# Official Journal C 362/30 S

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 362 |
| | |
| English edition | Information and Notices | Volume 5930 September 2016 |

ISSN 1977-091X

Official Journal

of the European Union

C 362

English edition

Information and Notices

Volume 5930 September 2016

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2016/C 362/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2016 to 31 August 2016(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2016/C 362/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2016 to 31 August 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 362/01

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

2016/C 362/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2016 to 31 August 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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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 30.9.2016 | EN | Official Journal of the European Union | C 362/1 |
| --- | --- | --- | --- |

30.9.2016

EN

Official Journal of the European Union

C 362/1

---

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

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

(2016/C 362/01)

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.8.2016 | Cinqaero | reslizumab | Teva Pharmaceuticals Limited
  Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom | EU/1/16/1125 | Concentrate for solution for infusion | R03DX08 | 18.8.2016 |
| 18.8.2016 | Aerivio Spiromax | salmeterol/fluticasone propionate | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/16/1122 | Inhalation powder | R03AK06 | 22.8.2016 |
| 18.8.2016 | Airexar Spiromax | salmeterol/fluticasone propionate | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/16/1123 | Inhalation powder | R03AK06 | 22.8.2016 |
| 18.8.2016 | Nordimet | methotrexate | Nordic Group B.V.
  Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland | EU/1/16/1124 | Solution for injection | L01BA01 | 22.8.2016 |
| 18.8.2016 | Zalmoxis | Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2) | MolMed S.p.A.
  Via Olgettina 58, I-20132 Milano, Italia | EU/1/16/1121 | Dispersion for infusion | Pending | 23.8.2016 |
| 22.8.2016 | Atazanavir Mylan | atazanavir | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1091 | Capsule, hard | J05AE08 | 24.8.2016 |
| 25.8.2016 | Kisplyx | lenvatinib | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | EU/1/16/1128 | Capsule, hard | L01XE29 | 30.8.2016 |

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

16.8.2016

Cinqaero

reslizumab

Teva Pharmaceuticals Limited

Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom

EU/1/16/1125

Concentrate for solution for infusion

R03DX08

18.8.2016

18.8.2016

Aerivio Spiromax

salmeterol/fluticasone propionate

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/16/1122

Inhalation powder

R03AK06

22.8.2016

18.8.2016

Airexar Spiromax

salmeterol/fluticasone propionate

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/16/1123

Inhalation powder

R03AK06

22.8.2016

18.8.2016

Nordimet

methotrexate

Nordic Group B.V.

Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland

EU/1/16/1124

Solution for injection

L01BA01

22.8.2016

18.8.2016

Zalmoxis

Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)

MolMed S.p.A.

Via Olgettina 58, I-20132 Milano, Italia

EU/1/16/1121

Dispersion for infusion

Pending

23.8.2016

22.8.2016

Atazanavir Mylan

atazanavir

Mylan S.A.S

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

EU/1/16/1091

Capsule, hard

J05AE08

24.8.2016

25.8.2016

Kisplyx

lenvatinib

Eisai Europe Limited

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

EU/1/16/1128

Capsule, hard

L01XE29

30.8.2016

—   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 |
| --- | --- | --- | --- | --- |
| 1.8.2016 | Aripiprazole Mylan Pharma | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/15/1005 | 3.8.2016 |
| 1.8.2016 | Ilaris | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/564 | 3.8.2016 |
| 1.8.2016 | Pegasys | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/221 | 3.8.2016 |
| 1.8.2016 | Pradaxa | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/08/442 | 3.8.2016 |
| 1.8.2016 | Rasagiline ratiopharm | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/977 | 3.8.2016 |
| 1.8.2016 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 3.8.2016 |
| 8.8.2016 | Desloratadine ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/11/746 | 10.8.2016 |
| 8.8.2016 | Desloratadine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/732 | 10.8.2016 |
| 8.8.2016 | Levetiracetam Actavis Group | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/11/738 | 10.8.2016 |
| 8.8.2016 | Plenadren | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/715 | 10.8.2016 |
| 8.8.2016 | Zavesca | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/238 | 10.8.2016 |
| 9.8.2016 | IDflu | Sanofi Pasteur SA
  2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/08/507 | 11.8.2016 |
| 9.8.2016 | Intanza | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/08/505 | 11.8.2016 |
| 9.8.2016 | Kaletra | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/01/172 | 11.8.2016 |
| 9.8.2016 | Memantine ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/13/836 | 11.8.2016 |
| 12.8.2016 | Ibandronic acid Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/798 | 17.8.2016 |
| 12.8.2016 | Imvanex | Bavarian Nordic A/S
  Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark | EU/1/13/855 | 17.8.2016 |
| 12.8.2016 | Myclausen | Passauer Pharma GmbH
  Eiderstedter Weg 3, 14129 Berlin, Deutschland | EU/1/10/647 | 17.8.2016 |
| 12.8.2016 | Scenesse | Clinuvel UK Limited
  Devonshire House, 60 Goswell Road, London EC1M 7AD, United Kingdom | EU/1/14/969 | 17.8.2016 |
| 16.8.2016 | Aflunov | Seqirus S.r.l.
  Via Fiorentina, 1, Siena, Italia | EU/1/10/658 | 18.8.2016 |
| 16.8.2016 | Dasselta | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/739 | 18.8.2016 |
| 16.8.2016 | Eylea | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/12/797 | 18.8.2016 |
| 16.8.2016 | HALAVEN | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/11/678 | 18.8.2016 |
| 16.8.2016 | Mekinist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/931 | 18.8.2016 |
| 18.8.2016 | Kaletra | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/01/172 | 22.8.2016 |
| 18.8.2016 | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 22.8.2016 |
| 18.8.2016 | OLYSIO | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/924 | 22.8.2016 |
| 18.8.2016 | Sevelamer carbonate Zentiva | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/14/952 | 22.8.2016 |
| 18.8.2016 | Tracleer | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220 | 22.8.2016 |
| 18.8.2016 | Truvada | Gilead Sciences International Ltd.
  Cambridge, CB21 6GT, United Kingdom | EU/1/04/305 | 22.8.2016 |
| 18.8.2016 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 22.8.2016 |
| 18.8.2016 | Viekirax | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/14/982 | 22.8.2016 |
| 22.8.2016 | Brimica Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/963 | 24.8.2016 |
| 22.8.2016 | Dificlir | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/11/733 | 24.8.2016 |
| 22.8.2016 | Duaklir Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/964 | 24.8.2016 |
| 22.8.2016 | Lumark | IDB Holland B.V.
  Weverstraat 17, 5111 PV Baarle-Nassau, Nederland | EU/1/15/1013 | 24.8.2016 |
| 22.8.2016 | Nimenrix | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/767 | 24.8.2016 |
| 22.8.2016 | Tasmar | Meda AB
  Pipers väg 2A, S-170 09 Solna, Sverige | EU/1/97/044 | 24.8.2016 |
| 25.8.2016 | Iclusig | ARIAD Pharma Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 30.8.2016 |
| 25.8.2016 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/945 | 29.8.2016 |
| 25.8.2016 | Orencia | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/07/389 | 30.8.2016 |
| 25.8.2016 | Renvela | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/09/521 | 29.8.2016 |
| 25.8.2016 | Revestive | Shire Pharmaceuticals Ireland Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/12/787 | 29.8.2016 |
| 25.8.2016 | Tasermity | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/14/953 | 29.8.2016 |
| 25.8.2016 | VPRIV | Shire Pharmaceuticals Ireland Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/10/646 | 29.8.2016 |
| 25.8.2016 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 30.8.2016 |
| 25.8.2016 | Zurampic | Grünenthal GmbH
  Zieglerstrasse 6, D-52078, Aachen, Deutschland | EU/1/15/1080 | 29.8.2016 |
| 31.8.2016 | Ketoconazole HRA | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/14/965 | 2.9.2016 |
| 31.8.2016 | Renagel | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/99/123 | 2.9.2016 |

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

1.8.2016

Aripiprazole Mylan Pharma

Mylan S.A.S

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

EU/1/15/1005

3.8.2016

1.8.2016

Ilaris

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/564

3.8.2016

1.8.2016

Pegasys

Roche Registration Limited

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

EU/1/02/221

3.8.2016

1.8.2016

Pradaxa

Boehringer Ingelheim International GmbH

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

EU/1/08/442

3.8.2016

1.8.2016

Rasagiline ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/977

3.8.2016

1.8.2016

XALKORI

Pfizer Limited

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

EU/1/12/793

3.8.2016

8.8.2016

Desloratadine ratiopharm

ratiopharm GmbH

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

EU/1/11/746

10.8.2016

8.8.2016

Desloratadine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/732

10.8.2016

8.8.2016

Levetiracetam Actavis Group

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/11/738

10.8.2016

8.8.2016

Plenadren

Shire Services BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België

EU/1/11/715

10.8.2016

8.8.2016

Zavesca

Actelion Registration Ltd

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

EU/1/02/238

10.8.2016

9.8.2016

IDflu

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/08/507

11.8.2016

9.8.2016

Intanza

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/08/505

11.8.2016

9.8.2016

Kaletra

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/01/172

11.8.2016

9.8.2016

Memantine ratiopharm

ratiopharm GmbH

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

EU/1/13/836

11.8.2016

12.8.2016

Ibandronic acid Accord

Accord Healthcare Limited

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

EU/1/12/798

17.8.2016

12.8.2016

Imvanex

Bavarian Nordic A/S

Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark

EU/1/13/855

17.8.2016

12.8.2016

Myclausen

Passauer Pharma GmbH

Eiderstedter Weg 3, 14129 Berlin, Deutschland

EU/1/10/647

17.8.2016

12.8.2016

Scenesse

Clinuvel UK Limited

Devonshire House, 60 Goswell Road, London EC1M 7AD, United Kingdom

EU/1/14/969

17.8.2016

16.8.2016

Aflunov

Seqirus S.r.l.

Via Fiorentina, 1, Siena, Italia

EU/1/10/658

18.8.2016

16.8.2016

Dasselta

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/739

18.8.2016

16.8.2016

Eylea

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/12/797

18.8.2016

16.8.2016

HALAVEN

Eisai Europe Limited

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

EU/1/11/678

18.8.2016

16.8.2016

Mekinist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/931

18.8.2016

18.8.2016

Kaletra

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/01/172

22.8.2016

18.8.2016

KEYTRUDA

Merck Sharp & Dohme Limited

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

EU/1/15/1024

22.8.2016

18.8.2016

OLYSIO

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/924

22.8.2016

18.8.2016

Sevelamer carbonate Zentiva

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/14/952

22.8.2016

18.8.2016

Tracleer

Actelion Registration Ltd

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

EU/1/02/220

22.8.2016

18.8.2016

Truvada

Gilead Sciences International Ltd.

Cambridge, CB21 6GT, United Kingdom

EU/1/04/305

22.8.2016

18.8.2016

Vargatef

Boehringer Ingelheim International GmbH

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

EU/1/14/954

22.8.2016

18.8.2016

Viekirax

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/14/982

22.8.2016

22.8.2016

Brimica Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/963

24.8.2016

22.8.2016

Dificlir

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/11/733

24.8.2016

22.8.2016

Duaklir Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/964

24.8.2016

22.8.2016

Lumark

IDB Holland B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

24.8.2016

22.8.2016

Nimenrix

Pfizer Limited

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

EU/1/12/767

24.8.2016

22.8.2016

Tasmar

Meda AB

Pipers väg 2A, S-170 09 Solna, Sverige

EU/1/97/044

24.8.2016

25.8.2016

Iclusig

ARIAD Pharma Ltd

Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom

EU/1/13/839

30.8.2016

25.8.2016

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/945

29.8.2016

25.8.2016

Orencia

Bristol-Myers Squibb Pharma EEIG

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

EU/1/07/389

30.8.2016

25.8.2016

Renvela

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/09/521

29.8.2016

25.8.2016

Revestive

Shire Pharmaceuticals Ireland Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/12/787

29.8.2016

25.8.2016

Tasermity

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/14/953

29.8.2016

25.8.2016

VPRIV

Shire Pharmaceuticals Ireland Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/10/646

29.8.2016

25.8.2016

XALKORI

Pfizer Limited

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

EU/1/12/793

30.8.2016

25.8.2016

Zurampic

Grünenthal GmbH

Zieglerstrasse 6, D-52078, Aachen, Deutschland

EU/1/15/1080

29.8.2016

31.8.2016

Ketoconazole HRA

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/14/965

2.9.2016

31.8.2016

Renagel

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/99/123

2.9.2016

—   Issuing 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 | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.8.2016 | Sedadex | dexmedetomidine | Le Vet Beheer B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/16/198 | Solution for injection | QN05CM18 | 17.8.2016 |

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

12.8.2016

Sedadex

dexmedetomidine

Le Vet Beheer B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/16/198

Solution for injection

QN05CM18

17.8.2016

—   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 |
| --- | --- | --- | --- | --- |
| 9.8.2016 | Recocam | Cross Vetpharm Group, Ltd
  Broomhill Road, Tallaght Dublin 24, Ireland | EU/2/11/133 | 11.8.2016 |
| 12.8.2016 | Metacam | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/97/004 | 17.8.2016 |
| 26.8.2016 | Panacur AquaSol | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/11/135 | 30.8.2016 |

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

9.8.2016

Recocam

Cross Vetpharm Group, Ltd

Broomhill Road, Tallaght Dublin 24, Ireland

EU/2/11/133

11.8.2016

12.8.2016

Metacam

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/97/004

17.8.2016

26.8.2016

Panacur AquaSol

Intervet International B.V.

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

EU/2/11/135

30.8.2016

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 22.8.2016 | Velactis | Ceva Santé Animale
  10 av. de La Ballastière, 33500 Libourne, France | EU/2/15/192 | 24.8.2016 |

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

22.8.2016

Velactis

Ceva Santé Animale

10 av. de La Ballastière, 33500 Libourne, France

EU/2/15/192

24.8.2016

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.

