Hexacima
diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Hepatitis B
Tetanus
Immunization
Meningitis, Haemophilus
Whooping Cough
Poliomyelitis
Diphtheria
Date of authorisation:
Date of refusal:
Revision: 30
Last updated:
MedicineHumanAuthorised
EMEA-003037-PIP01-21 - paediatric investigation plan
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: DiagnosticOncology
PIP number: P/0435/2021
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Powder and solvent for dispersion for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
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Withdrawn opinion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
Imagify
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application
EMEA-000194-PIP03-10 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Diagnostic
PIP number: P/116/2011
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Powder for suspension for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Perflubutane - paediatric investigation plan
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Cardiovascular diseases
PIP number: P/106/2008
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Lyophilisate for suspension for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman