Volibris
ambrisentan
Hypertension, Pulmonary
Date of authorisation:
Revision: 24
Last updated:
MedicineHumanAuthorised
Ambrisentan Mylan
ambrisentan
Hypertension, Pulmonary
Date of authorisation:
Revision: 5
Last updated:
MedicineHumanAuthorised
Divence Penta
Bovine respiratory syncytial virus, strain LYM-56, Live / Infectious bovine rhinotracheitis virus, strain CEDDEL, gE- tk- double-gene deleted, Live / Bovine parainfluenza virus 3, strain SF-4 Reisinger, Inactivated / Bovine viral diarrhoea virus 1, E2 recombinant protein / Bovine viral diarrhoea virus 2, E2 recombinant protein
Cattle
Opinion date:
Last updated:
MedicineVeterinaryOpinion
EMEA-002030-PIP01-16 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: P/0038/2017
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000434-PIP01-08-M09 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: P/0428/2022
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Ambrisentan Zentiva
ambrisentan
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application