# Úradný vestník C 50/31.

| | ISSN 1977-1037 |
| --- | --- |
| Úradný vestník
  Európskej únie | C 50 |
| | |
| Slovenské vydanie | Informácie a oznámenia | Ročník 6531. januára 2022 |

ISSN 1977-1037

Úradný vestník

Európskej únie

C 50

Slovenské vydanie

Informácie a oznámenia

Ročník 6531. januára 2022

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| Obsah | Strana |
| --- | --- |
| | IV   Informácie |
| | INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE |
| | Európska komisia |
| 2022/C 50/01 | Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. decembra 2021 do 31. decembra 2021[Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004] | 1 |

Obsah

Strana

IV   Informácie

INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE

Európska komisia

2022/C 50/01

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. decembra 2021 do 31. decembra 2021[Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004]

[Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004]

1

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

SK

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IV Informácie

INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE

Európska komisia

| 31.1.2022 | SK | Úradný vestník Európskej únie | C 50/1 |
| --- | --- | --- | --- |

31.1.2022

SK

Úradný vestník Európskej únie

C 50/1

---

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. decembra 2021 do 31. decembra 2021

[Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004 (1)]

(2022/C 50/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.12.2021 | Cibinqo | abrocitinib | Pfizer Europe MA EEIG |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |

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

9.12.2021

Cibinqo

abrocitinib

Pfizer Europe MA EEIG

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

EU/1/21/1593

Filmom obalená tableta

D11AH

10.12.2021

9.12.2021

Rybrevant

amivantamab

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/21/1594

Koncentrát na infúzny roztok

L01FX18

10.12.2021

9.12.2021

Sitagliptin SUN

sitagliptín-fumarát

| Sun Pharmaceutical Industries Europe BV |
| --- |
| Polarisavenue 87, 2132 JH Hoofddorp, Nederland |

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/21/1598

Filmom obalená tableta

A10BH01

15.12.2021

13.12.2021

ASPAVELI

pegcetacoplano

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| 112 76 Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/21/1595

Infúzny intravenózny roztok

L04AA54

14.12.2021

13.12.2021

Vaxneuvance

Pneumokoková polysacharidová konjugovaná očkovacia látka (15-valentná, adsorbovaná)

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/21/1591

Injekčná suspenzia

J07AL

14.12.2021

17.12.2021

Xevudy

sotrovimab

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

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/21/1562

Koncentrát na infúzny roztok

Pending

17.12.2021

20.12.2021

Nuvaxovid

Očkovacia látka proti COVID-19 (rekombinantná, s adjuvans)

| Novavax CZ, a. s. |
| --- |
| Bohumil 138, 281 63 Jevany, Česká republika |

Novavax CZ, a. s.

Bohumil 138, 281 63 Jevany, Česká republika

EU/1/21/1618

Injekčná disperzia

J07BX03

20.12.2021

—   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 |
| --- | --- | --- | --- | --- |
| 2.12.2021 | Cimzia | UCB Pharma S.A. |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

2.12.2021

Cimzia

UCB Pharma S.A.

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

EU/1/09/544

3.12.2021

2.12.2021

Ebilfumin

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

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/14/915

7.12.2021

2.12.2021

Ivozall

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

ORPHELIA Pharma SAS

85 boulevard Saint-Michel, 75005 Paris, France

EU/1/19/1396

7.12.2021

2.12.2021

Kaletra

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/01/172

3.12.2021

2.12.2021

Revinty Ellipta

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

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/929

3.12.2021

3.12.2021

Kiovig

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

Baxter AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/05/329

6.12.2021

3.12.2021

Lojuxta

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

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/13/851

15.12.2021

3.12.2021

Naglazyme

| BioMarin International Limited |
| --- |
| Shanbally, Ringaskiddy, County Cork P43 R298, Ireland |

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork P43 R298, Ireland

EU/1/05/324

11.1.2022

3.12.2021

Ocrevus

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

Roche Registration GmbH

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

EU/1/17/1231

6.12.2021

3.12.2021

Polivy

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

Roche Registration GmbH

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

EU/1/19/1388

7.12.2021

3.12.2021

Xagrid

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| 50-58 Baggot Street Lower, Block 3 Miesian Plaza, Dublin 2, Co Dublin, D02 Y754, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

50-58 Baggot Street Lower, Block 3 Miesian Plaza, Dublin 2, Co Dublin, D02 Y754, Ireland

EU/1/04/295

6.12.2021

6.12.2021

RoActemra

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

Roche Registration GmbH

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

EU/1/08/492

7.12.2021

7.12.2021

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

7.12.2021

8.12.2021

Spikevax

| MODERNA BIOTECH SPAIN, S.L. |
| --- |
| Calle Monte Esquinza 30, 28010 Madrid, España |

MODERNA BIOTECH SPAIN, S.L.

