EMEA-003200-PIP01-22 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Uro-nephrology
PIP number: P/0520/2022
Route(s) of administration: Oral use
Pharmaceutical form(s):
Powder for oral suspension
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Diacomit
stiripentol
Myoclonic Epilepsy, Juvenile
Date of authorisation:
Date of refusal:
Revision: 18
Last updated:
MedicineHumanAuthorised
Posatex
orbifloxacin
mometasone furoate
posaconazole
Dogs
Date of authorisation:
Revision: 9
Last updated:
MedicineVeterinaryAuthorised
Orbax - referral
orbifloxacin
Article 33
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralVeterinary