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: | Dolomol (General sale) |
| Active Ingredients: | Ibuprofen 200mg Paracetamol 500mg |
| Dosage Form: | Soft gelatin capsule |
| New Zealand Sponsor: | AdiraMedica Pty Limited |
| Manufacturer: | Softgel Healthcare Pvt. Limited, Pudupakkam Village, India |
| Product: | Dolomol (Pharmacy only) |
| Active Ingredients: | Ibuprofen 200mg Paracetamol 500mg |
| Dosage Form: | Soft gelatin capsule |
| New Zealand Sponsor: | AdiraMedica Pty Limited |
| Manufacturer: | Softgel Healthcare Pvt. Limited, Pudupakkam Village, India |
| Product: | Habitrol Step 1 |
| Active Ingredient: | Nicotine 52.5mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Haleon New Zealand ULC |
| Manufacturer: | LTS Lohmann Therapie-Systeme AG, Andernach, Germany |
| Product: | Habitrol Step 2 |
| Active Ingredient: | Nicotine 35mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Haleon New Zealand ULC |
| Manufacturer: | LTS Lohmann Therapie-Systeme AG, Andernach, Germany |
| Product: | Habitrol Step 3 |
| Active Ingredient: | Nicotine 17.5mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Haleon New Zealand ULC |
| Manufacturer: | LTS Lohmann Therapie-Systeme AG, Andernach, Germany |
| Product: | Teriflunomide Sandoz |
| Active Ingredient: | Teriflunomide 14mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturers: | AET Laboratories Private Limited, Gaddapotharam Village, India Combino Pharm (Malta) Limited, Birzebbuga, Malta |
Dated this 4th day of March 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).