Albrioza
sodium phenylbutyrate
Ursodoxicoltaurine
Amyotrophic Lateral Sclerosis
Date of refusal:
Last updated:
MedicineHumanRefused
Pheburane
sodium phenylbutyrate
Carbamoyl-Phosphate Synthase I Deficiency Disease
Date of authorisation:
Revision: 11
Last updated:
MedicineHumanAuthorised
Ammonaps
sodium phenylbutyrate
Ornithine Carbamoyltransferase Deficiency Disease
Citrullinemia
Carbamoyl-Phosphate Synthase I Deficiency Disease
Date of authorisation:
Revision: 21
Last updated:
MedicineHumanAuthorised
EMEA-002876-PIP01-20 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: P/0495/2020
Route(s) of administration: Oral use
Pharmaceutical form(s):
Powder for oral suspension
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Pharmaceutics International Inc. - referral
sodium phenylbutyrate
progesterone
dutasteride
colecalciferol
Article 31 referrals
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman