# Službeni list C 37/31.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 37 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 66.31. siječnja 2023. |

ISSN 1977-1088

Službeni list

Europske unije

C 37

Hrvatsko izdanje

Informacije i objave

Godište 66.31. siječnja 2023.

---

| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2023/C 37/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2022. do 31. prosinca 2022.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća ili člankom 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća) | 1 |

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2023/C 37/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2022. do 31. prosinca 2022.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća ili člankom 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća)

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća ili člankom 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća)

1

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| HR | |
| --- | --- |

HR

---

IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 31.1.2023 | HR | Službeni list Europske unije | C 37/1 |
| --- | --- | --- | --- |

31.1.2023

HR

Službeni list Europske unije

C 37/1

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2022. do 31. prosinca 2022.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1) ili člankom 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća (2))

(2023/C 37/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.12.2022. | Mycapssa | oktreotid | Amryt Pharmaceuticals DAC |
| 45 Mespil Road, Dublin 4, Ireland |

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

2.12.2022.

Mycapssa

oktreotid

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/22/1690

Želučanootporna tvrda kapsula

H01CB02

5.12.2022.

5.12.2022.

Qdenga

četverovalentno cjepivo protiv denge (živo, atenuirano)

| Takeda GmbH |
| --- |
| Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/22/1699

Prašak i otapalo za otopinu za injekciju

J07BX04

6.12.2022.

9.12.2022.

Livmarli

maraliksibatklorid

| Mirum Pharmaceuticals International B.V. |
| --- |
| Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland |

Mirum Pharmaceuticals International B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland

EU/1/22/1704

Peroralna otopina

A05AX04

12.12.2022.

9.12.2022.

Locametz

gozetotid

| 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/1/22/1692

Prašak za otopinu za injekciju

V09IX14

12.12.2022.

9.12.2022.

Pemetreksed Baxter

pemetrekseda

| Baxter Holding B.V. |
| --- |
| Kobaltweg 49, 3542 CE Utrecht, Nederland |

Baxter Holding B.V.

Kobaltweg 49, 3542 CE Utrecht, Nederland

EU/1/22/1705

Prašak za koncentrat za otopinu za infuziju

L01BA04

13.12.2022.

9.12.2022.

Pluvicto

lutecij[177Lu]vipivotidtetraksetan

| 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/1/22/1703

otopina za injekciju ili infuziju

V10XX05

12.12.2022.

9.12.2022.

Spevigo

spezolimab

| 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/1/22/1688

Koncentrat za otopinu za infuziju

L04AC22

12.12.2022.

12.12.2022.

Dimethyl Fumarate Teva

dimetilfumarat

| Teva GmbH |
| --- |
| Graf-Arco-Straße 3, 89079 Ulm, Deutschland |

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/22/1702

Želučanootporna tvrda kapsula

L04AX07

3.1.2023.

12.12.2022.

Eladynos

abaloparatid

| Radius Health (Ireland) Ltd. |
| --- |
| 13 Classon House, Dundrum Business Park, Dundrum, Dublin D14 W9Y3, Ireland |

Radius Health (Ireland) Ltd.

13 Classon House, Dundrum Business Park, Dundrum, Dublin D14 W9Y3, Ireland

EU/1/22/1706

Otopina za injekciju

H05AA04

13.12.2022.

16.12.2022.

Ebvallo

Tabelekleucel

| Atara Biotherapeutics Ireland Limited |
| --- |
| Arthur Cox Building, 10 Earlsfort Terrace, Dublin 2 D02 T380, Ireland |

Atara Biotherapeutics Ireland Limited

Arthur Cox Building, 10 Earlsfort Terrace, Dublin 2 D02 T380, Ireland

EU/1/22/1700

Disperzija za injekciju

Pending

16.12.2022.

16.12.2022.

Plerixafor Accord

pleriksafor

| 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/1/22/1701

Otopina za injekciju

L03AX16

19.12.2022.

20.12.2022.

Zynlonta

lonkastuksimab tesirin

| ADC Therapeutics (NL) B.V. |
| --- |
| Laarderhoogtweg 25, Amsterdam, Noord-Holland, 1101 EB, Nederland |

ADC Therapeutics (NL) B.V.

Laarderhoogtweg 25, Amsterdam, Noord-Holland, 1101 EB, Nederland

EU/1/22/1695

Prašak za koncentrat za otopinu za infuziju

L01FX22

22.12.2022.

—   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 |
| --- | --- | --- | --- | --- |
| 2.12.2022. | Comirnaty | BioNTech Manufacturing GmbH |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

2.12.2022.

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

2.12.2022.

2.12.2022.

DuoPlavin

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/10/619

5.12.2022.

2.12.2022.

Kaftrio

| Vertex Pharmaceuticals (Ireland) Limited |
| --- |
| Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland |

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland

EU/1/20/1468

5.12.2022.

2.12.2022.

Kalydeco

| Vertex Pharmaceuticals (Ireland) Limited |
| --- |
| Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland |

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland

EU/1/12/782

5.12.2022.

2.12.2022.

QINLOCK

| Deciphera Pharmaceuticals (Netherlands) B.V. |
| --- |
| Atrium Building Floor 4th, Strawinskylaan 3051, Amsterdam, Noord-Holland, 1077 ZX, Nederland |

Deciphera Pharmaceuticals (Netherlands) B.V.

Atrium Building Floor 4th, Strawinskylaan 3051, Amsterdam, Noord-Holland, 1077 ZX, Nederland

EU/1/21/1569

8.12.2022.

2.12.2022.

Sifrol

| 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/1/97/050

7.12.2022.

2.12.2022.

Spikevax

| MODERNA BIOTECH SPAIN, S.L. |
| --- |
| Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España |

MODERNA BIOTECH SPAIN, S.L.

Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España

EU/1/20/1507

7.12.2022.

2.12.2022.

Trizivir

| ViiV Healthcare BV |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland |

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/00/156

5.12.2022.

2.12.2022.

Trogarzo

| Theratechnologies Europe Limited |
| --- |
| 4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland |

Theratechnologies Europe Limited

4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland

EU/1/19/1359

14.12.2022.

2.12.2022.

Trydonis

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A, 43122 Parma, Italia |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1274

5.12.2022.

2.12.2022.

Zyclara

| Viatris Healthcare Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland |

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/12/783

6.12.2022.

5.12.2022.

Shingrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

6.12.2022.

5.12.2022.

Steglujan

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1266

6.12.2022.

5.12.2022.

Xarelto

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

6.12.2022.

9.12.2022.

Abevmy

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

Mylan IRE Healthcare Limited

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

EU/1/20/1515

14.12.2022.

9.12.2022.

Atriance

| Sandoz Pharmaceuticals d.d. |
| --- |
| Verovškova ulica 57, 1000 Ljubljana, Slovenija |

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57, 1000 Ljubljana, Slovenija

EU/1/07/403

12.12.2022.

9.12.2022.

Aybintio

| Samsung Bioepis NL B.V. |
| --- |
| Olof Palmestraat 10, 2616 LR Delft, Nederland |

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/20/1454

13.12.2022.

9.12.2022.

Bortezomib 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/1/15/1019

15.12.2022.

9.12.2022.

Deferiprone Lipomed

| Lipomed GmbH |
| --- |
| Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland |

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/18/1310

12.12.2022.

9.12.2022.

Duaklir Genuair

| Covis Pharma Europe B.V. |
| --- |
| Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland |

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/14/964

12.12.2022.

9.12.2022.

Eklira Genuair

| Covis Pharma Europe B.V. |
| --- |
| Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland |

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/12/778

14.12.2022.

9.12.2022.

Erleada

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/18/1342

12.12.2022.

9.12.2022.

Eylea

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

13.12.2022.

9.12.2022.

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

14.12.2022.

9.12.2022.

Insulin aspart Sanofi

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1447

13.12.2022.

9.12.2022.

Insulin lispro Sanofi

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1203

13.12.2022.

9.12.2022.

Onbevzi

| Samsung Bioepis NL B.V. |
| --- |
| Olof Palmestraat 10, 2616 LR Delft, Nederland |

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/20/1499

13.12.2022.

