Notice Title

Consent to the Distribution of New Medicines

Publication Date
27 Feb 2025

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2025-go980
Title
View PDF
File Type and Size
PDF (34 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 set out in the Schedule hereto:

Schedule

Product: Omjjara
Active Ingredient: Momelotinib dihydrochloride monohydrate 121.94mg equivalent to momelotinib 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturer: Patheon Inc, Mississauga, Canada
   
Product: Omjjara
Active Ingredient: Momelotinib dihydrochloride monohydrate 182.91mg equivalent to momelotinib 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturer: Patheon Inc, Mississauga, Canada
   
Product: Omjjara
Active Ingredient: Momelotinib dihydrochloride monohydrate 243.88mg equivalent to momelotinib 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturer: Patheon Inc, Mississauga, Canada


Dated this 21st day of February 2025.

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