# Official Journal C 318/25 S

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 318 |
| | |
| English edition | Information and Notices | Volume 5825 September 2015 |

ISSN 1977-091X

Official Journal

of the European Union

C 318

English edition

Information and Notices

Volume 5825 September 2015

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2015/C 318/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2015 to 31 August 2015(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2015/C 318/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2015 to 31 August 2015(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 8 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2015/C 318/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2015 to 31 August 2015(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

2015/C 318/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2015 to 31 August 2015(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)

8

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 25.9.2015 | EN | Official Journal of the European Union | C 318/1 |
| --- | --- | --- | --- |

25.9.2015

EN

Official Journal of the European Union

C 318/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2015 to 31 August 2015

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

(2015/C 318/01)

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.8.2015 | Odomzo | sonidegib | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1030 | Capsule, hard | L01XX48 | 18.8.2015 |
| 14.8.2015 | Unituxin | dinutuximab | United Therapeutics Europe Ltd
  Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom | EU/1/15/1022 | Concentrate for solution for infusion | L01XC16 | 18.8.2015 |
| 20.8.2015 | Aripiprazole Sandoz | Aripiprazole | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/15/1029 | Tablet | N05AX12 | 24.8.2015 |
| 20.8.2015 | Duloxetine Zentiva | duloxetine | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1028 | Gastro-resistant capsule, hard | N06AX21 | 25.8.2015 |
| 20.8.2015 | Respreeza | human alpha1-proteinase inhibitor | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/15/1006 | Powder and solvent for solution for infusion | B02AB02 | 25.8.2015 |
| 28.8.2015 | Docetaxel Hospira UK Limited | docetaxel | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/15/1017 | Concentrate for solution for infusion | L01CD02 | 1.9.2015 |
| 28.8.2015 | Farydak | panobinostat | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1023 | Capsule, hard | L01XX42 | 1.9.2015 |
| 28.8.2015 | Kanuma | sebelipase alfa | Synageva BioPharma Ltd
  1A Local Board Road, Watford, Hertfordshire WD 17 2JP, United Kingdom | EU/1/15/1033 | Concentrate and solvent for solution for infusion | Pending | 1.9.2015 |
| 28.8.2015 | Pregabalin Accord | pregabalin | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1027 | Capsule, hard | N03AX16 | 1.9.2015 |
| 28.8.2015 | Strensiq | asfotase alfa | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/15/1015 | Solution for injection | Pending | 1.9.2015 |

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

14.8.2015

Odomzo

sonidegib

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1030

Capsule, hard

L01XX48

18.8.2015

14.8.2015

Unituxin

dinutuximab

United Therapeutics Europe Ltd

Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom

EU/1/15/1022

Concentrate for solution for infusion

L01XC16

18.8.2015

20.8.2015

Aripiprazole Sandoz

Aripiprazole

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/15/1029

Tablet

N05AX12

24.8.2015

20.8.2015

Duloxetine Zentiva

duloxetine

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1028

Gastro-resistant capsule, hard

N06AX21

25.8.2015

20.8.2015

Respreeza

human alpha1-proteinase inhibitor

CSL Behring GmbH

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

EU/1/15/1006

Powder and solvent for solution for infusion

B02AB02

25.8.2015

28.8.2015

Docetaxel Hospira UK Limited

docetaxel

Hospira UK Limited

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

EU/1/15/1017

Concentrate for solution for infusion

L01CD02

1.9.2015

28.8.2015

Farydak

panobinostat

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1023

Capsule, hard

L01XX42

1.9.2015

28.8.2015

Kanuma

sebelipase alfa

Synageva BioPharma Ltd

1A Local Board Road, Watford, Hertfordshire WD 17 2JP, United Kingdom

EU/1/15/1033

Concentrate and solvent for solution for infusion

Pending

1.9.2015

28.8.2015

Pregabalin Accord

pregabalin

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/15/1027

Capsule, hard

N03AX16

1.9.2015

28.8.2015

Strensiq

asfotase alfa

Alexion Europe SAS

1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

EU/1/15/1015

Solution for injection

Pending

1.9.2015

—   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 |
| --- | --- | --- | --- | --- |
| 6.8.2015 | Aerius | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/160 | 10.8.2015 |
| 6.8.2015 | Azomyr | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/157 | 10.8.2015 |
| 6.8.2015 | IDflu | Sanofi Pasteur SA
  2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/08/507 | 10.8.2015 |
| 6.8.2015 | Intanza | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/08/505 | 10.8.2015 |
| 12.8.2015 | Cyanokit | SERB S.A.
  Avenue Louise 480, 1050 Brussels, Belgique | EU/1/07/420 | 14.8.2015 |
| 12.8.2015 | Retacrit | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/07/431 | 14.8.2015 |
| 14.8.2015 | Cialis | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/02/237 | 18.8.2015 |
| 14.8.2015 | Komboglyze | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/731 | 18.8.2015 |
| 14.8.2015 | Norvir | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/96/016 | 18.8.2015 |
| 20.8.2015 | Adcirca | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/08/476 | 24.8.2015 |
| 20.8.2015 | BeneFIX | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/97/047 | 24.8.2015 |
| 20.8.2015 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/11/691 | 24.8.2015 |
| 20.8.2015 | Entyvio | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/923 | 24.8.2015 |
| 20.8.2015 | Eporatio | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/573 | 24.8.2015 |
| 20.8.2015 | Fareston | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/96/004 | 24.8.2015 |
| 20.8.2015 | Infanrix hexa | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/00/152 | 1.9.2015 |
| 20.8.2015 | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/13/884 | 24.8.2015 |
| 20.8.2015 | Kalydeco | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/12/782 | 27.8.2015 |
| 20.8.2015 | Keppra | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/00/146 | 24.8.2015 |
| 20.8.2015 | OLYSIO | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/924 | 24.8.2015 |
| 20.8.2015 | Qutenza | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/09/524 | 24.8.2015 |
| 20.8.2015 | Stayveer | Marklas Nederland B.V.
  Beneluxlaan 2b, NL-3446 GR Woerden, Nederland | EU/1/13/832 | 24.8.2015 |
| 20.8.2015 | Tracleer | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220 | 24.8.2015 |
| 20.8.2015 | Twynsta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/10/648 | 24.8.2015 |
| 20.8.2015 | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/918 | 24.8.2015 |
| 25.8.2015 | Adasuve | Ferrer Internacional S.A.
  Gran Via Carlos III, 94 08028 Barcelona Spain | EU/1/13/823 | 27.8.2015 |
| 25.8.2015 | Biopoin | Teva GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/565 | 27.8.2015 |
| 25.8.2015 | IDflu | Sanofi Pasteur SA
  2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/08/507 | 27.8.2015 |
| 25.8.2015 | Intanza | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/08/505 | 27.8.2015 |
| 25.8.2015 | Mekinist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/931 | 27.8.2015 |
| 25.8.2015 | Optaflu | Novartis Influenza Vaccines Marburg GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/07/394 | 27.8.2015 |
| 25.8.2015 | Revolade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/612 | 27.8.2015 |
| 25.8.2015 | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 27.8.2015 |
| 25.8.2015 | Temozolomide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/606 | 27.8.2015 |
| 25.8.2015 | Zykadia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/999 | 27.8.2015 |
| 28.8.2015 | Fluenz Tetra | MedImmune, LLC
  Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland | EU/1/13/887 | 1.9.2015 |

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

6.8.2015

Aerius

Merck Sharp & Dohme Limited

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

EU/1/00/160

10.8.2015

6.8.2015

Azomyr

Merck Sharp & Dohme Limited

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

EU/1/00/157

10.8.2015

6.8.2015

IDflu

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/08/507

10.8.2015

6.8.2015

Intanza

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/08/505

10.8.2015

12.8.2015

Cyanokit

SERB S.A.

Avenue Louise 480, 1050 Brussels, Belgique

EU/1/07/420

14.8.2015

12.8.2015

Retacrit

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

EU/1/07/431

14.8.2015

14.8.2015

Cialis

Eli Lilly Nederland B.V.

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

EU/1/02/237

18.8.2015

14.8.2015

Komboglyze

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/731

18.8.2015

14.8.2015

Norvir

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/96/016

18.8.2015

20.8.2015

Adcirca

Eli Lilly Nederland B.V.

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

EU/1/08/476

24.8.2015

20.8.2015

BeneFIX

Pfizer Limited

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

EU/1/97/047

24.8.2015

20.8.2015

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/11/691

24.8.2015

20.8.2015

Entyvio

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/923

24.8.2015

20.8.2015

Eporatio

ratiopharm GmbH

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

EU/1/09/573

24.8.2015

20.8.2015

Fareston

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/96/004

24.8.2015

20.8.2015

Infanrix hexa

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/00/152

1.9.2015

20.8.2015

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/13/884

24.8.2015

20.8.2015

Kalydeco

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/12/782

27.8.2015

20.8.2015

Keppra

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/00/146

24.8.2015

20.8.2015

OLYSIO

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/924

24.8.2015

20.8.2015

Qutenza

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/09/524

24.8.2015

20.8.2015

Stayveer

Marklas Nederland B.V.

Beneluxlaan 2b, NL-3446 GR Woerden, Nederland

EU/1/13/832

24.8.2015

20.8.2015

Tracleer

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/220

24.8.2015

20.8.2015

Twynsta

Boehringer Ingelheim International GmbH

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

EU/1/10/648

24.8.2015

20.8.2015

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/918

24.8.2015

25.8.2015

Adasuve

Ferrer Internacional S.A.

Gran Via Carlos III, 94 08028 Barcelona Spain

EU/1/13/823

27.8.2015

25.8.2015

Biopoin

Teva GmbH

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

EU/1/09/565

27.8.2015

25.8.2015

IDflu

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/08/507

27.8.2015

25.8.2015

Intanza

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/08/505

27.8.2015

25.8.2015

Mekinist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/931

27.8.2015

25.8.2015

Optaflu

Novartis Influenza Vaccines Marburg GmbH

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

EU/1/07/394

27.8.2015

25.8.2015

Revolade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/612

27.8.2015

25.8.2015

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/865

27.8.2015

25.8.2015

Temozolomide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/606

27.8.2015

25.8.2015

Zykadia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/999

27.8.2015

28.8.2015

Fluenz Tetra

MedImmune, LLC

Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland

EU/1/13/887

1.9.2015

—   Issuing 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 | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 28.8.2015 | Porcilis PCV ID | Porcine circovirus type 2 ORF2 subunit antigen | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/15/187 | Emulsion for injection | QI09AA07 | 1.9.2015 |

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

28.8.2015

Porcilis PCV ID

Porcine circovirus type 2 ORF2 subunit antigen

Intervet International B.V.

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

EU/2/15/187

Emulsion for injection

QI09AA07

1.9.2015

—   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 |
| --- | --- | --- | --- | --- |
| 6.8.2015 | Advocate | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/03/039 | 10.8.2015 |
| 20.8.2015 | Eurican Herpes 205 | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/01/029 | 24.8.2015 |
| 28.8.2015 | Equilis StrepE | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/04/043 | 1.9.2015 |
| 28.8.2015 | Fevaxyn Pentofel | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/96/002 | 1.9.2015 |

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

6.8.2015

Advocate

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/03/039

10.8.2015

20.8.2015

Eurican Herpes 205

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/01/029

24.8.2015

28.8.2015

Equilis StrepE

Intervet International B.V.

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

EU/2/04/043

1.9.2015

28.8.2015

Fevaxyn Pentofel

Zoetis Belgium S.A.

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

EU/2/96/002

1.9.2015

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.

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| 25.9.2015 | EN | Official Journal of the European Union | C 318/8 |
| --- | --- | --- | --- |

25.9.2015

EN

Official Journal of the European Union

C 318/8

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2015 to 31 August 2015

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

(2015/C 318/02)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 14.8.2015 | Adrenaline auto injectors | See Annex I | See Annex I | See Annex I | 17.8.2015 |
| 20.8.2015 | Amoxil and associated names | See Annex II | See Annex II | See Annex II | 21.8.2015 |
| 28.8.2015 | Coglapix suspension for injection for pigs | See Annex III | See Annex III | See Annex III | 31.8.2015 |
| 28.8.2015 | Bosentan | Bonentan | Not applicable | Not applicable | 1.9.2015 |
| 28.8.2015 | Sodium oxybate | Sodium oxybate | Not applicable | Not applicable | 31.8.2015 |

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

14.8.2015

Adrenaline auto injectors

See Annex I

See Annex I

See Annex I

17.8.2015

20.8.2015

Amoxil and associated names

See Annex II

See Annex II

See Annex II

21.8.2015

28.8.2015

Coglapix suspension for injection for pigs

See Annex III

See Annex III

See Annex III

31.8.2015

28.8.2015

Bosentan

Bonentan

Not applicable

Not applicable

1.9.2015

28.8.2015

Sodium oxybate

Sodium oxybate

Not applicable

Not applicable

31.8.2015

---

(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 form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the Member States

