EMEA-001780-PIP01-15 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: P/0363/2016
Route(s) of administration: Endotracheopulmonary use
Pharmaceutical form(s):
Endotracheopulmonary instillation
Suspension
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001191-PIP01-11-M03 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: P/0367/2019
Route(s) of administration: Oral use
Pharmaceutical form(s):
Chewable tablet
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Daklinza
daclatasvir
Hepatitis C, Chronic
Date of authorisation:
Revision: 15
Last updated:
MedicineHumanExpired
EMEA-001485-PIP01-13-M01 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: P/0002/2015
Route(s) of administration: Oral use
Pharmaceutical form(s):
Age-appropriate oral solid dosage form
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman