# Official Journal C 312/26 A

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 312 |
| | |
| English edition | Information and Notices | Volume 5926 August 2016 |

ISSN 1977-091X

Official Journal

of the European Union

C 312

English edition

Information and Notices

Volume 5926 August 2016

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2016/C 312/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2016/C 312/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 10 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2016/C 312/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

2016/C 312/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016(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)

10

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| | Corrigenda |
| --- | --- |
| 2016/C 312/03 | Corrigendum to Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016
  ( OJ C 154, 29.4.2016 ) | 22 |

Corrigenda

2016/C 312/03

Corrigendum to Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016
  ( OJ C 154, 29.4.2016 )

( OJ C 154, 29.4.2016 )

22

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 26.8.2016 | EN | Official Journal of the European Union | C 312/1 |
| --- | --- | --- | --- |

26.8.2016

EN

Official Journal of the European Union

C 312/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016

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

(2016/C 312/01)

—   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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.7.2016 | Zinbryta | daclizumab | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | Solution for injection | L04AC01 | 5.7.2016 |
| 6.7.2016 | EndolucinBeta | Lutetium (177 Lu) chloride | ITG Isotope Technologies Garching GmbH
  Lichtenbergstr. 1, D-85748 Garching, Deutschland | EU/1/16/1105 | Radiopharmaceutical precursor, solution | Pending | 8.7.2016 |
| 6.7.2016 | Epclusa | sofosbuvir/velpatasvir | Gilead Sciences International Ltd
  Cambridge, CB21 6GT, United Kingdom | EU/1/16/1116 | Film-coated tablet | Pending | 8.7.2016 |
| 15.7.2016 | Qtern | saxagliptin/dapagliflozin | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/16/1108 | Film-coated tablet | A10BD21 | 19.7.2016 |
| 22.7.2016 | Bortezomib Hospira | bortezomib | Hospira UK Limited
  Horizon, Honey Lane, Hurley, SL6 6RJ, United Kingdom | EU/1/16/1114 | Powder for solution for infusion | L01XX32 | 26.7.2016 |
| 22.7.2016 | Bortezomib SUN | bortezomib | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/16/1102 | Powder for solution for injection | L01XX32 | 26.7.2016 |
| 22.7.2016 | Pemetrexed Fresenius Kabi | pemetrexed | Fresenius Kabi Oncology Plc.
  Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom | EU/1/16/1115 | Powder for concentrate for solution for infusion | L01BA04 | 26.7.2016 |
| 22.7.2016 | Zepatier | elbasvir/grazoprevir | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/16/1119 | Film-coated tablet | J05A | 26.7.2016 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

1.7.2016

Zinbryta

daclizumab

Biogen Idec Limited

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

EU/1/16/1107

Solution for injection

L04AC01

5.7.2016

6.7.2016

EndolucinBeta

Lutetium (177 Lu) chloride

ITG Isotope Technologies Garching GmbH

Lichtenbergstr. 1, D-85748 Garching, Deutschland

EU/1/16/1105

Radiopharmaceutical precursor, solution

Pending

8.7.2016

6.7.2016

Epclusa

sofosbuvir/velpatasvir

Gilead Sciences International Ltd

Cambridge, CB21 6GT, United Kingdom

EU/1/16/1116

Film-coated tablet

Pending

8.7.2016

15.7.2016

Qtern

saxagliptin/dapagliflozin

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/16/1108

Film-coated tablet

A10BD21

19.7.2016

22.7.2016

Bortezomib Hospira

bortezomib

Hospira UK Limited

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

EU/1/16/1114

Powder for solution for infusion

L01XX32

26.7.2016

22.7.2016

Bortezomib SUN

bortezomib

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/16/1102

Powder for solution for injection

L01XX32

26.7.2016

22.7.2016

Pemetrexed Fresenius Kabi

pemetrexed

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom

EU/1/16/1115

Powder for concentrate for solution for infusion

L01BA04

26.7.2016

22.7.2016

Zepatier

elbasvir/grazoprevir

Merck Sharp & Dohme Limited

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

EU/1/16/1119

Film-coated tablet

J05A

26.7.2016

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.7.2016 | BiResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/921 | 6.7.2016 |
| 4.7.2016 | Clopidogrel Apotex | Apotex Europe B.V.
  Darwinweg 20, NL- 2333 CR Leiden, Nederland | EU/1/09/568 | 6.7.2016 |
| 4.7.2016 | Duloxetine Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/972 | 6.7.2016 |
| 4.7.2016 | DuoResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/920 | 6.7.2016 |
| 6.7.2016 | Arzerra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/625 | 8.7.2016 |
| 6.7.2016 | Budesonide/Formoterol Teva | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/948 | 8.7.2016 |
| 6.7.2016 | Mircera | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/07/400 | 8.7.2016 |
| 6.7.2016 | Nivestim | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/10/631 | 8.7.2016 |
| 6.7.2016 | Olanzapine Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/08/475 | 12.7.2016 |
| 6.7.2016 | Oprymea | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/08/469 | 8.7.2016 |
| 6.7.2016 | Rapilysin | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/96/018 | 8.7.2016 |
| 6.7.2016 | Vylaer Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/949 | 8.7.2016 |
| 6.7.2016 | Xarelto | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/08/472 | 8.7.2016 |
| 8.7.2016 | Otezla | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/14/981 | 12.7.2016 |
| 8.7.2016 | Revlimid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/07/391 | 12.7.2016 |
| 14.7.2016 | Ariclaim | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/283 | 18.7.2016 |
| 14.7.2016 | Votrient | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/628 | 18.7.2016 |
| 15.7.2016 | ATryn | GTC Biotherapeutics UK Limited
  10 Norwich Street, London EC4A 1BD, United Kingdom | EU/1/06/355 | 19.7.2016 |
| 15.7.2016 | Exjade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/356 | 19.7.2016 |
| 15.7.2016 | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 19.7.2016 |
| 15.7.2016 | Komboglyze | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/731 | 19.7.2016 |
| 15.7.2016 | Leflunomide medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/10/637 | 19.7.2016 |
| 15.7.2016 | Levetiracetam Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/701 | 19.7.2016 |
| 15.7.2016 | Luminity | Lantheus MI UK Limited
  Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom | EU/1/06/361 | 19.7.2016 |
| 15.7.2016 | NeoRecormon | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/97/031 | 19.7.2016 |
| 15.7.2016 | Noxafil | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/320 | 19.7.2016 |
| 15.7.2016 | Opsumit | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/13/893 | 19.7.2016 |
| 15.7.2016 | Pramipexole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/728 | 19.7.2016 |
| 15.7.2016 | Remicade | Janssen Biologics B.V.
  Einsteinweg 101, NL-2333 CB Leiden, Nederland | EU/1/99/116 | 19.7.2016 |
| 15.7.2016 | Sprycel | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/363 | 19.7.2016 |
| 15.7.2016 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/08/494 | 19.7.2016 |
| 15.7.2016 | Synjardy | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | 19.7.2016 |
| 15.7.2016 | Temozolomide HEXAL | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/10/616 | 19.7.2016 |
| 15.7.2016 | Temozolomide Sandoz | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/10/617 | 19.7.2016 |
| 15.7.2016 | Thalidomide Celgene | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/08/443 | 19.7.2016 |
| 15.7.2016 | Thyrogen | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/99/122 | 19.7.2016 |
| 15.7.2016 | Zoledronic acid Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/772 | 19.7.2016 |
| 22.7.2016 | Byetta | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/06/362 | 26.7.2016 |
| 22.7.2016 | Cialis | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/02/237 | 26.7.2016 |
| 22.7.2016 | Conbriza | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/09/511 | 26.7.2016 |
| 22.7.2016 | Cymbalta | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/296 | 26.7.2016 |
| 22.7.2016 | EDURANT | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/736 | 26.7.2016 |
| 22.7.2016 | Eviplera | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/11/737 | 26.7.2016 |
| 22.7.2016 | Granupas | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/13/896 | 26.7.2016 |
| 22.7.2016 | Harvoni | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/958 | 26.7.2016 |
| 22.7.2016 | Levetiracetam Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/712 | 26.7.2016 |
| 22.7.2016 | Noxafil | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/320 | 26.7.2016 |
| 22.7.2016 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 26.7.2016 |
| 22.7.2016 | Rebif | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/98/063 | 27.7.2016 |
| 22.7.2016 | Ryzodeg | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/12/806 | 26.7.2016 |
| 22.7.2016 | Temomedac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/09/605 | 26.7.2016 |
| 22.7.2016 | Vizamyl | GE Healthcare Ltd
  Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom | EU/1/14/941 | 26.7.2016 |
| 22.7.2016 | Vyndaqel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/11/717 | 26.7.2016 |
| 22.7.2016 | Xeristar | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/297 | 26.7.2016 |
| 29.7.2016 | Cervarix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/07/419 | 2.8.2016 |
| 29.7.2016 | Firdapse | BioMarin Europe Ltd
  10 Bloomsbury Way, London WC1A 2SL, United Kingdom | EU/1/09/601 | 2.8.2016 |
| 29.7.2016 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 2.8.2016 |
| 29.7.2016 | Jakavi | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/773 | 2.8.2016 |
| 29.7.2016 | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 2.8.2016 |
| 29.7.2016 | Nevanac | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/07/433 | 2.8.2016 |
| 29.7.2016 | ReFacto AF | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/99/103 | 3.8.2016 |
| 29.7.2016 | Revatio | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/05/318 | 3.8.2016 |
| 29.7.2016 | Ribavirin Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/10/634 | 4.8.2016 |
| 29.7.2016 | RoActemra | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/08/492 | 2.8.2016 |
| 29.7.2016 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 4.8.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

4.7.2016

BiResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/921

6.7.2016

4.7.2016

Clopidogrel Apotex

Apotex Europe B.V.

Darwinweg 20, NL- 2333 CR Leiden, Nederland

EU/1/09/568

6.7.2016

4.7.2016

Duloxetine Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/972

6.7.2016

4.7.2016

DuoResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/920

6.7.2016

6.7.2016

Arzerra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/625

8.7.2016

6.7.2016

Budesonide/Formoterol Teva

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/948

8.7.2016

6.7.2016

Mircera

Roche Registration Limited

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

EU/1/07/400

8.7.2016

6.7.2016

Nivestim

Hospira UK Limited

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

EU/1/10/631

8.7.2016

6.7.2016

Olanzapine Mylan

Generics [UK] Limited

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

EU/1/08/475

12.7.2016

6.7.2016

Oprymea

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/469

8.7.2016

6.7.2016

Rapilysin

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/96/018

8.7.2016

6.7.2016

Vylaer Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/949

8.7.2016

6.7.2016

Xarelto

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/08/472

8.7.2016

8.7.2016

Otezla

Celgene Europe Limited

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

EU/1/14/981

12.7.2016

8.7.2016

Revlimid

Celgene Europe Limited

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

EU/1/07/391

12.7.2016

14.7.2016

Ariclaim

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/283

18.7.2016

14.7.2016

Votrient

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/628

18.7.2016

15.7.2016

ATryn

GTC Biotherapeutics UK Limited

10 Norwich Street, London EC4A 1BD, United Kingdom

EU/1/06/355

19.7.2016

15.7.2016

Exjade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/356

19.7.2016

15.7.2016

Jardiance

Boehringer Ingelheim International GmbH

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

EU/1/14/930

19.7.2016

15.7.2016

Komboglyze

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/731

19.7.2016

15.7.2016

Leflunomide medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/10/637

19.7.2016

15.7.2016

Levetiracetam Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/701

19.7.2016

15.7.2016

Luminity

Lantheus MI UK Limited

Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom

EU/1/06/361

19.7.2016

15.7.2016

NeoRecormon

Roche Registration Limited

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

EU/1/97/031

19.7.2016

15.7.2016

Noxafil

Merck Sharp & Dohme Limited

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

EU/1/05/320

19.7.2016

15.7.2016

Opsumit

Actelion Registration Ltd

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

EU/1/13/893

19.7.2016

15.7.2016

Pramipexole Accord

Accord Healthcare Limited

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

EU/1/11/728

19.7.2016

15.7.2016

Remicade

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/99/116

19.7.2016

15.7.2016

Sprycel

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/363

19.7.2016

15.7.2016

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/494

19.7.2016

15.7.2016

Synjardy

Boehringer Ingelheim International GmbH

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

EU/1/15/1003

19.7.2016

15.7.2016

Temozolomide HEXAL

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/10/616

19.7.2016

15.7.2016

Temozolomide Sandoz

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/10/617

19.7.2016

15.7.2016

Thalidomide Celgene

Celgene Europe Limited

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

EU/1/08/443

19.7.2016

15.7.2016

Thyrogen

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/99/122

19.7.2016

15.7.2016

Zoledronic acid Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/772

19.7.2016

22.7.2016

Byetta

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/06/362

26.7.2016

22.7.2016

Cialis

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/02/237

26.7.2016

22.7.2016

Conbriza

Pfizer Limited

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

EU/1/09/511

26.7.2016

22.7.2016

Cymbalta

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/296

26.7.2016

22.7.2016

EDURANT

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/736

26.7.2016

22.7.2016

Eviplera

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/11/737

26.7.2016

22.7.2016

Granupas

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/896

26.7.2016

22.7.2016

Harvoni

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/958

26.7.2016

22.7.2016

Levetiracetam Accord

Accord Healthcare Limited

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

EU/1/11/712

26.7.2016

22.7.2016

Noxafil

Merck Sharp & Dohme Limited

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

EU/1/05/320

26.7.2016

22.7.2016

Ofev

Boehringer Ingelheim International GmbH

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

EU/1/14/979

26.7.2016

22.7.2016

Rebif

Merck Serono Europe Limited

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

EU/1/98/063

27.7.2016

22.7.2016

Ryzodeg

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/806

26.7.2016

22.7.2016

Temomedac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/09/605

26.7.2016

22.7.2016

Vizamyl

GE Healthcare Ltd

Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom

EU/1/14/941

26.7.2016

22.7.2016

Vyndaqel

Pfizer Limited

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

EU/1/11/717

26.7.2016

22.7.2016

Xeristar

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/297

26.7.2016

29.7.2016

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/07/419

2.8.2016

29.7.2016

Firdapse

BioMarin Europe Ltd

10 Bloomsbury Way, London WC1A 2SL, United Kingdom

EU/1/09/601

2.8.2016

29.7.2016

Imnovid

Celgene Europe Limited

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

EU/1/13/850

2.8.2016

29.7.2016

Jakavi

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/773

2.8.2016

29.7.2016

KEYTRUDA

Merck Sharp & Dohme Limited

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

EU/1/15/1024

2.8.2016

29.7.2016

Nevanac

Alcon Laboratories (UK) Ltd

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

EU/1/07/433

2.8.2016

29.7.2016

ReFacto AF

Pfizer Limited

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

EU/1/99/103

3.8.2016

29.7.2016

Revatio

Pfizer Limited

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

EU/1/05/318

3.8.2016

29.7.2016

Ribavirin Mylan

Generics [UK] Limited

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

EU/1/10/634

4.8.2016

29.7.2016

RoActemra

Roche Registration Limited

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

EU/1/08/492

2.8.2016

29.7.2016

XALKORI

Pfizer Limited

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

EU/1/12/793

4.8.2016

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 29.7.2016 | ChondroCelect | TiGenix NV
  Romeinse straat 12/2, B-3001 Leuven, België | EU/1/09/563 | 2.8.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

29.7.2016

ChondroCelect

TiGenix NV

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

EU/1/09/563

2.8.2016

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.7.2016 | Suvaxyn CSF Marker | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/179 | 6.7.2016 |
| 8.7.2016 | Oxyglobin | OPK Biotech Netherlands BV
  Teleportboulevard 140, NL-1043 EJ Amsterdam, Nederland | EU/2/99/015 | 12.7.2016 |
| 19.7.2016 | ERYSENG | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | EU/2/14/166 | 21.7.2016 |
| 25.7.2016 | Eurican Herpes 205 | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/01/029 | 27.7.2016 |
| 25.7.2016 | Osurnia | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM | EU/2/14/170 | 27.7.2016 |
| 25.7.2016 | Porcilis ColiClos | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/12/141 | 27.7.2016 |
| 25.7.2016 | Prac-Tic | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM | EU/2/06/066 | 27.7.2016 |
| 25.7.2016 | STARTVAC | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | EU/2/08/092 | 27.7.2016 |
| 29.7.2016 | Ingelvac CircoFLEX | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/07/079 | 2.8.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

4.7.2016

Suvaxyn CSF Marker

Zoetis Belgium S.A.

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

EU/2/14/179

6.7.2016

8.7.2016

Oxyglobin

OPK Biotech Netherlands BV

Teleportboulevard 140, NL-1043 EJ Amsterdam, Nederland

EU/2/99/015

12.7.2016

19.7.2016

ERYSENG

Laboratorios Hipra, S.A.

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

EU/2/14/166

21.7.2016

25.7.2016

Eurican Herpes 205

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/01/029

27.7.2016

25.7.2016

Osurnia

Elanco Europe Ltd

Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM

EU/2/14/170

27.7.2016

25.7.2016

Porcilis ColiClos

Intervet International B.V.

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

EU/2/12/141

27.7.2016

25.7.2016

Prac-Tic

Elanco Europe Ltd

Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM

EU/2/06/066

27.7.2016

25.7.2016

STARTVAC

Laboratorios Hipra, S.A.

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

EU/2/08/092

27.7.2016

29.7.2016

Ingelvac CircoFLEX

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/07/079

2.8.2016

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

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

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

---

| 26.8.2016 | EN | Official Journal of the European Union | C 312/10 |
| --- | --- | --- | --- |

26.8.2016

EN

Official Journal of the European Union

C 312/10

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016

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

(2016/C 312/02)

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 8.8.2016 | Saizen (and associated names) and Humatrope (and associated names) | somatropin | Not applicable | Not applicable | 9.8.2016 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

8.8.2016

Saizen (and associated names) and Humatrope (and associated names)

somatropin

Not applicable

Not applicable

9.8.2016

—   Revocation of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 14.7.2016 | Colistin combinations | colistin | See Annex I | See Annex I | 15.7.2016 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

14.7.2016

Colistin combinations

colistin

See Annex I

See Annex I

15.7.2016

---

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

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

---

ANNEX

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

| Member State EU/EEA | Marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Bulgaria | Farma vet Ltd
  40 Otec Paisii str.
  Shumen
  Bulgaria | Колитетравит/COLI — TETRAVIT | Oxytetracycline hydrochloride
  Colistin sulphate | 5,0  g
  3 500 000 UI | Oral solution | Chickens and pigs | Oral administration |
| Bulgaria | COOPHAVET S.A.S.
  B.P. 7 Saint Herblon
  44153 ANCENIS Cedex
  France | Колисултрикс/COLISULTRIX | Trimethoprim
  Colistin sulphate | 3,75  g
  50 MIU | Oral powder | Chickens, rabbits, pigs, calves and lambs | Oral administration |
| Croatia | Arnika Veterina d.o.o.
  Vodovodna 20a
  10000 Zagreb
  Croatia | COLISULTRIX | Trimethoprim
  Colistin sulphate | 3,75  g
  50 MIU | Oral powder | Calves, lambs, kids, piglets, poultry and rabbits | Oral |
| Croatia | Ceva Santé Animale
  10 Avenue de la Ballastière
  33500 Libourne
  France | QUINOCOL | Enrofloxacin
  Colistin sulphate | 100 g
  41,67  g | Oral solution | Chicken, turkey | Oral |
| Cyprus | FATRO S.p.A.
  Via Emilia, 285
  40064 Ozzano Emilia (Bologna)
  Italy | BACOLAM powder for oral solution for calves, sheep, goats, pigs, foals, chickens, turkeys (excluding layers) | Amoxicillin trihydrate
  Colistin sulphate | 100 mg
  500 000 I.U. | Powder for oral solution | Calves, sheep, goats, pigs, foals, chickens, turkeys (excluding layers) | Administer the dose subdivided into two administrations each day, dissolved in drinking water or in milk. |
| Cyprus | Vetoquinol Italia S.R.L
  Via Piana, 265
  47032 Bertinoro
  Italy | ZEMAMIX premix for medicated feedingstuff for pigs | Amoxicillin trihydrate
  Colistin sulphate | 11,48  g
  4,00  g | Premix for medicated feedingstuff | Pigs | Premix for medicated feedingstuff in insoluble powder, to be administered orally properly mixed in solid feed. |
| Czech Republic | LAVET Pharmaceuticals Ltd
  Ottó u.14
  1161 Budapest
  Hungary | AMOXYCOL plv.sol. | Amoxicillin trihydrate
  Colistin sulphate | 640 mg/g
  3 200 000 IU/g | Powder for oral solution for use in drinking water or in feed | Pigs, chicken (broilers) | Oral |
| Czech Republic | COOPHAVET S.A.S.
  B.P. 7 Saint Herblon
  44153 ANCENIS Cedex
  France | BELCOSPIRA ORAL prášek pro přípravu perorálního roztoku | Colistin sulphate Spiramycin adipate | 500 000 IU
  650 000 IU | Powder for oral solution | Calves, piglets, foals, chicken | Oral |
| Czech Republic | COOPHAVET S.A.S.
  B.P. 7 Saint Herblon
  44153 ANCENIS Cedex
  France | COLISULTRIX plv. sol. | Trimethoprim
  Colistin sulphate | 37,5  mg
  500 000 IU/g | Powder for oral solution | Chicken | Oral |
| Czech Republic | Industria Italiana Integratori Trei S.p.A.
  Via Corassori, 62
  41100 Modena
  Italy | MICROAMOX COLI premix pro medikaci krmiva | Amoxicillin trihydrate
  Colistin sulphate | 100 mg/g
  600 000 IU/g | Premix for medicated feed | Pigs | Oral |
| France | MERIAL
  29 avenue Tony Garnier
  69007 LYON
  France | BELCOSPIRA ORAL | Colistin sulphate
  Spiramycin adipate | 500 000 IU/g
  650 000 IU/g | Powder for oral use | Cattle, pigs, poultry | Oral use |
| France | LABORATOIRES BIOVE
  3 Rue de Lorraine
  62510 Arques
  France | COLAMPI B | Ampicillin trihydrate
  Colistin sulphate | 25 mg/g
  0,075 MIU/g | Powder for oral use | Pigs, calves | Oral use |
| France | LABORATOIRES BIOVE
  3 Rue de Lorraine
  62510 Arques
  France | COLAMPI O | Ampicillin trihydrate
  Colistin sulphate | 1 g/tablet
  1 MIU/tablet | Tablet | Calves | Oral use |
| France | VETOQUINOL
  Magny Vernois
  70200 Lure
  France | COLIDIARYL | Colistin sulphate Erythromycin estolate | 83 400 IU/g
  16 600 IU/g | Powder for oral use | Lamb, goat, piglets, foals, calves | Oral use |
| France | MERIAL
  29 avenue Tony Garnier
  69007 LYON
  France | COLISULTRIX POUDRE | Colistin sulphate
  Trimethoprim | 500 000 IU/g
  37,5  mg/g | Powder for oral use | Lamb, goat, rabbits, pigs, calves, poultry | Oral use |
| France | VIRBAC
  1ere Avenue 2065m L.I.D.
  06516 Carros Cedex
  France | ENTEROGEL 30 | Colistin sulphate
  Scopolamine
  Sulfaguanidine | 10,5 MIU/syringe
  0,216  g/syringe
  4,2  g/syringe | Oral paste | Foals, calves | Oral use |
| France | VIRBAC
  1ere Avenue 2065m L.I.D.
  06516 Carros Cedex
  France | INTESTIVO | Colistin sulphate
  Sulfaguanidine | 2,5 MIU/tablet
  1 g/tablet | Tablet | Lamb, goat, calve | Oral use |
| France | MERIAL
  29 avenue Tony Garnier
  69007 LYON
  France | N.P. 8 | Colistin sulphate
  Neomycin sulfate | 300 000 IU/g
  60 000 IU/g | Powder for oral use | Lamb, goat, rabbits, pigs, calves, poultry | Oral use |
| France | QALIAN
  34 rue Jean Monnet
  ZI D’Etiché
  BP20341
  49503 Segré Cedex
  France | OXYCOLI | Colistin sulphate
  Oxytetracycline hydrochloride | 200 000 IU/g
  0,07  g/g | Premix for medicated feed | Pigs, calves | Oral use |
| France | Ceva Santé Animale
  10 Avenue de la Ballastière
  33500 Libourne
  France | PHADILACT | Ampicillin trihydrate
  Colistin sulphate | 5,00  mg/g
  1 000 000 IU/g | Powder for oral use | Lamb, goat, calves, poultry | Oral use |
| France | QALIAN
  34 rue Jean Monnet
  ZI D’Etiché
  BP20341
  49503 Segré Cedex
  France | PRÉMELANGE MÉDICAMENTEUX CS FRANVET | Colistin sulphate
  Sulfadimethoxine | 700 000 IU/g
  210 mg/g | Premix | Lamb, calves | Oral use |
| France | VETOQUINOL
  Magny Vernois
  70200 Lure
  France | SEPTOTRYL-COLISTINE | Colistin sulphate
  Sulfamethoxypyridazine | 2 MIU/tablet
  1 g/tablet | Tablet | Lamb, dogs, foals, calves | Oral use |
| Hungary | Lavet Gyógyszergyártó Kft.
  Ottó u. 14
  1161 Budapest
  Hungary | Amoxycol por belsőleges oldathoz A.U.V. | Amoxicillin trihydrate
  Colistin sulphate | 640,0  mg/g
  133,3  mg/g | Powder for oral solution | Pigs, chickens | In drinking water use |
| Hungary | Industria Italiana Integratori Trei S.p.A.
  Viale Corassori, 62
  41100 Modena
  Italy | BETAMICYN gyógypremix sertések részére A.U.V. | Amoxicillin trihydrate
  Colistin sulphate | 100 g/kg
  600 MIU/kg | Premix for medicated feeding stuff | Pigs | In feed use |
| Hungary | Rhone Vet Kft.
  Petőfi u. 9.
  2053 Herceghalom
  Hungary | Colisutrix belsőleges por | Trimethoprim
  Colistin sulphate | 3,75  g/100 g
  50 MIU/100 g | Powder for oral solution | Cattle (calves), sheep (lambs), pigs and chickens, rabbit, goat | In drinking water use |
| Italy | Fatro S.p.a.
  Via Emilia, 285
  40064 Ozzano Emilia
  Italy | COMBOMIX | Amoxicillin trihydrate
  Colistin sulphate | 115 mg/g
  40 mg/g | Premix for medicated feeding stuff | Pigs, chickens (other than laying hens in lay) | Oral |
| Italy | Industria Italiana Integratori Trei S.P.A.
  Via Affarosa, 4
  42010 — Rio Saliceto
  Italy | BETAMICYN | Amoxicillin trihydrate
  Colistin sulphate | 100 g/kg
  600 MIU/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Italy | Doxal Italia S.p.a.
  largo Donegani 2
  20121 — Milano
  Italy | CLOVER BMP | Amoxicillin trihydrate
  Colistin sulphate | 115 g/kg
  40 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Italy | Industria Italiana Integratori Trei S.P.A.
  Via Affarosa, 4
  42010 — Rio Saliceto
  Italy | DUOBAN | Doxycycline hyclate
  Colistin sulphate | 60 mg/g
  1 200 000 UI/g | Premix for medicated feeding stuff | Pigs, rabbits | Oral |
| Italy | Virbac S.r.l.
  Via Caldera 21
  20153 Milano
  Italy | DUALMIX | Amoxicillin trihydrate
  Colistin sulphate | 115 mg/g
  4 mg/g (20 000 UI/mg) | Premix for medicated feeding stuff | Pigs, chickens (except hens producing eggs for human consumption) | Oral |
| Italy | Fatro S.p.a.
  Via Emilia, 285
  40064 Ozzano Emilia
  Italy | BACOLAM | Amoxicillin trihydrate
  Colistin sulphate | 500 mg/g
  2 500 000 IU/g | Powder for oral solution | Calves, sheep and goats, pigs, ponies, chickens, turkeys (excluding hens) | Oral |
| Italy | Intervet Productions S.r.l.
  Via Nettunense, km 20,300
  04011 — Aprilia
  Italy | NADASIN | Amoxicillin trihydrate
  Colistin sulphate | 500 mg/g
  200 mg/g | Oral powder for use in drinking water or liquid feed | Calves, pigs, chickens (other than laying hens), turkeys | Oral |
| Italy | Vetoquinol Italia S.r.l.
  Via Piana, 265
  47032 Bertinoro
  Italy | NEOMIX COMPLEX | Neomycin sulfate
  Colistin sulphate | 200 mg/g
  20 000 IU/g | Oral powder, for use in drinking water or liquid feed | Calves, piglets, broilers and turkeys | Oral |
| Italy | Vétoquinol Italia S.r.l.
  Via Piana 265
  47032 Bertinoro
  Italy | ZEMAMIX | Amoxicillin trihydrate
  Colistin sulphate | 100 mg/g
  40 mg/g | Oral powder | Pigs | Oral use |
| Italy | Virbac S.r.l.
  Via Caldera 21
  20153 Milano
  Italy | STABOX COLI | Amoxicillin trihydrate
  Colistin sulphate | 100 mg/g
  800 000 IU/g | Premix for medicated feeding | Pigs, chickens (except hens producing eggs for human consumption) | Oral |
| Latvia | Ceva Santé Animale
  10 Avenue de la Ballastière
  33500 Libourne
  France | Quinocol Oral Solution | Enrofloxacin
  Colistin sulphate | 100 g
  41,67  g | Solution for oral use | Chicken, turkeys | Oral use |
| Lithuania | Lavet Pharmaceuticals Ltd
  Ottó u. 14.
  H-1161 Budapest
  Hungary | AMOXYCOL, geriamieji milteliai | Amoxicillin trihydrate
  Colistin sulphate | 640 mg/ml
  3 200 000 IU/ml | Water soluble oral solution | Pig, chicken | Oral |
| Lithuania | COOPHAVET S.A.S.
  B.P. 7 Saint Herblon
  44153 ANCENIS Cedex
  France | COLISULTRIX, geriamieji milteliai | Trimethoprim
  Colistin sulphate | 3,75  g/100 g
  50 MIU/100 g | Oral powder | Calves, lamb, kid, piglets, poultry and rabbits | Oral |
| Lithuania | COOPHAVET S.A.S.
  B.P. 7 Saint Herblon
  44153 ANCENIS Cedex
  France | BELCOSPIRA ORAL, geriamieji milteliai | Spiramycin adipate
  Colistin sulphate | 65 MIU/100 g
  50 MIU/100 g | Oral powder | Calves, lamb, kid, foals, piglets, poultry and rabbits. | Oral |
| Luxembourg | VETOQUINOL
  Magny Vernois
  70200 Lure
  France | COLIDIARYL | Erythromycin estolate
  Colistin sulphate | 83 400 UI/g
  16 600 UI/g | Powder for oral use | Lamb, goat, piglets, foals, calves | Oral use |
| Luxembourg | VETOQUINOL
  Magny Vernois
  70200 Lure
  France | SEPTOTRYL-COLISTINE | Colistin sulphate
  Sulfamethoxypyridazine | 2 MIU/tablet
  1 g/tablet | Tablet | Lamb, dogs, foals, calves | Oral use |
| Netherlands | Dopharma B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | AMOXY-COL WSP | Amoxicillin trihydrate
  Colistin sulphate | 150 mg/g
  500 000 IU/g | Powder for oral use via drinking water | Pigs | Oral, via drinking water |
| Poland | Dopharma B.V.
  Zalmweg 24
  4941 VX Raamsdonksveer
  The Netherlands | Amoxy-col WSP | Amoxicillin trihydrate
  Colistin sulphate | 150 mg/g
  500 000 IU/g | Powder for oral solution | Pigs | Oral use |
| Poland | Fatro S.p.A.
  Via Emilia
  285-40064
  Ozzano Emilia
  Italy | Bacolam | Amoxicillin trihydrate
  Colistin sulphate | 100 mg/g
  500 000 IU/g | Powder for administration in drinking water or milk | Cattle, chickens, pigs | Oral use |
| Poland | SkanVet Poland Sp. z o.o.
  Skiereszewo, ul. Kiszkowska 9
  62-200 Gniezno
  Poland | Colamox 3200/640 | Amoxicillin trihydrate
  Colistin sulphate | 640 mg/g
  3 200 000 IU/g | Powder for oral solution | Chicken, pigs | Oral use |
| Poland | Drwalewskie Zakłady Przemysłu
  Bioweterynaryjnego S.A
  ul. Grójecka 6
  05-651 Drwalew
  Poland | Spiracol AD | Spiramycin adipate
  Colistin sulphate | 100 000 IU/g
  130 000 IU/g | Powder for use in drinking water | Cattle, chickens, pigs | Oral use |
| Portugal | DIVASA FARMAVIC DE PORTUGAL Produtos e Equipamentos Veterinários, Lda.
  Praceta Jaime Cortesão, No 1 — R/C Loja Esq.
  2625-170 Póvoa de Santa Iria
  Portugal | NUTRIVET TOTAL, pó para suspensão oral, para vitelos e cordeiros | Ampicillin trihydrate
  Colistin sulphate | 0,7  g
  1 500 000 IU | Powder for oral suspension for administration in drinking water | Calves and lambs | Oral |
| Portugal | VETLIMA-Sociedade Distribuidora de Produtos Agro-Pecuários, S.A.
  Centro Empresarial da Rainha, Lote 27
  2050-501 Vila Nova da Rainha
  Portugal | COLIMIX (116 g/kg/40 g/kg), pré-mistura medicamentosa para alimento medicamentoso para suínos | Amoxicillin trihydrate
  Colistin sulphate | 116 g/kg
  40 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Portugal | Fatro S.p.A
  Via Emilia No 285
  Ozzano Emilia
  Italy | Premaxol, 100 mg/g + 40 mg/g de pré-mistura medicamentosa para alimento medicamentoso para suínos, frangos e galinhas (excepto poedeiras) | Amoxicillin trihydrate
  Colistin sulphate | 100 mg/g
  40 mg/g | Premix for medicated feeding stuff | Pigs and chickens (except laying) | Oral |
| Romania | Industria Italiana Integratori Trei S.p.A
  Viale Corassori, 62
  41100 Modena
  Italy | DUOBAN | Doxycycline hyclate
  Colistin sulphate | 60 mg/g
  1 200 000 IU/g | Premix | Pigs | Mixed in feeding stuffs |
| Romania | Industria Italiana Integratori Trei S.p.A
  Viale Corassori, 62
  41100 Modena
  Italy | MICROAMOX COLI | Amoxicillin trihydrate
  Colistin sulphate | 100 mg/g
  600 000 IU/g | Premix | Pigs | Mixed in feeding stuffs |
| Romania | COOPHAVET SAS
  Herblon
  44150 Ancenis
  France | COLISULTRIX | Trimethoprim
  Colistin sulphate | 37,5  mg
  500 000 IU | Powder for oral solution | Calves, lambs, kids, pigs, rabbits and poultry | Oral administration in drinking water or liquid feed |
| Romania | SC ROMVAC COMPANY SA
  Sos. Centurii nr.7
  077194 Voluntari
  Romania | GALIPROTECT C | Oxytetracycline hydrochloride
  Colistin sulphate | 12 mg/tablet
  5 mg/tablet | Tablets | Poultry (grouse and web-footed) | Oral administration individually |
| Romania | Lavet Pharmecuticals LTD.
  Otto u.14.
  H-1161 Budapest
  Hungary | AMOXYCOL | Amoxicillin trihydrate
  Colistin sulphate | 640 mg/g
  3 200 000 IU/g | Powder for oral solution | Pigs, chickens | Oral administration in drinking water |
| Slovakia | Pharmagal spol. s.r.o.
  Murgašova 5
  949 01 Nitra
  Slovakia | Amikol perorálny prášok | Amoxicillin trihydrate
  Colistin sulphate | 57,5  mg/g
  8,1  mg/g | Oral powder | Pig, calves, poultry (chicken, turkey), pigeon | Oral administration, after incorporation into the feed |
| Slovakia | Pharmagal spol. s.r.o.
  Murgašova 5
  949 01 Nitra
  Slovakia | Amikol premix na medikáciu krmiva | Amoxicillin trihydrate
  Colistin sulphate | 57,5  mg/g
  200 000 IU/g | Premix for medicated feeding stuff | Pig | Oral administration, after incorporation into the feed |
| Slovakia | Pharmagal spol. s.r.o.
  Murgašova 5
  949 01 Nitra
  Slovakia | Amikol-S prášok na perorálny roztok | Amoxicillin trihydrate
  Colistin sulphate | 575 mg/g
  81 mg/g | Powder for oral solution | Pig, calves, poultry (chicken, turkey), pigeon | Oral administration via drinking water |
| Slovakia | Pharmagal spol. s.r.o.
  Murgašova 5
  949 01 Nitra
  Slovakia | SUTRICOL prášok na perorálny roztok | Colistin sulphate
  Sulfadimidine sodium Trimethoprim | 300 000 IU/g
  50 mg/g
  12,5  mg/g | Powder for oral solution | Broiler chicken, pig, rabbit, calve | Oral administration via drinking water |
| Slovakia | Pharmagal spol. s.r.o.
  Murgašova 5
  949 01 Nitra
  Slovakia | TETRAKOL prášok na perorálny roztok | Chlortetracycline hydrochloride
  Colistin sulphate | 120 mg/g
  120 000 IU/g | Powder for oral solution | Pig, calves, poultry (chicken) | Oral administration via drinking water |
| Spain | CENAVISA, S.A.
  Camí Pedra Estela s/n. Reus (Tarragona)
  43205
  Spain | TRISOL | Ampicillin trihydrate
  Colistin sulphate | 200 mg/g
  1 025 000 IU/g | Oral powder | Lambs | In drinking water use |
| Spain | LABORATORIOS MAYMO, S.A.
  Via Augusta, 302.
  Barcelona 08017
  Spain | COLIPHUR 100 000 /1 200 000 UI/ml solución para administración en agua de bebida | Neomycin sulfate
  Colistin sulphate | 100 000 IU/ml
  1 200 000 IU/ml | Solution for use in drinking water | Pig for fattening | In drinking water use |

