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Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of New Medicines

Publication Date
13 Nov 2025

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2025-go6512
Title
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PDF (23 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 are set out in the Schedule hereto:

Schedule

Product: Eurofolic (50mg/5mL)
Active Ingredient: Calcium folinate 10.8mg/mL equivalent to folinic acid 10mg
Dosage Form: Solution for injection
New Zealand Sponsor: ORSPEC Pharma Management Limited
Manufacturer: Kleva Pharmaceuticals S.A., Attiki, Greece

Note: This consent is given subject to the following conditions:

The medicine may only be marketed or distributed when no other calcium folinate (folinic acid) solution for injection medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations.

Note: This consent is valid for two years from the date of publication of this notice.
Product: Eurofolic (100mg/10mL)
Active Ingredient: Calcium folinate 10.8mg/mL equivalent to folinic acid 10mg
Dosage Form: Solution for injection
New Zealand Sponsor: ORSPEC Pharma Management Limited
Manufacturer: Kleva Pharmaceuticals S.A., Attiki, Greece

Note: This consent is given subject to the following conditions:

The medicine may only be marketed or distributed when no other calcium folinate (folinic acid) solution for injection medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations.

Note: This consent is valid for two years from the date of publication of this notice.
Product: Eurofolic (1000mg/100mL)
Active Ingredient: Calcium folinate 10.8mg/mL equivalent to folinic acid 10mg
Dosage Form: Solution for injection
New Zealand Sponsor: ORSPEC Pharma Management Limited
Manufacturer: Kleva Pharmaceuticals S.A., Attiki, Greece

Note: This consent is given subject to the following conditions:

The medicine may only be marketed or distributed when no other calcium folinate (folinic acid) solution for injection medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations.

Note: This consent is valid for two years from the date of publication of this notice.


Dated this 11th day of November 2025.

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