# C_2020285EN.01000101.xml

| 28.8.2020 | EN | Official Journal of the European Union | C 285/1 |
| --- | --- | --- | --- |

28.8.2020

EN

Official Journal of the European Union

C 285/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2020 to 31 July 2020

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2020/C 285/01)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.7.2020 | Mvabea | Ebola vaccine (MVA-BN-Filo [recombinant]) | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/20/1445 | Suspension for injection | J07BX02 | 6.7.2020 |
| 1.7.2020 | Zabdeno | Ebola vaccine (Ad26.ZEBOV-GP [recombinant]) | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/20/1444 | Suspension for injection | J07BX02 | 6.7.2020 |
| 3.7.2020 | Enerzair Breezhaler | indacaterol/glycopyrronium/mometasone furoate | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/20/1438 | Inhalation powder, hard capsule | R03AL12 | 6.7.2020 |
| 3.7.2020 | Veklury | remdesivir | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/20/1459 | Concentrate for solution for infusion
  Powder for concentrate for solution for infusion | Pending | 3.7.2020 |
| 3.7.2020 | Zimbus Breezhaler | indacaterol/glycopyrronium/mometasone furoate | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/20/1440 | Inhalation powder, hard capsule | R03AL12 | 6.7.2020 |
| 23.7.2020 | Apixaban Accord | apixaban | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/20/1458 | Film-coated tablet | B01AF02 | 27.7.2020 |
| 27.7.2020 | Piqray | alpelisib | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/20/1455 | Film-coated tablet | L01XX65 | 28.7.2020 |
| 27.7.2020 | Xenleta | lefamulin | Nabriva Therapeutics Ireland DAC
  Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland | EU/1/20/1457 | Film-coated tablet | J01XX12 | 28.7.2020 |
| 27.7.2020 | Zercepac | trastuzumab | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/20/1456 | Powder for concentrate for solution for infusion | L01XC03 | 28.7.2020 |
| 31.7.2020 | Hepcludex | bulevirtide | Myr GmbH
  Hessenring 89, 61348 Bad Homburg, Deutschland | EU/1/20/1446 | Powder for solution for injection | J05AX28 | 5.8.2020 |
| 31.7.2020 | Pretomanid FGK | pretomanid | FGK Representative Service GmbH
  Heimeranstraße 35, 80339 München, Deutschland | EU/1/20/1437 | Tablet | Pending | 4.8.2020 |
| 31.7.2020 | Rozlytrek | entrectinib | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/20/1460 | Capsule, hard | L01XE56 | 3.8.2020 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

1.7.2020

Mvabea

Ebola vaccine (MVA-BN-Filo [recombinant])

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1445

Suspension for injection

J07BX02

6.7.2020

1.7.2020

Zabdeno

Ebola vaccine (Ad26.ZEBOV-GP [recombinant])

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1444

Suspension for injection

J07BX02

6.7.2020

3.7.2020

Enerzair Breezhaler

indacaterol/glycopyrronium/mometasone furoate

Novartis Europharm Limited

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

EU/1/20/1438

Inhalation powder, hard capsule

R03AL12

6.7.2020

3.7.2020

Veklury

remdesivir

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

Concentrate for solution for infusion

Powder for concentrate for solution for infusion

Pending

3.7.2020

3.7.2020

Zimbus Breezhaler

indacaterol/glycopyrronium/mometasone furoate

Novartis Europharm Limited

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

EU/1/20/1440

Inhalation powder, hard capsule

R03AL12

6.7.2020

23.7.2020

Apixaban Accord

apixaban

Accord Healthcare S.L.U.

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

EU/1/20/1458

Film-coated tablet

B01AF02

27.7.2020

27.7.2020

Piqray

alpelisib

Novartis Europharm Limited

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

EU/1/20/1455

Film-coated tablet

L01XX65

28.7.2020

27.7.2020

Xenleta

lefamulin

Nabriva Therapeutics Ireland DAC

Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland

EU/1/20/1457

Film-coated tablet

J01XX12

28.7.2020

27.7.2020

Zercepac

trastuzumab

Accord Healthcare S.L.U.

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

EU/1/20/1456

Powder for concentrate for solution for infusion

L01XC03

28.7.2020

31.7.2020

Hepcludex

bulevirtide

Myr GmbH

Hessenring 89, 61348 Bad Homburg, Deutschland

EU/1/20/1446

Powder for solution for injection

J05AX28

5.8.2020

31.7.2020

Pretomanid FGK

pretomanid

FGK Representative Service GmbH

Heimeranstraße 35, 80339 München, Deutschland

EU/1/20/1437

Tablet

Pending

4.8.2020

31.7.2020

Rozlytrek

entrectinib

Roche Registration GmbH

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

EU/1/20/1460

Capsule, hard

L01XE56

3.8.2020

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.7.2020 | Hopveus | D&A PHARMA
  18 Rue Saint Matthieu, 78550 Houdan, France | — | 8.7.2020 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

6.7.2020

Hopveus

D&A PHARMA

18 Rue Saint Matthieu, 78550 Houdan, France

—

8.7.2020

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.7.2020 | Brintellix | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/13/891 | 7.7.2020 |
| 3.7.2020 | Capecitabine Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/12/762 | 6.7.2020 |
| 3.7.2020 | Capecitabine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/761 | 6.7.2020 |
| 3.7.2020 | Ecansya | KRKA d d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/12/763 | 6.7.2020 |
| 3.7.2020 | Exforge | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/370 | 6.7.2020 |
| 3.7.2020 | Harvoni | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/958 | 7.7.2020 |
| 3.7.2020 | Hetlioz | Vanda Pharmaceuticals Germany GmbH
  Französische Str. 12, c/o Satellite Office, 10117 Berlin, Deutschland | EU/1/15/1008 | 6.7.2020 |
| 3.7.2020 | Imatinib Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/808 | 6.7.2020 |
| 3.7.2020 | Insulatard | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/233 | 6.7.2020 |
| 3.7.2020 | Lemtrada | Sanofi Belgium
  Leonardo Da Vincilaan 19, B-1831 Diegem, België | EU/1/13/869 | 13.7.2020 |
| 3.7.2020 | Lynparza | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/959 | 7.7.2020 |
| 3.7.2020 | Mixtard | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/231 | 6.7.2020 |
| 3.7.2020 | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 7.7.2020 |
| 3.7.2020 | Pregabalin Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/15/1027 | 7.7.2020 |
| 3.7.2020 | PREVYMIS | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/17/1245 | 7.7.2020 |
| 3.7.2020 | Protaphane | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/234 | 6.7.2020 |
| 3.7.2020 | Suboxone | Indivior Europe Limited
  27 Windsor Place, Dublin 2, Ireland | EU/1/06/359 | 6.7.2020 |
| 3.7.2020 | Teysuno | Nordic Group B.V.
  Siriusdreef 41, 2132 WT Hoofddorp, Nederland | EU/1/11/669 | 7.7.2020 |
| 3.7.2020 | Xeloda | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/163 | 6.7.2020 |
| 6.7.2020 | Capecitabine medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/12/802 | 7.7.2020 |
| 6.7.2020 | Kolbam | Retrophin Europe Limited
  Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/13/895 | 17.7.2020 |
| 6.7.2020 | Picato | LEO Laboratories Ltd
  285 Cashel Road, Crumlin, Dublin 12, Ireland | EU/1/12/796 | 8.7.2020 |
| 13.7.2020 | Aripiprazole Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/15/1045 | 15.7.2020 |
| 13.7.2020 | BiResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/921 | 16.7.2020 |
| 13.7.2020 | DuoResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/920 | 16.7.2020 |
| 13.7.2020 | Kisqali | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/17/1221 | 15.7.2020 |
| 13.7.2020 | Lonquex | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/13/856 | 16.7.2020 |
| 13.7.2020 | Mulpleo | Shionogi B.V.
  Kingsfordweg 151, 1043 GR Amsterdam, Nederland | EU/1/18/1348 | 17.7.2020 |
| 13.7.2020 | Namuscla | Lupin Europe GmbH
  Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland | EU/1/18/1325 | 15.7.2020 |
| 13.7.2020 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 15.7.2020 |
| 13.7.2020 | Tracleer | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/02/220 | 14.7.2020 |
| 16.7.2020 | Capecitabine medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/12/802 | 22.7.2020 |
| 16.7.2020 | Dukoral | Valneva Sweden AB
  105 21 Stockholm, Sverige | EU/1/03/263 | 23.7.2020 |
| 16.7.2020 | Toviaz | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/07/386 | 17.7.2020 |
| 17.7.2020 | Capecitabine Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/12/762 | 23.7.2020 |
| 17.7.2020 | Capecitabine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/761 | 21.7.2020 |
