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: | Chlorhexidine 1% Hand Rub |
| Active Ingredients: | Chlorhexidine gluconate 1.066%w/v equivalent to chlorhexidine gluconate 20% 5.330%w/v Ethanol 72%v/v equivalent to ethanol 96% (XNS denatured F6 Bitrex) 75%v/v |
| Dosage Form: | Topical solution |
| New Zealand Sponsor: | Jaychem Industries Limited |
| Manufacturer: | Jaychem Industries Limited, Auckland, New Zealand |
| Product: | Advil minis (General sale) |
| Active Ingredient: | Ibuprofen 200mg |
| Dosage Form: | Liquid filled capsule |
| New Zealand Sponsor: | Haleon New Zealand ULC |
| Manufacturer: | Catalent Pharma Solutions LLC, Florida, United States of America |
| Product: | Advil minis (Pharmacy only) |
| Active Ingredient: | Ibuprofen 200mg |
| Dosage Form: | Liquid filled capsule |
| New Zealand Sponsor: | Haleon New Zealand ULC |
| Manufacturer: | Catalent Pharma Solutions LLC, Florida, United States of America |
| Product: | Labixten Meltlets |
| Active Ingredient: | Bilastine 10mg |
| Dosage Form: | Orodispersible tablet |
| New Zealand Sponsor: | A. Menarini New Zealand Pty Limited |
| Manufacturer: | A. Menarini Manufacturing Logistics & Services Srl, L’Aquila, Italy |
| Product: | SUGAMMADEX (200mg/2mL) (Medicianz) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | USV Private Limited, Daman, India |
| Product: | SUGAMMADEX (500mg/5mL) (Medicianz) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | USV Private Limited, Daman, India |
| Product: | SUGAMMADEX (200mg/2mL) (Medsurge) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | USV Private Limited, Daman, India |
| Product: | SUGAMMADEX (500mg/5mL) (Medsurge) |
| Active Ingredient: | Sugammadex sodium 108.8mg/mL equivalent to sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | USV Private Limited, Daman, India |
| Product: | TYLENOL (General sale) |
| Active Ingredient: | Paracetamol 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Johnson & Johnson (New Zealand) Limited |
| Manufacturer: | Shanghai Johnson & Johnson Pharmaceuticals Limited, Shanghai, China |
| Product: | TYLENOL (Pharmacy only) |
| Active Ingredient: | Paracetamol 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Johnson & Johnson (New Zealand) Limited |
| Manufacturer: | Shanghai Johnson & Johnson Pharmaceuticals Limited, Shanghai, China |
Dated this 9th day of October 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).