# Official Journal C 328/29 S

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 328 |
| | |
| English edition | Information and Notices | Volume 6029 September 2017 |

ISSN 1977-091X

Official Journal

of the European Union

C 328

English edition

Information and Notices

Volume 6029 September 2017

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2017/C 328/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2017 to 31 August 2017(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2017/C 328/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2017 to 31 August 2017(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 14 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2017/C 328/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2017 to 31 August 2017(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

2017/C 328/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2017 to 31 August 2017(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)

14

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 29.9.2017 | EN | Official Journal of the European Union | C 328/1 |
| --- | --- | --- | --- |

29.9.2017

EN

Official Journal of the European Union

C 328/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2017 to 31 August 2017

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

(2017/C 328/01)

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

—

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.7.2017 | OXERVATE | cenegermin | Dompé farmaceutici S.p.A.
  Via Santa Lucia 6, 20122 Milano, Italia | EU/1/17/1197 | Eye drops, solution | Pending | 10.7.2017 |
| 10.7.2017 | Spherox | spheroids of human autologous matrix-associated chondrocytes | CO.DON AG
  Warthestraße 21, 14513 Teltow, Deutschland | EU/1/17/1181 | Implantation suspension | M09AX02 | 12.7.2017 |
| 13.7.2017 | Blitzima | rituximab | Celltrion Healthcare Hungary Kft.
  1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország | EU/1/17/1205 | Concentrate for solution for infusion | L01XC02 | 17.7.2017 |
| 13.7.2017 | Reagila | cariprazine | Gedeon Richter Plc.
  Gyömrői út 19-21., H-1103 Budapest, Magyarország | EU/1/17/1209 | Capsule, hard | N05AX15 | 17.7.2017 |
| 13.7.2017 | Ritemvia | rituximab | Celltrion Healthcare Hungary Kft.
  1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország | EU/1/17/1207 | Concentrate for solution for infusion | L01XC02 | 17.7.2017 |
| 13.7.2017 | Tuxella | rituximab | Celltrion Healthcare Hungary Kft.
  1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország | EU/1/17/1206 | Concentrate for solution for infusion | L01XC02 | 17.7.2017 |
| 17.7.2017 | Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | efavirenz/emtricitabine/tenofovir disoproxil | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/17/1210 | Film-coated tablet | J05AR06 | 19.7.2017 |
| 17.7.2017 | Kyntheum | brodalumab | Leo Pharma A/S
  Industriparken 55, DK-2750 Ballerup, Danmark | EU/1/16/1155 | Solution for injection | L04AC12 | 19.7.2017 |
| 17.7.2017 | Trimbow | beclometasone/formoterol/glycopyrronium bromide | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/17/1208 | Pressurised inhalation, solution | R03AL09 | 19.7.2017 |
| 19.7.2017 | Insulin lispro Sanofi | insulin lispro | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/17/1203 | Solution for injection | A10AB04 | 21.7.2017 |
| 19.7.2017 | Veltassa | patiromer | Vifor Fresenius Medical Care Renal Pharma France
  100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France | EU/1/17/1179 | Powder for oral suspension | V03AE09 | 21.7.2017 |
| 26.7.2017 | Maviret | glecaprevir/pibrentasvir | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/17/1213 | Film-coated tablet | J05AX | 28.7.2017 |
| 26.7.2017 | Vosevi | sofosbuvir/velpatasvir/voxilaprevir | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/17/1223 | Film-coated tablet | Pending | 28.7.2017 |
| 26.7.2017 | Zykadia | ceritinib | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/999 | Capsule, hard | L01XE28 | 28.7.2017 |
| 22.8.2017 | Kisqali | ribociclib | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/17/1221 | Film-coated tablet | L01XE42 | 24.8.2017 |
| 22.8.2017 | MAVENCLAD | cladribine | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/17/1212 | Tablet | L01BB04 | 24.8.2017 |
| 24.8.2017 | Fotivda | tivozanib | EUSA Pharma (UK) Limited
  Breakspear Park, Breakspear Way, HP2 4TZ, Hemel Hempstead, United Kingdom | EU/1/17/1215 | Capsule, hard | L01XE34 | 29.8.2017 |
| 24.8.2017 | Imraldi | adalimumab | Samsung Bioepis UK Limited
  5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom | EU/1/17/1216 | Solution for injection | L04AB04 | 29.8.2017 |
| 24.8.2017 | Nitisinone MendeliKABS | nitisinone | MendeliKABS Europe Limited
  Office 7, Gateway 1000, Whittle Way, Stevenage, Hertfordshire, SG1 2FP, United Kingdom | EU/1/17/1217 | Capsule, hard | A16AX04 | 29.8.2017 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

6.7.2017

OXERVATE

cenegermin

Dompé farmaceutici S.p.A.

Via Santa Lucia 6, 20122 Milano, Italia

EU/1/17/1197

Eye drops, solution

Pending

10.7.2017

10.7.2017

Spherox

spheroids of human autologous matrix-associated chondrocytes

CO.DON AG

Warthestraße 21, 14513 Teltow, Deutschland

EU/1/17/1181

Implantation suspension

M09AX02

12.7.2017

13.7.2017

Blitzima

rituximab

Celltrion Healthcare Hungary Kft.

1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország

EU/1/17/1205

Concentrate for solution for infusion

L01XC02

17.7.2017

13.7.2017

Reagila

cariprazine

Gedeon Richter Plc.

Gyömrői út 19-21., H-1103 Budapest, Magyarország

EU/1/17/1209

Capsule, hard

N05AX15

17.7.2017

13.7.2017

Ritemvia

rituximab

Celltrion Healthcare Hungary Kft.

1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország

EU/1/17/1207

Concentrate for solution for infusion

L01XC02

17.7.2017

13.7.2017

Tuxella

rituximab

Celltrion Healthcare Hungary Kft.

1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország

EU/1/17/1206

Concentrate for solution for infusion

L01XC02

17.7.2017

17.7.2017

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

efavirenz/emtricitabine/tenofovir disoproxil

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/17/1210

Film-coated tablet

J05AR06

19.7.2017

17.7.2017

Kyntheum

brodalumab

Leo Pharma A/S

Industriparken 55, DK-2750 Ballerup, Danmark

EU/1/16/1155

Solution for injection

L04AC12

19.7.2017

17.7.2017

Trimbow

beclometasone/formoterol/glycopyrronium bromide

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/17/1208

Pressurised inhalation, solution

R03AL09

19.7.2017

19.7.2017

Insulin lispro Sanofi

insulin lispro

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/17/1203

Solution for injection

A10AB04

21.7.2017

19.7.2017

Veltassa

patiromer

Vifor Fresenius Medical Care Renal Pharma France

100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France

EU/1/17/1179

Powder for oral suspension

V03AE09

21.7.2017

26.7.2017

Maviret

glecaprevir/pibrentasvir

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/17/1213

Film-coated tablet

J05AX

28.7.2017

26.7.2017

Vosevi

sofosbuvir/velpatasvir/voxilaprevir

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/17/1223

Film-coated tablet

Pending

28.7.2017

26.7.2017

Zykadia

ceritinib

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/999

Capsule, hard

L01XE28

28.7.2017

22.8.2017

Kisqali

ribociclib

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/17/1221

Film-coated tablet

L01XE42

24.8.2017

22.8.2017

MAVENCLAD

cladribine

Merck Serono Europe Limited

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

EU/1/17/1212

Tablet

L01BB04

24.8.2017

24.8.2017

Fotivda

tivozanib

EUSA Pharma (UK) Limited

Breakspear Park, Breakspear Way, HP2 4TZ, Hemel Hempstead, United Kingdom

EU/1/17/1215

Capsule, hard

L01XE34

29.8.2017

24.8.2017

Imraldi

adalimumab

Samsung Bioepis UK Limited

5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom

EU/1/17/1216

Solution for injection

L04AB04

29.8.2017

24.8.2017

Nitisinone MendeliKABS

nitisinone

MendeliKABS Europe Limited

Office 7, Gateway 1000, Whittle Way, Stevenage, Hertfordshire, SG1 2FP, United Kingdom

