Provisional Consent to the Distribution of a New Medicine

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 medicine set out in the Schedule hereto:

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*Product:*	Benzetacil
Active Ingredient:	Benzathine benzylpenicillin 948.07mg equivalent to 1,200,000 IU
Dosage Form:	Powder for injection with diluent
New Zealand Sponsor:	ORSPEC Pharma Management Limited
Manufacturer:	Laboratorio Reig Jofre SA, Toledo, Spain
Note: This consent is given subject to the following condition: The medicine may only be marketed or distributed when no other benzathine benzylpenicillin 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.

Dated this 29th day of May 2026.

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

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