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: | Actemra |
| Active Ingredient: | Tocilizumab 20mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | Chugai Pharma Manufacturing Co. Limited, Utsunomiya City, Japan |
| Product: | Act-HIB vaccine |
| Active Ingredient: | Haemophilus influenzae type b vaccine 10mcg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturers: | Sanofi Pasteur SA, Marcy L’Etoile, France Sanofi Pasteur SA, Val-De-Reuil, France |
| Product: | Deolate |
| Active Ingredient: | Terbinafine hydrochloride 281.25mg equivalent to terbinafine 250mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | REX Medical Limited |
| Manufacturers: | Cipla Limited, Patalganga, India Cipla Limited, Verna, India |
| Product: | Zaditen (Preserved formulation) |
| Active Ingredient: | Ketotifen fumarate 345mcg/mL equivalent to ketotifen 250mcg/mL |
| Dosage Form: | Eye drops, solution |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Excelvision, Annonay, France |
| Product: | Zaditen (Unpreserved formulation) |
| Active Ingredient: | Ketotifen fumarate 345mcg/mL equivalent to ketotifen 250mcg/mL |
| Dosage Form: | Eye drops, solution |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Excelvision, Annonay, France |
Dated this 10th day of May 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).