# Službeni list C 144/31.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 144 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 65.31. ožujka 2022. |

ISSN 1977-1088

Službeni list

Europske unije

C 144

Hrvatsko izdanje

Informacije i objave

Godište 65.31. ožujka 2022.

---

| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2022/C 144/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2022. do 28. veljače 2022.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2022/C 144/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2022. do 28. veljače 2022.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 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

| 31.3.2022 | HR | Službeni list Europske unije | C 144/1 |
| --- | --- | --- | --- |

31.3.2022

HR

Službeni list Europske unije

C 144/1

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2022. do 28. veljače 2022.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))

(2022/C 144/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.2.2022. | Apexxnar | Cjepivo protiv pneumokoka, polisaharidno, konjugirano (20-valentno, adsorbirano) | Pfizer Europe MA EEIG |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |

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

14.2.2022.

Apexxnar

Cjepivo protiv pneumokoka, polisaharidno, konjugirano (20-valentno, adsorbirano)

Pfizer Europe MA EEIG

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

EU/1/21/1612

Suspenzija za injekciju

J07AL02

15.2.2022.

14.2.2022.

Ngenla

Somatrogon

| 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/1/21/1617

Otopina za injekciju

Pending

15.2.2022.

14.2.2022.

OKEDI

risperidon

| Laboratorios Farmacéuticos Rovi, S.A. |
| --- |
| Julián Camarillo 35, 28037 Madrid, España |

Laboratorios Farmacéuticos Rovi, S.A.

Julián Camarillo 35, 28037 Madrid, España

EU/1/21/1621

Prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem

N05AX08

15.2.2022.

14.2.2022.

Oxbryta

vokselotora

| Global Blood Therapeutics Netherlands B.V. |
| --- |
| Strawinskylaan 3051, 1077 ZX Amsterdam, Noord-Holland, Nederland |

Global Blood Therapeutics Netherlands B.V.

Strawinskylaan 3051, 1077 ZX Amsterdam, Noord-Holland, Nederland

EU/1/21/1622

Filmom obložena tableta

B06AX

15.2.2022.

14.2.2022.

Saphnelo

anifrolumab

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1623

Koncentrat za otopinu za infuziju

L04AA51

15.2.2022.

16.2.2022.

Kerendia

finerenon

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/21/1616

Filmom obložena tableta

C03DA05

17.2.2022.

16.2.2022.

Sapropterin Dipharma

sapropterin

| Dipharma B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland |

Dipharma B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/21/1620

Prašak za oralnu otopinu.

Tableta za oralnu otopinu

A16AX07

17.2.2022.

16.2.2022.

Sitagliptin/Metformin hydrochloride Mylan

sitagliptin/metforminklorid

| 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/1/21/1619

Filmom obložena tableta

A10BD07

21.2.2022.

16.2.2022.

Tepmetko

tepotinib

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

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/21/1596

Filmom obložena tableta

L01EX21

17.2.2022.

21.2.2022.

Ontilyv

opikapon

| Bial – Portela & Ca, SA |
| --- |
| À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal |

Bial – Portela & Ca, SA

À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

EU/1/21/1578

Kapsula, tvrda

N04BX04

22.2.2022.

—   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 |
| --- | --- | --- | --- | --- |
| 2.2.2022. | Vaxzevria | AstraZeneca AB |
| 151 85 Södertälje, Sverige |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

2.2.2022.

Vaxzevria

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

2.2.2022.

3.2.2022.

Clopidogrel Viatris

| Viatris Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland |

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/09/568

7.2.2022.

3.2.2022.

DaTSCAN

| GE Healthcare B.V. |
| --- |
| De Rondom 8, 5612 AP, Eindhoven, Nederland |

GE Healthcare B.V.

De Rondom 8, 5612 AP, Eindhoven, Nederland

EU/1/00/135

9.2.2022.

3.2.2022.

Edarbi

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbæk Strand, Danmark

EU/1/11/734

8.2.2022.

3.2.2022.

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

| 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/1/17/1263

9.2.2022.

3.2.2022.

Nyxoid

| Mundipharma Corporation (Ireland) Limited |
| --- |
| Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland |

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

EU/1/17/1238

7.2.2022.

3.2.2022.

Pregabalin 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/1/15/1021

8.2.2022.

3.2.2022.

Vivanza

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/03/249

7.2.2022.

3.2.2022.

Voriconazole 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/1/13/835

4.2.2022.

3.2.2022.

Xigduo

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

4.2.2022.

4.2.2022.

Cialis

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/02/237

8.2.2022.

4.2.2022.

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

4.2.2022.

4.2.2022.

Ebixa

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

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/02/219

8.2.2022.

4.2.2022.

Ebymect

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1051

7.2.2022.

4.2.2022.

Entacapone Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/665

8.2.2022.

4.2.2022.

