Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines 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:
Schedule
Product: | Boostrix |
Active Ingredients: | Diphtheria toxoid, adsorbed 2IU Pertactin 2.5mcg Pertussis filamentous haemagglutinin 8mcg Pertussis toxoid, adsorbed 8mcg Tetanus toxoid, adsorbed 20IU |
Dosage Form: | Suspension for injection |
New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
Manufacturers: | GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France |
Product: | Sprycel |
Active Ingredient: | Dasatinib 20mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
Manufacturer: | AstraZeneca Pharmaceuticals LP, Indiana, United States of America |
Product: | Sprycel |
Active Ingredient: | Dasatinib 50mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
Manufacturer: | AstraZeneca Pharmaceuticals LP, Indiana, United States of America |
Product: | Sprycel |
Active Ingredient: | Dasatinib 70mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
Manufacturer: | AstraZeneca Pharmaceuticals LP, Indiana, United States of America |
Product: | Sprycel |
Active Ingredient: | Dasatinib 100mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
Manufacturer: | AstraZeneca Pharmaceuticals LP, Indiana, United States of America |
Dated this 6th day of April 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).