| Member State
  (in EEA) | Marketing authorisation holder | INN | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | Anapen Junior 150 Mikrogramm in 0,3 ml — Injektionslösung (Fertigspritze) | 150 Mikrogramm/0,3 ml | Solution for injection | Intramuscular use |
| Austria | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | Anapen 300 Mikrogramm in 0,3 ml — Injektionslösung (Fertigspritze) | 300 Mikrogramm/0,3 ml | Solution for injection | Intramuscular use |
| Austria | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | Anapen 500 Mikrogramm/0,3 ml Injektionslösung in einer Fertigspritze | 500 Mikrogramm/0,3 ml | Solution for injection | Intramuscular use |
| Austria | Meda Pharma GmbH
  Guglgasse 15
  1110 Wien
  Austria | Epinephrine | EpiPen Junior 150 Mikrogramm Injektionslösung in einem Fertigpen | 150 Mikrogramm | Solution for injection | Intramuscular use |
| Austria | Meda Pharma GmbH
  Guglgasse 15
  1110 Wien
  Austria | Epinephrine | EpiPen 300 Mikrogramm Injektionslösung in einem FertigPen | 300 Mikrogramm | Solution for injection | Intramuscular use |
| Austria | Alk Abello A/S
  Boge Alle 6-8
  2970 Horsholm
  Denmark | Epinephrine hydrotartrat | Jext 150 Mikrogramm Injektionslösung in einem Fertigpen | 150 Mikrogramm | Solution for injection | Intramuscular use |
| Austria | Alk Abello A/S
  Boge Alle 6-8
  2970 Horsholm
  Denmark | Epinephrine hydrotartrat | Jext 300 Mikrogramm Injektionslösung in einem Fertigpen | 300 Mikrogramm | Solution for injection | Intramuscular use |
| Belgium | Meda Pharma sa-nv
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Epinephrine | Epipen | 300 μg | Solution for injection | Intramuscular use |
| Belgium | Meda Pharma sa-nv
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Epinephrine | Epipen junior | 150 μg | Solution for injection | Intramuscular use |
| Belgium | ALK-Abello
  Boge Alle 6-8
  2970 Horsholm
  Denmark | Epinephrine Bitartrate | Jext | 150 μg | Solution for injection | Intramuscular use |
| Belgium | ALK-Abello
  Boge Alle 6-8
  2970 Horsholm
  Denmark | Epinephrine Bitartrate | Jext | 300 μg | Solution for injection | Intramuscular use |
| Bulgaria | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | Anapen Junior | 150 mcg/0,3 ml | Solution for injection | Intramuscular use |
| Bulgaria | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | Anapen | 300 mcg/0,3 ml | Solution for injection | Intramuscular use |
| Bulgaria | MEDA Pharma GmbH & Co. KG
  Benzstr. 1 + Bad Homburg
  61352 Germany | Adrenaline | EpiPen Jr. | 150 mcg/0,3 ml | Solution for injection | Intramuscular use |
| Bulgaria | MEDA Pharma GmbH & Co. KG
  Benzstr. 1 + Bad Homburg
  61352 Germany | Adrenaline | EpiPen | 300 mcg/0,3 ml | Solution for injection | Intramuscular use |
| Croatia | Medical Intertrade d.o.o.
  Dr Franje Tuđmana 3
  Sveta Nedjelja
  10431 Croatia | Epinephrine | EpiPen 0,3 mg otopina za injekciju | 0,3 mg | Solution for injection | Intramuscular use |
| Croatia | Medical Intertrade d.o.o.
  Dr Franje Tuđmana 3 Sveta Nedjelja
  10431 Croatia | Epinephrine | EpiPen Jr 0,15 mg otopina za injekciju | 0,15 mg | Solution for injection | Intramuscular use |
| Cyprus | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | Anapen | 300 mcg/0,3 ml | Solution for injection | Intramuscular use |
| Cyprus | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | Anapen Junior | 150 mcg/0,3 ml | Solution for injection | Intramuscular use |
| Czech Republic | MEDA Pharma s.r.o.
  Kodaňská 1441/46
  110 00 Prague 10
  Czech Republic | Epinephrine | Epipen 300 mikrogramů | 0,3 mg per dose (0,3 mg/0,3 ml) | Solution for injection in pre-filled pen | Intramuscular use |
| Czech Republic | MEDA Pharma s.r.o.
  Kodaňská 1441/46
  110 00 Prague 10
  Czech Republic | Epinephrine | Epipen JR. 150 mikrogramů | 0,15 mg per dose (0,15 mg/0,3 ml) | Solution for injection in pre-filled pen | Intramuscular use |
| Czech Republic | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | Anapen injekční roztok 300 mikrogramů/0,3 ml (předplněná injekční stříkačka) | 0,3 mg per dose (0,3 mg/0,3 ml) | Solution for injection | Intramuscular use |
| Czech Republic | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | Anapen Junior injekční roztok 150 mikrogramů/0,3 ml (předplněná injekční stříkačka) | 0,15 mg per dose (0,15 mg/0,3 ml) | Solution for injection | Intramuscular use |
| Denmark | Lincoln Medical Limited
  Unit 8 Wilton Business Centre Wilton Salisbury SP2 0AH United Kingdom | Adrenaline | Anapen | 300 mcg/0,3 ml | Solution for injection | Intramuscular use |
| Denmark | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | Anapen Junior | 150 mcg/0,3 ml | Solution for injection | Intramuscular use |
| Denmark | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Adrenaline | EpiPen | 0,3 mg/dose | Solution for injection | Intramuscular use |
| Denmark | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Adrenaline | EpiPen Jr. | 0,15 mg/dose | Solution for injection | Intramuscular use |
| Denmark | ALK-Abello A/S
  Bøge Alle 6-8
  DK-2970 Hørsholm
  Denmark | Adrenaline | Jext | 150 mcg | Solution for injection, pre-filled pen | Intramuscular use |
| Denmark | ALK-Abello A/S
  Bøge Alle 6-8
  DK-2970 Hørsholm Denmark | Adrenaline | Jext | 300 mcg | Solution for injection, pre-filled pen | Intramuscular use |
| Estonia | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | ANAPEN | 150 mcg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Estonia | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | ANAPEN | 300 mcg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Estonia | SIA Meda Pharma
  Vienibas gatve 109,
  Riga LV-1058
  Latvia | Epinephrine | EPIPEN | 150 mcg/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| Estonia | SIA Meda Pharma
  Vienibas gatve 109,
  Riga LV-1058
  Latvia | Epinephrine | EPIPEN | 300 mcg/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| Finland | Lincoln Medical Ltd
  Unit 8 Wilton Business
  Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | ANAPEN | 0,3 mg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Finland | Lincoln Medical Ltd
  Unit 8 Wilton Business
  Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | ANAPEN JUNIOR | 0,15 mg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Finland | Meda Oy
  Vaisalantie 4
  02130 Espoo
  Finland | Adrenaline | EPIPEN | 300 mikrog | Solution for injection in pre-filled pen | Intramuscular use |
| Finland | Meda Oy
  Vaisalantie 4
  02130 Espoo
  Finland | Adrenaline | EPIPEN JR. | 150 mikrog | Solution for injection in pre-filled pen | Intramuscular use |
| Finland | ALK-Abello A/S
  Bøge Alle 6-8
  B.O. BOX 408
  2970 Horsholm
  Denmark | Adrenaline tartrate | JEXT | 150 mikrog | Solution for injection in pre-filled pen | Intramuscular use |
| Finland | ALK-Abello A/S
  Bøge Alle 6-8
  B.O. BOX 408
  2970 Horsholm
  Denmark | Adrenaline tartrate | JEXT | 300 mikrog | Solution for injection in pre-filled pen | Intramuscular use |
| France | BIOPROJET PHARMA
  9 Rue Rameau
  75002 Paris
  France | Adrenaline | ANAPEN 150 microgrammes/0,3 ml,
  solution for injection in pre-filled syringe | 150 μg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| France | BIOPROJET PHARMA
  9 Rue Rameau
  75002 Paris
  France | Adrenaline | ANAPEN 300 microgrammes/0,3 ml,
  solution for injection in pre-filled syringe | 300 μg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| France | Meda Pharma
  25 boulevard de l’Amiral Bruix
  75016 Paris
  France | Adrenaline | EPIPEN
  0,15 mg/0,3 ml, solution for injection in pre-filled pen | 0,15 mg/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| France | Meda Pharma
  25 boulevard de l’Amiral Bruix
  75016 Paris
  France | Adrenaline | EPIPEN
  0,30 mg/0,3 ml, solution for injection in pre-filled pen | 0,30 mg/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| France | ALK-Abelló A/S
  Boge Allé 6-8.
  2970 Horsholm
  Denmark | Adrenaline | JEXT
  150 microgrammes, solution for injection in pre-filled pen | 150 μg | Solution for injection in pre-filled pen | Intramuscular use |
| France | ALK-Abelló A/S
  Boge Allé 6-8.
  2970 Horsholm
  Denmark | Adrenaline | JEXT
  300 microgrammes, solution for injection in pre-filled pen | 300 μg | Solution for injection in pre-filled pen | Intramuscular use |
| Germany | ALK-ABELLO A/S
  Boge Alle 6-8
  2970 Horsholm
  Denmark | Epinephrine | JEXT 300 Mikrogramm Injektionslösung in einem Fertigpen | 0,3 mg/0,3 ml | Solution for injection | Intramuscular use |
| Germany | ALK-ABELLO A/S
  Boge Alle 6-8
  2970 Horsholm
  Denmark | Epinephrine | JEXT 150 Mikrogramm Injektionslösung in einem Fertigpen | 0,15 mg/0,15 ml | Solution for injection | Intramuscular use |
| Germany | Lincoln Medical Ltd
  Unit 8 Wilton Buisiness Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | Anapen 300 Mikrogramm Injektionslösung | 300 μg/0,3 ml | Solution for injection | Intramuscular use |
| Germany | Lincoln Medical Ltd
  Unit 8 Wilton Buisiness Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | Anapen Junior 150 Mikrogramm Injektionslösung | 150 μg/0,3 ml | Solution for injection | Intramuscular use |
| Germany | MEDA Pharma GmbH & Co. KG
  Benzstr. 1
  61352 Bad Homburg
  Germany | Epinephrine | Fastjekt | 2 mg/2 ml | Solution for injection | Intramuscular use |
| Germany | MEDA Pharma GmbH & Co. KG
  Benzstr. 1
  61352 Bad Homburg
  Germany | Epinephrine | FASTJEKT Junior | 0,5 mg/1 ml | Solution for injection | Intramuscular use |
| Germany | PharmaSwiss Ceska republika s.r.o.
  Jankovcova 1569/2c
  170 00 Prague
  Czech Republic | Epinephrine | Emerade 150 Mikrogramm Injektionslösung in einem Fertigpen | 0,5 mg/0,5 ml | Solution for injection | Intramuscular use |
| Germany | PharmaSwiss Ceska republika s.r.o.
  Jankovcova 1569/2c
  170 00 Prague
  Czech Republic | Epinephrine | Emerade 300 Mikrogramm Injektionslösung in einem Fertigpen | 0,5 mg/0,5 ml | Solution for injection | Intramuscular use |
| Germany | PharmaSwiss Ceska republika s.r.o.
  Jankovcova 1569/2c
  170 00 Prague
  Czech Republic | Epinephrine | Emerade 500 Mikrogramm Injektionslösung in einem Fertigpen | 0,5 mg/0,5 ml | Solution for injection | Intramuscular use |
| Greece | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | ANAPEN | 300 mcg/0,3 ml | Solution for injection | Intramuscular use |
| Greece | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | ANAPEN | 150 mcg/0,3 ml | Solution for injection | Intramuscular use |
| Greece | DOCTUM FARMAKEYTIKI K. GIOKARIS & SIA A.E.,
  1st Km Leof. Paianias-Markopoulou,
  19002 Paiania,
  Greece | Epinephrine | FASTPEN | 0,15 mg/3 ml | Solution for injection | Intramuscular use |
| Greece | DOCTUM FARMAKEYTIKI K. GIOKARIS & SIA A.E.,
  1st Km Leof. Paianias-Markopoulou,
  19002 Paiania,
  Greece | Epinephrine | FASTPEN | 0,30 mg/0,3 ml | Solution for injection | Intramuscular use |
| Hungary | Lincoln Medical Ltd
  Unit 8, Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | ANAPEN 300 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben | 300 microgramm/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Hungary | Lincoln Medical Ltd
  Unit 8, Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | ANAPEN JUNIOR 150 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben | 150 microgramm/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Hungary | Meda Pharma Hungary Kft.
  Váci út 91.
  Budapest
  H-1139
  Hungary | Adrenaline | EPIPEN 300 mikrogramm oldatos injekció előre töltött tollban | 300 microgramm/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| Hungary | Meda Pharma Hungary Kft.
  Váci út 91.
  Budapest
  H-1139
  Hungary | Adrenaline | EPIPEN JUNIOR 150 mikrogramm oldatos injekció előre töltött tollban | 150 microgramm/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| Iceland | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenalinum
  (Epinephrinum) | Anapen | 300 microg/0,3 ml | Solution for injection | Intramuscular use |
| Iceland | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenalinum
  (Epinephrinum) | Anapen Junior | 150 microg/0,3 ml | Solution for injection | Intramuscular use |
| Iceland | Meda AB
  Pipers väg 2A, Box 906
  SE-170 09, Solna
  Sweden | Adrenalinum
  (Epinephrinum) | EpiPen | 300 microg | Solution for injection | Intramuscular use |
| Iceland | Meda AB
  Pipers väg 2A, Box 906
  SE-170 09, Solna
  Sweden | Adrenalinum
  (Epinephrinum) | EpiPen Junior | 150 microg | Solution for injection | Intramuscular use |
| Iceland | ALK-Abelló A/S
  Böge Alle 6-8, 2970 Horsholm
  Denmark | Adrenalinum bítartrat
  (Epinephrinum bítartrat) | Jext | 150 microg | Solution for injection | Intramuscular use |
| Iceland | ALK-Abelló A/S,
  Böge Alle 6-8, 2970 Horsholm
  Denmark | Adrenalinum bítartrat
  (Epinephrinum bítartrat) | Jext | 300 microg | Solution for injection | Intramuscular use |
| Ireland | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre, Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline (epinephrine) BP | Anapen 300 micrograms in 0,3 ml solution for injection in a pre-filled syringe | 300 micrograms in 0,3 ml solution | Solution for injection in a pre-filled syringe | Intramuscular use |
| Ireland | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre, Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline (epinephrine) BP | Adrenaline (epinephrine) BP | 150 micrograms in 0,3 ml solution | Solution for injection in a pre- filled syringe | Intramuscular use |
| Ireland | Meda Health Sales Ireland Limited
  Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co. Meath Ireland | Adrenaline Ph. Eur. | Epipen 300 micrograms solution for injection in pre-filled pen | 300 micrograms in 0,3 ml solution | Solution for injection in a pre-filled pen | Intramuscular use |
| Ireland | Meda Health Sales Ireland Limited
  Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co. Meath Ireland | Adrenaline Ph. Eur. | Epipen Junior 150 micrograms solution for injection in pre-filled pen | 150 micrograms | Solution for injection in a pre-filled pen | Intramuscular use |
| Ireland | ALK-Abello A/S
  Boge Alle 6-8
  DK-2970 Horsholm
  Denmark | Adrenaline (as adrenaline tartrate) | Jext 300 micrograms solution for injection in pre-filled pen | 300 micrograms | Solution for injection in pre-filled pen | Intramuscular use |
| Ireland | ALK-Abello A/S
  Boge Alle 6-8
  DK-2970 Horsholm
  Denmark | Adrenaline (as adrenaline tartrate) | Jext 150 micrograms solution for injection in pre-filled pen | 150 micrograms | Solution for injection in pre-filled pen | Intramuscular use |
| Italy | MEDA PHARMA S.P.A.
  Viale Brenta 18
  20139 Milano
  Italy | Adrenaline | FASTJEKT | 330 mcg | Solution for injection in a pre-filled injector | Intramuscular use |
| Italy | MEDA PHARMA S.P.A.
  Viale Brenta 18
  20139 Milano
  Italy | Adrenaline | FASTJEKT | 165 mcg | Solution for injection in a pre-filled injector | Intramuscular use |
| Italy | ALK-ABELLÓ A/S
  Boge Alle 6-8
  DK-2970 Horsholm
  Denmark | Adrenaline tartrate | JEXT | 300 mcg | Solution for injection in a pre-filled pen | Intramuscular use |
| Italy | ALK-ABELLÓ A/S
  Boge Alle 6-8
  DK-2970 Horsholm
  Denmark | Adrenaline tartrate | JEXT | 150 mcg | Solution for injection in a pre-filled pen | Intramuscular use |
| Italy | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | CHENPEN | 300 mcg | Solution for injection in a pre-filled syringe | Parenteral use |
| Italy | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | CHENPEN | 150 mcg | Solution for injection in a pre-filled syringe | Parenteral use |
| Latvia | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | Anapen 150 micrograms/0,3 ml solution for injection in pre-filled syringe | 150 micrograms/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Latvia | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Epinephrine | Anapen 300 micrograms/0,3 ml solution for injection in pre-filled syringe | 300 micrograms/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Latvia | Meda Pharma SIA
  Vienibas gatve 109
  Riga, LV-1058
  Latvia | Epinephrine | Epipen 150 micrograms solution for injection in pre-filled pen | 150 micrograms | Solution for injection in pre-filled pen | Intramuscular use |
| Latvia | Meda Pharma SIA
  Vienibas gatve 109
  Riga, LV-1058
  Latvia | Epinephrine | Epipen 300 micrograms solution for injection in pre-filled pen | 300 micrograms | Solution for injection in pre-filled pen | Intramuscular use |
| Lithuania | Lincoln Medical Ltd
  Unit 8, Wilton Business Centre
  Wilton
  Salisbury SP2 0AH
  United Kingdom | Epinephrine | Anapen | 300 microgram/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Lithuania | Lincoln Medical Ltd
  Unit 8, Wilton Business Centre
  Wilton
  Salisbury SP2 0AH
  United Kingdom | Epinephrine | Anapen | 150 microgram/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Lithuania | SIA Meda Pharma
  Vienibas gatve 109
  Riga LV-1058
  Latvia | Epinephrine | Epipen | 300 microgram/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| Lithuania | SIA Meda Pharma
  Vienibas gatve 109
  Riga LV-1058
  Latvia | Epinephrine | Epipen | 150 microgram/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| Luxembourg | Lincoln Medical Ltd
  Unit 8, Wilton Business Centre, Wilton
  Salisbury
  SP2 OAH
  United kingdom | Adrenalin | Anapen | 150 μg | Solution for injection in pre-filled pen | Intramuscular use |
| Luxembourg | Lincoln Medical Ltd
  Unit 8, Wilton Business Centre, Wilton
  Salisbury
  SP2 OAH
  United kingdom | Adrenalin | Anapen | 300 μg | Solution for injection in pre-filled pen | Intramuscular use |
| Luxembourg | Meda Pharma GmbH&Co.KG
  Benzstrasse 1
  61352 Bad Homburg
  Germany | Adrenalin (hydrochloride) | Fastjekt | 300 μg | Solution for injection in pre-filled pen | Intramuscular use |
| Luxembourg | Meda Pharma GmbH&Co.KG
  Benzstrasse 1
  61352 Bad Homburg
  Germany | Adrenalin (hydrochloride) | Fastjekt junior | 150 μg | Solution for injection in pre-filled pen | Intramuscular use |
| Luxembourg | Alk Abello A/S
  Boge Alle 6-8
  2970 Horsholm
  Denmark | Adrenalin (tartrate) | Jext | 150 μg | Solution for injection in pre-filled pen | Intramuscular use |
| Luxembourg | Alk Abello A/S
  Boge Alle 6-8
  2970 Horsholm
  Denmark | Adrenalin (tartrate) | Jext | 300 μg | Solution for injection in pre-filled pen | Intramuscular use |
| Malta | Lincoln Medical Limited Unit 8 Wilton Business Centre Wilton Salisbury SP2 0AH United Kingdom | Adrenalin | Anapen 300 micrograms in 0,3 ml solution for injection in a pre-filled syringe | 300 micrograms/0,3 ml | Solution for injection | Intramuscular use |
| Malta | Lincoln Medical Limited Unit 8 Wilton Business Centre Wilton Salisbury SP2 0AH United Kingdom | Adrenalin | Anapen Junior 150 micrograms in 0,3 ml solution for injection in a pre-filled syringe | 150 micrograms/0,3 ml | Solution for injection | Intramuscular use |
| Norway | Lincoln Medical limited Unit 8 Wilton Business Centre
  Wilton
  Salisbury SP2 0AH Great Britain | Adrenaline | Anapen | 300 microg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Norway | Lincoln Medical limited Unit 8 Wilton Business Centre
  Wilton
  Salisbury SP2 0AH Great Britain | Adrenaline | Anapen Junior | 150 microg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Norway | Meda AS
  Askerveien 61
  Postboks 194
  1371 Asker Norway | Adrenaline | EpiPen | 300 microg | Solution for injection in pre-filled syringe | Intramuscular use |
| Norway | Meda AS
  Askerveien 61
  Postboks 194
  1371 Asker Norway | Adrenaline | EpiPen Jr | 150 microg | Solution for injection in pre-filled syringe | Intramuscular use |
| Norway | ALK-Abelló AS Bøge Alle 6-8
  DK-2970 Hørsholm
  Denmark | Adrenaline tartrate | Jext | 150 microg | Solution for injection in pre-filled syringe | Intramuscular use |
| Norway | ALK-Abelló AS Bøge Alle 6-8
  DK-2970 Hørsholm
  Denmark | Adrenaline tartrate | Jext | 300 microg | Solution for injection in pre-filled syringe | Intramuscular use |
| Poland | Warszawskie Zakłady Farmaceutyczne POLFA S.A.
  ul. Karolkowa 22/24
  01-207 Warszawa | Adrenaline | Adrenalina WZF | 300 mcg/0,3 ml | Solution for infusion in pre-filled syringe/pen | Intramuscular use |
| Poland | Lincoln Medical Limited
  Unit 8, Wilton Business Centre,
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | Anapen | 300 mcg | Solution for infusion | Intramuscular use |
| Poland | Lincoln Medical Limited
  Unit 8, Wilton Business Centre,
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | Anapen Junior | 150 mcg | Solution for infusion | Intramuscular use |
| Poland | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  61352 Bad Homburg
  Germany | Adrenaline | EpiPen Jr. | 150 mcg/dose | Solution for infusion | Intramuscular use |
| Poland | Meda Pharma GmbH & Co. KG
  Benzstrasse 1
  61352 Bad Homburg
  Germany | Adrenaline | EpiPen Senior | 300 mcg/dose | Solution for infusion | Intramuscular use |
| Portugal | Lincoln Medical Ltd
  Unit 8, Wilton Business Centre, Wilton
  SP2 0AH Salisbury
  United Kingdom | Adrenaline | Anapen 0,15 mg/0,3 ml | 0,15 mg/0,3 ml | Solution for injection | Intramuscular use |
| Portugal | Lincoln Medical Ltd
  Unit 8, Wilton Business Centre, Wilton
  SP2 0AH Salisbury
  United Kingdom | Adrenaline | Anapen 0,3 mg/0,3 ml | 0,3 mg/0,3 ml | Solution for injection | Intramuscular use |
| Portugal | Meda Pharma — Produtos Farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  1749-066 Lisboa
  Portugal | Adrenaline | Epipen | 0,15 mg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Portugal | Meda Pharma — Produtos Farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  1749-066 Lisboa
  Portugal | Adrenaline | Epipen | 0,3 mg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Romania | MEDA Pharma GmbH & Co. KG Benzstr. 1, 61352 Bad Homburg v.d. Höhe
  Germany | Adrenalină
  (epinefrină) | EpiPen 150 micrograme | 150 micrograms/dose | Solution for injection in a pre-filled pen | Intramuscular use |
| Romania | MEDA Pharma GmbH & Co. KG Benzstr. 1, 61352 Bad Homburg v.d. Höhe Germany | Adrenalină
  (epinefrină) | EpiPen 300 micrograme | 300 micrograms/dose | Solution for injection in a pre-filled pen | Intramuscular use |
| Slovak Republic | Meda Pharma spol. s r. o.
  Trnavská cesta 50
  821 02 Bratislava Slovak Republic | Epinephrine | EpiPen | 300 μg/dose | Solution for injection in pre-filled pen | Intramuscular use |
| Slovak Republic | Meda Pharma spol. s r. o.
  Trnavská cesta 50
  821 02 Bratislava Slovak Republic | Epinephrine | EpiPen Jr. | 150 μg/dose | Solution for injection in pre-filled pen | Intramuscular use |
| Slovak Republic | ALK-Abelló A/S Boge Allé 6-8
  DK-2970 Horsholm
  Denmark | Epinephrine | Jext 150 mikrogramov | 150 μg/dose | Solution for injection in pre-filled pen | Intramuscular use |
| Slovak Republic | ALK-Abelló A/S Boge Allé 6-8
  DK-2970 Horsholm
  Denmark | Epinephrine | Jext 300 mikrogramov | 300 μg/dose | Solution for injection in pre-filled pen | Intramuscular use |
| Slovenia | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United kingdom | Adrenaline | Anapen 300 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi | 300 mcg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Slovenia | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United kingdom | Adrenaline | Anapen za otroke 150 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi | 150 mcg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Slovenia | Meda Pharma GmbH & Co. KG, Benzstrasse 1
  61352 Bad Homburg
  Germany | Adrenaline | Epipen 300 mikrogramov/0,3 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku | 300 mcg/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| Slovenia | Meda Pharma GmbH & Co. KG, Benzstrasse 1
  61352 Bad Homburg Germany | Adrenaline | Epipen za otroke 150 mikrogramov/0,3 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku | 150 mcg/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| Spain | MEDA PHARMA, SAU Avda. de Castilla, 2 Edificio Berlín 2a planta Parque Empresarial San Fernando 28830 San Fernando de Henares (Madrid) Spain | Adrenaline | Altellus 150 microgramos niños, solución inyectable en pluma precargada | 0,15 mg/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| Spain | MEDA PHARMA, SAU Avda. de Castilla, 2 Edificio Berlín 2a planta Parque Empresarial San Fernando 28830 San Fernando de Henares (Madrid) Spain | Adrenaline | Altellus 300 microgramos adultos solución inyectable en pluma precargada | 0,30 mg/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| Spain | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | Anapen 0,15 mg/0,3 ml solución inyectable en jeringa precargada | 0,15 mg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Spain | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | Anapen 0,30 mg/0,3 ml solución inyectable en jeringa precargada | 0,30 mg/0,3 ml | Solution for injection in pre-filled syringe | Intramuscular use |
| Spain | ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970 Horsholm Denmark | Adrenaline tartrate | Jext 150 microgramos solución inyectable en pluma precargada | 0,15 mg/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| Spain | ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970 Horsholm Denmark | Adrenaline tartrate | Jext 300 microgramos solución inyectable en pluma precargada | 0,30 mg/0,3 ml | Solution for injection in pre-filled pen | Intramuscular use |
| Sweden | Meda AB
  Box 906
  170 09 Solna
  Sweden | Adrenaline | EpiPen | 300 mikrogram | Solution for injection in pre-filled pen | Parenteral use |
| Sweden | Meda AB
  Box 906
  170 09 Solna Sweden | Adrenaline | EpiPen jr | 150 mikrogram | Solution for injection in pre-filled pen | Parenteral use |
| Sweden | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre Wilton Salisbury SP20AH
  United Kingdom | Adrenaline | Anapen | 0,3 mg/dose | Solution for injection in pre-filled syringe | Parenteral use |
| Sweden | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre Wilton Salisbury SP20AH
  United Kingdom | Adrenaline | Anapen Junior | 0,15 mg/dose | Solution for injection in pre-filled syringe | Parenteral use |
| Sweden | ALK-Abelló A/S
  Boge Allé 6-8 DK-2970 Horsholm
  Denmark | Adrenaline tartrate | Jext | 300 mikrogram | Solution for injection in pre-filled pen | Parenteral use |
| Sweden | ALK-Abelló A/S
  Boge Allé 6-8
  DK-2970 Horsholm
  Denmark | Adrenaline tartrate | Jext | 150 mikrogram | Solution for injection in pre-filled pen | Parenteral use |
| Sweden | PharmaSwiss Ceska republika s.r.o.
  Jankovcova 1569/2c
  170 00 Prague
  Czech Republic | Adrenaline tartrate | Emerade | 500 mikrogram | Solution for injection in pre-filled pen | Parenteral use |
| Sweden | PharmaSwiss Ceska republika s.r.o.
  Jankovcova 1569/2c
  170 00 Prague
  Czech Republic | Adrenaline tartrate | Emerade | 300 mikrogram | Solution for injection in pre-filled pen | Parenteral use |
| Sweden | PharmaSwiss Ceska republika s.r.o.
  Jankovcova 1569/2c
  170 00 Prague
  Czech Republic | Adrenaline tartrate | Emerade | 150 mikrogram | Solution for injection in pre-filled pen | Parenteral use |
| Sweden | Meda AB
  Box 906
  170 09 Solna
  Sweden | Adrenaline | Nepipe | 300 mikrogram | Solution for injection in pre-filled pen | Parenteral use |
| Sweden | Meda AB
  Box 906
  170 09 Solna
  Sweden | Adrenaline | Nepipe Junior | 150 mikrogram | Solution for injection in pre-filled pen | Parenteral use |
| The Netherlands | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | Anapen, oplossing voor injectie | 0,3 microgram/ dosis | Solution for injection | Intramuscular use |
| The Netherlands | Lincoln Medical Ltd
  Unit 8 Wilton Business Centre
  Wilton, Salisbury
  SP2 0AH
  United Kingdom | Adrenaline | Anapen junior, oplossing voor injectie | 0,15 microgram/ dosis | Solution for injection | Intramuscular use |
| The Netherlands | Meda Pharma B.V.
  Krijgsman 20
  1186 DM Amstelveen
  The Netherlands | Adrenaline | EpiPen Junior 150 microgram/dosis | 0,15 microgram/ dosis | Solution for injection in a pre-filled syringe | Intramuscular use |
| The Netherlands | Meda Pharma B.V.
  Krijgsman 20
  1186 DM Amstelveen
  The Netherlands | Adrenaline | EpiPen 300 microgram/dosis | 0,3 microgram/ dosis | Solution for injection in a pre-filled syringe | Intramuscular use |
| The Netherlands | ALK-Abelló A/S
  Boge Allé 6-8
  DK-2970 Horshlom
  Denmark | Adrenaline | Jext 150 microgram, oplossing voor injectie | 0,15 microgram/ dosis | Solution for injection | Intramuscular use |
| The Netherlands | ALK-Abelló A/S
  Boge Allé 6-8
  DK-2970 Horshlom
  Denmark | Adrenaline | Jext 300 microgram, oplossing voor injectie | 0,3 microgram/ dosis | Solution for injection | Intramuscular use |
| United Kingdom | Alk Abello A-S
  Boge Alle 6-8
  Hersholm 2970
  Denmark | Adrenaline tartrate | Jext 150 micrograms solution for injection in pre-filled pen | 150 micrograms | Solution for injection | Intramuscular use |
| United Kingdom | Alk Abello A-S
  Boge Alle 6-8.
  Hersholm 2970
  Denmark | Adrenaline tartrate | Jext 300 micrograms solution for injection in pre-filled pen | 300 micrograms | Solution for injection | Intramuscular use |
| United Kingdom | Aurum Pharmaceuticals Limited, Bampton Road Harold Hill
  Romford Essex
  RM3 8UG
  United Kingdom | Adrenaline acid tartrate | Adrenaline (epinephrine) 1 in 1  000 solution for injection BP auto-injector | 1 in 1  000 | Solution for injection | Intramuscular/subcutaneous use |
| United Kingdom | Meda Pharmaceuticals Limited, Skyway House Parsonage Road, Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Adrenaline | Epipen auto-injector 0,3 mg | 0,3 mg | Solution for injection | Intramuscular use |
| United Kingdom | Meda Pharmaceuticals Limited
  Skyway House, Parsonage Road, Takeley
  Bishops Stortford
  CM22 6PU
  United Kingdom | Adrenaline | Epipen auto-injector 0,15 mg | 0,15 mg | Solution for injection | Intramuscular use |
| United Kingdom | PharmaSwiss Ceska republika s.r.o.
  Jankovcova 1569/2c
  170 00 Prague
  Czech Republic | Adrenaline tartrate | Emerade 150 micrograms solution for injection in pre-filled pen | 150 micrograms | Solution for injection | Intramuscular use |
| United Kingdom | PharmaSwiss Ceska republika s.r.o.
  Jankovcova 1569/2c
  170 00 Prague
  Czech Republic | Adrenaline tartrate | Emerade 300 micrograms solution for injection in pre-filled pen | 300 micrograms | Solution for injection | Intramuscular use |
| United Kingdom | PharmaSwiss Ceska republika s.r.o.
  Jankovcova 1569/2c
  170 00 Prague
  Czech Republic | Adrenaline tartrate | Emerade 500 micrograms solution for injection in pre-filled pen | 500 micrograms | Solution for injection | Intramuscular use |

