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 set out in the Schedule hereto:
Schedule
| Product: | Dimethyl Fumarate Te Arai |
| Active Ingredient: | Dimethyl fumarate 120mg |
| Dosage Form: | Modified release capsule |
| New Zealand Sponsor: | Te Arai BioFarma Limited |
| Manufacturer: | Sanovel Ilac Sanayi Ve Ticaret A.S., Istanbul, Turkey |
| Product: | Dimethyl Fumarate Te Arai |
| Active Ingredient: | Dimethyl fumarate 240mg |
| Dosage Form: | Modified release capsule |
| New Zealand Sponsor: | Te Arai BioFarma Limited |
| Manufacturer: | Sanovel Ilac Sanayi Ve Ticaret A.S., Istanbul, Turkey |
| Product: | Epidyolex |
| Active Ingredient: | Cannabidiol 100mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | Chiesi New Zealand Limited t/a Emerge Health |
| Manufacturer: | GW Pharma Limited, Sittingbourne, United Kingdom |
| Product: | Pfizer Bendamustine Concentrated Injection |
| Active Ingredient: | Bendamustine hydrochloride monohydrate 26.1mg
equivalent to 25mg bendamustine hydrochloride |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Zydus Hospira Oncology Limited (ZHOPL), Ahmedabad, India |
| Product: | Pfizer Bendamustine Concentrated Injection |
| Active Ingredient: | Bendamustine hydrochloride monohydrate 104.6mg
equivalent to 100mg bendamustine hydrochloride |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Zydus Hospira Oncology Limited (ZHOPL), Ahmedabad, India |
| Product: | Qinlock |
| Active Ingredient: | Ripretinib 50mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Specialised Therapeutics Limited |
| Manufacturer: | Bend Research Inc, Oregon, United States of America |
Dated this 13th day of January 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).