Palonosetron Accord
palonosetron
Vomiting
Nausea
Cancer
Date of authorisation:
Revision: 7
Last updated:
MedicineHumanAuthorised
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-001198-PIP03-17-M04 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: P/0272/2020
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Powder for concentrate for solution for infusion
Concentrate for solution for infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001198-PIP02-16 - paediatric investigation plan
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Other
PIP number: P/0358/2016
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Powder for solution for infusion
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
EMEA-001198-PIP01-11 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: P/0014/2012
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman