EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document C:2020:318:FULL
Official Journal of the European Union, C 318, 25 September 2020
Official Journal of the European Union, C 318, 25 September 2020
Official Journal of the European Union, C 318, 25 September 2020
ISSN 1977-091X |
||
Official Journal of the European Union |
C 318 |
|
English edition |
Information and Notices |
Volume 63 |
Contents |
page |
|
|
IV Notices |
|
|
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
|
|
European Commission |
|
2020/C 318/01 |
||
2020/C 318/02 |
EN |
|
IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
25.9.2020 |
EN |
Official Journal of the European Union |
C 318/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2020 to 31 August 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 318/01)
— 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 |
||
19.8.2020 |
Aybintio |
bevacizumab |
|
EU/1/20/1454 |
Concentrate for solution for infusion |
L01XC07 |
20.8.2020 |
||
19.8.2020 |
Bavencio |
avelumab |
|
EU/1/17/1214 |
Concentrate for solution for infusion |
L01XC31 |
25.8.2020 |
||
19.8.2020 |
Gencebok |
caffeine citrate |
|
EU/1/20/1465 |
Solution for infusion |
N06BC01 |
20.8.2020 |
||
19.8.2020 |
Methylthioninium chloride Cosmo |
methylthioninium chloride |
|
EU/1/20/1470 |
Prolonged-release tablet |
V04CX |
20.8.2020 |
||
21.8.2020 |
Kaftrio |
ivacaftor / tezacaftor / elexacaftor |
|
EU/1/20/1468 |
Film-coated tablet |
R07AX32 |
21.8.2020 |
||
25.8.2020 |
BLENREP |
belantamab mafodotin |
|
EU/1/20/1474 |
Powder for concentrate for solution for infusion |
L01XC39 |
26.8.2020 |
||
25.8.2020 |
Idefirix |
imlifidase |
|
EU/1/20/1471 |
Powder for concentrate for solution for infusion |
L04AA |
1.9.2020 |
||
27.8.2020 |
Livogiva |
teriparatide |
|
EU/1/20/1462 |
Solution for injection |
H05AA02 |
28.8.2020 |
||
27.8.2020 |
Qutavina |
teriparatide |
|
EU/1/20/1463 |
Solution for injection |
H05AA02. |
31.8.2020 |
||
28.8.2020 |
Cabazitaxel Accord |
cabazitaxel |
|
EU/1/20/1448 |
Concentrate for solution for infusion |
L01CD04 |
31.8.2020 |
— 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 |
||
6.8.2020 |
Panretin |
|
EU/1/00/149 |
7.8.2020 |
||
6.8.2020 |
Pramipexole Accord |
|
EU/1/11/728 |
10.8.2020 |
||
6.8.2020 |
Raxone |
|
EU/1/15/1020 |
12.8.2020 |
||
6.8.2020 |
Zavicefta |
|
EU/1/16/1109 |
11.8.2020 |
||
10.8.2020 |
Colobreathe |
|
EU/1/11/747 |
14.8.2020 |
||
10.8.2020 |
Fotivda |
|
EU/1/17/1215 |
3.9.2020 |
||
10.8.2020 |
Inflectra |
|
EU/1/13/854 |
11.8.2020 |
||
10.8.2020 |
Jylamvo |
|
EU/1/17/1172 |
24.8.2020 |
||
10.8.2020 |
Levetiracetam Teva |
|
EU/1/11/701 |
17.8.2020 |
||
10.8.2020 |
Nucala |
|
EU/1/15/1043 |
14.8.2020 |
||
10.8.2020 |
Onivyde pegylated liposomal |
|
EU/1/16/1130 |
11.8.2020 |
||
10.8.2020 |
Pemetrexed Hospira |
|
EU/1/15/1057 |
10.8.2020 |
||
13.8.2020 |
Apealea |
|
EU/1/18/1292 |
24.8.2020 |
||
13.8.2020 |
Armisarte |
|
EU/1/15/1063 |
22.8.2020 |
||
13.8.2020 |
Cresemba |
|
EU/1/15/1036 |
14.8.2020 |
||
13.8.2020 |
Duloxetine Zentiva |
|
EU/1/15/1028 |
17.8.2020 |
||
13.8.2020 |
Imatinib Accord |
|
EU/1/13/845 |
17.8.2020 |
||
13.8.2020 |
Qtrilmet |
|
EU/1/19/1401 |
17.8.2020 |
||
13.8.2020 |
Twynsta |
|
EU/1/10/648 |
14.8.2020 |
||
17.8.2020 |
Circadin |
|
EU/1/07/392 |
20.8.2020 |
||
19.8.2020 |
Elocta |
|
EU/1/15/1046 |
21.8.2020 |
||
19.8.2020 |
Emend |
|
EU/1/03/262 |
24.8.2020 |
||
19.8.2020 |
IDELVION |
|
EU/1/16/1095 |
24.8.2020 |
||
19.8.2020 |
IMBRUVICA |
|
EU/1/14/945 |
24.8.2020 |
||
19.8.2020 |
Pemetrexed medac |
|
EU/1/15/1038 |
20.8.2020 |
||
19.8.2020 |
Pemetrexed Sandoz |
|
EU/1/15/1037 |
28.8.2020 |
||
19.8.2020 |
Praluent |
|
EU/1/15/1031 |
20.8.2020 |
||
19.8.2020 |
Skilarence |
|
EU/1/17/1201 |
26.8.2020 |
||
19.8.2020 |
Tecentriq |
|
EU/1/17/1220 |
20.8.2020 |
||
21.8.2020 |
Kalydeco |
|
EU/1/12/782 |
21.8.2020 |
||
25.8.2020 |
Aimovig |
|
EU/1/18/1293 |
3.9.2020 |
||
25.8.2020 |
Axumin |
|
EU/1/17/1186 |
26.8.2020 |
||
25.8.2020 |
Ebymect |
|
EU/1/15/1051 |
1.9.2020 |
||
25.8.2020 |
Epclusa |
|
EU/1/16/1116 |
26.8.2020 |
||
25.8.2020 |
Esperoct |
|
EU/1/19/1374 |
26.8.2020 |
||
25.8.2020 |
Latuda |
|
EU/1/14/913 |
4.9.2020 |
||
25.8.2020 |
Ninlaro |
|
EU/1/16/1094 |
1.9.2020 |
||
25.8.2020 |
Ravicti |
|
EU/1/15/1062 |
26.8.2020 |
||
25.8.2020 |
RotaTeq |
|
EU/1/06/348 |
27.8.2020 |
||
25.8.2020 |
Shingrix |
|
EU/1/18/1272 |
26.8.2020 |
||
25.8.2020 |
Vemlidy |
|
EU/1/16/1154 |
26.8.2020 |
||
25.8.2020 |
VITRAKVI |
|
EU/1/19/1385 |
26.8.2020 |
||
25.8.2020 |
Votubia |
|
EU/1/11/710 |
25.8.2020 |
||
27.8.2020 |
Atriance |
|
EU/1/07/403 |
27.8.2020 |
||
27.8.2020 |
Betaferon |
|
EU/1/95/003 |
28.8.2020 |
||
27.8.2020 |
Fortacin |
|
EU/1/13/881 |
3.9.2020 |
||
27.8.2020 |
Imatinib Actavis |
|
EU/1/13/825 |
28.8.2020 |
||
27.8.2020 |
Imfinzi |
|
EU/1/18/1322 |
31.8.2020 |
||
27.8.2020 |
NovoThirteen |
|
EU/1/12/775 |
28.8.2020 |
||
27.8.2020 |
Skyrizi |
|
EU/1/19/1361 |
28.8.2020 |
||
28.8.2020 |
Actraphane |
|
EU/1/02/229 |
31.8.2020 |
||
28.8.2020 |
Actrapid |
|
EU/1/02/230 |
31.8.2020 |
||
28.8.2020 |
Eurartesim |
|
EU/1/11/716 |
31.8.2020 |
||
28.8.2020 |
IMBRUVICA |
|
EU/1/14/945 |
2.9.2020 |
||
28.8.2020 |
Olanzapine Mylan |
|
EU/1/08/475 |
31.8.2020 |
||
28.8.2020 |
PREZISTA |
|
EU/1/06/380 |
1.9.2020 |
||
28.8.2020 |
Reyataz |
|
EU/1/03/267 |
31.8.2020 |
||
28.8.2020 |
Vyxeos liposomal |
|
EU/1/18/1308 |
31.8.2020 |
||
28.8.2020 |
Xarelto |
|
EU/1/08/472 |
31.8.2020 |
— 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 |
||
14.8.2020 |
Qtrilmet |
|
EU/1/19/1401 |
17.8.2020 |
— 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 |
||
5.8.2020 |
Econor |
|
EU/2/98/010 |
6.8.2020 |
||
5.8.2020 |
Halocur |
|
EU/2/99/013 |
10.8.2020 |
||
12.8.2020 |
ECOPORC SHIGA |
|
EU/2/13/149 |
14.8.2020 |
||
12.8.2020 |
Nobilis IB Primo QX |
|
EU/2/14/174 |
14.8.2020 |
||
12.8.2020 |
Respiporc Flu3 |
|
EU/2/09/103 |
31.8.2020 |
||
12.8.2020 |
RESPIPORC FLUpan H1N1 |
|
EU/2/17/209 |
31.8.2020 |
||
12.8.2020 |
Simparica |
|
EU/2/15/191 |
17.8.2020 |
||
18.8.2020 |
Suvaxyn PRRS MLV |
|
EU/2/17/215 |
21.8.2020 |
||
20.8.2020 |
BLUEVAC BTV |
|
EU/2/11/122 |
26.8.2020 |
||
20.8.2020 |
Zycortal |
|
EU/2/15/189 |
26.8.2020 |
||
28.8.2020 |
VEPURED |
|
EU/2/17/214 |
1.9.2020 |
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 |
25.9.2020 |
EN |
Official Journal of the European Union |
C 318/9 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2020 to 31 August 2020
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2020/C 318/02)
— Refusal of a national marketing authorisation
Date of the decision |
Name(s) of the medicinal product |
INN (International Non-Proprietary Name) |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
19.8.2020 |
Budesonide SUN and associated names |
budesonide |
See Annex |
See Annex |
20.8.2020 |
ANNEX
List of medicinal products and presentations
Member State EU/EEA |
Applicant |
Invented Name |
Strength |
Pharmaceutical form |
Route of administration |
||||
Germany |
|
Budesonid SUN |
0,25 mg |
nebuliser suspension |
Inhalation use |
||||
Germany |
|
Budesonid SUN |
0,5 mg |
nebuliser suspension |
Inhalation use |
||||
Germany |
|
Budesonid SUN |
1 mg |
nebuliser suspension |
Inhalation use |
||||
Italy |
|
Budesonide SUN |
0,125 mg/ml |
nebuliser suspension |
Inhalation use |
||||
Italy |
|
Budesonide SUN |
0,25 mg/ml |
nebuliser suspension |
Inhalation use |
||||
Italy |
|
Budesonide SUN |
0,5 mg/ml |
nebuliser suspension |
Inhalation use |
||||
The Netherlands |
|
Budesonide SUN |
250 microgram/2 ml |
nebuliser suspension |
Inhalation use |
||||
The Netherlands |
|
Budesonide SUN |
500 microgram /2 ml |
nebuliser suspension |
Inhalation use |
||||
The Netherlands |
|
Budesonide SUN |
1 000 microgram/2 ml |
nebuliser suspension |
Inhalation use |
||||
Poland |
|
Budezonid SUN |
0,125 mg/ml |
nebuliser suspension |
Inhalation use |
||||
Poland |
|
Budezonid SUN |
0,25 mg/ml |
nebuliser suspension |
Inhalation use |
||||
Poland |
|
Budezonid SUN |
0,5 mg/ml |
nebuliser suspension |
Inhalation use |
||||
Spain |
|
Budesónida SUN |
0,25 mg/ml |
nebuliser suspension |
Inhalation use |
||||
Spain |
|
Budesónida SUN |
0,5 mg/ml |
nebuliser suspension |
Inhalation use |
||||
Sweden |
|
Budesonid SUN |
0,125 mg/ml |
nebuliser suspension |
Inhalation use |
||||
Sweden |
|
Budesonid SUN |
0,25 mg/ml |
nebuliser suspension |
Inhalation use |
||||
Sweden |
|
Budesonid SUN |
0,5 mg/ml |
nebuliser suspension |
Inhalation use |
||||
United Kingdom |
|
Budesonide |
0,125 mg/ml |
nebuliser suspension |
Inhalation use |
||||
United Kingdom |
|
Budesonide |
0,25 mg/ml |
nebuliser suspension |
Inhalation use |
||||
United Kingdom |
|
Budesonide |
0,5 mg/ml |
nebuliser suspension |
Inhalation use |