Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: 3TC
Active Ingredient: Lamivudine 10mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturer: Bora Pharmaceutical Services Inc, Mississauga, Canada
   
Product: 3TC
Active Ingredient: Lamivudine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Ware, United Kingdom
Delpharm Poznan S.A., Poznan, Poland
   
Product: 3TC
Active Ingredient: Lamivudine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Ware, United Kingdom
Delpharm Poznan S.A., Poznan, Poland
   
Product: Kivexa
Active Ingredients: Abacavir sulphate 702mg equivalent to abacavir 600mg
Lamivudine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Ware, United Kingdom
Delpharm Poznan S.A., Poznan, Poland
   
Product: Rinvoq
Active Ingredient: Upadacitinib hemihydrate 15.4mg equivalent to upadacitinib 15mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AbbVie Limited
Manufacturer: AbbVie Ireland NL B.V., Sligo, Ireland
   
Product: Rinvoq
Active Ingredient: Upadacitinib hemihydrate 30.7mg equivalent to upadacitinib 30mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AbbVie Limited
Manufacturer: AbbVie Ireland NL B.V., Sligo, Ireland


Dated this 23rd day of June 2023.

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