EMEA-003311-PIP01-22 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Vaccines
PIP number: P/0043/2023
Route(s) of administration: Intramuscular useSubcutaneous use
Pharmaceutical form(s):
Suspension for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001834-PIP02-16-M01 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: P/0168/2018
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Age-appropriate oral solid dosage form
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Dexxience
betrixaban
Venous Thromboembolism
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Withdrawn opinion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
Globorix
Diphtheria toxoid
Tetanus toxoid
Bordetella pertussis (inactivated)
Haemophilus influenzae type b polysaccharide
Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid
Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid
hepatitis B surface antigen
Immunization
Hepatitis B
Diphtheria-Tetanus-Pertussis Vaccine
Bordetella pertussis
Haemophilus influenzae type b
Neisseria meningitidis, Serogroup A
Neisseria meningitidis, Serogroup C
Withdrawn application
Last updated:
EU-M4allHuman