# Službeni list C 328/29.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 328 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 60.29 rujna 2017. |

ISSN 1977-1088

Službeni list

Europske unije

C 328

Hrvatsko izdanje

Informacije i objave

Godište 60.29 rujna 2017.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2017/C 328/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. srpnja 2017. do 31. kolovoza 2017.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2017/C 328/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. srpnja 2017. do 31. kolovoza 2017.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ) | 14 |

Obavijest br.

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2017/C 328/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. srpnja 2017. do 31. kolovoza 2017.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

1

2017/C 328/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. srpnja 2017. do 31. kolovoza 2017.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

14

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| HR | |
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HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 29.9.2017 | HR | Službeni list Europske unije | C 328/1 |
| --- | --- | --- | --- |

29.9.2017

HR

Službeni list Europske unije

C 328/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. srpnja 2017. do 31. kolovoza 2017.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))

(2017/C 328/01)

| — | Izdavanje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno |
| --- | --- |

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Izdavanje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.7.2017. | OXERVATE | cenegermin | Dompé farmaceutici S.p.A.
  Via Santa Lucia 6, 20122 Milano, Italia | EU/1/17/1197 | Kapi za oko, otopina | Pending | 10.7.2017. |
| 10.7.2017. | Spherox | sferoidi ljudskih autolognih hondrocita vezanih na matriks | CO.DON AG
  Warthestraße 21, 14513 Teltow, Deutschland | EU/1/17/1181 | Suspenzija implantata | M09AX02 | 12.7.2017. |
| 13.7.2017. | Blitzima | rituksimab | Celltrion Healthcare Hungary Kft.
  1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország | EU/1/17/1205 | Koncentrat za otopinu za infuziju | L01XC02 | 17.7.2017. |
| 13.7.2017. | Reagila | kariprazina | Gedeon Richter Plc.
  Gyömrői út 19-21., H-1103 Budapest, Magyarország | EU/1/17/1209 | Kapsula, tvrda | N05AX15 | 17.7.2017. |
| 13.7.2017. | Ritemvia | rituksimab | Celltrion Healthcare Hungary Kft.
  1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország | EU/1/17/1207 | Koncentrat za otopinu za infuziju | L01XC02 | 17.7.2017. |
| 13.7.2017. | Tuxella | rituksimab | Celltrion Healthcare Hungary Kft.
  1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország | EU/1/17/1206 | Koncentrat za otopinu za infuziju | L01XC02 | 17.7.2017. |
| 17.7.2017. | Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | efavirenz/emtricitabin/tenofovirdizoproksil | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/17/1210 | Filmom obložena tableta | J05AR06 | 19.7.2017. |
| 17.7.2017. | Kyntheum | brodalumab | Leo Pharma A/S
  Industriparken 55, DK-2750 Ballerup, Danmark | EU/1/16/1155 | Otopina za injekciju | L04AC12 | 19.7.2017. |
| 17.7.2017. | Trimbow | beklometazon/formoterol/glikopironij bromid | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/17/1208 | Stlačeni inhalat, otopina | R03AL09 | 19.7.2017. |
| 19.7.2017. | Insulin lispro Sanofi | inzulin lispro | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/17/1203 | Otopina za injekciju | 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 | Prašak za oralnu suspenziju | V03AE09 | 21.7.2017. |
| 26.7.2017. | Maviret | glekaprevir/pibrentasvir. | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/17/1213 | Filmom obložena tableta | J05AX | 28.7.2017. |
| 26.7.2017. | Vosevi | sofosbuvir/velpatasvir/voksilaprevir | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/17/1223 | Filmom obložena tableta | Pending | 28.7.2017. |
| 26.7.2017. | Zykadia | ceritinib | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/999 | Kapsula, tvrda | L01XE28 | 28.7.2017. |
| 22.8.2017. | Kisqali | ribociklib | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/17/1221 | Filmom obložena tableta | L01XE42 | 24.8.2017. |
| 22.8.2017. | MAVENCLAD | kladribin | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/17/1212 | Tableta | 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 | Kapsula, tvrda | 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 | Otopina za injekciju | L04AB04 | 29.8.2017. |
| 24.8.2017. | Nitisinone MendeliKABS | nitizinon | MendeliKABS Europe Limited
  Office 7, Gateway 1000, Whittle Way, Stevenage, Hertfordshire, SG1 2FP, United Kingdom | EU/1/17/1217 | Kapsula, tvrda | A16AX04 | 29.8.2017. |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

6.7.2017.

OXERVATE

cenegermin

Dompé farmaceutici S.p.A.

Via Santa Lucia 6, 20122 Milano, Italia

EU/1/17/1197

Kapi za oko, otopina

Pending

10.7.2017.

10.7.2017.

Spherox

sferoidi ljudskih autolognih hondrocita vezanih na matriks

CO.DON AG

Warthestraße 21, 14513 Teltow, Deutschland

EU/1/17/1181

Suspenzija implantata

M09AX02

12.7.2017.

13.7.2017.

Blitzima

rituksimab

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1205

Koncentrat za otopinu za infuziju

L01XC02

17.7.2017.

13.7.2017.

Reagila

kariprazina

Gedeon Richter Plc.

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

EU/1/17/1209

Kapsula, tvrda

N05AX15

17.7.2017.

13.7.2017.

Ritemvia

rituksimab

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1207

Koncentrat za otopinu za infuziju

L01XC02

17.7.2017.

13.7.2017.

Tuxella

rituksimab

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1206

Koncentrat za otopinu za infuziju

L01XC02

17.7.2017.

17.7.2017.

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

efavirenz/emtricitabin/tenofovirdizoproksil

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/17/1210

Filmom obložena tableta

J05AR06

19.7.2017.

17.7.2017.

Kyntheum

brodalumab

Leo Pharma A/S

Industriparken 55, DK-2750 Ballerup, Danmark

EU/1/16/1155

Otopina za injekciju

L04AC12

19.7.2017.

17.7.2017.

Trimbow

beklometazon/formoterol/glikopironij bromid

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/17/1208

Stlačeni inhalat, otopina

R03AL09

19.7.2017.

19.7.2017.

Insulin lispro Sanofi

inzulin lispro

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/17/1203

Otopina za injekciju

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

Prašak za oralnu suspenziju

V03AE09

21.7.2017.

26.7.2017.

Maviret

glekaprevir/pibrentasvir.

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/17/1213

Filmom obložena tableta

J05AX

28.7.2017.

26.7.2017.

Vosevi

sofosbuvir/velpatasvir/voksilaprevir

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/17/1223

Filmom obložena tableta

Pending

28.7.2017.

26.7.2017.

Zykadia

ceritinib

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/999

Kapsula, tvrda

L01XE28

28.7.2017.

22.8.2017.

Kisqali

ribociklib

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/17/1221

Filmom obložena tableta

L01XE42

24.8.2017.

22.8.2017.

MAVENCLAD

kladribin

Merck Serono Europe Limited

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

EU/1/17/1212

Tableta

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

Kapsula, tvrda

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

Otopina za injekciju

L04AB04

29.8.2017.

24.8.2017.

Nitisinone MendeliKABS

nitizinon

MendeliKABS Europe Limited

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

EU/1/17/1217

Kapsula, tvrda

A16AX04

29.8.2017.

| — | Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno |
| --- | --- |

—

Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 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. | Memantin 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. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

Memantin 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.

| — | Povlačenje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) |
| --- | --- |

—

Povlačenje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 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. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

| — | Izdavanje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno |
| --- | --- |

—

Izdavanje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.8.2017. | VEPURED | Cjepivo protiv bakterije Escherichia coli koja proizvodi verotoxin (inaktivirani recombinant) | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/17/214 | Suspenzija za injekciju | 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 | Suspenzija za upotrebu u vodi za piće | QP53BE02 | 22.8.2017. |
| 22.8.2017. | Innovax-ND-IBD | Newcastle bolest, zarazna bolest burze i cjepivo za Marekovu bolest (živo rekombinirano) | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/17/213 | Suspenzija i otapalo za suspenziju za injekciju | QI01AD | 24.8.2017. |
| 24.8.2017. | Suvaxyn PRRS MLV | Cjepivo koje sadrži virus respiratornog i reproduktivnog sindroma svinja (živi) | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/215 | Liofilizat i otapalo, suspenzija za injekciju | QI09AD03 | 28.8.2017. |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

17.8.2017.

VEPURED

Cjepivo protiv bakterije Escherichia coli koja proizvodi verotoxin (inaktivirani recombinant)

Laboratorios Hipra, S.A.

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

EU/2/17/214

Suspenzija za injekciju

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

Suspenzija za upotrebu u vodi za piće

QP53BE02

22.8.2017.

22.8.2017.

Innovax-ND-IBD

Newcastle bolest, zarazna bolest burze i cjepivo za Marekovu bolest (živo rekombinirano)

Intervet International B.V.

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

EU/2/17/213

Suspenzija i otapalo za suspenziju za injekciju

QI01AD

24.8.2017.

24.8.2017.

Suvaxyn PRRS MLV

Cjepivo koje sadrži virus respiratornog i reproduktivnog sindroma svinja (živi)

Zoetis Belgium S.A.

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

EU/2/17/215

Liofilizat i otapalo, suspenzija za injekciju

QI09AD03

28.8.2017.

| — | Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno |
| --- | --- |

—

Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 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. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:

| 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)  SL L 136, 30.4.2004, str. 1.

---

| 29.9.2017 | HR | Službeni list Europske unije | C 328/14 |
| --- | --- | --- | --- |

29.9.2017

HR

Službeni list Europske unije

C 328/14

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. srpnja 2017. do 31. kolovoza 2017.

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ (1) ili člankom 38. Direktive 2001/82/EZ (2))

(2017/C 328/02)

| — | Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet |
| --- | --- |

—

Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet

| Datum odluke | Naziv(i) lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj(i) odobrenja za stavljanje u promet | Država članica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- | --- |
| 7.8.2017. | Paracetamol/ibuprofen 500 mg/150 mg Film-coated tablets and associated names | paracetamol/ibuprofen | Vidi Prilog I | Vidi Prilog 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 | Vidi Prilog II | Vidi Prilog II | 11.7.2017. |
| 19.7.2017. | Cardioxane | dexrazoxane | Vidi Prilog III | Vidi Prilog 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) | Vidi Prilog IV | Vidi Prilog IV | 30.8.2017. |
| 14.7.2017. | Denagard 45 % and associated names | Tiamulin hydrogen fumarate | Vidi Prilog V | Vidi Prilog V | 17.7.2017. |

Datum odluke

Naziv(i) lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj(i) odobrenja za stavljanje u promet

Država članica na koju se odnosi

Datum obavijesti

7.8.2017.

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

paracetamol/ibuprofen

Vidi Prilog I

Vidi Prilog 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

Vidi Prilog II

Vidi Prilog II

11.7.2017.

19.7.2017.

Cardioxane

dexrazoxane

Vidi Prilog III

Vidi Prilog 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)

Vidi Prilog IV

Vidi Prilog IV

30.8.2017.

14.7.2017.

Denagard 45 % and associated names

Tiamulin hydrogen fumarate

Vidi Prilog V

Vidi Prilog V

17.7.2017.

| — | Odbijanje nacionalnog odobrenja za stavljanje u promet |
| --- | --- |

—

Odbijanje nacionalnog odobrenja za stavljanje u promet

| Datum odluke | Naziv(i) lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj(i) odobrenja za stavljanje u promet | Država članica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- | --- |
| 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 | Vidi Prilog II | Vidi Prilog II | 11.7.2017. |

Datum odluke

Naziv(i) lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj(i) odobrenja za stavljanje u promet

Država članica na koju se odnosi

Datum obavijesti

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

Vidi Prilog II

Vidi Prilog II

11.7.2017.

---

(1)  SL L 311, 28.11.2001., str. 67.

(2)  SL L 311, 28.11.2001., str. 1.

---

PRILOG I.

Popis lijekova i oblika

| Država članica EU/EGP-a | Podnositelj zahtjeva | (Zaštićeno) ime | INN + Jačina | Farmaceutski oblik4 | Put primjene5 |
| --- | --- | --- | --- | --- | --- |
| Austrija | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Irska | Ibucomb | 500 mg/150 mg | filmom
  obložene tablete | kroz usta |
| Belgija | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Irska | Combogesic | 500 mg/150 mg | filmom
  obložene tablete | kroz usta |
| Hrvatska | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Irska | Combogesic | 500 mg/150 mg | filmom
  obložene tablete | kroz usta |
| Francuska | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Irska | Paracetamol/Ibuprofen Vale | 500 mg/150 mg | filmom
  obložene tablete | kroz usta |
| Njemačka | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Irska | Paracetamol/Ibuprofen Vale | 500 mg/150 mg | filmom
  obložene tablete | kroz usta |
| Irska | Clonmel Healthcare
  Waterford Road
  Clonmel
  Co. Tipperary
  E91 D768
  Irska | Easolief Duo | 500 mg/150 mg | filmom
  obložene tablete | kroz usta |
| Luksemburg | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Irska | Paracomb | 500 mg/150 mg | filmom
  obložene tablete | kroz usta |
| Nizozemska | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Irska | Paraprofen | 500 mg/150 mg | filmom
  obložene tablete | kroz usta |
| Portugal | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Irska | Maxigesic | 500 mg/150 mg | filmom
  obložene tablete | kroz usta |
| Španjolska | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Irska | Dolostop Plus
  500 mg/150 mg comprimidos recubiertos con película | 500 mg/150 mg | filmom
  obložene tablete | kroz usta |
| Ujedinjeno Kraljevstvo
  (UK/H/6034/001/DC) | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Irska | Paracetamol/Ibuprofen 500 mg/150 mg film
  coated tablets | 500 mg/150 mg | filmom
  obložene tablete | kroz usta |
| Ujedinjeno Kraljevstvo (UK/H/6035/001/DC) | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Irska | Paracetamol/Ibuprofen 500 mg/150 mg film
  coated tablets | 500 mg/150 mg | filmom
  obložene tablete | kroz usta |
| Ujedinjeno Kraljevstvo (UK/H/6176/001/DC) | Vale Pharmaceuticals Limited, Unit 1B Gurtnafleur Business Park, Gurtnafleur Clonmel, Co. Tipperary, Irska | Novogesic 500 mg/150 mg film coated tablets | 500 mg/150 mg | filmom
  obložene tablete | kroz usta |

Država članica EU/EGP-a

Podnositelj zahtjeva

(Zaštićeno) ime

INN + Jačina

Farmaceutski oblik4

Put primjene5

Austrija

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

Ibucomb

500 mg/150 mg

filmom

obložene tablete

kroz usta

Belgija

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

Combogesic

500 mg/150 mg

filmom

obložene tablete

kroz usta

Hrvatska

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

Combogesic

500 mg/150 mg

filmom

obložene tablete

kroz usta

Francuska

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

Paracetamol/Ibuprofen Vale

500 mg/150 mg

filmom

obložene tablete

kroz usta

Njemačka

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

Paracetamol/Ibuprofen Vale

500 mg/150 mg

filmom

obložene tablete

kroz usta

Irska

Clonmel Healthcare

Waterford Road

Clonmel

Co. Tipperary

E91 D768

Irska

Easolief Duo

500 mg/150 mg

filmom

obložene tablete

kroz usta

Luksemburg

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

Paracomb

500 mg/150 mg

filmom

obložene tablete

kroz usta

Nizozemska

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

Paraprofen

500 mg/150 mg

filmom

obložene tablete

kroz usta

Portugal

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

Maxigesic

500 mg/150 mg

filmom

obložene tablete

kroz usta

Španjolska

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

Dolostop Plus

500 mg/150 mg comprimidos recubiertos con película

500 mg/150 mg

filmom

obložene tablete

kroz usta

Ujedinjeno Kraljevstvo

(UK/H/6034/001/DC)

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

Paracetamol/Ibuprofen 500 mg/150 mg film

coated tablets

500 mg/150 mg

filmom

obložene tablete

kroz usta

Ujedinjeno Kraljevstvo (UK/H/6035/001/DC)

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

Paracetamol/Ibuprofen 500 mg/150 mg film

coated tablets

500 mg/150 mg

filmom

obložene tablete

kroz usta

Ujedinjeno Kraljevstvo (UK/H/6176/001/DC)

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

Novogesic 500 mg/150 mg film coated tablets

500 mg/150 mg

filmom

obložene tablete

kroz usta

---

DODATAK II

Popis naziva, farmaceutskih oblika, jačina veterinarsko-medicinskih proizvoda, životinjskih vrsta, putova primjene, podnositelja zahtjeva/nositelja odobrenja za stavljanje lijeka u promet u državama članicama

| Država članica EU-a/EGP-a | Podnositelj zahtjeva/nositelj odobrenja za stavljanje lijeka u promet | Naziv | Međunarodni nezaštićeni naziv | Farmaceutski oblik | Jačina | Životinjske vrste | Put primjene |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austrija | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | PHARMASIN 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Austrija | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Austrija | Vana GmbH
  Wolfgang Schmälzl-Gasse 6
  1020 Wien
  Austria | Vanatyl 200 mg/ml – Injektionslösung für Tiere | Tylosin | Otopina za injekciju | 200,000 IU/ml | Stoka, telad, ovce, koze, svinje, psi | i.m. |
| Belgija | Cross Vetpharma Group Ltd
  Broomhill Road, Tallagh Dublin 24
  Ireland | Bilovet | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje | i.m. |
| Belgija | VETOQUINOL SA/NV
  Kontichsesteenweg 42
  2630 Aartselaar
  Belgium | Tylucyl | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Bugarska | Biovet JSC
  39, Petar Rakov Str.
  4550 Pesthera
  Bulgaria | PHARMASIN 200 mg/ml solution for injection for cattle, sheep, goats and pigs | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Hrvatska | VETOQUINOL SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/mL otopina za injekcije za goveda i svinje | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Cipar | VETOQUINOL SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/ml raztopina za injiciranje za govedo in prašiče | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Danska | Biovet JSC
  39, Petar Rakov Str.
  4550 Pesthera
  Bulgaria | Tylaxene | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Danska | Huvepharma NV Uitbreidingstraat 80
  BE-2600 Antwerpen
  Belgium | Tylmasin | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Danska | Vetoquinol Scandinavia AB Lyngbyvej 20
  DK-2100 København
  Denmark | Tylucyl | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Estonija | Vétoquinol SA,
  Magny-Vernois
  70200 Lure
  France | Tylucyl | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Finska | VETOQUINOL SA/NV
  Kontichsesteenweg 42
  2630 Aartselaar
  Belgium | Tylucyl | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Francuska | LILLY France
  24 Boulevard Vital Bouhot
  92200 Neuilly Sur Seine
  France | TYLAN 200 | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Francuska | HUVEPHARMA
  Uitbredingstraat 53
  2600 Antwerp
  Belgium | PHARMASIN 200 MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS CAPRINS ET PORCINS | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Francuska | Biovet JSC
  39, Petar Rakov Str.
  4550 Pesthera
  Bulgaria | TYLAXEN 200 MG/ML SOLUTION INJECTABLE POUR BOVINS, OVINS, CAPRINS ET PORCINS | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Francuska | CROSS VETPHARM GROUP
  Broomhill Road
  Dublin 24
  Tallaght
  Ireland | BILOVET 200 MG/ML SOLUTION INJECTABLE | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Francuska | VETOQUINOL
  Magny Vernois
  70200 Lure
  France | TYLUCYL 200 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCINS | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Njemačka | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | Tylmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Njemačka | Vétoquinol GmbH
  Parkstr. 10
  88212 Ravensburg
  Germany | Tylucyl 200 mg/ml | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Njemačka | HUVEPHARMA NV
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | Pharmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Njemačka | 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 | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje | i.m. |
| Grčka | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Mađarska | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | PHARMASIN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Mađarska | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Mađarska | VETOQUINOL SA
  Magny Vernois
  70200 LURE
  France | Tylucyl 200 mg/ml oldatos injekció szarvasmarhák és sertések részére | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Irska | Eli Lilly & Company Limited
  Elanco Animal Health
  Priestley Road
  Basingstoke
  Hampshire RG24 9NL
  United Kingdom | Tylan 200, 200 mg/ml Solution for Injection | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje | i.m. |
| Irska | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | Tylaxen 200 mg/ml solution for injection for cattle, sheep, goats and pigs. | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Irska | Huvepharma N.V.
  Uitbreidingsstraat 80
  2600 Antwerpen
  Belgium | Pharmasin 200 mg/ml solution for injection for cattle, sheep, goats and pigs | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Irska | Cross Vetpharm Group Ltd.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml Solution for Injection for cattle and pigs. | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje | i.m. |
| Italija | Vetoquinol Italia S.r.l.
  Via Piana 265
  47032 Bertinoro (FC)
  Italy | TYLUCYL 200 mg/ml soluzione iniettabile per bovini e suini | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Italija | FATRO S.p.A.
  Via Emilia 285
  40064 Ozzano Emilia (BO)
  Italy | VETIL | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje, psi | i.m. |
| Italija | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 mg/ml. soluzione iniettabile | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Italija | ELI LILLY ITALIA S.p.A.
  Via Gramsci, 731/733
  50019 Sesto Fiorentino
  Firenze
  Italy | TYLAN 200 | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje | i.m. |
| Italija | HUVEPHARMA NV
  Uitbreidingstraat 80
  2600 Anversa
  Belgium | PHARMASIN 200 mg/ml soluzione iniettabile per bovini, ovini, caprini e suini | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Latvija | Vetoquinol S.A.
  Magny-Vernois B.P. 189
  Lure Cedex
  France | Tylucyl | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Nizozemska | CROSS VETPHARM GROUP Ltd.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | BILOVET 200 mg/ml oplossing voor injectie voor runderen en varkens | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje | i.m. |
| Poljska | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerpia
  Belgium | Pharmasin | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Poljska | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | Tylaxen | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Poljska | Aniserve UG Geyerspergerstrasse 27
  80689 Munich
  Germany | Bilovet 200 | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje | i.m. |
| Poljska | Vetoquinol Biowet Sp. z o.o.
  ul. Kosynierów Gdyńskich 13-14
  66-400 Gorzów Wielkopolski
  Poland | Tylucyl 200 mg/ml solution for injection | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Portugal | Vetoquinol S.A.
  Magny-Vernois B.P. 189
  Lure Cedex
  France | Tylucyl 200 mg/ml, solução injetável para bovinos e suínos | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Portugal | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | PHARMASIN 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Portugal | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 mg/ml solução injetável para bovinos, ovinos, caprinos e suínos | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| 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 | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje | i.m. |
| Rumunjska | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | Tylaxen 200 mg/ml | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Rumunjska | Cross Vetpharm Group Ltd.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje | i.m. |
| Slovačka Republika | Vétoquinol s.r.o.
  Zámečnická 411
  288 02 Nymburk
  Czech Republic | TYLUCYL 200 mg/ml injekčný roztok pre hovädzí dobytok a ošípané | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Slovačka Republika | Biovet JSC
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLOVET B-200 mg/ml injekčný roztok | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje | i.m. |
| Slovenija | VETOQUINOL SA
  Magny-Vernois
  70200 Lure
  France | Tylucyl 200 mg/ml raztopina za injiciranje za govedo in prašiče | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Španjolska | CROSS VETPHARM GROUP LIMITED.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | BILOVET 200 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje | i.m. |
| Španjolska | 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 | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Španjolska | Huvepharma NV
  Uitbreidingstraat 80
  2600 Antwerpen
  Belgium | PHARMASIN 200 MG/ML SOLUCIÓN INYECTABLE PARA BOVINO OVINO CAPRINO Y PO | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Španjolska | Biovet JSC,
  39 Petar Rakov Str.
  4550 Peshtera
  Bulgaria | TYLAXEN 200 MG/ML SOLUCIÓN INYECTABLE PARA BOVINO OVINO CAPRINO Y PORC | Tylosin | Otopina za injekciju | 200,000 IU/ml | Stoka
  Ovce
  Koze
  Svinje | i.m.
  sporo i.v. (goveda) |
| Švedska | Vetoquinol Scandinavia AB
  Box 9
  265 21 Åstorp
  Sweden | Tylucyl | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |
| Ujedinjena Kraljevina | Cross Vetpharm Group Ltd.
  Broomhill Road, Tallaght
  Dublin 24
  Ireland | Bilovet 200 mg/ml Solution for Injection for Cattle and Pigs | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje | i.m. |
| Ujedinjena Kraljevina | Eli Lilly & Company Ltd
  Elanco Animal Health
  Priestley Road
  Basingstoke
  Hampshire RG24 9NL
  United Kingdom | Tylan 200, 200 mg/ml Solution for Injection | Tylosin | Otopina za injekciju | 200,000 IU/ml | Goveda, svinje | i.m. |
| Ujedinjena Kraljevina | 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 | Otopina za injekciju | 200,000 IU/ml | Goveda
  Svinje | i.m.
  sporo i.v. (goveda) |

Država članica EU-a/EGP-a

Podnositelj zahtjeva/nositelj odobrenja za stavljanje lijeka u promet

Naziv

Međunarodni nezaštićeni naziv

Farmaceutski oblik

Jačina

Životinjske vrste

Put primjene

Austrija

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Austrija

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Austrija

Vana GmbH

Wolfgang Schmälzl-Gasse 6

1020 Wien

Austria

Vanatyl 200 mg/ml – Injektionslösung für Tiere

Tylosin

Otopina za injekciju

200,000 IU/ml

Stoka, telad, ovce, koze, svinje, psi

i.m.

Belgija

Cross Vetpharma Group Ltd

Broomhill Road, Tallagh Dublin 24

Ireland

Bilovet

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda, svinje

i.m.

Belgija

VETOQUINOL SA/NV

Kontichsesteenweg 42

2630 Aartselaar

Belgium

Tylucyl

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Bugarska

Biovet JSC

39, Petar Rakov Str.

4550 Pesthera

Bulgaria

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Hrvatska

VETOQUINOL SA

Magny-Vernois

70200 Lure

France

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Cipar

VETOQUINOL SA

Magny-Vernois

70200 Lure

France

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Danska

Biovet JSC

39, Petar Rakov Str.

4550 Pesthera

Bulgaria

Tylaxene

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Danska

Huvepharma NV Uitbreidingstraat 80

BE-2600 Antwerpen

Belgium

Tylmasin

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Danska

Vetoquinol Scandinavia AB Lyngbyvej 20

DK-2100 København

Denmark

Tylucyl

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Estonija

Vétoquinol SA,

Magny-Vernois

70200 Lure

France

Tylucyl

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Finska

VETOQUINOL SA/NV

Kontichsesteenweg 42

2630 Aartselaar

Belgium

Tylucyl

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Francuska

LILLY France

24 Boulevard Vital Bouhot

92200 Neuilly Sur Seine

France

TYLAN 200

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Francuska

HUVEPHARMA

Uitbredingstraat 53

2600 Antwerp

Belgium

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Francuska

Biovet JSC

39, Petar Rakov Str.

4550 Pesthera

Bulgaria

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Francuska

CROSS VETPHARM GROUP

Broomhill Road

Dublin 24

Tallaght

Ireland

BILOVET 200 MG/ML SOLUTION INJECTABLE

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Francuska

VETOQUINOL

Magny Vernois

70200 Lure

France

TYLUCYL 200 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCINS

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Njemačka

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Njemačka

Vétoquinol GmbH

Parkstr. 10

88212 Ravensburg

Germany

Tylucyl 200 mg/ml

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Njemačka

HUVEPHARMA NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Njemačka

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

Otopina za injekciju

200,000 IU/ml

Goveda, svinje

i.m.

Grčka

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLAXEN

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Mađarska

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

Belgium

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Mađarska

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Mađarska

VETOQUINOL SA

Magny Vernois

70200 LURE

France

Tylucyl 200 mg/ml oldatos injekció szarvasmarhák és sertések részére

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Irska

Eli Lilly & Company Limited

Elanco Animal Health

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Tylan 200, 200 mg/ml Solution for Injection

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda, svinje

i.m.

Irska

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Irska

Huvepharma N.V.

Uitbreidingsstraat 80

2600 Antwerpen

Belgium

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Irska

Cross Vetpharm Group Ltd.

Broomhill Road, Tallaght

Dublin 24

Ireland

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda, svinje

i.m.

Italija

Vetoquinol Italia S.r.l.

Via Piana 265

47032 Bertinoro (FC)

Italy

TYLUCYL 200 mg/ml soluzione iniettabile per bovini e suini

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Italija

FATRO S.p.A.

Via Emilia 285

40064 Ozzano Emilia (BO)

Italy

VETIL

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda, svinje, psi

i.m.

