EMEA-003066-PIP01-21 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseasesVaccines
PIP number: P/0489/2021
Route(s) of administration: Intramuscular use
Pharmaceutical form(s):
Solution for injection in pre-filled syringe
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Alsitek
masitinib
Amyotrophic Lateral Sclerosis
Date of refusal:
Last updated:
MedicineHumanRefused
Hexaxim
Diphtheria toxoid
Tetanus toxoid
Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin
Inactivated poliovirus: type 1 (Mahoney strain)
Inactivated poliovirus: type 2 (MEF-1 strain)
Inactivated poliovirus: type 3 (Saukett strain)
hepatitis B surface antigen
Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate)
Hepatitis B
Tetanus
Immunization
Meningitis, Haemophilus
Whooping Cough
Poliomyelitis
Diphtheria
Withdrawn opinion
Opinion date:
Last updated:
EU-M4allHuman
Masipro
masitinib
Mastocytosis
Date of refusal:
Last updated:
MedicineHumanRefused
EMEA-000500-PIP01-08-M03 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: P/0035/2015
Route(s) of administration: Intramuscular use
Pharmaceutical form(s):
Suspension for injection
Suspension for injection in pre-filled syringe
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
Masiviera
masitinib
Pancreatic Neoplasms
Last updated:
MedicineHumanRefused
Masican
masitinib
Gastrointestinal Stromal Tumors
Date of refusal:
Last updated:
MedicineHumanRefused