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: | Aspen Codeine |
| Active Ingredient: | Codeine phosphate hemihydrate 30mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Aspen Pharma Pty Limited, Dandenong South, Australia |
Note: This consent is given subject to the following condition:
The medicine may only be marketed or distributed when no other codeine phosphate medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC tender obligations.
Note: This consent is valid for two years from the date of publication of this notice.
| Product: | Aspen Dexamfetamine |
| Active Ingredient: | Dexamfetamine sulfate 5mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Aspen Pharma Pty Limited, Dandenong South, Australia |
Note: This consent is given subject to the following condition:
The medicine may only be marketed or distributed when no other dexamfetamine medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC tender obligations.
Note: This consent is valid for two years from the date of publication of this notice.
| Product: | Nadolol BNM |
| Active Ingredient: | Nadolol 40mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturer: | Zenara Pharma Pvt. Limited, Hyderabad, India |
Note: This consent is given subject to the following condition:
The medicine may only be marketed or distributed when no other nadolol medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC tender obligations.
Note: This consent is valid for two years from the date of publication of this notice.
| Product: | Nadolol BNM |
| Active Ingredient: | Nadolol 80mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturer: | Zenara Pharma Pvt. Limited, Hyderabad, India |
Note: This consent is given subject to the following condition:
The medicine may only be marketed or distributed when no other nadolol medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC tender obligations.
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 10th day of October 2022.
MATTHEW SPENCER, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).