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: | Fycompa |
| Active Ingredient: | Perampanel hemisesquihydrate 2.1mg equivalent to perampanel 2mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Eisai Manufacturing Limited, Hatfield, United Kingdom |
| Product: | Fycompa |
| Active Ingredient: | Perampanel hemisesquihydrate 4.2mg equivalent to perampanel 4mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Eisai Manufacturing Limited, Hatfield, United Kingdom |
| Product: | Fycompa |
| Active Ingredient: | Perampanel hemisesquihydrate 6.2mg equivalent to perampanel 6mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Eisai Manufacturing Limited, Hatfield, United Kingdom |
| Product: | Fycompa |
| Active Ingredient: | Perampanel hemisesquihydrate 8.3mg equivalent to perampanel 8mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Eisai Manufacturing Limited, Hatfield, United Kingdom |
| Product: | Fycompa |
| Active Ingredient: | Perampanel hemisesquihydrate 10.4mg equivalent to perampanel 10mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Eisai Manufacturing Limited, Hatfield, United Kingdom |
| Product: | Fycompa |
| Active Ingredient: | Perampanel hemisesquihydrate 12.5mg equivalent to perampanel 12mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Eisai Manufacturing Limited, Hatfield, United Kingdom |
| Product: | Mylan Fentanyl Patch |
| Active Ingredient: | Fentanyl 1.28mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Technologies, Vermont, United States of America |
| Product: | Mylan Fentanyl Patch |
| Active Ingredient: | Fentanyl 2.55mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Technologies, Vermont, United States of America |
| Product: | Mylan Fentanyl Patch |
| Active Ingredient: | Fentanyl 5.1mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Technologies, Vermont, United States of America |
| Product: | Mylan Fentanyl Patch |
| Active Ingredient: | Fentanyl 7.65mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Technologies, Vermont, United States of America |
| Product: | Mylan Fentanyl Patch |
| Active Ingredient: | Fentanyl 10.2mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Technologies, Vermont, United States of America |
| Product: | Nicorette Cooldrops |
| Active Ingredient: | Nicotine polacrilex 10mg equivalent to nicotine 2mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | Johnson & Johnson (New Zealand) Limited |
| Manufacturer: | McNeil AB, Helsingborg, Sweden |
| Product: | Nicorette Cooldrops |
| Active Ingredient: | Nicotine polacrilex 20mg equivalent to nicotine 4mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | Johnson & Johnson (New Zealand) Limited |
| Manufacturer: | McNeil AB, Helsingborg, Sweden |
| Product: | Optrex Eye Drops |
| Active Ingredient: | Naphazoline hydrochloride 0.01%w/v |
| Dosage Form: | Eye drops, solution |
| New Zealand Sponsor: | Reckitt Benckiser (New Zealand) Limited |
| Manufacturer: | Reckitt Benckiser Healthcare International Limited, Nottingham, United Kingdom |
Dated this 22nd day of April 2022.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).