9.12.2022.

Oyavas

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18, 61118 Bad Vilbel, Deutschland |

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/20/1510

12.12.2022.

9.12.2022.

Qarziba

| EUSA Pharma (Netherlands) B.V. |
| --- |
| Beechavenue 54, 1119PW Schiphol-Rijk, Nederland |

EUSA Pharma (Netherlands) B.V.

Beechavenue 54, 1119PW Schiphol-Rijk, Nederland

EU/1/17/1191

14.12.2022.

9.12.2022.

Retsevmo

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

12.12.2022.

9.12.2022.

Riarify

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A, 43122 Parma, Italia |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1275

12.12.2022.

9.12.2022.

Spravato

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/19/1410

12.12.2022.

9.12.2022.

Suliqua

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/16/1157

13.12.2022.

9.12.2022.

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

13.12.2022.

9.12.2022.

Vydura

| 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/1/22/1645

12.12.2022.

9.12.2022.

Xydalba

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/986

12.12.2022.

9.12.2022.

Zirabev

| 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/1/18/1344

12.12.2022.

12.12.2022.

Alymsys

| Mabxience Research SL |
| --- |
| C/ Manuel Pombo Angulo 28 – 3a y 4a Planta, 28050 Madrid, España |

Mabxience Research SL

C/ Manuel Pombo Angulo 28 – 3a y 4a Planta, 28050 Madrid, España

EU/1/20/1509

13.12.2022.

12.12.2022.

Cablivi

| Ablynx N.V. |
| --- |
| Technologiepark 21, 9052 Zwijnaarde, België |

Ablynx N.V.

Technologiepark 21, 9052 Zwijnaarde, België

EU/1/18/1305

21.12.2022.

12.12.2022.

Dificlir

| Tillotts Pharma GmbH |
| --- |
| Warmbacher Strasse 80, 79618 Rheinfelden, Deutschland |

Tillotts Pharma GmbH

Warmbacher Strasse 80, 79618 Rheinfelden, Deutschland

EU/1/11/733

13.12.2022.

12.12.2022.

DuoPlavin

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/10/619

14.12.2022.

12.12.2022.

Dupixent

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1229

13.12.2022.

12.12.2022.

Enhertu

| Daiichi Sankyo Europe GmbH |
| --- |
| Zielstattstraße 48, 81379 München, Deutschland |

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

13.12.2022.

12.12.2022.

Karvezide

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/085

13.12.2022.

12.12.2022.

Kisqali

| 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/1/17/1221

13.12.2022.

12.12.2022.

Refixia

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1193

13.12.2022.

16.12.2022.

Avastin

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

Roche Registration GmbH

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

EU/1/04/300

19.12.2022.

16.12.2022.

Bretaris Genuair

| Covis Pharma Europe B.V. |
| --- |
| Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland |

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/12/781

3.1.2023.

16.12.2022.

Brilique

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/655

19.12.2022.

16.12.2022.

Brimica Genuair

| Covis Pharma Europe B.V. |
| --- |
| Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland |

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/14/963

19.12.2022.

16.12.2022.

Caprelsa

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/11/749

19.12.2022.

16.12.2022.

Ceprotin

| Baxter AG |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Baxter AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/01/190

19.12.2022.

16.12.2022.

Combivir

| ViiV Healthcare BV |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland |

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/98/058

19.12.2022.

16.12.2022.

Corbilta

| Orion Corporation |
| --- |
| Orionintie 1, 02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/13/859

20.12.2022.

16.12.2022.

DUAVIVE

| 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/1/14/960

20.12.2022.

16.12.2022.

DuoPlavin

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/10/619

19.12.2022.

16.12.2022.

Dupixent

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1229

19.12.2022.

16.12.2022.

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

19.12.2022.

16.12.2022.

Granpidam

| 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/1/16/1137

19.12.2022.

16.12.2022.

Imatinib 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/1/13/845

19.12.2022.

16.12.2022.

Imfinzi

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

19.12.2022.

16.12.2022.

Inhixa

| Techdow Pharma Netherlands B.V. |
| --- |
| Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland |

Techdow Pharma Netherlands B.V.

