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: | Dabigatran etexilate Sandoz |
| Active Ingredient: | Dabigatran etexilate mesylate 86.475mg equivalent to dabigatran etexilate 75mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturer: | MSN Laboratories Private Limited, Nandigama, India |
| Product: | Dabigatran etexilate Sandoz |
| Active Ingredient: | Dabigatran etexilate mesylate 126.83mg equivalent to dabigatran etexilate 110mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturer: | MSN Laboratories Private Limited, Nandigama, India |
| Product: | Dabigatran etexilate Sandoz |
| Active Ingredient: | Dabigatran etexilate mesylate 172.95mg equivalent to dabigatran etexilate 150mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturer: | MSN Laboratories Private Limited, Nandigama, India |
| Product: | Prasugrel Viatris |
| Active Ingredient: | Prasugrel besilate 7.118mg equivalent to prasugrel 5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Pithampur, India |
| Product: | Prasugrel Viatris |
| Active Ingredient: | Prasugrel besilate 14.236mg equivalent to prasugrel 10mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Pithampur, India |
Dated this 22nd day of September 2023.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).