| Zercepac |
Human |
trastuzumab |
trastuzumab |
EMEA/H/C/005209 |
Accord Healthcare S.L.U. |
2020/07/27
|
Authorised |
| Apixaban Accord |
Human |
apixaban |
apixaban |
EMEA/H/C/005358 |
Accord Healthcare S.L.U. |
2020/07/23
|
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 |
| Veklury |
Human |
remdesivir |
remdesivir |
EMEA/H/C/005622 |
Gilead Sciences Ireland UC |
2020/07/03
|
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 |
| 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 |
| Daurismo |
Human |
glasdegib |
Glasdegib maleate |
EMEA/H/C/004878 |
Pfizer Europe MA EEIG |
2020/06/26
|
Authorised |
| Reblozyl |
Human |
luspatercept |
Luspatercept |
EMEA/H/C/004444 |
Bristol Myers Squibb Pharma EEIG |
2020/06/25
|
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 |
| 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 |
| Bemrist Breezhaler |
Human |
indacaterol;mometasone |
indacaterol;mometasone furoate |
EMEA/H/C/005516 |
Novartis Europharm Limited |
2020/05/30
|
Authorised |
| Sarclisa |
Human |
isatuximab |
Isatuximab |
EMEA/H/C/004977 |
Sanofi Winthrop Industrie |
2020/05/30
|
Authorised |
| Zeposia |
Human |
ozanimod |
ozanimod hydrochloride |
EMEA/H/C/004835 |
Bristol-Myers Squibb Pharma EEIG |
2020/05/20
|
Authorised |
| Nepexto |
Human |
etanercept |
etanercept |
EMEA/H/C/004711 |
Biosimilar Collaborations Ireland Limited |
2020/05/20
|
Authorised |
| Fluad Tetra |
Human |
influenza vaccine (surface antigen, inactivated, adjuvanted) |
A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238) / A/Thailand/8/2022 (H3N2)-like strain (A/Thailand/8/2022 IVR-237) / B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) / B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, BVR-1B) influenza virus |
EMEA/H/C/004993 |
Seqirus Netherlands B.V. |
2020/05/20
|
Authorised |
| Zolgensma |
Human |
onasemnogene abeparvovec |
onasemnogene abeparvovec |
EMEA/H/C/004750 |
Novartis Europharm Limited |
2020/05/18
|
Authorised |
| Fetcroja |
Human |
cefiderocol |
cefiderocol sulfate tosilate |
EMEA/H/C/004829 |
Shionogi B.V. |
2020/04/23
|
Authorised |