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

EU/1/16/1132

22.12.2022.

16.12.2022.

Intuniv

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/15/1040

20.12.2022.

16.12.2022.

Iscover

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/070

19.12.2022.

16.12.2022.

Iscover

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/070

19.12.2022.

16.12.2022.

Iscover

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/070

19.12.2022.

16.12.2022.

Karvea

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/97/049

20.12.2022.

16.12.2022.

Levodopa/Carbidopa/Entacapone Orion

| Orion Corporation |
| --- |
| Orionintie 1, 02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/706

21.12.2022.

16.12.2022.

Lynparza

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

19.12.2022.

16.12.2022.

Moventig

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

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/14/962

21.12.2022.

16.12.2022.

Mvabea

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1445

20.12.2022.

16.12.2022.

Myalepta

| Amryt Pharmaceuticals DAC |
| --- |
| 45 Mespil Road, Dublin 4, Ireland |

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/18/1276

21.12.2022.

16.12.2022.

Neulasta

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/227

20.12.2022.

16.12.2022.

Ocaliva

| ADVANZ PHARMA Limited |
| --- |
| Suite 17, Northwood House, Northwood Avenue, Santry, Dublin 9, Ireland |

ADVANZ PHARMA Limited

Suite 17, Northwood House, Northwood Avenue, Santry, Dublin 9, Ireland

EU/1/16/1139

19.12.2022.

16.12.2022.

Ozawade

| Bioprojet Pharma |
| --- |
| 9 rue Rameau, 75002 Paris, France |

Bioprojet Pharma

9 rue Rameau, 75002 Paris, France

EU/1/21/1546

19.12.2022.

16.12.2022.

Plavix

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/069

19.12.2022.

16.12.2022.

Plavix

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/069

19.12.2022.

16.12.2022.

Plavix

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/069

19.12.2022.

16.12.2022.

Resolor

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland

EU/1/09/581

20.12.2022.

16.12.2022.

Rybelsus

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/20/1430

20.12.2022.

16.12.2022.

Sarclisa

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1435

19.12.2022.

16.12.2022.

Saxenda

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/15/992

19.12.2022.

16.12.2022.

Spikevax

| MODERNA BIOTECH SPAIN, S.L. |
| --- |
| Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España |

MODERNA BIOTECH SPAIN, S.L.

Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España

EU/1/20/1507

19.12.2022.

16.12.2022.

Trajenta

| 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/1/11/707

19.12.2022.

16.12.2022.

Tresiba

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/12/807

20.12.2022.

16.12.2022.

Truvelog Mix 30

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/22/1639

19.12.2022.

16.12.2022.

Twynsta

| 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/1/10/648

3.1.2023.

16.12.2022.

Zoledronic acid 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/1/13/834

19.12.2022.

19.12.2022.

Inrebic

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/20/1514

20.12.2022.

20.12.2022.

Ibandronic acid 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/1/12/798

22.12.2022.

20.12.2022.

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

4.1.2023.

20.12.2022.

Rivaroxaban 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/1/20/1488

22.12.2022.

20.12.2022.

Sarclisa

| Sanofi Winthrop Industrie |
| --- |
| 82 avenue Raspail, 94250 Gentilly, France |

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1435

21.12.2022.

20.12.2022.

Sirturo

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/901

21.12.2022.

20.12.2022.

Skytrofa

| Ascendis Pharma Endocrinology Division A/S |
| --- |
| Tuborg Boulevard 12, 2900 Hellerup, Danmark |

Ascendis Pharma Endocrinology Division A/S

Tuborg Boulevard 12, 2900 Hellerup, Danmark

EU/1/21/1607

21.12.2022.

22.12.2022.

Comirnaty

| BioNTech Manufacturing GmbH |
| --- |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

22.12.2022.

22.12.2022.

Paxlovid

| 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/1/22/1625

22.12.2022.

—   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 |
| --- | --- | --- | --- | --- |
| 5.12.2022. | Trogarzo | Theratechnologies Europe Limited |
| 4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

5.12.2022.

Trogarzo

Theratechnologies Europe Limited

4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland

EU/1/19/1359

5.1.2023.

9.12.2022.

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

12.12.2022.

—   Izdavanje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća; Članak 5. Uredbe (EU) 2019/6 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 20.12.2022. | NEOLEISH | Cjepivo protiv lišmanioze u pasa (plazmid rekombinantne DNK) | CZ Veterinaria, S.A. |
| La Relva s/n – Torneiros, 36410 Porriño, España |

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

20.12.2022.

NEOLEISH

Cjepivo protiv lišmanioze u pasa (plazmid rekombinantne DNK)

CZ Veterinaria, S.A.

La Relva s/n – Torneiros, 36410 Porriño, España

EU/2/22/290

sprej za nos, otopina

Pending

21.12.2022.

—   Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća; članak 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 2.12.2022. | CYTOPOINT | Zoetis Belgium |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

2.12.2022.

CYTOPOINT

Zoetis Belgium

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

EU/2/17/205

5.12.2022.

2.12.2022.

Fevaxyn Pentofel

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

Zoetis Belgium

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

EU/2/96/002

6.12.2022.

2.12.2022.

Solensia

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

Zoetis Belgium SA

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

EU/2/20/269

5.12.2022.

2.12.2022.

Tulissin

| VIRBAC |
| --- |
| 1ère avenue 2065 m LID, 06516 Carros, France |

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/20/252

6.12.2022.

2.12.2022.

Zenalpha

| Vetcare Oy |
| --- |
| P.O. Box 99, 24101 Salo, Suomi |

Vetcare Oy

P.O. Box 99, 24101 Salo, Suomi

EU/2/21/279

7.12.2022.

9.12.2022.

Convenia

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

Zoetis Belgium

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

EU/2/06/059

14.12.2022.

9.12.2022.

Zeleris

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/210

14.12.2022.

13.12.2022.

Innovax-ND-ILT

| 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

14.12.2022.

13.12.2022.

Versican Plus DHPPi/L4R

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

Zoetis Belgium

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

EU/2/14/163

14.12.2022.

15.12.2022.

Exzolt

| 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/2/17/212

20.12.2022.

15.12.2022.

Librela

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

Zoetis Belgium SA

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

EU/2/20/261

21.12.2022.

15.12.2022.

NEXGARD SPECTRA

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/14/177

16.12.2022.

15.12.2022.

Porcilis PCV M Hyo

| 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/2/14/175

20.12.2022.

15.12.2022.

Simparica Trio

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

Zoetis Belgium

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

EU/2/19/243

20.12.2022.

15.12.2022.

Simparica Trio

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

Zoetis Belgium

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

EU/2/19/243

20.12.2022.

15.12.2022.

UBAC

| 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/2/18/227

21.12.2022.

15.12.2022.

Versican Plus Pi/L4R

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

Zoetis Belgium

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

EU/2/14/173

16.12.2022.

16.12.2022.

Equip WNV

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

Zoetis Belgium

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

EU/2/08/086

20.12.2022.

20.12.2022.

Lydaxx

| VETOQUINOL S.A. |
| --- |
| Magny-Vernois, 70200 Lure, France |

VETOQUINOL S.A.

Magny-Vernois, 70200 Lure, France

EU/2/20/253

21.12.2022.

20.12.2022.

Novem

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/042

22.12.2022.

20.12.2022.

Onsior

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/08/089

21.12.2022.

20.12.2022.

ProteqFlu

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/03/037

22.12.2022.

20.12.2022.

ProteqFlu-Te

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/03/038

22.12.2022.

20.12.2022.

Rabitec

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/219

21.12.2022.

20.12.2022.

RHINISENG

| 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/2/10/109

22.12.2022.

20.12.2022.

Suprelorin

| VIRBAC S.A. |
| --- |
| 1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France |

VIRBAC S.A.

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

EU/2/07/072

23.12.2022.

20.12.2022.

Tulaven

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/20/251

21.12.2022.

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 |
| NIZOZEMSKA |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NIZOZEMSKA

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

(2)  SL L 4, 7.1.2019., str. 43.

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