Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines are set out in the Schedule hereto:

Schedule

*Product:*	AndroFeme 1
Active Ingredient:	Testosterone 10mg/mL
Dosage Form:	Topical cream
New Zealand Sponsor:	Alchemy Health Limited
Manufacturer:	Orion Laboratories Pty Limited t/a Perrigo Australia, Perth, Australia

*Product:*	Ocrevus SC
Active Ingredient:	Ocrelizumab 40mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Roche Products (NZ) Limited
Manufacturer:	Roche Diagnostics GmbH, Mannheim, Germany

*Product:*	Pharmacor Dabigatran Etexilate
Active Ingredient:	Dabigatran etexilate mesylate 86.475mg equivalent to dabigatran etexilate 75mg
Dosage Form:	Capsule
New Zealand Sponsor:	Pharmacor Limited
Manufacturer:	Alkem Laboratories Limited, Daman, India

*Product:*	Pharmacor Dabigatran Etexilate
Active Ingredient:	Dabigatran etexilate mesylate 126.83mg equivalent to dabigatran etexilate 110mg
Dosage Form:	Capsule
New Zealand Sponsor:	Pharmacor Limited
Manufacturer:	Alkem Laboratories Limited, Daman, India

*Product:*	Pharmacor Dabigatran Etexilate
Active Ingredient:	Dabigatran etexilate mesylate 172.95mg equivalent to dabigatran etexilate 150mg
Dosage Form:	Capsule
New Zealand Sponsor:	Pharmacor Limited
Manufacturer:	Alkem Laboratories Limited, Daman, India

*Product:*	Plerixafor-AFT
Active Ingredient:	Plerixafor 20mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	AFT Pharmaceuticals Limited
Manufacturer:	Sichuan Huiyu Pharmaceutical Company Limited, Neijiang, China

Dated this 22nd day of April 2025.

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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