Member State

(in EEA)

Marketing authorisation holder

INN

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

Anapen Junior 150 Mikrogramm in 0,3 ml — Injektionslösung (Fertigspritze)

150 Mikrogramm/0,3 ml

Solution for injection

Intramuscular use

Austria

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

Anapen 300 Mikrogramm in 0,3 ml — Injektionslösung (Fertigspritze)

300 Mikrogramm/0,3 ml

Solution for injection

Intramuscular use

Austria

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

Anapen 500 Mikrogramm/0,3 ml Injektionslösung in einer Fertigspritze

500 Mikrogramm/0,3 ml

Solution for injection

Intramuscular use

Austria

Meda Pharma GmbH

Guglgasse 15

1110 Wien

Austria

Epinephrine

EpiPen Junior 150 Mikrogramm Injektionslösung in einem Fertigpen

150 Mikrogramm

Solution for injection

Intramuscular use

Austria

Meda Pharma GmbH

Guglgasse 15

1110 Wien

Austria

Epinephrine

EpiPen 300 Mikrogramm Injektionslösung in einem FertigPen

300 Mikrogramm

Solution for injection

Intramuscular use

Austria

Alk Abello A/S

Boge Alle 6-8

2970 Horsholm

Denmark

Epinephrine hydrotartrat

Jext 150 Mikrogramm Injektionslösung in einem Fertigpen

150 Mikrogramm

Solution for injection

Intramuscular use

Austria

Alk Abello A/S

Boge Alle 6-8

2970 Horsholm

Denmark

Epinephrine hydrotartrat

Jext 300 Mikrogramm Injektionslösung in einem Fertigpen

300 Mikrogramm

Solution for injection

Intramuscular use

Belgium

Meda Pharma sa-nv

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Epinephrine

Epipen

300 μg

Solution for injection

Intramuscular use

Belgium

Meda Pharma sa-nv

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Epinephrine

Epipen junior

150 μg

Solution for injection

Intramuscular use

Belgium

ALK-Abello

Boge Alle 6-8

2970 Horsholm

Denmark

Epinephrine Bitartrate

Jext

150 μg

Solution for injection

Intramuscular use

Belgium

ALK-Abello

Boge Alle 6-8

2970 Horsholm

Denmark

Epinephrine Bitartrate

Jext

300 μg

Solution for injection

Intramuscular use

Bulgaria

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

Anapen Junior

150 mcg/0,3 ml

Solution for injection

Intramuscular use

Bulgaria

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

Anapen

300 mcg/0,3 ml

Solution for injection

Intramuscular use

Bulgaria

MEDA Pharma GmbH & Co. KG

Benzstr. 1 + Bad Homburg

61352 Germany

Adrenaline

EpiPen Jr.

150 mcg/0,3 ml

Solution for injection

Intramuscular use

Bulgaria

MEDA Pharma GmbH & Co. KG

Benzstr. 1 + Bad Homburg

61352 Germany

Adrenaline

EpiPen

300 mcg/0,3 ml

Solution for injection

Intramuscular use

Croatia

Medical Intertrade d.o.o.

Dr Franje Tuđmana 3

Sveta Nedjelja

10431 Croatia

Epinephrine

EpiPen 0,3 mg otopina za injekciju

0,3 mg

Solution for injection

Intramuscular use

Croatia

Medical Intertrade d.o.o.

Dr Franje Tuđmana 3 Sveta Nedjelja

10431 Croatia

Epinephrine

EpiPen Jr 0,15 mg otopina za injekciju

0,15 mg

Solution for injection

Intramuscular use

Cyprus

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

Anapen

300 mcg/0,3 ml

Solution for injection

Intramuscular use

Cyprus

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

Anapen Junior

150 mcg/0,3 ml

Solution for injection

Intramuscular use

Czech Republic

MEDA Pharma s.r.o.

Kodaňská 1441/46

110 00 Prague 10

Czech Republic

Epinephrine

Epipen 300 mikrogramů

0,3 mg per dose (0,3 mg/0,3 ml)

Solution for injection in pre-filled pen

Intramuscular use

Czech Republic

MEDA Pharma s.r.o.

Kodaňská 1441/46

110 00 Prague 10

Czech Republic

Epinephrine

Epipen JR. 150 mikrogramů

0,15 mg per dose (0,15 mg/0,3 ml)

Solution for injection in pre-filled pen

Intramuscular use

Czech Republic

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

Anapen injekční roztok 300 mikrogramů/0,3 ml (předplněná injekční stříkačka)

0,3 mg per dose (0,3 mg/0,3 ml)

Solution for injection

Intramuscular use

Czech Republic

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

Anapen Junior injekční roztok 150 mikrogramů/0,3 ml (předplněná injekční stříkačka)

0,15 mg per dose (0,15 mg/0,3 ml)

Solution for injection

Intramuscular use

Denmark

Lincoln Medical Limited

Unit 8 Wilton Business Centre Wilton Salisbury SP2 0AH United Kingdom

Adrenaline

Anapen

300 mcg/0,3 ml

Solution for injection

Intramuscular use

Denmark

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

Anapen Junior

150 mcg/0,3 ml

Solution for injection

Intramuscular use

Denmark

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Adrenaline

EpiPen

0,3 mg/dose

Solution for injection

Intramuscular use

Denmark

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Adrenaline

EpiPen Jr.

0,15 mg/dose

Solution for injection

Intramuscular use

Denmark

ALK-Abello A/S

Bøge Alle 6-8

DK-2970 Hørsholm

Denmark

Adrenaline

Jext

150 mcg

Solution for injection, pre-filled pen

Intramuscular use

Denmark

ALK-Abello A/S

Bøge Alle 6-8

DK-2970 Hørsholm Denmark

Adrenaline

Jext

300 mcg

Solution for injection, pre-filled pen

Intramuscular use

Estonia

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

ANAPEN

150 mcg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Estonia

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

ANAPEN

300 mcg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Estonia

SIA Meda Pharma

Vienibas gatve 109,

Riga LV-1058

Latvia

Epinephrine

EPIPEN

150 mcg/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

Estonia

SIA Meda Pharma

Vienibas gatve 109,

Riga LV-1058

Latvia

Epinephrine

EPIPEN

300 mcg/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

Finland

Lincoln Medical Ltd

Unit 8 Wilton Business

Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

ANAPEN

0,3 mg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Finland

Lincoln Medical Ltd

Unit 8 Wilton Business

Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

ANAPEN JUNIOR

0,15 mg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Finland

Meda Oy

Vaisalantie 4

02130 Espoo

Finland

Adrenaline

EPIPEN

300 mikrog

Solution for injection in pre-filled pen

Intramuscular use

Finland

Meda Oy

Vaisalantie 4

02130 Espoo

Finland

Adrenaline

EPIPEN JR.

