# Službeni list C 289/29.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 289 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 65.29. srpnja 2022. |

ISSN 1977-1088

Službeni list

Europske unije

C 289

Hrvatsko izdanje

Informacije i objave

Godište 65.29. srpnja 2022.

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| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2022/C 289/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2022. do 30. lipnja 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

2022/C 289/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2022. do 30. lipnja 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

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 29.7.2022 | HR | Službeni list Europske unije | C 289/1 |
| --- | --- | --- | --- |

29.7.2022

HR

Službeni list Europske unije

C 289/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2022. do 30. lipnja 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))

(2022/C 289/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.6.2022. | Lunsumio | mosunetuzumab | Roche Registration GmbH |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, 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

3.6.2022.

Lunsumio

mosunetuzumab

Roche Registration GmbH

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

EU/1/22/1649

Koncentrat za otopinu za infuziju

L01XC

7.6.2022.

14.6.2022.

Yselty

linzagoliks kolin

| ObsEva Ireland Ltd. |
| --- |
| Penthouse Floor, 5 Lapps Quay, Cork, T12 RW7D, Ireland |

ObsEva Ireland Ltd.

Penthouse Floor, 5 Lapps Quay, Cork, T12 RW7D, Ireland

EU/1/21/1606

Filmom obložena tableta

U tijeku

17.6.2022.

20.6.2022.

Pirfenidone AET

pirfenidon

| Alfred E. Tiefenbacher (GmbH & Co. KG) |
| --- |
| Van der Smissen Strasse 1, 22767 Hamburg, Deutschland |

Alfred E. Tiefenbacher (GmbH & Co. KG)

Van der Smissen Strasse 1, 22767 Hamburg, Deutschland

EU/1/22/1655

Filmom obložena tableta

L04AX05

27.6.2022.

20.6.2022.

Tabrecta

kapmatinib

| 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/1/22/1650

Filmom obložena tableta

L01EX17

21.6.2022.

21.6.2022.

Filsuvez

ekstrakt brezove kore

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

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/22/1652

Gel

D03AX13

23.6.2022.

24.6.2022.

Nexviadyme

avalglukozidaza alfa

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/21/1579

Prašak za koncentrat za otopinu za infuziju

U tijeku

27.6.2022.

24.6.2022.

Xenpozyme

olipudaza alfa

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/22/1659

Prašak za koncentrat za otopinu za infuziju

A16AB25

27.6.2022.

—   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 |
| --- | --- | --- | --- | --- |
| 2.6.2022. | Abraxane | Bristol-Myers Squibb Pharma EEIG |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

2.6.2022.

Abraxane

Bristol-Myers Squibb Pharma EEIG

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

EU/1/07/428

8.6.2022.

2.6.2022.

Anoro Ellipta

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

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/898

5.6.2022.

2.6.2022.

Comtan

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/98/081

3.6.2022.

2.6.2022.

Cufence

| Univar Solutions B.V. |
| --- |
| Schouwburgplein 30, Rotterdam, 3012 CL, Nederland |

Univar Solutions B.V.

Schouwburgplein 30, Rotterdam, 3012 CL, Nederland

EU/1/19/1365

7.6.2022.

2.6.2022.

Exviera

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

3.6.2022.

2.6.2022.

HALAVEN

| Eisai GmbH |
| --- |
| Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland |

Eisai GmbH

Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland

EU/1/11/678

3.6.2022.

2.6.2022.

Imcivree

| Rhythm Pharmaceuticals Netherlands B.V. |
| --- |
| Radarweg 29, 1043 NX Amsterdam, Nederland |

Rhythm Pharmaceuticals Netherlands B.V.

Radarweg 29, 1043 NX Amsterdam, Nederland

EU/1/21/1564

7.6.2022.

2.6.2022.

Instanyl

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/09/531

14.6.2022.

2.6.2022.