---

| 30.9.2016 | EN | Official Journal of the European Union | C 362/10 |
| --- | --- | --- | --- |

30.9.2016

EN

Official Journal of the European Union

C 362/10

---

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

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

(2016/C 362/02)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 1.8.2016 | Levonelle Art 13 | levonorgestrel | See Annex I | See Annex I | 2.8.2016 |
| 22.8.2016 | Lincomycin and spectinomycin combination Art 35 | Lincomycin and spectinomycin | See Annex II | See Annex II | 24.8.2016 |

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

1.8.2016

Levonelle Art 13

levonorgestrel

See Annex I

See Annex I

2.8.2016

22.8.2016

Lincomycin and spectinomycin combination Art 35

Lincomycin and spectinomycin

See Annex II

See Annex II

24.8.2016

---

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

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

---

ANNEX I

List of medicinal products and presentations

| Member State EU/EEA | Marketing authorisation holder | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Postinor 1500 | 1,5  mg | Tablet | Oral use |
| Belgium | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Postinor 1500 | 1,5  mg | Tablet | Oral use |
| Czech Republic | Gedeon Richter Plc.
  Gyömrői út 19-21
  1103 Budapest
  Hungary | Escapelle | 1,5  mg | Tablet | Oral use |
| France | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Levonorgestrel Biogaran | 1,5  mg | Tablet | Oral use |
| Germany | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Postinor 1500 | 1,5  mg | Tablet | Oral use |
| Greece | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Postinor 1500 | 1,5  mg | Tablet | Oral use |
| Iceland | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Postinor 1500 | 1,5  mg | Tablet | Oral use |
| Ireland | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Prevenelle | 1,5  mg | Tablet | Oral use |
| Italy | Gedeon Richter Plc.
  Gyömrői út 19-21.
  1103 Budapest
  Hungary | Escapelle | 1,5  mg | Tablet | Oral use |
| Lithuania | Gedeon Richter Plc.
  Gyömrői út 19-21.
  1103 Budapest
  Hungary | Escapelle | 1,5  mg | Tablet | Oral use |
| Luxembourg | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Postinor 1500 | 1,5  mg | Tablet | Oral use |
| Norway | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Postinor 1,5 | 1,5  mg | Tablet | Oral use |
| Poland | Gedeon Richter Plc.
  Gyömrői út 19-21.
  1103 Budapest
  Hungary | Escapelle tabletka 1 500 mikrogramów | 1,5  mg | Tablet | Oral use |
| Portugal | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Postinor | 1,5  mg | Tablet | Oral use |
| Spain | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Postinor 1,5  mg comprimido | 1,5  mg | Tablet | Oral use |
| Sweden | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Postinor | 1,5  mg | Tablet | Oral use |
| The Netherlands | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Postinor 1 500 microgram | 1,5  mg | Tablet | Oral use |
| United Kingdom | Medimpex UK LTD
  127 Shirland road,
  W9 2EP London,
  United Kingdom | Levonelle 1500 | 1,5  mg | Tablet | Oral use |

Member State EU/EEA

Marketing authorisation holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Postinor 1500

1,5  mg

Tablet

Oral use

Belgium

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Postinor 1500

1,5  mg

Tablet

Oral use

Czech Republic

Gedeon Richter Plc.

Gyömrői út 19-21

1103 Budapest

Hungary

Escapelle

1,5  mg

Tablet

Oral use

France

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Levonorgestrel Biogaran

1,5  mg

Tablet

Oral use

Germany

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Postinor 1500

1,5  mg

Tablet

Oral use

Greece

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Postinor 1500

1,5  mg

Tablet

Oral use

Iceland

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Postinor 1500

1,5  mg

Tablet

Oral use

Ireland

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Prevenelle

1,5  mg

Tablet

Oral use

Italy

Gedeon Richter Plc.

Gyömrői út 19-21.

1103 Budapest

Hungary

Escapelle

1,5  mg

Tablet

Oral use

Lithuania

Gedeon Richter Plc.

Gyömrői út 19-21.

1103 Budapest

Hungary

Escapelle

1,5  mg

Tablet

Oral use

Luxembourg

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Postinor 1500

1,5  mg

Tablet

Oral use

Norway

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Postinor 1,5

1,5  mg

Tablet

Oral use

Poland

Gedeon Richter Plc.

Gyömrői út 19-21.

1103 Budapest

Hungary

Escapelle tabletka 1 500 mikrogramów

1,5  mg

Tablet

Oral use

Portugal

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Postinor

1,5  mg

Tablet

Oral use

Spain

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Postinor 1,5  mg comprimido

1,5  mg

Tablet

Oral use

Sweden

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Postinor

1,5  mg

Tablet

Oral use

The Netherlands

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Postinor 1 500 microgram

1,5  mg

Tablet

Oral use

United Kingdom

Medimpex UK LTD

127 Shirland road,

W9 2EP London,

United Kingdom

Levonelle 1500

1,5  mg

Tablet

Oral use

---

ANNEX II

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Zoetis Österreich GmbH
  Floridsdorfer Hauptstrasse 1
  1210 Wien
  Austria | Linco–Spectin 22/22 mg/g — Arzneimittelvormischung zur Herstellung von Fütterungsarzneimitteln für Schweine | Lincomycin and Spectinomycin | 22 mg/g
  22 mg/g | Premix for medicated feeding stuff | Pigs | Oral |
| Austria | Zoetis Österreich GmbH
  Floridsdorfer Hauptstrasse 1
  1210 Wien
  Austria | Linco-Spectin 222 mg/g + 444,7  mg/g — Pulver zum Eingeben über das Trinkwasser für Schweine und Hühner | Lincomycin and Spectinomycin | 222 mg/g
  444,7  mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Austria | Animed Service AG
  Liebochstrasse 9
  8143 Dobl
  Austria | Lincomycin-Spectinomycin 1,1  % ‘Animed Service’ — Pulver zum Eingeben für Schweine | Lincomycin and Spectinomycin | 5,5  g/kg
  5,5  g/kg | Powder to be administered with the feed | Pigs | Oral |
| Belgium | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linco-Spectin 100 | Lincomycin and Spectinomycin | 222 mg/g
  444,7  mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Belgium | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linco-Spectin 22 + 22 | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Belgium | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linco-Spectin 44 | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Powder to be administered with the feed | Pigs | Oral |
| Belgium | KELA N.V.
  Sint Lenaartseweg 48
  2320 Hoogstraten
  Belgium | Spectoliphen 100 | Lincomycin and Spectinomycin | 222 mg/g
  444 mg/g | Powder for use in drinking water | Pigs, poultry | Oral |
| Belgium | V.M.D. nv
  Hoge Mauw 900
  2370 Arendonk
  Belgium | Lincomycine-Spectinomycine VMD Pulvis | Lincomycin and Spectinomycin | 33,3  g/150 g
  66,6  g/150 g | Powder for use in drinking water | Pigs | Oral |
| Bulgaria | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linco-Spectin 100, powder for oral solution | Lincomycin and Spectinomycin | 33,3  g/150 g
  66,7  g/150 g | Powder for use in drinking water | Pigs, chickens, turkeys | Oral |
| Bulgaria | Kepro B.V.
  Maagdenburgstraat 17
  7421 ZE Deventer
  The Netherlands | L.S.POWDER WSP | Lincomycin and Spectinomycin | 222 mg/g
  444 mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Bulgaria | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linko-spectin 44 premix | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs, chickens | Oral |
| Bulgaria | Zavet AD
  Ul. Kiril I Metodiy No 5
  Zavet
  Bulgaria | Lincomycin 222 Spectinomycin 444 WSP | Lincomycin and Spectinomycin | 222 mg
  444 mg | Powder for use in drinking water | Pigs, chickens | Oral |
| Croatia | Zoetis Netherlands Holdings B.V.
  Podružnica Zagreb za promidžbu
  Petra Hektorovića 2
  10000 Zagreb
  Croatia | LINCO-SPECTIN 100 | Lincomycin and Spectinomycin | 33,3  g/150 g
  66,7  g/150 g | Powder for use in drinking water | Pigs,
  chickens | Oral |
| Croatia | Zoetis Netherlands Holdings B.V.
  Podružnica Zagreb za promidžbu
  Petra Hektorovića 2
  10000 Zagreb
  Croatia | LINCO-SPECTIN 44 | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Croatia | Vet Consulting d.o.o.
  Matije Gupca 42
  43500 Daruvar
  Croatia | L-SPEC 100 S | Lincomycin and Spectinomycin | 33,3  g/150 g
  66,6  g/150 g | Powder for use in drinking water | Pigs | Oral |
| Cyprus | Zoetis Hellas SA
  253-255 Messogeion Ave
  15451 Neo Psychiko
  Athens
  Greece | Linco-Spectin 100 SP
  66,7  g Spectinomycin, 33,3  g Lincomycin
  Σκόνη για χορήγηση μέσω διαλύματος από το στόμα για ορνίθια | Lincomycin and Spectinomycin | 33,3  g/150 g
  66,7  g/150 g | Powder for use in drinking water | Chickens | Oral |
| Cyprus | Zoetis Hellas SA
  253-255 Messogeion Ave
  15451 Neo Psychiko
  Athens
  Greece | LINCO-SPECTIN 44 PREMIX POWDER, πρόμιγμα για φαρμακούχο ζωοτροφή | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Czech Republic | Zoetis Česká republika s.r.o.
  Stroupežnického 17
  150 00 Praha 5
  Czech Republic | LINCO — SPECTIN 22/22 mg/g premix pro medikaci krmiva | Lincomycin and Spectinomycin | 22 mg/g
  22 mg/g | Premix for medicated feeding stuff | Pigs | Oral |
| Czech Republic | Zoetis Česká republika s.r.o.
  Stroupežnického 17
  150 00 Praha 5
  Czech Republic | Linco-spectin 222/444,7  mg/g prášek pro podání v pitné vodě pro prasata a kura domácího | Lincomycin and Spectinomycin | 222 mg/g
  444,7  mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Czech Republic | FATRO S.p.A.
  Via Emilia, 285
  40064 Ozzano Emilia (BO)
  Italy | MICOSPECTONE plv. sol. | Lincomycin and Spectinomycin | 166,5  mg/g 333,5  mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Denmark | Pfizer Oy Animal Health
  Tietokuja 4
  FI-003300 Helsinki
  Finland | Linco-spectin Vet | Lincomycin and Spectinomycin | 22 mg/g
  22 mg/g | Powder to be administered with the feed | Pigs | Oral |
| Denmark | Pfizer Oy Animal Health
  Tietokuja 4
  FI-003300 Helsinki
  Finland | Linco-spectin Vet | Lincomycin and Spectinomycin | 220 mg/g
  440 mg/g | Powder for use in drinking water | Pigs, poultry | Oral |
| Estonia | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linco-Spectin 100 | Lincomycin and Spectinomycin | 222 mg/g
  444,7  mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Estonia | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linco-Spectin 44 Premix | Lincomycin and Spectinomycin | 22 mg/g
  22 mg/g | Premix for medicated feeding stuff | Pigs | Oral |
| France | Zoetis France
  23-25 Avenue du Docteur Lannelongue
  75014 Paris
  France | LINCO-SPECTIN 100, 222/444,7 MG/G POUDRE POUR ADMINISTRATION DANS L’EAU DE BOISSON POUR PORCINS ET POULETS | Lincomycin and Spectinomycin | 222 mg/g
  444,7  mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| France | Deltavit
  Zone D’Activites Du Bois De Teillay
  35150 Janze
  France | PM 27 LINCOMYCINE 4,4 SPECTINOMYCINE 4,4 PORC | Lincomycin and Spectinomycin | 4,4  mg/g
  4,4  mg/g | Premix for medicated feeding stuff | Pigs | Oral |
| France | Sogeval
  200 Avenue de Mayenne
  Zone Industrielle des Touches
  53000 Laval
  France | CONCENTRAT V061 LINCOMYCINE 4,4 SPECTINOMYCINE 4,4 PORC | Lincomycin and Spectinomycin | 4,4  mg/g
  4,4  mg/g | Premix for medicated feeding stuff | Pigs | Oral |
| France | Qalian
  34 rue Jean Monnet
  ZI d’Etriche
  49500 SEGRE
  France | LINCOMYCINE 4,4 SPECTINOMYCINE 4,4 PORC FRANVET | Lincomycin and Spectinomycin | 4,4  mg/g
  4,4  mg/g | Premix for medicated feeding stuff | Pigs | Oral |
| Germany | Zoetis Deutschland GmbH
  Schellingstrasse 1
  D-10785 Berlin
  Germany | Lincospectin Top | Lincomycin and Spectinomycin | 22 mg/g
  22 mg/g | Powder to be administered with the feed | Pigs | Oral |
| Germany | Zoetis Deutschland GmbH
  Schellingstrasse 1
  D-10785 Berlin
  Germany | Lincospectin Pulver | Lincomycin and Spectinomycin | 222 mg/g
  445 mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Germany | Bela-Pharm GmbH & Co.KG
  Lohner Str. 19
  49377 Vechta
  Germany | Pyanosid Pulver | Lincomycin and Spectinomycin | 227 mg/g
  455 mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Germany | Kon-Pharma GmbH
  Senator-Bauer-Str. 34
  D-30625 Hannover
  Germany | Lincomycin-Spectinomycin Pulver | Lincomycin and Spectinomycin | 227 mg/g
  455 mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Germany | Pharmacia GmbH
  Linkstr. 10
  D-10785 Berlin
  Germany | Lincospectin 44 Premix | Lincomycin and Spectinomycin | 22 mg/g
  22 mg/g | Premix for medicated feeding stuff | Pigs | Oral |
| Greece | PROVET AE
  19300, Aspropyrgos
  Attikis
  Greece | LINCOVET-S | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Greece | PROVET AE
  19300, Aspropyrgos
  Attikis
  Greece | LINCOVET-S WSP | Lincomycin and Spectinomycin | 33,3  g/150 g
  66,7  g/150 g | Powder for use in drinking water | Chickens (broilers) | Oral |
| Greece | Zoetis Hellas SA
  253-255 Messogeion Ave
  15451 Neo Psychiko
  Athens
  Greece | LINCO-SPECTIN | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Greece | Zoetis Hellas SA
  253-255 Messogeion Ave
  15451 Neo Psychiko
  Athens
  Greece | LINCO-SPECTIN | Lincomycin and Spectinomycin | 33,3  g/150 g
  66,7  g/150 g | Powder for use in drinking water | Chickens (broilers) | Oral |
| Greece | AVICO AE
  2 Km Paiania-Spata Av
  1902 Paiania Attiki
  Greece | MICOSPECTONE | Lincomycin and Spectinomycin | 16,65  g/100 g
  33,35  g/100 g | Powder for use in drinking water | Pigs, chickens (broilers) | Oral |
| Hungary | Zoetis Hungary Kft.
  1123 Budapest
  Alkotás u. 53.
  Hungary | LincoSpectin SolPO 222/444,7  mg/g por ivóvízbe keveréshez sertések és házityúkok számára A.U.V. | Lincomycin and Spectinomycin | 222 mg/g
  444,7  mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Hungary | Zoetis Hungary Kft.
  1123 Budapest
  Alkotás u. 53.
  Hungary | Linco-Spectin 44 gyógypremix A.U.V. | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Ireland | Zoetis Ireland Limited
  25/28 North Wall Quay
  Dublin 1
  Ireland | Linco-Spectin 100, 222/444,7  mg/g Powder for use in drinking water for pigs and chickens | Lincomycin and Spectinomycin | 222 mg/g
  444,7  mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Ireland | Zoetis Ireland Limited
  25/28 North Wall Quay
  Dublin 1
  Ireland | Linco-Spectin Premix for medicated feed. | Lincomycin and Spectinomycin | 22 mg/g
  22 mg/g | Premix for medicated feed | Pigs | Oral |
| Italy | Zoetis Italia S.r.l.
  Via Andrea Doria, 41 M
  00192 Roma
  Italy | Lincospectin 222/444,7  mg/g | Lincomycin and Spectinomycin | 222 mg
  444,7  mg | Powder for use in drinking water | Pigs, chickens | Oral |
| Italy | Zoetis Italia S.r.l.
  Via Andrea Doria, 41 M
  00192 Roma
  Italy | Lincospectin 44 mg/g | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Italy | FATRO S.p.A.
  Via Emilia, 285
  40064 Ozzano Emilia (BO)
  Italy | MICOSPECTONE 166,5  mg/g + 333,5  mg/g polvere per soluzione orale per vitelli, suinetti e polli. | Lincomycin and Spectinomycin | 166,5  mg/g
  333,5  mg/g | Powder for use in drinking water or milk | Calves, piglets, chickens | Oral |
| Latvia | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linco-Spectin 44 Premix | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Latvia | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linco-Spectin 100 | Lincomycin and Spectinomycin | 222 mg/g
  444,7  mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Lithuania | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | LINCO-SPECTIN 44 vaistinis premiksas | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg, | Premix for medicated feeding stuff | Pigs | Oral |
| Lithuania | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linco-Spectin 100, 222/444,7  mg/g milteliai, skirti naudoti su geriamuoju vandeniu kiaulėms ir
  vištoms | Lincomycin and Spectinomycin | 222 mg/g
  444,7  mg/g | Powder for use in drinking water | Pigs, poultry | Oral |
| Lithuania | Bela-Pharm GmbH & Co.KG
  Lohner Str. 19
  49377 Vechta
  Germany | PYANOSID, geriamieji milteliai | Lincomycin and Spectinomycin | 33,3  g/146,36  g
  66,7  g/146,36  g | Powder for use in drinking water | Pigs, poultry (broiler, pullet) and turkey | Oral |
| Luxembourg | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | LINCO-SPECTIN 100 | Lincomycin and Spectinomycin | 222 mg/g
  444,7  mg/g | Powder for use in drinking water | Pigs,
  poultry | Oral |
| Luxembourg | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | LINCO-SPECTIN 22 + 22 premix | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Luxembourg | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | LINCO-SPECTIN 44 | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Powder to be administered with the feed | Pigs | Oral |
| Malta | FATRO S.p.A.
  Via Emilia, 285
  40064 Ozzano Emilia (BO)
  Italy | Micospectone | Lincomycin and Spectinomycin | 166,5  mg/g 333,5  mg/g | Powder for use in drinking water | Piglets, calves, chickens | Oral |
| Malta | V.M.D. nv
  Hoge Mauw 900
  2370 Arendonk
  Belgium | Lincomycin-spectinomycin VMD Pulvis | Lincomycin and Spectinomycin | 33,3  g/150 g 66,6  g/150 g | Powder for use in drinking water | Pigs | Oral |
| The Netherlands | Zoetis B.V.
  Rivium Westlaan 74
  2909 LD Capelle a/d Ijssel
  The Netherlands | LINCO-SPECTIN 100, 222 mg/g + 444,7  mg/g poeder voor gebruik in drinkwater voor varkens en kippen, REG NL 9916 | Lincomycin and Spectinomycin | 222 mg/g
  444,7  mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| The Netherlands | Zoetis B.V.
  Rivium Westlaan 74
  2909 LD Capelle a/d Ijssel
  The Netherlands | LINCO-SPECTIN PREMIX voor varkens, REG NL 9708 | Lincomycin and Spectinomycin | 22 mg/g
  22 mg/g | Premix for medicated feeding stuff | Pigs | Oral |
| Poland | Zoetis Polska Sp. z o.o.
  ul. Postępu 17 B
  02-676 Warszawa
  Poland | Linco-Spectin 100 | Lincomycin and Spectinomycin | 222 g/kg
  444 g/kg | Powder for use in drinking water | Pigs, hens
  pigeons,
  ducks,
  turkeys | Oral |
| Poland | Zoetis Polska Sp. z o.o.
  ul. Postępu 17 B
  02-676 Warszawa
  Poland | Linco-Spectin Premix | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Portugal | Zoetis Portugal Lda.
  Lagoas Park, Edifício 10
  2740-271 Porto Salvo
  Portugal | LINCO-SPECTIN 44 pré-mistura medicamentosa para Suínos | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Portugal | Zoetis Portugal Lda.
  Lagoas Park, Edifício 10
  2740-271 Porto Salvo
  Portugal | Linco-Spectin 100, 222 + 444,7  mg/g pó para administração na água de bebida para suínos e galinhas | Lincomycin and Spectinomycin | 222 mg/g
  444,7  mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Portugal | Laboratorios Maymó, S.A.
  Via Augusta, 302
  08017 Barcelona
  Spain | Lismay Premix, Pré-mistura medicamentosa para alimento medicamentoso | Lincomycin and Spectinomycin | 440 g/1,5  kg
  440 g/1,5  kg | Premix for medicated feeding stuff | Pigs | Oral |
| Romania | Pfizer Animal Health MA EEIG
  Ramsgate Road
  Sandwich, Kent
  CT13 9NJ
  United Kingdom | Linco-Spectin 44 | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Romania | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linco-Spectin 880 | Lincomycin and Spectinomycin | 293,3  g/kg
  293,3  g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Romania | Pfizer Animal Health MA EEIG
  Ramsgate Road
  Sandwich, Kent
  CT13 9NJ
  United Kingdom | Linco-Spectin 100 | Lincomycin and Spectinomycin | 33,3  g/150 g 66,7  g/150 g | Powder for use in drinking water | Pigs, chickens, turkeys | Oral |
| Slovakia | Zoetis Česká republika s.r.o.
  Stroupežnického 17
  150 00 Praha 5
  Czech Republic | Linco-Spectin 44 g/kg premix na medikáciu krmiva | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Slovakia | Zoetis Česká republika s.r.o.
  Stroupežnického 17
  150 00 Praha 5
  Czech Republic | Linco-Spectin 100 prášok na perorálny roztok | Lincomycin and Spectinomycin | 33,3  g/150 g
  66,7  g/150 g | Powder for use in drinking water | Pigs, poultry | Oral |
| Slovakia | FATRO S.p.A.
  Via Emilia, 285
  40064 Ozzano Emilia (BO)
  Italy | MICOSPECTONE 166,5  mg + 333,5  mg prášok na perorálny roztok | Lincomycin and Spectinomycin | 166,50  mg/g
  333,50  mg/g | Powder for use in drinking water | Piglets, chickens | Oral |
| Slovenia | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linco Spectin 100 prašek za peroralno raztopino za prašiče in perutnino | Lincomycin and Spectinomycin | 33,3  g/150 g
  66,7  g/150 g | Powder for use in drinking water | Pigs, poultry | Oral |
| Slovenia | Zoetis Belgium SA
  Rue Laid Burniat, 1
  1348 Louvain-la-Neuve
  Belgium | Linco Spectin 44 predmešanica za zdravilno krmno mešanico za prašiče | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Spain | Laboratorios Ovejero S.A.
  Ctra. León-Vilecha, 30
  24192 León
  Spain | HEMOENTEROL PREMEZCLA MEDICAMENTOSA | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Spain | SUPER'S DIANA, S.L
  Ctra. C-17, km 17
  Parets del Valles
  08150 Barcelona
  Spain | LINCOTRIMEX-PREMIX | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Spain | Laboratorios Maymó, S.A.
  Via Augusta, 302
  08017 Barcelona
  Spain | LISMAY PREMIX | Lincomycin and Spectinomycin | 440 g/1,5  kg
  440 g/1,5  kg | Premix for medicated feeding stuff | Pigs | Oral |
| Spain | Zoetis Spain, S.L.
  Avda. de Europa, 20B
  Parque Empresarial La Moraleja
  Alcobendas 28108
  Spain | LINCO-SPECTIN 22/22 mg/g premezcla medicamentosa para porcino | Lincomycin and Spectinomycin | 22 g/kg
  22 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| Spain | Zoetis Spain, S.L.
  Avda. de Europa, 20B
  Parque Empresarial La Moraleja
  Alcobendas 28108
  Spain | LINCO-SPECTIN 100 | Lincomycin and Spectinomycin | 222 mg/g 444,7  mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Spain | MEVET, S.A.
  Poligono Industrial El Segre
  Parc. 409-410
  25191 Lérida
  Spain | LINESVALL 22 g/Kg PREMEZCLA MEDICAMENTOSA | Lincomycin and Spectinomycin | 11 g/kg
  11 g/kg | Premix for medicated feeding stuff | Pigs | Oral |
| United Kingdom | Zoetis UK Limited
  5th Floor, 6 St. Andrew Street
  London, EC4A 3AE
  United Kingdom | Linco-Spectin 100, 222/444,7  mg/g Powder for Use in Drinking Water for Pigs and Chickens | Lincomycin and Spectinomycin | 222 mg/g
  444,7  mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| United Kingdom | Zoetis UK Limited
  5th Floor, 6 St. Andrew Street
  London, EC4A 3AE
  United Kingdom | Linco-Spectin Premix for Medicated Feed | Lincomycin and Spectinomycin | 2,2  % w/w 2,2  % w/w | Premix for medicated feeding stuff | Pigs | Oral |
| United Kingdom | Zoetis UK Limited
  5th Floor, 6 St. Andrew Street
  London, EC4A 3AE
  United Kingdom | Linco-Spectin SP 222 mg/g + 444,7  mg/g powder for use in drinking water for pigs and chickens | Lincomycin and Spectinomycin | 22,2  % w/w 44,4  % w/w | Powder for use in drinking water | Pigs, chickens | Oral |