150 mikrog

Solution for injection in pre-filled pen

Intramuscular use

Finland

ALK-Abello A/S

Bøge Alle 6-8

B.O. BOX 408

2970 Horsholm

Denmark

Adrenaline tartrate

JEXT

150 mikrog

Solution for injection in pre-filled pen

Intramuscular use

Finland

ALK-Abello A/S

Bøge Alle 6-8

B.O. BOX 408

2970 Horsholm

Denmark

Adrenaline tartrate

JEXT

300 mikrog

Solution for injection in pre-filled pen

Intramuscular use

France

BIOPROJET PHARMA

9 Rue Rameau

75002 Paris

France

Adrenaline

ANAPEN 150 microgrammes/0,3 ml,

solution for injection in pre-filled syringe

150 μg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

France

BIOPROJET PHARMA

9 Rue Rameau

75002 Paris

France

Adrenaline

ANAPEN 300 microgrammes/0,3 ml,

solution for injection in pre-filled syringe

300 μg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

France

Meda Pharma

25 boulevard de l’Amiral Bruix

75016 Paris

France

Adrenaline

EPIPEN

0,15 mg/0,3 ml, solution for injection in pre-filled pen

0,15 mg/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

France

Meda Pharma

25 boulevard de l’Amiral Bruix

75016 Paris

France

Adrenaline

EPIPEN

0,30 mg/0,3 ml, solution for injection in pre-filled pen

0,30 mg/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

France

ALK-Abelló A/S

Boge Allé 6-8.

2970 Horsholm

Denmark

Adrenaline

JEXT

150 microgrammes, solution for injection in pre-filled pen

150 μg

Solution for injection in pre-filled pen

Intramuscular use

France

ALK-Abelló A/S

Boge Allé 6-8.

2970 Horsholm

Denmark

Adrenaline

JEXT

300 microgrammes, solution for injection in pre-filled pen

300 μg

Solution for injection in pre-filled pen

Intramuscular use

Germany

ALK-ABELLO A/S

Boge Alle 6-8

2970 Horsholm

Denmark

Epinephrine

JEXT 300 Mikrogramm Injektionslösung in einem Fertigpen

0,3 mg/0,3 ml

Solution for injection

Intramuscular use

Germany

ALK-ABELLO A/S

Boge Alle 6-8

2970 Horsholm

Denmark

Epinephrine

JEXT 150 Mikrogramm Injektionslösung in einem Fertigpen

0,15 mg/0,15 ml

Solution for injection

Intramuscular use

Germany

Lincoln Medical Ltd

Unit 8 Wilton Buisiness Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

Anapen 300 Mikrogramm Injektionslösung

300 μg/0,3 ml

Solution for injection

Intramuscular use

Germany

Lincoln Medical Ltd

Unit 8 Wilton Buisiness Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

Anapen Junior 150 Mikrogramm Injektionslösung

150 μg/0,3 ml

Solution for injection

Intramuscular use

Germany

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Epinephrine

Fastjekt

2 mg/2 ml

Solution for injection

Intramuscular use

Germany

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Epinephrine

FASTJEKT Junior

0,5 mg/1 ml

Solution for injection

Intramuscular use

Germany

PharmaSwiss Ceska republika s.r.o.

Jankovcova 1569/2c

170 00 Prague

Czech Republic

Epinephrine

Emerade 150 Mikrogramm Injektionslösung in einem Fertigpen

0,5 mg/0,5 ml

Solution for injection

Intramuscular use

Germany

PharmaSwiss Ceska republika s.r.o.

Jankovcova 1569/2c

170 00 Prague

Czech Republic

Epinephrine

Emerade 300 Mikrogramm Injektionslösung in einem Fertigpen

0,5 mg/0,5 ml

Solution for injection

Intramuscular use

Germany

PharmaSwiss Ceska republika s.r.o.

Jankovcova 1569/2c

170 00 Prague

Czech Republic

Epinephrine

Emerade 500 Mikrogramm Injektionslösung in einem Fertigpen

0,5 mg/0,5 ml

Solution for injection

Intramuscular use

Greece

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

ANAPEN

300 mcg/0,3 ml

Solution for injection

Intramuscular use

Greece

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

ANAPEN

150 mcg/0,3 ml

Solution for injection

Intramuscular use

Greece

DOCTUM FARMAKEYTIKI K. GIOKARIS & SIA A.E.,

1st Km Leof. Paianias-Markopoulou,

19002 Paiania,

Greece

Epinephrine

FASTPEN

0,15 mg/3 ml

Solution for injection

Intramuscular use

Greece

DOCTUM FARMAKEYTIKI K. GIOKARIS & SIA A.E.,

1st Km Leof. Paianias-Markopoulou,

19002 Paiania,

Greece

Epinephrine

FASTPEN

0,30 mg/0,3 ml

Solution for injection

Intramuscular use

Hungary

Lincoln Medical Ltd

Unit 8, Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

ANAPEN 300 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben

300 microgramm/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Hungary

Lincoln Medical Ltd

Unit 8, Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

ANAPEN JUNIOR 150 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben

150 microgramm/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Hungary

Meda Pharma Hungary Kft.

Váci út 91.

Budapest

H-1139

Hungary

Adrenaline

EPIPEN 300 mikrogramm oldatos injekció előre töltött tollban

300 microgramm/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

Hungary

Meda Pharma Hungary Kft.

Váci út 91.

Budapest

H-1139

Hungary

Adrenaline

EPIPEN JUNIOR 150 mikrogramm oldatos injekció előre töltött tollban

150 microgramm/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

Iceland

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenalinum

(Epinephrinum)

Anapen

300 microg/0,3 ml

Solution for injection

Intramuscular use

Iceland

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenalinum

(Epinephrinum)

Anapen Junior

150 microg/0,3 ml

Solution for injection

Intramuscular use

Iceland

Meda AB

Pipers väg 2A, Box 906

SE-170 09, Solna

Sweden

Adrenalinum

(Epinephrinum)

EpiPen

300 microg

Solution for injection

Intramuscular use

Iceland

Meda AB

Pipers väg 2A, Box 906

SE-170 09, Solna

Sweden

Adrenalinum

(Epinephrinum)

EpiPen Junior

150 microg

Solution for injection

Intramuscular use

Iceland

ALK-Abelló A/S

Böge Alle 6-8, 2970 Horsholm

Denmark

Adrenalinum bítartrat

(Epinephrinum bítartrat)

Jext

150 microg

Solution for injection

Intramuscular use

Iceland

ALK-Abelló A/S,

Böge Alle 6-8, 2970 Horsholm

Denmark

Adrenalinum bítartrat

(Epinephrinum bítartrat)

Jext

300 microg

Solution for injection

Intramuscular use

Ireland

Lincoln Medical Ltd

Unit 8 Wilton Business Centre, Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline (epinephrine) BP

Anapen 300 micrograms in 0,3 ml solution for injection in a pre-filled syringe

300 micrograms in 0,3 ml solution

Solution for injection in a pre-filled syringe

Intramuscular use

Ireland

Lincoln Medical Ltd

Unit 8 Wilton Business Centre, Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline (epinephrine) BP

Adrenaline (epinephrine) BP

150 micrograms in 0,3 ml solution

Solution for injection in a pre- filled syringe

Intramuscular use

Ireland

Meda Health Sales Ireland Limited

Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co. Meath Ireland

Adrenaline Ph. Eur.

Epipen 300 micrograms solution for injection in pre-filled pen

300 micrograms in 0,3 ml solution

Solution for injection in a pre-filled pen

Intramuscular use

Ireland

Meda Health Sales Ireland Limited

Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co. Meath Ireland

Adrenaline Ph. Eur.

Epipen Junior 150 micrograms solution for injection in pre-filled pen

150 micrograms

Solution for injection in a pre-filled pen

Intramuscular use

Ireland

ALK-Abello A/S

Boge Alle 6-8

DK-2970 Horsholm

Denmark

Adrenaline (as adrenaline tartrate)

Jext 300 micrograms solution for injection in pre-filled pen

300 micrograms

Solution for injection in pre-filled pen

Intramuscular use

Ireland

ALK-Abello A/S

Boge Alle 6-8

DK-2970 Horsholm

Denmark

Adrenaline (as adrenaline tartrate)

Jext 150 micrograms solution for injection in pre-filled pen

150 micrograms

Solution for injection in pre-filled pen

Intramuscular use

Italy

MEDA PHARMA S.P.A.

Viale Brenta 18

20139 Milano

Italy

Adrenaline

FASTJEKT

330 mcg

Solution for injection in a pre-filled injector

Intramuscular use

Italy

MEDA PHARMA S.P.A.

Viale Brenta 18

20139 Milano

Italy

Adrenaline

FASTJEKT

165 mcg

Solution for injection in a pre-filled injector

Intramuscular use

Italy

ALK-ABELLÓ A/S

Boge Alle 6-8

DK-2970 Horsholm

Denmark

Adrenaline tartrate

JEXT

300 mcg

Solution for injection in a pre-filled pen

Intramuscular use

Italy

ALK-ABELLÓ A/S

Boge Alle 6-8

DK-2970 Horsholm

Denmark

Adrenaline tartrate

JEXT

150 mcg

Solution for injection in a pre-filled pen

Intramuscular use

Italy

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

CHENPEN

300 mcg

Solution for injection in a pre-filled syringe

Parenteral use

Italy

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

CHENPEN

150 mcg

Solution for injection in a pre-filled syringe

Parenteral use

Latvia

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

Anapen 150 micrograms/0,3 ml solution for injection in pre-filled syringe

150 micrograms/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Latvia

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Epinephrine

Anapen 300 micrograms/0,3 ml solution for injection in pre-filled syringe

300 micrograms/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Latvia

Meda Pharma SIA

Vienibas gatve 109

Riga, LV-1058

Latvia

Epinephrine

Epipen 150 micrograms solution for injection in pre-filled pen

150 micrograms

Solution for injection in pre-filled pen

Intramuscular use

Latvia

Meda Pharma SIA

Vienibas gatve 109

Riga, LV-1058

Latvia

Epinephrine

Epipen 300 micrograms solution for injection in pre-filled pen

300 micrograms

Solution for injection in pre-filled pen

Intramuscular use

Lithuania

Lincoln Medical Ltd

Unit 8, Wilton Business Centre

Wilton

Salisbury SP2 0AH

United Kingdom

Epinephrine

Anapen

300 microgram/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Lithuania

Lincoln Medical Ltd

Unit 8, Wilton Business Centre

Wilton

Salisbury SP2 0AH

United Kingdom

Epinephrine

Anapen

150 microgram/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Lithuania

SIA Meda Pharma

Vienibas gatve 109

Riga LV-1058

Latvia

Epinephrine

Epipen

300 microgram/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

Lithuania

SIA Meda Pharma

Vienibas gatve 109

Riga LV-1058

Latvia

Epinephrine

Epipen

150 microgram/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

Luxembourg

Lincoln Medical Ltd

Unit 8, Wilton Business Centre, Wilton

Salisbury

SP2 OAH

United kingdom

Adrenalin

Anapen

150 μg

Solution for injection in pre-filled pen

Intramuscular use

Luxembourg

Lincoln Medical Ltd

Unit 8, Wilton Business Centre, Wilton

Salisbury

SP2 OAH

United kingdom

Adrenalin

Anapen

300 μg

Solution for injection in pre-filled pen

Intramuscular use

Luxembourg

Meda Pharma GmbH&Co.KG

Benzstrasse 1

61352 Bad Homburg

Germany

Adrenalin (hydrochloride)

Fastjekt

300 μg

Solution for injection in pre-filled pen

Intramuscular use

Luxembourg

Meda Pharma GmbH&Co.KG

Benzstrasse 1

61352 Bad Homburg

Germany

Adrenalin (hydrochloride)

Fastjekt junior

150 μg

Solution for injection in pre-filled pen

Intramuscular use

Luxembourg

Alk Abello A/S

Boge Alle 6-8

2970 Horsholm

Denmark

Adrenalin (tartrate)

Jext

150 μg

Solution for injection in pre-filled pen

Intramuscular use

Luxembourg

Alk Abello A/S

Boge Alle 6-8

2970 Horsholm

Denmark

Adrenalin (tartrate)

Jext

300 μg

Solution for injection in pre-filled pen

Intramuscular use

Malta

Lincoln Medical Limited Unit 8 Wilton Business Centre Wilton Salisbury SP2 0AH United Kingdom

Adrenalin

Anapen 300 micrograms in 0,3 ml solution for injection in a pre-filled syringe

300 micrograms/0,3 ml

Solution for injection

Intramuscular use

Malta

Lincoln Medical Limited Unit 8 Wilton Business Centre Wilton Salisbury SP2 0AH United Kingdom

Adrenalin

Anapen Junior 150 micrograms in 0,3 ml solution for injection in a pre-filled syringe

150 micrograms/0,3 ml

Solution for injection

Intramuscular use

Norway

Lincoln Medical limited Unit 8 Wilton Business Centre

Wilton

Salisbury SP2 0AH Great Britain

Adrenaline

Anapen

300 microg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Norway

Lincoln Medical limited Unit 8 Wilton Business Centre

Wilton

Salisbury SP2 0AH Great Britain

Adrenaline

Anapen Junior

150 microg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Norway

Meda AS

Askerveien 61

Postboks 194

1371 Asker Norway

Adrenaline

EpiPen

300 microg

Solution for injection in pre-filled syringe

Intramuscular use

Norway

Meda AS

Askerveien 61

Postboks 194

1371 Asker Norway

Adrenaline

EpiPen Jr

150 microg

Solution for injection in pre-filled syringe

Intramuscular use

Norway

ALK-Abelló AS Bøge Alle 6-8

DK-2970 Hørsholm

Denmark

Adrenaline tartrate

Jext

150 microg

Solution for injection in pre-filled syringe

Intramuscular use

Norway

ALK-Abelló AS Bøge Alle 6-8

DK-2970 Hørsholm

Denmark

Adrenaline tartrate

Jext

300 microg

Solution for injection in pre-filled syringe

Intramuscular use

Poland

Warszawskie Zakłady Farmaceutyczne POLFA S.A.

ul. Karolkowa 22/24

01-207 Warszawa

Adrenaline

Adrenalina WZF

300 mcg/0,3 ml

Solution for infusion in pre-filled syringe/pen

Intramuscular use

Poland

Lincoln Medical Limited

Unit 8, Wilton Business Centre,

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

Anapen

300 mcg

Solution for infusion

Intramuscular use

Poland

Lincoln Medical Limited

Unit 8, Wilton Business Centre,

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

Anapen Junior

150 mcg

Solution for infusion

Intramuscular use

Poland

Meda Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Adrenaline

EpiPen Jr.

