INFORMATION FOR HEALTH PROFESSIONALS
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| AGENDA FOR THE 35TH MEETING OF THE MEDICINES CLASSIFICATION COMMITTEE TO BE HELD ON 9 JUNE 2006 IN THE MEDSAFE MEETING ROOM, SIXTH FLOOR, DELOITTE HOUSE, 10 BRANDON ST, WELLINGTON COMMENCING AT 9AM |
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1. |
WELCOME |
2. |
APOLOGIES |
4. |
DECLARATION OF CONFLICTS OF INTEREST |
5 |
MATTERS ARISING |
6. |
SUBMISSIONS FOR RECLASSIFICATION |
6.1 |
Clotrimazole – product range for the treatment of vaginal thrush (Canesten, Bayer) |
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A company submission for the reclassification
of clotrimazole creams and pessaries for the treatment of vaginal thrush
from restricted medicine to pharmacy-only medicine. |
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6.2 |
Ibuprofen 400 mg tablets (Reckitt Benckiser) |
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A company submission for the reclassification
of 400 milligram solid dose forms from prescription medicine to
pharmacy-only medicine when for the same indications, dose regime, maximum
daily dose and maximum milligrams per pack as for 200 milligram
over-the-counter tablets. |
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6.3 |
Ibuprofen 200 mg tablets |
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A submission from the Pharmaceutical Society
of New Zealand for the reclassification from general sale medicine to
pharmacy-only medicine of 200 milligram tablets or capsules in packs
containing not more than 25 dose units and when in packs which have
received the consent of the Minister or the Director-General to their sale
as general sale medicines. |
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6.3 |
Omeprazole (Losec MUPS 20mg, AstraZeneca) |
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A company submission for the reclassification
from prescription medicine to pharmacy-only medicine of 20 milligram
tablets for the short-term treatment and prevention of symptoms of
frequent acid heartburn in adults 18 years and older. |
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6.4 |
Sumatriptan 50 mg tablets (Imigran, GlaxoSmithKline) |
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A company submission for the reclassification
from prescription medicine to restricted medicine of 50 milligram tablets
in packs of two tablets for the treatment of migraine. |
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7. |
NEW MEDICINES FOR CLASSIFICATION |
7.1 |
New chemical entities for classification |
7.2 |
Diphenhydramine |
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This is a new medicine application for a day/night pack containing diphenhydramine in the night-time dose. The Committee will consider whether or not the pharmacy-only classification is appropriate for this presentation. The proposed new product is the first in which the sedating antihistamine, which is in the night-time dose, is presented in liquid form and is in a separate primary container from the day-time dose. |
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8. |
HARMONISATION OF NZ AND AUSTRALIAN SCHEDULES |
8.1 |
Recommendations to the MCC made by the NDPSC in October 2005 |
8.1.1 |
Anagralide |
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Add to the schedule as a prescription medicine. |
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8.1.2 |
Brugmansia spp |
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Add to the schedule as a prescription medicine. |
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8.1.3 |
Sedating antihistamines |
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Remove the indications from the schedule entries for pharmacy-only sedating antihistamines so that they are not limited only to the treatment of coughs, colds or ‘flu at this level of access. |
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8.1.4 |
Thenyldiamine |
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Remove the pharmacy-only and restricted medicine entries from the schedule. There are no products containing thenyldiamine in either New Zealand or Australia. |
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8.1.5 |
Aciclovir |
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Remove the pharmacy-only entry from the schedule. This entry covered packs to treat herpes labialis with concentrations greater than 5% and in packs of more than 10 grams. There are no products in this category in either New Zealand or Australia. |
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9. |
FOR THE NEXT MEETING |
10. |
GENERAL BUSINESS |