Member State EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Zoetis Österreich GmbH

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Linco–Spectin 22/22 mg/g — Arzneimittelvormischung zur Herstellung von Fütterungsarzneimitteln für Schweine

Lincomycin and Spectinomycin

22 mg/g

22 mg/g

Premix for medicated feeding stuff

Pigs

Oral

Austria

Zoetis Österreich GmbH

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Linco-Spectin 222 mg/g + 444,7  mg/g — Pulver zum Eingeben über das Trinkwasser für Schweine und Hühner

Lincomycin and Spectinomycin

222 mg/g

444,7  mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Austria

Animed Service AG

Liebochstrasse 9

8143 Dobl

Austria

Lincomycin-Spectinomycin 1,1  % ‘Animed Service’ — Pulver zum Eingeben für Schweine

Lincomycin and Spectinomycin

5,5  g/kg

5,5  g/kg

Powder to be administered with the feed

Pigs

Oral

Belgium

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linco-Spectin 100

Lincomycin and Spectinomycin

222 mg/g

444,7  mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Belgium

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linco-Spectin 22 + 22

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Belgium

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linco-Spectin 44

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Powder to be administered with the feed

Pigs

Oral

Belgium

KELA N.V.

Sint Lenaartseweg 48

2320 Hoogstraten

Belgium

Spectoliphen 100

Lincomycin and Spectinomycin

222 mg/g

444 mg/g

Powder for use in drinking water

Pigs, poultry

Oral

Belgium

V.M.D. nv

Hoge Mauw 900

2370 Arendonk

Belgium

Lincomycine-Spectinomycine VMD Pulvis

Lincomycin and Spectinomycin

33,3  g/150 g

66,6  g/150 g

Powder for use in drinking water

Pigs

Oral

Bulgaria

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linco-Spectin 100, powder for oral solution

Lincomycin and Spectinomycin

33,3  g/150 g

66,7  g/150 g

Powder for use in drinking water

Pigs, chickens, turkeys

Oral

Bulgaria

Kepro B.V.

Maagdenburgstraat 17

7421 ZE Deventer

The Netherlands

L.S.POWDER WSP

Lincomycin and Spectinomycin

222 mg/g

444 mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Bulgaria

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linko-spectin 44 premix

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs, chickens

Oral

Bulgaria

Zavet AD

Ul. Kiril I Metodiy No 5

Zavet

Bulgaria

Lincomycin 222 Spectinomycin 444 WSP

Lincomycin and Spectinomycin

222 mg

444 mg

Powder for use in drinking water

Pigs, chickens

Oral

Croatia

Zoetis Netherlands Holdings B.V.

Podružnica Zagreb za promidžbu

Petra Hektorovića 2

10000 Zagreb

Croatia

LINCO-SPECTIN 100

Lincomycin and Spectinomycin

33,3  g/150 g

66,7  g/150 g

Powder for use in drinking water

Pigs,

chickens

Oral

Croatia

Zoetis Netherlands Holdings B.V.

Podružnica Zagreb za promidžbu

Petra Hektorovića 2

10000 Zagreb

Croatia

LINCO-SPECTIN 44

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Croatia

Vet Consulting d.o.o.

Matije Gupca 42

43500 Daruvar

Croatia

L-SPEC 100 S

Lincomycin and Spectinomycin

33,3  g/150 g

66,6  g/150 g

Powder for use in drinking water

Pigs

Oral

Cyprus

Zoetis Hellas SA

253-255 Messogeion Ave

15451 Neo Psychiko

Athens

Greece

Linco-Spectin 100 SP

66,7  g Spectinomycin, 33,3  g Lincomycin

Σκόνη για χορήγηση μέσω διαλύματος από το στόμα για ορνίθια

Lincomycin and Spectinomycin

33,3  g/150 g

66,7  g/150 g

Powder for use in drinking water

Chickens

Oral

Cyprus

Zoetis Hellas SA

253-255 Messogeion Ave

15451 Neo Psychiko

Athens

Greece

LINCO-SPECTIN 44 PREMIX POWDER, πρόμιγμα για φαρμακούχο ζωοτροφή

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Czech Republic

Zoetis Česká republika s.r.o.

Stroupežnického 17

150 00 Praha 5

Czech Republic

LINCO — SPECTIN 22/22 mg/g premix pro medikaci krmiva

Lincomycin and Spectinomycin

22 mg/g

22 mg/g

Premix for medicated feeding stuff

Pigs

Oral

Czech Republic

Zoetis Česká republika s.r.o.

