Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
|Active Ingredients:||Diphtheria toxoid, adsorbed 30Lf U equivalent to not less than 20IU
Haemophilus influenzae type b polysaccharide 12mcg
Hepatitis B virus surface antigen 10mcg
Pertussis filamentous haemagglutinin 25mcg
Pertussis toxoid, adsorbed 25mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 10Lf U equivalent to not less than 40IU
|Dosage Form:||Suspension for injection|
|New Zealand Sponsor:||Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics|
|Manufacturer:||Sanofi Pasteur SA, Val-De-Reuil Cedex, France|
Dated this 15th day of February 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).