# Úradný vestník C 37/31.

| | ISSN 1977-1037 |
| --- | --- |
| Úradný vestník
  Európskej únie | C 37 |
| | |
| Slovenské vydanie | Informácie a oznámenia | Ročník 6631. januára 2023 |

ISSN 1977-1037

Úradný vestník

Európskej únie

C 37

Slovenské vydanie

Informácie a oznámenia

Ročník 6631. januára 2023

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| Obsah | Strana |
| --- | --- |
| | IV   Informácie |
| | INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE |
| | Európska komisia |
| 2023/C 37/01 | Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. decembra 2022 do 31. decembra 2022(Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004 alebo s článkom 5 nariadenia Európskeho parlamentu a Rady (EÚ) 2019/6) | 1 |

Obsah

Strana

IV   Informácie

INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE

Európska komisia

2023/C 37/01

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. decembra 2022 do 31. decembra 2022(Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004 alebo s článkom 5 nariadenia Európskeho parlamentu a Rady (EÚ) 2019/6)

(Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004 alebo s článkom 5 nariadenia Európskeho parlamentu a Rady (EÚ) 2019/6)

1

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| SK | |
| --- | --- |

SK

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IV Informácie

INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE

Európska komisia

| 31.1.2023 | SK | Úradný vestník Európskej únie | C 37/1 |
| --- | --- | --- | --- |

31.1.2023

SK

Úradný vestník Európskej únie

C 37/1

---

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. decembra 2022 do 31. decembra 2022

(Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004 (1) alebo s článkom 5 nariadenia Európskeho parlamentu a Rady (EÚ) 2019/6 (2))

(2023/C 37/01)

—   Udelenie povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté

| Dátum rozhodnutia | Názov lieku | INN (medzinárodný neregistrovaný názov) | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Lieková forma | Kód ATC (anatomicko-terapeuticko-chemický kód) | Dátum oznámenia |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.12.2022 | Mycapssa | oktreotid | Amryt Pharmaceuticals DAC |
| 45 Mespil Road, Dublin 4, Ireland |

Dátum rozhodnutia

Názov lieku

INN (medzinárodný neregistrovaný názov)

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Lieková forma

Kód ATC (anatomicko-terapeuticko-chemický kód)

Dátum oznámenia

2.12.2022

Mycapssa

oktreotid

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/22/1690

Gastrorezistentná kapsula, tvrdá

H01CB02

5.12.2022

5.12.2022

Qdenga

tetravalentná očkovacia látka proti horúčke dengue (živá, atenuovaná)

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

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/22/1699

Prášok a rozpúšťadlo na injekčný roztok

J07BX04

6.12.2022

9.12.2022

Livmarli

maralixibátium-chlorid

| 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

Perorálny roztok

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

Prášok na injekčný roztok

V09IX14

12.12.2022

9.12.2022

Pemetrexed Baxter

pemetrexedu

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

Baxter Holding B.V.

Kobaltweg 49, 3542 CE Utrecht, Nederland

EU/1/22/1705

Prášok na prípravu infúzneho koncentrátu

L01BA04

13.12.2022

9.12.2022

Pluvicto

lutécium (177Lu) vipivotid tetraxetan

| 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

Injekčný alebo infúzny roztok

V10XX05

12.12.2022

9.12.2022

Spevigo

spesolimab

| 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

Koncentrát na infúzny roztok

L04AC22

12.12.2022

12.12.2022

Dimethyl Fumarate Teva

dimetyl-fumarát

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

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/22/1702

Gastrorezistentná kapsula, tvrdá

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

Injekčný roztok

H05AA04

13.12.2022

16.12.2022

Ebvallo

tabelecleucel

| 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

Injekčná disperzia

Pending

16.12.2022

16.12.2022

Plerixafor Accord

plerixafor

| 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

Injekčný roztok

L03AX16

19.12.2022

20.12.2022

Zynlonta

lonkastuximab-tesirín

| 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

Prášok na prípravu infúzneho koncentrátu

L01FX22

22.12.2022

—   Zmena povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 2.12.2022 | Comirnaty | BioNTech Manufacturing GmbH |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

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

Eptifibatide 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

—   Odňatie povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004)

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 5.12.2022 | Trogarzo | Theratechnologies Europe Limited |
| 4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

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

—   Udelenie povolenia na uvedenie na trh (článok 38 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004; Článok 5 nariadenia Európskeho parlamentu a Rady (EÚ) 2019/6): Prijaté

| Dátum rozhodnutia | Názov lieku | INN (medzinárodný neregistrovaný názov) | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Lieková forma | Kód ATC (anatomicko-terapeuticko-chemický kód) | Dátum oznámenia |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 20.12.2022 | NEOLEISH | Vakcína proti psej leishmanióze (rekombinantná plazmidová DNA) | CZ Veterinaria, S.A. |
| La Relva s/n – Torneiros, 36410 Porriño, España |

Dátum rozhodnutia

Názov lieku

INN (medzinárodný neregistrovaný názov)

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Lieková forma

Kód ATC (anatomicko-terapeuticko-chemický kód)

Dátum oznámenia

20.12.2022

NEOLEISH

Vakcína proti psej leishmanióze (rekombinantná plazmidová DNA)

CZ Veterinaria, S.A.

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

EU/2/22/290

Nosový sprej, roztok

Pending

21.12.2022

—   Zmena povolenia na uvedenie na trh (článok 38 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004; Článok 5 nariadenia Európskeho parlamentu a Rady (EÚ) 2019/6): Prijaté

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 2.12.2022 | CYTOPOINT | Zoetis Belgium |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

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

Ak sa chcete oboznámiť s verejnou hodnotiacou správou o príslušných liekoch a s ňou súvisiacimi rozhodnutiami, môžete kontaktovať:

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

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(1)  Ú. v. EÚ L 136, 30.4.04, s. 1.

(2)  Ú. v. EÚ L 4, 7.1.2019, s. 43.

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