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

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

(2022/C 96/02)

— 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

6.1.2022

Lumykras

sotorasib

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/21/1603

Filmom obalená tableta

L01XX73

7.1.2022

6.1.2022

Riltrava Aerosphere

Formoterol / glykopyrónium-bromid / budezonid

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1604

Inhalačná suspenzia v tlakovom obale

R03AL11

7.1.2022

6.1.2022

Tecovirimat SIGA

tecovirimat

SIGA Technologies Netherlands B.V.

Prinsenhil 29, Breda 4825 AX, Nederland

EU/1/21/1600

Tvrdá kapsula

J05AX24

7.1.2022

6.1.2022

Wegovy

Semaglutid

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/21/1608

Injekčný roztok

A10BJ06

7.1.2022

11.1.2022

Lonapegsomatropin Ascendis Pharma

Lonapegsomatropín

Ascendis Pharma Endocrinology Division A/S

Tuborg Boulevard 12, 2900 Hellerup, Danmark

EU/1/21/1607

Prášok a rozpúšťadlo na injekčný roztok

Pending

17.1.2022

11.1.2022

Tavneos

avakopan

Vifor Fresenius Medical Care Renal Pharma France

100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France

EU/1/21/1605

Tvrdá kapsula

Pending

19.1.2022

11.1.2022

Voraxaze

glukarpidáza

SERB SAS

40 Avenue George V, 75008 Paris, France

EU/1/21/1586

Prášok na injekčný roztok

V03AF09

13.1.2022

24.1.2022

Vyepti

eptinezumab

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/21/1599

Koncentrát na infúzny roztok

N02CD05

25.1.2022

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

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

6.1.2022

Nouryant

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

—

11.1.2022

— 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

3.1.2022

COVID-19 Vaccine Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

4.1.2022

6.1.2022

ADYNOVI

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/17/1247

7.1.2022

6.1.2022

Arsenic trioxide Mylan

Mylan Ireland Limited

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

EU/1/20/1427

7.1.2022

6.1.2022

Bavencio

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

10.1.2022

6.1.2022

Braftovi

Pierre Fabre Médicament

Les Cauquillous, 81500 Lavaur, France

EU/1/18/1314

10.1.2022

6.1.2022

CRYSVITA

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/17/1262

12.1.2022

6.1.2022

Darzalex

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

7.1.2022

6.1.2022

Dupixent

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1229

7.1.2022

6.1.2022

Elocta

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/15/1046

10.1.2022

6.1.2022

Emtricitabine /Tenofovir disoproxil Krka d.d.

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1182

12.1.2022

6.1.2022

Ferriprox

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/99/108

3.2.2022

6.1.2022

Inhixa

Techdow Pharma Netherlands B.V.

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

EU/1/16/1132

18.1.2022

6.1.2022

Metalyse

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/00/169

11.1.2022

6.1.2022

Noxafil

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/320

10.1.2022

6.1.2022

Nuwiq

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/14/936

10.1.2022

6.1.2022

Qarziba

EUSA Pharma (Netherlands) B.V.

Beechavenue 54, 1119PW Schiphol-Rijk, Nederland

EU/1/17/1191

12.1.2022

6.1.2022

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/901

7.1.2022

6.1.2022

Tecfidera

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/13/837

7.1.2022

6.1.2022

Trydonis

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1274

7.1.2022

6.1.2022

Vfend

Pfizer Europe MA EEIG

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

EU/1/02/212

7.1.2022

6.1.2022

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/714

7.1.2022

Epclusa

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1116

10.1.2022

7.1.2022

Kaftrio

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/20/1468

10.1.2022

7.1.2022

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/12/782

10.1.2022

7.1.2022

Ledaga

Helsinn Birex Pharmaceuticals Ltd.

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/16/1171

10.1.2022

7.1.2022

LIBTAYO

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27 Ireland

EU/1/19/1376

11.1.2022

7.1.2022

Rolufta Ellipta

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1174

11.1.2022

7.1.2022

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

13.1.2022

11.1.2022

Caprelsa

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/11/749

13.1.2022

11.1.2022

elmiron

bene-Arzneimittel GmbH

Herterichstraße 1-3, 81479 München, Deutschland

EU/1/17/1189

12.1.2022

11.1.2022

Ozempic

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1251

12.1.2022

11.1.2022

Yargesa

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland

EU/1/17/1176

13.1.2022

12.1.2022

Multaq

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/09/591

13.1.2022

12.1.2022

Ocaliva

Intercept Pharma International Limited

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

EU/1/16/1139

13.1.2022

14.1.2022

COVID-19 Vaccine Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

14.1.2022

Lonquex

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/856

18.1.2022

14.1.2022

Vaxzevria

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

14.1.2022

20.1.2022

Abecma

Bristol-Myers Squibb Pharma EEIG

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

EU/1/21/1539

21.1.2022

20.1.2022

Cosentyx

Novartis Europharm Limited

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

EU/1/14/980

24.1.2022

20.1.2022

Inhixa

Techdow Pharma Netherlands B.V.

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

EU/1/16/1132

21.1.2022

20.1.2022

Lumigan

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/02/205

25.1.2022

20.1.2022

Plenadren

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/11/715

24.1.2022

20.1.2022

Pradaxa

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

24.1.2022

20.1.2022

Yescarta

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

EU/1/18/1299

21.1.2022

24.1.2022

Bridion

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/466

25.1.2022

24.1.2022

Cinryze

Shire Services BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België

EU/1/11/688

25.1.2022

24.1.2022

Circadin

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

EU/1/07/392

26.1.2022

24.1.2022

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

24.1.2022

Exjade

Novartis Europharm Limited

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

EU/1/06/356

25.1.2022

24.1.2022

Fotivda

EUSA Pharma (Netherlands) B.V.

Beechavenue 54, 1119PW Schiphol-Rijk, Nederland

EU/1/17/1215

28.1.2022

24.1.2022

Javlor

PIERRE FABRE MEDICAMENT

Les Cauquillous, 81500 Lavaur, France

EU/1/09/550

25.1.2022

24.1.2022

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

25.1.2022

24.1.2022

Kymriah

Novartis Europharm Limited

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

EU/1/18/1297

25.1.2022

24.1.2022

Lokelma

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

25.1.2022

24.1.2022

NUCEIVA

Evolus Pharma B.V.

Apollolaan 151, 1077 AR Amsterdam, Nederland

EU/1/19/1364

7.2.2022

24.1.2022

Oslif Breezhaler

Novartis Europharm Limited

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

EU/1/09/586

25.1.2022

24.1.2022

Pregabalin Sandoz GmbH

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1012

25.1.2022

24.1.2022

Tecartus

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

EU/1/20/1492

25.1.2022

24.1.2022

Teysuno

Nordic Group B.V.

Siriusdreef 41, 2132 WT Hoofddorp, Nederland

EU/1/11/669

26.1.2022

24.1.2022

Ultibro Breezhaler

Novartis Europharm Limited

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

EU/1/13/862

25.1.2022

24.1.2022

Vizarsin

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/551

26.1.2022

24.1.2022

Zynquista

Guidehouse Germany GmbH

Albrechtstrasse 10c, 10117 Berlin, Deutschland

EU/1/19/1363

29.1.2022

25.1.2022

Actraphane

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/229

31.1.2022

25.1.2022

Actrapid

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/230

26.1.2022

25.1.2022

Fasenra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1252

27.1.2022

25.1.2022

Lantus

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134

26.1.2022

25.1.2022

Prolia

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/10/618

27.1.2022

25.1.2022

Sixmo

L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A

Strada Statale 67, 50018 Scandicci (Firenze), Italia

EU/1/19/1369

27.1.2022

Arsenic trioxide medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/20/1475

31.1.2022

27.1.2022

Desloratadin ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/11/746

30.1.2022

27.1.2022

Gilenya

Novartis Europharm Limited

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

EU/1/11/677

28.1.2022

27.1.2022

Libmeldy

Orchard Therapeutics (Netherlands) B.V.

Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland

EU/1/20/1493

31.1.2022

27.1.2022

Lorviqua

Pfizer Europe MA EEIG

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

EU/1/19/1355

28.1.2022

27.1.2022

Pemetrexed Accord

Accord Healthcare S.L.U.

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

EU/1/15/1071

28.1.2022

27.1.2022

Staquis

Pfizer Europe MA EEIG

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

EU/1/19/1421

28.1.2022

27.1.2022

Telmisartan Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/719

28.1.2022

27.1.2022

Zinforo

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/12/785

28.1.2022

27.1.2022

Zonegran

Amdipharm Limited

3 Burlington Road, Dublin 4, D04 RD68, IRELAND

EU/1/04/307

28.1.2022

31.1.2022

Avastin

Roche Registration GmbH

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

EU/1/04/300

1.2.2022

31.1.2022

Benepali

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/15/1074

4.2.2022

31.1.2022

Besremi

AOP Orphan Pharmaceuticals GmbH,

Leopold-Ungar-Platz 2, 1190 Wien, Österreich

EU/1/18/1352

2.2.2022

31.1.2022

Entyvio

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/14/923

2.2.2022

31.1.2022

Ervebo

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/19/1392

2.2.2022

31.1.2022

Fareston

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/96/004

1.2.2022

31.1.2022

Juluca

ViiV Healthcare B.V.

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

EU/1/18/1282

1.2.2022

31.1.2022

Luveris

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/00/155

2.2.2022

31.1.2022

Mulpleo

Shionogi B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Nederland

EU/1/18/1348

1.2.2022

31.1.2022

Pemetrexed Hospira

Pfizer Europe MA EEIG

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

EU/1/15/1057

1.2.2022

31.1.2022

Rhokiinsa

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/19/1400

2.2.2022

31.1.2022

Spinraza

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/17/1188

1.2.2022

31.1.2022

Tivicay

ViiV Healthcare BV

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

EU/1/13/892

1.2.2022

— 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

31.1.2022

Staquis

Pfizer Europe MA EEIG

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

EU/1/19/1421

1.2.2022

— 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

11.1.2022

CircoMax

Vakcína proti prasaciemu cirkovírusu (inaktivovaná, rekombinantná)

Zoetis Belgium S.A.

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

EU/2/21/281

Injekčná emulzia

QI09AA07

12.1.2022

— 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

4.1.2022

Meloxidolor

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/13/148

11.1.2022

4.1.2022

Sileo

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/15/181

5.1.2022

4.1.2022

VarroMed

BeeVital GmbH

Wiesenbergstrasse 19,A- 5164, Seeham, Österreich

EU/2/16/203

17.1.2022

11.1.2022

Innovax-ILT

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/182

13.1.2022

11.1.2022

Vectormune FP ILT + AE

Ceva-Phylaxia Co.Ltd.

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/20/250

17.1.2022

20.1.2022

Improvac

Zoetis Belgium S.A.

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

EU/2/09/095

21.1.2022

24.1.2022

Suvaxyn Aujeszky 783 + O/W

Zoetis Belgium S.A.

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

EU/2/98/009

25.1.2022

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

(1) Ú. v. EÚ L 136, 30.4.2004, s. 1.