Notice Type
Departmental
Notice Title

Corrigendum—Provisional Consent to the Distribution of a New Medicine

In the notice with the above heading, published in the New Zealand Gazette, 3 June 2020, Notice No. 2020-go2377. This corrigendum amends the notice by replacing the entry:

Schedule

Product: Necon 0.5/35
Active Ingredients: Ethinylestradiol 0.035mg
Norethisterone 0.5mg
Dosage Form: Tablet
New Zealand Sponsor: Link Pharmaceuticals Limited
Manufacturer: Teva Women’s Health Inc, Ohio, United States of America

Note: This consent is given subject to the following conditions:

  • Provisional consent is to be granted for six months to address an urgent shortage in the market and only applies to batch number 1000134540.
  • The medicine may only be marketed or distributed when no other norethisterone 0.5mg/ethinylestradiol 0.035mg tablet with consent under section 20 or section 23 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 oral contraceptives.
Note: This consent is valid for six months from the date of publication of this notice.

With:

Product: Necon 0.5/35
Active Ingredients: Ethinylestradiol 0.035mg
Norethisterone 0.5mg
Dosage Form: Tablet
Dosage Form: Placebo Tablet
New Zealand Sponsor: Link Pharmaceuticals Limited
Manufacturer: Teva Women’s Health Inc, Ohio, United States of America

Note: This consent is given subject to the following conditions:

  • Provisional consent is to be granted for six months to address an urgent shortage in the market and only applies to batch numbers 100013454 and 100015743.
  • The medicine may only be marketed or distributed when no other norethisterone 0.5mg/ethinylestradiol 0.035mg tablet with consent under section 20 or section 23 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 oral contraceptives.
Note: This consent is valid for six months from the date of publication of this notice.


Dated this 15th 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).