Member State EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Bulgaria

Farma vet Ltd

40 Otec Paisii str.

Shumen

Bulgaria

Колитетравит/COLI — TETRAVIT

Oxytetracycline hydrochloride

Colistin sulphate

5,0  g

3 500 000 UI

Oral solution

Chickens and pigs

Oral administration

Bulgaria

COOPHAVET S.A.S.

B.P. 7 Saint Herblon

44153 ANCENIS Cedex

France

Колисултрикс/COLISULTRIX

Trimethoprim

Colistin sulphate

3,75  g

50 MIU

Oral powder

Chickens, rabbits, pigs, calves and lambs

Oral administration

Croatia

Arnika Veterina d.o.o.

Vodovodna 20a

10000 Zagreb

Croatia

COLISULTRIX

Trimethoprim

Colistin sulphate

3,75  g

50 MIU

Oral powder

Calves, lambs, kids, piglets, poultry and rabbits

Oral

Croatia

Ceva Santé Animale

10 Avenue de la Ballastière

33500 Libourne

France

QUINOCOL

Enrofloxacin

Colistin sulphate

100 g

41,67  g

Oral solution

Chicken, turkey

Oral

Cyprus

FATRO S.p.A.

Via Emilia, 285

40064 Ozzano Emilia (Bologna)

Italy

BACOLAM powder for oral solution for calves, sheep, goats, pigs, foals, chickens, turkeys (excluding layers)

Amoxicillin trihydrate

Colistin sulphate

100 mg

500 000 I.U.

Powder for oral solution

Calves, sheep, goats, pigs, foals, chickens, turkeys (excluding layers)

Administer the dose subdivided into two administrations each day, dissolved in drinking water or in milk.

Cyprus

Vetoquinol Italia S.R.L

Via Piana, 265

47032 Bertinoro

Italy

ZEMAMIX premix for medicated feedingstuff for pigs

Amoxicillin trihydrate

Colistin sulphate

11,48  g

4,00  g

Premix for medicated feedingstuff

Pigs

Premix for medicated feedingstuff in insoluble powder, to be administered orally properly mixed in solid feed.

Czech Republic

LAVET Pharmaceuticals Ltd

Ottó u.14

1161 Budapest

Hungary

AMOXYCOL plv.sol.

Amoxicillin trihydrate

Colistin sulphate

640 mg/g

3 200 000 IU/g

Powder for oral solution for use in drinking water or in feed

Pigs, chicken (broilers)

Oral

Czech Republic

COOPHAVET S.A.S.

B.P. 7 Saint Herblon

44153 ANCENIS Cedex

France

BELCOSPIRA ORAL prášek pro přípravu perorálního roztoku

Colistin sulphate Spiramycin adipate

500 000 IU

650 000 IU

Powder for oral solution

Calves, piglets, foals, chicken

Oral

Czech Republic

COOPHAVET S.A.S.

B.P. 7 Saint Herblon

44153 ANCENIS Cedex

France

COLISULTRIX plv. sol.

Trimethoprim

Colistin sulphate

37,5  mg

500 000 IU/g

Powder for oral solution

Chicken

Oral

Czech Republic

Industria Italiana Integratori Trei S.p.A.

Via Corassori, 62

41100 Modena

Italy

MICROAMOX COLI premix pro medikaci krmiva

Amoxicillin trihydrate

Colistin sulphate

100 mg/g

600 000 IU/g

Premix for medicated feed

Pigs

Oral

France

MERIAL

29 avenue Tony Garnier

69007 LYON

France

BELCOSPIRA ORAL

Colistin sulphate

Spiramycin adipate

500 000 IU/g

650 000 IU/g

Powder for oral use

Cattle, pigs, poultry

Oral use

France

LABORATOIRES BIOVE

3 Rue de Lorraine

62510 Arques

France

COLAMPI B

Ampicillin trihydrate

Colistin sulphate

25 mg/g

0,075 MIU/g

Powder for oral use

Pigs, calves

Oral use

France

LABORATOIRES BIOVE

3 Rue de Lorraine

62510 Arques

France

COLAMPI O

Ampicillin trihydrate

Colistin sulphate

1 g/tablet

1 MIU/tablet

Tablet

Calves

Oral use

France

VETOQUINOL

Magny Vernois

70200 Lure

France

COLIDIARYL

Colistin sulphate Erythromycin estolate

83 400 IU/g

16 600 IU/g

Powder for oral use

Lamb, goat, piglets, foals, calves

Oral use

France

MERIAL

29 avenue Tony Garnier

69007 LYON

France

COLISULTRIX POUDRE

Colistin sulphate

Trimethoprim

500 000 IU/g

37,5  mg/g

Powder for oral use

Lamb, goat, rabbits, pigs, calves, poultry

Oral use

France

VIRBAC

1ere Avenue 2065m L.I.D.

06516 Carros Cedex

France

ENTEROGEL 30

Colistin sulphate

Scopolamine

Sulfaguanidine

10,5 MIU/syringe

0,216  g/syringe

4,2  g/syringe

Oral paste

Foals, calves

Oral use

France

VIRBAC

1ere Avenue 2065m L.I.D.

