Revised: 19 June 2013

Committees

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

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)

A company submission for the reclassification of clotrimazole creams and pessaries for the treatment of vaginal thrush from restricted medicine to pharmacy-only medicine.
Bayer submission (Adobe Acrobat document 728KB)

6.2

Ibuprofen 400 mg tablets (Reckitt Benckiser)

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.
Reckitt Benckiser submission (Adobe Acrobat document 104KB)

6.3

Ibuprofen 200 mg tablets

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.
Pharmaceutical Society submission (Adobe Acrobat document 149KB)

6.3

Omeprazole (Losec MUPS 20mg, AstraZeneca)

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.
AstraZeneca submission (Adobe Acrobat document 405KB)

6.4

Sumatriptan 50 mg tablets (Imigran, GlaxoSmithKline)

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.
GlaxoSmithKline submission (Adobe Acrobat document 130KB)

7.

New Medicines for Classification

7.1

New chemical entities for classification

7.2

Diphenhydramine

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.

8.

Harmonisation of New Zealand and Australian Schedules

8.1

Recommendations to the MCC made by the NDPSC in October 2005

8.1.1

Anagralide

Add to the schedule as a prescription medicine.

8.1.2

Brugmansia spp

Add to the schedule as a prescription medicine.

8.1.3

Sedating antihistamines

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.

8.1.4

Thenyldiamine

Remove the pharmacy-only and restricted medicine entries from the schedule. There are no products containing thenyldiamine in either New Zealand or Australia.

8.1.5

Aciclovir

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.

9.

For the Next Meeting

10.

General Business

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