Provisional Consent to the Distribution of New Medicines
Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:
| Product: | Lyllana |
| Active Ingredient: | Estradiol hemihydrate 0.484mg equivalent to estradiol 0.470mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Wellmed.NZ Limited |
| Manufacturer: | Amneal Pharmaceuticals LLC, New Jersey, United States of America |
| Note: This consent is given subject to the following condition: | |
| The medicine may only be marketed or distributed when no other estradiol transdermal patch medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations. | |
| Note: This consent is valid for two years from the date of publication of this notice. | |
| Product: | Lyllana |
| Active Ingredient: | Estradiol hemihydrate 0.646mg equivalent to estradiol 0.627mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Wellmed.NZ Limited |
| Manufacturer: | Amneal Pharmaceuticals LLC, New Jersey, United States of America |
| Note: This consent is given subject to the following condition: | |
| The medicine may only be marketed or distributed when no other estradiol transdermal patch medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations. | |
| Note: This consent is valid for two years from the date of publication of this notice. | |
| Product: | Lyllana |
| Active Ingredient: | Estradiol hemihydrate 0.323mg equivalent to estradiol 0.314mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Wellmed.NZ Limited |
| Manufacturer: | Amneal Pharmaceuticals LLC, New Jersey, United States of America |
| Note: This consent is given subject to the following condition: | |
| The medicine may only be marketed or distributed when no other estradiol transdermal patch medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations. | |
| Note: This consent is valid for two years from the date of publication of this notice. | |
| Product: | Lyllana |
| Active Ingredient: | Estradiol hemihydrate 1.291mg equivalent to estradiol 1.253mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Wellmed.NZ Limited |
| Manufacturer: | Amneal Pharmaceuticals LLC, New Jersey, United States of America |
| Note: This consent is given subject to the following condition: | |
| The medicine may only be marketed or distributed when no other estradiol transdermal patch medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations. | |
| Note: This consent is valid for two years from the date of publication of this notice. | |
| Product: | Lyllana |
| Active Ingredient: | Estradiol hemihydrate 0.968mg equivalent to estradiol 0.940mg |
| Dosage Form: | Transdermal patch |
| New Zealand Sponsor: | Wellmed.NZ Limited |
| Manufacturer: | Amneal Pharmaceuticals LLC, New Jersey, United States of America |
| Note: This consent is given subject to the following condition: | |
| The medicine may only be marketed or distributed when no other estradiol transdermal patch medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations. | |
| Note: This consent is valid for two years from the date of publication of this notice. | |
| Product: | Norethindrone Tablets USP |
| Active Ingredient: | Norethisterone 0.35mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | ORSPEC Pharma Management Limited |
| Manufacturer: | Glenmark Pharmaceuticals Limited, Bardez, India |
| Note: This consent is given subject to the following conditions: | |
|
|
| Note: This consent is valid for two years from the date of publication of this notice. | |
Dated this 24th day of September 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).