Gazette.govt.nzPursuant 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).