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:*	Erlotinib (Teva)
Active Ingredient:	Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	S.C. Sindan-Pharma S.R.L., Bucharest, Romania

*Product:*	Erlotinib (Teva)
Active Ingredient:	Erlotinib hydrochloride 109.28mg equivalent to erlotinib 100mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	S.C. Sindan-Pharma S.R.L., Bucharest, Romania

*Product:*	Erlotinib (Teva)
Active Ingredient:	Erlotinib hydrochloride 163.93mg equivalent to erlotinib 150mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	S.C. Sindan-Pharma S.R.L., Bucharest, Romania

*Product:*	Jorveza
Active Ingredient:	Budesonide 0.5mg
Dosage Form:	Orodispersible tablet
New Zealand Sponsor:	Dr Falk Pharma New Zealand Limited
Manufacturer:	Losan Pharma GmbH, Neuenburg, Germany

*Product:*	Jorveza
Active Ingredient:	Budesonide 1mg
Dosage Form:	Orodispersible tablet
New Zealand Sponsor:	Dr Falk Pharma New Zealand Limited
Manufacturer:	Losan Pharma GmbH, Neuenburg, Germany

*Product:*	Travel Ease
Active Ingredient:	Meclozine hydrochloride 25mg
Dosage Form:	Tablet
New Zealand Sponsor:	Pharmabroker Sales Limited
Manufacturer:	Delpharm Evreux SAS, Evreux, France

Dated this 20th day of June 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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