| 17.7.2020 | Filgrastim Hexal | Hexal AG
  Industriestraße 25, 83607 Holzkirchen, Deutschland | EU/1/08/496 | 23.7.2020 |
| 17.7.2020 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 22.7.2020 |
| 17.7.2020 | Imlygic | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1064 | 27.7.2020 |
| 17.7.2020 | Silodyx | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/09/607 | 27.7.2020 |
| 17.7.2020 | Vihuma | Octapharma AB
  Lars Forssells gata 23, 112 75 Stockholm, Sverige | EU/1/16/1168 | 30.7.2020 |
| 23.7.2020 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 27.7.2020 |
| 23.7.2020 | Bavencio | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/17/1214 | 27.7.2020 |
| 23.7.2020 | Besponsa | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/17/1200 | 24.7.2020 |
| 23.7.2020 | Ciambra | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Luxembourg | EU/1/15/1055 | 27.7.2020 |
| 23.7.2020 | Dectova | GlaxoSmithKline Trading Services Limited
  Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland | EU/1/18/1349 | 28.7.2020 |
| 23.7.2020 | Emtricitabine/Tenofovir disoproxil Krka | KRKA d d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/16/1151 | 30.7.2020 |
| 23.7.2020 | Nordimet | Nordic Group B.V.
  Siriusdreef 41, 2132 WT Hoofddorp, Nederland | EU/1/16/1124 | 28.7.2020 |
| 23.7.2020 | Omidria | Omeros Ireland Limited
  Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, Ireland | EU/1/15/1018 | 27.7.2020 |
| 23.7.2020 | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 24.7.2020 |
| 23.7.2020 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 24.7.2020 |
| 23.7.2020 | Votubia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/11/710 | 24.7.2020 |
| 23.7.2020 | VPRIV | Shire Pharmaceuticals Ireland Limited
  Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland | EU/1/10/646 | 24.7.2020 |
| 24.7.2020 | Remsima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/13/853 | 27.7.2020 |
| 27.7.2020 | APTIVUS | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/05/315 | 28.7.2020 |
| 27.7.2020 | Buccolam | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/709 | 29.7.2020 |
| 27.7.2020 | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 5.8.2020 |
| 27.7.2020 | Duzallo | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/18/1300 | 28.7.2020 |
| 27.7.2020 | Flucelvax Tetra | Seqirus Netherlands B.V.
  Paasheuvelweg 28, 1105 BJ Amsterdam, Netherlands | EU/1/18/1326 | 29.7.2020 |
| 27.7.2020 | Fluenz Tetra | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/887 | 6.8.2020 |
| 27.7.2020 | Iclusig | Incyte Biosciences Distribution B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/13/839 | 4.8.2020 |
| 27.7.2020 | Imfinzi | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/18/1322 | 29.7.2020 |
| 27.7.2020 | Nerlynx | Pierre Fabre Médicament
  45, place Abel Gance, 92100 Boulogne-Billancourt, France | EU/1/18/1311 | 28.7.2020 |
| 27.7.2020 | Nuwiq | Octapharma AB
  Lars Forssells gata 23, 112 75 Stockholm, Sverige | EU/1/14/936 | 4.8.2020 |
| 27.7.2020 | Orphacol | Laboratoires CTRS
  63 rue de l’Est, 92100 Boulogne-Billancourt, France | EU/1/13/870 | 29.7.2020 |
| 27.7.2020 | Praxbind | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/15/1056 | 28.7.2020 |
| 27.7.2020 | Rilutek | Sanofi Mature IP
  54 rue La Boétie, 75008, Paris, France | EU/1/96/010 | 28.7.2020 |
| 27.7.2020 | Votrient | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/628 | 28.7.2020 |
| 31.7.2020 | Cinryze | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/688 | 4.8.2020 |
| 31.7.2020 | Cosentyx | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/980 | 4.8.2020 |
| 31.7.2020 | Evista | SUBSTIPHARM
  24 rue Erlanger, 75016 Paris, France | EU/1/98/073 | 4.8.2020 |
| 31.7.2020 | Exjade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/356 | 4.8.2020 |
| 31.7.2020 | LIBTAYO | Regeneron Ireland Designated Activity Company (DAC)
  Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland | EU/1/19/1376 | 4.8.2020 |
| 31.7.2020 | Olanzapine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/427 | 3.8.2020 |
| 31.7.2020 | Qutenza | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/09/524 | 4.8.2020 |
| 31.7.2020 | Retacrit | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/07/431 | 4.8.2020 |
| 31.7.2020 | Ruxience | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/20/1431 | 4.8.2020 |
| 31.7.2020 | Xolair | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/05/319 | 4.8.2020 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.7.2020

