| Lumeblue (previously Methylthioninium chloride Cosmo) |
Human |
methylthioninium chloride |
methylthioninium chloride |
EMEA/H/C/002776 |
Cosmo Technologies Ltd |
2020/08/19
|
Authorised |
| Gencebok |
Human |
caffeine citrate |
Caffeine citrate |
EMEA/H/C/005435 |
Gennisium Pharma |
2020/08/19
|
Authorised |
| Hepcludex |
Human |
bulevirtide |
bulevirtide acetate |
EMEA/H/C/004854 |
Gilead Sciences Ireland UC |
2020/07/31
|
Authorised |
| Dovprela (previously Pretomanid FGK) |
Human |
pretomanid |
pretomanid |
EMEA/H/C/005167 |
Mylan IRE Healthcare Limited |
2020/07/31
|
Authorised |
| Rozlytrek |
Human |
entrectinib |
Entrectinib |
EMEA/H/C/004936 |
Roche Registration GmbH |
2020/07/31
|
Authorised |
| Zercepac |
Human |
trastuzumab |
trastuzumab |
EMEA/H/C/005209 |
Accord Healthcare S.L.U. |
2020/07/27
|
Authorised |
| Piqray |
Human |
alpelisib |
alpelisib |
EMEA/H/C/004804 |
Novartis Europharm Limited |
2020/07/27
|
Authorised |
| Xenleta |
Human |
lefamulin |
lefamulin acetate |
EMEA/H/C/005048 |
Nabriva Therapeutics Ireland DAC |
2020/07/27
|
Authorised |
| Apixaban Accord |
Human |
apixaban |
apixaban |
EMEA/H/C/005358 |
Accord Healthcare S.L.U. |
2020/07/23
|
Authorised |
| Veklury |
Human |
remdesivir |
remdesivir |
EMEA/H/C/005622 |
Gilead Sciences Ireland UC |
2020/07/03
|
Authorised |
| Enerzair Breezhaler |
Human |
indacaterol;glycopyrronium bromide;mometasone |
indacaterol;glycopyrronium bromide;mometasone |
EMEA/H/C/005061 |
Novartis Europharm Limited |
2020/07/03
|
Authorised |
| Zimbus Breezhaler |
Human |
indacaterol;glycopyrronium;mometasone furoate |
glycopyrronium bromide;Indacaterol (acetate);mometasone furoate |
EMEA/H/C/005518 |
Novartis Europharm Limited |
2020/07/03
|
Authorised |
| Mvabea |
Human |
Ebola vaccine (MVA-BN-Filo [recombinant]) |
recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP |
EMEA/H/C/005343 |
Janssen-Cilag International N.V. |
2020/07/01
|
Authorised |
| Zabdeno |
Human |
ebola vaccine (Ad26.ZEBOV-GP [recombinant]) |
recombinant adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain |
EMEA/H/C/005337 |
Janssen-Cilag International N.V. |
2020/07/01
|
Authorised |
| Daurismo |
Human |
glasdegib |
Glasdegib maleate |
EMEA/H/C/004878 |
Pfizer Europe MA EEIG |
2020/06/26
|
Authorised |
| Fingolimod Accord |
Human |
fingolimod |
fingolimod hydrochloride |
EMEA/H/C/005191 |
Accord Healthcare S.L.U. |
2020/06/25
|
Authorised |
| Insulin aspart Sanofi |
Human |
insulin aspart |
insulin aspart |
EMEA/H/C/005033 |
Sanofi Winthrop Industrie |
2020/06/25
|
Authorised |
| Reblozyl |
Human |
luspatercept |
Luspatercept |
EMEA/H/C/004444 |
Bristol Myers Squibb Pharma EEIG |
2020/06/25
|
Authorised |
| Byannli (previously Paliperidone Janssen-Cilag International) |
Human |
paliperidone |
paliperidone palmitate |
EMEA/H/C/005486 |
Janssen-Cilag International N.V. |
2020/06/18
|
Authorised |
| Atectura Breezhaler |
Human |
indacaterol;mometasone |
indacaterol acetate;mometasone furoate |
EMEA/H/C/005067 |
Novartis Europharm Limited |
2020/05/30
|
Authorised |
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