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: | Bisolvon Chesty Forte |
| Active Ingredient: | Bromhexine hydrochloride 1.6mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Delpharm Reims SAS, Reims, France |
| Product: | Bisolvon Chesty Forte |
| Active Ingredient: | Bromhexine hydrochloride 8mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturer: | Delpharm Reims SAS, Reims, France |
| Product: | Cervarix |
| Active Ingredients: | Human Papillomavirus (HPV) 16 L1 Protein 20mcg Human Papillomavirus (HPV) 18 L1 Protein 20mcg |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturer: | GlaxoSmithKline Biologicals SA, Wavre, Belgium |
| Product: | Curosurf |
| Active Ingredient: | Poractant Alfa 80mg/mL |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Chiesi New Zealand Limited t/a Emerge Health |
| Manufacturer: | Chiesi Farmaceutici SpA, Parma, Italy |
| Product: | Lopresor |
| Active Ingredient: | Metoprolol tartrate 50mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey |
| Product: | Lopresor |
| Active Ingredient: | Metoprolol tartrate 100mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey |
| Product: | Pemetrexed Accord |
| Active Ingredient: | Pemetrexed disodium hemipentahydrate 110.29mg equivalent to pemetrexed 100mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Pemetrexed Accord |
| Active Ingredient: | Pemetrexed disodium hemipentahydrate 551.45mg equivalent to pemetrexed 500mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Pemetrexed Accord |
| Active Ingredient: | Pemetrexed disodium hemipentahydrate 1102.9mg equivalent to pemetrexed 1000mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
| Product: | Slow Lopresor |
| Active Ingredient: | Metoprolol tartrate 200mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Farma SpA, Torre Annunziata, Italy Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey |
Dated this 17th day of August 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).