Stroupežnického 17

150 00 Praha 5

Czech Republic

Linco-spectin 222/444,7  mg/g prášek pro podání v pitné vodě pro prasata a kura domácího

Lincomycin and Spectinomycin

222 mg/g

444,7  mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Czech Republic

FATRO S.p.A.

Via Emilia, 285

40064 Ozzano Emilia (BO)

Italy

MICOSPECTONE plv. sol.

Lincomycin and Spectinomycin

166,5  mg/g 333,5  mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Denmark

Pfizer Oy Animal Health

Tietokuja 4

FI-003300 Helsinki

Finland

Linco-spectin Vet

Lincomycin and Spectinomycin

22 mg/g

22 mg/g

Powder to be administered with the feed

Pigs

Oral

Denmark

Pfizer Oy Animal Health

Tietokuja 4

FI-003300 Helsinki

Finland

Linco-spectin Vet

Lincomycin and Spectinomycin

220 mg/g

440 mg/g

Powder for use in drinking water

Pigs, poultry

Oral

Estonia

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linco-Spectin 100

Lincomycin and Spectinomycin

222 mg/g

444,7  mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Estonia

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linco-Spectin 44 Premix

Lincomycin and Spectinomycin

22 mg/g

22 mg/g

Premix for medicated feeding stuff

Pigs

Oral

France

Zoetis France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

LINCO-SPECTIN 100, 222/444,7 MG/G POUDRE POUR ADMINISTRATION DANS L’EAU DE BOISSON POUR PORCINS ET POULETS

Lincomycin and Spectinomycin

222 mg/g

444,7  mg/g

Powder for use in drinking water

Pigs, chickens

Oral

France

Deltavit

Zone D’Activites Du Bois De Teillay

35150 Janze

France

PM 27 LINCOMYCINE 4,4 SPECTINOMYCINE 4,4 PORC

Lincomycin and Spectinomycin

4,4  mg/g

4,4  mg/g

Premix for medicated feeding stuff

Pigs

Oral

France

Sogeval

200 Avenue de Mayenne

Zone Industrielle des Touches

53000 Laval

France

CONCENTRAT V061 LINCOMYCINE 4,4 SPECTINOMYCINE 4,4 PORC

Lincomycin and Spectinomycin

4,4  mg/g

4,4  mg/g

Premix for medicated feeding stuff

Pigs

Oral

France

Qalian

34 rue Jean Monnet

ZI d’Etriche

49500 SEGRE

France

LINCOMYCINE 4,4 SPECTINOMYCINE 4,4 PORC FRANVET

Lincomycin and Spectinomycin

4,4  mg/g

4,4  mg/g

Premix for medicated feeding stuff

Pigs

Oral

Germany

Zoetis Deutschland GmbH

Schellingstrasse 1

D-10785 Berlin

Germany

Lincospectin Top

Lincomycin and Spectinomycin

22 mg/g

22 mg/g

Powder to be administered with the feed

Pigs

Oral

Germany

Zoetis Deutschland GmbH

Schellingstrasse 1

D-10785 Berlin

Germany

Lincospectin Pulver

Lincomycin and Spectinomycin

222 mg/g

445 mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Germany

Bela-Pharm GmbH & Co.KG

Lohner Str. 19

49377 Vechta

Germany

Pyanosid Pulver

Lincomycin and Spectinomycin

227 mg/g

455 mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Germany

Kon-Pharma GmbH

Senator-Bauer-Str. 34

D-30625 Hannover

Germany

Lincomycin-Spectinomycin Pulver

Lincomycin and Spectinomycin

227 mg/g

455 mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Germany

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Germany

Lincospectin 44 Premix

Lincomycin and Spectinomycin

22 mg/g

22 mg/g

Premix for medicated feeding stuff

Pigs

Oral

Greece

PROVET AE

19300, Aspropyrgos

Attikis

Greece

LINCOVET-S

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Greece

PROVET AE

19300, Aspropyrgos

Attikis

Greece

LINCOVET-S WSP

Lincomycin and Spectinomycin

33,3  g/150 g

66,7  g/150 g

Powder for use in drinking water

Chickens (broilers)

Oral

Greece

Zoetis Hellas SA

253-255 Messogeion Ave

15451 Neo Psychiko

Athens

Greece

LINCO-SPECTIN

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Greece

Zoetis Hellas SA

253-255 Messogeion Ave

15451 Neo Psychiko

Athens

Greece

LINCO-SPECTIN

Lincomycin and Spectinomycin

33,3  g/150 g

66,7  g/150 g

Powder for use in drinking water

Chickens (broilers)

Oral

Greece

AVICO AE

2 Km Paiania-Spata Av

1902 Paiania Attiki

Greece

MICOSPECTONE

Lincomycin and Spectinomycin

16,65  g/100 g

33,35  g/100 g

Powder for use in drinking water

Pigs, chickens (broilers)

Oral

Hungary

Zoetis Hungary Kft.

1123 Budapest

Alkotás u. 53.

Hungary

LincoSpectin SolPO 222/444,7  mg/g por ivóvízbe keveréshez sertések és házityúkok számára A.U.V.

Lincomycin and Spectinomycin

222 mg/g

444,7  mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Hungary

Zoetis Hungary Kft.

1123 Budapest

Alkotás u. 53.

Hungary

Linco-Spectin 44 gyógypremix A.U.V.

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Ireland

Zoetis Ireland Limited

25/28 North Wall Quay

Dublin 1

Ireland

Linco-Spectin 100, 222/444,7  mg/g Powder for use in drinking water for pigs and chickens

Lincomycin and Spectinomycin

222 mg/g

444,7  mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Ireland

Zoetis Ireland Limited

25/28 North Wall Quay

Dublin 1

Ireland

Linco-Spectin Premix for medicated feed.

Lincomycin and Spectinomycin

22 mg/g

22 mg/g

Premix for medicated feed

Pigs

Oral

Italy

Zoetis Italia S.r.l.

Via Andrea Doria, 41 M

00192 Roma

Italy

Lincospectin 222/444,7  mg/g

Lincomycin and Spectinomycin

222 mg

444,7  mg

Powder for use in drinking water

Pigs, chickens

Oral

Italy

Zoetis Italia S.r.l.

Via Andrea Doria, 41 M

00192 Roma

Italy

Lincospectin 44 mg/g

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Italy

FATRO S.p.A.

Via Emilia, 285

40064 Ozzano Emilia (BO)

Italy

MICOSPECTONE 166,5  mg/g + 333,5  mg/g polvere per soluzione orale per vitelli, suinetti e polli.

Lincomycin and Spectinomycin

166,5  mg/g

333,5  mg/g

Powder for use in drinking water or milk

Calves, piglets, chickens

Oral

Latvia

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linco-Spectin 44 Premix

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Latvia

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linco-Spectin 100

Lincomycin and Spectinomycin

222 mg/g

444,7  mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Lithuania

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

LINCO-SPECTIN 44 vaistinis premiksas

Lincomycin and Spectinomycin

22 g/kg

22 g/kg,

Premix for medicated feeding stuff

Pigs

Oral

Lithuania

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linco-Spectin 100, 222/444,7  mg/g milteliai, skirti naudoti su geriamuoju vandeniu kiaulėms ir

vištoms

Lincomycin and Spectinomycin

222 mg/g

444,7  mg/g

Powder for use in drinking water

Pigs, poultry

Oral

Lithuania

Bela-Pharm GmbH & Co.KG

Lohner Str. 19

49377 Vechta

Germany

PYANOSID, geriamieji milteliai

Lincomycin and Spectinomycin

33,3  g/146,36  g

66,7  g/146,36  g

Powder for use in drinking water

Pigs, poultry (broiler, pullet) and turkey

Oral

Luxembourg

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

LINCO-SPECTIN 100

Lincomycin and Spectinomycin

222 mg/g

444,7  mg/g

Powder for use in drinking water

Pigs,

poultry

Oral

Luxembourg

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

LINCO-SPECTIN 22 + 22 premix

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Luxembourg

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

LINCO-SPECTIN 44

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Powder to be administered with the feed

Pigs

Oral

Malta

FATRO S.p.A.

Via Emilia, 285

40064 Ozzano Emilia (BO)

Italy

Micospectone

Lincomycin and Spectinomycin

166,5  mg/g 333,5  mg/g

Powder for use in drinking water

Piglets, calves, chickens

Oral

Malta

V.M.D. nv

Hoge Mauw 900

2370 Arendonk

Belgium

Lincomycin-spectinomycin VMD Pulvis

Lincomycin and Spectinomycin

33,3  g/150 g 66,6  g/150 g

Powder for use in drinking water

Pigs

Oral

The Netherlands

Zoetis B.V.

Rivium Westlaan 74

2909 LD Capelle a/d Ijssel

The Netherlands

LINCO-SPECTIN 100, 222 mg/g + 444,7  mg/g poeder voor gebruik in drinkwater voor varkens en kippen, REG NL 9916

Lincomycin and Spectinomycin

222 mg/g

444,7  mg/g

Powder for use in drinking water

Pigs, chickens

Oral

The Netherlands

Zoetis B.V.

Rivium Westlaan 74

2909 LD Capelle a/d Ijssel

The Netherlands

LINCO-SPECTIN PREMIX voor varkens, REG NL 9708

Lincomycin and Spectinomycin

22 mg/g

22 mg/g

Premix for medicated feeding stuff

Pigs

Oral

Poland

Zoetis Polska Sp. z o.o.

ul. Postępu 17 B

02-676 Warszawa

Poland

Linco-Spectin 100

Lincomycin and Spectinomycin

222 g/kg

444 g/kg

Powder for use in drinking water

Pigs, hens

pigeons,

ducks,

turkeys

Oral

Poland

Zoetis Polska Sp. z o.o.

ul. Postępu 17 B

02-676 Warszawa

Poland

Linco-Spectin Premix

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Portugal

Zoetis Portugal Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

LINCO-SPECTIN 44 pré-mistura medicamentosa para Suínos

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Portugal

Zoetis Portugal Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Linco-Spectin 100, 222 + 444,7  mg/g pó para administração na água de bebida para suínos e galinhas

Lincomycin and Spectinomycin

222 mg/g

444,7  mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Portugal

Laboratorios Maymó, S.A.

Via Augusta, 302

08017 Barcelona

Spain

Lismay Premix, Pré-mistura medicamentosa para alimento medicamentoso

Lincomycin and Spectinomycin

440 g/1,5  kg

440 g/1,5  kg

Premix for medicated feeding stuff

Pigs

Oral

Romania

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich, Kent

CT13 9NJ

United Kingdom

Linco-Spectin 44

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Romania

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linco-Spectin 880

Lincomycin and Spectinomycin

293,3  g/kg

293,3  g/kg

Premix for medicated feeding stuff

Pigs

Oral

Romania

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich, Kent

CT13 9NJ

United Kingdom

Linco-Spectin 100

Lincomycin and Spectinomycin

33,3  g/150 g 66,7  g/150 g

Powder for use in drinking water

Pigs, chickens, turkeys

Oral

Slovakia

Zoetis Česká republika s.r.o.

Stroupežnického 17

150 00 Praha 5

Czech Republic

Linco-Spectin 44 g/kg premix na medikáciu krmiva

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Slovakia

Zoetis Česká republika s.r.o.

Stroupežnického 17

150 00 Praha 5

Czech Republic

Linco-Spectin 100 prášok na perorálny roztok

Lincomycin and Spectinomycin

33,3  g/150 g

66,7  g/150 g

Powder for use in drinking water

Pigs, poultry

Oral

Slovakia

FATRO S.p.A.

Via Emilia, 285

40064 Ozzano Emilia (BO)

Italy

MICOSPECTONE 166,5  mg + 333,5  mg prášok na perorálny roztok

Lincomycin and Spectinomycin

166,50  mg/g

333,50  mg/g

Powder for use in drinking water

Piglets, chickens

Oral

Slovenia

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linco Spectin 100 prašek za peroralno raztopino za prašiče in perutnino

Lincomycin and Spectinomycin

33,3  g/150 g

66,7  g/150 g

Powder for use in drinking water

Pigs, poultry

Oral

Slovenia

Zoetis Belgium SA

Rue Laid Burniat, 1

1348 Louvain-la-Neuve

Belgium

Linco Spectin 44 predmešanica za zdravilno krmno mešanico za prašiče

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Spain

Laboratorios Ovejero S.A.

Ctra. León-Vilecha, 30

24192 León

Spain

HEMOENTEROL PREMEZCLA MEDICAMENTOSA

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Spain

SUPER'S DIANA, S.L

Ctra. C-17, km 17

Parets del Valles

08150 Barcelona

Spain

LINCOTRIMEX-PREMIX

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Spain

Laboratorios Maymó, S.A.

Via Augusta, 302

08017 Barcelona

Spain

LISMAY PREMIX

Lincomycin and Spectinomycin

440 g/1,5  kg

440 g/1,5  kg

Premix for medicated feeding stuff

Pigs

Oral

Spain

Zoetis Spain, S.L.

Avda. de Europa, 20B

Parque Empresarial La Moraleja

Alcobendas 28108

Spain

LINCO-SPECTIN 22/22 mg/g premezcla medicamentosa para porcino

Lincomycin and Spectinomycin

22 g/kg

22 g/kg

Premix for medicated feeding stuff

Pigs

Oral

Spain

Zoetis Spain, S.L.

Avda. de Europa, 20B

Parque Empresarial La Moraleja

Alcobendas 28108

Spain

LINCO-SPECTIN 100

Lincomycin and Spectinomycin

222 mg/g 444,7  mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Spain

MEVET, S.A.

Poligono Industrial El Segre

Parc. 409-410

25191 Lérida

Spain

LINESVALL 22 g/Kg PREMEZCLA MEDICAMENTOSA

Lincomycin and Spectinomycin

11 g/kg

11 g/kg

Premix for medicated feeding stuff

Pigs

Oral

United Kingdom

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London, EC4A 3AE

United Kingdom

Linco-Spectin 100, 222/444,7  mg/g Powder for Use in Drinking Water for Pigs and Chickens

Lincomycin and Spectinomycin

222 mg/g

444,7  mg/g

Powder for use in drinking water

Pigs, chickens

Oral

United Kingdom

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London, EC4A 3AE

United Kingdom

Linco-Spectin Premix for Medicated Feed

Lincomycin and Spectinomycin

2,2  % w/w 2,2  % w/w

Premix for medicated feeding stuff

Pigs

Oral

United Kingdom

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London, EC4A 3AE

United Kingdom

Linco-Spectin SP 222 mg/g + 444,7  mg/g powder for use in drinking water for pigs and chickens

Lincomycin and Spectinomycin

22,2  % w/w 44,4  % w/w

Powder for use in drinking water

Pigs, chickens

Oral

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