Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Brolene
Active Ingredient: Propamidine isetionate 0.1%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturer: Zentiva ks, Prague, Czech Republic
   
Product: Canesten Clotrimazole Thrush 3 Day Cream
Active Ingredient: Clotrimazole 2%w/w
Dosage Form: Vaginal cream
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Kern Pharma SL, Barcelona, Spain
Encube Ethicals Private Limited, Goa, India
GP Grenzach Produktions GmbH, Grenzach-Wyhlen, Germany
   
Product: Lignocaine Gel (non-sterile)
Active Ingredient: Lidocaine hydrochloride monohydrate 2.2%w/w
Dosage Form: Topical gel
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Orion Laboratories Pty Limited t/a Perrigo Australia, Perth, Australia
   
Product: Livostin
Active Ingredient: Levocabastine hydrochloride 0.54mg/mL equivalent to levocabastine 0.50mg/mL
Dosage Form: Eye drops, suspension
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Janssen Pharmaceutica NV, Plant 2, Beerse, Belgium
Famar SA, Athens, Greece


Dated this 17th day of July 2020.

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