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 set out in the Schedule hereto:

Schedule

*Product:*	GlycoNeo 0.5/2.5
Active Ingredients:	Glycopyrronium bromide 0.5mg/mL Neostigmine metilsulfate 2.5mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	KSJ Pharmatech Limited
Manufacturer:	Cadila Pharmaceuticals Limited, Dholka, India

*Product:*	Paracetamol & Caffeine Soft Gel Caps
Active Ingredients:	Caffeine 65mg Paracetamol 500mg
Dosage Form:	Soft gelatin capsule
New Zealand Sponsor:	AFT Pharmaceuticals Limited
Manufacturer:	XL Laboratories Pvt. Limited, Neemrana, India

*Product:*	Paracetamol & Ibuprofen Tab (Pharmacy only)
Active Ingredients:	Ibuprofen 150mg Paracetamol 500mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	AFT Pharmaceuticals Limited
Manufacturers:	Sigma Laboratories Private Limited, Mapusa, India Qilu Pharmaceutical Co Limited, Jinan, China Yiling Pharmaceutical Limited (YPL), Shijiazhuang, China

*Product:*	Temozolomide Devatis
Active Ingredient:	Temozolomide 5mg
Dosage Form:	Capsule
New Zealand Sponsor:	Devatis Limited
Manufacturer:	Deva Holding AS, Kapakli, Turkey

*Product:*	Temozolomide Devatis
Active Ingredient:	Temozolomide 20mg
Dosage Form:	Capsule
New Zealand Sponsor:	Devatis Limited
Manufacturer:	Deva Holding AS, Kapakli, Turkey

*Product:*	Temozolomide Devatis
Active Ingredient:	Temozolomide 100mg
Dosage Form:	Capsule
New Zealand Sponsor:	Devatis Limited
Manufacturer:	Deva Holding AS, Kapakli, Turkey

*Product:*	Temozolomide Devatis
Active Ingredient:	Temozolomide 140mg
Dosage Form:	Capsule
New Zealand Sponsor:	Devatis Limited
Manufacturer:	Deva Holding AS, Kapakli, Turkey

*Product:*	Temozolomide Devatis
Active Ingredient:	Temozolomide 180mg
Dosage Form:	Capsule
New Zealand Sponsor:	Devatis Limited
Manufacturer:	Deva Holding AS, Kapakli, Turkey

*Product:*	Temozolomide Devatis
Active Ingredient:	Temozolomide 250mg
Dosage Form:	Capsule
New Zealand Sponsor:	Devatis Limited
Manufacturer:	Deva Holding AS, Kapakli, Turkey

*Product:*	Vyalev
Active Ingredients:	Foscarbidopa 12mg/mL Foslevodopa 240mg/mL
Dosage Form:	Solution for infusion
New Zealand Sponsor:	AbbVie Limited
Manufacturer:	Patheon Manufacturing Services LLC, North Carolina, United States of America

Dated this 6th day of December 2024.

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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