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:*	Hyrimoz (20mg/0.2mL pre-filled syringe)
Active Ingredient:	Adalimumab 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	Novartis Pharmaceutical Manufacturing GmbH, Langkampfen, Austria

*Product:*	Hyrimoz (40mg/0.4mL pre-filled syringe)
Active Ingredient:	Adalimumab 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	Novartis Pharmaceutical Manufacturing GmbH, Langkampfen, Austria

*Product:*	Hyrimoz (80mg/0.8mL pre-filled syringe)
Active Ingredient:	Adalimumab 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	Novartis Pharmaceutical Manufacturing GmbH, Langkampfen, Austria

*Product:*	Hyrimoz (40mg/0.4mL pre-filled pen)
Active Ingredient:	Adalimumab 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	Novartis Pharmaceutical Manufacturing GmbH, Langkampfen, Austria

*Product:*	Hyrimoz (80mg/0.8mL pre-filled pen)
Active Ingredient:	Adalimumab 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	Novartis Pharmaceutical Manufacturing GmbH, Langkampfen, Austria

*Product:*	Permethrin Scabies Cream
Active Ingredient:	Permethrin 50mg/g
Dosage Form:	Topical cream
New Zealand Sponsor:	Medsurge Pharma Limited
Manufacturer:	Galentic Pharma India Pvt Limited., Gandhidham, India

*Product:*	Sandrena (0.5g)
Active Ingredient:	Estradiol hemihydrate 1.03mg/g equivalent to estradiol 1.0mg/g
Dosage Form:	Transdermal gel
New Zealand Sponsor:	Orion Pharma (NZ) Limited
Manufacturer:	Orion Corporation, Turku Factory, Turku, Finland

*Product:*	Sandrena (1g)
Active Ingredient:	Estradiol hemihydrate 1.03mg/g equivalent to estradiol 1.0mg/g
Dosage Form:	Transdermal gel
New Zealand Sponsor:	Orion Pharma (NZ) Limited
Manufacturer:	Orion Corporation, Turku Factory, Turku, Finland

*Product:*	Scabemed Scabies Cream
Active Ingredient:	Permethrin 50mg/g
Dosage Form:	Topical cream
New Zealand Sponsor:	Medsurge Pharma Limited
Manufacturer:	Galentic Pharma India Pvt Limited, Gandhidham, India

Dated this 30th 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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