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:*	Bonjela Mouth Ulcer Gel
Active Ingredient:	Choline salicylate 8.714%w/w (formed in process from choline bicarbonate and salicylic acid)
Dosage Form:	Oral topical gel
New Zealand Sponsor:	Reckitt Benckiser (New Zealand) Limited
Manufacturer:	Reckitt Benckiser Healthcare (UK) Limited, Hull, United Kingdom

*Product:*	Jakavi
Active Ingredient:	Ruxolitinib phosphate 6.6mg equivalent to ruxolitinib 5mg
Dosage Form:	Tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein, Switzerland

*Product:*	Jakavi
Active Ingredient:	Ruxolitinib phosphate 13.2mg equivalent to ruxolitinib 10mg
Dosage Form:	Tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein, Switzerland

*Product:*	Jakavi
Active Ingredient:	Ruxolitinib phosphate 19.8mg equivalent to ruxolitinib 15mg
Dosage Form:	Tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein, Switzerland

*Product:*	Jakavi
Active Ingredient:	Ruxolitinib phosphate 26.4mg equivalent to ruxolitinib 20mg
Dosage Form:	Tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharma Stein AG, Stein, Switzerland

*Product:*	Vimpat
Active Ingredient:	Lacosamide 10mg/mL
Dosage Form:	Oral solution
New Zealand Sponsor:	Seqirus (NZ) Limited
Manufacturer:	Unither Manufacturing LLC, New York, United States of America

*Product:*	Vimpat
Active Ingredient:	Lacosamide 50mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Seqirus (NZ) Limited
Manufacturer:	UCB Pharma SA, Braine-l’Alleud, Belgium

*Product:*	Vimpat
Active Ingredient:	Lacosamide 100mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Seqirus (NZ) Limited
Manufacturer:	UCB Pharma SA, Braine-l’Alleud, Belgium

*Product:*	Vimpat
Active Ingredient:	Lacosamide 150mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Seqirus (NZ) Limited
Manufacturer:	UCB Pharma SA, Braine-l’Alleud, Belgium

*Product:*	Vimpat
Active Ingredient:	Lacosamide 200mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Seqirus (NZ) Limited
Manufacturer:	UCB Pharma SA, Braine-l’Alleud, Belgium

*Product:*	Vimpat
Active Ingredient:	Lacosamide 10mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Seqirus (NZ) Limited
Manufacturers:	UCB Pharma SA, Braine-l’Alleud, Belgium Patheon Italia SpA, Monza, Italy

Dated this 29th day of July 2022.

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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