingdom |

Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,

West Sussex

RH11 9RT

United Kingdom

Norditropin SimpleXx

5 mg/1,5 ml

solution for injection

subcutaneous use

United Kingdom

| Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, |
| --- |
| West Sussex |
| RH11 9RT |
| United Kingdom |

Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,

West Sussex

RH11 9RT

United Kingdom

Norditropin SimpleXx

10 mg/1,5 ml

solution for injection

subcutaneous use

United Kingdom

| Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, |
| --- |
| West Sussex |
| RH11 9RT |
| United Kingdom |

Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,

West Sussex

RH11 9RT

United Kingdom

Norditropin SimpleXx

15 mg/1,5 mL

solution for injection

subcutaneous use

United Kingdom

| Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, |
| --- |
| West Sussex |
| RH11 9RT |
| United Kingdom |

Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,

West Sussex

RH11 9RT

United Kingdom

Norditropin Nordiflex 5 mg/1,5 ml

5 mg/1,5 mL

solution for injection

subcutaneous use

United Kingdom

| Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, |
| --- |
| West Sussex |
| RH11 9RT |
| United Kingdom |

Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,

West Sussex

RH11 9RT

United Kingdom

Norditropin Nordiflex 10 mg/1,5 ml

10 mg/1,5 mL

solution for injection

subcutaneous use

United Kingdom

| Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, |
| --- |
| West Sussex |
| RH11 9RT |
| United Kingdom |

Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,

West Sussex

RH11 9RT

United Kingdom

Norditropin Nordiflex 15 mg/1,5 ml

15 mg/1,5 mL

solution for injection

subcutaneous use

United Kingdom

| Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, |
| --- |
| West Sussex |
| RH11 9RT |
| United Kingdom |

Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,

West Sussex

RH11 9RT

United Kingdom

Norditropin Flexpro

5 mg/1,5 mL

solution for injection

subcutaneous use

United Kingdom

| Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, |
| --- |
| West Sussex |
| RH11 9RT |
| United Kingdom |

Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,

West Sussex

RH11 9RT

United Kingdom

Norditropin Flexpro

10 mg/1,5 mL

solution for injection

subcutaneous use

United Kingdom

| Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, |
| --- |
| West Sussex |
| RH11 9RT |
| United Kingdom |

Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley,

West Sussex

RH11 9RT

United Kingdom

Norditropin Flexpro

15 mg/1,5 mL

solution for injection

subcutaneous use

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