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Document 52016XC0826(01)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016 (Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016 (Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016 (Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
OJ C 312, 26.8.2016, p. 1–9
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
26.8.2016 |
EN |
Official Journal of the European Union |
C 312/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016
(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 312/01)
— 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 authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
|
1.7.2016 |
Zinbryta |
daclizumab |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/16/1107 |
Solution for injection |
L04AC01 |
5.7.2016 |
|
6.7.2016 |
EndolucinBeta |
Lutetium (177 Lu) chloride |
ITG Isotope Technologies Garching GmbH Lichtenbergstr. 1, D-85748 Garching, Deutschland |
EU/1/16/1105 |
Radiopharmaceutical precursor, solution |
Pending |
8.7.2016 |
|
6.7.2016 |
Epclusa |
sofosbuvir/velpatasvir |
Gilead Sciences International Ltd Cambridge, CB21 6GT, United Kingdom |
EU/1/16/1116 |
Film-coated tablet |
Pending |
8.7.2016 |
|
15.7.2016 |
Qtern |
saxagliptin/dapagliflozin |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/16/1108 |
Film-coated tablet |
A10BD21 |
19.7.2016 |
|
22.7.2016 |
Bortezomib Hospira |
bortezomib |
Hospira UK Limited Horizon, Honey Lane, Hurley, SL6 6RJ, United Kingdom |
EU/1/16/1114 |
Powder for solution for infusion |
L01XX32 |
26.7.2016 |
|
22.7.2016 |
Bortezomib SUN |
bortezomib |
Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland |
EU/1/16/1102 |
Powder for solution for injection |
L01XX32 |
26.7.2016 |
|
22.7.2016 |
Pemetrexed Fresenius Kabi |
pemetrexed |
Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom |
EU/1/16/1115 |
Powder for concentrate for solution for infusion |
L01BA04 |
26.7.2016 |
|
22.7.2016 |
Zepatier |
elbasvir/grazoprevir |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/16/1119 |
Film-coated tablet |
J05A |
26.7.2016 |
— 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 |
|
4.7.2016 |
BiResp Spiromax |
Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland |
EU/1/14/921 |
6.7.2016 |
|
4.7.2016 |
Clopidogrel Apotex |
Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland |
EU/1/09/568 |
6.7.2016 |
|
4.7.2016 |
Duloxetine Lilly |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/14/972 |
6.7.2016 |
|
4.7.2016 |
DuoResp Spiromax |
Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland |
EU/1/14/920 |
6.7.2016 |
|
6.7.2016 |
Arzerra |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/625 |
8.7.2016 |
|
6.7.2016 |
Budesonide/Formoterol Teva |
Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland |
EU/1/14/948 |
8.7.2016 |
|
6.7.2016 |
Mircera |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/07/400 |
8.7.2016 |
|
6.7.2016 |
Nivestim |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom |
EU/1/10/631 |
8.7.2016 |
|
6.7.2016 |
Olanzapine Mylan |
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
EU/1/08/475 |
12.7.2016 |
|
6.7.2016 |
Oprymea |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/08/469 |
8.7.2016 |
|
6.7.2016 |
Rapilysin |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland |
EU/1/96/018 |
8.7.2016 |
|
6.7.2016 |
Vylaer Spiromax |
Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland |
EU/1/14/949 |
8.7.2016 |
|
6.7.2016 |
Xarelto |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/08/472 |
8.7.2016 |
|
8.7.2016 |
Otezla |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/14/981 |
12.7.2016 |
|
8.7.2016 |
Revlimid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/07/391 |
12.7.2016 |
|
14.7.2016 |
Ariclaim |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/04/283 |
18.7.2016 |
|
14.7.2016 |
Votrient |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/628 |
18.7.2016 |
|
15.7.2016 |
ATryn |
GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom |
EU/1/06/355 |
19.7.2016 |
|
15.7.2016 |
Exjade |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/356 |
19.7.2016 |
|
15.7.2016 |
Jardiance |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/14/930 |
19.7.2016 |
|
15.7.2016 |
Komboglyze |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/11/731 |
19.7.2016 |
|
15.7.2016 |
Leflunomide medac |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland |
EU/1/10/637 |
19.7.2016 |
|
15.7.2016 |
Levetiracetam Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/11/701 |
19.7.2016 |
|
15.7.2016 |
Luminity |
Lantheus MI UK Limited Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom |
EU/1/06/361 |
19.7.2016 |
|
15.7.2016 |
NeoRecormon |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/97/031 |
19.7.2016 |
|
15.7.2016 |
Noxafil |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/05/320 |
19.7.2016 |
|
15.7.2016 |
Opsumit |
Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
EU/1/13/893 |
19.7.2016 |
|
15.7.2016 |
Pramipexole Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/11/728 |
19.7.2016 |
|
15.7.2016 |
Remicade |
Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland |
EU/1/99/116 |
19.7.2016 |
|
15.7.2016 |
Sprycel |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/06/363 |
19.7.2016 |
|
15.7.2016 |
Stelara |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/08/494 |
19.7.2016 |
|
15.7.2016 |
Synjardy |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/15/1003 |
19.7.2016 |
|
15.7.2016 |
Temozolomide HEXAL |
Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland |
EU/1/10/616 |
19.7.2016 |
|
15.7.2016 |
Temozolomide Sandoz |
Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich |
EU/1/10/617 |
19.7.2016 |
|
15.7.2016 |
Thalidomide Celgene |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/08/443 |
19.7.2016 |
|
15.7.2016 |
Thyrogen |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/99/122 |
19.7.2016 |
|
15.7.2016 |
Zoledronic acid Teva Pharma |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/772 |
19.7.2016 |
|
22.7.2016 |
Byetta |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/06/362 |
26.7.2016 |
|
22.7.2016 |
Cialis |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/02/237 |
26.7.2016 |
|
22.7.2016 |
Conbriza |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/09/511 |
26.7.2016 |
|
22.7.2016 |
Cymbalta |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/04/296 |
26.7.2016 |
|
22.7.2016 |
EDURANT |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/11/736 |
26.7.2016 |
|
22.7.2016 |
Eviplera |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/11/737 |
26.7.2016 |
|
22.7.2016 |
Granupas |
Lucane Pharma 172 rue de Charonne, 75011 Paris, France |
EU/1/13/896 |
26.7.2016 |
|
22.7.2016 |
Harvoni |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/14/958 |
26.7.2016 |
|
22.7.2016 |
Levetiracetam Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/11/712 |
26.7.2016 |
|
22.7.2016 |
Noxafil |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/05/320 |
26.7.2016 |
|
22.7.2016 |
Ofev |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/14/979 |
26.7.2016 |
|
22.7.2016 |
Rebif |
Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/98/063 |
27.7.2016 |
|
22.7.2016 |
Ryzodeg |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/12/806 |
26.7.2016 |
|
22.7.2016 |
Temomedac |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland |
EU/1/09/605 |
26.7.2016 |
|
22.7.2016 |
Vizamyl |
GE Healthcare Ltd Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom |
EU/1/14/941 |
26.7.2016 |
|
22.7.2016 |
Vyndaqel |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/11/717 |
26.7.2016 |
|
22.7.2016 |
Xeristar |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/04/297 |
26.7.2016 |
|
29.7.2016 |
Cervarix |
GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique |
EU/1/07/419 |
2.8.2016 |
|
29.7.2016 |
Firdapse |
BioMarin Europe Ltd 10 Bloomsbury Way, London WC1A 2SL, United Kingdom |
EU/1/09/601 |
2.8.2016 |
|
29.7.2016 |
Imnovid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/13/850 |
2.8.2016 |
|
29.7.2016 |
Jakavi |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/12/773 |
2.8.2016 |
|
29.7.2016 |
KEYTRUDA |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/15/1024 |
2.8.2016 |
|
29.7.2016 |
Nevanac |
Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |
EU/1/07/433 |
2.8.2016 |
|
29.7.2016 |
ReFacto AF |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/99/103 |
3.8.2016 |
|
29.7.2016 |
Revatio |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/05/318 |
3.8.2016 |
|
29.7.2016 |
Ribavirin Mylan |
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
EU/1/10/634 |
4.8.2016 |
|
29.7.2016 |
RoActemra |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/08/492 |
2.8.2016 |
|
29.7.2016 |
XALKORI |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/12/793 |
4.8.2016 |
— 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 |
|
29.7.2016 |
ChondroCelect |
TiGenix NV Romeinse straat 12/2, B-3001 Leuven, België |
EU/1/09/563 |
2.8.2016 |
— 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 |
|
4.7.2016 |
Suvaxyn CSF Marker |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/14/179 |
6.7.2016 |
|
8.7.2016 |
Oxyglobin |
OPK Biotech Netherlands BV Teleportboulevard 140, NL-1043 EJ Amsterdam, Nederland |
EU/2/99/015 |
12.7.2016 |
|
19.7.2016 |
ERYSENG |
Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España |
EU/2/14/166 |
21.7.2016 |
|
25.7.2016 |
Eurican Herpes 205 |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/01/029 |
27.7.2016 |
|
25.7.2016 |
Osurnia |
Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM |
EU/2/14/170 |
27.7.2016 |
|
25.7.2016 |
Porcilis ColiClos |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/12/141 |
27.7.2016 |
|
25.7.2016 |
Prac-Tic |
Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM |
EU/2/06/066 |
27.7.2016 |
|
25.7.2016 |
STARTVAC |
Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España |
EU/2/08/092 |
27.7.2016 |
|
29.7.2016 |
Ingelvac CircoFLEX |
Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland |
EU/2/07/079 |
2.8.2016 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
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European Medicines Agency |
|
30 Churchill Place |
|
Canary Wharf |
|
London E14 5EU |
|
United Kingdom |
(1) OJ L 136, 30.4.2004, p. 1.