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 medicines set out in the Schedule hereto:

Schedule

Product: Pravastatin Sodium
Active Ingredient: Pravastatin sodium 10mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Sinnar, India
Note: This consent is given subject to the following conditions: Provisional consent is to be granted to address an urgent shortage in the market. The medicine may only be marketed or distributed when no other pravastatin sodium tablet with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Pravastatin Sodium
Active Ingredient: Pravastatin sodium 20mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Sinnar, India
Note: This consent is given subject to the following conditions: Provisional consent is to be granted to address an urgent shortage in the market. The medicine may only be marketed or distributed when no other pravastatin sodium tablet with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Pravastatin Sodium
Active Ingredient: Pravastatin sodium 40mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Sinnar, India
Note: This consent is given subject to the following conditions: Provisional consent is to be granted to address an urgent shortage in the market. The medicine may only be marketed or distributed when no other pravastatin sodium tablet medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Note: This consent is valid for two years from the date of publication of this notice.


Dated this 30th day of June 2020.

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