EU/1/17/1217

Capsule, hard

A16AX04

29.8.2017

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

—

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.7.2017 | Celsentri | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/07/418 | 10.7.2017 |
| 6.7.2017 | Clopidogrel Krka d.d. | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/562 | 10.7.2017 |
| 6.7.2017 | Imlygic | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1064 | 10.7.2017 |
| 6.7.2017 | Kivexa | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/04/298 | 10.7.2017 |
| 6.7.2017 | Nexavar | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/06/342 | 10.7.2017 |
| 6.7.2017 | Toviaz | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/386 | 10.7.2017 |
| 10.7.2017 | Memantine Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/880 | 12.7.2017 |
| 10.7.2017 | Myozyme | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/06/333 | 12.7.2017 |
| 10.7.2017 | Xeloda | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/163 | 12.7.2017 |
| 13.7.2017 | Edistride | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/15/1052 | 17.7.2017 |
| 13.7.2017 | Enurev Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/789 | 17.7.2017 |
| 13.7.2017 | Eylea | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/12/797 | 17.7.2017 |
| 13.7.2017 | Incruse | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/922 | 17.7.2017 |
| 13.7.2017 | Isentress | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/436 | 17.7.2017 |
| 13.7.2017 | Kuvan | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/08/481 | 17.7.2017 |
| 13.7.2017 | Latuda | Sunovion Pharmaceuticals Europe Ltd
  First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom | EU/1/14/913 | 17.7.2017 |
| 13.7.2017 | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstrasse 48, D-81379 München, Deutschland | EU/1/15/993 | 17.7.2017 |
| 13.7.2017 | Memantine Merz | Merz Pharmaceuticals GmbH
  Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland | EU/1/12/799 | 17.7.2017 |
| 13.7.2017 | Picato | LEO Laboratories Ltd.
  285 Cashel Road, Crumlin, Dublin 12, Ireland | EU/1/12/796 | 17.7.2017 |
| 13.7.2017 | Praxbind | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1056 | 17.7.2017 |
| 13.7.2017 | Torisel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/424 | 17.7.2017 |
| 13.7.2017 | Xaluprine | Nova Laboratories Limited
  Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom | EU/1/11/727 | 17.7.2017 |
| 13.7.2017 | Xultophy | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/14/947 | 17.7.2017 |
| 13.7.2017 | Zalmoxis | MolMed S.p.A.
  Via Olgettina 58, I-20132 Milano, Italia | EU/1/16/1121 | 17.7.2017 |
| 13.7.2017 | Zoledronic acid Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/834 | 17.7.2017 |
| 14.7.2017 | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 18.7.2017 |
| 17.7.2017 | Dinutuximab beta Apeiron | EUSA Pharma (UK) Limited
  Breakspear Park, Breakspear Way, HP2 4TZ, Hemel Hempstead, United Kingdom | EU/1/17/1191 | 19.7.2017 |
| 17.7.2017 | Inhixa | Techdow Europe AB
  Kåbovägen 32, 75236 Uppsala, Sverige | EU/1/16/1132 | 20.7.2017 |
| 17.7.2017 | Opsumit | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/13/893 | 19.7.2017 |
| 17.7.2017 | Rivastigmine Sandoz | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/09/599 | 19.7.2017 |
| 17.7.2017 | Thorinane | Techdow Pharma Netherlands B.V.
  Strawinskylaan 1143, Toren C-11, 1077XX Amsterdam, Nederland | EU/1/16/1131 | 19.7.2017 |
| 17.7.2017 | Zinforo | Pfizer Ireland Pharmaceuticals
  Operations Services Group, Ringaskiddy, County Cork, Ireland | EU/1/12/785 | 19.7.2017 |
| 19.7.2017 | Clopidogrel BGR | Laboratoires BIOGARAN
  15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France | EU/1/09/558 | 21.7.2017 |
| 19.7.2017 | Clopidogrel Krka | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/556 | 21.7.2017 |
| 19.7.2017 | Clopidogrel TAD | TAD Pharma GmbH
  Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland | EU/1/09/555 | 21.7.2017 |
| 19.7.2017 | Cuprymina | SPARKLE S.r.l.
  Località Cavallino, 62010 Montecosaro (MC), Italia | EU/1/12/784 | 24.7.2017 |
| 19.7.2017 | Forxiga | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/795 | 24.7.2017 |
| 19.7.2017 | Grepid | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/09/535 | 21.7.2017 |
| 19.7.2017 | Harvoni | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/958 | 24.7.2017 |
| 19.7.2017 | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 21.7.2017 |
| 19.7.2017 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 21.7.2017 |
| 19.7.2017 | Qtern | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/16/1108 | 24.7.2017 |
| 19.7.2017 | Raxone | Santhera Pharmaceuticals (Deutschland) GmbH
  Marie-Curie Strasse 8, D-79539 Lörrach, Deutschland | EU/1/15/1020 | 24.7.2017 |
| 19.7.2017 | Revolade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/612 | 21.7.2017 |
| 19.7.2017 | Seebri Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/788 | 21.7.2017 |
| 19.7.2017 | Synjardy | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | 21.7.2017 |
| 19.7.2017 | Tracleer | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220 | 21.7.2017 |
| 19.7.2017 | Zavesca | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/238 | 21.7.2017 |
| 19.7.2017 | Zavicefta | Pfizer Ireland Pharmaceuticals
  Operations Services Group, Ringaskiddy, County Cork, Ireland | EU/1/16/1109 | 24.7.2017 |
| 25.7.2017 | Faslodex | AstraZeneca UK Limited
  Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom | EU/1/03/269 | 27.7.2017 |
| 25.7.2017 | Granupas | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/13/896 | 27.7.2017 |
| 25.7.2017 | Olanzapine Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/08/475 | 31.7.2017 |
| 25.7.2017 | Orencia | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/07/389 | 27.7.2017 |
| 25.7.2017 | Rivastigmine 1 A Pharma | 1 A Pharma GmbH
  Keltenring 1 + 3, D-82041 Oberhaching, Deutschland | EU/1/09/585 | 28.7.2017 |
| 25.7.2017 | Victoza | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/09/529 | 27.7.2017 |
| 25.7.2017 | Voncento | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/13/857 | 28.7.2017 |
| 26.7.2017 | Aripiprazole Mylan Pharma | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/15/1005 | 28.7.2017 |
| 26.7.2017 | Bridion | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/466 | 28.7.2017 |
| 26.7.2017 | Kaletra | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/01/172 | 28.7.2017 |
| 26.7.2017 | Oprymea | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/08/469 | 28.7.2017 |
| 26.7.2017 | Tovanor Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/790 | 28.7.2017 |
| 26.7.2017 | Velphoro | Vifor Fresenius Medical Care Renal Pharma France
  100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France | EU/1/14/943 | 28.7.2017 |
| 26.7.2017 | Votubia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/710 | 28.7.2017 |
| 26.7.2017 | Yellox | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Česká republika | EU/1/11/692 | 28.7.2017 |
| 2.8.2017 | Stivarga | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/858 | 4.8.2017 |
| 2.8.2017 | Zyllt | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/553 | 4.8.2017 |
| 3.8.2017 | Abilify | Otsuka Pharmaceutical Europe Ltd.
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/04/276 | 17.8.2017 |
| 3.8.2017 | Apidra | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/04/285 | 7.8.2017 |
| 7.8.2017 | Colobreathe | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/747 | 9.8.2017 |
| 7.8.2017 | Nordimet | Nordic Group B.V.
  Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland | EU/1/16/1124 | 9.8.2017 |
| 7.8.2017 | Stivarga | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/858 | 9.8.2017 |
| 14.8.2017 | Exjade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/356 | 17.8.2017 |
| 14.8.2017 | Mekinist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/931 | 18.8.2017 |
| 14.8.2017 | Soliris | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/07/393 | 17.8.2017 |
| 14.8.2017 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 17.8.2017 |
| 14.8.2017 | Xofigo | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/873 | 17.8.2017 |
| 22.8.2017 | CoAprovel | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/086 | 24.8.2017 |
| 22.8.2017 | Ketoconazole HRA | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/14/965 | 24.8.2017 |
| 22.8.2017 | Rasilez | Noden Pharma DAC
  D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland | EU/1/07/405 | 24.8.2017 |
| 22.8.2017 | SonoVue | Bracco International B.V.
  Strawinskylaan 3051, NL-1077 ZX Amsterdam, Nederland | EU/1/01/177 | 24.8.2017 |
| 22.8.2017 | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 24.8.2017 |
| 24.8.2017 | Aranesp | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/01/185 | 28.8.2017 |
| 24.8.2017 | BYDUREON | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/696 | 28.8.2017 |
| 24.8.2017 | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/12/792 | 28.8.2017 |
| 24.8.2017 | EDURANT | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/736 | 28.8.2017 |
| 24.8.2017 | Fluenz Tetra | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/13/887 | 28.8.2017 |
| 24.8.2017 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/945 | 28.8.2017 |
| 24.8.2017 | Invega | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/07/395 | 28.8.2017 |
| 24.8.2017 | Kaletra | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/01/172 | 29.8.2017 |
| 24.8.2017 | Karvezide | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/085 | 28.8.2017 |
| 24.8.2017 | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 29.8.2017 |
| 24.8.2017 | Norvir | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/96/016 | 29.8.2017 |
| 24.8.2017 | Orkambi | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/15/1059 | 29.8.2017 |
| 24.8.2017 | Ruconest | Pharming Group N.V.
  Darwinweg 24, NL-2333 CR Leiden, Nederland | EU/1/10/641 | 28.8.2017 |
| 24.8.2017 | Zoledronic acid Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/12/800 | 29.8.2017 |
| 28.8.2017 | Constella | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/12/801 | 30.8.2017 |
| 28.8.2017 | Ecalta | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/416 | 30.8.2017 |
| 28.8.2017 | Forxiga | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/795 | 30.8.2017 |
| 28.8.2017 | Irbesartan HCT Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/06/377 | 30.8.2017 |
| 28.8.2017 | Mimpara | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/04/292 | 30.8.2017 |
| 28.8.2017 | Rasilez HCT | Noden Pharma DAC
  D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland | EU/1/08/491 | 30.8.2017 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

