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

1. Provisional consent is to be granted for two years to address an urgent shortage in the market.
2. The medicine may only be marketed or distributed when no other norethisterone 0.5mg/ethinylestradiol 0.035mg 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.
3. Provisional consent can only be renewed while assessment of a section 20 new medicine application for Brevinor 28 Day tablets or a changed medicine notification to change the name of Norimin tablets is in progress.

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

1. The medicine may only be prescribed by:
   • A medical practitioner who is vocationally registered by the Medical Council of New Zealand in the scope of practice of psychiatry (hereinafter referred to as a Psychiatrist).
   • A medical practitioner or nurse practitioner who is prescribing under the supervision of a Psychiatrist.
   • A medical practitioner who is registered by the Medical Council of New Zealand in a general scope of practice provided the medical practitioner is prescribing clozapine for a patient whose illness is being well controlled by clozapine and the prescribing decision is taken in collaboration with, or following consultation with, a Community Mental Health Team.
2. Persons prescribing the medicine must comply with appropriate local treatment guidelines.
3. The medicine must be dispensed in accordance with appropriate local dispensing guidelines.
4. Sale or marketing of this medicine may only occur if the sponsor has an appropriate blood monitoring and patient record database in place.