Brintellix

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/13/891

7.7.2020

3.7.2020

Capecitabine Accord

Accord Healthcare S.L.U.

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

EU/1/12/762

6.7.2020

3.7.2020

Capecitabine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/761

6.7.2020

3.7.2020

Ecansya

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/12/763

6.7.2020

3.7.2020

Exforge

Novartis Europharm Limited

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

EU/1/06/370

6.7.2020

3.7.2020

Harvoni

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/958

7.7.2020

3.7.2020

Hetlioz

Vanda Pharmaceuticals Germany GmbH

Französische Str. 12, c/o Satellite Office, 10117 Berlin, Deutschland

EU/1/15/1008

6.7.2020

3.7.2020

Imatinib Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/808

6.7.2020

3.7.2020

Insulatard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/233

6.7.2020

3.7.2020

Lemtrada

Sanofi Belgium

Leonardo Da Vincilaan 19, B-1831 Diegem, België

EU/1/13/869

13.7.2020

3.7.2020

Lynparza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

7.7.2020

3.7.2020

Mixtard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/231

6.7.2020

3.7.2020

Mysimba

Orexigen Therapeutics Ireland Limited

2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/14/988

7.7.2020

3.7.2020

Pregabalin Accord

Accord Healthcare S.L.U.

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

EU/1/15/1027

7.7.2020

3.7.2020

PREVYMIS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/17/1245

7.7.2020

3.7.2020

Protaphane

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/234

6.7.2020

3.7.2020

Suboxone

Indivior Europe Limited

27 Windsor Place, Dublin 2, Ireland

EU/1/06/359

6.7.2020

3.7.2020

Teysuno

Nordic Group B.V.

Siriusdreef 41, 2132 WT Hoofddorp, Nederland

EU/1/11/669

7.7.2020

3.7.2020

Xeloda

Roche Registration GmbH

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

EU/1/00/163

6.7.2020

6.7.2020

Capecitabine medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/12/802

7.7.2020

6.7.2020

Kolbam

Retrophin Europe Limited

Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/13/895

17.7.2020

6.7.2020

Picato

LEO Laboratories Ltd

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

8.7.2020

13.7.2020

Aripiprazole Accord

Accord Healthcare S.L.U.

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

EU/1/15/1045

15.7.2020

13.7.2020

BiResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/921

16.7.2020

13.7.2020

DuoResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/920

16.7.2020

13.7.2020

Kisqali

Novartis Europharm Limited

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

EU/1/17/1221

15.7.2020

13.7.2020

Lonquex

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/856

16.7.2020

13.7.2020

Mulpleo

Shionogi B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Nederland

EU/1/18/1348

17.7.2020

13.7.2020

Namuscla

Lupin Europe GmbH

Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland

EU/1/18/1325

15.7.2020

13.7.2020

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

15.7.2020

13.7.2020

Tracleer

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/02/220

14.7.2020

16.7.2020

Capecitabine medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/12/802

22.7.2020

16.7.2020

Dukoral

Valneva Sweden AB

105 21 Stockholm, Sverige

EU/1/03/263

23.7.2020

16.7.2020

Toviaz

Pfizer Europe MA EEIG

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

EU/1/07/386

17.7.2020

17.7.2020

Capecitabine Accord

Accord Healthcare S.L.U.

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

EU/1/12/762

23.7.2020

17.7.2020

Capecitabine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/761

21.7.2020

17.7.2020

Filgrastim Hexal

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/08/496

23.7.2020

17.7.2020

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

22.7.2020

17.7.2020

Imlygic

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1064

27.7.2020

17.7.2020

Silodyx

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/09/607

27.7.2020

17.7.2020

Vihuma

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/16/1168

30.7.2020

23.7.2020

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

27.7.2020

23.7.2020

Bavencio

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

27.7.2020

23.7.2020

Besponsa

Pfizer Europe MA EEIG

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

EU/1/17/1200

24.7.2020

23.7.2020

Ciambra

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/15/1055

27.7.2020

23.7.2020

Dectova

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/18/1349

28.7.2020

23.7.2020

Emtricitabine/Tenofovir disoproxil Krka

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/16/1151

30.7.2020

23.7.2020

Nordimet

Nordic Group B.V.

Siriusdreef 41, 2132 WT Hoofddorp, Nederland

EU/1/16/1124

28.7.2020

23.7.2020

Omidria

Omeros Ireland Limited

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

EU/1/15/1018

27.7.2020

23.7.2020

Translarna

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

EU/1/13/902

24.7.2020

23.7.2020

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

24.7.2020

23.7.2020

Votubia

Novartis Europharm Limited

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

EU/1/11/710

24.7.2020

23.7.2020

VPRIV

Shire Pharmaceuticals Ireland Limited

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

EU/1/10/646

24.7.2020

24.7.2020

Remsima

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/13/853

27.7.2020

27.7.2020

APTIVUS

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/05/315

28.7.2020

27.7.2020

Buccolam

Shire Services BVBA

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

EU/1/11/709

29.7.2020

27.7.2020

Cimzia

UCB Pharma S.A.

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

EU/1/09/544

5.8.2020

27.7.2020

Duzallo

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/18/1300

28.7.2020

27.7.2020

Flucelvax Tetra

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Netherlands

EU/1/18/1326

29.7.2020

27.7.2020

Fluenz Tetra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/887

6.8.2020

27.7.2020

Iclusig

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/13/839

4.8.2020

27.7.2020

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

29.7.2020

27.7.2020

Nerlynx

Pierre Fabre Médicament

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

EU/1/18/1311

28.7.2020

27.7.2020

Nuwiq

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/14/936

4.8.2020

27.7.2020

Orphacol

Laboratoires CTRS

63 rue de l’Est, 92100 Boulogne-Billancourt, France

EU/1/13/870

29.7.2020

27.7.2020

Praxbind

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1056

28.7.2020

27.7.2020

Rilutek

Sanofi Mature IP

54 rue La Boétie, 75008, Paris, France

EU/1/96/010

28.7.2020

27.7.2020

Votrient

Novartis Europharm Limited

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

EU/1/10/628

28.7.2020

31.7.2020

Cinryze

Shire Services BVBA

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

EU/1/11/688

4.8.2020

31.7.2020

Cosentyx

Novartis Europharm Limited

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

EU/1/14/980

4.8.2020

31.7.2020

Evista

SUBSTIPHARM

24 rue Erlanger, 75016 Paris, France

EU/1/98/073

4.8.2020

31.7.2020

Exjade

Novartis Europharm Limited

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

EU/1/06/356

4.8.2020

31.7.2020

LIBTAYO

Regeneron Ireland Designated Activity Company (DAC)

Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland

EU/1/19/1376

4.8.2020

31.7.2020

Olanzapine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/427

3.8.2020

31.7.2020

Qutenza

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/09/524

4.8.2020

31.7.2020

Retacrit

Pfizer Europe MA EEIG

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

EU/1/07/431

4.8.2020

31.7.2020

Ruxience

Pfizer Europe MA EEIG

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

EU/1/20/1431

4.8.2020

31.7.2020

Xolair

Novartis Europharm Limited

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

EU/1/05/319

4.8.2020

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 13.7.2020 | Kolbam | Retrophin Europe Limited
  Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/13/895 | 15.7.2020 |
| 16.7.2020 | Zurampic | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/15/1080 | 31.7.2020 |
| 31.7.2020 | Duzallo | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/18/1300 | 31.7.2020 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

13.7.2020

Kolbam

Retrophin Europe Limited

Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/13/895

15.7.2020

16.7.2020

Zurampic

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/15/1080

31.7.2020

31.7.2020

Duzallo

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/18/1300

31.7.2020

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 20.7.2020 | PREVEXXION RN | Marek’s disease vaccine (live recombinant) | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/20/254 | Concentrate and solvent for suspension for injection | QI01AD03 | 23.7.2020 |
| 20.7.2020 | PREVEXXION RN+HVT+IBD | Infectious bursal disease and Marek’s disease vaccine (live recombinant) | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/20/255 | Concentrate and solvent for suspension for injection | QI01AD15 | 23.7.2020 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

20.7.2020

PREVEXXION RN

Marek’s disease vaccine (live recombinant)

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/254

Concentrate and solvent for suspension for injection

QI01AD03

23.7.2020

20.7.2020

PREVEXXION RN+HVT+IBD

Infectious bursal disease and Marek’s disease vaccine (live recombinant)

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/255

Concentrate and solvent for suspension for injection

QI01AD15

23.7.2020

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.7.2020 | Leucofeligen FeLV/RCP | VIRBAC
  1ère avenue 2065 m LID, 06516 Carros, France | EU/2/09/097 | 10.7.2020 |
| 1.7.2020 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/07/078 | 13.7.2020 |
| 1.7.2020 | Zulvac 1 + 8 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/139 | 2.7.2020 |
| 20.7.2020 | FORTEKOR PLUS | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/15/185 | 23.7.2020 |
| 20.7.2020 | Rabitec | Ceva Santé Animale
  10 avenue de La Ballastière, 33500 Libourne, France | EU/2/17/219 | 23.7.2020 |
| 20.7.2020 | Vectormune ND | CEVA-Phylaxia Co. Ltd
  Szállás u. 5, 1107 Budapest, Magyarország | EU/2/15/188 | 24.7.2020 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

1.7.2020

Leucofeligen FeLV/RCP

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/09/097

10.7.2020

1.7.2020

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/07/078

13.7.2020

1.7.2020

Zulvac 1 + 8 Bovis

Zoetis Belgium S.A.

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

EU/2/12/139

2.7.2020

20.7.2020

FORTEKOR PLUS

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/15/185

23.7.2020

20.7.2020

Rabitec

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/219

23.7.2020

20.7.2020

Vectormune ND

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/15/188

24.7.2020

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| 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)  OJ L 136, 30.4.2004, p. 1.

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