Poulvac Procerta HVT-IBD
turkey herpes virus, strain FC-126, expressing infectious bursal disease virus VP2 protein, live
Last updated:
MedicineVeterinaryAuthorised
Nuvaxovid
COVID-19 Vaccine (recombinant, adjuvanted)
COVID-19 virus infection
Date of authorisation:
Revision: 13
Last updated:
MedicineHumanAuthorised
Respreeza
alpha1-proteinase inhibitor (human)
Genetic Diseases, Inborn
Lung Diseases
Date of authorisation:
Revision: 13
Last updated:
MedicineHumanAuthorised
Zykadia
ceritinib
Carcinoma, Non-Small-Cell Lung
Date of authorisation:
Revision: 20
Last updated:
MedicineHumanAuthorised
Intuniv
guanfacine
Attention Deficit Disorder with Hyperactivity
Date of authorisation:
Revision: 13
Last updated:
MedicineHumanAuthorised
PRAC recommendations on safety signals

Each month, the European Medicines Agency publishes an overview listing all safety signals discussed during the latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting and the recommendations given for each of them. The overview includes PRAC recommendations for centrally and nationally authorised medicines.

Last updated:
HumanRegulatory and procedural guidancePharmacovigilance
EMEA-003184-PIP01-22 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseasesVaccines
PIP number: P/0139/2023
Route(s) of administration: Intramuscular use
Pharmaceutical form(s):
Dispersion for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman