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:*	Allegron
Active Ingredient:	Nortriptyline hydrochloride 11.4mg equivalent to nortriptyline 10mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Arrotex Pharmaceuticals (NZ) Limited
Manufacturers:	Strides Pharma Science Limited, Bangalore South, India Strides Pharma Science Limited, Bangalore, India
Note: This consent is given subject to the following condition: The medicine may only be marketed or distributed when no other nortriptyline hydrochloride 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:*	Allegron
Active Ingredient:	Nortriptyline hydrochloride 28.5mg equivalent to nortriptyline 25mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Arrotex Pharmaceuticals (NZ) Limited
Manufacturers:	Strides Pharma Science Limited, Bangalore South, India Strides Pharma Science Limited, Bangalore, India
Note: This consent is given subject to the following condition: The medicine may only be marketed or distributed when no other nortriptyline hydrochloride 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 21st day of July 2025.

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

Provisional Consent to the Distribution of New Medicines

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