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: Benztrop
Active Ingredient: Benzatropine mesilate 2mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, Quebec, Canada
Note: This renewed consent is valid for two years from 13 May 2012.
Product: Clozaril
Active Ingredient: Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharmaceuticals UK Limited, West Sussex, United Kingdom
Note: This consent is given subject to the following conditions:
1. The medicine may only be prescribed by:
- Registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry; and
- Medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of persons of the kind referred to above.
- Medical officers of special scale who:
- work solely in the field of psychiatry;
- are in the employment of a District Health Board; and
- are under the supervision of persons who are registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry.
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; and
- the sponsor creates or participates in a central "red flag" database identifying patients who have previously been prescribed clozapine and who developed adverse drug reactions, which mean further use is contraindicated.
Also Note: This renewed consent is valid for two years from 3 June 2012.
Product: Clozaril
Active Ingredient: Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharmaceuticals UK Limited, West Sussex, United Kingdom
Note: This consent is given subject to the following conditions:
1. The medicine may only be prescribed by:
- Registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry; and
- Medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of persons of the kind referred to above.
- Medical Officers of Special Scale who:
- work solely in the field of psychiatry;
- are in the employment of a District Health Board; and
- are under the supervision of persons who are registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry.
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; and
- the sponsor creates or participates in a central "red flag" database identifying patients who have previously been prescribed clozapine and who developed adverse drug reactions, which mean further use is contraindicated.
Also Note: This renewed consent is valid for two years from 3 June 2012.
Product: Pinorax
Active Ingredients: Dantron 5mg/mL
Poloxamer 188 40mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Co. Tipperary, Ireland
Note: This consent is given subject to the following conditions:
- Pinorax may only be used for the prevention or treatment of constipation in the terminally ill.
Also Note: This renewed consent is valid for two years from 22 April 2012.
Product: Pinorax
Active Ingredients: Dantron 15mg/mL
Poloxamer 188 200mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Co. Tipperary, Ireland
Note: This consent is given subject to the following conditions:
- Pinorax may only be used for the prevention or treatment of constipation in the terminally ill.
Also Note: This renewed consent is valid for two years from 2 June 2012.
Dated this 22nd day of March 2012.
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).