Notice Title

Consent to the Distribution of New Medicines

Publication Date
28 Jul 2022

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2022-go3076
Title
View PDF
File Type and Size
PDF (38 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: Lamictal
Active Ingredient: Lamotrigine 2mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturer: GlaxoSmithKline LLC, North Carolina, United States of America
   
Product: Lamictal
Active Ingredient: Lamotrigine 5mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Ware, United Kingdom
GlaxoSmithKline Pharmaceuticals SA, Poznan, Poland
   
Product: Lamictal
Active Ingredient: Lamotrigine 25mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Ware, United Kingdom
GlaxoSmithKline Australia Pty Limited, Melbourne, Australia
GlaxoSmithKline Pharmaceuticals SA, Poznan, Poland
   
Product: Lamictal
Active Ingredient: Lamotrigine 50mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: GlaxoSmithKline Australia Pty Limited, Melbourne, Australia
GlaxoSmithKline Pharmaceuticals SA, Poznan, Poland
   
Product: Lamictal
Active Ingredient: Lamotrigine 100mg
Dosage Form: Chewable/dispersible tablet
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: GlaxoSmithKline Australia Pty Limited, Melbourne, Australia
GlaxoSmithKline Pharmaceuticals SA, Poznan, Poland
   
Product: Medical Air
Active Ingredient: Argon 1%
Nitrogen 78%
Oxygen 21%
Dosage Form: Gas
New Zealand Sponsor: Air Liquide New Zealand Limited
Manufacturer: BOC Limited, Auckland, New Zealand
   
Product: Panadol Osteo
Active Ingredient: Paracetamol 665mg
Dosage Form: Modified release tablet
New Zealand Sponsor: GlaxoSmithKline Consumer Healthcare New Zealand ULC
Manufacturers: GlaxoSmithKline Dungarvan Limited, Waterford, Ireland
Glaxo Wellcome SA, Avenida de Extremadura 3, Burgos, Spain
GlaxoSmithKline Australia Pty Limited, Sydney, Australia
   
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


Dated this 25th day of July 2022.

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