Italija

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLAXEN 200 mg/ml. soluzione iniettabile

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Italija

ELI LILLY ITALIA S.p.A.

Via Gramsci, 731/733

50019 Sesto Fiorentino

Firenze

Italy

TYLAN 200

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda, svinje

i.m.

Italija

HUVEPHARMA NV

Uitbreidingstraat 80

2600 Anversa

Belgium

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Latvija

Vetoquinol S.A.

Magny-Vernois B.P. 189

Lure Cedex

France

Tylucyl

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Nizozemska

CROSS VETPHARM GROUP Ltd.

Broomhill Road, Tallaght

Dublin 24

Ireland

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda, svinje

i.m.

Poljska

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpia

Belgium

Pharmasin

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Poljska

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylaxen

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Poljska

Aniserve UG Geyerspergerstrasse 27

80689 Munich

Germany

Bilovet 200

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda, svinje

i.m.

Poljska

Vetoquinol Biowet Sp. z o.o.

ul. Kosynierów Gdyńskich 13-14

66-400 Gorzów Wielkopolski

Poland

Tylucyl 200 mg/ml solution for injection

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Portugal

Vetoquinol S.A.

Magny-Vernois B.P. 189

Lure Cedex

France

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Portugal

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Portugal

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

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

Otopina za injekciju

200,000 IU/ml

Goveda, svinje

i.m.

Rumunjska

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylaxen 200 mg/ml

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Rumunjska

Cross Vetpharm Group Ltd.

Broomhill Road, Tallaght

Dublin 24

Ireland

Bilovet 200 mg/ml

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda, svinje

i.m.

Slovačka Republika

Vétoquinol s.r.o.

Zámečnická 411

288 02 Nymburk

Czech Republic

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Slovačka Republika

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLOVET B-200 mg/ml injekčný roztok

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda, svinje

i.m.

Slovenija

VETOQUINOL SA

Magny-Vernois

70200 Lure

France

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Španjolska

CROSS VETPHARM GROUP LIMITED.

Broomhill Road, Tallaght

Dublin 24

Ireland

BILOVET 200 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda, svinje

i.m.

Španjolska

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

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Španjolska

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Španjolska

Biovet JSC,

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Stoka

Ovce

Koze

Svinje

i.m.

sporo i.v. (goveda)

Švedska

Vetoquinol Scandinavia AB

Box 9

265 21 Åstorp

Sweden

Tylucyl

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

Ujedinjena Kraljevina

Cross Vetpharm Group Ltd.

Broomhill Road, Tallaght

Dublin 24

Ireland

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

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda, svinje

i.m.

Ujedinjena Kraljevina

Eli Lilly & Company Ltd

Elanco Animal Health

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Tylan 200, 200 mg/ml Solution for Injection

Tylosin

Otopina za injekciju

200,000 IU/ml

Goveda, svinje

i.m.

Ujedinjena Kraljevina

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

Otopina za injekciju

200,000 IU/ml

Goveda

Svinje

i.m.

sporo i.v. (goveda)

---

PRILOG III.

Popis naziva i farmaceutskih oblika, jačina i puteva primjene

| Država članica EU-a/EGP | Nositelj odobrenja | Zaštićeni naziv | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| Češka Republika | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW,
  Ujedinjeno Kraljevstvo | Cardioxane | 500 mg | Prašak za otopinu za infuziju | Intravenska primjena |
| Francuska | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW,
  Ujedinjeno Kraljevstvo | Cardioxane | 500 mg | Prašak za otopinu za infuziju | Intravenska primjena |
| Njemačka | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW,
  Ujedinjeno Kraljevstvo | Cardioxane | 500 mg | Prašak za otopinu za infuziju | Intravenska primjena |
| Italija | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW,
  Ujedinjeno Kraljevstvo | Cardioxane | 500 mg | Prašak za otopinu za infuziju | Intravenska primjena |
| Nizozemska | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW,
  Ujedinjeno Kraljevstvo | Cardioxane | 500 mg | Prašak za otopinu za infuziju | Intravenska primjena |
| Poljska | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW,
  Ujedinjeno Kraljevstvo | Cardioxane | 500 mg | Prašak za otopinu za infuziju | Intravenska primjena |
| Španjolska | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW,
  Ujedinjeno Kraljevstvo | Cardioxane 500 mg polvo para solución para perfusión | 500 mg | Prašak za otopinu za infuziju | Intravenska primjena |
| Ujedinjeno Kraljevstvo | Clinigen Healthcare Ltd.
  Pitcairn House, Crown Square
  First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW,
  Ujedinjeno Kraljevstvo | Cardioxane | 500 mg | Prašak za otopinu za infuziju | Intravenska primjena |

Država članica EU-a/EGP

Nositelj odobrenja

Zaštićeni naziv

Jačina

Farmaceutski oblik

Put primjene

Češka Republika

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

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

Ujedinjeno Kraljevstvo

Cardioxane

500 mg

Prašak za otopinu za infuziju

Intravenska primjena

Francuska

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

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

Ujedinjeno Kraljevstvo

Cardioxane

500 mg

Prašak za otopinu za infuziju

Intravenska primjena

Njemačka

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

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

Ujedinjeno Kraljevstvo

Cardioxane

500 mg

Prašak za otopinu za infuziju

Intravenska primjena

Italija

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

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

Ujedinjeno Kraljevstvo

Cardioxane

500 mg

Prašak za otopinu za infuziju

Intravenska primjena

Nizozemska

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

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

Ujedinjeno Kraljevstvo

Cardioxane

500 mg

Prašak za otopinu za infuziju

Intravenska primjena

Poljska

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

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

Ujedinjeno Kraljevstvo

Cardioxane

500 mg

Prašak za otopinu za infuziju

Intravenska primjena

Španjolska

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

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

Ujedinjeno Kraljevstvo

Cardioxane 500 mg polvo para solución para perfusión

500 mg

Prašak za otopinu za infuziju

Intravenska primjena

Ujedinjeno Kraljevstvo

Clinigen Healthcare Ltd.

Pitcairn House, Crown Square

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

Ujedinjeno Kraljevstvo

Cardioxane

500 mg

Prašak za otopinu za infuziju

Intravenska primjena

---

PRILOG IV.

Popis nacionalno odobrenih lijekova

| Država članica | Nositelj odobrenja za stavljanje u promet | Skraćeni naziv lijeka | Djelatna tvar + jačina | Farmaceutski oblik |
| --- | --- | --- | --- | --- |
| Austrija | Symbiopharm Gmbh | Symbioflor E. Coli | Escherichia Coli 15 – 45 Mega Cells/ml | Oralne kapi, suspenzija |
| Njemačka | Symbiopharm Gmbh | Symbioflor 2 | Escherichia Coli 15 – 45 Mega Cells/ml | Oralne kapi, suspenzija |
| Mađarska | Symbiopharm Gmbh | Symbioflor Escherichia | Escherichia Coli 15 – 45 Mega Cells/ml | Oralne kapi, suspenzija |

Država članica

Nositelj odobrenja za stavljanje u promet

Skraćeni naziv lijeka

Djelatna tvar + jačina

Farmaceutski oblik

Austrija

Symbiopharm Gmbh

Symbioflor E. Coli

Escherichia Coli 15 – 45 Mega Cells/ml

Oralne kapi, suspenzija

Njemačka

Symbiopharm Gmbh

Symbioflor 2

Escherichia Coli 15 – 45 Mega Cells/ml

Oralne kapi, suspenzija

Mađarska

Symbiopharm Gmbh

Symbioflor Escherichia

Escherichia Coli 15 – 45 Mega Cells/ml

Oralne kapi, suspenzija

---

PRILOG V

Popis naziva, farmaceutskih oblika, jačina veterinarsko medicinskog proizvoda, vrsta životinja, puteva primjene, nositelja odobrenja za stavljanje u promet u državama članicama

| Država članica EU/EEA | Nositelji odobrenja za stavljanje u promet | Naziv | INN | Jačina | Farmaceutski oblik | Vrste životinja | Put primjene |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austrija | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 450 mg/g Granulat zum Eingeben über das Trinkwasser | Tiamulinfumarat | 450 mg/g | Granule | Svinje, kokoši, pure | Kroz usta |
| Belgija | VMD nv
  Hoge Mauw 900
  2370 Arendonk
  Belgium | Tiamutin 45 % Pigs | Tiamulinfumarat | 450 mg/g | Granule za uporabu u vodi za piće | Svinje | Kroz usta |
| Belgija | VMD nv
  Hoge Mauw 900
  2370 Arendonk
  Belgium | Tiamutin 45 % Chicken-Turkey | Tiamulinfumarat | 450 mg/g | Granule za uporabu u vodi za piće | Kokoši, pure | Kroz usta |
| Belgija | VMD nv
  Hoge Mauw 900
  2370 Arendonk
  Belgium | Tiamutin 45 % Pigs-Chicken-Turkey | Tiamulinfumarat | 450 mg/g | Granule za uporabu u vodi za piće | Svinje, kokoši, pure | Kroz usta |
| Češka Republika | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | DENAGARD 450 mg/g granule pro přípravu perorálního roztoku | Tiamulinfumarat | 450 mg/g | Granule za uporabu u vodi za piće | Svinje, kokoši (brojleri, pilenke, nesilice i rasplodne životinje), pure (za tov i rasplod) | Kroz usta |
| Finska | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard vet 450 mg/g rakeet | Tiamulinfumarat | 450 mg/g | Granule | Svinje | Kroz usta, u vodi za piće |
| Njemačka | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 45 % Granulat | Tiamulinfumarat | 45 % w/w
  (36.4 % tiamulin w/w) | Granule | Svinje, kokoši, pure | U vodi za piće |
| Njemačka | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 45 % oral | Tiamulinfumarat | 45 % w/w
  (36.4 % tiamulin w/w) | Granule | Svinje | U vodi za piće ili u hrani |
| Grčka | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | DENAGARD 45 %, κοκκία για πόσιμο διάλυμα | Tiamulinfumarat | 450 mg/g | Granule za oralnu otopinu | Svinje, kokoši, pure | Kroz usta |
| Mađarska | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 45 % granulátum belsőleges oldathoz A.U.V. | Tiamulinfumarat | 450 mg/g | Granule za uporabu u vodi za piće | Svinje, kokoši, pure | U vodi za piće |
| Italija | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | DENAGARD 45 % | Tiamulinfumarat | 450 mg/g | Prašak za uporabu u vodi za piće | Svinje, kokoši | Kroz usta |
| Latvija | Novartis Animal Health d.o.o.
  Verovškova 57
  1000 Ljubljana
  Slovenia | Denagard 45 % WSG | Tiamulinfumarat | 450 mg/g | Vodotopljive granule | Svinje, kokoši, pure | U vodi za piće |
| Litva | Novartis Animal Health d.o.o.
  Verovškova 57
  1000 Ljubljana
  Slovenia | DENAGARD 45 %, vandenyje tirpios granulės | Tiamulinfumarat | 450 mg/g, corresponds to 365 mg tiamulin/g | Vodotopljive granule | Svinje, kokoši (brojleri, uzgojne pilenke, nesilice/rasplodne životinje), pure (za uzgoj i rasplod) | Kroz usta |
| Nizozemska | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | DENAGARD 45 % W.S.G. voor varkens en kippen | Tiamulinfumarat | 450 mg/g | Granulat za uporabu u vodi za piće | Svinje, kokoši | Kroz usta |
| Poljska | Novartis Animal Health d.o.o.
  Verovškova 57
  1000 Ljubljana
  Slovenia | Denagard 45 % granulat dla świń, kur i indyków | Tiamulinfumarat | 450 mg/g | Granule | Svinje, kokoši, pure | Kroz usta |
| 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 | Tiamulinfumarat | 450 mg/g | Oralne granule | Svinje, kokoši (brojleri, uzgoj brojlera, nesilice/rasplodne životinje), pure (za tov i rasplod) | Kroz usta, za primjenu u vodi za piće |
| Rumunjska | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 45 % | Tiamulinfumarat | 45 mg tiamulin hydrogen fumarate/g product | Granule za uporabu u vodi za piće | Svinje, kokoši (brojleri, uzgojne pilenke, nesilice/rasplodne životinje), pure (za uzgoj i rasplod) | U vodi za piće |
| Slovačka Republika | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 450 mg/g granulát na perorálny roztok | Tiamulinfumarat | 450 mg/g | Granule za oralnu otopinu | Svinje, kokoši (brojleri, nesilice i kokoši za rasplod), pure | Kroz usta |
| Španjolska | Elanco Europe Ltd.
  Lilly House, Priestley Road
  Basingstoke, Hampshire
  RG24 9NL
  United Kingdom | Denagard 450 mg/g Granulado Oral | Tiamulinfumarat | 450 mg/g | Granule za uporabu u vodi za piće | Svinje, kokoši, pure | Kroz usta |

