Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2019 to 28 February 2019 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2019-03-29
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2019118EN.01000101.xml










29.3.2019   


EN


Official Journal of the European Union


C 118/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2019 to 28 February 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 118/01)






—



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




14.2.2019


Zirabev


bevacizumab


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/18/1344


Concentrate for solution for infusion


L01XC07


18.2.2019




15.2.2019


Besremi


ropeginterferon alfa-2b


AOP Orphan Pharmaceuticals AG
Wilhelminenstraβe 91/II f, 1160 Wien, Österreich


EU/1/18/1352


Solution for injection


L03AB15


19.2.2019




18.2.2019


Lusutrombopag Shionogi


lusutrombopag


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


EU/1/18/1348


Film-coated tablet


B02BX07


20.2.2019




18.2.2019


Miglustat Dipharma


miglustat


Dipharma B.V.
Prins Bernhardplein 200, 1097 JB Amsterdam, Netherlands


EU/1/18/1346


Capsule, hard


A16AX06


20.2.2019




18.2.2019


Rizmoic


naldemedine


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


EU/1/18/1291


Film-coated tablet


A06AH05


20.2.2019




18.2.2019


Tobramycin PARI


tobramycin


PARI Pharma GmbH
Moosstraße 3, 82319 Starnberg, Deutschland


EU/1/18/1350


Nebuliser solution


J01GB01


20.2.2019










—



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




6.2.2019


Accofil


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/14/946


8.2.2019




6.2.2019


ADCETRIS


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/12/794


8.2.2019




6.2.2019


Ammonaps


Swedish Orphan Biovitrum International AB
112 76 Stockholm, Sverige


EU/1/99/120


11.2.2019




6.2.2019


Axumin


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


EU/1/17/1186


8.2.2019




6.2.2019


Epivir


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/96/015


8.2.2019




6.2.2019


Eptifibatide Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/15/1065


8.2.2019




6.2.2019


Ivabradine Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/17/1190


8.2.2019




6.2.2019


Mirapexin


Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/97/051


8.2.2019




6.2.2019


Mvasi


Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland


EU/1/17/1246


8.2.2019




6.2.2019


Revolade


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/10/612


8.2.2019




6.2.2019


Sprycel


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/06/363


8.2.2019




6.2.2019


Taltz


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


EU/1/15/1085


8.2.2019




6.2.2019


Terrosa


Gedeon Richter Plc.
Gyömrői út 19-21., 1103 Budapest, Magyarország


EU/1/16/1159


8.2.2019




6.2.2019


Tolucombi


Krka d. d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/13/821


11.2.2019




6.2.2019


Zyprexa Velotab


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


EU/1/99/125


8.2.2019




7.2.2019


Circadin


RAD Neurim Pharmaceuticals EEC SARL
4 rue de Marivaux, 75002 Paris, France


EU/1/07/392


15.2.2019




7.2.2019


Dacogen


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/12/792


11.2.2019




7.2.2019


Dasselta


Krka d. d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/11/739


11.2.2019




7.2.2019


Kisplyx


Eisai GmbH
Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland


EU/1/16/1128


11.2.2019




7.2.2019


Lenvima


Eisai GmbH
Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland


EU/1/15/1002


11.2.2019




7.2.2019


Raxone


Santhera Pharmaceuticals (Deutschland) GmbH
Marie-Curie Straße 8, 79539 Lörrach, Deutschland


EU/1/15/1020


11.2.2019




7.2.2019


Sifrol


Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/97/050


11.2.2019




7.2.2019


Sycrest


Organon N.V.
Kloosterstraat 6, 5349 AB Oss, Nederland


EU/1/10/640


11.2.2019




7.2.2019


Tarceva


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


EU/1/05/311


11.2.2019




7.2.2019


Teysuno


Nordic Group B.V.
Siriusdreef 22, 2132 WT Hoofddorp, Nederland


EU/1/11/669


11.2.2019




8.2.2019


Helicobacter Test INFAI


INFAI GmbH
Gottfried-Hagen-Straße 60-62, 51105 Köln, Deutschland


EU/1/97/045


12.2.2019




12.2.2019


Buccolam


Shire Services BVBA
rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België


EU/1/11/709


14.2.2019




12.2.2019


Caspofungin Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/15/1081


15.2.2019




12.2.2019


Ebilfumin


Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland


EU/1/14/915


14.2.2019




12.2.2019


Envarsus


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


EU/1/14/935


14.2.2019




12.2.2019


Imraldi


Samsung Bioepis NL B.V.
Olof Palmestraat 10, 2616 LR Delft, Nederland


EU/1/17/1216


14.2.2019




12.2.2019


Jinarc


Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland


EU/1/15/1000


14.2.2019




12.2.2019


Liprolog


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


EU/1/01/195


14.2.2019




12.2.2019


Yargesa


Piramal Critical Care B.V.
Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland


EU/1/17/1176


14.2.2019




14.2.2019


Aripiprazole Mylan Pharma


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/15/1005


18.2.2019




14.2.2019


Bortezomib Hospira


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/16/1114


18.2.2019




14.2.2019


Fotivda


EUSA Pharma (Netherlands) B.V.
Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland


EU/1/17/1215


18.2.2019




14.2.2019


Hemlibra


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


EU/1/18/1271


18.2.2019




14.2.2019


Imatinib Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/13/845


18.2.2019




14.2.2019


Jardiance


Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/14/930


18.2.2019




14.2.2019


Mekinist


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/14/931


18.2.2019




14.2.2019


Modigraf


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


EU/1/09/523


18.2.2019




14.2.2019


Pioglitazone Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/11/722


18.2.2019




14.2.2019


Quinsair


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


EU/1/14/973


18.2.2019




14.2.2019


Silgard


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/06/358


18.2.2019




14.2.2019


Sutent


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/06/347


18.2.2019




18.2.2019


Advagraf


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


EU/1/07/387


20.2.2019




18.2.2019


ATryn


Laboratoire français du Fractionnement et des Biotechnologies
3 avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France


EU/1/06/355


20.2.2019




18.2.2019


Bosulif


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/13/818


20.2.2019




18.2.2019


Pixuvri


CTI Life Sciences Deutschland GmbH
Universitätsstraβe 71, 50931 Köln, Deutschland


EU/1/12/764


20.2.2019




18.2.2019


Simponi


Janssen Biologics B.V.
Einsteinweg 101, 2333 CB Leiden, Nederland


EU/1/09/546


20.2.2019




18.2.2019


Zelboraf


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


EU/1/12/751


20.2.2019




18.2.2019


Zyprexa


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


EU/1/96/022


20.2.2019




20.2.2019


Bortezomib Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/15/1019


22.2.2019




20.2.2019


Bortezomib SUN


Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, 2132 JH Hoofddorp, Nederland


EU/1/16/1102


22.2.2019




20.2.2019


Entyvio


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/14/923


22.2.2019




20.2.2019


Eurartesim


Alfasigma S.p.A.
Via Ragazzi del ‘99, n.5, 40133 Bologna, Italia


EU/1/11/716


22.2.2019




20.2.2019


Ibandronic acid Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/12/798


22.2.2019




20.2.2019


Mepact


Takeda France SAS
Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France


EU/1/08/502


22.2.2019




20.2.2019


Renvela


Genzyme Europe B.V.
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland


EU/1/09/521


26.2.2019




20.2.2019


Simbrinza


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/14/933


22.2.2019




20.2.2019


Sustiva


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/99/110


22.2.2019




20.2.2019


Vabomere


Menarini International Operations Luxembourg S.A.
1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg


EU/1/18/1334


25.2.2019




20.2.2019


VELCADE


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/04/274


22.2.2019




20.2.2019


Voriconazole Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/13/835


22.2.2019




20.2.2019


Zytiga


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/11/714


22.2.2019




25.2.2019


AFSTYLA


CSL Behring GmbH
Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland


EU/1/16/1158


27.2.2019




25.2.2019


Amlodipine/Valsartan Mylan


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/16/1092


27.2.2019




25.2.2019


Bortezomib Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/15/1019


27.2.2019




25.2.2019


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


27.2.2019




25.2.2019


Entecavir Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/17/1211


27.2.2019




25.2.2019


Fasenra


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/17/1252


27.2.2019




25.2.2019


Fiasp


Novo Nordisk A/S
Novo Allé, 2880 Bagsvaerd, Danmark


EU/1/16/1160


27.2.2019




25.2.2019


Hetlioz


Vanda Pharmaceuticals Germany GmbH
Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland


EU/1/15/1008


27.2.2019




25.2.2019


Miglustat Gen.Orph


Gen.Orph
185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France


EU/1/17/1232


27.2.2019




25.2.2019


Pemetrexed Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/15/1071


27.3.2019




25.2.2019


Repaglinide Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/11/743


27.2.2019




25.2.2019


Tecentriq


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


EU/1/17/1220


27.2.2019




25.2.2019


Temozolomide Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/10/615


27.2.2019




25.2.2019


Zavicefta


Pfizer Ireland Pharmaceuticals
Operations Support Group, Ringaskiddy, County Cork, Ireland


EU/1/16/1109


27.2.2019




25.2.2019


Zyclara


Meda AB
Pipers väg 2A, 170 73 Solna, Sverige


EU/1/12/783


27.2.2019




25.2.2019


Zypadhera


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


EU/1/08/479


27.2.2019










—



Withdrawal of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




14.2.2019


Imatinib Medac


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6, 22880 Wedel, Deutschland


EU/1/13/876


18.2.2019




18.2.2019


Silgard


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/06/358


20.2.2019




18.2.2019


Vantobra


PARI Pharma GmbH
Moosstraße 3, 82319 Starnberg, Deutschland


EU/1/14/932


20.2.2019




20.2.2019


ATryn


Laboratoire français du Fractionnement et des Biotechnologies
3 avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France


EU/1/06/355


22.2.2019




25.2.2019


Altargo


Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/07/390


27.2.2019




25.2.2019


Arzerra


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/10/625


27.2.2019










—



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




5.2.2019


EVANT


Coccidiosis vaccine live for chickens


Laboratorios Hipra, S.A.
Avda. La Selva, 135, 17170 Amer (Girona), España


EU/2/18/233


Suspension and solvent for oral spray


QI01AN01


7.2.2019




8.2.2019


Kriptazen


halofuginone


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


EU/2/18/234


Oral solution


QP51AX08


12.2.2019










—



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




4.2.2019


CYTOPOINT


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/17/205


6.2.2019




4.2.2019


Zycortal


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


EU/2/15/189


6.2.2019




5.2.2019


Bravecto


Intervet International B.V.
Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland


EU/2/13/158


7.2.2019




5.2.2019


Equisolon


Le Vet B.V.
Wilgenweg 7, 3421 TV Oudewater, Nederland


EU/2/14/161


7.2.2019




8.2.2019


Halagon


Emdoka bvba
J. Lijsenstraat 16, 2321 Hoogstraten, België


EU/2/16/201


12.2.2019




8.2.2019


STARTVAC


Laboratorios Hipra, S.A.
Avda. La Selva, 135, 17170 Amer (Girona), España


EU/2/08/092


12.2.2019




8.2.2019


Vaxxitek HVT + IBD


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/02/032


12.2.2019




8.2.2019


Vectra Felis


Ceva Santé Animale
10 avenue de la Ballastière, 33500 Libourne, France


EU/2/14/165


12.2.2019




21.2.2019


BLUEVAC BTV8


CZ Veterinaria, S.A.
La Relva s/n, P.O. Box 16, 36400 Porriño, España


EU/2/11/122


25.2.2019




21.2.2019


Zulvac BTV


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/17/207


25.2.2019




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






(1)  OJ L 136, 30.4.2004, p. 1.