HyQvia

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

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/13/840

7.2.2022.

4.2.2022.

Iressa

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/09/526

7.2.2022.

4.2.2022.

Neupro

| 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/1/05/331

9.2.2022.

4.2.2022.

Noxafil

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/320

8.2.2022.

4.2.2022.

Plegridy

| Biogen Netherlands B.V. |
| --- |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/14/934

9.2.2022.

4.2.2022.

Revolade

| 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/1/10/612

7.2.2022.

4.2.2022.

Roclanda

| Santen Oy |
| --- |
| Niittyhaankatu 20, 33720 Tampere, Suomi |

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/20/1502

10.2.2022.

4.2.2022.

Sivextro

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/991

8.2.2022.

4.2.2022.

Temozolomide 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/1/10/615

9.2.2022.

4.2.2022.

Vantobra

| PARI Pharma GmbH |
| --- |
| Moosstraße 3, 82319 Starnberg, Deutschland |

PARI Pharma GmbH

Moosstraße 3, 82319 Starnberg, Deutschland

EU/1/18/1350

10.2.2022.

4.2.2022.

Yellox

| BAUSCH + LOMB IRELAND LIMITED |
| --- |
| 3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT3, Ireland |

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT3, Ireland

EU/1/11/692

14.2.2022.

4.2.2022.

Zoledronic acid Hospira

| 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/1/12/800

7.2.2022.

10.2.2022.

Ameluz

| Biofrontera Bioscience GmbH |
| --- |
| Hemmelrather Weg 201, 51377 Leverkusen, Deutschland |

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, 51377 Leverkusen, Deutschland

EU/1/11/740

15.2.2022.

10.2.2022.

Axumin

| Blue Earth Diagnostics Ireland Ltd |
| --- |
| 6th Floor, 2 Grand Canal Square, Dublin 2, Ireland |

Blue Earth Diagnostics Ireland Ltd

6th Floor, 2 Grand Canal Square, Dublin 2, Ireland

EU/1/17/1186

15.2.2022.

10.2.2022.

Cotellic

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

Roche Registration GmbH

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

EU/1/15/1048

14.2.2022.

10.2.2022.

Nityr

| Cycle Pharmaceuticals (Europe) Ltd |
| --- |
| 70 Sir John Rogerson’s Quay, Dublin 2, Ireland |

Cycle Pharmaceuticals (Europe) Ltd

70 Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/18/1290

15.2.2022.

10.2.2022.

Wakix

| Bioprojet Pharma |
| --- |
| 9 rue Rameau, 75002 Pariz, France |

Bioprojet Pharma

9 rue Rameau, 75002 Pariz, France

EU/1/15/1068

3.3.2022.

14.2.2022.

Cubicin

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/328

18.2.2022.

14.2.2022.

Incruse Ellipta

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

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

4.3.2022.

14.2.2022.

Ivabradin 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/1/17/1190

15.2.2022.

14.2.2022.

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

16.2.2022.

14.2.2022.

Waylivra

| Akcea Therapeutics Ireland Limited |
| --- |
| Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland |

Akcea Therapeutics Ireland Limited

Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland

EU/1/19/1360

21.2.2022.

14.2.2022.

Xromi

| Nova Laboratories Ireland Limited |
| --- |
| 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland |

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland

EU/1/19/1366

17.2.2022.

16.2.2022.

AMGLIDIA

| AMMTeK |
| --- |
| 55 rue de Turbigo, 75003 Pariz, France |

AMMTeK

55 rue de Turbigo, 75003 Pariz, France

EU/1/18/1279

16.2.2022.

16.2.2022.

Besponsa

| 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/1/17/1200

17.2.2022.

16.2.2022.

CellCept

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

Roche Registration GmbH

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

EU/1/96/005

17.2.2022.

16.2.2022.

Deltyba

| Otsuka Novel Products GmbH |
| --- |
| Erika-Mann-Straße 21, 80636 München, Deutschland |

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

17.2.2022.

16.2.2022.

Eliquis

| Bristol-Myers Squibb/Pfizer EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland |

Bristol-Myers Squibb/Pfizer EEIG

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

EU/1/11/691

17.2.2022.

16.2.2022.

ellaOne

| Laboratoire HRA Pharma |
| --- |
| 200 avenue de Pariz, 92320 Chatillon, France |

Laboratoire HRA Pharma

200 avenue de Pariz, 92320 Chatillon, France

EU/1/09/522

23.2.2022.

16.2.2022.

Envarsus

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A, 43122 Parma, Italia |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/935

21.2.2022.

16.2.2022.

Febuxostat Mylan

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

Mylan Pharmaceuticals Limited

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

EU/1/17/1194

17.2.2022.

16.2.2022.

JEMPERLI

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

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/21/1538

17.2.2022.

16.2.2022.

Laventair Ellipta

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

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/899

4.3.2022.

