# Službeni list C 367/30.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 367 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 63.30. listopada 2020. |

ISSN 1977-1088

Službeni list

Europske unije

C 367

Hrvatsko izdanje

Informacije i objave

Godište 63.30. listopada 2020.

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| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2020/C 367/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2020. do 31. kolovoza 2020.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2020/C 367/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2020. do 30. rujna 2020.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 5 |
| 2020/C 367/03 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2020. do 30. rujna 2020.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ) | 14 |

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2020/C 367/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2020. do 31. kolovoza 2020.(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

2020/C 367/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2020. do 30. rujna 2020.(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)

5

2020/C 367/03

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2020. do 30. rujna 2020.(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 | |
| --- | --- |

HR

---

IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 30.10.2020 | HR | Službeni list Europske unije | C 367/1 |
| --- | --- | --- | --- |

30.10.2020

HR

Službeni list Europske unije

C 367/1

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2020. do 31. kolovoza 2020.

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

(2020/C 367/01)

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

| Datum odluke | Naziv lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 20.5.2020. | Zeposia | ozanimod | Celgene Europe B.V. |
| Winthontlaan 6 N, 3526 KV Utrecht, Nederland |

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

20.5.2020.

Zeposia

ozanimod

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/20/1442

Kapsula, tvrda

L04AA38

25.5.2020.

—   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 |
| --- | --- | --- | --- | --- |
| 17.4.2020. | Natpar | Shire Pharmaceuticals Ireland Limited |
| Blocks 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

17.4.2020.

Natpar

Shire Pharmaceuticals Ireland Limited

Blocks 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/15/1078

20.5.2020.

23.4.2020.

Cyanokit

| SERB S.A. |
| --- |
| Avenue Louise 480, 1050 Bruxelles, Belgique/Louizalaan 480, 1050 Brussel, België |

SERB S.A.

Avenue Louise 480, 1050 Bruxelles, Belgique/Louizalaan 480, 1050 Brussel, België

EU/1/07/420

12.5.2020.

23.4.2020.

Oncaspar

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, 92284 Suresnes Cedex, France |

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/15/1070

13.5.2020.

28.4.2020.

Miglustat Gen.Orph

| Gen.Orph |
| --- |
| 185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France |

Gen.Orph

185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France

EU/1/17/1232

4.6.2020.

28.4.2020.

NeuroBloc

| Sloan Pharma S.a.r.l. |
| --- |
| 33 Rue de Puits Romain, 8070 Bertrange, Luxembourg |

Sloan Pharma S.a.r.l.

33 Rue de Puits Romain, 8070 Bertrange, Luxembourg

EU/1/00/166

19.5.2020.

28.4.2020.

Privigen

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland |

CSL Behring GmbH

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

EU/1/08/446

20.5.2020.

22.6.2020.

Avonex

| Biogen Netherlands B.V. |
| --- |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/97/033

17.7.2020.

25.6.2020.

Emtricitabine/Tenofovir disoproxil Krka d.d.

| KRKA d d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1182

20.7.2020.

17.7.2020.

Jentadueto

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

27.7.2020.

17.7.2020.

Zarzio

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/08/495

17.8.2020.

27.7.2020.

TOBI Podhaler

| Mylan IRE Healthcare Ltd |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland |

Mylan IRE Healthcare Ltd

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/10/652

29.7.2020.

31.7.2020.

CABOMETYX

| Ipsen Pharma |
| --- |
| 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/16/1136

6.8.2020.

31.7.2020.

Oprymea

| KRKA d d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/469

13.8.2020.

28.8.2020.

Effentora

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/441

7.9.2020.

28.8.2020.

Olanzapine Glenmark

| Glenmark Arzneimittel GmbH |
| --- |
| Industriestr. 31, D – 82194 Gröbenzell, Deutschland |

Glenmark Arzneimittel GmbH

Industriestr. 31, D – 82194 Gröbenzell, Deutschland

EU/1/09/587

9.9.2020.

28.8.2020.

Olanzapine Glenmark Europe

| Glenmark Arzneimittel GmbH |
| --- |
| Industriestr. 31, D – 82194 Gröbenzell, Deutschland |

Glenmark Arzneimittel GmbH

Industriestr. 31, D – 82194 Gröbenzell, Deutschland

EU/1/09/588

9.9.2020.

—   Obustava odobrenja za stavljanje u promet (članak 20. 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 |
| --- | --- | --- | --- | --- |
| 25.3.2020. | Ulipristal Acetate Gedeon Richter | Gedeon Richter Plc. |
| Gyömrői út 19-21., 1103 Budapest, Magyarország |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

25.3.2020.

Ulipristal Acetate Gedeon Richter

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/18/1309

27.3.2020.

—   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 |
| --- | --- | --- | --- | --- |
| 24.4.2020. | Suprelorin | VIRBAC S.A. |
| 1ère Avenue – 2065 m – L.I.D., 06516 Carros Cedex, France |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

24.4.2020.

Suprelorin

VIRBAC S.A.

1ère Avenue – 2065 m – L.I.D., 06516 Carros Cedex, France

EU/2/07/072

20.5.2020.

24.6.2020.

Novaquin

| Le Vet Beheer B.V. |
| --- |
| Wilgenweg 7, 3421 TV Oudewater, Nederland |

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/15/186

20.7.2020.

28.8.2020.

Syvazul BTV

| LABORATORIOS SYVA, S.A.U. |
| --- |
| Av. Párroco Pablo Diez 49-57, 24010 León, España |

LABORATORIOS SYVA, S.A.U.

Av. Párroco Pablo Diez 49-57, 24010 León, España

EU/2/18/231

7.9.2020.

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 |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

---

| 30.10.2020 | HR | Službeni list Europske unije | C 367/5 |
| --- | --- | --- | --- |

30.10.2020

HR

Službeni list Europske unije

C 367/5

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2020. do 30. rujna 2020.

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

(2020/C 367/02)

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

| Datum odluke | Naziv lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.9.2020. | Arsenic trioxide medac | arsenov trioksid | medac Gesellschaft für klinische Spezialpräparate mbH |
| Theaterstraße 6, 22880 Wedel, Deutschland |

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

17.9.2020.

Arsenic trioxide medac

arsenov trioksid

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/20/1475

Koncentrat za otopinu za infuziju

L01XX27

18.9.2020.

24.9.2020.

AYVAKYT

avapritiniba

| Blueprint Medicines (Netherlands) B.V. |
| --- |
| Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland |

Blueprint Medicines (Netherlands) B.V.

Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland

EU/1/20/1473

Filmom obložena tableta

L01EX18

25.9.2020.

24.9.2020.

Equidacent

bevacizumab

| Centus Biotherapeutics Europe Limited |
| --- |
| 6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland |

Centus Biotherapeutics Europe Limited

6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland

EU/1/20/1472

Koncentrat za otopinu za infuziju

L01XC07

25.9.2020.

24.9.2020.

Fampridine Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/20/1477

Tablete s produženim oslobađanjem

N07XX07

29.9.2020.

24.9.2020.

Jyseleca

filgotinib

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1480

Filmom obložena tableta

L04AA45

25.9.2020.

24.9.2020.

Zynrelef

bupivakain/meloksikam

| Heron Therapeutics, B.V. |
| --- |
| Herengracht 500, 1017 CB Amsterdam, Nederland |

Heron Therapeutics, B.V.

Herengracht 500, 1017 CB Amsterdam, Nederland

EU/1/20/1478

Otopina za injekciju s produljenim oslobađanjem

Pending

25.9.2020.

—   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 |
| --- | --- | --- | --- | --- |
| 3.9.2020. | HyQvia | Baxalta Innovations GmbH |
| Industriestraße 67, 1221 Wien, Österreich |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

3.9.2020.

