ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 478
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Izdevums latviešu valodā

Informācija un paziņojumi

64. gadagājums
2021. gada 26. novembris

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Lappuse

 

IV   Paziņojumi

 

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

 

Eiropas Komisija

2021/C 478/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2021. gada 1. oktobra līdz 2021. gada 31. oktobrim(publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

1

LV

 

IV Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

26.11.2021   

LV

Eiropas Savienības Oficiālais Vēstnesis

C 478/1

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2021. gada 1. oktobra līdz 2021. gada 31. oktobrim

(publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004 (1))

(2021/C 478/01)

—   Tirdzniecības atļaujas grozīšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

1.10.2021.

COVID-19 Vaccine Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

1.10.2021.

4.10.2021.

Docetaxel Accord

Accord Healthcare S.L.U.

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

EU/1/12/769

5.10.2021.

4.10.2021.

Docetaxel Kabi

Fresenius Kabi Deutschland GmbH

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

EU/1/12/770

6.10.2021.

4.10.2021.

Posaconazole Accord

Accord Healthcare S.L.U.

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

EU/1/19/1379

5.10.2021.

4.10.2021.

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle Monte Esquinza 30, 28010 Madrid, España

EU/1/20/1507

4.10.2021.

5.10.2021.

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

5.10.2021.

5.10.2021.

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle Monte Esquinza 30, 28010 Madrid, España

EU/1/20/1507

5.10.2021.

11.10.2021.

Copalia

Novartis Europharm Limited

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

EU/1/06/372

12.10.2021.

11.10.2021.

COVID-19 Vaccine Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

11.10.2021.

11.10.2021.

Dafiro

Novartis Europharm Limited

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

EU/1/06/371

12.10.2021.

11.10.2021.

Entecavir Mylan

Mylan Pharmaceuticals Limited

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

EU/1/17/1227

12.10.2021.

11.10.2021.

Equidacent

Centus Biotherapeutics Europe Limited

6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland

EU/1/20/1472

8.11.2021.

11.10.2021.

Exforge

Novartis Europharm Limited

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

EU/1/06/370

12.10.2021.

11.10.2021.

Onpattro

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/18/1320

13.10.2021.

11.10.2021.

Ovitrelle

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/00/165

12.10.2021.

11.10.2021.

ReFacto AF

Pfizer Europe MA EEIG

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

EU/1/99/103

12.10.2021.

11.10.2021.

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/050

14.10.2021.

11.10.2021.

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

27.10.2021.

11.10.2021.

Vyndaqel

Pfizer Europe MA EEIG

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

EU/1/11/717

12.10.2021.

15.10.2021.

Vaxzevria

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

15.10.2021.

19.10.2021.

Ammonaps

Immedica Pharma AB

SE-113 29 Stockholm, Sverige

EU/1/99/120

20.10.2021.

19.10.2021.

Busilvex

Pierre Fabre Médicament

45 place Abel Gance, 92654 Boulogne-Billancourt CEDEX, France

EU/1/03/254

20.10.2021.

19.10.2021.

Ceprotin

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/01/190

20.10.2021.

19.10.2021.

Clopidogrel/Acetylsalicylic acid Mylan

Mylan Pharmaceuticals Limited

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

EU/1/19/1395

20.10.2021.

19.10.2021.

Duloxetine Mylan

Mylan Pharmaceuticals Limited

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

EU/1/15/1010

21.10.2021.

19.10.2021.

Ecalta

Pfizer Europe MA EEIG

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

EU/1/07/416

20.10.2021.

19.10.2021.

Erelzi

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1195

20.10.2021.

19.10.2021.

Firmagon

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark

EU/1/08/504

25.10.2021.

19.10.2021.

Forsteo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/03/247

25.10.2021.

19.10.2021.

Gazyvaro

Roche Registration GmbH

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

EU/1/14/937

20.10.2021.

19.10.2021.

Gefitinib Mylan

Mylan Pharmaceuticals Limited

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

EU/1/18/1321

20.10.2021.

19.10.2021.

Hefiya

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

20.10.2021.

19.10.2021.

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

21.10.2021.

19.10.2021.

Inrebic

Bristol-Myers Squibb Pharma EEIG

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

EU/1/20/1514

21.10.2021.

19.10.2021.

Integrilin

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/99/109

20.10.2021.

19.10.2021.

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

21.10.2021.

19.10.2021.

Lopinavir/Ritonavir Mylan

Mylan Pharmaceuticals Limited

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

EU/1/15/1067

21.10.2021.

19.10.2021.

Memantine LEK

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/13/826

21.10.2021.

19.10.2021.

Memantine Mylan

Mylan Pharmaceuticals Limited

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

EU/1/13/827

20.10.2021.

19.10.2021.

Mirapexin

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/051

21.10.2021.

19.10.2021.

Myozyme

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/06/333

25.10.2021.

19.10.2021.

NovoEight

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/13/888

21.10.2021.

19.10.2021.

NovoMix

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/00/142

21.10.2021.

19.10.2021.

Noxafil

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/320

21.10.2021.

19.10.2021.

OPDIVO

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

9.11.2021.

19.10.2021.

Prasugrel Mylan

Mylan Pharmaceuticals Limited

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

EU/1/18/1273

20.10.2021.

19.10.2021.

Rasagiline Mylan

Mylan Pharmaceuticals Limited

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

EU/1/16/1090

20.10.2021.

19.10.2021.

REKAMBYS

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1482

20.10.2021.

19.10.2021.

Repaglinide Krka

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/579

21.10.2021.

19.10.2021.

Semglee

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/18/1270

20.10.2021.

19.10.2021.

Spedra

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/13/841

21.10.2021.

19.10.2021.

Sunosi

Jazz Pharmaceuticals Ireland Ltd

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

EU/1/19/1408

21.10.2021.

19.10.2021.

Tasmar

Meda AB

Pipers väg 2A, 170 09 Solna, Sverige

EU/1/97/044

21.10.2021.

19.10.2021.

Tenofovir disoproxil Mylan

Mylan Pharmaceuticals Limited

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

EU/1/16/1129

20.10.2021.

19.10.2021.

Torisel

Pfizer Europe MA EEIG

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

EU/1/07/424

20.10.2021.

19.10.2021.

Vaborem

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/18/1334

20.10.2021.

19.10.2021.

Vfend

Pfizer Europe MA EEIG

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

EU/1/02/212

21.10.2021.

19.10.2021.

Vocabria

ViiV Healthcare BV

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

EU/1/20/1481

20.10.2021.

19.10.2021.

Xydalba

Allergan Pharmaceuticals International Limited

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

EU/1/14/986

20.10.2021.

19.10.2021.

Zessly

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1280

20.10.2021.

22.10.2021.

Adempas

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/907

5.11.2021.

22.10.2021.

Alofisel

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/17/1261

28.10.2021.

22.10.2021.

Betaferon

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/95/003

5.11.2021.

22.10.2021.

Biktarvy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/18/1289

27.10.2021.

22.10.2021.

Clopidogrel ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/975

26.10.2021.

22.10.2021.

Hyrimoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1286

25.10.2021.

22.10.2021.

Idacio

Fresenius Kabi Deutschland GmbH

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

EU/1/19/1356

25.10.2021.

22.10.2021.

Imcivree

Rhythm Pharmaceuticals Netherlands B.V.

Herengracht 280, 1016 BX Amsterdam, Nederland

EU/1/21/1564

26.10.2021.

22.10.2021.

Inflectra

Pfizer Europe MA EEIG

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

EU/1/13/854

25.10.2021.

22.10.2021.

Jardiance

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/930

25.10.2021.

22.10.2021.

Retacrit

Pfizer Europe MA EEIG

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

EU/1/07/431

25.10.2021.

22.10.2021.

Steglatro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1267

25.10.2021.

22.10.2021.

Veltassa

Vifor Fresenius Medical Care Renal Pharma France

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

EU/1/17/1179

9.11.2021.

22.10.2021.

Zepatier

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1119

25.10.2021.

25.10.2021.

Clopidogrel Taw Pharma

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/09/559

26.10.2021.

25.10.2021.

Clopidogrel Viatris

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/09/568

1.11.2021.

25.10.2021.

Firazyr

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/08/461

27.10.2021.

25.10.2021.

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

26.11.2021.

25.10.2021.

Latuda

Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.

Viale Amelia 70, 00181 Roma, Italia

EU/1/14/913

26.10.2021.

25.10.2021.

Nerlynx

Pierre Fabre Médicament

45, place Abel Gance, 92100 Boulogne-Billancourt, France

EU/1/18/1311

10.11.2021.

25.10.2021.

Segluromet

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1265

28.10.2021.

25.10.2021.

Zyllt

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/553

27.10.2021.

28.10.2021.

Clopidogrel Krka

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556

2.11.2021.

28.10.2021.

Clopidogrel TAD

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland

EU/1/09/555

3.11.2021.

28.10.2021.

Darunavir Mylan

Mylan Pharmaceuticals Limited

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

EU/1/16/1140

5.11.2021.

28.10.2021.

Mysildecard

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/16/1134

29.10.2021.

28.10.2021.

Ontozry

Angelini Pharma S.p.A

Viale Amelia 70, 00181 Rome, Italia

EU/1/21/1530

29.10.2021.

28.10.2021.

Tyverb

Novartis Europharm Limited

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

EU/1/07/440

29.10.2021.

28.10.2021.

Voriconazole Accord

Accord Healthcare S.L.U.

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

EU/1/13/835

29.10.2021.

29.10.2021.

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle Monte Esquinza 30, 28010 Madrid, España

EU/1/20/1507

29.10.2021.

—   Tirdzniecības atļaujas izņemšana no aprites (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

11.10.2021.

Docetaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/611

12.10.2021.

11.10.2021.

Equidacent

Centus Biotherapeutics Europe Limited

6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland

EU/1/20/1472

8.11.2021.

—   Tirdzniecības atļaujas grozīšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

18.10.2021.

Oxyglobin

OPK Biotech Netherlands BV

Herikerbergweg 88, 1101CM Amsterdam, Nederland

EU/2/99/015

5.11.2021.

25.10.2021.

Activyl Tick Plus

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/137

26.10.2021.

25.10.2021.

Canigen L4

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/183

26.10.2021.

25.10.2021.

Nobilis IB Primo QX

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/174

27.10.2021.

25.10.2021.

Tulissin

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/20/252

28.10.2021.

25.10.2021.

Vectra 3D

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/13/156

26.10.2021.

Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

(1)  OV L 136, 30.4.2004., 1. lpp.