150 mcg/dose

Solution for infusion

Intramuscular use

Poland

Meda Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Adrenaline

EpiPen Senior

300 mcg/dose

Solution for infusion

Intramuscular use

Portugal

Lincoln Medical Ltd

Unit 8, Wilton Business Centre, Wilton

SP2 0AH Salisbury

United Kingdom

Adrenaline

Anapen 0,15 mg/0,3 ml

0,15 mg/0,3 ml

Solution for injection

Intramuscular use

Portugal

Lincoln Medical Ltd

Unit 8, Wilton Business Centre, Wilton

SP2 0AH Salisbury

United Kingdom

Adrenaline

Anapen 0,3 mg/0,3 ml

0,3 mg/0,3 ml

Solution for injection

Intramuscular use

Portugal

Meda Pharma — Produtos Farmacêuticos, S.A.

Rua do Centro Cultural, 13

1749-066 Lisboa

Portugal

Adrenaline

Epipen

0,15 mg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Portugal

Meda Pharma — Produtos Farmacêuticos, S.A.

Rua do Centro Cultural, 13

1749-066 Lisboa

Portugal

Adrenaline

Epipen

0,3 mg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Romania

MEDA Pharma GmbH & Co. KG Benzstr. 1, 61352 Bad Homburg v.d. Höhe

Germany

Adrenalină

(epinefrină)

EpiPen 150 micrograme

150 micrograms/dose

Solution for injection in a pre-filled pen

Intramuscular use

Romania

MEDA Pharma GmbH & Co. KG Benzstr. 1, 61352 Bad Homburg v.d. Höhe Germany

Adrenalină

(epinefrină)

EpiPen 300 micrograme

300 micrograms/dose

Solution for injection in a pre-filled pen

Intramuscular use

Slovak Republic

Meda Pharma spol. s r. o.

Trnavská cesta 50

821 02 Bratislava Slovak Republic

Epinephrine

EpiPen

300 μg/dose

Solution for injection in pre-filled pen

Intramuscular use

Slovak Republic

Meda Pharma spol. s r. o.

Trnavská cesta 50

821 02 Bratislava Slovak Republic

Epinephrine

EpiPen Jr.

150 μg/dose

Solution for injection in pre-filled pen

Intramuscular use

Slovak Republic

ALK-Abelló A/S Boge Allé 6-8

DK-2970 Horsholm

Denmark

Epinephrine

Jext 150 mikrogramov

150 μg/dose

Solution for injection in pre-filled pen

Intramuscular use

Slovak Republic

ALK-Abelló A/S Boge Allé 6-8

DK-2970 Horsholm

Denmark

Epinephrine

Jext 300 mikrogramov

300 μg/dose

Solution for injection in pre-filled pen

Intramuscular use

Slovenia

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United kingdom

Adrenaline

Anapen 300 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi

300 mcg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Slovenia

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United kingdom

Adrenaline

Anapen za otroke 150 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi

150 mcg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Slovenia

Meda Pharma GmbH & Co. KG, Benzstrasse 1

61352 Bad Homburg

Germany

Adrenaline

Epipen 300 mikrogramov/0,3 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku

300 mcg/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

Slovenia

Meda Pharma GmbH & Co. KG, Benzstrasse 1

61352 Bad Homburg Germany

Adrenaline

Epipen za otroke 150 mikrogramov/0,3 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku

150 mcg/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

Spain

MEDA PHARMA, SAU Avda. de Castilla, 2 Edificio Berlín 2a planta Parque Empresarial San Fernando 28830 San Fernando de Henares (Madrid) Spain

Adrenaline

Altellus 150 microgramos niños, solución inyectable en pluma precargada

0,15 mg/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

Spain

MEDA PHARMA, SAU Avda. de Castilla, 2 Edificio Berlín 2a planta Parque Empresarial San Fernando 28830 San Fernando de Henares (Madrid) Spain

Adrenaline

Altellus 300 microgramos adultos solución inyectable en pluma precargada

0,30 mg/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

Spain

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

Anapen 0,15 mg/0,3 ml solución inyectable en jeringa precargada

0,15 mg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Spain

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

Anapen 0,30 mg/0,3 ml solución inyectable en jeringa precargada

0,30 mg/0,3 ml

Solution for injection in pre-filled syringe

Intramuscular use

Spain

ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970 Horsholm Denmark

Adrenaline tartrate

Jext 150 microgramos solución inyectable en pluma precargada

0,15 mg/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

Spain

ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970 Horsholm Denmark

Adrenaline tartrate

Jext 300 microgramos solución inyectable en pluma precargada

0,30 mg/0,3 ml

Solution for injection in pre-filled pen

Intramuscular use

Sweden

Meda AB

Box 906

170 09 Solna

Sweden

Adrenaline

EpiPen

300 mikrogram

Solution for injection in pre-filled pen

Parenteral use

Sweden

Meda AB

Box 906

170 09 Solna Sweden

Adrenaline

EpiPen jr

150 mikrogram

Solution for injection in pre-filled pen

Parenteral use

Sweden

Lincoln Medical Ltd

Unit 8 Wilton Business Centre Wilton Salisbury SP20AH

United Kingdom

Adrenaline

Anapen

0,3 mg/dose

Solution for injection in pre-filled syringe

Parenteral use

Sweden

Lincoln Medical Ltd

Unit 8 Wilton Business Centre Wilton Salisbury SP20AH

United Kingdom

Adrenaline

Anapen Junior

0,15 mg/dose

Solution for injection in pre-filled syringe

Parenteral use

Sweden

ALK-Abelló A/S

Boge Allé 6-8 DK-2970 Horsholm

Denmark

Adrenaline tartrate

Jext

300 mikrogram

Solution for injection in pre-filled pen

Parenteral use

Sweden

ALK-Abelló A/S

Boge Allé 6-8

DK-2970 Horsholm

Denmark

Adrenaline tartrate

Jext

150 mikrogram

Solution for injection in pre-filled pen

Parenteral use

Sweden

PharmaSwiss Ceska republika s.r.o.

Jankovcova 1569/2c

170 00 Prague

Czech Republic

Adrenaline tartrate

Emerade

500 mikrogram

Solution for injection in pre-filled pen

Parenteral use

Sweden

PharmaSwiss Ceska republika s.r.o.

Jankovcova 1569/2c

170 00 Prague

Czech Republic

Adrenaline tartrate

Emerade

300 mikrogram

Solution for injection in pre-filled pen

Parenteral use

Sweden

PharmaSwiss Ceska republika s.r.o.

Jankovcova 1569/2c

170 00 Prague

Czech Republic

Adrenaline tartrate

Emerade

150 mikrogram

Solution for injection in pre-filled pen

Parenteral use

Sweden

Meda AB

Box 906

170 09 Solna

Sweden

Adrenaline

Nepipe

300 mikrogram

Solution for injection in pre-filled pen

Parenteral use

Sweden

Meda AB

Box 906

170 09 Solna

Sweden

Adrenaline

Nepipe Junior

150 mikrogram

Solution for injection in pre-filled pen

Parenteral use

The Netherlands

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

Anapen, oplossing voor injectie

0,3 microgram/ dosis

Solution for injection

Intramuscular use

The Netherlands

Lincoln Medical Ltd

Unit 8 Wilton Business Centre

Wilton, Salisbury

SP2 0AH

United Kingdom

Adrenaline

Anapen junior, oplossing voor injectie

0,15 microgram/ dosis

Solution for injection

Intramuscular use

The Netherlands

Meda Pharma B.V.

Krijgsman 20

1186 DM Amstelveen

The Netherlands

Adrenaline

EpiPen Junior 150 microgram/dosis

0,15 microgram/ dosis

Solution for injection in a pre-filled syringe

Intramuscular use

The Netherlands

Meda Pharma B.V.

Krijgsman 20

1186 DM Amstelveen

The Netherlands

Adrenaline

EpiPen 300 microgram/dosis

0,3 microgram/ dosis

Solution for injection in a pre-filled syringe

Intramuscular use

The Netherlands

ALK-Abelló A/S

Boge Allé 6-8

DK-2970 Horshlom

Denmark

Adrenaline

Jext 150 microgram, oplossing voor injectie

0,15 microgram/ dosis

Solution for injection

Intramuscular use

The Netherlands

ALK-Abelló A/S

Boge Allé 6-8

DK-2970 Horshlom

Denmark

Adrenaline

Jext 300 microgram, oplossing voor injectie

0,3 microgram/ dosis

Solution for injection

Intramuscular use

United Kingdom

Alk Abello A-S

Boge Alle 6-8

Hersholm 2970

Denmark

Adrenaline tartrate

Jext 150 micrograms solution for injection in pre-filled pen

150 micrograms

Solution for injection

Intramuscular use

United Kingdom

Alk Abello A-S

Boge Alle 6-8.

Hersholm 2970

Denmark

Adrenaline tartrate

Jext 300 micrograms solution for injection in pre-filled pen

300 micrograms

Solution for injection

Intramuscular use

United Kingdom

Aurum Pharmaceuticals Limited, Bampton Road Harold Hill

Romford Essex

RM3 8UG

United Kingdom

Adrenaline acid tartrate

Adrenaline (epinephrine) 1 in 1  000 solution for injection BP auto-injector

1 in 1  000

Solution for injection

Intramuscular/subcutaneous use

United Kingdom

Meda Pharmaceuticals Limited, Skyway House Parsonage Road, Takeley Bishops Stortford

CM22 6PU

United Kingdom

Adrenaline

Epipen auto-injector 0,3 mg

0,3 mg

Solution for injection

Intramuscular use

United Kingdom

Meda Pharmaceuticals Limited

Skyway House, Parsonage Road, Takeley

Bishops Stortford

CM22 6PU

United Kingdom

Adrenaline

Epipen auto-injector 0,15 mg

0,15 mg

Solution for injection

Intramuscular use

United Kingdom

PharmaSwiss Ceska republika s.r.o.

Jankovcova 1569/2c

170 00 Prague

Czech Republic

Adrenaline tartrate

Emerade 150 micrograms solution for injection in pre-filled pen

150 micrograms

Solution for injection

Intramuscular use

United Kingdom

PharmaSwiss Ceska republika s.r.o.

Jankovcova 1569/2c

170 00 Prague

Czech Republic

Adrenaline tartrate

Emerade 300 micrograms solution for injection in pre-filled pen

300 micrograms

Solution for injection

Intramuscular use

United Kingdom

PharmaSwiss Ceska republika s.r.o.