HyQvia

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/13/840

5.9.2020.

3.9.2020.

Vimpat

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |

UCB Pharma S.A.

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

EU/1/08/470

4.9.2020.

15.9.2020.

ADCETRIS

| Takeda Pharma A/S |
| --- |
| Delta Park 45, 2665 Vallensbaek Strand, Danmark |

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/12/794

16.9.2020.

15.9.2020.

CellCept

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/96/005

16.9.2020.

15.9.2020.

Ervebo

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/19/1392

16.9.2020.

15.9.2020.

Hepsera

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/03/251

16.9.2020.

15.9.2020.

Herzuma

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/17/1257

16.9.2020.

15.9.2020.

JETREA

| Inceptua AB |
| --- |
| Gustavslundsv. 143, 16751 Bromma, Sverige |

Inceptua AB

Gustavslundsv. 143, 16751 Bromma, Sverige

EU/1/13/819

16.9.2020.

15.9.2020.

Levetiracetam Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/11/712

16.9.2020.

15.9.2020.

Levetiracetam Actavis

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland |

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/713

16.9.2020.

15.9.2020.

Mvasi

| Amgen Technology (Ireland) UC |
| --- |
| Pottery Road, Dun Laoghaire, Co. Dublin, Ireland |

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

EU/1/17/1246

17.9.2020.

15.9.2020.

Prasugrel Mylan

| Mylan S.A.S. |
| --- |
| 117 allée des Parcs, 69800 Saint Priest, France |

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1273

16.9.2020.

15.9.2020.

Simbrinza

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/14/933

16.9.2020.

15.9.2020.

Stayveer

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/832

16.9.2020.

15.9.2020.

Thalidomide Celgene

| Celgene Europe B.V. |
| --- |
| Winthontlaan 6 N, 3526 KV Utrecht, Nederland |

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/443

16.9.2020.

15.9.2020.

Tremfya

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

16.9.2020.

17.9.2020.

Cosentyx

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/14/980

18.9.2020.

17.9.2020.

Dengvaxia

| Sanofi Pasteur |
| --- |
| 14 Espace Henry Vallée, 69007 Lyon, France |

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/18/1338

18.9.2020.

17.9.2020.

Episalvan

| Amryt GMBH |
| --- |
| Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland |

Amryt GMBH

Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland

EU/1/15/1069

29.9.2020.

17.9.2020.

Genvoya

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

18.9.2020.

17.9.2020.

Hetlioz

| Vanda Pharmaceuticals Netherlands B.V., |
| --- |
| Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland |

Vanda Pharmaceuticals Netherlands B.V.,

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/15/1008

19.9.2020.

17.9.2020.

Ivozall

| ORPHELIA Pharma SAS |
| --- |
| 85 boulevard Saint-Michel, 75005 Paris, France |

ORPHELIA Pharma SAS

85 boulevard Saint-Michel, 75005 Paris, France

EU/1/19/1396

29.9.2020.

17.9.2020.

Kovaltry

| Bayer AG |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/15/1076

21.9.2020.

17.9.2020.

Lumark

| IDB Holland B.V. |
| --- |
| Weverstraat 17, 5111 PV Baarle-Nassau, Nederland |

IDB Holland B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

21.9.2020.

17.9.2020.

Tadalafil Mylan

| Mylan S.A.S. |
| --- |
| 117 allée des Parcs, 69800 Saint Priest, France |

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/14/961

18.9.2020.

17.9.2020.

Tyverb

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/07/440

18.9.2020.

17.9.2020.

Zoledronic acid medac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Theaterstraße 6, 22880 Wedel, Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/12/779

21.9.2020.

24.9.2020.

Bavencio

| Merck Europe B.V. |
| --- |
| Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

25.9.2020.

24.9.2020.

Cinacalcet Mylan

| Mylan S.A.S. |
| --- |
| 117 allée des Parcs, 69800 Saint Priest, France |

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1054

28.9.2020.

24.9.2020.

Edistride

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

28.9.2020.

24.9.2020.

EndolucinBeta

| ITM Medical Isotopes GmbH |
| --- |
| Lichtenbergstraße 1, 85748 Garching, Deutschland |

ITM Medical Isotopes GmbH

Lichtenbergstraße 1, 85748 Garching, Deutschland

EU/1/16/1105

28.9.2020.

24.9.2020.

Eylea

| Bayer AG |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

25.9.2020.

24.9.2020.

Inbrija

| Acorda Therapeutics Ireland Limited |
| --- |
| 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland |

Acorda Therapeutics Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/19/1390

5.10.2020.

24.9.2020.

Incruse Ellipta

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

2.10.2020.

24.9.2020.

Lenalidomide Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/18/1316

28.9.2020.

24.9.2020.

Levetiracetam Actavis Group

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland |

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/738

29.10.2020.

24.9.2020.

Lymphoseek

| Navidea Biopharmaceuticals Europe Ltd. |
| --- |
| Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland |

Navidea Biopharmaceuticals Europe Ltd.

Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland

EU/1/14/955

25.9.2020.

24.9.2020.

Lynparza

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

28.9.2020.

24.9.2020.

Olazax

| Glenmark Pharmaceuticals s.r.o. |
| --- |
| Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |

Glenmark Pharmaceuticals s.r.o.

Hvězdova 1716/2b, 140 78 Praha 4, Česká republika

EU/1/09/597

29.9.2020.

24.9.2020.

Plegridy

| Biogen Netherlands B.V. |
| --- |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/14/934

28.9.2020.

24.9.2020.

Revlimid

| Celgene Europe B.V. |
| --- |
| Winthontlaan 6 N, 3526 KV Utrecht, Nederland |

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/07/391

28.9.2020.

24.9.2020.

Saxenda

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/15/992

28.9.2020.

24.9.2020.

Spectrila

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Theaterstraße 6, 22880 Wedel, Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/15/1072

25.9.2020.

24.9.2020.

Vaxelis

| MCM Vaccine B.V. |
| --- |
| Robert Boyleweg 4, 2333 CG Leiden, Nederland |

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden, Nederland

EU/1/15/1079

9.10.2020.

24.9.2020.

Victoza

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/09/529

28.9.2020.

24.9.2020.

Xermelo

| Ipsen Pharma |
| --- |
| 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/17/1224

2.10.2020.

24.9.2020.

Yondelis

| Pharma Mar S.A. |
| --- |
| Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España |

Pharma Mar S.A.

Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España

EU/1/07/417

28.9.2020.

24.9.2020.

Zalviso

| Grünenthal GmbH |
| --- |
| Zieglerstraße 6, 52078, Aachen, Deutschland |

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/15/1042

5.10.2020.

30.9.2020.

Aripiprazole Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/15/1045

1.10.2020.

30.9.2020.

Blitzima

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/17/1205

1.10.2020.

30.9.2020.

CRYSVITA

| Kyowa Kirin Holdings B.V. |
| --- |
| Bloemlaan 2, 2132 NP Hoofddorp, Nederland |

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/17/1262

2.10.2020.

30.9.2020.

Eptifibatid Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/15/1065

1.10.2020.

30.9.2020.

Erelzi

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1195

1.10.2020.

30.9.2020.

Extavia

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/08/454

1.10.2020.

30.9.2020.

Exviera

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

2.10.2020.

30.9.2020.

Febuxostat Krka

| KRKA d d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/18/1347

1.10.2020.

30.9.2020.

Fiasp

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/16/1160

1.10.2020.

30.9.2020.

Herceptin

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/00/145

1.10.2020.

30.9.2020.

Icandra

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/08/484

1.10.2020.

30.9.2020.

Kyntheum

| Leo Pharma A/S |
| --- |
| Industriparken 55, 2750 Ballerup, Danmark |

Leo Pharma A/S

Industriparken 55, 2750 Ballerup, Danmark

EU/1/16/1155

2.10.2020.

30.9.2020.

Mepsevii

| Ultragenyx Germany GmbH |
| --- |
| Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland |

Ultragenyx Germany GmbH

Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland

EU/1/18/1301

1.10.2020.

30.9.2020.

Neparvis

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/16/1103

1.10.2020.

30.9.2020.

Ozempic

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1251

1.10.2020.

30.9.2020.

Pemetrexed Hospira

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/15/1057

2.10.2020.

30.9.2020.

ReFacto AF

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/99/103

1.10.2020.

30.9.2020.

Rolufta Ellipta

| GlaxoSmithKline Trading Services Limited |
| --- |
| Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1174

2.10.2020.

30.9.2020.

Simulect

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/98/084

1.10.2020.

30.9.2020.

Temozolomide HEXAL

| Hexal AG |
| --- |
| Industriestraße 25, 83607 Holzkirchen, Deutschland |

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/10/616

1.10.2020.

30.9.2020.

Temozolomide Sandoz

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/10/617

1.10.2020.

30.9.2020.

Xigduo

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

1.10.2020.

30.9.2020.

Zomarist

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/08/483

1.10.2020.

—   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 |
| --- | --- | --- | --- | --- |
| 24.9.2020. | Vepacel | Ology Bioservices Ireland LTD |
| Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

24.9.2020.

Vepacel

Ology Bioservices Ireland LTD

Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland

EU/1/12/752

2.10.2020.

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

| Datum odluke | Naziv lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.9.2020. | Increxxa | tulatromicin | Elanco GmbH |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

16.9.2020.

Increxxa

tulatromicin

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/20/258

Otopina za injekciju

QJ01FA94

17.9.2020.

16.9.2020.

Innovax-ND-ILT

Cjepivo protiv Marekove bolesti, Newcastleske bolesti & infektivnog laringotraheitisa (živo rekombinirano)

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/20/256

Koncentrat i otapalo za suspenziju za injekciju.

QI01AD17

17.9.2020.

16.9.2020.

Tulinovet

tulatromicin

| V.M.D.n.v. |
| --- |
| Hoge Mauw 900, 2370 Arendonk, Belgïe |

V.M.D.n.v.

Hoge Mauw 900, 2370 Arendonk, Belgïe

EU/2/20/257

Otopina za injekciju

QJ01FA94

17.9.2020.

18.9.2020.

MHYOSPHERE PCV ID

Vakcina protiv Mycoplasma hyopneumoniae i svinjskog cirkovirusa (inaktivirana, rekombinancijska)

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, 17170 Amer (Girona), España |

Laboratorios Hipra, S.A.

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

EU/2/20/259

Emulzija za injekciju

QI09AL08

21.9.2020.

—   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 |
| --- | --- | --- | --- | --- |
| 8.9.2020. | Ingelvac CircoFLEX | Boehringer Ingelheim Vetmedica GmbH |
| D-55216 Ingelheim am Rhein, Deutschland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

8.9.2020.

Ingelvac CircoFLEX

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/07/079

22.9.2020.

16.9.2020.

Osurnia

| Dechra Regulatory B.V. |
| --- |
| Handelsweg 25, 5531 AE Bladel, Nederland |

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/14/170

17.9.2020.

16.9.2020.

Suvaxyn Circo + MH RTU

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

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

EU/2/15/190

17.9.2020.

30.9.2020.

Imrestor

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/15/193

1.10.2020.

30.9.2020.

Vectra Felis

| Ceva Santé Animale |
| --- |
| 10 avenue de La Ballastière, 33500 Libourne, France |

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/14/165

1.10.2020.

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 |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

---

| 30.10.2020 | HR | Službeni list Europske unije | C 367/14 |
| --- | --- | --- | --- |

30.10.2020

HR

Službeni list Europske unije

C 367/14

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2020. do 30. rujna 2020.

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

(2020/C 367/03)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 16.9.2020. | Dinolytic 12,5  mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof | Dinoprost | Vidi Prilog II | Vidi Prilog II | 18.9.2020. |

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

16.9.2020.

Dinolytic 12,5  mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof

Dinoprost

Vidi Prilog II

Vidi Prilog II

18.9.2020.

—   Obustava 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 |
| --- | --- | --- | --- | --- | --- |
| 24.9.2020. | medicinal products for human use which have been authorised or are pending approval based on clinical trials performed at Panexcell Clinical Laboratories Priv. Ltd | medicinal products for human use which have been authorised or are pending approval based on clinical trials performed at Panexcell Clinical Laboratories Priv. Ltd | Vidi Prilog I | Vidi Prilog I | 25.9.2020. |

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

24.9.2020.

medicinal products for human use which have been authorised or are pending approval based on clinical trials performed at Panexcell Clinical Laboratories Priv. Ltd

medicinal products for human use which have been authorised or are pending approval based on clinical trials performed at Panexcell Clinical Laboratories Priv. Ltd

Vidi Prilog I

Vidi Prilog I

25.9.2020.

---

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

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

---

PRILOG I.

Popis nacionalno odobrenih lijekova

| Država članica EGP-a | Nositelj odobrenja za stavljanje u promet | Podnositelj zahtjeva | Naziv proizvoda | Međunarodno nezaštićeno ime (INN) | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Danska | | Laurus Generics GmBH | Atazanavir Laurus | atazanavir | 150 mg | Kapsula, tvrda | Peroralna primjena |
| Danska | | Laurus Generics GmBH | Atazanavir Laurus | atazanavir | 200 mg | Kapsula, tvrda | Peroralna primjena |
| Danska | | Laurus Generics GmBH | Atazanavir Laurus | atazanavir | 300 mg | Kapsula, tvrda | Peroralna primjena |
| Finska | | Laurus Generics GmbH | Atazanavir Laurus | atazanavirsulfat | 150 mg | Kapsula, tvrda | Peroralna primjena |
| Finska | | Laurus Generics GmbH | Atazanavir Laurus | atazanavirsulfat | 200 mg | Kapsula, tvrda | Peroralna primjena |
| Finska | | Laurus Generics GmbH | Atazanavir Laurus | atazanavirsulfat | 300 mg | Kapsula, tvrda | Peroralna primjena |
| Francuska | ALMUS FRANCE | | Amoxicilline Almus Pharma 500 mg gélule | AMOKSICILIN TRIHIDRAT | 500 mg | Kapsula, tvrda | Peroralna primjena |
| Francuska | Baxter Holding B.V. | | FER BAXTER 20 mg/mL, solution pour injection/perfusion | ŽELJEZOVA SAHAROZA | 20 mg/ml | otopina za injekciju/infuziju | Intravenska primjena |
| Njemačka | | Laurus Generics GmbH | Atazanavir Laurus 150 mg Hartkapseln | atazanavir sulfat | 150 mg | Kapsula, tvrda | Peroralna primjena |
| Njemačka | | Laurus Generics GmbH | Atazanavir Laurus 200 mg Hartkapseln | atazanavir sulfat | 200 mg | Kapsula, tvrda | Peroralna primjena |
| Njemačka | | Laurus Generics GmbH | Atazanavir Laurus 300 mg Hartkapseln | atazanavir sulfat | 300 mg | Kapsula, tvrda | Peroralna primjena |
| Njemačka | Baxter Holding B.V. | | Eisen Sucrose Baxter 20 mg/ml Injektions-/Infusionslösung | željezova saharoza | 20 mg/ml | otopina za injekciju/infuziju | Intravenska primjena |
| Malta | NEXCAPE PHARMACEUTICALS LIMITED | | AMOXICILLIN 250MG CAPSULES | AMOKSICILIN TRIHIDRAT | 250 mg | Kapsula, tvrda | Peroralna primjena |
| Malta | NEXCAPE PHARMACEUTICALS LIMITED | | AMOXICILLIN 500MG CAPSULES | AMOKSICILIN TRIHIDRAT | 500 mg | Kapsula, tvrda | Peroralna primjena |
| Nizozemska | | Laurus Generics GmbH | Atazanavir Laurus 150 mg, hard capsules | atazanavir | 150 mg | Kapsula, tvrda | Peroralna primjena |
| Nizozemska | | Laurus Generics GmbH | Atazanavir Laurus 200 mg, hard capsules | atazanavir | 200 mg | Kapsula, tvrda | Peroralna primjena |
| Nizozemska | | Laurus Generics GmbH | Atazanavir Laurus 300 mg, hard capsules | atazanavir | 300 mg | Kapsula, tvrda | Peroralna primjena |
| Španjolska | ALMUS FARMACEUTICA, S.A. | | AMOXICILINA ALMUS 500 mg cápsulas duras EFG | AMOKSICILIN | 500 mg | Kapsula, tvrda | Peroralna primjena |
| Švedska | | Laurus Generics GmbH | Atazanavir Laurus | atazanavir sulfat | 150 mg | Kapsula, tvrda | Peroralna primjena |
| Švedska | | Laurus Generics GmbH | Atazanavir Laurus | atazanavir sulfat | 200 mg | Kapsula, tvrda | Peroralna primjena |
| Švedska | | Laurus Generics GmbH | Atazanavir Laurus | atazanavir sulfat | 300 mg | Kapsula, tvrda | Peroralna primjena |
| Ujedinjena Kraljevina | MANX HEALTHCARE LIMITED | | AZITHROMYCIN 250MG CAPSULES | AZITROMICIN DIHIDRAT | 250 mg | Kapsula, tvrda | Peroralna primjena |
| Ujedinjena Kraljevina | MANX HEALTHCARE LIMITED | | CARBOCISTEINE 375MG CAPSULE HARD | KARBOCISTEIN | 375 mg | Kapsula, tvrda | Peroralna primjena |
| Ujedinjena Kraljevina | | STRANDHAVEN LIMITED | CARBOCISTEINE 375 MG CAPSULES, HARD | KARBOCISTEIN | 375 mg | Kapsula, tvrda | Peroralna primjena |
| Ujedinjena Kraljevina | | DAWA LIMITED | AMOXICILLIN 250 MG CAPSULES | AMOKSICILIN TRIHIDRAT | 250 mg | Kapsula, tvrda | Peroralna primjena |
| Ujedinjena Kraljevina | | DAWA LIMITED | AMOXICILLIN 500 MG CAPSULE | AMOKSICILIN TRIHIDRAT | 500 mg | Kapsula, tvrda | Peroralna primjena |
| Ujedinjena Kraljevina | | SPECIAL CONCEPT DEVELOPMENT (UK) LIMITED | TRIMETHOPRIM 100MG TABLETS | TRIMETOPRIM | 100 mg | tableta | Peroralna primjena |
| Ujedinjena Kraljevina | | SPECIAL CONCEPT DEVELOPMENT (UK) LIMITED | TRIMETHOPRIM 200MG TABLETS | TRIMETOPRIM | 200 mg | tableta | Peroralna primjena |
| Ujedinjena Kraljevina | BAXTER HEALTHCARE LIMITED | | IRON SUCROSE 20 MG IRON/ML, SOLUTION FOR INJECTION /INFUSION | ŽELJEZOVA SAHAROZA | 20 mg/ml | Prašak za otopinu za injekciju/infuziju | Intravenska primjena |
| Ujedinjena Kraljevina | | LAURUS GENERICS GMBH | ATAZANAVIR LAURUS 150 MG CAPSULES, HARD | ATAZANAVIR SULFAT | 150 mg | Kapsula, tvrda | Peroralna primjena |
| Ujedinjena Kraljevina | | LAURUS GENERICS GMBH | ATAZANAVIR LAURUS 200 MG, CAPSULES, HARD | ATAZANAVIR SULFAT | 200 mg | Kapsula, tvrda | Peroralna primjena |
| Ujedinjena Kraljevina | | LAURUS GENERICS GMBH | ATAZANAVIR LAURUS 300 MG, CAPSULES, HARD | ATAZANAVIR SULFAT | 300 mg | Kapsula, tvrda | Peroralna primjena |
| Ujedinjena Kraljevina | NEXCAPE PHARMACEUTICALS LIMITED | | AMOXICILLIN 250MG CAPSULES | AMOKSICILIN TRIHIDRAT | 250 mg | Kapsula, tvrda | Peroralna primjena |
| Ujedinjena Kraljevina | NEXCAPE PHARMACEUTICALS LIMITED | | AMOXICILLIN 500MG CAPSULES | AMOKSICILIN TRIHIDRAT | 500 mg | Kapsula, tvrda | Peroralna primjena |

Država članica EGP-a

Nositelj odobrenja za stavljanje u promet

Podnositelj zahtjeva

Naziv proizvoda

Međunarodno nezaštićeno ime (INN)

Jačina

Farmaceutski oblik

Put primjene

Danska

Laurus Generics GmBH

Atazanavir Laurus

atazanavir

150 mg

Kapsula, tvrda

Peroralna primjena

Danska

Laurus Generics GmBH

Atazanavir Laurus

atazanavir

200 mg

Kapsula, tvrda

Peroralna primjena

Danska

Laurus Generics GmBH

Atazanavir Laurus

atazanavir

300 mg

Kapsula, tvrda

Peroralna primjena

Finska

Laurus Generics GmbH

Atazanavir Laurus

atazanavirsulfat

150 mg

Kapsula, tvrda

Peroralna primjena

Finska

Laurus Generics GmbH

Atazanavir Laurus

atazanavirsulfat

200 mg

Kapsula, tvrda

Peroralna primjena

Finska

Laurus Generics GmbH

Atazanavir Laurus

atazanavirsulfat

300 mg

Kapsula, tvrda

Peroralna primjena

Francuska

ALMUS FRANCE

Amoxicilline Almus Pharma 500 mg gélule

AMOKSICILIN TRIHIDRAT

500 mg

Kapsula, tvrda

Peroralna primjena

Francuska

Baxter Holding B.V.

FER BAXTER 20 mg/mL, solution pour injection/perfusion

ŽELJEZOVA SAHAROZA

20 mg/ml

otopina za injekciju/infuziju

Intravenska primjena

Njemačka

Laurus Generics GmbH

Atazanavir Laurus 150 mg Hartkapseln

atazanavir sulfat

150 mg

Kapsula, tvrda

Peroralna primjena

Njemačka

Laurus Generics GmbH

Atazanavir Laurus 200 mg Hartkapseln

atazanavir sulfat

200 mg

Kapsula, tvrda

Peroralna primjena

Njemačka

Laurus Generics GmbH

Atazanavir Laurus 300 mg Hartkapseln

atazanavir sulfat

300 mg

Kapsula, tvrda

Peroralna primjena

Njemačka

Baxter Holding B.V.

