Notice Type
Departmental
Notice Title

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:

Schedule

Product: Trandate
Active Ingredient: Labetalol hydrochloride 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Aspen Pharma Pty Limited, Melbourne, Australia

Note:
This consent is given subject to the following conditions:
  • Provisional consent is to be granted for 2 years to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other labetalol hydrochloride tablet medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
  • Provisional consent can only be renewed while assessment of a section 20 new medicine application is in progress. The new medicine application should be accompanied by a full data set in compliance with Medsafe's stated requirements.
Note: This consent is valid for two years from the date of publication of this notice.

Product: Trandate
Active Ingredient: Labetalol hydrochloride 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Aspen Pharma Pty Limited, Melbourne, Australia

Note:
This consent is given subject to the following conditions:
  • Provisional consent is to be granted for 2 years to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other labetalol hydrochloride tablet medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
  • Provisional consent can only be renewed while assessment of a section 20 new medicine application is in progress. The new medicine application should be accompanied by a full data set in compliance with Medsafe's stated requirements.
Note: This consent is valid for two years from the date of publication of this notice.

Dated this 13th day of March 2020.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).