Notice Title

Consent to the Distribution of New Medicines

Publication Date
5 Dec 2024

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2024-go6245
Title
View PDF
File Type and Size
PDF (37 KB)

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: Zeposia (Combination product)
Component 1:  
Active Ingredient: Ozanimod 0.23mg equivalent to ozanimod hydrochloride 0.25mg
Dosage Form: Capsule
Component 2:  
Active Ingredient: Ozanimod 0.46mg equivalent to ozanimod hydrochloride 0.5mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Patheon Inc, Mississauga, Canada
Celgene International Sarl, Boudry, Switzerland
   
Product: Zeposia
Active Ingredient: Ozanimod 0.92mg equivalent to ozanimod hydrochloride 1mg
Dosage Form: Capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturers: Patheon Inc, Mississauga, Canada
Celgene International Sarl, Boudry, Switzerland
   
Product: Zyprexa
Active Ingredient: Olanzapine 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Lilly del Caribe Inc, Carolina, Puerto Rico
Lilly SA, Madrid, Spain
   
Product: Zyprexa
Active Ingredient: Olanzapine 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Lilly del Caribe Inc, Carolina, Puerto Rico
Lilly SA, Madrid, Spain
   
Product: Zyprexa
Active Ingredient: Olanzapine 7.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Lilly del Caribe Inc, Carolina, Puerto Rico
Lilly SA, Madrid, Spain
   
Product: Zyprexa
Active Ingredient: Olanzapine 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Lilly del Caribe Inc, Carolina, Puerto Rico
Lilly SA, Madrid, Spain
   
Product: Zyprexa IM
Active Ingredient: Olanzapine 10mg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Eli Lilly and Company Inc, Indiana, United States of America
Patheon Italia S.p.A, Milan, Italy


Dated this 2nd day of December 2024.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).