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-002047-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/0081/2017
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001364-PIP01-12 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: P/0034/2013
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001353-PIP01-12 - 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/0010/2013
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001232-PIP01-11 - 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/0103/2012
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001204-PIP01-11 - 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/0018/2012
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001085-PIP01-10 - 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/94/2011
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Atorvastatin calcium - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: P/53/2008
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Age-appropriate oral formulation
Decision date:
Last updated:
Compliance check: ✔
PIPHuman