06516 Carros Cedex

France

INTESTIVO

Colistin sulphate

Sulfaguanidine

2,5 MIU/tablet

1 g/tablet

Tablet

Lamb, goat, calve

Oral use

France

MERIAL

29 avenue Tony Garnier

69007 LYON

France

N.P. 8

Colistin sulphate

Neomycin sulfate

300 000 IU/g

60 000 IU/g

Powder for oral use

Lamb, goat, rabbits, pigs, calves, poultry

Oral use

France

QALIAN

34 rue Jean Monnet

ZI D’Etiché

BP20341

49503 Segré Cedex

France

OXYCOLI

Colistin sulphate

Oxytetracycline hydrochloride

200 000 IU/g

0,07  g/g

Premix for medicated feed

Pigs, calves

Oral use

France

Ceva Santé Animale

10 Avenue de la Ballastière

33500 Libourne

France

PHADILACT

Ampicillin trihydrate

Colistin sulphate

5,00  mg/g

1 000 000 IU/g

Powder for oral use

Lamb, goat, calves, poultry

Oral use

France

QALIAN

34 rue Jean Monnet

ZI D’Etiché

BP20341

49503 Segré Cedex

France

PRÉMELANGE MÉDICAMENTEUX CS FRANVET

Colistin sulphate

Sulfadimethoxine

700 000 IU/g

210 mg/g

Premix

Lamb, calves

Oral use

France

VETOQUINOL

Magny Vernois

70200 Lure

France

SEPTOTRYL-COLISTINE

Colistin sulphate

Sulfamethoxypyridazine

2 MIU/tablet

1 g/tablet

Tablet

Lamb, dogs, foals, calves

Oral use

Hungary

Lavet Gyógyszergyártó Kft.

Ottó u. 14

1161 Budapest

Hungary

Amoxycol por belsőleges oldathoz A.U.V.

Amoxicillin trihydrate

Colistin sulphate

640,0  mg/g

133,3  mg/g

Powder for oral solution

Pigs, chickens

In drinking water use

Hungary

Industria Italiana Integratori Trei S.p.A.

Viale Corassori, 62

41100 Modena

Italy

BETAMICYN gyógypremix sertések részére A.U.V.

Amoxicillin trihydrate

Colistin sulphate

100 g/kg

600 MIU/kg

Premix for medicated feeding stuff

Pigs

In feed use

Hungary

Rhone Vet Kft.

Petőfi u. 9.

2053 Herceghalom

Hungary

Colisutrix belsőleges por

Trimethoprim

Colistin sulphate

3,75  g/100 g

50 MIU/100 g

Powder for oral solution

Cattle (calves), sheep (lambs), pigs and chickens, rabbit, goat

In drinking water use

Italy

Fatro S.p.a.

Via Emilia, 285

40064 Ozzano Emilia

Italy

COMBOMIX

Amoxicillin trihydrate

Colistin sulphate

115 mg/g

40 mg/g

Premix for medicated feeding stuff

Pigs, chickens (other than laying hens in lay)

Oral

Italy

Industria Italiana Integratori Trei S.P.A.

Via Affarosa, 4

42010 — Rio Saliceto

Italy

BETAMICYN

Amoxicillin trihydrate

Colistin sulphate

100 g/kg

600 MIU/kg

Premix for medicated feeding stuff

Pigs

Oral

Italy

Doxal Italia S.p.a.

largo Donegani 2

20121 — Milano

Italy

CLOVER BMP

Amoxicillin trihydrate

Colistin sulphate

115 g/kg

40 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Italy

Industria Italiana Integratori Trei S.P.A.

Via Affarosa, 4

42010 — Rio Saliceto

Italy

DUOBAN

Doxycycline hyclate

Colistin sulphate

60 mg/g

1 200 000 UI/g

Premix for medicated feeding stuff

Pigs, rabbits

Oral

Italy

Virbac S.r.l.

Via Caldera 21

20153 Milano

Italy

DUALMIX

Amoxicillin trihydrate

Colistin sulphate

115 mg/g

4 mg/g (20 000 UI/mg)

Premix for medicated feeding stuff

Pigs, chickens (except hens producing eggs for human consumption)

Oral

Italy

Fatro S.p.a.

Via Emilia, 285

40064 Ozzano Emilia

Italy

BACOLAM

Amoxicillin trihydrate

Colistin sulphate

500 mg/g

2 500 000 IU/g

Powder for oral solution

Calves, sheep and goats, pigs, ponies, chickens, turkeys (excluding hens)

Oral

Italy

Intervet Productions S.r.l.

Via Nettunense, km 20,300

04011 — Aprilia

Italy

NADASIN

Amoxicillin trihydrate

Colistin sulphate

500 mg/g

200 mg/g

Oral powder for use in drinking water or liquid feed

Calves, pigs, chickens (other than laying hens), turkeys

Oral

Italy

Vetoquinol Italia S.r.l.

Via Piana, 265

47032 Bertinoro

Italy

NEOMIX COMPLEX

Neomycin sulfate

Colistin sulphate

200 mg/g

20 000 IU/g

Oral powder, for use in drinking water or liquid feed

Calves, piglets, broilers and turkeys

Oral

Italy

Vétoquinol Italia S.r.l.

Via Piana 265

47032 Bertinoro

Italy

ZEMAMIX

Amoxicillin trihydrate

Colistin sulphate

100 mg/g

40 mg/g

Oral powder

Pigs

Oral use

Italy

Virbac S.r.l.

Via Caldera 21

20153 Milano

Italy

STABOX COLI

Amoxicillin trihydrate

Colistin sulphate

100 mg/g

800 000 IU/g

Premix for medicated feeding

Pigs, chickens (except hens producing eggs for human consumption)

Oral

Latvia

Ceva Santé Animale

10 Avenue de la Ballastière

33500 Libourne

France

Quinocol Oral Solution

Enrofloxacin

Colistin sulphate

100 g

41,67  g

Solution for oral use

Chicken, turkeys

Oral use

Lithuania

Lavet Pharmaceuticals Ltd

Ottó u. 14.

H-1161 Budapest

Hungary

AMOXYCOL, geriamieji milteliai

Amoxicillin trihydrate

Colistin sulphate

640 mg/ml

3 200 000 IU/ml

Water soluble oral solution

Pig, chicken

Oral

Lithuania

COOPHAVET S.A.S.

B.P. 7 Saint Herblon

44153 ANCENIS Cedex

France

COLISULTRIX, geriamieji milteliai

Trimethoprim

Colistin sulphate

3,75  g/100 g

50 MIU/100 g

Oral powder

Calves, lamb, kid, piglets, poultry and rabbits

Oral

Lithuania

COOPHAVET S.A.S.

B.P. 7 Saint Herblon

44153 ANCENIS Cedex

France

BELCOSPIRA ORAL, geriamieji milteliai

Spiramycin adipate

Colistin sulphate

65 MIU/100 g

50 MIU/100 g

Oral powder

Calves, lamb, kid, foals, piglets, poultry and rabbits.

Oral

Luxembourg

VETOQUINOL

Magny Vernois

70200 Lure

France

COLIDIARYL

Erythromycin estolate

Colistin sulphate

83 400 UI/g

16 600 UI/g

Powder for oral use

Lamb, goat, piglets, foals, calves

Oral use

Luxembourg

VETOQUINOL

Magny Vernois

70200 Lure

France

SEPTOTRYL-COLISTINE

Colistin sulphate

Sulfamethoxypyridazine

2 MIU/tablet

1 g/tablet

Tablet

Lamb, dogs, foals, calves

Oral use

Netherlands

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

AMOXY-COL WSP

Amoxicillin trihydrate

Colistin sulphate

150 mg/g

500 000 IU/g

Powder for oral use via drinking water

Pigs

Oral, via drinking water

Poland

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Amoxy-col WSP

Amoxicillin trihydrate

Colistin sulphate

150 mg/g

500 000 IU/g

Powder for oral solution

Pigs

Oral use

Poland

Fatro S.p.A.

Via Emilia

285-40064

Ozzano Emilia

Italy

Bacolam

Amoxicillin trihydrate

Colistin sulphate

100 mg/g

500 000 IU/g

Powder for administration in drinking water or milk

Cattle, chickens, pigs

Oral use

Poland

SkanVet Poland Sp. z o.o.

Skiereszewo, ul. Kiszkowska 9

62-200 Gniezno

Poland

Colamox 3200/640

Amoxicillin trihydrate

Colistin sulphate

640 mg/g

3 200 000 IU/g

Powder for oral solution

Chicken, pigs

Oral use

Poland

Drwalewskie Zakłady Przemysłu

Bioweterynaryjnego S.A

ul. Grójecka 6

05-651 Drwalew

Poland

Spiracol AD

Spiramycin adipate

Colistin sulphate

100 000 IU/g

130 000 IU/g

Powder for use in drinking water

Cattle, chickens, pigs

Oral use

Portugal

DIVASA FARMAVIC DE PORTUGAL Produtos e Equipamentos Veterinários, Lda.

Praceta Jaime Cortesão, No 1 — R/C Loja Esq.

2625-170 Póvoa de Santa Iria

Portugal

NUTRIVET TOTAL, pó para suspensão oral, para vitelos e cordeiros

Ampicillin trihydrate

Colistin sulphate

0,7  g

1 500 000 IU

Powder for oral suspension for administration in drinking water

Calves and lambs

Oral

Portugal

VETLIMA-Sociedade Distribuidora de Produtos Agro-Pecuários, S.A.

Centro Empresarial da Rainha, Lote 27

2050-501 Vila Nova da Rainha

Portugal

COLIMIX (116 g/kg/40 g/kg), pré-mistura medicamentosa para alimento medicamentoso para suínos

Amoxicillin trihydrate

Colistin sulphate

116 g/kg

40 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Portugal

Fatro S.p.A

Via Emilia No 285

Ozzano Emilia

Italy

Premaxol, 100 mg/g + 40 mg/g de pré-mistura medicamentosa para alimento medicamentoso para suínos, frangos e galinhas (excepto poedeiras)

Amoxicillin trihydrate

Colistin sulphate

100 mg/g

40 mg/g

Premix for medicated feeding stuff

Pigs and chickens (except laying)

Oral

Romania

Industria Italiana Integratori Trei S.p.A

Viale Corassori, 62

41100 Modena

Italy

DUOBAN

Doxycycline hyclate

Colistin sulphate

60 mg/g

1 200 000 IU/g

Premix

Pigs

Mixed in feeding stuffs

Romania

Industria Italiana Integratori Trei S.p.A

Viale Corassori, 62

41100 Modena

Italy

MICROAMOX COLI

Amoxicillin trihydrate

Colistin sulphate

100 mg/g

600 000 IU/g

Premix

Pigs

Mixed in feeding stuffs

Romania

COOPHAVET SAS

Herblon

44150 Ancenis

France

COLISULTRIX

Trimethoprim

Colistin sulphate

37,5  mg

500 000 IU

Powder for oral solution

Calves, lambs, kids, pigs, rabbits and poultry

Oral administration in drinking water or liquid feed

Romania

SC ROMVAC COMPANY SA

Sos. Centurii nr.7

077194 Voluntari

Romania

GALIPROTECT C

Oxytetracycline hydrochloride

Colistin sulphate

12 mg/tablet

5 mg/tablet

Tablets

Poultry (grouse and web-footed)

Oral administration individually

Romania

Lavet Pharmecuticals LTD.

Otto u.14.

H-1161 Budapest

Hungary

AMOXYCOL

Amoxicillin trihydrate

Colistin sulphate

640 mg/g

3 200 000 IU/g

Powder for oral solution

Pigs, chickens

Oral administration in drinking water

Slovakia

Pharmagal spol. s.r.o.

Murgašova 5

949 01 Nitra

Slovakia

Amikol perorálny prášok

Amoxicillin trihydrate

Colistin sulphate

57,5  mg/g

8,1  mg/g

Oral powder

Pig, calves, poultry (chicken, turkey), pigeon

Oral administration, after incorporation into the feed

Slovakia

Pharmagal spol. s.r.o.

Murgašova 5

949 01 Nitra

Slovakia

Amikol premix na medikáciu krmiva

Amoxicillin trihydrate

Colistin sulphate

57,5  mg/g

200 000 IU/g

Premix for medicated feeding stuff

Pig

Oral administration, after incorporation into the feed

Slovakia

Pharmagal spol. s.r.o.

Murgašova 5

949 01 Nitra

Slovakia

Amikol-S prášok na perorálny roztok

Amoxicillin trihydrate

Colistin sulphate

575 mg/g

81 mg/g

Powder for oral solution

Pig, calves, poultry (chicken, turkey), pigeon

Oral administration via drinking water

Slovakia

Pharmagal spol. s.r.o.

Murgašova 5

949 01 Nitra

Slovakia

SUTRICOL prášok na perorálny roztok

Colistin sulphate

Sulfadimidine sodium Trimethoprim

300 000 IU/g

50 mg/g

12,5  mg/g

Powder for oral solution

Broiler chicken, pig, rabbit, calve

Oral administration via drinking water

Slovakia

Pharmagal spol. s.r.o.

Murgašova 5

949 01 Nitra

Slovakia

TETRAKOL prášok na perorálny roztok

Chlortetracycline hydrochloride

Colistin sulphate

120 mg/g

120 000 IU/g

Powder for oral solution

Pig, calves, poultry (chicken)

Oral administration via drinking water

Spain

CENAVISA, S.A.

Camí Pedra Estela s/n. Reus (Tarragona)

43205

Spain

TRISOL

Ampicillin trihydrate

Colistin sulphate

200 mg/g

1 025 000 IU/g

Oral powder

Lambs

In drinking water use

Spain

LABORATORIOS MAYMO, S.A.

Via Augusta, 302.

Barcelona 08017

Spain

COLIPHUR 100 000 /1 200 000 UI/ml solución para administración en agua de bebida

Neomycin sulfate

Colistin sulphate

100 000 IU/ml

1 200 000 IU/ml

Solution for use in drinking water

Pig for fattening

In drinking water use

---

Corrigenda

| 26.8.2016 | EN | Official Journal of the European Union | C 312/22 |
| --- | --- | --- | --- |

26.8.2016

EN

Official Journal of the European Union

C 312/22

---

Corrigendum to Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016

(
  Official Journal of the European Union C 154 of 29 April 2016
  )

(2016/C 312/03)

On page 6:

for:

| ‘— | Suspension of a marketing authorisation (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

‘—

Suspension of a marketing authorisation (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 23.3.2016 | Zydelig | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | 30.3.2016’ |

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

23.3.2016

Zydelig

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

30.3.2016’

read:

| ‘— | Modification of a marketing authorisation (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

‘—

Modification of a marketing authorisation (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 23.3.2016 | Zydelig | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | 30.3.2016’ |

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

23.3.2016

Zydelig

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

30.3.2016’

---