Notice Type
Departmental
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 medicine set out in the Schedule hereto:

Schedule

Product: Fentanyl GH
Active Ingredient: Fentanyl citrate 0.157mg
Dosage Form: Solution for injection
New Zealand Sponsor: Boucher & Muir (NZ) Limited t/a Mercury Pharma (NZ)
Manufacturer: Panpharma GmbH, Trittau, Germany
Note: This consent is given subject to the following conditions: Provisional consent is to be granted for 2 years to address an urgent shortage in the market. The medicine may only be marketed or distributed when no other fentanyl solution for injection with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or if the medicine is required to maintain assurance of supply for PHARMAC-funded fentanyl products.
Note: This consent is valid for two years from the date of publication of this notice.
 
Product: Influvac Tetra (Saison 2019/2020)
Active Ingredients:

Influenza virus A/Brisbane/02/2018 (H1N1) – pdm09-like virus 15mcg
Influenza virus A/Kansas/14/2017 (H3N2) – like strain 15mcg
Influenza virus B/Colorado/06/2017 – like strain 15mcg
Influenza virus B/Phuket/3073/2013 – like strain 15mcg

Dosage Form: Suspension for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Abbott Biologicals BV, Olst, Netherlands
Abbott Biologicals BV, Weesp, Netherlands
Note: This consent is given subject to the following conditions: Provisional consent is to be granted for 1 year to address an urgent shortage in the market. The medicine may only be administered to patients who are not eligible to receive a PHARMAC-funded influenza vaccine during the 2020 influenza season.
Note: This consent is valid for one year from the date of publication of this notice.


Dated this 15th day of May 2020.

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