Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:
Schedule
Product: Ketamine
Active Ingredient: Ketamine hydrochloride 1.153mg/mL equivalent to ketamine 1mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This renewed consent is valid for two years from 5 May 2013.
Product: Ketamine
Active Ingredient: Ketamine hydrochloride 2.307mg/mL equivalent to ketamine 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This renewed consent is valid for two years from 5 May 2013.
Product: Ketamine
Active Ingredient: Ketamine hydrochloride 4.613mg/mL equivalent to ketamine 4mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This renewed consent is valid for two years from 5 May 2013.
Product: Ketamine
Active Ingredient: Ketamine hydrochloride 11.53mg/mL equivalent to ketamine 10mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This renewed consent is valid for two years from 5 May 2013.
Dated this 22nd day of April 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).