Ayvakyt
avapritinib
Gastrointestinal Stromal Tumors
Date of authorisation:
Revision: 9
Last updated:
MedicineHumanAuthorised
EMEA-002358-PIP02-18-M02 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: P/0016/2022
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Age-appropriate oral solid dosage form
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000669-PIP01-09-M02 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: P/0022/2019
Route(s) of administration: Intramuscular use
Pharmaceutical form(s):
Suspension and emulsion for injection
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
EMEA-002358-PIP03-19 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: P/0083/2020
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Arepanrix
pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Influenza, Human
Immunization
Disease Outbreaks
Date of authorisation:
Revision: 1
Last updated:
MedicineHumanWithdrawn
Humenza
pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Influenza, Human
Immunization
Disease Outbreaks
Date of authorisation:
Last updated:
MedicineHumanWithdrawn
EMEA-000687-PIP01-09-M02 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: P/148/2010
Route(s) of administration: Intramuscular use
Pharmaceutical form(s):
Suspension and emulsion for emulsion for injection
Decision date:
Last updated:
Compliance check: ✔
PIPHuman