Eisen Sucrose Baxter 20 mg/ml Injektions-/Infusionslösung

željezova saharoza

20 mg/ml

otopina za injekciju/infuziju

Intravenska primjena

Malta

NEXCAPE PHARMACEUTICALS LIMITED

AMOXICILLIN 250MG CAPSULES

AMOKSICILIN TRIHIDRAT

250 mg

Kapsula, tvrda

Peroralna primjena

Malta

NEXCAPE PHARMACEUTICALS LIMITED

AMOXICILLIN 500MG CAPSULES

AMOKSICILIN TRIHIDRAT

500 mg

Kapsula, tvrda

Peroralna primjena

Nizozemska

Laurus Generics GmbH

Atazanavir Laurus 150 mg, hard capsules

atazanavir

150 mg

Kapsula, tvrda

Peroralna primjena

Nizozemska

Laurus Generics GmbH

Atazanavir Laurus 200 mg, hard capsules

atazanavir

200 mg

Kapsula, tvrda

Peroralna primjena

Nizozemska

Laurus Generics GmbH

Atazanavir Laurus 300 mg, hard capsules

atazanavir

300 mg

Kapsula, tvrda

Peroralna primjena

Španjolska

ALMUS FARMACEUTICA, S.A.

AMOXICILINA ALMUS 500 mg cápsulas duras EFG

AMOKSICILIN

500 mg

Kapsula, tvrda

Peroralna primjena

Švedska

Laurus Generics GmbH

Atazanavir Laurus

atazanavir sulfat

150 mg

Kapsula, tvrda

Peroralna primjena

Švedska

Laurus Generics GmbH

Atazanavir Laurus

atazanavir sulfat

200 mg

Kapsula, tvrda

Peroralna primjena

Švedska

Laurus Generics GmbH

Atazanavir Laurus

atazanavir sulfat

300 mg

Kapsula, tvrda

Peroralna primjena

Ujedinjena Kraljevina

MANX HEALTHCARE LIMITED

AZITHROMYCIN 250MG CAPSULES

AZITROMICIN DIHIDRAT

250 mg

Kapsula, tvrda

Peroralna primjena

Ujedinjena Kraljevina

MANX HEALTHCARE LIMITED

CARBOCISTEINE 375MG CAPSULE HARD

KARBOCISTEIN

375 mg

Kapsula, tvrda

Peroralna primjena

Ujedinjena Kraljevina

STRANDHAVEN LIMITED

CARBOCISTEINE 375 MG CAPSULES, HARD

KARBOCISTEIN

375 mg

Kapsula, tvrda

Peroralna primjena

Ujedinjena Kraljevina

DAWA LIMITED

AMOXICILLIN 250 MG CAPSULES

AMOKSICILIN TRIHIDRAT

250 mg

Kapsula, tvrda

Peroralna primjena

Ujedinjena Kraljevina

DAWA LIMITED

AMOXICILLIN 500 MG CAPSULE

AMOKSICILIN TRIHIDRAT

500 mg

Kapsula, tvrda

Peroralna primjena

Ujedinjena Kraljevina

SPECIAL CONCEPT DEVELOPMENT (UK) LIMITED

TRIMETHOPRIM 100MG TABLETS

TRIMETOPRIM

100 mg

tableta

Peroralna primjena

Ujedinjena Kraljevina

SPECIAL CONCEPT DEVELOPMENT (UK) LIMITED

TRIMETHOPRIM 200MG TABLETS

TRIMETOPRIM

200 mg

tableta

Peroralna primjena

Ujedinjena Kraljevina

BAXTER HEALTHCARE LIMITED

IRON SUCROSE 20 MG IRON/ML, SOLUTION FOR INJECTION /INFUSION

ŽELJEZOVA SAHAROZA

20 mg/ml

Prašak za otopinu za injekciju/infuziju

Intravenska primjena

Ujedinjena Kraljevina

LAURUS GENERICS GMBH

ATAZANAVIR LAURUS 150 MG CAPSULES, HARD

ATAZANAVIR SULFAT

150 mg

Kapsula, tvrda

Peroralna primjena

Ujedinjena Kraljevina

LAURUS GENERICS GMBH

ATAZANAVIR LAURUS 200 MG, CAPSULES, HARD

ATAZANAVIR SULFAT

200 mg

Kapsula, tvrda

Peroralna primjena

Ujedinjena Kraljevina

LAURUS GENERICS GMBH

ATAZANAVIR LAURUS 300 MG, CAPSULES, HARD

ATAZANAVIR SULFAT

300 mg

Kapsula, tvrda

Peroralna primjena

Ujedinjena Kraljevina

NEXCAPE PHARMACEUTICALS LIMITED

AMOXICILLIN 250MG CAPSULES

AMOKSICILIN TRIHIDRAT

250 mg

Kapsula, tvrda

Peroralna primjena

Ujedinjena Kraljevina

NEXCAPE PHARMACEUTICALS LIMITED

AMOXICILLIN 500MG CAPSULES

AMOKSICILIN TRIHIDRAT

500 mg

Kapsula, tvrda

Peroralna primjena

---

PRILOG II.

Popis naziva, farmaceutskih oblika, jačine veterinarsko-medicinskih proizvoda, životinjskih vrsta, putova primjene, nositelja odobrenja za stavljanje VMP-a u promet u državama članicama

| Država članica EU-a/EGP-a | Nositelji odobrenja za stavljanje VMP-a u promet | Naziv | Međunarodno nezaštićeno ime (INN) | Jačina | Farmaceutski oblik | Životinjska vrsta | Put primjene |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austrija | Ceva Santé Animale |
| 10 Avenue de la Ballastiere |
| 33500 Libourne |
| France |

Država članica EU-a/EGP-a

Nositelji odobrenja za stavljanje VMP-a u promet

Naziv

Međunarodno nezaštićeno ime (INN)

Jačina

Farmaceutski oblik

Životinjska vrsta

Put primjene

Austrija

Ceva Santé Animale

10 Avenue de la Ballastiere

33500 Libourne

France

Enzaprost Bovis 12,5  mg/ml Injektionslösung für Rinder

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Austrija

| Zoetis Österreich GmbH |
| --- |
| Floridsdorfer Hauptstraße 1 |
| 1210 Vienna |
| Austria |

Zoetis Österreich GmbH

Floridsdorfer Hauptstraße 1

1210 Vienna

Austria

Dinolytic 5 mg/ml – Injektionslösung für Tiere

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Austrija

| Ceva Santé Animale |
| --- |
| 10 Avenue de la Ballastiere |
| 33500 Libourne |
| France |

Ceva Santé Animale

10 Avenue de la Ballastiere

33500 Libourne

France

ENZAPROST T 5 mg/ml Injektionslösung für Rinder und Schweine

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Belgija

| Ceva Santé |
| --- |
| 10 Avenue de la Ballastiere |
| Libourne, Gironde 33500 |
| France |

Ceva Santé

10 Avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost Bovis

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Belgija

| Zoetis Belgium s.a. |
| --- |
| Rue Laid Burniat, 1 |
| B-1348 Louvain-La-Neuve |
| Belgium |

Zoetis Belgium s.a.

Rue Laid Burniat, 1

B-1348 Louvain-La-Neuve

Belgium

Dinolytic, 5 mg-ml

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Belgija

| Ceva Santé Animale N.V. |
| --- |
| Metrologielaan 6 |
| 1130 Brussel |
| Belgium |

Ceva Santé Animale N.V.

Metrologielaan 6

1130 Brussel

Belgium

Enzaprost

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Bugarska

| Ceva Animal Health Bulgaria Ltd |
| --- |
| str. Elemag 26Б, app. 1, fl. 1 |
| 1113 Sofia |
| Bulgaria |

Ceva Animal Health Bulgaria Ltd

str. Elemag 26Б, app. 1, fl. 1

1113 Sofia

Bulgaria

Enzaprost bovis 12,5  mg/ml solution for injection for cattle

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Bugarska

| Ceva Animal Health Bulgaria Ltd |
| --- |
| str. Elemag 26Б, app. 1, fl. 1 |
| 1113 Sofia |
| Bulgaria |

Ceva Animal Health Bulgaria Ltd

str. Elemag 26Б, app. 1, fl. 1

1113 Sofia

Bulgaria

ENZAPROST T 5 mg/ml solution for injection for cattle and pig

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Cipar

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| Libourne |
| Gironde, 33500 |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne

Gironde, 33500

France

Enzaprost Bovis 12,5  mg/ml solution for injection for cattle

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Češka

| Ceva Santé Animale, |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne Cedex |
| France |

Ceva Santé Animale,

10 avenue de la Ballastiere

33500 Libourne Cedex

France

Enzaprost Bovis 12,5  mg/ injekční roztok pro skot

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Češka

| Zoetis Česká republika s. r. o. |
| --- |
| Náměstí 14. října 642/17 |
| 150 00 Praha 5 |
| Czech Republic |

Zoetis Česká republika s. r. o.

Náměstí 14. října 642/17

150 00 Praha 5

Czech Republic

Dinolytic 5 mg/ml injekční roztok

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Češka

| Ceva Animal Health Slovakia s.r.o., |
| --- |
| Račianska 153 |
| Bratislava, 831 53 |
| Slovakia |

Ceva Animal Health Slovakia s.r.o.,

Račianska 153

Bratislava, 831 53

Slovakia

ENZAPROST T 5 mg/ml injekční roztok

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Danska

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| Libourne, Gironde 33500 |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Danska

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| Libourne, Gironde 33500 |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost Bovis

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Estonija

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, |
| 1348 Louvain-la-Neuve, |
| Belgium |

Zoetis Belgium S.A.

Rue Laid Burniat 1,

1348 Louvain-la-Neuve,

Belgium

Dinolytic 12,5  mg

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Estonija

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, |
| 1348 Louvain-la-Neuve, |
| Belgium |

Zoetis Belgium S.A.

Rue Laid Burniat 1,

1348 Louvain-la-Neuve,

Belgium

Dinolytic

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Estonija

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| Libourne, Gironde 33500 |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost Bovis

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Finska

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Finska

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost Bovis

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Finska

| Zoetis Finland Oy |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Finland |

Zoetis Finland Oy

Tietokuja 4

00330 Helsinki

Finland

Dinolytic vet.

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Finska

| Zoetis Finland Oy |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Finland |

Zoetis Finland Oy

Tietokuja 4

00330 Helsinki

Finland

Dinolytic vet.

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Francuska

| Zoetis France |
| --- |
| 10 Rue Raymond David |
| 92240 Malakoff |
| France |

Zoetis France

10 Rue Raymond David

92240 Malakoff

France

DINOLYTIC 12,5 MG/ML Solution Injectable pour bovins

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Francuska

| Ceva Sante Animale |
| --- |
| 10 Avenue de la Ballastiere |
| 33500 Libourne |
| France |

Ceva Sante Animale

10 Avenue de la Ballastiere

33500 Libourne

France

ENZAPROST BOVIS 12,5  mg/ml Solution injectable pour bovins

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Francuska

| Zoetis France |
| --- |
| 10 Rue Raymond David |
| 92240 Malakoff |
| France |

Zoetis France

10 Rue Raymond David

92240 Malakoff

France

DINOLYTIC

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Francuska

| Ceva Sante Animale |
| --- |
| 10 Avenue de la Ballastiere |
| 33500 Libourne |
| France |

Ceva Sante Animale

10 Avenue de la Ballastiere

33500 Libourne

France

ENZAPROST T

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Grčka

| Ceva Hellas LLC, |
| --- |
| 15, Agiou Nikolaou str. |
| Alimos, 17455 |
| Greece |

Ceva Hellas LLC,

15, Agiou Nikolaou str.

Alimos, 17455

Greece

Enzaprost Bovis inj. Sol 12,5  mg/ml

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Grčka

| Ceva Hellas LLC, |
| --- |
| 15, Agiou Nikolaou str. |
| Alimos, 17455 |
| Greece |

Ceva Hellas LLC,

15, Agiou Nikolaou str.

Alimos, 17455

Greece

Cevaprost 5 mg/ml

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Grčka

| Zoetis Hellas S.A. |
| --- |
| Frangokklisias 7 |
| 151 25, Maroussi Attica |
| Greece |

Zoetis Hellas S.A.

Frangokklisias 7

151 25, Maroussi Attica

Greece

Dinolytic Inj. Sol 5 mg/ml

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Hrvatska

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| France |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost Bovis, 12,5  mg/mL, otopina za injekciju, za goveda

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Hrvatska

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| France |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost, 5 mg/mL, otopina za injekciju, za goveda i svinje

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Hrvatska

| Zoetis B.V., |
| --- |
| Podružnica Zagreb za promidžbu |
| Petra Hektorovića 2 |
| 10000 Zagreb |
| Croatia |

Zoetis B.V.,

Podružnica Zagreb za promidžbu

Petra Hektorovića 2

10000 Zagreb

Croatia

DINOLYTIC, 5 mg/mL, otopina za injekciju, za goveda, konje i svinje

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Irska

| Zoetis Belgium S.A. |
| --- |
| 2nd Floor, Building 10 |
| Cherrywood Business Park, Loughlinstown |
| Co Dublin |
| Ireland |

Zoetis Belgium S.A.

2nd Floor, Building 10

Cherrywood Business Park, Loughlinstown

Co Dublin

Ireland

Lutalyse

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Irska

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne, |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

33500 Libourne,

France

Enzaprost 5 mg/ml Solution for injection for cattle and pig

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Irska

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne, |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

33500 Libourne,

France

Enzaprost Bovis 12,5  mg/ml Solution for Injection for Cattle

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Irska

| Zoetis Belgium S.A. |
| --- |
| 2nd Floor, Building 10, Cherrywood Business Park, Loughlinstown, Co Dublin, Ireland |

Zoetis Belgium S.A.

2nd Floor, Building 10, Cherrywood Business Park, Loughlinstown, Co Dublin, Ireland

Lutalyse High Concentration 12,5  mg/ml solution for injection for cattle

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Island

| Ceva Santé Animale, |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| France |

Ceva Santé Animale,

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost Bovis

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Italija

| Zoetis Italia S.r.l. |
| --- |
| Via Andrea Doria, 41 M |
| 00192 Roma |
| Italy |

Zoetis Italia S.r.l.

Via Andrea Doria, 41 M

00192 Roma

Italy

DINOLYTIC

5 mg/ml soluzione iniettabile per bovini, equini e suini

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Italija

| Zoetis Italia S.r.l. |
| --- |
| Via Andrea Doria, 41 M |
| 00192 Roma |
| Italy |

Zoetis Italia S.r.l.

Via Andrea Doria, 41 M

00192 Roma

Italy

DINOLYTIC 12,5  mg/ml soluzione iniettabile per bovini

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Italija

| Ceva Salute Animale S.p.A. |
| --- |
| Viale Bartolomeo Colleoni 15 |
| 20864 Agrate Brianza (MB) |
| Italia |

Ceva Salute Animale S.p.A.

Viale Bartolomeo Colleoni 15

20864 Agrate Brianza (MB)

Italia

Enzaprost 5 mg/ml Soluzione iniettabile per bovini e suini

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Italija

| Ceva Salute Animale S.p.A. |
| --- |
| Viale Bartolomeo Colleoni 15 |
| 20864 Agrate Brianza (MB) |
| Italia |

Ceva Salute Animale S.p.A.

