Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of a New Medicine

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: Keflor
Active Ingredient: Cefaclor monohydrate 26.86mg/mL equivalent to cefaclor 25mg/mL
Dosage Form: Granules for oral suspension
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: ACS Dobfar SpA, Pomezia, Italy


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 cefaclor granules for oral suspension medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
  • Provisional consent can only be renewed while assessment of a section 20 new medicine application is in progress. The new medicine application should be accompanied by a full data set in compliance with Medsafe‚Äôs stated requirements.

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

Dated this 12th day of July 2019.

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