Ketoconazole HRA

| HRA Pharma Rare Diseases |
| --- |
| 200 avenue de Paris, 92320 Chatillon, France |

HRA Pharma Rare Diseases

200 avenue de Paris, 92320 Chatillon, France

EU/1/14/965

14.6.2022.

2.6.2022.

Kigabeq

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

ORPHELIA Pharma SAS

85 boulevard Saint-Michel, 75005 Paris, France

EU/1/18/1302

10.6.2022.

2.6.2022.

Posaconazole 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/1/19/1379

7.6.2022.

2.6.2022.

Slenyto

| RAD Neurim Pharmaceuticals EEC SARL |
| --- |
| 4 rue de Marivaux, 75002 Paris, France |

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

EU/1/18/1318

7.6.2022.

2.6.2022.

Sugammadex Mylan

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

Mylan Ireland Limited

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

EU/1/21/1583

21.6.2022.

2.6.2022.

Trulicity

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

7.6.2022.

2.6.2022.

TUKYSA

| Seagen B.V. |
| --- |
| Evert van de Beekstraat 1-104, 1118CL Schiphol, Nederland |

Seagen B.V.

Evert van de Beekstraat 1-104, 1118CL Schiphol, Nederland

EU/1/20/1526

7.6.2022.

2.6.2022.

Viekirax

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

3.6.2022.

2.6.2022.

Vyxeos liposomal

| Jazz Pharmaceuticals Ireland Ltd |
| --- |
| 5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland |

Jazz Pharmaceuticals Ireland Ltd

5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland

EU/1/18/1308

7.6.2022.

2.6.2022.

Zepatier

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1119

14.6.2022.

7.6.2022.

Benlysta

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

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/11/700

13.6.2022.

7.6.2022.

Constella

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/12/801

13.6.2022.

7.6.2022.

CONTROLOC Control

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

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/515

9.6.2022.

7.6.2022.

Ifirmacombi

| 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/1/11/673

9.6.2022.

7.6.2022.

Ilaris

| 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/1/09/564

8.6.2022.

7.6.2022.

Irbesartan HCT Zentiva

| Zentiva k.s. |
| --- |
| U kabelovny 130, 102 37 Praha 10, Česká republika |

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/06/377

9.6.2022.

7.6.2022.

Mozobil

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/09/537

8.6.2022.

7.6.2022.

Ondexxya

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1345

20.6.2022.

7.6.2022.

PANTOZOL Control

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

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/517

9.6.2022.

7.6.2022.

Perjeta

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

Roche Registration GmbH

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

EU/1/13/813

8.6.2022.

7.6.2022.

Rebetol

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/107

14.6.2022.

7.6.2022.

Rivastigmine Actavis

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

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/693

8.6.2022.

7.6.2022.

SOMAC Control

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

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/516

9.6.2022.

7.6.2022.

Stayveer

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/832

8.6.2022.

7.6.2022.

Tecentriq

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

Roche Registration GmbH

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

EU/1/17/1220

8.6.2022.

7.6.2022.

Truvada

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/04/305

8.6.2022.

7.6.2022.

VELCADE

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/04/274

8.6.2022.

7.6.2022.

Xeplion

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/672

8.6.2022.

13.6.2022.

Afinitor

| 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/1/09/538

15.6.2022.

13.6.2022.

Aimovig

| 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/1/18/1293

14.6.2022.

13.6.2022.

Descovy

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1099

14.6.2022.

13.6.2022.

Enurev Breezhaler

| 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/1/12/789

14.6.2022.

13.6.2022.

Feraccru

| Norgine B.V. |
| --- |
| Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland |

Norgine B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/15/1075

21.6.2022.

13.6.2022.

Fintepla

| Zogenix ROI Limited |
| --- |
| Trinity House, Charleston Road, Ranelagh, Dublin 6, D06 C8X4, Ireland |

Zogenix ROI Limited

Trinity House, Charleston Road, Ranelagh, Dublin 6, D06 C8X4, Ireland

EU/1/20/1491

14.6.2022.

13.6.2022.

Imfinzi

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

15.6.2022.

13.6.2022.

Leqvio

| 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/1/20/1494

15.6.2022.

13.6.2022.

Nyvepria

| 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/1/20/1486

14.6.2022.

13.6.2022.

Ozurdex

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/10/638

14.6.2022.

13.6.2022.

Pelgraz

| 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/1/18/1313

15.6.2022.

13.6.2022.

Pregabalin 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/1/15/1027

15.6.2022.

13.6.2022.

Xydalba

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/986

14.6.2022.

14.6.2022.

Lakozamid UCB

| 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/1/19/1383

20.6.2022.

14.6.2022.

Odefsey

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1112

15.6.2022.

14.6.2022.

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

29.6.2022.

20.6.2022.

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

21.6.2022.

20.6.2022.

Ilumetri

| Almirall, S.A. |
| --- |
| Ronda General Mitre, 151, 08022 Barcelona, España |

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/18/1323

21.6.2022.

20.6.2022.

OBIZUR

| Baxalta Innovations GmbH |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/15/1035

21.6.2022.

20.6.2022.

Olumiant

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

21.6.2022.

20.6.2022.

Translarna

| PTC Therapeutics International Limited |
| --- |
| 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland |

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

EU/1/13/902

21.6.2022.

21.6.2022.

Cresemba

| Basilea Pharmaceutica Deutschland GmbH |
| --- |
| Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland |

Basilea Pharmaceutica Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland

EU/1/15/1036

22.6.2022.

21.6.2022.

Cuprymina

| A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L. |
| --- |
| Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia |

A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.

Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia

EU/1/12/784

22.6.2022.

21.6.2022.

Elonva

| N.V. Organon |
| --- |
| P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland |

N.V. Organon

P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland

EU/1/09/609

23.6.2022.

21.6.2022.

Entecavir Mylan

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/17/1227

22.6.2022.

21.6.2022.

Hepcludex

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1446

27.6.2022.

21.6.2022.

Hycamtin

| 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/1/96/027

22.6.2022.

21.6.2022.

KEYTRUDA

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

29.6.2022.

21.6.2022.

Lemtrada

| Sanofi Belgium |
| --- |
| Leonardo Da Vincilaan 19, B-1831 Diegem, België |

Sanofi Belgium

Leonardo Da Vincilaan 19, B-1831 Diegem, België

EU/1/13/869

22.6.2022.

21.6.2022.

Mektovi

| Pierre Fabre Médicament |
| --- |
| Les Cauquillous, 81500 Lavaur, France |

Pierre Fabre Médicament

Les Cauquillous, 81500 Lavaur, France

EU/1/18/1315

22.6.2022.

21.6.2022.

Mysimba

| Orexigen Therapeutics Ireland Limited |
| --- |
| 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland |

Orexigen Therapeutics Ireland Limited

2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/14/988

23.6.2022.

21.6.2022.

NexoBrid

| MediWound Germany GmbH |
| --- |
| Hans-Sachs-Strasse 100, 65428 Rüsselsheim, Deutschland |

MediWound Germany GmbH

Hans-Sachs-Strasse 100, 65428 Rüsselsheim, Deutschland

EU/1/12/803

27.6.2022.

21.6.2022.

Pemetrexed Fresenius Kabi

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/16/1115

27.6.2022.

21.6.2022.

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

22.6.2022.

21.6.2022.

TOOKAD

| Steba Biotech S.A |
| --- |
| 7 Place du Théâtre, 2613 Luxembourg, Luxembourg |

Steba Biotech S.A

7 Place du Théâtre, 2613 Luxembourg, Luxembourg

EU/1/17/1228

23.6.2022.

21.6.2022.

Vocabria

| 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/1/20/1481

22.6.2022.

21.6.2022.

Votubia

| 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/1/11/710

23.6.2022.

