Notice Title

Provisional Consent to the Distribution of New Medicines

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: Epkinly
Active Ingredient: Epcoritamab 5mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: AbbVie Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co KG, Eisenbahnstrasse, Germany

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

  • The sponsor must provide the final report for study GCT3013-05 by 31 December 2026, unless otherwise agreed with Medsafe.

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

   
Product: Epkinly
Active Ingredient: Epcoritamab 60mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AbbVie Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co KG, Eisenbahnstrasse, Germany

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

  • The sponsor must provide the final report for study GCT3013-05 by 31 December 2026, unless otherwise agreed with Medsafe.

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


Dated this 24th day of January 2025.

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