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REPEVAX, suspension for injection, in pre-filled syringe Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content)

0.5 millilitre(s) Suspension for injection

Sanofi PasteurPA2131/006/001

Main Information

Trade NameREPEVAX, suspension for injection, in pre-filled syringe Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content)
Active SubstancesTetanus toxoid
Diphtheria toxoid
Pertussis toxoid
Filamentous haemagglutinin (fha)
Pertactin
Polio virus type 1 inactivated
Polio virus type 2 inactivated
Polio virus type 3 inactivated
Adsorbed aluminium phosphate
Adsorbed fimbriae types 2 + 3
Strength0.5 millilitre(s)
Dosage FormSuspension for injection
Licence HolderSanofi Pasteur
Licence NumberPA2131/006/001

Group Information

ATC CodeJ07CA Bacterial and viral vaccines, combined
J07CA02 diphtheria-pertussis-poliomyelitis-tetanus

Status

Authorised/WithdrawnAuthorised
Licence Issued25/07/2003
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceBatches marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.1 of Directive 2001/83/EC, as amended.
Marketing StatusNot marketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
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