16.2.2022.

Mayzent

| 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/1/19/1414

17.2.2022.

16.2.2022.

Modigraf

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

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/09/523

17.2.2022.

16.2.2022.

Myclausen

| Passauer Pharma GmbH |
| --- |
| Eiderstedter Weg 3, 14129 Berlin, Deutschland |

Passauer Pharma GmbH

Eiderstedter Weg 3, 14129 Berlin, Deutschland

EU/1/10/647

17.2.2022.

16.2.2022.

Pemazyre

| Incyte Biosciences Distribution B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/21/1535

21.2.2022.

16.2.2022.

Pregabalin Sandoz

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1011

21.2.2022.

16.2.2022.

Riximyo

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1184

17.2.2022.

16.2.2022.

Temybric Ellipta

| 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/1/19/1378

4.3.2022.

16.2.2022.

Yuflyma

| 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/1/20/1513

2.3.2022.

16.2.2022.

Zykadia

| 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/1/15/999

17.2.2022.

17.2.2022.

Advagraf

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

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/07/387

21.2.2022.

17.2.2022.

Avonex

| Biogen Netherlands B.V. |
| --- |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/97/033

23.2.2022.

17.2.2022.

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

18.2.2022.

17.2.2022.

Myfenax

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/438

21.2.2022.

17.2.2022.

Nexium Control

| GlaxoSmithKline Dungarvan Limited |
| --- |
| Dungarvan, Co. Waterford, Ireland |

GlaxoSmithKline Dungarvan Limited

Dungarvan, Co. Waterford, Ireland

EU/1/13/860

24.2.2022.

18.2.2022.

Tarceva

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

Roche Registration GmbH

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

EU/1/05/311

21.2.2022.

18.2.2022.

Zelboraf

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

Roche Registration GmbH

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

EU/1/12/751

21.2.2022.

21.2.2022.

Clopidogrel Taw Pharma

| Taw Pharma (Ireland) Limited |
| --- |
| 104 Lower Baggot Street, Dublin 2, Ireland |

Taw Pharma (Ireland) Limited

104 Lower Baggot Street, Dublin 2, Ireland

EU/1/09/559

22.2.2022.

21.2.2022.

Jardiance

| 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/1/14/930

25.2.2022.

21.2.2022.

Ogivri

| Viatris Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland |

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/18/1341

23.2.2022.

21.2.2022.

Refixia

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsværd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/17/1193

24.2.2022.

21.2.2022.

Skilarence

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

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/17/1201

23.2.2022.

23.2.2022.

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

25.2.2022.

24.2.2022.

ADVATE

| Takeda Manufacturing Austria AG |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/03/271

28.2.2022.

24.2.2022.

Bortezomib Hospira

| 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/1/16/1114

25.2.2022.

24.2.2022.

Briviact

| 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/1/15/1073

25.2.2022.

24.2.2022.

Irbesartan Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/576

28.2.2022.

24.2.2022.

JEVTANA

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Pariz, France

EU/1/11/676

28.2.2022.

24.2.2022.

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

25.2.2022.

24.2.2022.

Rixathon

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1185

25.2.2022.

24.2.2022.

Senshio

| Shionogi B.V. |
| --- |
| Kingsfordweg 151, 1043 GR Amsterdam, Nederland |

Shionogi B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Nederland

EU/1/14/978

25.2.2022.

28.2.2022.

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

28.2.2022.

28.2.2022.

Imfinzi

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

2.3.2022.

28.2.2022.

Nimenrix

| 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/1/12/767

1.3.2022.

28.2.2022.

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

2.3.2022.

28.2.2022.

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

1.3.2022.

—   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 |
| --- | --- | --- | --- | --- |
| 3.2.2022. | Vivanza | Bayer AG |
| D-51368 Leverkusen, Deutschland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

3.2.2022.

Vivanza

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/03/249

7.2.2022.

—   Izmjena odobrenja za stavljanje u promet (članak 38. 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 |
| --- | --- | --- | --- | --- |
| 1.2.2022. | Bravecto | Intervet International B.V. |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

1.2.2022.

Bravecto

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/13/158

3.2.2022.

1.2.2022.

Mirataz

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

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/19/247

2.2.2022.

8.2.2022.

Exzolt

| 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/2/17/212

9.2.2022.

8.2.2022.

Zulvac 8 Ovis

| 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/2/09/104

9.2.2022.

10.2.2022.

Draxxin

| 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/2/03/041

16.2.2022.

10.2.2022.

Nobilis IB 4-91

| 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/2/98/006

14.2.2022.

10.2.2022.

Onsior

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/08/089

11.2.2022.

28.2.2022.

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

2.3.2022.

28.2.2022.

Innovax-ND-ILT

| 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/2/20/256

2.3.2022.

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, 30.4.2004., str. 1.

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