Hexyon
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: 31
Last updated:
MedicineHumanAuthorised
EMEA-001545-PIP01-13-M02 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: P/0065/2020
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Powder and solvent for suspension for injection
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
EMEA-001888-PIP01-15-M01 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: P/0429/2020
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Powder and solvent for solution 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Withdrawn opinion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