Poulvac Procerta HVT-IBD
turkey herpes virus, strain FC-126, expressing infectious bursal disease virus VP2 protein, live
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MedicineVeterinaryAuthorised
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.

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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
Website outages and upgrades

The European Medicines Agency (EMA) makes upgrades to this website from time to time, to improve user experience. During these upgrades, the website is unavailable for a short period of time, outside of EMA working hours. This page lists when we are planning the next outage and the main improvements made.

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Corporate
EMEA-003080-PIP03-22 - 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 diseases
PIP number: P/0118/2023
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Concentrate for solution for infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-002612-PIP02-22 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: P/0151/2023
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Solution for injection/infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-003079-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 diseases
PIP number: P/0119/2023
Route(s) of administration: Intramuscular useIntravenous use
Pharmaceutical form(s):
Solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman