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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

*Product:*	DBL Methotrexate
Active Ingredient:	Methotrexate 2.5mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturer:	Hospira Australia Pty Limited, Melbourne, Australia

*Product:*	DBL Methotrexate
Active Ingredient:	Methotrexate 25mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturer:	Hospira Australia Pty Limited, Melbourne, Australia

*Product:*	DBL Methotrexate
Active Ingredient:	Methotrexate 100mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturer:	Hospira Australia Pty Limited, Melbourne, Australia

*Product:*	Saizen
Active Ingredient:	Somatropin 5.83mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Merck Serono SpA, Bari, Italy

*Product:*	Saizen
Active Ingredient:	Somatropin 8mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Merck Serono SpA, Bari, Italy

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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