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Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of New Medicines

Publication Date
16 Sep 2025

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2025-go5138
Title
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PDF (24 KB)

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Methylphenidate Sandoz XR
Active Ingredient: Methylphenidate hydrochloride 18mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Sandoz New Zealand Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
Note: This consent is given subject to the following condition:
  • The medicine may only be marketed or distributed when PHARMAC supply requirements for methylphenidate hydrochloride extended release tablets cannot be met with products with consent under section 20 of the Medicines Act 1981.
Note: This consent is valid for two years from the date of publication of this notice.
 
Product: Methylphenidate Sandoz XR
Active Ingredient: Methylphenidate hydrochloride 27mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Sandoz New Zealand Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
Note: This consent is given subject to the following condition:
  • The medicine may only be marketed or distributed when PHARMAC supply requirements for methylphenidate hydrochloride extended release tablets cannot be met with products with consent under section 20 of the Medicines Act 1981.
Note: This consent is valid for two years from the date of publication of this notice.
 
Product: Methylphenidate Sandoz XR
Active Ingredient: Methylphenidate hydrochloride 36mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Sandoz New Zealand Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
Note: This consent is given subject to the following condition:
  • The medicine may only be marketed or distributed when PHARMAC supply requirements for methylphenidate hydrochloride extended release tablets cannot be met with products with consent under section 20 of the Medicines Act 1981.
Note: This consent is valid for two years from the date of publication of this notice.
 
Product: Methylphenidate Sandoz XR
Active Ingredient: Methylphenidate hydrochloride 54mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Sandoz New Zealand Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
Note: This consent is given subject to the following condition:
  • The medicine may only be marketed or distributed when PHARMAC supply requirements for methylphenidate hydrochloride extended release tablets cannot be met with products with consent under section 20 of the Medicines Act 1981.
Note: This consent is valid for two years from the date of publication of this notice.


Dated this 16th day of September 2025.

DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).