Jankovcova 1569/2c

170 00 Prague

Czech Republic

Adrenaline tartrate

Emerade 500 micrograms solution for injection in pre-filled pen

500 micrograms

Solution for injection

Intramuscular use

---

ANNEX II

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 | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Belgium | GlaxoSmithKline Pharmaceuticals s.a./n.v.
  Site Apollo
  Avenue Pascal, 2- 4- 6
  B-1300 Wavre
  Belgium | Clamoxyl | 1 g | Dispersible tablet | Oral Use | N/A |
| Belgium | GlaxoSmithKline Pharmaceuticals s.a./n.v.
  Site Apollo
  Avenue Pascal, 2- 4- 6
  B-1300 Wavre
  Belgium | Clamoxyl | 500 mg | Capsule, hard | Oral Use | N/A |
| Belgium | GlaxoSmithKline Pharmaceuticals s.a./n.v.
  Site Apollo
  Avenue Pascal, 2- 4- 6
  B-1300 Wavre
  Belgium | Clamoxyl | 125 mg | Powder for oral suspension | Oral Use | 125 mg/5 ml |
| Belgium | GlaxoSmithKline Pharmaceuticals s.a./n.v.
  Site Apollo
  Avenue Pascal, 2- 4- 6
  B-1300 Wavre
  Belgium | Clamoxyl | 250 mg | Powder for oral suspension | Oral Use | 250 mg/5 ml |
| Belgium | GlaxoSmithKline Pharmaceuticals s.a./n.v.
  Site Apollo
  Avenue Pascal, 2- 4- 6
  B-1300 Wavre
  Belgium | Clamoxyl | 500 mg | Powder for oral suspension | Oral Use | 500 mg |
| Belgium | GlaxoSmithKline Pharmaceuticals s.a./n.v.
  Site Apollo
  Avenue Pascal, 2- 4- 6
  B-1300 Wavre
  Belgium | Clamoxyl | 1 g | Powder and solvent for solution for injection | Intravenous/
  Intramuscular | 1 g |
| Cyprus | SmithKline Beecham Limited, 980 Great West Road Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil | 500 mg | Capsule | Oral Use | N/A |
| Cyprus | SmithKline Beecham Limited, 980 Great West Road Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil Forte | 250 mg | Powder for oral suspension | Oral Use | 250 mg/5 ml |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Clamoxyl | 500 mg | Capsule | Oral Use | N/A |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Clamoxyl | 1 g | Dispersible tablet | Oral Use | N/A |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Clamoxyl | 250 mg | Powder for oral suspension | Oral Use | 250 mg/5 ml |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Clamoxyl | 500 mg | Powder for solution for injection | Intravenous/
  Intramuscular | 500 mg |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Clamoxyl | 1 g | Powder for solution for injection | Intravenous/
  Intramuscular | 1 g |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Clamoxyl | 2 g | Powder for solution for injection | Intravenous | 2 g |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Clamoxyl | 1 g | Powder and solvent for solution for injection | Intramuscular | 1 g |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Clamoxyl | 1 g | Powder for oral suspension (sachet) | Oral Use | N/A |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Clamoxyl | 125 mg | Powder for oral suspension | Oral Use | 125 mg/5 ml |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Clamoxyl | 500 mg | Powder for oral suspension | Oral Use | 500 mg/5 ml |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Amoxicilline Biogaran | 1 g | Dispersible tablet | Oral Use | N/A |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Amoxicilline Biogaran | 500 mg | Capsule | Oral Use | N/A |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Amoxicilline Biogaran | 125 mg | Powder for oral suspension | Oral Use | 125 mg/5 ml |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Amoxicilline Biogaran | 250 mg | Powder for oral suspension | Oral Use | 250 mg/5 ml |
| France | Laboratoire GlaxoSmithKline
  100, route de Versailles
  78163 Marly-le-Roi Cedex
  France | Amoxicilline Biogaran | 500 mg | Powder for oral suspension | Oral Use | 500 mg/5 ml |
| Greece | GlaxoSmithKline a.e.b.e.
  266 Kifisias Avenue
  152 32 Halandri
  Greece | Amoxil | 500 mg | Capsule, hard | Oral Use | N/A |
| Greece | GlaxoSmithKline a.e.b.e.
  266 Kifisias Avenue
  152 32 Halandri
  Greece | Amoxil | 250 mg | Powder for oral suspension | Oral Use | 250 mg/5 ml |
| Greece | GlaxoSmithKline a.e.b.e.
  266 Kifisias Avenue
  152 32 Halandri
  Greece | Amoxil | 500 mg | Powder for oral suspension | Oral Use | 500 mg/5 ml |
| Greece | GlaxoSmithKline a.e.b.e.
  266 Kifisias Avenue
  152 32 Halandri
  Greece | Amoxil | 1 g | Dispersible tablet | Oral Use | N/A |
| Greece | GlaxoSmithKline a.e.b.e.
  266 Kifisias Avenue
  152 32 Halandri
  Greece | Amoxil | 1 g | Powder and solvent for solution for injection | Intravenous/
  Intramuscular | 1 g/vial |
| Ireland | GlaxoSmithKline (Ireland) Ltd
  Stonemasons Way
  Rathfarnham
  Dublin 16
  Ireland | Amoxil Paediatric 125 mg/1,25 ml Powder for Oral Suspension | 125 mg | Powder for oral suspension | Oral Use | 125 mg/1,25 ml |
| Ireland | GlaxoSmithKline (Ireland) Ltd
  Stonemasons Way
  Rathfarnham
  Dublin 16
  Ireland | Amoxil 3 g Powder for Oral Suspension Sachets | 3 g | Powder for oral suspension (sachet) | Oral Use | 3 g |
| Ireland | GlaxoSmithKline (Ireland) Ltd
  Stonemasons Way
  Rathfarnham
  Dublin 16
  Ireland | Amoxil Vials 500 mg, powder for solution for injection or infusion | 500 mg | Powder for solution for injection or infusion | Intravenous/
  Intramuscular | 500 mg |
| Latvia | GlaxoSmithKline Latvia SIA
  Duntes iela 11
  Rīga
  LV-1013
  Latvia | Amoxil 500 mg kapsulas | 500 mg | Capsule | Oral Use | N/A |
| Lithuania | Beecham Group plc.
  Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil | 1 g | Dispersible tablet | Oral Use | N/A |
| Lithuania | Beecham Group plc
  Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil | 250 mg | Powder for oral suspension | Oral Use | 250 mg/5 ml |
| Lithuania | Beecham Group plc
  Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil | 500 mg | Capsule, hard | Oral Use | N/A |
| Luxembourg | GlaxoSmithKline Pharmaceuticals s.a./n.v.
  Site Apollo
  Avenue Pascal, 2- 4- 6
  B-1300 Wavre
  Belgium | Clamoxyl | 1 g | Powder and solvent for solution for injection | Intravenous/
  Intramuscular | 1 g |
| Luxembourg | GlaxoSmithKline Pharmaceuticals s.a./n.v.
  Site Apollo
  Avenue Pascal, 2- 4- 6
  B-1300 Wavre
  Belgium | Clamoxyl | 1 g | Powder for solution for injection | Intravenous/
  Intramuscular | 1 g |
| Luxembourg | GlaxoSmithKline Pharmaceuticals s.a./n.v.
  Site Apollo
  Avenue Pascal, 2- 4- 6
  B-1300 Wavre
  Belgium | Clamoxyl | 125 mg | Powder for oral suspension | Oral Use | 125 mg/5 ml |
| Luxembourg | GlaxoSmithKline Pharmaceuticals s.a./n.v.
  Site Apollo
  Avenue Pascal, 2- 4- 6
  B-1300 Wavre
  Belgium | Clamoxyl | 1 g | Dispersible tablet | Oral Use | N/A |
| Luxembourg | GlaxoSmithKline Pharmaceuticals s.a./n.v.
  Site Apollo
  Avenue Pascal, 2- 4- 6
  B-1300 Wavre
  Belgium | Clamoxyl | 250 mg | Powder for oral suspension | Oral Use | 250 mg/5 ml |
| Luxembourg | GlaxoSmithKline Pharmaceuticals s.a./n.v.
  Site Apollo
  Avenue Pascal, 2- 4- 6
  B-1300 Wavre
  Belgium | Clamoxyl | 500 mg | Capsule | Oral Use | N/A |
| Luxembourg | GlaxoSmithKline Pharmaceuticals s.a./n.v.
  Site Apollo
  Avenue Pascal, 2- 4- 6
  B-1300 Wavre
  Belgium | Clamoxyl | 500 mg | Powder for oral suspension | Oral Use | 500 mg/5 ml |
| Malta | Beecham Group plc
  Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil Syrup Sucrose-Free/Dye-Free 250 mg/5 ml | 250 mg | Powder for Oral Suspension | Oral Use | 250 mg/5 ml |
| Malta | Beecham Group plc
  Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil Capsules 500 mg | 500 mg | Capsule | Oral Use | N/A |
| Portugal | Beecham Portuguesa — Produtos Farmacêuticos e Químicos, Lda.
  Rua Dr António Loureiro Borges, 3
  Arquiparque-Miraflores
  1495-131 Algés
  Portugal | Clamoxyl | 500 mg | Capsule | Oral Use | N/A |
| Portugal | Beecham Portuguesa — Produtos Farmacêuticos e Químicos, Lda.
  Rua Dr António Loureiro Borges, 3
  Arquiparque-Miraflores
  1495-131 Algés
  Portugal | Clamoxyl | 1 g | Dispersible tablet | Oral Use | N/A |
| Portugal | Beecham Portuguesa — Produtos Farmacêuticos e Químicos, Lda.
  Rua Dr António Loureiro Borges, 3
  Arquiparque-Miraflores
  1495-131 Algés
  Portugal | Clamoxyl | 250 mg/5 ml | Powder for oral suspension | Oral Use | 250 mg/5 ml |
| Portugal | Beecham Portuguesa — Produtos Farmacêuticos e Químicos, Lda.
  Rua Dr António Loureiro Borges, 3
  Arquiparque-Miraflores
  1495-131 Algés
  Portugal | Clamoxyl | 500 mg/5 ml | Powder for oral suspension | Oral Use | 500 mg/5 ml |
| Spain | GlaxoSmithKline, S.A.
  PTM- Severo Ochoa, 2
  28760-Tres Cantos (Madrid)
  Spain | Clamoxyl 1 g comprimidos | 1 g | Tablet | Oral Use | N/A |
| Spain | GlaxoSmithKline, S.A.
  PTM- Severo Ochoa, 2
  28760-Tres Cantos (Madrid)
  Spain | Clamoxyl 750 mg comprimidos | 750 mg | Tablet | Oral Use | N/A |
| Spain | GlaxoSmithKline, S.A.
  PTM- Severo Ochoa, 2
  28760-Tres Cantos (Madrid)
  Spain | Clamoxyl 500 mg cápsulas | 500 mg | Capsule, hard | Oral Use | N/A |
| Spain | GlaxoSmithKline, S.A.
  PTM- Severo Ochoa, 2
  28760-Tres Cantos (Madrid)
  Spain | Clamoxyl 1 g polvo para suspensión oral en sobre | 1 g | Powder for oral suspension | Oral Use | N/A |
| Spain | GlaxoSmithKline, S.A.
  PTM- Severo Ochoa, 2
  28760-Tres Cantos (Madrid)
  Spain | Clamoxyl 500 mg polvo para suspensión oral en sobre | 500 mg | Powder for oral suspension | Oral Use | N/A |
| Spain | GlaxoSmithKline, S.A.
  PTM- Severo Ochoa, 2
  28760-Tres Cantos (Madrid)
  Spain | Clamoxyl 250 mg polvo para suspensión oral en sobre | 250 mg | Powder for oral suspension | Oral Use | N/A |
| Spain | GlaxoSmithKline, S.A.
  PTM- Severo Ochoa, 2
  28760-Tres Cantos (Madrid)
  Spain | Clamoxyl 250 mg/5 ml polvo para suspensión oral en frasco | 250 mg | Powder for oral suspension | Oral Use | 250 mg/5 ml |
| Spain | GlaxoSmithKline, S.A.
  PTM- Severo Ochoa, 2
  28760-Tres Cantos (Madrid)
  Spain | Clamoxyl 1 g intramuscular | 1 g | Powder and solvent for solution for injection | Intramuscular Use | 1 g/vial |
| United Kingdom | Beecham Group plc
  Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil | 250 mg | Capsule | Oral Use | N/A |
| United Kingdom | Beecham Group plc
  Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil | 500 mg | Capsule | Oral Use | N/A |
| United Kingdom | Beecham Group plc
  Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil paediatric suspension | 125 mg | Powder for oral suspension | Oral Use | 125 mg/1,25 ml |
| United Kingdom | Beecham Group plc
  Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil sachets 3 g sucrose free | 3 g | Powder for oral suspension | Oral Use | 3 g |
| United Kingdom | Beecham Group plc
  Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil Vials for Injection | 250 mg | Powder for solution for injection | Intravenous/
  Intramuscular | 250 mg |
| United Kingdom | Beecham Group plc
  Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil Vials for Injection | 500 mg | Powder for solution for injection | Intravenous/
  Intramuscular | 500 mg |
| United Kingdom | Beecham Group plc
  Great West Road
  Brentford
  Middlesex TW8 9GS
  United Kingdom | Amoxil Vials for Injection | 1 g | Powder for solution for injection | Intravenous/
  Intramuscular | 1 g |

Member State (in EEA)

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Content (concentration)

Belgium

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Site Apollo

Avenue Pascal, 2- 4- 6

B-1300 Wavre

Belgium

Clamoxyl

1 g

Dispersible tablet

Oral Use

N/A

Belgium

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Site Apollo

Avenue Pascal, 2- 4- 6

B-1300 Wavre

Belgium

Clamoxyl

500 mg

Capsule, hard

Oral Use

N/A

Belgium

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Site Apollo

Avenue Pascal, 2- 4- 6

B-1300 Wavre

Belgium

Clamoxyl

125 mg

Powder for oral suspension

Oral Use

125 mg/5 ml

Belgium

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Site Apollo

Avenue Pascal, 2- 4- 6

B-1300 Wavre

Belgium

Clamoxyl

250 mg

Powder for oral suspension

Oral Use

250 mg/5 ml

Belgium

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Site Apollo

Avenue Pascal, 2- 4- 6

B-1300 Wavre

Belgium

Clamoxyl

500 mg

Powder for oral suspension

Oral Use

500 mg

Belgium

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Site Apollo

Avenue Pascal, 2- 4- 6

B-1300 Wavre

Belgium

Clamoxyl

1 g

Powder and solvent for solution for injection

Intravenous/

Intramuscular

1 g

Cyprus

SmithKline Beecham Limited, 980 Great West Road Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil

500 mg

Capsule

Oral Use

N/A

Cyprus

SmithKline Beecham Limited, 980 Great West Road Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil Forte

250 mg

Powder for oral suspension

Oral Use

250 mg/5 ml

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Clamoxyl

500 mg

Capsule

Oral Use

N/A

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Clamoxyl

1 g

Dispersible tablet

Oral Use

N/A

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Clamoxyl

250 mg

Powder for oral suspension

Oral Use

250 mg/5 ml

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Clamoxyl

500 mg

Powder for solution for injection

Intravenous/

Intramuscular

500 mg

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Clamoxyl

1 g

Powder for solution for injection

Intravenous/

Intramuscular

1 g

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Clamoxyl

2 g

Powder for solution for injection

Intravenous

2 g

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Clamoxyl

1 g

Powder and solvent for solution for injection

Intramuscular

1 g

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Clamoxyl

1 g

Powder for oral suspension (sachet)

Oral Use

N/A

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Clamoxyl

125 mg

Powder for oral suspension

Oral Use

125 mg/5 ml

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Clamoxyl

500 mg

Powder for oral suspension

Oral Use

500 mg/5 ml

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Amoxicilline Biogaran

1 g

Dispersible tablet

Oral Use

N/A

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Amoxicilline Biogaran

500 mg

Capsule

Oral Use

N/A

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Amoxicilline Biogaran

125 mg

Powder for oral suspension

Oral Use

125 mg/5 ml

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Amoxicilline Biogaran

250 mg

Powder for oral suspension

Oral Use

250 mg/5 ml

France

Laboratoire GlaxoSmithKline

100, route de Versailles

78163 Marly-le-Roi Cedex

France

Amoxicilline Biogaran

500 mg

Powder for oral suspension

Oral Use

500 mg/5 ml

Greece

GlaxoSmithKline a.e.b.e.

266 Kifisias Avenue

152 32 Halandri

Greece

Amoxil

500 mg

Capsule, hard

Oral Use

N/A

Greece

GlaxoSmithKline a.e.b.e.

266 Kifisias Avenue

152 32 Halandri

Greece

Amoxil

250 mg

Powder for oral suspension

Oral Use

250 mg/5 ml

Greece

GlaxoSmithKline a.e.b.e.

266 Kifisias Avenue

152 32 Halandri

Greece

Amoxil

500 mg

Powder for oral suspension

Oral Use

500 mg/5 ml

Greece

GlaxoSmithKline a.e.b.e.

266 Kifisias Avenue

152 32 Halandri

Greece

Amoxil

1 g

Dispersible tablet

Oral Use

N/A

Greece

GlaxoSmithKline a.e.b.e.

266 Kifisias Avenue

152 32 Halandri

Greece

Amoxil

1 g

Powder and solvent for solution for injection

Intravenous/

Intramuscular

1 g/vial

Ireland

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Amoxil Paediatric 125 mg/1,25 ml Powder for Oral Suspension

125 mg

Powder for oral suspension

Oral Use

125 mg/1,25 ml

Ireland

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Amoxil 3 g Powder for Oral Suspension Sachets

3 g

Powder for oral suspension (sachet)

Oral Use

3 g

Ireland

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Amoxil Vials 500 mg, powder for solution for injection or infusion

500 mg

Powder for solution for injection or infusion

Intravenous/

Intramuscular

500 mg

Latvia

GlaxoSmithKline Latvia SIA

Duntes iela 11

Rīga

LV-1013

Latvia

Amoxil 500 mg kapsulas

500 mg

Capsule

Oral Use

N/A

Lithuania

Beecham Group plc.

Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil

1 g

Dispersible tablet

Oral Use

N/A

Lithuania

Beecham Group plc

Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil

250 mg

Powder for oral suspension

Oral Use

250 mg/5 ml

Lithuania

Beecham Group plc

Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil

500 mg

Capsule, hard

Oral Use

N/A

Luxembourg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Site Apollo

Avenue Pascal, 2- 4- 6

B-1300 Wavre

Belgium

Clamoxyl

1 g

Powder and solvent for solution for injection

Intravenous/

Intramuscular

1 g

Luxembourg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Site Apollo

Avenue Pascal, 2- 4- 6

B-1300 Wavre

Belgium

Clamoxyl

1 g

Powder for solution for injection

Intravenous/

Intramuscular

1 g

Luxembourg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Site Apollo

Avenue Pascal, 2- 4- 6

B-1300 Wavre

Belgium

Clamoxyl

125 mg

Powder for oral suspension

Oral Use

125 mg/5 ml

Luxembourg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Site Apollo

Avenue Pascal, 2- 4- 6

B-1300 Wavre

Belgium

Clamoxyl

1 g

Dispersible tablet

Oral Use

N/A

Luxembourg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Site Apollo

Avenue Pascal, 2- 4- 6

B-1300 Wavre

Belgium

Clamoxyl

250 mg

Powder for oral suspension

Oral Use

250 mg/5 ml

Luxembourg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Site Apollo

Avenue Pascal, 2- 4- 6

B-1300 Wavre

Belgium

Clamoxyl

500 mg

Capsule

Oral Use

N/A

Luxembourg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Site Apollo

Avenue Pascal, 2- 4- 6

B-1300 Wavre

Belgium

Clamoxyl

500 mg

Powder for oral suspension

Oral Use

500 mg/5 ml

Malta

Beecham Group plc

Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil Syrup Sucrose-Free/Dye-Free 250 mg/5 ml

250 mg

Powder for Oral Suspension

Oral Use

250 mg/5 ml

Malta

Beecham Group plc

Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil Capsules 500 mg

500 mg

Capsule

Oral Use

N/A

Portugal

Beecham Portuguesa — Produtos Farmacêuticos e Químicos, Lda.

Rua Dr António Loureiro Borges, 3

Arquiparque-Miraflores

1495-131 Algés

Portugal

Clamoxyl

500 mg

Capsule

Oral Use

N/A

Portugal

Beecham Portuguesa — Produtos Farmacêuticos e Químicos, Lda.

Rua Dr António Loureiro Borges, 3

Arquiparque-Miraflores

1495-131 Algés

Portugal

Clamoxyl

1 g

Dispersible tablet

Oral Use

N/A

Portugal

Beecham Portuguesa — Produtos Farmacêuticos e Químicos, Lda.

Rua Dr António Loureiro Borges, 3

Arquiparque-Miraflores

1495-131 Algés

Portugal

Clamoxyl

250 mg/5 ml

Powder for oral suspension

Oral Use

250 mg/5 ml

Portugal

Beecham Portuguesa — Produtos Farmacêuticos e Químicos, Lda.

Rua Dr António Loureiro Borges, 3

Arquiparque-Miraflores

1495-131 Algés

Portugal

Clamoxyl

500 mg/5 ml

Powder for oral suspension

Oral Use

500 mg/5 ml

Spain

GlaxoSmithKline, S.A.

PTM- Severo Ochoa, 2

28760-Tres Cantos (Madrid)

Spain

Clamoxyl 1 g comprimidos

1 g

Tablet

Oral Use

N/A

Spain

GlaxoSmithKline, S.A.

PTM- Severo Ochoa, 2

28760-Tres Cantos (Madrid)

Spain

Clamoxyl 750 mg comprimidos

750 mg

Tablet

Oral Use

N/A

Spain

GlaxoSmithKline, S.A.

PTM- Severo Ochoa, 2

28760-Tres Cantos (Madrid)

Spain

Clamoxyl 500 mg cápsulas

500 mg

Capsule, hard

Oral Use

N/A

Spain

GlaxoSmithKline, S.A.

PTM- Severo Ochoa, 2

28760-Tres Cantos (Madrid)

Spain

Clamoxyl 1 g polvo para suspensión oral en sobre

1 g

Powder for oral suspension

Oral Use

N/A

Spain

GlaxoSmithKline, S.A.

PTM- Severo Ochoa, 2

28760-Tres Cantos (Madrid)

Spain

Clamoxyl 500 mg polvo para suspensión oral en sobre

500 mg

Powder for oral suspension

Oral Use

N/A

Spain

GlaxoSmithKline, S.A.

PTM- Severo Ochoa, 2

28760-Tres Cantos (Madrid)

Spain

Clamoxyl 250 mg polvo para suspensión oral en sobre

250 mg

Powder for oral suspension

Oral Use

N/A

Spain

GlaxoSmithKline, S.A.

PTM- Severo Ochoa, 2

28760-Tres Cantos (Madrid)

Spain

Clamoxyl 250 mg/5 ml polvo para suspensión oral en frasco

250 mg

Powder for oral suspension

Oral Use

250 mg/5 ml

Spain

GlaxoSmithKline, S.A.

PTM- Severo Ochoa, 2

28760-Tres Cantos (Madrid)

Spain

Clamoxyl 1 g intramuscular

1 g

Powder and solvent for solution for injection

Intramuscular Use

1 g/vial

United Kingdom

Beecham Group plc

Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil

250 mg

Capsule

Oral Use

N/A

United Kingdom

Beecham Group plc

Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil

500 mg

Capsule

Oral Use

N/A

United Kingdom

Beecham Group plc

Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil paediatric suspension

125 mg

Powder for oral suspension

Oral Use

125 mg/1,25 ml

United Kingdom

Beecham Group plc

Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil sachets 3 g sucrose free

3 g

Powder for oral suspension

Oral Use

3 g

United Kingdom

Beecham Group plc

Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil Vials for Injection

250 mg

Powder for solution for injection

Intravenous/

Intramuscular

250 mg

United Kingdom

Beecham Group plc

Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil Vials for Injection

500 mg

Powder for solution for injection

Intravenous/

Intramuscular

500 mg

United Kingdom

Beecham Group plc

Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Amoxil Vials for Injection

1 g

Powder for solution for injection

Intravenous/

Intramuscular

1 g

---

ANNEX III

List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States

| Member State
  (EU/EEA) | Marketing authorisation holder | Product name | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Ceva Santé Animale
  10, av. de La Ballastière
  33500 Libourne
  France | Coglapix suspension for injection for pigs | Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)
  expressing ApxI toxoid min. 28,9 ELISA unit/ml*
  ApxII toxoid min. 16,7 ELISA unit/ml
  ApxIII toxoid min. 6,8 ELISA unit/ml






  - | Elisa unit/ml calculated serological titre in sera of immunised rabbits |

Member State

(EU/EEA)

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Belgium

Ceva Santé Animale S.A/N.V.

Metrologielaan 6

1130 Brussel

Belgium

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Bulgaria

Ceva Animal Health Bulgaria

ul. Elemag 26, vh.b, Et.1, Apt.1

Sofia - 1113

Bulgaria

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Croatia

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Cyprus

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Czech Republic

Ceva Animal Health Slovakia, s.r.o.

Račianska 153

831 53 Bratislava

Slovakia

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Estonia

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

FRANCE

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Finland

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Germany

Ceva Tiergesundheit GmbH

Kanzlerstr. 4

40472 Düsseldorf

Germany

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Greece

Ceva Hellas LLC

15, Agiou Nikolaou str.

17455 ALIMOS

Greece

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Hungary

CEVA-Phylaxia Veterinary Biologicals Co. Ltd

Szállás u. 5.

1107 Budapest

Hungary

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Iceland

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Ireland

Ceva Santé Animale

10, av. de La Ballastière, 33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Italy

Ceva Salute Animale S.p.A.

Viale Colleoni 15, 20864 Agrate Brianza (MB)

Italy

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Latvia

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Lituania

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

The Netherlands

Ceva Sante Animale B.V.

Tiendweg 8 c, 2670 AB Naaldwijk

The Netherlands

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Poland

Ceva Animal Health Polska Sp. z o.o.

ul. Okrzei 1A,

03-715 Warszawa

Poland

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Portugal

Ceva Saúde Animal

Produtos Farmacéuticos e Imunológicos, Lda.

Rua Doutor António Loureiro Borges

9/9A — 9oA, Miraflores, 1495 — 131 Algès

Portugal

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Romania

Ceva Santé Animale Romania

Str. Chindiei nr. 5

Sector 4

040185 Bucharest

Romania

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Slovakia

Ceva Animal Health Slovakia, s.r.o.

Račianska 153

831 53 Bratislava

Slovakia

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Slovenia

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Sweden

Ceva Animal Health A.B.

Annedalsvägen 9

227 64 Lund

Sweden

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

United Kingdom

Ceva Animal Health Ltd

Unit 3, Anglo Office Park, White Lion Road

Amersham, Bucks HP7 9FB

United Kingdom

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

| * | Elisa unit/ml calculated serological titre in sera of immunised rabbits |
| --- | --- |

*

Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

---