Država članica EU/EEA

Nositelji odobrenja za stavljanje u promet

Naziv

INN

Jačina

Farmaceutski oblik

Vrste životinja

Put primjene

Austrija

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 450 mg/g Granulat zum Eingeben über das Trinkwasser

Tiamulinfumarat

450 mg/g

Granule

Svinje, kokoši, pure

Kroz usta

Belgija

VMD nv

Hoge Mauw 900

2370 Arendonk

Belgium

Tiamutin 45 % Pigs

Tiamulinfumarat

450 mg/g

Granule za uporabu u vodi za piće

Svinje

Kroz usta

Belgija

VMD nv

Hoge Mauw 900

2370 Arendonk

Belgium

Tiamutin 45 % Chicken-Turkey

Tiamulinfumarat

450 mg/g

Granule za uporabu u vodi za piće

Kokoši, pure

Kroz usta

Belgija

VMD nv

Hoge Mauw 900

2370 Arendonk

Belgium

Tiamutin 45 % Pigs-Chicken-Turkey

Tiamulinfumarat

450 mg/g

Granule za uporabu u vodi za piće

Svinje, kokoši, pure

Kroz usta

Češka Republika

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

DENAGARD 450 mg/g granule pro přípravu perorálního roztoku

Tiamulinfumarat

450 mg/g

Granule za uporabu u vodi za piće

Svinje, kokoši (brojleri, pilenke, nesilice i rasplodne životinje), pure (za tov i rasplod)

Kroz usta

Finska

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard vet 450 mg/g rakeet

Tiamulinfumarat

450 mg/g

Granule

Svinje

Kroz usta, u vodi za piće

Njemačka

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 45 % Granulat

Tiamulinfumarat

45 % w/w

(36.4 % tiamulin w/w)

Granule

Svinje, kokoši, pure

U vodi za piće

Njemačka

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 45 % oral

Tiamulinfumarat

45 % w/w

(36.4 % tiamulin w/w)

Granule

Svinje

U vodi za piće ili u hrani

Grčka

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

DENAGARD 45 %, κοκκία για πόσιμο διάλυμα

Tiamulinfumarat

450 mg/g

Granule za oralnu otopinu

Svinje, kokoši, pure

Kroz usta

Mađarska

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

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

Tiamulinfumarat

450 mg/g

Granule za uporabu u vodi za piće

Svinje, kokoši, pure

U vodi za piće

Italija

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

DENAGARD 45 %

Tiamulinfumarat

450 mg/g

Prašak za uporabu u vodi za piće

Svinje, kokoši

Kroz usta

Latvija

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

Denagard 45 % WSG

Tiamulinfumarat

450 mg/g

Vodotopljive granule

Svinje, kokoši, pure

U vodi za piće

Litva

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

DENAGARD 45 %, vandenyje tirpios granulės

Tiamulinfumarat

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

Vodotopljive granule

Svinje, kokoši (brojleri, uzgojne pilenke, nesilice/rasplodne životinje), pure (za uzgoj i rasplod)

Kroz usta

Nizozemska

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

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

Tiamulinfumarat

450 mg/g

Granulat za uporabu u vodi za piće

Svinje, kokoši

Kroz usta

Poljska

Novartis Animal Health d.o.o.

Verovškova 57

1000 Ljubljana

Slovenia

Denagard 45 % granulat dla świń, kur i indyków

Tiamulinfumarat

450 mg/g

Granule

Svinje, kokoši, pure

Kroz usta

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

Tiamulinfumarat

450 mg/g

Oralne granule

Svinje, kokoši (brojleri, uzgoj brojlera, nesilice/rasplodne životinje), pure (za tov i rasplod)

Kroz usta, za primjenu u vodi za piće

Rumunjska

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 45 %

Tiamulinfumarat

45 mg tiamulin hydrogen fumarate/g product

Granule za uporabu u vodi za piće

Svinje, kokoši (brojleri, uzgojne pilenke, nesilice/rasplodne životinje), pure (za uzgoj i rasplod)

U vodi za piće

Slovačka Republika

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 450 mg/g granulát na perorálny roztok

Tiamulinfumarat

450 mg/g

Granule za oralnu otopinu

Svinje, kokoši (brojleri, nesilice i kokoši za rasplod), pure

Kroz usta

Španjolska

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke, Hampshire

RG24 9NL

United Kingdom

Denagard 450 mg/g Granulado Oral

Tiamulinfumarat

450 mg/g

Granule za uporabu u vodi za piće

Svinje, kokoši, pure

Kroz usta

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