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-002954-PIP02-21 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: P/0473/2021
Route(s) of administration: Intramuscular use
Pharmaceutical form(s):
Suspension 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Withdrawn opinion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