EMEA-001665-PIP01-14-M06 - paediatric investigation plan
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: P/0175/2022
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Dispersion for infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Zynteglo
betibeglogene autotemcel
beta-Thalassemia
Date of authorisation:
Revision: 5
Last updated:
MedicineHumanWithdrawn
Zynteglo - referral
betibeglogene autotemcel
Article 20 procedures
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
EMEA-001764-PIP03-15 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Anaesthesiology
PIP number: P/0082/2016
Route(s) of administration: Nasal use
Pharmaceutical form(s):
Nasal spray (solution)
Decision date:
Last updated:
Compliance check: ✔
PIPHuman