6.7.2017

Celsentri

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/07/418

10.7.2017

6.7.2017

Clopidogrel Krka d.d.

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

10.7.2017

6.7.2017

Imlygic

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1064

10.7.2017

6.7.2017

Kivexa

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/04/298

10.7.2017

6.7.2017

Nexavar

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/06/342

10.7.2017

6.7.2017

Toviaz

Pfizer Limited

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

EU/1/07/386

10.7.2017

10.7.2017

Memantine Accord

Accord Healthcare Limited

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

EU/1/13/880

12.7.2017

10.7.2017

Myozyme

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/333

12.7.2017

10.7.2017

Xeloda

Roche Registration Limited

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

EU/1/00/163

12.7.2017

13.7.2017

Edistride

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/15/1052

17.7.2017

13.7.2017

Enurev Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/789

17.7.2017

13.7.2017

Eylea

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

17.7.2017

13.7.2017

Incruse

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/14/922

17.7.2017

13.7.2017

Isentress

Merck Sharp & Dohme Limited

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

EU/1/07/436

17.7.2017

13.7.2017

Kuvan

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/08/481

17.7.2017

13.7.2017

Latuda

Sunovion Pharmaceuticals Europe Ltd

First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom

EU/1/14/913

17.7.2017

13.7.2017

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48, D-81379 München, Deutschland

EU/1/15/993

17.7.2017

13.7.2017

Memantine Merz

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

EU/1/12/799

17.7.2017

13.7.2017

Picato

LEO Laboratories Ltd.

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

17.7.2017

13.7.2017

Praxbind

Boehringer Ingelheim International GmbH

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

EU/1/15/1056

17.7.2017

13.7.2017

Torisel

Pfizer Limited

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

EU/1/07/424

17.7.2017

13.7.2017

Xaluprine

Nova Laboratories Limited

Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom

EU/1/11/727

17.7.2017

13.7.2017

Xultophy

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/14/947

17.7.2017

13.7.2017

Zalmoxis

MolMed S.p.A.

Via Olgettina 58, I-20132 Milano, Italia

EU/1/16/1121

17.7.2017

13.7.2017

Zoledronic acid Accord

Accord Healthcare Limited

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

EU/1/13/834

17.7.2017

14.7.2017

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

18.7.2017

17.7.2017

Dinutuximab beta Apeiron

EUSA Pharma (UK) Limited

Breakspear Park, Breakspear Way, HP2 4TZ, Hemel Hempstead, United Kingdom

EU/1/17/1191

19.7.2017

17.7.2017

Inhixa

Techdow Europe AB

Kåbovägen 32, 75236 Uppsala, Sverige

EU/1/16/1132

20.7.2017

17.7.2017

Opsumit

Actelion Registration Ltd

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

EU/1/13/893

19.7.2017

17.7.2017

Rivastigmine Sandoz

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/09/599

19.7.2017

17.7.2017

Thorinane

Techdow Pharma Netherlands B.V.

Strawinskylaan 1143, Toren C-11, 1077XX Amsterdam, Nederland

EU/1/16/1131

19.7.2017

17.7.2017

Zinforo

Pfizer Ireland Pharmaceuticals

Operations Services Group, Ringaskiddy, County Cork, Ireland

EU/1/12/785

19.7.2017

19.7.2017

Clopidogrel BGR

Laboratoires BIOGARAN

15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France

EU/1/09/558

21.7.2017

19.7.2017

Clopidogrel Krka

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556

21.7.2017

19.7.2017

Clopidogrel TAD

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland

EU/1/09/555

21.7.2017

19.7.2017

Cuprymina

SPARKLE S.r.l.

Località Cavallino, 62010 Montecosaro (MC), Italia

EU/1/12/784

24.7.2017

19.7.2017

Forxiga

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/795

24.7.2017

19.7.2017

Grepid

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535

21.7.2017

19.7.2017

Harvoni

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/958

24.7.2017

19.7.2017

Jardiance

Boehringer Ingelheim International GmbH

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

EU/1/14/930

21.7.2017

19.7.2017

Ofev

Boehringer Ingelheim International GmbH

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

EU/1/14/979

21.7.2017

19.7.2017

Qtern

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/16/1108

24.7.2017

19.7.2017

Raxone

Santhera Pharmaceuticals (Deutschland) GmbH

Marie-Curie Strasse 8, D-79539 Lörrach, Deutschland

EU/1/15/1020

24.7.2017

19.7.2017

Revolade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/612

21.7.2017

19.7.2017

Seebri Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/788

21.7.2017

19.7.2017

Synjardy

Boehringer Ingelheim International GmbH

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

EU/1/15/1003

21.7.2017

19.7.2017

Tracleer

Actelion Registration Ltd

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

EU/1/02/220

21.7.2017

19.7.2017

Zavesca

Actelion Registration Ltd

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

EU/1/02/238

21.7.2017

19.7.2017

Zavicefta

Pfizer Ireland Pharmaceuticals

Operations Services Group, Ringaskiddy, County Cork, Ireland

EU/1/16/1109

24.7.2017

25.7.2017

Faslodex

AstraZeneca UK Limited

Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom

EU/1/03/269

27.7.2017

25.7.2017

Granupas

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/896

27.7.2017

25.7.2017

Olanzapine Mylan

Generics [UK] Limited

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

EU/1/08/475

31.7.2017

25.7.2017

Orencia

Bristol-Myers Squibb Pharma EEIG

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

EU/1/07/389

27.7.2017

25.7.2017

Rivastigmine 1 A Pharma

1 A Pharma GmbH

Keltenring 1 + 3, D-82041 Oberhaching, Deutschland

EU/1/09/585

28.7.2017

25.7.2017

Victoza

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/09/529

27.7.2017

25.7.2017

Voncento

CSL Behring GmbH

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

EU/1/13/857

28.7.2017

26.7.2017

Aripiprazole Mylan Pharma

Mylan S.A.S

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

EU/1/15/1005

28.7.2017

26.7.2017

Bridion

Merck Sharp & Dohme Limited

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

EU/1/08/466

28.7.2017

26.7.2017

Kaletra

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/01/172

28.7.2017

26.7.2017

Oprymea

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/469

28.7.2017

26.7.2017

Tovanor Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/790

28.7.2017

26.7.2017

Velphoro

Vifor Fresenius Medical Care Renal Pharma France

100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France

EU/1/14/943

28.7.2017

26.7.2017

Votubia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/710

28.7.2017

26.7.2017

Yellox

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Česká republika

EU/1/11/692

28.7.2017

2.8.2017

Stivarga

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/858

4.8.2017

2.8.2017

Zyllt

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/553

4.8.2017

3.8.2017

Abilify

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/04/276

17.8.2017

3.8.2017

Apidra

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/04/285

7.8.2017

7.8.2017

Colobreathe

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/747

9.8.2017

7.8.2017

Nordimet

Nordic Group B.V.

Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland

EU/1/16/1124

9.8.2017

7.8.2017

Stivarga

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/858

9.8.2017

14.8.2017

Exjade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/356

17.8.2017

14.8.2017

Mekinist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/931

18.8.2017

14.8.2017

Soliris

Alexion Europe SAS

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

EU/1/07/393

17.8.2017

14.8.2017

Vargatef

Boehringer Ingelheim International GmbH

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

EU/1/14/954

17.8.2017

14.8.2017

Xofigo

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/873

17.8.2017

22.8.2017

CoAprovel

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/98/086

24.8.2017

22.8.2017

Ketoconazole HRA

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/14/965

24.8.2017

22.8.2017

Rasilez

Noden Pharma DAC

D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland

EU/1/07/405

24.8.2017

22.8.2017

SonoVue

Bracco International B.V.

Strawinskylaan 3051, NL-1077 ZX Amsterdam, Nederland

EU/1/01/177

24.8.2017

22.8.2017

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

24.8.2017

24.8.2017

Aranesp

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/01/185

28.8.2017

24.8.2017

BYDUREON

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/696

28.8.2017

24.8.2017

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/12/792

28.8.2017

24.8.2017

EDURANT

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/736

28.8.2017

24.8.2017

Fluenz Tetra

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/13/887

28.8.2017

24.8.2017

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/945

28.8.2017

24.8.2017

Invega

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/07/395

28.8.2017

24.8.2017

Kaletra

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/01/172

29.8.2017

24.8.2017

Karvezide

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/98/085

28.8.2017

24.8.2017

KEYTRUDA

Merck Sharp & Dohme Limited

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

EU/1/15/1024

29.8.2017

24.8.2017

Norvir

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/96/016

29.8.2017

24.8.2017

Orkambi

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/15/1059

29.8.2017

24.8.2017

Ruconest

Pharming Group N.V.

Darwinweg 24, NL-2333 CR Leiden, Nederland

EU/1/10/641

28.8.2017

24.8.2017

Zoledronic acid Hospira

Hospira UK Limited

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

EU/1/12/800

29.8.2017

28.8.2017

Constella

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/12/801

30.8.2017

28.8.2017

Ecalta

Pfizer Limited

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

EU/1/07/416

30.8.2017

28.8.2017

Forxiga

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/795

30.8.2017

28.8.2017

Irbesartan HCT Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/06/377

30.8.2017

28.8.2017

Mimpara

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/04/292

30.8.2017

28.8.2017

Rasilez HCT

Noden Pharma DAC

D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland

EU/1/08/491

30.8.2017

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

—

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 19.7.2017 | Enzepi | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/16/1113 | 21.7.2017 |
| 19.7.2017 | Repso | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/674 | 21.7.2017 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

19.7.2017

Enzepi

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/16/1113

21.7.2017

19.7.2017

Repso

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/674

21.7.2017

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

—

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.8.2017 | VEPURED | E. coli verotoxoid vaccine (inactivated recombinant) | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/17/214 | Suspension for injection | QI09AB02 | 21.8.2017 |
| 18.8.2017 | Exzolt | fluralaner | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/17/212 | Solution for use in drinking water | QP53BE02 | 22.8.2017 |
| 22.8.2017 | Innovax-ND-IBD | Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant) | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/17/213 | Suspension and solvent for suspension for injection | QI01AD | 24.8.2017 |
| 24.8.2017 | Suvaxyn PRRS MLV | Porcine respiratory and reproductive syndrome virus vaccine (live) | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/215 | Lyophilisate and solvent for suspension for injection | QI09AD03 | 28.8.2017 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

17.8.2017

VEPURED

E. coli verotoxoid vaccine (inactivated recombinant)

Laboratorios Hipra, S.A.

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

EU/2/17/214

Suspension for injection

QI09AB02

21.8.2017

18.8.2017

Exzolt

fluralaner

Intervet International B.V.

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

EU/2/17/212

Solution for use in drinking water

QP53BE02

22.8.2017

22.8.2017

Innovax-ND-IBD

Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)

Intervet International B.V.

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

EU/2/17/213

Suspension and solvent for suspension for injection

QI01AD

24.8.2017

24.8.2017

Suvaxyn PRRS MLV

Porcine respiratory and reproductive syndrome virus vaccine (live)

Zoetis Belgium S.A.

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

EU/2/17/215

Lyophilisate and solvent for suspension for injection

QI09AD03

28.8.2017

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

—

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 10.7.2017 | Onsior | Elanco Europe Ltd.
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/08/089 | 12.7.2017 |
| 14.7.2017 | Nobilis IB Primo QX | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/14/174 | 18.7.2017 |
| 14.7.2017 | Zolvix | Elanco Europe Ltd.
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/09/101 | 18.7.2017 |
| 19.7.2017 | Aivlosin | ECO Animal Health Ltd
  78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom | EU/2/04/044 | 21.7.2017 |
| 28.7.2017 | Loxicom | Norbrook Laboratories Ltd
  Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | EU/2/08/090 | 1.8.2017 |
| 28.7.2017 | Vaxxitek HVT + IBD | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/02/032 | 1.8.2017 |
| 3.8.2017 | BLUEVAC BTV8 | CZ Veterinaria, S.A.
  La Relva s/n, 36400 Porriño, España | EU/2/11/122 | 7.8.2017 |
| 10.8.2017 | Canigen L4 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/15/183 | 14.8.2017 |

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

10.7.2017

Onsior

Elanco Europe Ltd.

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/08/089

12.7.2017

14.7.2017

Nobilis IB Primo QX

Intervet International B.V.

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

EU/2/14/174

18.7.2017

14.7.2017

Zolvix

Elanco Europe Ltd.

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/09/101

18.7.2017

19.7.2017

Aivlosin

ECO Animal Health Ltd

78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom

EU/2/04/044

21.7.2017

28.7.2017

Loxicom

Norbrook Laboratories Ltd

Station Works, Newry, Co. Down, BT35 6JP, United Kindgom

EU/2/08/090

1.8.2017

28.7.2017

Vaxxitek HVT + IBD

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/02/032

1.8.2017

3.8.2017

BLUEVAC BTV8

CZ Veterinaria, S.A.

La Relva s/n, 36400 Porriño, España

EU/2/11/122

7.8.2017

10.8.2017

Canigen L4

Intervet International B.V.

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

EU/2/15/183

14.8.2017

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.

---

| 29.9.2017 | EN | Official Journal of the European Union | C 328/14 |
| --- | --- | --- | --- |

29.9.2017

EN

Official Journal of the European Union

C 328/14

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2017 to 31 August 2017

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

(2017/C 328/02)

| — | Issuing, maintenance or modification of a national marketing authorisation |
| --- | --- |

—

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 |
| --- | --- | --- | --- | --- | --- |
| 7.8.2017 | Paracetamol/ibuprofen 500 mg/150 mg Film-coated tablets and associated names | paracetamol/ibuprofen | See Annex I | See Annex I | 8.8.2017 |
| 10.7.2017 | Veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp. | tylosin | See Annex II | See Annex II | 11.7.2017 |
| 19.7.2017 | Cardioxane | dexrazoxane | See Annex III | See Annex III | 24.7.2017 |
| 28.8.2017 | Symbioflor 2 and associated names containing Escherichia coli bacteria (cells and autolysate) | Symbioflor 2 and associated names containing Escherichia coli bacteria (cells and autolysate) | See Annex IV | See Annex IV | 30.8.2017 |
| 14.7.2017 | Denagard 45 % and associated names | Tiamulin hydrogen fumarate | See Annex V | See Annex V | 17.7.2017 |

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

7.8.2017

Paracetamol/ibuprofen 500 mg/150 mg Film-coated tablets and associated names

paracetamol/ibuprofen

See Annex I

See Annex I

8.8.2017

10.7.2017

Veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.

tylosin

See Annex II

See Annex II

11.7.2017

19.7.2017

Cardioxane

dexrazoxane

See Annex III

See Annex III

24.7.2017

28.8.2017

Symbioflor 2 and associated names containing Escherichia coli bacteria (cells and autolysate)

Symbioflor 2 and associated names containing Escherichia coli bacteria (cells and autolysate)

See Annex IV

See Annex IV

30.8.2017

14.7.2017

Denagard 45 % and associated names

Tiamulin hydrogen fumarate

See Annex V

See Annex V

17.7.2017

| — | Refusal of a national marketing authorisation |
| --- | --- |

—

Refusal 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 |
| --- | --- | --- | --- | --- | --- |
| 10.7.2017 | Veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp. | tylosin | See Annex II | See Annex II | 11.7.2017 |

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

10.7.2017

Veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.

tylosin

See Annex II

See Annex II

11.7.2017

---

(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 | Applicant | (Invented) Name | INN + Strength | Pharmaceutical form4 | Route of administration5 |
| --- | --- | --- | --- | --- | --- |
| Austria | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Ibucomb | 500 mg/150 mg | film
  coated tablet | oral |
| Belgium | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Combogesic | 500 mg/150 mg | film
  coated tablet | oral |
| Croatia | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Combogesic | 500 mg/150 mg | film
  coated tablet | oral |
| France | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Paracetamol/Ibuprofen Vale | 500 mg/150 mg | film
  coated tablet | oral |
| Germany | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Paracetamol/Ibuprofen Vale | 500 mg/150 mg | film
  coated tablet | oral |
| Ireland | Clonmel Healthcare
  Waterford Road
  Clonmel
  Co. Tipperary
  E91 D768
  Ireland | Easolief Duo | 500 mg/150 mg | film
  coated tablet | oral |
| Luxembourg | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Paracomb | 500 mg/150 mg | film
  coated tablet | oral |
| The Netherlands | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Paraprofen | 500 mg/150 mg | film
  coated tablet | oral |
| Portugal | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Maxigesic | 500 mg/150 mg | film
  coated tablet | oral |
| Spain | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Dolostop Plus
  500 mg/150 mg comprimidos recubiertos con película | 500 mg/150 mg | film
  coated tablet | oral |
| United Kingdom
  (UK/H/6034/001/DC) | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Paracetamol/Ibuprofen 500 mg/150 mg film
  coated tablets | 500 mg/150 mg | film
  coated tablet | oral |
| United Kingdom (UK/H/6035/001/DC) | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Paracetamol/Ibuprofen 500 mg/150 mg film
  coated tablets | 500 mg/150 mg | film
  coated tablet | oral |
| United Kingdom (UK/H/6176/001/DC) | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland | Novogesic 500 mg/150 mg film coated tablets | 500 mg/150 mg | film
  coated tablet | oral |

Member State EU/EEA

Applicant

(Invented) Name

INN + Strength

Pharmaceutical form4

Route of administration5

Austria

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Ibucomb

500 mg/150 mg

film

coated tablet

oral

Belgium

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Combogesic

500 mg/150 mg

film

coated tablet

oral

Croatia

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Combogesic

500 mg/150 mg

film

coated tablet

oral

France

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Paracetamol/Ibuprofen Vale

500 mg/150 mg

film

coated tablet

oral

Germany

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Paracetamol/Ibuprofen Vale

500 mg/150 mg

film

coated tablet

oral

Ireland

Clonmel Healthcare

Waterford Road

Clonmel

Co. Tipperary

E91 D768

Ireland

Easolief Duo

500 mg/150 mg

film

coated tablet

oral

Luxembourg

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Paracomb

500 mg/150 mg

film

coated tablet

oral

The Netherlands

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Paraprofen

500 mg/150 mg

film

coated tablet

oral

Portugal

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Maxigesic

500 mg/150 mg

film

coated tablet

oral

Spain

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Dolostop Plus

500 mg/150 mg comprimidos recubiertos con película

500 mg/150 mg

film

coated tablet

oral

United Kingdom

(UK/H/6034/001/DC)

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Paracetamol/Ibuprofen 500 mg/150 mg film

coated tablets

500 mg/150 mg

film

coated tablet

oral

United Kingdom (UK/H/6035/001/DC)

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Paracetamol/Ibuprofen 500 mg/150 mg film

coated tablets

500 mg/150 mg

film

coated tablet

oral

United Kingdom (UK/H/6176/001/DC)

Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Ireland

Novogesic 500 mg/150 mg film coated tablets

500 mg/150 mg

film

coated tablet

oral

---

ANNEX II

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

| Member State EU/EEA | Applicant/Marketing authorisation holder | Name | INN | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | PHARMASIN 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Austria | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Austria | Vana GmbH
  Wolfgang Schmälzl-Gasse 6
  1020 Wien
  Austria | Vanatyl 200 mg/ml — Injektionslösung für Tiere | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Calves Sheep Goats Pigs Dogs | IM |
| Belgium | Cross Vetpharma Group Ltd
  Broomhill Road, Tallagh Dublin 24
  Ireland | Bilovet | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Belgium | VETOQUINOL SA/NV
  Kontichsesteenweg 42
  2630 Aartselaar
  Belgium | Tylucyl | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Bulgaria | Biovet JSC
  39, Petar Rakov Str.
  4550 Pesthera
  Bulgaria | PHARMASIN 200 mg/ml solution for injection for cattle, sheep, goats and pigs | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Croatia | VETOQUINOL SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/mL otopina za injekcije za goveda i svinje | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Cyprus | VETOQUINOL SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/ml raztopina za injiciranje za govedo in prašiče | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Denmark | Biovet JSC
  39, Petar Rakov Str.
  4550 Pesthera
  Bulgaria | Tylaxene | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Denmark | Huvepharma NV Uitbreidingstraat 80
  BE-2600 Antwerpen
  Belgium | Tylmasin | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Denmark | Vetoquinol Scandinavia AB Lyngbyvej 20
  DK-2100 København
  Denmark | Tylucyl | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Estonia | Vétoquinol SA,
  Magny-Vernois
  70200 Lure
  France | Tylucyl | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Finland | VETOQUINOL SA/NV
  Kontichsesteenweg 42
  2630 Aartselaar
  Belgium | Tylucyl | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| France | LILLY France
  24 Boulevard Vital Bouhot
  92200 Neuilly Sur Seine
  France | TYLAN 200 | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| France | HUVEPHARMA
  Uitbredingstraat 53
  2600 Antwerp
  Belgium | PHARMASIN 200 MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS CAPRINS ET PORCINS | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| France | Biovet JSC
  39, Petar Rakov Str.
  4550 Pesthera
  Bulgaria | TYLAXEN 200 MG/ML SOLUTION INJECTABLE POUR BOVINS, OVINS, CAPRINS ET PORCINS | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| France | CROSS VETPHARM GROUP
  Broomhill Road
  Dublin 24
  Tallaght
  Ireland | BILOVET 200 MG/ML SOLUTION INJECTABLE | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| France | VETOQUINOL
  Magny Vernois
  70200 Lure
  France | TYLUCYL 200 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCINS | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Germany | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | Tylmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Germany | Vétoquinol GmbH
  Parkstr. 10
  88212 Ravensburg
  Germany | Tylucyl 200 mg/ml | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Germany | HUVEPHARMA NV
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | Pharmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Germany | Bimeda Chemicals Export a Division of Cross Vetpharm Group, Ltd.
  Broomhill Road, Tallagh Dublin 24
  Ireland | Bilovet 200 mg/ml Injektionslösung für Rinder und Schweine | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Greece | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Hungary | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | PHARMASIN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Hungary | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Hungary | VETOQUINOL SA
  Magny Vernois
  70200 LURE
  France | Tylucyl 200 mg/ml oldatos injekció szarvasmarhák és sertések részére | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Ireland | Eli Lilly & Company Limited
  Elanco Animal Health
  Priestley Road
  Basingstoke
  Hampshire RG24 9NL
  United Kingdom | Tylan 200, 200 mg/ml Solution for Injection | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Ireland | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | Tylaxen 200 mg/ml solution for injection for cattle, sheep, goats and pigs. | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Ireland | Huvepharma N.V.
  Uitbreidingsstraat 80
  2600 Antwerpen
  Belgium | Pharmasin 200 mg/ml solution for injection for cattle, sheep, goats and pigs | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Ireland | Cross Vetpharm Group Ltd.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml Solution for Injection for cattle and pigs. | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Italy | Vetoquinol Italia S.r.l.
  Via Piana 265
  47032 Bertinoro (FC)
  Italy | TYLUCYL 200 mg/ml soluzione iniettabile per bovini e suini | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Italy | FATRO S.p.A.
  Via Emilia 285
  40064 Ozzano Emilia (BO)
  Italy | VETIL | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs Dogs | IM |
| Italy | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 mg/ml soluzione iniettabile | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Italy | ELI LILLY ITALIA S.p.A.
  Via Gramsci, 731/733
  50019 Sesto Fiorentino
  Firenze
  Italy | TYLAN 200 | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Italy | HUVEPHARMA NV
  Uitbreidingstraat 80
  2600 Anversa
  Belgium | PHARMASIN 200 mg/ml soluzione iniettabile per bovini, ovini, caprini e suini | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Latvia | Vetoquinol S.A.
  Magny-Vernois B.P. 189
  Lure Cedex
  France | Tylucyl | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| The Netherlands | CROSS VETPHARM GROUP Ltd.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | BILOVET 200 mg/ml oplossing voor injectie voor runderen en varkens | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Poland | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerpia
  Belgium | Pharmasin | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Poland | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | Tylaxen | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Poland | Aniserve UG Geyerspergerstrasse 27
  80689 Munich
  Germany | Bilovet 200 | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Poland | Vetoquinol Biowet Sp. z o.o.
  ul. Kosynierów Gdyńskich 13-14
  66-400 Gorzów Wielkopolski
  Poland | Tylucyl 200 mg/ml solution for injection | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Portugal | Vetoquinol S.A.
  Magny-Vernois B.P. 189
  Lure Cedex
  France | Tylucyl 200 mg/ml, solução injetável para bovinos e suínos | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Portugal | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | PHARMASIN 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Portugal | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Portugal | Lilly Portugal — Produtos Farmacêuticos, Lda

  R. Cesário Verde, 5 — piso 4
  Linda-a-Pastora
  2790-326 Queijas
  Portugal | Tylan 200 mg/ml Solução injetável para bovinos e suínos | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Romania | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | Tylaxen 200 mg/ml | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Romania | Cross Vetpharm Group Ltd.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Slovak Republic | Vétoquinol s.r.o.
  Zámečnická 411
  288 02 Nymburk
  Czech Republic | TYLUCYL 200 mg/ml injekčný roztok pre hovädzí dobytok a ošípané | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Slovak Republic | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLOVET B-200 mg/ml injekčný roztok | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Slovenia | VETOQUINOL SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/ml raztopina za injiciranje za govedo in prašiče | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Spain | CROSS VETPHARM GROUP LIMITED.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | BILOVET 200 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| Spain | VETOQUINOL ESPECIALIDADES VETERINARIAS, S.A.
  A. Fuencarral Alcobendas km 15 700 Edificio Europa I Portal 3 2o5
  28108 Alcobendas (Madrid)
  Spain | TYLUCIL 200 mg/ml SOLUCIÓN INYECTABLE | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| Spain | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | PHARMASIN 200 MG/ML SOLUCIÓN INYECTABLE PARA BOVINO OVINO CAPRINO Y PO | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Spain | Biovet JSC,
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 MG/ML SOLUCIÓN INYECTABLE PARA BOVINO OVINO CAPRINO Y PORC | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  sheep
  Goats
  Pigs | IM
  slow IV (cattle) |
| Sweden | Vetoquinol Scandinavia AB
  Box 9
  265 21 Åstorp
  Sweden | Tylucyl | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |
| United Kingdom | Cross Vetpharm Group Ltd.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml Solution for Injection for Cattle and Pigs | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| United Kingdom | Eli Lilly & Company Ltd
  Elanco Animal Health
  Priestley Road
  Basingstoke
  Hampshire RG24 9NL
  United Kingdom | Tylan 200, 200 mg/ml Solution for Injection | Tylosin | Solution for injection | 200,000 IU/ml | Cattle Pigs | IM |
| United Kingdom | Vetoquinol UK Ltd
  Vetoquinol House
  Great Slade
  Buckingham Industrial Park Buckingham MK18 1PA
  United Kingdom | Tylucyl 200 mg/ml solution for injection for cattle and pigs | Tylosin | Solution for injection | 200,000 IU/ml | Cattle
  Pigs | IM
  slow IV (cattle) |

Member State EU/EEA

Applicant/Marketing authorisation holder

Name

INN

Pharmaceutical form

Strength

Animal species

Route of administration

Austria

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

PHARMASIN 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Austria

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLAXEN 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Austria

Vana GmbH

Wolfgang Schmälzl-Gasse 6

1020 Wien

Austria

Vanatyl 200 mg/ml — Injektionslösung für Tiere

Tylosin

Solution for injection

200,000 IU/ml

Cattle Calves Sheep Goats Pigs Dogs

IM

Belgium

Cross Vetpharma Group Ltd

Broomhill Road, Tallagh Dublin 24

Ireland

Bilovet

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Belgium

VETOQUINOL SA/NV

Kontichsesteenweg 42

2630 Aartselaar

Belgium

Tylucyl

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Bulgaria

Biovet JSC

39, Petar Rakov Str.

4550 Pesthera

Bulgaria

PHARMASIN 200 mg/ml solution for injection for cattle, sheep, goats and pigs

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Croatia

VETOQUINOL SA

Magny-Vernois

70200 Lure

France

Tylucyl 200 mg/mL otopina za injekcije za goveda i svinje

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Cyprus

VETOQUINOL SA

Magny-Vernois

70200 Lure

France

Tylucyl 200 mg/ml raztopina za injiciranje za govedo in prašiče

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Denmark

Biovet JSC

39, Petar Rakov Str.

4550 Pesthera

Bulgaria

Tylaxene

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Denmark

Huvepharma NV Uitbreidingstraat 80

BE-2600 Antwerpen

Belgium

Tylmasin

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Denmark

Vetoquinol Scandinavia AB Lyngbyvej 20

DK-2100 København

Denmark

Tylucyl

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Estonia

Vétoquinol SA,

Magny-Vernois

70200 Lure

France

Tylucyl

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Finland

VETOQUINOL SA/NV

Kontichsesteenweg 42

2630 Aartselaar

Belgium

Tylucyl

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

France

LILLY France

24 Boulevard Vital Bouhot

92200 Neuilly Sur Seine

France

TYLAN 200

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

France

HUVEPHARMA

Uitbredingstraat 53

2600 Antwerp

Belgium

PHARMASIN 200 MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS CAPRINS ET PORCINS

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

France

Biovet JSC

39, Petar Rakov Str.

4550 Pesthera

Bulgaria

TYLAXEN 200 MG/ML SOLUTION INJECTABLE POUR BOVINS, OVINS, CAPRINS ET PORCINS

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

France

CROSS VETPHARM GROUP

Broomhill Road

Dublin 24

Tallaght

Ireland

BILOVET 200 MG/ML SOLUTION INJECTABLE

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

France

VETOQUINOL

Magny Vernois

70200 Lure

France

TYLUCYL 200 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCINS

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Germany

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Germany

Vétoquinol GmbH

Parkstr. 10

88212 Ravensburg

Germany

Tylucyl 200 mg/ml

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Germany

HUVEPHARMA NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Pharmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Germany

Bimeda Chemicals Export a Division of Cross Vetpharm Group, Ltd.

Broomhill Road, Tallagh Dublin 24

Ireland

Bilovet 200 mg/ml Injektionslösung für Rinder und Schweine

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Greece

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLAXEN

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Hungary

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

Belgium

PHARMASIN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Hungary

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLAXEN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Hungary

VETOQUINOL SA

Magny Vernois

70200 LURE

France

Tylucyl 200 mg/ml oldatos injekció szarvasmarhák és sertések részére

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Ireland

Eli Lilly & Company Limited

Elanco Animal Health

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Tylan 200, 200 mg/ml Solution for Injection

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Ireland

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylaxen 200 mg/ml solution for injection for cattle, sheep, goats and pigs.

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Ireland

Huvepharma N.V.

Uitbreidingsstraat 80

2600 Antwerpen

Belgium

Pharmasin 200 mg/ml solution for injection for cattle, sheep, goats and pigs

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Ireland

Cross Vetpharm Group Ltd.

Broomhill Road, Tallaght

Dublin 24

Ireland

Bilovet 200 mg/ml Solution for Injection for cattle and pigs.

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Italy

Vetoquinol Italia S.r.l.

Via Piana 265

47032 Bertinoro (FC)

Italy

TYLUCYL 200 mg/ml soluzione iniettabile per bovini e suini

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Italy

FATRO S.p.A.

Via Emilia 285

40064 Ozzano Emilia (BO)

Italy

VETIL

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs Dogs

IM

Italy

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLAXEN 200 mg/ml soluzione iniettabile

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Italy

ELI LILLY ITALIA S.p.A.

Via Gramsci, 731/733

50019 Sesto Fiorentino

Firenze

Italy

TYLAN 200

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Italy

HUVEPHARMA NV

Uitbreidingstraat 80

2600 Anversa

Belgium

PHARMASIN 200 mg/ml soluzione iniettabile per bovini, ovini, caprini e suini

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Latvia

Vetoquinol S.A.

Magny-Vernois B.P. 189

Lure Cedex

France

Tylucyl

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

The Netherlands

CROSS VETPHARM GROUP Ltd.

Broomhill Road, Tallaght

Dublin 24

Ireland

BILOVET 200 mg/ml oplossing voor injectie voor runderen en varkens

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Poland

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpia

Belgium

Pharmasin

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Poland

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylaxen

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Poland

Aniserve UG Geyerspergerstrasse 27

80689 Munich

Germany

Bilovet 200

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Poland

Vetoquinol Biowet Sp. z o.o.

ul. Kosynierów Gdyńskich 13-14

66-400 Gorzów Wielkopolski

Poland

Tylucyl 200 mg/ml solution for injection

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Portugal

Vetoquinol S.A.

Magny-Vernois B.P. 189

Lure Cedex

France

Tylucyl 200 mg/ml, solução injetável para bovinos e suínos

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Portugal

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

PHARMASIN 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Portugal

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLAXEN 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Portugal

Lilly Portugal — Produtos Farmacêuticos, Lda

R. Cesário Verde, 5 — piso 4

Linda-a-Pastora

2790-326 Queijas

Portugal

Tylan 200 mg/ml Solução injetável para bovinos e suínos

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Romania

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylaxen 200 mg/ml

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Romania

Cross Vetpharm Group Ltd.

Broomhill Road, Tallaght

Dublin 24

Ireland

Bilovet 200 mg/ml

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Slovak Republic

Vétoquinol s.r.o.

Zámečnická 411

288 02 Nymburk

Czech Republic

TYLUCYL 200 mg/ml injekčný roztok pre hovädzí dobytok a ošípané

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Slovak Republic

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLOVET B-200 mg/ml injekčný roztok

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Slovenia

VETOQUINOL SA

Magny-Vernois

70200 Lure

France

Tylucyl 200 mg/ml raztopina za injiciranje za govedo in prašiče

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Spain

CROSS VETPHARM GROUP LIMITED.

Broomhill Road, Tallaght

Dublin 24

Ireland

BILOVET 200 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

Spain

VETOQUINOL ESPECIALIDADES VETERINARIAS, S.A.

A. Fuencarral Alcobendas km 15 700 Edificio Europa I Portal 3 2o5

28108 Alcobendas (Madrid)

Spain

TYLUCIL 200 mg/ml SOLUCIÓN INYECTABLE

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

Spain

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

PHARMASIN 200 MG/ML SOLUCIÓN INYECTABLE PARA BOVINO OVINO CAPRINO Y PO

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Sheep

Goats

Pigs

IM

slow IV (cattle)

Spain

Biovet JSC,

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLAXEN 200 MG/ML SOLUCIÓN INYECTABLE PARA BOVINO OVINO CAPRINO Y PORC

Tylosin

Solution for injection

200,000 IU/ml

Cattle

sheep

Goats

Pigs

IM

slow IV (cattle)

Sweden

Vetoquinol Scandinavia AB

Box 9

265 21 Åstorp

Sweden

Tylucyl

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

United Kingdom

Cross Vetpharm Group Ltd.

Broomhill Road, Tallaght

Dublin 24

Ireland

Bilovet 200 mg/ml Solution for Injection for Cattle and Pigs

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

United Kingdom

Eli Lilly & Company Ltd

Elanco Animal Health

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Tylan 200, 200 mg/ml Solution for Injection

Tylosin

Solution for injection

200,000 IU/ml

Cattle Pigs

IM

United Kingdom

Vetoquinol UK Ltd

Vetoquinol House

Great Slade

Buckingham Industrial Park Buckingham MK18 1PA

United Kingdom

Tylucyl 200 mg/ml solution for injection for cattle and pigs

Tylosin

Solution for injection

200,000 IU/ml

Cattle

Pigs

IM

slow IV (cattle)

---

ANNEX III

List of medicinal products and presentations

| Member State EU/EEA | Marketing authorisation holder | Invented Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Czech Republic | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |
| France | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |
| Germany | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |
| Italy | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |
| The Netherlands | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |
| Poland | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |
| Spain | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane 500 mg polvo para solución para perfusión | 500 mg | Powder for solution for infusion | Intravenous use |
| United Kingdom | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
  United Kingdom | Cardioxane | 500 mg | Powder for solution for infusion | Intravenous use |

Member State EU/EEA

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Czech Republic

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

France

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

Germany

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

Italy

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

The Netherlands

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

Poland

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

Spain

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane 500 mg polvo para solución para perfusión

500 mg

Powder for solution for infusion

Intravenous use

United Kingdom

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW

United Kingdom

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

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ANNEX IV

List of nationally authorised medicinal products

| Member state | Marketing Authorisation Holder | Short name of the Medicinal Product | Active substance + Strength | Pharmaceutical Form |
| --- | --- | --- | --- | --- |
| Austria | Symbiopharm Gmbh | Symbioflor E. Coli | Escherichia Coli 15 — 45 Mega Cells/ml | Oral Drops, Suspension |
| Germany | Symbiopharm Gmbh | Symbioflor 2 | Escherichia Coli 15 — 45 Mega Cells/ml | Oral Drops, Suspension |
| Hungary | Symbiopharm Gmbh | Symbioflor Escherichia | Escherichia Coli 15 — 45 Mega Cells/ml | Oral Drops, Suspension |

Member state

Marketing Authorisation Holder

Short name of the Medicinal Product

Active substance + Strength

Pharmaceutical Form

Austria

Symbiopharm Gmbh

Symbioflor E. Coli

Escherichia Coli 15 — 45 Mega Cells/ml

Oral Drops, Suspension

Germany

Symbiopharm Gmbh

Symbioflor 2

Escherichia Coli 15 — 45 Mega Cells/ml

Oral Drops, Suspension

Hungary

Symbiopharm Gmbh

Symbioflor Escherichia

Escherichia Coli 15 — 45 Mega Cells/ml

Oral Drops, Suspension

---

ANNEX V

List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States

| Member State EU/EEA | Marketing authorisation holders | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 450 mg/g Granulat zum Eingeben über das Trinkwasser | Tiamulin hydrogen fumarate | 450 mg/g | Granules | Pigs, chickens, turkeys | Oral |
| Belgium | VMD nv
  Hoge Mauw 900
  2370 Arendonk
  Belgium | Tiamutin 45 % Pigs | Tiamulin hydrogen fumarate | 450 mg/g | Granules for use in drinking water | Pigs | Oral |
| Belgium | VMD nv
  Hoge Mauw 900
  2370 Arendonk
  Belgium | Tiamutin 45 % Chicken-Turkey | Tiamulin hydrogen fumarate | 450 mg/g | Granules for use in drinking water | Chickens, turkeys | Oral |
| Belgium | VMD nv
  Hoge Mauw 900
  2370 Arendonk
  Belgium | Tiamutin 45 % Pigs-Chicken-Turkey | Tiamulin hydrogen fumarate | 450 mg/g | Granules for use in drinking water | Pigs, chickens, turkeys | Oral |
| Czech Republic | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | DENAGARD 450 mg/g granule pro přípravu perorálního roztoku | Tiamulin hydrogen fumarate | 450 mg/g | Granules for use in drinking water | Pigs, chickens (broilers, pullets, layers and breeders), turkeys (fattening and breeding birds) | Oral |
| Finland | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard vet 450 mg/g rakeet | Tiamulin hydrogen fumarate | 450 mg/g | Granules | Pigs | Oral to be administered in drinking water |
| Germany | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 45 % Granulat | Tiamulin hydrogen fumarate | 45 % w/w
  (36,4  % tiamulin w/w) | Granules | Pigs, chickens, turkeys | In drinking water |
| Germany | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 45 % oral | Tiamulin hydrogen fumarate | 45 % w/w
  (36,4  % tiamulin w/w) | Granules | Pigs | Use in drinking water or in feed |
| Greece | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | DENAGARD 45 %, κοκκία για πόσιμο διάλυμα | Tiamulin hydrogen fumarate | 450 mg/g | Granules for oral solution | Pigs, chickens, turkeys | Oral |
| Hungary | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 45 % granulátum belsőleges oldathoz A.U.V. | Tiamulin hydrogen fumarate | 450 mg/g | Granules for use in drinking water | Pigs, chickens, turkeys | In drinking water use |
| Italy | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | DENAGARD 45 % | Tiamulin hydrogen fumarate | 450 mg/g | Powder for use in drinking water | Pigs, chickens | Oral |
| Latvia | Novartis Animal Health d.o.o.
  Verovškova 57
  1000 Ljubljana
  Slovenia | Denagard 45 % WSG | Tiamulin hydrogen fumarate | 450 mg/g | Water soluble granules | Pigs, chickens, turkeys | In drinking water use |
| Lithuania | Novartis Animal Health d.o.o.
  Verovškova 57
  1000 Ljubljana
  Slovenia | DENAGARD 45 %, vandenyje tirpios granulės | Tiamulin hydrogen fumarate | 450 mg/g, corresponds to 365 mg tiamulin/g | Water soluble granules | Pigs, chickens (broiler, replacement pullet, layer/breeder), turkeys (grower and breeder) | Oral |
| The Netherlands | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | DENAGARD 45 % W.S.G. voor varkens en kippen | Tiamulin hydrogen fumarate | 450 mg/g | Granulate for administration through the drinking water | Pigs, chickens | Oral |
| Poland | Novartis Animal Health d.o.o.
  Verovškova 57
  1000 Ljubljana
  Slovenia | Denagard 45 % granulat dla świń, kur i indyków | Tiamulin hydrogen fumarate | 450 mg/g | Granules | Pigs, chickens, turkeys | Oral use |
| Portugal | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 450 mg/g granulado oral para suínos, galinhas e perus | Tiamulin hydrogen fumarate | 450 mg/g | Oral granules | Swine, chickens (broilers, rearing of broilers, layers/breeders), turkeys (for fattening and breeding) | Oral, administered in drinking water |
| Romania | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 45 % | Tiamulin hydrogen fumarate | 45 mg tiamulin hydrogen fumarate/g product | Granules for use in drinking water | Pigs, chickens (broiler, replacement pullet, layer/breeder), turkeys (grower and breeder) | In drinking water |
| Slovak Republic | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 450 mg/g granulát na perorálny roztok | Tiamulin hydrogen fumarate | 450 mg/g | Granules for oral solution | Pigs, chickens (broilers, laying and breeding hens), turkeys | Oral |
| Spain | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 450 mg/g Granulado Oral | Tiamulin hydrogen fumarate | 450 mg/g | Granules for use in drinking water | Pigs, chickens, turkeys | Oral |

Member State EU/EEA

Marketing authorisation holders

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 450 mg/g Granulat zum Eingeben über das Trinkwasser

Tiamulin hydrogen fumarate

450 mg/g

Granules

Pigs, chickens, turkeys

Oral

Belgium

VMD nv

Hoge Mauw 900

2370 Arendonk

Belgium

Tiamutin 45 % Pigs

Tiamulin hydrogen fumarate

450 mg/g

Granules for use in drinking water

Pigs

Oral

Belgium

VMD nv

Hoge Mauw 900

2370 Arendonk

Belgium

Tiamutin 45 % Chicken-Turkey

Tiamulin hydrogen fumarate

450 mg/g

Granules for use in drinking water

Chickens, turkeys

Oral

Belgium

VMD nv

Hoge Mauw 900

2370 Arendonk

Belgium

Tiamutin 45 % Pigs-Chicken-Turkey

Tiamulin hydrogen fumarate

450 mg/g

Granules for use in drinking water

Pigs, chickens, turkeys

Oral

Czech Republic

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

DENAGARD 450 mg/g granule pro přípravu perorálního roztoku

Tiamulin hydrogen fumarate

450 mg/g

Granules for use in drinking water

Pigs, chickens (broilers, pullets, layers and breeders), turkeys (fattening and breeding birds)

Oral

Finland

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard vet 450 mg/g rakeet

Tiamulin hydrogen fumarate

450 mg/g

Granules

Pigs

Oral to be administered in drinking water

Germany

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 45 % Granulat

Tiamulin hydrogen fumarate

45 % w/w

(36,4  % tiamulin w/w)

Granules

Pigs, chickens, turkeys

In drinking water

Germany

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 45 % oral

Tiamulin hydrogen fumarate

45 % w/w

(36,4  % tiamulin w/w)

Granules

Pigs

Use in drinking water or in feed

Greece

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

DENAGARD 45 %, κοκκία για πόσιμο διάλυμα

Tiamulin hydrogen fumarate

450 mg/g

Granules for oral solution

Pigs, chickens, turkeys

Oral

Hungary

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 45 % granulátum belsőleges oldathoz A.U.V.

Tiamulin hydrogen fumarate

450 mg/g

Granules for use in drinking water

Pigs, chickens, turkeys

In drinking water use

Italy

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

DENAGARD 45 %

Tiamulin hydrogen fumarate

450 mg/g

Powder for use in drinking water

Pigs, chickens

Oral

Latvia

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

Denagard 45 % WSG

Tiamulin hydrogen fumarate

450 mg/g

Water soluble granules

Pigs, chickens, turkeys

In drinking water use

Lithuania

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

DENAGARD 45 %, vandenyje tirpios granulės

Tiamulin hydrogen fumarate

450 mg/g, corresponds to 365 mg tiamulin/g

Water soluble granules

Pigs, chickens (broiler, replacement pullet, layer/breeder), turkeys (grower and breeder)

Oral

The Netherlands

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

DENAGARD 45 % W.S.G. voor varkens en kippen

Tiamulin hydrogen fumarate

450 mg/g

Granulate for administration through the drinking water

Pigs, chickens

Oral

Poland

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

Denagard 45 % granulat dla świń, kur i indyków

Tiamulin hydrogen fumarate

450 mg/g

Granules

Pigs, chickens, turkeys

Oral use

Portugal

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 450 mg/g granulado oral para suínos, galinhas e perus

Tiamulin hydrogen fumarate

450 mg/g

Oral granules

Swine, chickens (broilers, rearing of broilers, layers/breeders), turkeys (for fattening and breeding)

Oral, administered in drinking water

Romania

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 45 %

Tiamulin hydrogen fumarate

45 mg tiamulin hydrogen fumarate/g product

Granules for use in drinking water

Pigs, chickens (broiler, replacement pullet, layer/breeder), turkeys (grower and breeder)

In drinking water

Slovak Republic

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 450 mg/g granulát na perorálny roztok

Tiamulin hydrogen fumarate

450 mg/g

Granules for oral solution

Pigs, chickens (broilers, laying and breeding hens), turkeys

Oral

Spain

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 450 mg/g Granulado Oral

Tiamulin hydrogen fumarate

450 mg/g

Granules for use in drinking water

Pigs, chickens, turkeys

Oral

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