EMEA-001744-PIP01-14-M02 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0078/2023
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Concentrate for solution for infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Panexcell - referral
atazanavir
atazanavir sulfate
Amoxicillin trihydrate
iron sucrose
amoxicillin
azithromycin dihydrate
carbocisteine
trimethoprim
Article 31 referrals
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
EMEA-002548-PIP01-19 - 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/0184/2019
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Begedina
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application
Amoxil - referral
amoxicillin
Article 30 referrals
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
EMEA-001574-PIP01-13 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: P/0156/2014
Route(s) of administration: Oral use
Pharmaceutical form(s):
Orodispersible tablet
Film-coated tablet
Gastro-resistant tablet
Tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman