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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: Femme-Tab ED 20/100
Active Ingredients: Ethinylestradiol 20mcg
Levonorgestrel 100mcg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharbil Waltrop GmbH, Waltrop, Germany
Note: This consent is given subject to the following conditions:
  • Provisional consent is to be granted for 1 year to address an urgent shortage in the market
  • The medicine may only be marketed or distributed when no other ethinylestradiol 20 mcg/levonorgestrel 100 mcg tablet with consent under section 20 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.
Also note: This consent is valid for one year from the date of publication of this notice.
 
Product: Femme-Tab ED 30/150
Active Ingredients: Ethinylestradiol 30mcg
Levonorgestrel 150mcg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharbil Waltrop GmbH, Waltrop, Germany
Note: This consent is given subject to the following conditions:
  • Provisional consent is to be granted for 1 year to address an urgent shortage in the market
  • The medicine may only be marketed or distributed when no other ethinylestradiol 30 mcg/levonorgestrel 150 mcg tablet with consent under section 20 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.
Also note: This consent is valid for one year from the date of publication of this notice.


Dated this 16th day of July 2019.

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

Publication Date
17 Jul 2019

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2019-go3359
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