Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the 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.
Note: This renewed consent is valid for two years from 19 March 2022.

*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.
Note: This renewed consent is valid for two years from 19 March 2022.

Dated this 14th day of March 2022.

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

Renewal of Provisional Consent to the Distribution of Medicines

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