EMEA-003132-PIP01-21 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: P/0058/2022
Route(s) of administration: All routes of administration
Pharmaceutical form(s):
All pharmaceutical forms
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Qsiva
phentermine
topiramate
Obesity
Date of refusal:
Last updated:
MedicineHumanRefused
EMEA-000826-PIP01-09 - 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/223/2010
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Anorectics - referral
phentermine
amfepramome
clobenzorex
dexfenfluramine
fenbutrazate
fenfluramine
fenproporex
mazindol
mefenorex
norpseudoephedrine
phenmetrazine
phendimetrazine
propylhexedrine
Article 31 referrals
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman