# C_2019153EN.01000101.xml

| 3.5.2019 | EN | Official Journal of the European Union | C 153/1 |
| --- | --- | --- | --- |

3.5.2019

EN

Official Journal of the European Union

C 153/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2019 to 31 March 2019

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

(2019/C 153/01)

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

—

Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 25.3.2019 | Atazanavir Krka | atazanavir | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/19/1353 | Capsule, hard | J05AE08 | 27.3.2019 |
| 28.3.2019 | AJOVY | fremanezumab | Teva GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/19/1358 | Solution for injection | Pending | 1.4.2019 |
| 28.3.2019 | Febuxostat Krka | febuxostat | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/18/1347 | Film-coated tablet | M04AA03 | 1.4.2019 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

25.3.2019

Atazanavir Krka

atazanavir

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/19/1353

Capsule, hard

J05AE08

27.3.2019

28.3.2019

AJOVY

fremanezumab

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/19/1358

Solution for injection

Pending

1.4.2019

28.3.2019

Febuxostat Krka

febuxostat

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/18/1347

Film-coated tablet

M04AA03

1.4.2019

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

—

Modification of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.3.2019 | 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 | 5.3.2019 |
| 1.3.2019 | Herzuma | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1257 | 5.3.2019 |
| 1.3.2019 | Lacosamide Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/17/1230 | 5.3.2019 |
| 1.3.2019 | 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 | 5.3.2019 |
| 1.3.2019 | Levetiracetam Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/11/712 | 5.3.2019 |
| 1.3.2019 | Palonosetron Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/16/1104 | 5.3.2019 |
| 1.3.2019 | Tegsedi | Akcea Therapeutics Ireland Ltd
  Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland | EU/1/18/1296 | 5.3.2019 |
| 5.3.2019 | 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 | 7.3.2019 |
| 5.3.2019 | DaTSCAN | GE Healthcare B.V.
  De Rondom 8, 5612 AP, Eindhoven, The Netherlands | EU/1/00/135 | 7.3.2019 |
| 5.3.2019 | Granpidam | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/16/1137 | 7.3.2019 |
| 5.3.2019 | Instanyl | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/09/531 | 7.3.2019 |
| 5.3.2019 | Kiovig | Baxter AG
  Industriestraße 67, 1221 Wien, Österreich | EU/1/05/329 | 7.3.2019 |
| 5.3.2019 | Levetiracetam Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/11/713 | 7.3.2019 |
| 5.3.2019 | 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 | 7.3.2019 |
| 5.3.2019 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 7.3.2019 |
| 11.3.2019 | Actrapid | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/230 | 13.3.2019 |
| 11.3.2019 | Cresemba | Basilea Pharmaceutica Deutschland GmbH
  Marie-Curie-Strasse 8, 79539 Loerrach, Baden-Wuerttemberg, Deutschland | EU/1/15/1036 | 13.3.2019 |
| 11.3.2019 | Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1263 | 13.3.2019 |
| 11.3.2019 | Ferriprox | Apotex Europe B.V.
  Archimedesweg 2, 2333 CN Leiden, Nederland | EU/1/99/108 | 13.3.2019 |
| 11.3.2019 | Hemlibra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/18/1271 | 13.3.2019 |
| 11.3.2019 | Herceptin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/145 | 13.3.2019 |
| 11.3.2019 | INOmax | Linde Healthcare AB
  SE-181 81 Lidingö, Sverige | EU/1/01/194 | 13.3.2019 |
| 11.3.2019 | Intrarosa | Endoceutics S.A.
  Rue Belliard 40, 1040 Brussels, Belgium | EU/1/17/1255 | 15.3.2019 |
| 11.3.2019 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 13.3.2019 |
| 11.3.2019 | Luminity | Lantheus EU Limited
  Atlantic Avenue, Westpark Business Campus, Shannon, Co. Clare, Ireland | EU/1/06/361 | 13.3.2019 |
| 11.3.2019 | Mabthera | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/98/067 | 13.3.2019 |
| 11.3.2019 | Maviret | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/17/1213 | 13.3.2019 |
| 11.3.2019 | Pelgraz | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/18/1313 | 15.3.2019 |
| 11.3.2019 | Praluent | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/15/1031 | 13.3.2019 |
| 11.3.2019 | Pramipexole Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/11/728 | 13.3.2019 |
| 11.3.2019 | Qarziba | EUSA Pharma (Netherlands) B.V.
  Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland | EU/1/17/1191 | 13.3.2019 |
| 11.3.2019 | Senshio | Shionogi B.V.
  Kingsfordweg 151, 1043GR Amsterdam, Nederland | EU/1/14/978 | 13.3.2019 |
| 11.3.2019 | Slenyto | RAD Neurim Pharmaceuticals EEC SARL
  4 rue de Marivaux, 75002 Paris, France | EU/1/18/1318 | 13.3.2019 |
| 11.3.2019 | Stayveer | Janssen Pharmaceutica N.V.
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/13/832 | 13.3.2019 |
| 11.3.2019 | Varuby | TESARO Bio Netherlands B.V.
  Joop Geeskinkweg 901, 1114AB Amsterdam-Duisvendrecht, Nederland | EU/1/17/1180 | 13.3.2019 |
| 11.3.2019 | 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 | 15.3.2019 |
| 11.3.2019 | Zykadia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/999 | 13.3.2019 |
| 13.3.2019 | NovoMix | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/00/142 | 15.3.2019 |
| 13.3.2019 | Ongentys | Bial — Portela & Ca, SA
  À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal | EU/1/15/1066 | 15.3.2019 |
| 13.3.2019 | Reyataz | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/03/267 | 15.3.2019 |
| 13.3.2019 | Rubraca | Clovis Oncology Ireland Limited
  Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland | EU/1/17/1250 | 15.3.2019 |
| 20.3.2019 | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1052 | 22.3.2019 |
| 20.3.2019 | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/795 | 22.3.2019 |
| 20.3.2019 | SCENESSE | Clinuvel Europe Limited
  10 Earlsfort Terrace, Dublin 2, Ireland | EU/1/14/969 | 22.3.2019 |
| 25.3.2019 | ADYNOVI | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/17/1247 | 27.3.2019 |
| 25.3.2019 | Baraclude | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/06/343 | 27.3.2019 |
| 25.3.2019 | Clopidogrel Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/09/559 | 27.3.2019 |
| 25.3.2019 | Clopidogrel ratiopharm GmbH | Archie Samuel s.r.o.
  Slunná 16, 61700 Brno, Česká republika | EU/1/09/541 | 27.3.2019 |
| 25.3.2019 | Daklinza | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/14/939 | 27.3.2019 |
| 25.3.2019 | Edarbi | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/11/734 | 27.3.2019 |
| 25.3.2019 | Levemir | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/04/278 | 27.3.2019 |
| 25.3.2019 | Lutathera | Advanced Accelerator Applications
  20 rue Diesel, 01630 Saint-Genis-Pouilly, France | EU/1/17/1226 | 27.3.2019 |
| 25.3.2019 | Nordimet | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | EU/1/16/1124 | 27.3.2019 |
| 25.3.2019 | Omidria | Omeros Ireland Limited
  Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, Ireland | EU/1/15/1018 | 27.3.2019 |
| 25.3.2019 | Plegridy | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/14/934 | 27.3.2019 |
| 25.3.2019 | Rotarix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/05/330 | 27.3.2019 |
| 25.3.2019 | Spinraza | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/17/1188 | 27.3.2019 |
| 25.3.2019 | Velphoro | Vifor Fresenius Medical Care Renal Pharma France
  100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France | EU/1/14/943 | 27.3.2019 |
| 25.3.2019 | Zyllt | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/553 | 27.3.2019 |
| 28.3.2019 | AMGEVITA | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1164 | 1.4.2019 |
| 28.3.2019 | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 1.4.2019 |
| 28.3.2019 | Clopidogrel Krka | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/556 | 1.4.2019 |
| 28.3.2019 | Coagadex | BPL Bioproducts Laboratory GmbH
  Dornhofstrasse 34, 63263 Neu-Isenburg, Deutschland | EU/1/16/1087 | 29.3.2019 |
| 28.3.2019 | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/13/890 | 1.4.2019 |
| 28.3.2019 | Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/17/1210 | 1.4.2019 |
| 28.3.2019 | EndolucinBeta | ITG Isotope Technologies Garching GmbH
  Lichtenbergstraße 1, 85748 Garching, Deutschland | EU/1/16/1105 | 1.4.2019 |
| 28.3.2019 | EVOTAZ | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/15/1025 | 1.4.2019 |
| 28.3.2019 | Galafold | Amicus Therapeutics Europe Limited
  Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland | EU/1/15/1082 | 1.4.2019 |
| 28.3.2019 | Genvoya | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/15/1061 | 1.4.2019 |
| 28.3.2019 | Glivec | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/198 | 1.4.2019 |
| 28.3.2019 | Imatinib Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/808 | 1.4.2019 |
| 28.3.2019 | Insulatard | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/233 | 1.4.2019 |
| 28.3.2019 | Jylamvo | Therakind (Europe) Limited
  3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland | EU/1/17/1172 | 1.4.2019 |
| 28.3.2019 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 1.4.2019 |
| 28.3.2019 | Lamivudine/Zidovudine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/663 | 1.4.2019 |
| 28.3.2019 | Mixtard | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/231 | 1.4.2019 |
| 28.3.2019 | Nerlynx | Puma Biotechnology B.V.
  Beechavenue 54, 1119 PW Schiphol-Rijk, Nederland | EU/1/18/1311 | 29.3.2019 |
| 28.3.2019 | NovoRapid | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/99/119 | 1.4.2019 |
| 28.3.2019 | Opdivo | Bristol-Myers Squibb/Pfizer EEIG
  Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/15/1014 | 1.4.2019 |
| 28.3.2019 | Perjeta | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/813 | 1.4.2019 |
| 28.3.2019 | Qutenza | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/09/524 | 1.4.2019 |
| 28.3.2019 | Segluromet | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/18/1265 | 1.4.2019 |
| 28.3.2019 | Sialanar | Proveca Pharma Limited
  Marine House, Clanwilliam Place, Dublin 2, Ireland | EU/1/16/1135 | 1.4.2019 |
| 28.3.2019 | Sprycel | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/363 | 1.4.2019 |
| 28.3.2019 | Strensiq | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/15/1015 | 1.4.2019 |
| 28.3.2019 | Sustiva | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/99/110 | 1.4.2019 |
| 28.3.2019 | VPRIV | Shire Pharmaceuticals Ireland Limited
  Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland | EU/1/10/646 | 1.4.2019 |
| 28.3.2019 | Xeloda | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/163 | 1.4.2019 |
| 29.3.2019 | Jylamvo | Therakind (Europe) Limited
  3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland | EU/1/17/1172 | 2.4.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

1.3.2019

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

5.3.2019

1.3.2019

Herzuma

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1257

5.3.2019

1.3.2019

Lacosamide Accord

Accord Healthcare S.L.U.

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

EU/1/17/1230

5.3.2019

1.3.2019

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

5.3.2019

1.3.2019

Levetiracetam Accord

Accord Healthcare S.L.U.

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

EU/1/11/712

5.3.2019

1.3.2019

Palonosetron Accord

Accord Healthcare S.L.U.

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

EU/1/16/1104

5.3.2019

1.3.2019

Tegsedi

Akcea Therapeutics Ireland Ltd

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

EU/1/18/1296

5.3.2019

5.3.2019

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

7.3.2019

5.3.2019

DaTSCAN

GE Healthcare B.V.

De Rondom 8, 5612 AP, Eindhoven, The Netherlands

EU/1/00/135

7.3.2019

5.3.2019

Granpidam

Accord Healthcare S.L.U.

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

EU/1/16/1137

7.3.2019

5.3.2019

Instanyl

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/09/531

7.3.2019

5.3.2019

Kiovig

Baxter AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/05/329

7.3.2019

5.3.2019

Levetiracetam Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/713

7.3.2019

5.3.2019

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

7.3.2019

5.3.2019

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

7.3.2019

11.3.2019

Actrapid

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/230

13.3.2019

11.3.2019

Cresemba

Basilea Pharmaceutica Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Loerrach, Baden-Wuerttemberg, Deutschland

EU/1/15/1036

13.3.2019

11.3.2019

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1263

13.3.2019

11.3.2019

Ferriprox

Apotex Europe B.V.

Archimedesweg 2, 2333 CN Leiden, Nederland

EU/1/99/108

13.3.2019

11.3.2019

Hemlibra

Roche Registration GmbH

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

EU/1/18/1271

13.3.2019

11.3.2019

Herceptin

Roche Registration GmbH

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

EU/1/00/145

13.3.2019

11.3.2019

INOmax

Linde Healthcare AB

SE-181 81 Lidingö, Sverige

EU/1/01/194

13.3.2019

11.3.2019

Intrarosa

Endoceutics S.A.

Rue Belliard 40, 1040 Brussels, Belgium

EU/1/17/1255

15.3.2019

11.3.2019

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

13.3.2019

11.3.2019

Luminity

Lantheus EU Limited

Atlantic Avenue, Westpark Business Campus, Shannon, Co. Clare, Ireland

EU/1/06/361

13.3.2019

11.3.2019

Mabthera

Roche Registration GmbH

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

EU/1/98/067

13.3.2019

11.3.2019

Maviret

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

13.3.2019

11.3.2019

Pelgraz

Accord Healthcare S.L.U.

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

EU/1/18/1313

15.3.2019

11.3.2019

Praluent

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/15/1031

13.3.2019

11.3.2019

Pramipexole Accord

Accord Healthcare S.L.U.

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

EU/1/11/728

13.3.2019

11.3.2019

Qarziba

EUSA Pharma (Netherlands) B.V.

Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland

EU/1/17/1191

13.3.2019

11.3.2019

Senshio

Shionogi B.V.

Kingsfordweg 151, 1043GR Amsterdam, Nederland

EU/1/14/978

13.3.2019

11.3.2019

Slenyto

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

EU/1/18/1318

13.3.2019

11.3.2019

Stayveer

Janssen Pharmaceutica N.V.

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/832

13.3.2019

11.3.2019

Varuby

TESARO Bio Netherlands B.V.

Joop Geeskinkweg 901, 1114AB Amsterdam-Duisvendrecht, Nederland

EU/1/17/1180

13.3.2019

11.3.2019

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

15.3.2019

11.3.2019

Zykadia

Novartis Europharm Limited

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

EU/1/15/999

13.3.2019

13.3.2019

NovoMix

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/00/142

15.3.2019

13.3.2019

Ongentys

Bial — Portela & Ca, SA

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

EU/1/15/1066

15.3.2019

13.3.2019

Reyataz

Bristol-Myers Squibb Pharma EEIG

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

EU/1/03/267

15.3.2019

13.3.2019

Rubraca

Clovis Oncology Ireland Limited

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

EU/1/17/1250

15.3.2019

20.3.2019

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

22.3.2019

20.3.2019

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

22.3.2019

20.3.2019

SCENESSE

Clinuvel Europe Limited

10 Earlsfort Terrace, Dublin 2, Ireland

EU/1/14/969

22.3.2019

25.3.2019

ADYNOVI

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/17/1247

27.3.2019

25.3.2019

Baraclude

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/343

27.3.2019

25.3.2019

Clopidogrel Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/09/559

27.3.2019

25.3.2019

Clopidogrel ratiopharm GmbH

Archie Samuel s.r.o.

Slunná 16, 61700 Brno, Česká republika

EU/1/09/541

27.3.2019

25.3.2019

Daklinza

Bristol-Myers Squibb Pharma EEIG

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

EU/1/14/939

27.3.2019

25.3.2019

Edarbi

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/11/734

27.3.2019

25.3.2019

Levemir

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/04/278

27.3.2019

25.3.2019

Lutathera

Advanced Accelerator Applications

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

EU/1/17/1226

27.3.2019

25.3.2019

Nordimet

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

EU/1/16/1124

27.3.2019

25.3.2019

Omidria

Omeros Ireland Limited

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

EU/1/15/1018

27.3.2019

25.3.2019

Plegridy

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/14/934

27.3.2019

25.3.2019

Rotarix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/05/330

27.3.2019

25.3.2019

Spinraza

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/17/1188

27.3.2019

25.3.2019

Velphoro

Vifor Fresenius Medical Care Renal Pharma France

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

EU/1/14/943

27.3.2019

25.3.2019

Zyllt

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/553

27.3.2019

28.3.2019

AMGEVITA

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1164

1.4.2019

28.3.2019

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

1.4.2019

28.3.2019

Clopidogrel Krka

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556

1.4.2019

28.3.2019

Coagadex

BPL Bioproducts Laboratory GmbH

Dornhofstrasse 34, 63263 Neu-Isenburg, Deutschland

EU/1/16/1087

29.3.2019

28.3.2019

Cometriq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

1.4.2019

28.3.2019

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/17/1210

1.4.2019

28.3.2019

EndolucinBeta

ITG Isotope Technologies Garching GmbH

Lichtenbergstraße 1, 85748 Garching, Deutschland

EU/1/16/1105

1.4.2019

28.3.2019

EVOTAZ

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1025

1.4.2019

28.3.2019

Galafold

Amicus Therapeutics Europe Limited

Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland

EU/1/15/1082

1.4.2019

28.3.2019

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

1.4.2019

28.3.2019

Glivec

Novartis Europharm Limited

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

EU/1/01/198

1.4.2019

28.3.2019

Imatinib Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/808

1.4.2019

28.3.2019

Insulatard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/233

1.4.2019

28.3.2019

Jylamvo

Therakind (Europe) Limited

3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland

EU/1/17/1172

1.4.2019

28.3.2019

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

1.4.2019

28.3.2019

Lamivudine/Zidovudine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/663

1.4.2019

28.3.2019

Mixtard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/231

1.4.2019

28.3.2019

Nerlynx

Puma Biotechnology B.V.

Beechavenue 54, 1119 PW Schiphol-Rijk, Nederland

EU/1/18/1311

29.3.2019

28.3.2019

NovoRapid

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/99/119

1.4.2019

28.3.2019

Opdivo

Bristol-Myers Squibb/Pfizer EEIG

Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/15/1014

1.4.2019

28.3.2019

Perjeta

Roche Registration GmbH

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

EU/1/13/813

1.4.2019

28.3.2019

Qutenza

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/09/524

1.4.2019

28.3.2019

Segluromet

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1265

1.4.2019

28.3.2019

Sialanar

Proveca Pharma Limited

Marine House, Clanwilliam Place, Dublin 2, Ireland

EU/1/16/1135

1.4.2019

28.3.2019

Sprycel

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/363

1.4.2019

28.3.2019

Strensiq

Alexion Europe SAS

1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

EU/1/15/1015

1.4.2019

28.3.2019

Sustiva

Bristol-Myers Squibb Pharma EEIG

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

EU/1/99/110

1.4.2019

28.3.2019

VPRIV

Shire Pharmaceuticals Ireland Limited

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

EU/1/10/646

1.4.2019

28.3.2019

Xeloda

Roche Registration GmbH

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

EU/1/00/163

1.4.2019

29.3.2019

Jylamvo

Therakind (Europe) Limited

3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland

EU/1/17/1172

2.4.2019

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

—

Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 29.3.2019 | Arti-Cell Forte | Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells | Global Stem cell Technology (G.S.T.) NV
  Noorwegenstraat 4, 9940 Evergem, België | EU/2/18/228 | Suspension for injection | Pending | 2.4.2019 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

29.3.2019

Arti-Cell Forte

Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells

Global Stem cell Technology (G.S.T.) NV

Noorwegenstraat 4, 9940 Evergem, België

EU/2/18/228

Suspension for injection

Pending

2.4.2019

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

—

Modification of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.3.2019 | Melosus | CP-Pharma Handelsgesellschaft mbH
  Ostlandring 13, 31303 Burgdorf, Deutschland | EU/2/10/116 | 5.3.2019 |
| 1.3.2019 | Prevomax | Le Vet Beheer B.V.
  Wilgenweg 7, 3421 TV Oudewater, Nederland | EU/2/17/211 | 5.3.2019 |
| 12.3.2019 | Aivlosin | ECO Animal Health Europe Limited
  6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland | EU/2/04/044 | 14.3.2019 |
| 12.3.2019 | Reconcile | Pegasus Laboratories Ireland Limited
  10 McCurtain Hill, Clonakilty, County Cork, Ireland | EU/2/08/080 | 14.3.2019 |
| 12.3.2019 | Suprelorin | VIRBAC S.A.
  1ère Avenue - 2065 m — L.I.D., 06516 Carros Cedex, France | EU/2/07/072 | 14.3.2019 |
| 14.3.2019 | Fungitraxx | Avimedical B.V.
  Abbinkdijk 1, 7255 LX Hengelo (Gld), Nederland | EU/2/13/160 | 19.3.2019 |
| 14.3.2019 | Loxicom | Norbrook Laboratories (Ireland) Limited
  Rossmore Industrial Estate, Monaghan, Ireland | EU/2/08/090 | 19.3.2019 |
| 27.3.2019 | Activyl Tick Plus | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/11/137 | 29.3.2019 |
| 27.3.2019 | Versican Plus DHPPi | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/169 | 29.3.2019 |
| 27.3.2019 | Versican Plus Pi | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/168 | 29.3.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

1.3.2019

Melosus

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf, Deutschland

EU/2/10/116

5.3.2019

1.3.2019

Prevomax

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/17/211

5.3.2019

12.3.2019

Aivlosin

ECO Animal Health Europe Limited

6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland

EU/2/04/044

14.3.2019

12.3.2019

Reconcile

Pegasus Laboratories Ireland Limited

10 McCurtain Hill, Clonakilty, County Cork, Ireland

EU/2/08/080

14.3.2019

12.3.2019

Suprelorin

VIRBAC S.A.

1ère Avenue - 2065 m — L.I.D., 06516 Carros Cedex, France

EU/2/07/072

14.3.2019

14.3.2019

Fungitraxx

Avimedical B.V.

Abbinkdijk 1, 7255 LX Hengelo (Gld), Nederland

EU/2/13/160

19.3.2019

14.3.2019

Loxicom

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate, Monaghan, Ireland

EU/2/08/090

19.3.2019

27.3.2019

Activyl Tick Plus

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/137

29.3.2019

27.3.2019

Versican Plus DHPPi

Zoetis Belgium S.A.

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

EU/2/14/169

29.3.2019

27.3.2019

Versican Plus Pi

Zoetis Belgium S.A.

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

EU/2/14/168

29.3.2019

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 |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| UNITED KINGDOM |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

UNITED KINGDOM

---

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

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