ISSN 1977-1029

Jurnalul Oficial

al Uniunii Europene

C 441
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Ediţia în limba română

Comunicări şi informări

Anul 64
29 octombrie 2021

Cuprins

Pagina

 

IV   Informări

 

INFORMĂRI PROVENIND DE LA INSTITUŢIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

 

Comisia Europeană

2021/C 441/01

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 septembrie 2021 până la 30 septembrie 2021[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

1

RO

 

IV Informări

INFORMĂRI PROVENIND DE LA INSTITUŢIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

Comisia Europeană

29.10.2021   

RO

Jurnalul Oficial al Uniunii Europene

C 441/1

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 septembrie 2021 până la 30 septembrie 2021

[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului (1)]

(2021/C 441/01)

—   Emiterea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

Data deciziei

Denumirea medicamentului

DCI (Denumirea Comună Internațională)

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Formă farmaceutică

Codul ATC (Codul Anatomic-Terapeutic-Chimic)

Data notificării

16.9.2021

Cometriq

cabozantinib

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

Capsule

L01EX07

22.9.2021

22.9.2021

Imatinib Koanaa

imatinib

Koanaa Healthcare GmbH

Fehrgasse 7, 2401 Fischamend, Österreich

EU/1/21/1568

Soluţie orală

L01EA01

24.9.2021

—   Modificarea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

1.9.2021

Deferasirox Mylan

Mylan Pharmaceuticals Limited

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

EU/1/19/1386

2.9.2021

1.9.2021

Herceptin

Roche Registration GmbH

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

EU/1/00/145

29.9.2021

1.9.2021

Repaglinide Accord

Accord Healthcare S.L.U.

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

EU/1/11/743

2.9.2021

1.9.2021

Ultomiris

Alexion Europe SAS

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

EU/1/19/1371

2.9.2021

1.9.2021

ZINPLAVA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1156

3.9.2021

3.9.2021

COVID-19 Vaccine Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

6.9.2021

6.9.2021

Riluzole Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/12/768

7.9.2021

6.9.2021

Ristfor

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/10/620

7.9.2021

14.9.2021

Vaxzevria

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

14.9.2021

15.9.2021

Amlodipină/Valsartan Mylan

Mylan Pharmaceuticals Limited

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

EU/1/16/1092

17.9.2021

15.9.2021

Cystadrops

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/15/1049

28.9.2021

15.9.2021

Emtricitabine/Tenofovir disoproxil Krka

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/16/1151

16.9.2021

15.9.2021

Exjade

Novartis Europharm Limited

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

EU/1/06/356

16.9.2021

15.9.2021

Fulphila

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/18/1329

23.9.2021

15.9.2021

Janumet

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/455

17.9.2021

15.9.2021

Resolor

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/09/581

16.9.2021

15.9.2021

TachoSil

Corza Medical GmbH

Speditionsstraße 21, 40221 Düsseldorf, Deutschland

EU/1/04/277

16.9.2021

15.9.2021

Tadalafil Mylan

Mylan Pharmaceuticals Limited

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

EU/1/14/961

23.9.2021

16.9.2021

ADCETRIS

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/12/794

20.9.2021

16.9.2021

Darunavir Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1140

17.9.2021

16.9.2021

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

17.9.2021

16.9.2021

Elebrato Ellipta

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1237

17.9.2021

16.9.2021

Epivir

ViiV Healthcare B.V.

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

EU/1/96/015

20.9.2021

16.9.2021

Exviera

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

20.9.2021

16.9.2021

Infanrix hexa

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/00/152

21.9.2021

16.9.2021

Lenalidomide Accord

Accord Healthcare S.L.U.

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

EU/1/18/1316

17.9.2021

16.9.2021

Lenalidomide Mylan

Mylan Ireland Limited

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

EU/1/20/1490

23.9.2021

16.9.2021

Movymia

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/16/1161

17.9.2021

16.9.2021

Parsabiv

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1142

20.9.2021

16.9.2021

Revlimid

Bristol-Myers Squibb Pharma EEIG

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

EU/1/07/391

21.9.2021

16.9.2021

Rubraca

Clovis Oncology Ireland Limited

Regus Dublin Airport, Skybridge House – Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland

EU/1/17/1250

20.9.2021

16.9.2021

SomaKit TOC

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

EU/1/16/1141

20.9.2021

16.9.2021

Terrosa

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/16/1159

29.9.2021

16.9.2021

Trelegy Ellipta

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1236

17.9.2021

16.9.2021

Vosevi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/17/1223

20.9.2021

16.9.2021

Zynteglo

bluebird bio (Netherlands) B.V.

Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland

EU/1/19/1367

17.9.2021

22.9.2021

Acid zoledronic Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/12/759

23.9.2021

22.9.2021

AJOVY

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/19/1358

23.9.2021

22.9.2021

Anagrelidă Mylan

Mylan Pharmaceuticals Limited

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

EU/1/17/1256

29.9.2021

22.9.2021

Azilect

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/04/304

23.9.2021

22.9.2021

BeneFIX

Pfizer Europe MA EEIG

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

EU/1/97/047

23.9.2021

22.9.2021

Constella

Allergan Pharmaceuticals International Limited

Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland

EU/1/12/801

4.10.2021

22.9.2021

Defitelio

Gentium S.r.I.

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

EU/1/13/878

5.10.2021

22.9.2021

Docetaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/611

24.9.2021

22.9.2021

Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1133

27.9.2021

22.9.2021

Febuxostat Mylan

Mylan Pharmaceuticals Limited

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

EU/1/17/1194

27.9.2021

22.9.2021

Hepcludex

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1446

23.9.2021

22.9.2021

Insulatard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/233

23.9.2021

22.9.2021

Intuniv

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/15/1040

23.9.2021

22.9.2021

Mepsevii

Ultragenyx Germany GmbH

Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland

EU/1/18/1301

23.9.2021

22.9.2021

Mixtard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/231

26.9.2021

22.9.2021

NovoRapid

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/99/119

23.9.2021

22.9.2021

Protaphane

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/234

23.9.2021

22.9.2021

Telmisartan Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/10/639

23.9.2021

22.9.2021

Triumeq

ViiV Healthcare BV

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

EU/1/14/940

23.9.2021

22.9.2021

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

23.9.2021

22.9.2021

Vihuma

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/16/1168

28.9.2021

22.9.2021

Volibris

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/08/451

23.9.2021

22.9.2021

Xultophy

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/14/947

23.9.2021

22.9.2021

Zoledronic acid Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/12/786

5.10.2021

23.9.2021

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

23.9.2021

23.9.2021

Grastofil

Accord Healthcare S.L.U.

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

EU/1/13/877

27.9.2021

23.9.2021

Levemir

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/04/278

26.9.2021

23.9.2021

Liprolog

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/01/195

27.9.2021

23.9.2021

Rasagilină ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/977

24.9.2021

23.9.2021

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

24.9.2021

23.9.2021

Rivastigmine 1 A Pharma

1 A Pharma GmbH

Keltenring 1 + 3, 82041 Oberhaching, Deutschland

EU/1/09/585

27.9.2021

23.9.2021

Zoledronic acid Accord

Accord Healthcare S.L.U.

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

EU/1/13/834

27.9.2021

29.9.2021

Adakveo

Novartis Europharm Limited

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

EU/1/20/1476

30.9.2021

29.9.2021

Ambrisentan Mylan

Mylan Pharmaceuticals Limited

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

EU/1/19/1368

1.10.2021

29.9.2021

Atazanavir Mylan

Mylan Pharmaceuticals Limited

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

EU/1/16/1091

30.9.2021

29.9.2021

Brilique

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/655

1.10.2021

29.9.2021

Cinacalcet Mylan

Mylan Pharmaceuticals Limited

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

EU/1/15/1054

1.10.2021

29.9.2021

COVID-19 Vaccine Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

29.9.2021

29.9.2021

Duloxetine Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1010

30.9.2021

29.9.2021

Duloxetine Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10,

Česká republika

EU/1/15/1028

30.9.2021

29.9.2021

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Mylan Pharmaceuticals Limited

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

EU/1/17/1222

30.9.2021

29.9.2021

Entacapone Orion

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/708

1.10.2021

29.9.2021

Imatinib Accord

Accord Healthcare S.L.U.

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

EU/1/13/845

1.10.2021

29.9.2021

Ivabradine Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10,

Česká republika

EU/1/16/1144

30.9.2021

29.9.2021

Lamivudine/ Zidovudine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/663

1.10.2021

29.9.2021

Nevirapine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/598

1.10.2021

29.9.2021

NovoSeven

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/96/006

1.10.2021

29.9.2021

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/06/380

4.10.2021

29.9.2021

Ryzodeg

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/12/806

1.10.2021

29.9.2021

Sildenafil ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/09/603

4.10.2021

29.9.2021

Sildenafil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/584

1.10.2021

29.9.2021

Symtuza

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1225

30.9.2021

29.9.2021

TAKHZYRO

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/18/1340

30.9.2021

29.9.2021

Tresiba

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/12/807

1.10.2021

29.9.2021

Vemlidy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1154

30.9.2021

29.9.2021

Zalviso

FGK Representative Service GmbH

Heimeranstraße 35, 80339 München, Deutschland

EU/1/15/1042

4.10.2021

29.9.2021

Zydelig

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/938

30.9.2021

—   Modificarea unei autorizații de introducere pe piață [articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

16.9.2021

Halagon

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

EU/2/16/201

17.9.2021

16.9.2021

Nobivac L4

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/12/143

18.9.2021

16.9.2021

Respiporc Flu3

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/09/103

17.9.2021

28.9.2021

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/11/134

4.10.2021

28.9.2021

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/07/078

4.10.2021

Oricine este interesat să consulte raportul public de evaluare al medicamentului în cauză și deciziile aferente este invitat să contacteze:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

(1)  JO L 136, 30.4.2004, p. 1.