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: | Ilaris |
| Active Ingredient: | Canakinumab 150mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Hameln Pharmaceuticals GmbH, Hameln, Germany |
| Product: | Maviret |
| Active Ingredients: | Glecaprevir 100mg Pibrentasvir 40mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturers: | AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany Fournier Laboratories Ireland Limited, Carrigtwohill, Ireland |
| Product: | Ropin |
| Active Ingredient: | Ropinirole hydrochloride 0.285mg equivalent to ropinirole 0.25mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | Torrent Pharmaceuticals Limited, Kadi, India |
| Product: | Ropin |
| Active Ingredient: | Ropinirole hydrochloride 0.57mg equivalent to ropinirole 0.5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | Torrent Pharmaceuticals Limited, Kadi, India |
| Product: | Ropin |
| Active Ingredient: | Ropinirole hydrochloride 1.14mg equivalent to ropinirole 1mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | Torrent Pharmaceuticals Limited, Kadi, India |
| Product: | Ropin |
| Active Ingredient: | Ropinirole hydrochloride 2.28mg equivalent to ropinirole 2mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | Torrent Pharmaceuticals Limited, Kadi, India |
| Product: | Ropin |
| Active Ingredient: | Ropinirole hydrochloride 5.7mg equivalent to ropinirole 5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Mylan New Zealand Limited |
| Manufacturer: | Torrent Pharmaceuticals Limited, Kadi, India |
Dated this 9th day of April 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).