Viale Bartolomeo Colleoni 15

20864 Agrate Brianza (MB)

Italia

Enzaprost Bovis 12,5  mg/ml soluzione iniettabile per bovini

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Latvija

| Zoetis Belgium SA |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain-la-Neuve |
| Belgium |

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

Dinolytic 12,5  mg/ml šķīdums injekcijām

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Latvija

| Zoetis Belgium SA |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain-la-Neuve |
| Belgium |

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

Belgium

Dinolytic 5 mg/ml šķīdums injekcijām

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Latvija

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| Libourne, Gironde, 33500 |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde, 33500

France

Enzaprost Bovis 12,5  mg/ml šķīdums injekcijām

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Latvija

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| Libourne, Gironde, 33500 |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde, 33500

France

Enzaprost 5 mg/ml šķīdums injekcijām

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Litva

| Zoetis Belgium S.A., |
| --- |
| Rue Laid Burniat 1, |
| 1348 Louvain-la-Neuve |
| Belgium |

Zoetis Belgium S.A.,

Rue Laid Burniat 1,

1348 Louvain-la-Neuve

Belgium

DINOLYTIC 12,5  mg/ml injekcinis tirpalas galvijams

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Litva

| Zoetis Belgium S.A., |
| --- |
| Rue Laid Burniat 1, |
| 1348 Louvain-la-Neuve |
| Belgium |

Zoetis Belgium S.A.,

Rue Laid Burniat 1,

1348 Louvain-la-Neuve

Belgium

DINOLYTIC, 5 mg/ml injekcinis tirpalas galvijams, arkliams ir kiaulėms

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Litva

| Ceva Sante Animale, |
| --- |
| 10 avenue de la Ballastiere |
| Libourne, Gironde 33500 |
| France |

Ceva Sante Animale,

10 avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost Bovis 12,5  mg/ml solution for injection for cattle

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Litva

| Ceva Sante Animale Z.I. |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| France |

Ceva Sante Animale Z.I.

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost 5 mg/ml injekcinis tirpalas galvijams ir kiaulėms

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Luksemburg

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| Libourne, Gironde 33500 |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost Bovis

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Luksemburg

| Zoetis Belgium s.a. |
| --- |
| Rue Laid Burniat, 1 |
| B-1348 Louvain-La-Neuve |
| Belgium |

Zoetis Belgium s.a.

Rue Laid Burniat, 1

B-1348 Louvain-La-Neuve

Belgium

Dinolytic, 5 mg-ml

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Luksemburg

| Ceva Santé Animale N.V. |
| --- |
| Metrologielaan 6 |
| 1130 Brussel |
| Belgium |

Ceva Santé Animale N.V.

Metrologielaan 6

1130 Brussel

Belgium

Enzaprost

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Mađarska

| Zoetis Hungary Kft. |
| --- |
| 1123. Budapest |
| Alkotás u. 53. |
| Hungary |

Zoetis Hungary Kft.

1123. Budapest

Alkotás u. 53.

Hungary

Dinolytic injekció A.U.V.

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Mađarska

| Ceva-Phylaxia Zrt., |
| --- |
| 1107 Budapest |
| Szállás u. 5. |
| Hungary |

Ceva-Phylaxia Zrt.,

1107 Budapest

Szállás u. 5.

Hungary

Enzaprost T 5 mg/ml oldatos injekció szarvasmarhák és sertések részére A.U.V.

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Mađarska

| Ceva-Phylaxia Zrt., |
| --- |
| 1107 Budapest |
| Szállás u. 5. |
| Hungary |

Ceva-Phylaxia Zrt.,

1107 Budapest

Szállás u. 5.

Hungary

Enzaprost Bovis 12,5  mg/ml oldatos injekció szarvasmarhák részére A.U.V.

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Nizozemska

| Zoetis B.V. |
| --- |
| Rivium Westlaan 74, |
| 2909 LD Capelle a/d Ijssel, |
| The Netherlands |

Zoetis B.V.

Rivium Westlaan 74,

2909 LD Capelle a/d Ijssel,

The Netherlands

Dinolytic hoge conenctratie 12,5  mg/ml oplossing voor injectie voor runderen

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Nizozemska

| Ceva Santé |
| --- |
| 10 avenue de la Ballastiere |
| Libourne, Gironde 33500 |
| France |

Ceva Santé

10 avenue de la Ballastiere

Libourne, Gironde 33500

France

Enzaprost Bovis 12,5  mg/ml oplossing voor injectie voor runderen

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Nizozemska

| Zoetis B.V. |
| --- |
| Rivium Westlaan 74, |
| 2909 LD Capelle a/d Ijssel, |
| The Netherlands |

Zoetis B.V.

Rivium Westlaan 74,

2909 LD Capelle a/d Ijssel,

The Netherlands

Dinolytic 5 mg/ml oplossing voor injectie voor runderen, varkens en paarden

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Nizozemska

| Ceva Santé Animjale B.V |
| --- |
| Tiendweg 8c, |
| 2671 SB, Naaldwijk, |
| The Netherlands |

Ceva Santé Animjale B.V

Tiendweg 8c,

2671 SB, Naaldwijk,

The Netherlands

Enzaprost 5 mg/ml Solution for injection for cattle and pig

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Norveška

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| Libourne 33500 |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne 33500

France

Enzaprost

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Norveška

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| Libourne 33500 |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne 33500

France

Enzaprost Bovis

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Njemačka

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| F-33500 Libourne |
| France |

Ceva Sante Animale

10 avenue de la Ballastiere

F-33500 Libourne

France

Enzaprost Bovis 12,5  mg/ml solution for injection for cattle

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Njemačka

| Zoetis Deutschland GmbH |
| --- |
| Schellingstr. 1 |
| D-10785 Berlin |
| Germany |

Zoetis Deutschland GmbH

Schellingstr. 1

D-10785 Berlin

Germany

Dinolytic Forte 12,5  mg/ml

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Njemačka

| Zoetis Deutschland GmbH |
| --- |
| Schellingstr. 1 |
| D-10785 Berlin |
| Germany |

Zoetis Deutschland GmbH

Schellingstr. 1

D-10785 Berlin

Germany

Dinolytic

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Njemačka

| Ceva Tiergesundheit GmbH |
| --- |
| Kanzlerstr. 4 |
| D-40472 Düsseldorf |
| Germany |

Ceva Tiergesundheit GmbH

Kanzlerstr. 4

D-40472 Düsseldorf

Germany

Enzaprost T

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Poljska

| Ceva Animal Health Polska Sp. z o.o., |
| --- |
| Okrzei Street 1A |
| 03-715 Warsaw |
| Poland |

Ceva Animal Health Polska Sp. z o.o.,

Okrzei Street 1A

03-715 Warsaw

Poland

Enzaprost Bovis 12,5  mg/ml roztwór do wstrzykiwań dla bydła

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Poljska

| Zoetis Polska Sp. z o.o. |
| --- |
| ul. Postępu 17B |
| 02-676 Warsaw |
| Poland |

Zoetis Polska Sp. z o.o.

ul. Postępu 17B

02-676 Warsaw

Poland

Dinolytic Forte

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Poljska

| Ceva Animal Health Polska Sp. z o.o., |
| --- |
| Okrzei Street 1A |
| 03-715 Warsaw |
| Poland |

Ceva Animal Health Polska Sp. z o.o.,

Okrzei Street 1A

03-715 Warsaw

Poland

ENZAPROST 5 mg/ml, roztór do wstrzykiwań dla bydła i świń

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Poljska

| Zoetis Polska Sp. z o.o. |
| --- |
| ul. Postępu 17B |
| 02-676 Warsaw |
| Poland |

Zoetis Polska Sp. z o.o.