21.6.2022.

XALKORI

| 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/1/12/793

22.6.2022.

21.6.2022.

Xaluprine

| Nova Laboratories Ireland Limited |
| --- |
| 3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland |

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland

EU/1/11/727

27.6.2022.

21.6.2022.

Yescarta

| Kite Pharma EU B.V. |
| --- |
| Tufsteen 1, 2132 NT Hoofddorp, Nederland |

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

EU/1/18/1299

23.6.2022.

22.6.2022.

KEYTRUDA

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

27.6.2022.

24.6.2022.

Abecma

| 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/1/21/1539

27.6.2022.

24.6.2022.

Azopt

| 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/1/00/129

27.6.2022.

24.6.2022.

Bretaris Genuair

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/781

27.6.2022.

24.6.2022.

Brimica Genuair

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/963

27.6.2022.

24.6.2022.

Deferasirox 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/1/19/1412

27.6.2022.

24.6.2022.

Defitelio

| Gentium S.r.I. |
| --- |
| Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia |

Gentium S.r.I.

Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia

EU/1/13/878

28.6.2022.

24.6.2022.

Defitelio

| Gentium S.r.I. |
| --- |
| Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia |

Gentium S.r.I.

Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia

EU/1/13/878

28.6.2022.

24.6.2022.

Dificlir

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

Tillotts Pharma GmbH

Warmbacher Strasse 80, 79618 Rheinfelden, Deutschland

EU/1/11/733

30.6.2022.

24.6.2022.

Duaklir Genuair

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/964

27.6.2022.

24.6.2022.

Eklira Genuair

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/778

27.6.2022.

24.6.2022.

Norvir

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/96/016

27.6.2022.

24.6.2022.

Ocaliva

| Intercept Pharma International Limited |
| --- |
| Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland |

Intercept Pharma International Limited

Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland

EU/1/16/1139

28.6.2022.

24.6.2022.

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

29.6.2022.

24.6.2022.

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

27.6.2022.

24.6.2022.

Spravato

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/19/1410

27.6.2022.

24.6.2022.

Temodal

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/98/096

28.6.2022.

24.6.2022.

TRIXEO AEROSPHERE

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/20/1498

27.6.2022.

24.6.2022.

Xeljanz

| 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/1/17/1178

28.6.2022.

24.6.2022.

Zometa

| Phoenix Labs Unlimited Company |
| --- |
| Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland |

Phoenix Labs Unlimited Company

Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland

EU/1/01/176

30.6.2022.

29.6.2022.

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

4.7.2022.

29.6.2022.

Apixaban 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/1/20/1458

30.6.2022.

29.6.2022.

BLENREP

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

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/20/1474

30.6.2022.

29.6.2022.

Cerezyme

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/97/053

30.6.2022.

29.6.2022.

Dacogen

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/12/792

30.6.2022.

29.6.2022.

Epidyolex

| GW Pharma (International) B.V. |
| --- |
| Databankweg 26, 3821AL Amersfoort, Nederland |

GW Pharma (International) B.V.

Databankweg 26, 3821AL Amersfoort, Nederland

EU/1/19/1389

30.6.2022.

29.6.2022.

Isentress

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/436

30.6.2022.

29.6.2022.

LIBTAYO

| Regeneron Ireland Designated Activity Company (DAC) |
| --- |
| One Warrington Place, Dublin 2, D02 HH27 Ireland |

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27 Ireland

EU/1/19/1376

30.6.2022.

29.6.2022.

Optruma

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/98/074

1.7.2022.

29.6.2022.

PritorPlus

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/02/215

1.7.2022.

29.6.2022.

Respreeza

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

CSL Behring GmbH

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

EU/1/15/1006

1.7.2022.

29.6.2022.

Vizamyl

| GE Healthcare AS |
| --- |
| Nycoveien 1, 0485, Oslo, Norge |

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/14/941

30.6.2022.

29.6.2022.

Vizimpro

| 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/1/19/1354

30.6.2022.

29.6.2022.

Xerava

| PAION Deutschland GmbH |
| --- |
| Heussstraße 25, 52078 Aachen, Deutschland |

PAION Deutschland GmbH

Heussstraße 25, 52078 Aachen, Deutschland

EU/1/18/1312

30.6.2022.

30.6.2022.

Enspryng

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

Roche Registration GmbH

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

EU/1/21/1559

4.7.2022.

—   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 |
| --- | --- | --- | --- | --- |
| 7.6.2022. | Episalvan | Amryt GMBH |
| Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

7.6.2022.

Episalvan

Amryt GMBH

Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland

EU/1/15/1069

8.6.2022.

24.6.2022.

Senstend

| Plethora Pharma Solutions Ltd. |
| --- |
| 32 Merrion Street Upper, Dublin 2, Ireland |

Plethora Pharma Solutions Ltd.

32 Merrion Street Upper, Dublin 2, Ireland

EU/1/19/1387

28.6.2022.

—   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 |
| --- | --- | --- | --- | --- |
| 3.6.2022. | Reconcile | FORTE Healthcare Ltd |
| Cougar Lane, Naul, Co. Dublin, Ireland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

3.6.2022.

Reconcile

FORTE Healthcare Ltd

Cougar Lane, Naul, Co. Dublin, Ireland

EU/2/08/080

8.6.2022.

3.6.2022.

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

30.6.2022.

13.6.2022.

Increxxa

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/20/258

14.6.2022.

13.6.2022.

Purevax RCP

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/052

20.6.2022.

14.6.2022.

Purevax RC

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/051

20.6.2022.

14.6.2022.

Purevax RCPCh FeLV

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/047

20.6.2022.

14.6.2022.

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

16.6.2022.

20.6.2022.

Prevomax

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

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/17/211

29.6.2022.

20.6.2022.

REXXOLIDE

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

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/20/263

27.6.2022.

24.6.2022.

Apoquel

| 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/2/13/154

28.6.2022.

24.6.2022.

Emdocam

| Emdoka bvba |
| --- |
| J. Lijsenstraat 16, 2321 Hoogstraten, België |

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

EU/2/11/128

30.6.2022.

24.6.2022.

Enteroporc Coli AC

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/20/262

27.6.2022.

24.6.2022.

Innovax-ND-IBD

| 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/2/17/213

28.6.2022.

24.6.2022.

Lydaxx

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

VETOQUINOL S.A.

Magny-Vernois, 70200 Lure, France

EU/2/20/253

30.6.2022.

24.6.2022.

Neptra

| Bayer Animal Health GmbH |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/19/246

30.6.2022.

24.6.2022.

Purevax RC

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/051

27.6.2022.

24.6.2022.

Purevax RCP

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/052

28.6.2022.

24.6.2022.

Purevax RCPCh

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/050

28.6.2022.

24.6.2022.

Purevax RCPCh

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/050

27.6.2022.

24.6.2022.

Purevax RCPCh FeLV

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/047

27.6.2022.

24.6.2022.

Purevax RCP FeLV

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/048

27.6.2022.

24.6.2022.

Purevax RCP FeLV

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/048

27.6.2022.

24.6.2022.

Sileo

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/15/181

28.6.2022.

24.6.2022.

Vectormune ND

| CEVA-Phylaxia Co. Ltd |
| --- |
| Szállás u. 5, 1107 Budapest, Magyarország |

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/15/188

3.7.2022.

24.6.2022.

Zenalpha

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

Vetcare Oy

P.O. Box 99, 24101 Salo, Suomi

EU/2/21/279

27.6.2022.

28.6.2022.

CLYNAV

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/197

29.6.2022.

29.6.2022.

Porcilis PCV

| 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/2/08/091

1.7.2022.

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 |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

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(1)  SL L 136, 30.4.04, str. 1.

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

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