ISSN 1977-091X
Official Journal
of the European Union
C 331
English edition
Information and Notices
Volume 65
31 August 2022
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ISSN 1977-091X |
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Official Journal of the European Union |
C 331 |
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English edition |
Information and Notices |
Volume 65 |
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Contents |
page |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Commission |
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2022/C 331/01 |
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2022/C 331/02 |
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EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
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31.8.2022 |
EN |
Official Journal of the European Union |
C 331/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2022 to 31 July 2022
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2))
(2022/C 331/01)
— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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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 |
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1.7.2022 |
LIBTAYO |
cemiplimab |
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EU/1/19/1376 |
Concentrate for solution for infusion |
L01XC33 |
5.7.2022 |
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15.7.2022 |
Cevenfacta |
eptacog beta (activated) |
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EU/1/22/1664 |
Powder and solvent for solution for injection |
B02BD08 |
22.7.2022 |
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15.7.2022 |
Ertapenem SUN |
ertapenem |
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EU/1/22/1656 |
Powder for concentrate for solution for infusion |
J01DH03 |
22.7.2022 |
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15.7.2022 |
Ganirelix Gedeon Richter |
ganirelix |
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EU/1/22/1658 |
Solution for injection |
H01CC01 |
19.7.2022 |
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15.7.2022 |
Kinpeygo |
budesonide |
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EU/1/22/1657 |
Modified-release capsule, hard |
A07EA06 |
18.7.2022 |
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15.7.2022 |
Sugammadex Fresenius Kabi |
sugammadex |
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EU/1/22/1663 |
Solution for injection |
V03AB35 |
18.7.2022 |
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18.7.2022 |
NEXPOVIO |
selinexor |
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EU/1/21/1537 |
Film-coated tablet |
L01XX66 |
19.7.2022 |
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18.7.2022 |
Upstaza |
eladocagene exuparvovec |
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EU/1/22/1653 |
Solution for infusion |
Pending |
22.7.2022 |
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18.7.2022 |
Zokinvy |
lonafarnib |
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EU/1/22/1660 |
Capsule, hard |
A16AX20 |
19.7.2022 |
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22.7.2022 |
Sitagliptin/Metformin hydrochloride Accord |
sitagliptin/metformin hydrochloride |
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EU/1/22/1661 |
Film-coated tablet |
A10BD07 |
28.7.2022 |
— Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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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 |
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1.7.2022 |
Armisarte |
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EU/1/15/1063 |
6.7.2022 |
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1.7.2022 |
Entecavir Accord |
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EU/1/17/1211 |
4.7.2022 |
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1.7.2022 |
Hetlioz |
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EU/1/15/1008 |
8.8.2022 |
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1.7.2022 |
Irbesartan / Hydrochlorothiazide Teva |
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EU/1/09/583 |
4.7.2022 |
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1.7.2022 |
Kinzalkomb |
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EU/1/02/214 |
5.7.2022 |
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1.7.2022 |
Levodopa/Carbidopa/Entacapone Orion |
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EU/1/11/706 |
11.7.2022 |
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1.7.2022 |
Neparvis |
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EU/1/16/1103 |
7.7.2022 |
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1.7.2022 |
Nuvaxovid |
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EU/1/21/1618 |
1.7.2022 |
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1.7.2022 |
Orladeyo |
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EU/1/21/1544 |
5.7.2022 |
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1.7.2022 |
Paxlovid |
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EU/1/22/1625 |
1.7.2022 |
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1.7.2022 |
Strensiq |
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EU/1/15/1015 |
4.7.2022 |
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1.7.2022 |
Viramune |
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EU/1/97/055 |
19.7.2022 |
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1.7.2022 |
Zirabev |
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EU/1/18/1344 |
4.7.2022 |
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4.7.2022 |
Prialt |
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EU/1/04/302 |
7.7.2022 |
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8.7.2022 |
Amsparity |
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EU/1/19/1415 |
12.7.2022 |
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8.7.2022 |
AUBAGIO |
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EU/1/13/838 |
11.7.2022 |
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8.7.2022 |
Azacitidine Betapharm |
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EU/1/19/1416 |
12.7.2022 |
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8.7.2022 |
Azacitidine Mylan |
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EU/1/20/1426 |
12.7.2022 |
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8.7.2022 |
Calquence |
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EU/1/20/1479 |
11.7.2022 |
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8.7.2022 |
Dexdor |
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EU/1/11/718 |
11.7.2022 |
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8.7.2022 |
EDURANT |
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EU/1/11/736 |
12.7.2022 |
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8.7.2022 |
Efmody |
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EU/1/21/1549 |
13.7.2022 |
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8.7.2022 |
Eurartesim |
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EU/1/11/716 |
12.7.2022 |
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8.7.2022 |
Farydak |
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EU/1/15/1023 |
14.7.2022 |
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8.7.2022 |
Fingolimod Accord |
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EU/1/20/1450 |
11.7.2022 |
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8.7.2022 |
Fortacin |
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EU/1/13/881 |
12.7.2022 |
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8.7.2022 |
Giapreza |
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EU/1/19/1384 |
13.7.2022 |
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8.7.2022 |
Grasustek |
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EU/1/19/1375 |
12.7.2022 |
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8.7.2022 |
Herceptin |
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EU/1/00/145 |
11.7.2022 |
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8.7.2022 |
Iclusig |
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EU/1/13/839 |
15.7.2022 |
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8.7.2022 |
INCRELEX |
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EU/1/07/402 |
12.7.2022 |
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8.7.2022 |
Kadcyla |
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EU/1/13/885 |
11.7.2022 |
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8.7.2022 |
Keppra |
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EU/1/00/146 |
12.7.2022 |
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8.7.2022 |
Lenalidomide Mylan |
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EU/1/20/1490 |
11.7.2022 |
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8.7.2022 |
Lutathera |
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EU/1/17/1226 |
11.7.2022 |
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8.7.2022 |
Mabthera |
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EU/1/98/067 |
11.7.2022 |
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8.7.2022 |
MicardisPlus |
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EU/1/02/213 |
13.7.2022 |
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8.7.2022 |
Minjuvi |
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EU/1/21/1570 |
11.7.2022 |
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8.7.2022 |
Mvasi |
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EU/1/17/1246 |
12.7.2022 |
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8.7.2022 |
Orgovyx |
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EU/1/22/1642 |
11.7.2022 |
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8.7.2022 |
Palforzia |
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EU/1/20/1495 |
12.7.2022 |
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8.7.2022 |
Pemetrexed Sandoz |
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EU/1/15/1037 |
12.7.2022 |
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8.7.2022 |
Quinsair |
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EU/1/14/973 |
13.7.2022 |
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8.7.2022 |
Striascan |
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EU/1/19/1372 |
11.7.2022 |
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8.7.2022 |
Tepadina |
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EU/1/10/622 |
12.7.2022 |
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8.7.2022 |
Thiotepa Riemser |
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EU/1/21/1536 |
11.7.2022 |
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8.7.2022 |
Tracleer |
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EU/1/02/220 |
11.7.2022 |
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8.7.2022 |
Vimpat |
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EU/1/08/470 |
11.7.2022 |
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8.7.2022 |
Votrient |
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EU/1/10/628 |
11.7.2022 |
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8.7.2022 |
Xeloda |
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EU/1/00/163 |
11.7.2022 |
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8.7.2022 |
Xenleta |
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EU/1/20/1457 |
13.7.2022 |
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8.7.2022 |
Yondelis |
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EU/1/07/417 |
12.7.2022 |
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11.7.2022 |
Enhertu |
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EU/1/20/1508 |
13.7.2022 |
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15.7.2022 |
Alecensa |
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EU/1/16/1169 |
19.7.2022 |
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15.7.2022 |
AYVAKYT |
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EU/1/20/1473 |
18.7.2022 |
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15.7.2022 |
Edistride |
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EU/1/15/1052 |
19.7.2022 |
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15.7.2022 |
Elebrato Ellipta |
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EU/1/17/1237 |
19.7.2022 |
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15.7.2022 |
Emgality |
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EU/1/18/1330 |
19.7.2022 |
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15.7.2022 |
Forxiga |
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EU/1/12/795 |
19.7.2022 |
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15.7.2022 |
Fotivda |
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EU/1/17/1215 |
10.8.2022 |
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15.7.2022 |
Galvus |
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EU/1/07/414 |
18.7.2022 |
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15.7.2022 |
Idefirix |
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EU/1/20/1471 |
19.7.2022 |
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15.7.2022 |
Jalra |
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EU/1/08/485 |
18.7.2022 |
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15.7.2022 |
Nitisinone MDK |
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EU/1/17/1217 |
19.7.2022 |
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15.7.2022 |
PecFent |
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EU/1/10/644 |
20.7.2022 |
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15.7.2022 |
Posaconazole AHCL |
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EU/1/19/1380 |
3.8.2022 |
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15.7.2022 |
Raxone |
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EU/1/15/1020 |
2.8.2022 |
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15.7.2022 |
Remsima |
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EU/1/13/853 |
18.7.2022 |
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15.7.2022 |
Trelegy Ellipta |
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EU/1/17/1236 |
19.7.2022 |
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15.7.2022 |
Tremfya |
|
EU/1/17/1234 |
19.7.2022 |
||
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15.7.2022 |
Xiliarx |
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EU/1/08/486 |
18.7.2022 |
||
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18.7.2022 |
Accofil |
|
EU/1/14/946 |
8.8.2022 |
||
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18.7.2022 |
Bortezomib Fresenius Kabi |
|
EU/1/19/1397 |
20.7.2022 |
||
|
18.7.2022 |
Cyramza |
|
EU/1/14/957 |
22.7.2022 |
||
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18.7.2022 |
Darunavir Krka d.d. |
|
EU/1/17/1248 |
20.7.2022 |
||
|
18.7.2022 |
Irbesartan Zentiva |
|
EU/1/06/376 |
19.7.2022 |
||
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18.7.2022 |
Lenalidomide Krka |
|
EU/1/20/1519 |
22.7.2022 |
||
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18.7.2022 |
Mayzent |
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EU/1/19/1414 |
19.7.2022 |
||
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18.7.2022 |
Suboxone |
|
EU/1/06/359 |
22.7.2022 |
||
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18.7.2022 |
Zejula |
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EU/1/17/1235 |
20.7.2022 |
||
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19.7.2022 |
Veklury |
|
EU/1/20/1459 |
19.7.2022 |
||
|
22.7.2022 |
Fluad Tetra |
|
EU/1/20/1433 |
28.7.2022 |
||
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22.7.2022 |
Imvanex |
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EU/1/13/855 |
25.7.2022 |
||
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22.7.2022 |
Kirsty |
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EU/1/20/1506 |
26.7.2022 |
||
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22.7.2022 |
Lonquex |
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EU/1/13/856 |
2.8.2022 |
||
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22.7.2022 |
Miglustat Dipharma |
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EU/1/18/1346 |
26.7.2022 |
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22.7.2022 |
Onureg |
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EU/1/21/1556 |
27.7.2022 |
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22.7.2022 |
Rinvoq |
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EU/1/19/1404 |
25.7.2022 |
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22.7.2022 |
Ryeqo |
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EU/1/21/1565 |
27.7.2022 |
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22.7.2022 |
Xevudy |
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EU/1/21/1562 |
22.7.2022 |
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22.7.2022 |
Zavesca |
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EU/1/02/238 |
26.7.2022 |
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25.7.2022 |
Braftovi |
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EU/1/18/1314 |
26.7.2022 |
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25.7.2022 |
CRYSVITA |
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EU/1/17/1262 |
28.7.2022 |
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25.7.2022 |
Cyramza |
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EU/1/14/957 |
27.7.2022 |
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25.7.2022 |
Zerbaxa |
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EU/1/15/1032 |
26.7.2022 |
||
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27.7.2022 |
BroPair Spiromax |
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EU/1/21/1534 |
2.8.2022 |
||
|
27.7.2022 |
Flucelvax Tetra |
|
EU/1/18/1326 |
29.7.2022 |
||
|
27.7.2022 |
Fluenz Tetra |
|
EU/1/13/887 |
28.7.2022 |
||
|
27.7.2022 |
Phesgo |
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EU/1/20/1497 |
29.7.2022 |
||
|
27.7.2022 |
Rinvoq |
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EU/1/19/1404 |
28.7.2022 |
||
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27.7.2022 |
Seffalair Spiromax |
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EU/1/21/1533 |
2.8.2022 |
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27.7.2022 |
Zubsolv |
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EU/1/17/1233 |
8.8.2022 |
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28.7.2022 |
COVID-19 Vaccine (inactivated, adjuvanted) Valneva |
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EU/1/21/1624 |
29.7.2022 |
— Withdrawal of a marketing authorisation (Article 13 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 authorisation |
Number of the entry in the Community Register |
Date of notification |
||
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1.7.2022 |
Thymanax |
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EU/1/08/498 |
5.7.2022 |
— Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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 |
||
|
27.7.2022 |
Cortaderm |
Hydrocortisone aceponate |
|
EU/2/22/287 |
Cutaneous spray, solution |
QD07AC16 |
29.7.2022 |
||
|
27.7.2022 |
Evanovo |
Coccidiosis vaccine live for chickens |
|
EU/2/22/284 |
Suspension and solvent for suspension for injection |
Pending |
28.7.2022 |
— Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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 |
||
|
4.7.2022 |
BTVPUR |
|
EU/2/10/113 |
5.7.2022 |
||
|
4.7.2022 |
Tulinovet |
|
EU/2/20/257 |
5.7.2022 |
||
|
11.7.2022 |
Coliprotec F4/F18 |
|
EU/2/16/202 |
12.7.2022 |
||
|
11.7.2022 |
HorStem |
|
EU/2/18/226 |
12.7.2022 |
||
|
11.7.2022 |
Loxicom |
|
EU/2/08/090 |
14.7.2022 |
||
|
11.7.2022 |
Prevomax |
|
EU/2/17/211 |
13.7.2022 |
||
|
11.7.2022 |
VEPURED |
|
EU/2/17/214 |
14.7.2022 |
||
|
15.7.2022 |
Bravecto |
|
EU/2/13/158 |
19.7.2022 |
||
|
15.7.2022 |
Cerenia |
|
EU/2/06/062 |
19.7.2022 |
||
|
15.7.2022 |
GUMBOHATCH |
|
EU/2/19/245 |
19.7.2022 |
||
|
15.7.2022 |
Nobivac L4 |
|
EU/2/12/143 |
19.7.2022 |
||
|
15.7.2022 |
Suprelorin |
|
EU/2/07/072 |
19.7.2022 |
||
|
15.7.2022 |
Suvaxyn PRRS MLV |
|
EU/2/17/215 |
22.7.2022 |
||
|
22.7.2022 |
Comfortis |
|
EU/2/10/115 |
27.7.2022 |
||
|
22.7.2022 |
FRONTPRO |
|
EU/2/19/240 |
25.7.2022 |
||
|
22.7.2022 |
GALLIPRANT |
|
EU/2/17/221 |
27.7.2022 |
||
|
22.7.2022 |
Onsior |
|
EU/2/08/089 |
27.7.2022 |
||
|
22.7.2022 |
Vectra Felis |
|
EU/2/14/165 |
26.7.2022 |
||
|
22.7.2022 |
VEPURED |
|
EU/2/17/214 |
27.7.2022 |
||
|
27.7.2022 |
Circovac |
|
EU/2/07/075 |
29.7.2022 |
||
|
27.7.2022 |
Loxicom |
|
EU/2/08/090 |
29.7.2022 |
||
|
27.7.2022 |
Nobilis IB 4-91 |
|
EU/2/98/006 |
29.7.2022 |
— Withdrawal of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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 |
||
|
22.7.2022 |
Bovilis BTV8 |
|
EU/2/10/106 |
9.8.2022 |
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 |
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Domenico Scarlattilaan 6 |
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1083 HS Amsterdam |
|
NETHERLANDS |
|
31.8.2022 |
EN |
Official Journal of the European Union |
C 331/13 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2022 to 31 July 2022
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1), Article 38 of Directive 2001/82/EC (2) or Article 5 of Regulation (EU) 2019/6 (3) of the European Parliament and of the Council)
(2022/C 331/02)
— Issuing, maintenance or modification 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 authorisation |
Member State concerned |
Date of notification |
|
18.7.2022 |
Daruph and Anafezyn and associated names |
dasatinib (anhydrous) |
See Annex |
See Annex |
19.7.2022 |
(1) OJ L 311, 28.11.2001, p. 67.
ANNEX
List of medicinal products and presentations
|
Member State EU/EEA |
Applicant company name, address |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
||||
|
France |
|
Anafezyn 16 mg, comprimé pelliculé (1) |
16 mg |
film-coated tablet |
oral use |
||||
|
France |
|
Anafezyn 40 mg, comprimé pelliculé1 |
40 mg |
film-coated tablet |
oral use |
||||
|
France |
|
Anafezyn 55 mg, comprimé pelliculé1 |
55 mg |
film-coated tablet |
oral use |
||||
|
France |
|
Anafezyn 63 mg, comprimé pelliculé1 |
63 mg |
film-coated tablet |
oral use |
||||
|
France |
|
Anafezyn 79 mg, comprimé pelliculé1 |
79 mg |
film-coated tablet |
oral use |
||||
|
France |
|
Anafezyn 111 mg, comprimé pelliculé1 |
111 mg |
film-coated tablet |
oral use |
||||
|
Germany |
|
Anafezyn 16 mg Filmtabletten |
16 mg |
film-coated tablet |
oral use |
||||
|
Germany |
|
Daruph 16 mg Filmtabletten |
16 mg |
film-coated tablet |
oral use |
||||
|
Germany |
|
Anafezyn 40 mg Filmtabletten |
40 mg |
film-coated tablet |
oral use |
||||
|
Germany |
|
Daruph 40 mg Filmtabletten |
40 mg |
film-coated tablet |
oral use |
||||
|
Germany |
|
Anafezyn 55 mg Filmtabletten |
55 mg |
film-coated tablet |
oral use |
||||
|
Germany |
|
Daruph 55 mg Filmtabletten |
55 mg |
film-coated tablet |
oral use |
||||
|
Germany |
|
Anafezyn 63 mg Filmtabletten |
63 mg |
film-coated tablet |
oral use |
||||
|
Germany |
|
Daruph 63 mg Filmtabletten |
63 mg |
film-coated tablet |
oral use |
||||
|
Germany |
|
Anafezyn 79 mg Filmtabletten |
79 mg |
film-coated tablet |
oral use |
||||
|
Germany |
|
Daruph 79 mg Filmtabletten |
79 mg |
film-coated tablet |
oral use |
||||
|
Germany |
|
Anafezyn 111 mg Filmtabletten |
111 mg |
film-coated tablet |
oral use |
||||
|
Germany |
|
Daruph 111 mg Filmtabletten |
111 mg |
film-coated tablet |
oral use |
||||
|
Hungary |
|
Daruph 16 mg filmtabletta |
16 mg |
film-coated tablet |
oral use |
||||
|
Hungary |
|
Daruph 40 mg filmtabletta |
40 mg |
film-coated tablet |
oral use |
||||
|
Hungary |
|
Daruph 55 mg filmtabletta |
55 mg |
film-coated tablet |
oral use |
||||
|
Hungary |
|
Daruph 63 mg filmtabletta |
63 mg |
film-coated tablet |
oral use |
||||
|
Hungary |
|
Daruph 79 mg filmtabletta |
79 mg |
film-coated tablet |
oral use |
||||
|
Hungary |
|
Daruph 111 mg filmtabletta |
111 mg |
film-coated tablet |
oral use |
||||
|
Ireland |
|
Anafezyn 16 mg film-coated tablets |
16 mg |
film-coated tablet |
oral use |
||||
|
Ireland |
|
Anafezyn 40 mg film-coated tablets |
40 mg |
film-coated tablet |
oral use |
||||
|
Ireland |
|
Anafezyn 55 mg film-coated tablets |
55 mg |
film-coated tablet |
oral use |
||||
|
Ireland |
|
Anafezyn 63 mg film-coated tablets |
63 mg |
film-coated tablet |
oral use |
||||
|
Ireland |
|
Anafezyn 79 mg film-coated tablets |
79 mg |
film-coated tablet |
oral use |
||||
|
Ireland |
|
Anafezyn 111 mg film-coated tablets |
111 mg |
film-coated tablet |
oral use |
||||
|
Italy |
|
Daruph |
16 mg |
film-coated tablet |
oral use |
||||
|
Italy |
|
Daruph |
40 mg |
film-coated tablet |
oral use |
||||
|
Italy |
|
Daruph |
55 mg |
film-coated tablet |
oral use |
||||
|
Italy |
|
Daruph |
63 mg |
film-coated tablet |
oral use |
||||
|
Italy |
|
Daruph |
79 mg |
film-coated tablet |
oral use |
||||
|
Italy |
|
Daruph |
111 mg |
film-coated tablet |
oral use |
||||
|
Poland |
|
Daruph |
16 mg |
film-coated tablet |
oral use |
||||
|
Poland |
|
Daruph |
40 mg |
film-coated tablet |
oral use |
||||
|
Poland |
|
Daruph |
55 mg |
film-coated tablet |
oral use |
||||
|
Poland |
|
Daruph |
63 mg |
film-coated tablet |
oral use |
||||
|
Poland |
|
Daruph |
79 mg |
film-coated tablet |
oral use |
||||
|
Poland |
|
Daruph |
111 mg |
film-coated tablet |
oral use |
||||
|
Portugal |
|
Anafezyn |
16 mg |
film-coated tablet |
oral use |
||||
|
Portugal |
|
Anafezyn |
40 mg |
film-coated tablet |
oral use |
||||
|
Portugal |
|
Anafezyn |
55 mg |
film-coated tablet |
oral use |
||||
|
Portugal |
|
Anafezyn |
63 mg |
film-coated tablet |
oral use |
||||
|
Portugal |
|
Anafezyn |
79 mg |
film-coated tablet |
oral use |
||||
|
Portugal |
|
Anafezyn |
111 mg |
film-coated tablet |
oral use |
||||
|
Romania |
|
Daruph 16 mg comprimate filmate |
16 mg |
film-coated tablet |
oral use |
||||
|
Romania |
|
Daruph 40 mg comprimate filmate |
40 mg |
film-coated tablet |
oral use |
||||
|
Romania |
|
Daruph 55 mg comprimate filmate |
55 mg |
film-coated tablet |
oral use |
||||
|
Romania |
|
Daruph 63 mg comprimate filmate |
63 mg |
film-coated tablet |
oral use |
||||
|
Romania |
|
Daruph 79 mg comprimate filmate |
79 mg |
film-coated tablet |
oral use |
||||
|
Romania |
|
Daruph 111 mg comprimate filmate |
111 mg |
film-coated tablet |
oral use |
||||
|
Slovak Republic |
|
Daruph 16 mg |
16 mg |
film-coated tablet |
oral use |
||||
|
Slovak Republic |
|
Daruph 40 mg |
40 mg |
film-coated tablet |
oral use |
||||
|
Slovak Republic |
|
Daruph 55 mg |
55 mg |
film-coated tablet |
oral use |
||||
|
Slovak Republic |
|
Daruph 63 mg |
63 mg |
film-coated tablet |
oral use |
||||
|
Slovak Republic |
|
Daruph 79 mg |
79 mg |
film-coated tablet |
oral use |
||||
|
Slovak Republic |
|
Daruph 111 mg |
111 mg |
film-coated tablet |
oral use |
||||
|
Sweden |
|
Anafezyn |
16 mg |
film-coated tablet |
oral use |
||||
|
Sweden |
|
Daruph |
16 mg |
film-coated tablet |
oral use |
||||
|
Sweden |
|
Anafezyn |
40 mg |
film-coated tablet |
oral use |
||||
|
Sweden |
|
Daruph |
40 mg |
film-coated tablet |
oral use |
||||
|
Sweden |
|
Anafezyn |
55 mg |
film-coated tablet |
oral use |
||||
|
Sweden |
|
Daruph |
55 mg |
film-coated tablet |
oral use |
||||
|
Sweden |
|
Anafezyn |
63 mg |
film-coated tablet |
oral use |
||||
|
Sweden |
|
Daruph |
63 mg |
film-coated tablet |
oral use |
||||
|
Sweden |
|
Anafezyn |
79 mg |
film-coated tablet |
oral use |
||||
|
Sweden |
|
Daruph |
79 mg |
film-coated tablet |
oral use |
||||
|
Sweden |
|
Anafezyn |
111 mg |
film-coated tablet |
oral use |
||||
|
Sweden |
|
Daruph |
111 mg |
film-coated tablet |
oral use |
(1) Invented name not accepted by national competent authority, pending new proposal by the applicant.