EMEA-001983-PIP01-16-M01 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: DiagnosticUro-nephrology
PIP number: P/0457/2022
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000237-PIP01-08-M10 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: P/0530/2021
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Granules for oral suspension
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Edarbi
azilsartan medoxomil
Hypertension
Date of authorisation:
Revision: 10
Last updated:
MedicineHumanAuthorised
Ipreziv
azilsartan medoxomil
Hypertension
Date of authorisation:
Revision: 4
Last updated:
MedicineHumanWithdrawn
Renin-angiotensin-system (RAS)-acting agents - referral
captopril
imidapril
zofenopril
candesartan
delapril
telmisartan
aliskiren
moexipril
enalapril
valsartan
fosinopril
irbesartan
perindopril
quinapril
ramipril
eprosartan
olmesartan
trandolapril
losartan
azilsartan
lisinopril
spirapril
benazepril
cilazapril
Article 31 referrals
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
EMEA-001294-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/0224/2012
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman