| Herwenda |
Human |
trastuzumab |
trastuzumab |
EMEA/H/C/005769 |
Sandoz GmbH |
2023/11/15
|
Authorised |
| Aqumeldi |
Human |
enalapril maleate |
Enalapril (maleate) |
EMEA/H/C/005731 |
Proveca Pharma Limited |
2023/11/15
|
Authorised |
| Vanflyta |
Human |
quizartinib |
quizartinib dihydrochloride |
EMEA/H/C/005910 |
Daiichi Sankyo Europe GmbH |
2023/11/06
|
Authorised |
| Jaypirca |
Human |
pirtobrutinib |
pirtobrutinib |
EMEA/H/C/005863 |
Eli Lilly Nederland B.V. |
2023/10/30
|
Authorised |
| Zoonotic Influenza Vaccine Seqirus |
Human |
zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted) |
A/Astrakhan/3212/2020 (H5N8)-like strain (CBER-RG8A) (clade 2.3.4.4b) |
EMEA/H/C/006375 |
Seqirus S.r.l. |
2023/10/09
|
Authorised |
| Degarelix Accord |
Human |
degarelix |
degarelix acetate |
EMEA/H/C/006048 |
Accord Healthcare S.L.U. |
2023/09/29
|
Authorised |
| Tyruko |
Human |
natalizumab |
natalizumab |
EMEA/H/C/005752 |
Sandoz GmbH |
2023/09/22
|
Authorised |
| Tepkinly |
Human |
epcoritamab |
epcoritamab |
EMEA/H/C/005985 |
AbbVie Deutschland GmbH & Co. KG |
2023/09/22
|
Authorised |
| Orserdu |
Human |
elacestrant |
elacestrant |
EMEA/H/C/005898 |
Stemline Therapeutics B.V. |
2023/09/15
|
Authorised |
| Yesafili |
Human |
aflibercept |
aflibercept |
EMEA/H/C/006022 |
Biosimilar Collaborations Ireland Limited |
2023/09/15
|
Authorised |
| Enrylaze |
Human |
crisantaspase |
crisantaspase |
EMEA/H/C/005917 |
Jazz Pharmaceuticals Ireland Limited |
2023/09/15
|
Authorised |
| Tevimbra |
Human |
tislelizumab |
tislelizumab |
EMEA/H/C/005919 |
Beone Medicines Ireland Limited |
2023/09/15
|
Authorised |
| Lyfnua |
Human |
gefapixant |
gefapixant |
EMEA/H/C/005476 |
Merck Sharp & Dohme B.V. |
2023/09/15
|
Authorised |
| Tyenne |
Human |
tocilizumab |
tocilizumab |
EMEA/H/C/005781 |
Fresenius Kabi Deutschland GmbH |
2023/09/15
|
Authorised |
| Inaqovi |
Human |
cedazuridine;decitabine |
cedazuridine;decitabine |
EMEA/H/C/005823 |
Otsuka Pharmaceutical Netherlands B.V. |
2023/09/15
|
Authorised |
| Litfulo |
Human |
ritlecitinib |
ritlecitinib tosilate |
EMEA/H/C/006025 |
Pfizer Europe MA EEIG |
2023/09/15
|
Authorised |
| Apretude |
Human |
cabotegravir |
cabotegravir |
EMEA/H/C/005756 |
ViiV Healthcare B.V. |
2023/09/15
|
Authorised |
| Abrysvo |
Human |
respiratory syncytial virus vaccine (bivalent, recombinant) |
respiratory Syncytial Virus, subgroup A, stabilized prefusion F protein 847A;respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B |
EMEA/H/C/006027 |
Pfizer Europe MA EEIG |
2023/08/23
|
Authorised |
| Talvey |
Human |
talquetamab |
talquetamab |
EMEA/H/C/005864 |
Janssen-Cilag International N.V. |
2023/08/21
|
Authorised |
| Aquipta |
Human |
atogepant |
atogepant |
EMEA/H/C/005871 |
AbbVie Deutschland GmbH & Co. KG |
2023/08/11
|
Authorised |
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