ul. Postępu 17B

02-676 Warsaw

Poland

Dinolytic

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Portugal

| Ceva Saúde Animal |
| --- |
| Rua Dr. António Loureiro Borges, 9/9A – 9oA, |
| Miraflores, 1495-131 Algés – |
| Portugal |

Ceva Saúde Animal

Rua Dr. António Loureiro Borges, 9/9A – 9oA,

Miraflores, 1495-131 Algés –

Portugal

ENZAPROST T 5 mg/ml Solução injectável para bovinos e suínos

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Portugal

| Ceva Saúde Animal |
| --- |
| Rua Dr. António Loureiro Borges, 9/9A – 9oA, |
| Miraflores, 1495-131 Algés – |
| Portugal |

Ceva Saúde Animal

Rua Dr. António Loureiro Borges, 9/9A – 9oA,

Miraflores, 1495-131 Algés –

Portugal

Enzaprost Bovis 12,5  mg/ml Solution for Injection for Cattle

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Portugal

| Zoetis Portugal Lda. |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Zoetis Portugal Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

DINOLYTIC 5 mg/ml Solução injectável para bovinos, siunos e equinos

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Rumunjska

| Ceva Sante Animale |
| --- |
| 10 Avenue De La Ballastiere, 33500 Libourne Gironde, |
| France |

Ceva Sante Animale

10 Avenue De La Ballastiere, 33500 Libourne Gironde,

France

Enzaprost Bovis 12,5  mg/ml

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Rumunjska

| Ceva Sante Animale, |
| --- |
| 10 Avenue De La Ballastiere 33500 Libourne Gironde |
| France |

Ceva Sante Animale,

10 Avenue De La Ballastiere 33500 Libourne Gironde

France

Enzaprost T 5 mg/ml

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Rumunjska

| Zoetis Belgium SA, |
| --- |
| Rue Laid Burniat 1, |
| 1348 Louvain-la-Neuve, |
| Belgium |

Zoetis Belgium SA,

Rue Laid Burniat 1,

1348 Louvain-la-Neuve,

Belgium

Dinolytic 5 mg/ml

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Slovačka

| Zoetis Česká republika, s.r.o., náměstí 14. října 642/17, |
| --- |
| 150 00 Praha 5 |
| Česká republika |

Zoetis Česká republika, s.r.o., náměstí 14. října 642/17,

150 00 Praha 5

Česká republika

Dinolytic 5 mg/ml injekčný roztok

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Slovačka

| Ceva Animal Health Slovakia s.r.o., |
| --- |
| Račianska 153 |
| Bratislava, 831 53 |
| Slovakia |

Ceva Animal Health Slovakia s.r.o.,

Račianska 153

Bratislava, 831 53

Slovakia

Enzaprost T 5 mg/ml injekčný roztok

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Slovačka

| Ceva Animal Health Slovakia s.r.o., Račianska 153 |
| --- |
| Bratislava, 831 53 |
| Slovakia |

Ceva Animal Health Slovakia s.r.o., Račianska 153

Bratislava, 831 53

Slovakia

Enzaprost Bovis 12,5  mg/ml Solution for Injection for Cattle

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Slovenija

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| Libourne, Gironde, 33500 |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde, 33500

France

Enzaprost Bovis 12,5  mg/ml solution for injection for cattle

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Slovenija

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| Libourne, Gironde, 33500, France |

Ceva Santé Animale

10 avenue de la Ballastiere

Libourne, Gironde, 33500, France

Enzaprost 5 mg/ml raztopina za injiciranje za govedo in prašiče

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Slovenija

| Zoetis Belgium SA, |
| --- |
| Rue Laid Burniat 1, |
| 1348 Louvain-la-Neuve, |
| Belgium |

Zoetis Belgium SA,

Rue Laid Burniat 1,

1348 Louvain-la-Neuve,

Belgium

Dinolytic 5 mg/ml raztopina za injiciranje za govedo, konje in prašiče

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Španjolska

| Zoetis Spain, SL |
| --- |
| Avda. de Europa 20-B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas (Madrid) |
| Spain |

Zoetis Spain, SL

Avda. de Europa 20-B

Parque Empresarial la Moraleja

28108 Alcobendas (Madrid)

Spain

Dinolytic 12,5  mg/ml solución inyectable para bovino

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Španjolska

| Ceva Salud Animal, S.A. |
| --- |
| Avda. Diagonal 609-615 |
| Barcelona 08028 |
| Spain |

Ceva Salud Animal, S.A.

Avda. Diagonal 609-615

Barcelona 08028

Spain

Enzaprost Bovis 12,5  mg/ml solution for injection for cattle

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Španjolska

| Zoetis Spain, SL |
| --- |
| Avda. de Europa 20-B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas (Madrid) |
| Spain |

Zoetis Spain, SL

Avda. de Europa 20-B

Parque Empresarial la Moraleja

28108 Alcobendas (Madrid)

Spain

DINOLYTIC 5 mg/ml solución inyectable para bovino, porcino y caballos

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Španjolska

| Ceva Salud Animal, S.A. |
| --- |
| Avda. Diagonal 609-615 Barcelona 08028 |
| Spain |

Ceva Salud Animal, S.A.

Avda. Diagonal 609-615 Barcelona 08028

Spain

Enzaprost T

5 mg/ml solución inyectable para bovino y porcino

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Švedska

| Zoetis Finland Oy |
| --- |
| Tietokuja 4 |
| 00330 Helsingfors |
| Finland |

Zoetis Finland Oy

Tietokuja 4

00330 Helsingfors

Finland

Dinolytic vet.

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Švedska

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost Bovis

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Švedska

| Zoetis Finland Oy |
| --- |
| Tietokuja 4 |
| 00330 Helsingfors |
| Finland |

Zoetis Finland Oy

Tietokuja 4

00330 Helsingfors

Finland

Dinolytic® vet.

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Švedska

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| France |

Ceva Santé Animale

10 avenue de la Ballastiere

33500 Libourne

France

Enzaprost

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Ujedinjena Kraljevina

| Ceva Animal Health Ltd, |
| --- |
| Unit 3, Anglo Office Park, White Lion Road, Amersham, Buckinghamshire, HP7 9FB, United Kingdom |

Ceva Animal Health Ltd,

Unit 3, Anglo Office Park, White Lion Road, Amersham, Buckinghamshire, HP7 9FB, United Kingdom

Enzaprost Bovis 12,5  mg/ml Solution for Injection for Cattle

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Ujedinjena Kraljevina

| Zoetis UK Limited, |
| --- |
| 5th Floor, 6 St. Andrew Street, |
| London, EC4A 3AE, |
| United Kingdom |

Zoetis UK Limited,

5th Floor, 6 St. Andrew Street,

London, EC4A 3AE,

United Kingdom

Lutalyse 12,5  mg/ml Solution for Injection for Cattle

Dinoprost

12,5  mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Ujedinjena Kraljevina

| Ceva Animal Health Ltd, |
| --- |
| Unit 3, Anglo Office Park, White Lion Road, Amersham, Buckinghamshire, HP7 9FB, United Kingdom |

Ceva Animal Health Ltd,

Unit 3, Anglo Office Park, White Lion Road, Amersham, Buckinghamshire, HP7 9FB, United Kingdom

Enzaprost 5 mg/ml Solution for Injection for Cattle and Pig

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

Ujedinjena Kraljevina

| Zoetis UK Limited, |
| --- |
| 5th Floor, 6 St. Andrew Street, |
| London, EC4A 3AE, |
| United Kingdom |

Zoetis UK Limited,

5th Floor, 6 St. Andrew Street,

London, EC4A 3AE,

United Kingdom

Lutalyse 5 mg/ml Solution for Injection

Dinoprost

5 mg/ml

Otopina za injekciju

Goveda

Intramuskularno

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