Calle Monte Esquinza 30, 28010 Madrid, España

EU/1/20/1507

8.12.2021

9.12.2021

ADCETRIS

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbæk Strand, Danmark

EU/1/12/794

14.12.2021

9.12.2021

AMGEVITA

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1164

13.12.2021

9.12.2021

Amyvid

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/12/805

13.12.2021

9.12.2021

Apealea

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

Inceptua AB

Gustavslundsv. 143, 16751 Bromma, Sverige

EU/1/18/1292

10.12.2021

9.12.2021

Chenodeoxycholic acid Leadiant

| Leadiant GmbH |
| --- |
| Liebherrstr. 22, 80538 Munich, Deutschland |

Leadiant GmbH

Liebherrstr. 22, 80538 Munich, Deutschland

EU/1/16/1110

10.12.2021

9.12.2021

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

10.12.2021

9.12.2021

Dengvaxia

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

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/18/1338

13.12.2021

9.12.2021

Erleada

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/18/1342

10.12.2021

9.12.2021

Esbriet

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

Roche Registration GmbH

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

EU/1/11/667

10.12.2021

9.12.2021

Exelon

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

Novartis Europharm Limited

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

EU/1/98/066

10.12.2021

9.12.2021

Holoclar

| Holostem Terapie Avanzate S.r.l. |
| --- |
| Via Glauco Gottardi 100, Modena, MO 41125, Italia |

Holostem Terapie Avanzate S.r.l.

Via Glauco Gottardi 100, Modena, MO 41125, Italia

EU/1/14/987

13.12.2021

9.12.2021

JETREA

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

Inceptua AB

Gustavslundsv. 143, 16751 Bromma, Sverige

EU/1/13/819

10.12.2021

9.12.2021

Leganto

| 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/1/11/695

10.12.2021

9.12.2021

Livogiva

| Theramex Ireland Limited |
| --- |
| 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland |

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/20/1462

13.12.2021

9.12.2021

Ogluo

| Tetris Pharma B.V |
| --- |
| Element Offices, Bargelaan 180-200, 2333 CW, Leiden, Nederland |

Tetris Pharma B.V

Element Offices, Bargelaan 180-200, 2333 CW, Leiden, Nederland

EU/1/20/1523

13.12.2021

9.12.2021

Pioglitazone Accord

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

Accord Healthcare S.L.U.

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

EU/1/11/722

10.12.2021

9.12.2021

Pradaxa

| 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/1/08/442

14.12.2021

9.12.2021

Roteas

| Berlin-Chemie AG |
| --- |
| Glienicker Weg 125, 12489 Berlin, Deutschland |

Berlin-Chemie AG

Glienicker Weg 125, 12489 Berlin, Deutschland

EU/1/16/1152

15.12.2021

9.12.2021

Stalevo

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/03/260

10.12.2021

9.12.2021

Thalidomide BMS

| 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/1/08/443

10.12.2021

9.12.2021

Xospata

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, 2333 BE Leiden, Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/19/1399

10.12.2021

9.12.2021

ZALTRAP

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/12/814

10.12.2021

9.12.2021

Zyprexa

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/96/022

13.12.2021

9.12.2021

Zyprexa Velotab

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/99/125

13.12.2021

13.12.2021

ADCETRIS

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbæk Strand, Danmark

EU/1/12/794

14.12.2021

13.12.2021

Conbriza

| 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/1/09/511

14.12.2021

13.12.2021

Giotrif

| 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/1/13/879

14.12.2021

13.12.2021

Invanz

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/02/216

14.12.2021

13.12.2021

Kanuma

| Alexion Europe SAS |
| --- |
| 103-105 rue Anatole France, 92300 Levallois-Perret, France |

Alexion Europe SAS

103-105 rue Anatole France, 92300 Levallois-Perret, France

EU/1/15/1033

14.12.2021

13.12.2021

Kinzalmono

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/98/091

14.12.2021

13.12.2021

Mycophenolate mofetil Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/439

14.12.2021

13.12.2021

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

15.12.2021

13.12.2021

Neuraceq

| Life Radiopharma Berlin GmbH |
| --- |
| Max-Planck-Straße 4, 12489 Berlin, Deutschland |

Life Radiopharma Berlin GmbH

Max-Planck-Straße 4, 12489 Berlin, Deutschland

EU/1/13/906

15.12.2021

13.12.2021

NULOJIX

| 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/1/11/694

14.12.2021

13.12.2021

Pramipexole Accord

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

Accord Healthcare S.L.U.

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

EU/1/11/728

16.12.2021

13.12.2021

Pramipexole Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/490

17.12.2021

13.12.2021

Rapiscan

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

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/10/643

15.12.2021

13.12.2021

Rebif

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

Merck Europe B.V.

Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland

EU/1/98/063

17.12.2021

13.12.2021

Rivastigmine Sandoz

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/09/599

15.12.2021

13.12.2021

Thalidomide BMS

| 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/1/08/443

14.12.2021

13.12.2021

Xofigo

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/873

15.12.2021

16.12.2021

Ceprotin

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

Baxter AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/01/190

17.12.2021

16.12.2021

Cinacalcet Accordpharma

| 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/1/20/1429

17.12.2021

16.12.2021

Clopidogrel Krka d.d.

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

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

20.12.2021

16.12.2021

Clopidogrel 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/1/08/465

23.12.2021

16.12.2021

COVID-19 Vaccine Janssen

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

16.12.2021

16.12.2021

Dexdor

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/718

19.12.2021

16.12.2021

Grepid

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535

17.12.2021

16.12.2021

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

20.12.2021

16.12.2021

Humira

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/03/256

17.12.2021

16.12.2021

Jyseleca

| Galapagos NV |
| --- |
| Generaal De Wittelaan L11 A3, 2800 Mechelen Antwerp, België |

Galapagos NV

Generaal De Wittelaan L11 A3, 2800 Mechelen Antwerp, België

EU/1/20/1480

17.12.2021

16.12.2021

KANJINTI

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/18/1281

20.12.2021

16.12.2021

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

20.12.2021

16.12.2021

Revestive

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

Shire Pharmaceuticals Ireland Limited

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

EU/1/12/787

23.12.2021

16.12.2021

Rinvoq

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

17.12.2021

16.12.2021

Sarclisa

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/20/1435

17.12.2021

16.12.2021

Siklos

| Addmedica |
| --- |
| 37 rue de Caumartin, 75009 Paris, France |

Addmedica

37 rue de Caumartin, 75009 Paris, France

EU/1/07/397

17.12.2021

16.12.2021

Vemlidy

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1154

17.12.2021

16.12.2021

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

17.12.2021

16.12.2021

Zoely

| Theramex Ireland Limited |
| --- |
| 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland |

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/11/690

21.12.2021

16.12.2021

Zoely

| Theramex Ireland Limited |
| --- |
| 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland |

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/11/690

21.12.2021

17.12.2021

Kineret

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| 112 76 Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/02/203

17.12.2021

20.12.2021

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

21.12.2021

20.12.2021

Nitisinone MDK

| MendeliKABS Europe Limited |
| --- |
| Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23 AT2P, Ireland |

MendeliKABS Europe Limited

Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23 AT2P, Ireland

EU/1/17/1217

21.12.2021

20.12.2021

PANTOLOC Control

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

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/519

21.12.2021

20.12.2021

Raloxifene Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/627

23.12.2021

20.12.2021

Selincro

| H. Lundbeck A/S |
| --- |
| Ottiliavej 9, 2500 Valby, Danmark |

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/12/815

21.12.2021

20.12.2021

Veklury

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

20.12.2021

20.12.2021

Voriconazole Hikma

| Hikma Farmacêutica (Portugal), S.A. |
| --- |
| Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal |

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal

EU/1/15/1004

4.1.2022

—   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 |
| --- | --- | --- | --- | --- |
| 13.12.2021 | Leganto | UCB Pharma S.A. |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

13.12.2021

Leganto

UCB Pharma S.A.

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

EU/1/11/695

4.1.2022

20.12.2021

PANTOLOC Control

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

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/519

21.12.2021

20.12.2021

Rasilez HCT

| Noden Pharma DAC |
| --- |
| D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland |

Noden Pharma DAC

D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland

EU/1/08/491

22.12.2021

20.12.2021

Ytracis

| CIS bio international |
| --- |
| Boite Postale 32, 91192 Gif-sur-Yvette, France |

CIS bio international

Boite Postale 32, 91192 Gif-sur-Yvette, France

EU/1/03/250

22.12.2021

—   Udelenie povolenia na uvedenie na trh (článok 38 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.12.2021 | Imoxat | imidakloprid/moxidektin | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, Co. Galway, 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

7.12.2021

Imoxat

imidakloprid/moxidektin

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/21/280

Roztok na kvapkanie na kožu

QP54AB52

9.12.2021

7.12.2021

Suiseng Diff/A

Inaktivovaná vakcína proti Clostridioides difficile a Clostridium perfringens

| 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/2/21/278

Injekčná suspenzia

QI09AB12

9.12.2021

15.12.2021

Zenalpha

medetomidín hydrochlorid/vatinoxan hydrochlorid

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

Vetcare Oy

P.O. Box 99, 24101 Salo, Suomi

EU/2/21/279

Injekčný roztok

QN05CM99

16.12.2021

—   Zmena povolenia na uvedenie na trh (článok 38 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 |
| --- | --- | --- | --- | --- |
| 7.12.2021 | Circovac | CEVA-Phylaxia Co. Ltd |
| Szállás u. 5, 1107 Budapest, Magyarország |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

7.12.2021

Circovac

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/07/075

9.12.2021

7.12.2021

Stronghold Plus

| 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/2/16/204

13.12.2021

13.12.2021

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

15.12.2021

15.12.2021

Bravecto Plus

| 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/2/18/224

16.12.2021

15.12.2021

Cardalis

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/12/142

16.12.2021

15.12.2021

Osurnia

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

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/14/170

16.12.2021

15.12.2021

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

16.12.2021

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, 30.4.2004, s. 1.

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