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Document 52020XC0228(02)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2020 to 31 January 2020 (Published pursuant to Article 13 or Article 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 January 2020 to 31 January 2020 (Published pursuant to Article 13 or Article 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 January 2020 to 31 January 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
OJ C 66, 28.2.2020, p. 1–11
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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28.2.2020 |
EN |
Official Journal of the European Union |
C 66/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2020 to 31 January 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 66/01)
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— |
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 |
|||
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9.1.2020 |
Clopidogrel/Acetylsalicylic acid Mylan |
clopidogrel/acetylsalicylic acid |
|
EU/1/19/1395 |
Film-coated tablet |
B01AC30 |
13.1.2020 |
|||
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9.1.2020 |
Deferasirox Accord |
deferasirox |
|
EU/1/19/1412 |
Film-coated tablet |
V03AC03 |
13.1.2020 |
|||
|
9.1.2020 |
Isturisa |
osilodrostat |
|
EU/1/19/1407 |
Film-coated tablet |
H02CA02 |
13.1.2020 |
|||
|
9.1.2020 |
TAVLESSE |
fostamatinib |
|
EU/1/19/1405 |
Film-coated tablet |
B02BX09 |
13.1.2020 |
|||
|
13.1.2020 |
Mayzent |
siponimod |
|
EU/1/19/1414 |
Film-coated tablet |
L04AA42 |
15.1.2020 |
|||
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16.1.2020 |
Polivy |
polatuzumab vedotin |
|
EU/1/19/1388 |
Powder for concentrate for solution for infusion |
L01XC37 |
20.1.2020 |
|||
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16.1.2020 |
Sunosi |
solriamfetol |
|
EU/1/19/1408 |
Film-coated tablet |
N06BA14 |
20.1.2020 |
|
— |
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 |
|||
|
9.1.2020 |
Akynzeo |
|
EU/1/15/1001 |
13.1.2020 |
|||
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9.1.2020 |
Clopidogrel ratiopharm GmbH |
|
EU/1/09/541 |
13.1.2020 |
|||
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9.1.2020 |
Cymbalta |
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EU/1/04/296 |
13.1.2020 |
|||
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9.1.2020 |
Elebrato Ellipta |
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EU/1/17/1237 |
13.1.2020 |
|||
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9.1.2020 |
Kigabeq |
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EU/1/18/1302 |
13.1.2020 |
|||
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9.1.2020 |
Sirturo |
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EU/1/13/901 |
13.1.2020 |
|||
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9.1.2020 |
Sivextro |
|
EU/1/15/991 |
13.1.2020 |
|||
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9.1.2020 |
Taxotere |
|
EU/1/95/002 |
13.1.2020 |
|||
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9.1.2020 |
Tecfidera |
|
EU/1/13/837 |
13.1.2020 |
|||
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13.1.2020 |
Abasaglar |
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EU/1/14/944 |
15.1.2020 |
|||
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13.1.2020 |
Caprelsa |
|
EU/1/11/749 |
15.1.2020 |
|||
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13.1.2020 |
Darunavir Krka d.d. |
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EU/1/17/1248 |
15.1.2020 |
|||
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13.1.2020 |
Dexdor |
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EU/1/11/718 |
15.1.2020 |
|||
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13.1.2020 |
Hizentra |
|
EU/1/11/687 |
15.1.2020 |
|||
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13.1.2020 |
Infanrix hexa |
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EU/1/00/152 |
15.1.2020 |
|||
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13.1.2020 |
Invokana |
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EU/1/13/884 |
15.1.2020 |
|||
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13.1.2020 |
Orbactiv |
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EU/1/15/989 |
15.1.2020 |
|||
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13.1.2020 |
Tenofovir disoproxil Mylan |
|
EU/1/16/1129 |
15.1.2020 |
|||
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13.1.2020 |
Tenofovir disoproxil Zentiva |
|
EU/1/16/1127 |
15.1.2020 |
|||
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13.1.2020 |
Vaxelis |
|
EU/1/15/1079 |
16.1.2020 |
|||
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13.1.2020 |
Yescarta |
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EU/1/18/1299 |
15.1.2020 |
|||
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13.1.2020 |
Zepatier |
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EU/1/16/1119 |
15.1.2020 |
|||
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16.1.2020 |
Gardasil 9 |
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EU/1/15/1007 |
20.1.2020 |
|||
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16.1.2020 |
Humalog |
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EU/1/96/007 |
20.1.2020 |
|||
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16.1.2020 |
Lantus |
|
EU/1/00/134 |
20.1.2020 |
|||
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16.1.2020 |
Lemtrada |
|
EU/1/13/869 |
20.1.2020 |
|||
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16.1.2020 |
Liprolog |
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EU/1/01/195 |
20.1.2020 |
|||
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16.1.2020 |
Mysimba |
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EU/1/14/988 |
20.1.2020 |
|||
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16.1.2020 |
Prolia |
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EU/1/10/618 |
20.1.2020 |
|||
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16.1.2020 |
Semglee |
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EU/1/18/1270 |
20.1.2020 |
|||
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16.1.2020 |
Toujeo |
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EU/1/00/133 |
20.1.2020 |
|||
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16.1.2020 |
Viread |
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EU/1/01/200 |
20.1.2020 |
|||
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16.1.2020 |
Zirabev |
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EU/1/18/1344 |
20.2.2020 |
|||
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17.1.2020 |
Verzenios |
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EU/1/18/1307 |
21.1.2020 |
|||
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20.1.2020 |
Darzalex |
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EU/1/16/1101 |
22.1.2020 |
|||
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20.1.2020 |
Eurartesim |
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EU/1/11/716 |
22.1.2020 |
|||
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20.1.2020 |
Fertavid |
|
EU/1/09/510 |
22.1.2020 |
|||
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20.1.2020 |
OPDIVO |
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EU/1/15/1014 |
22.1.2020 |
|||
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20.1.2020 |
Stelara |
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EU/1/08/494 |
22.1.2020 |
|||
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20.1.2020 |
YERVOY |
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EU/1/11/698 |
22.1.2020 |
|||
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23.1.2020 |
Bydureon |
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EU/1/11/696 |
27.1.2020 |
|||
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23.1.2020 |
Cyramza |
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EU/1/14/957 |
27.1.2020 |
|||
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23.1.2020 |
Hemlibra |
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EU/1/18/1271 |
28.1.2020 |
|||
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23.1.2020 |
Ketoconazole HRA |
|
EU/1/14/965 |
27.1.2020 |
|||
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23.1.2020 |
Menveo |
|
EU/1/10/614 |
27.1.2020 |
|||
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23.1.2020 |
Sirturo |
|
EU/1/13/901 |
27.1.2020 |
|||
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23.1.2020 |
Xeristar |
|
EU/1/04/297 |
27.1.2020 |
|||
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23.1.2020 |
Zynquista |
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EU/1/19/1363 |
27.1.2020 |
|||
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27.1.2020 |
Delstrigo |
|
EU/1/18/1333 |
29.1.2020 |
|||
|
27.1.2020 |
Erleada |
|
EU/1/18/1342 |
29.1.2020 |
|||
|
27.1.2020 |
Rubraca |
|
EU/1/17/1250 |
29.1.2020 |
|||
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31.1.2020 |
Otezla |
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EU/1/14/981 |
4.2.2020 |
|||
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31.1.2020 |
Panretin |
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EU/1/00/149 |
4.2.2020 |
|||
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31.1.2020 |
Xeljanz |
|
EU/1/17/1178 |
4.2.2020 |
|||
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31.1.2020 |
Zejula |
|
EU/1/17/1235 |
4.2.2020 |
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— |
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 |
|||
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13.1.2020 |
Clopidogrel ratiopharm GmbH |
|
EU/1/09/541 |
15.1.2020 |
|||
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23.1.2020 |
Fertavid |
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EU/1/09/510 |
27.1.2020 |
|||
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23.1.2020 |
Varuby |
|
EU/1/17/1180 |
27.1.2020 |
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— |
Suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
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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 |
|||
|
17.1.2020 |
Picato |
|
EU/1/12/796 |
21.1.2020 |
|
— |
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 |
|||
|
15.1.2020 |
Stelfonta |
tigilanol tiglate |
|
EU/2/19/248 |
Solution for injection |
QL01XX91 |
17.1.2020 |
|||
|
28.1.2020 |
Aservo EquiHaler |
ciclesonide |
|
EU/2/19/249 |
Inhalation solution |
QR03BA08 |
30.1.2020 |
|
— |
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 |
|||
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15.1.2020 |
BTVPUR |
|
EU/2/10/113 |
17.1.2020 |
|||
|
15.1.2020 |
Coliprotec F4 |
|
EU/2/14/180 |
17.1.2020 |
|||
|
15.1.2020 |
Nobilis IB 4-91 |
|
EU/2/98/006 |
17.1.2020 |
|||
|
15.1.2020 |
Pirsue |
|
EU/2/00/027 |
17.1.2020 |
|||
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15.1.2020 |
ProteqFlu |
|
EU/2/03/037 |
17.1.2020 |
|||
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15.1.2020 |
ProteqFlu-Te |
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EU/2/03/038 |
17.1.2020 |
|||
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15.1.2020 |
Proteq West Nile |
|
EU/2/11/129 |
17.1.2020 |
|||
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15.1.2020 |
Purevax Rabies |
|
EU/2/10/117 |
17.1.2020 |
|||
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15.1.2020 |
Semintra |
|
EU/2/12/146 |
17.1.2020 |
|||
|
15.1.2020 |
Zulvac SBV |
|
EU/2/14/178 |
17.1.2020 |
|||
|
20.1.2020 |
Onsior |
|
EU/2/08/089 |
22.1.2020 |
|||
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27.1.2020 |
ERAVAC |
|
EU/2/16/199 |
29.1.2020 |
|||
|
27.1.2020 |
Kexxtone |
|
EU/2/12/145 |
29.1.2020 |
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 |
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Domenico Scarlattilaan 6 |
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1083 HS Amsterdam |
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NETHERLANDS |