1

Welcome

2

Apologies

3

Confirmation of the Minutes of the 40th Meeting

4

Declaration of Conflicts of Interest

5

MATTERS ARISING

5.1

Lansoprazole

At the 40th meeting the Committee recommended that there be no change to the current prescription medicine classification of lansoprazole 15 milligram capsules. This issue will be reconsidered if the sponsor company provides additional information in support of the classification change.

5.2

Chloramphenicol for ophthalmic use

At the 40th meeting the Committee recommended that chloramphenicol for ophthalmic use should remain classified as a prescription medicine except when sold in practice by a registered optometrist. The Committee is willing to reconsider the request for reclassification from prescription medicine to restricted medicine if additional supporting information is provided.

5.3

Codeine

At the 39th meeting the Committee recommended that codeine be classified as a prescription medicine when in combination products containing more than 15 milligrams of codeine per dose unit. This recommendation was not put into effect due to a subsequent objection. The Committee will now consider whether to confirm its original recommendation.

6

Submissions for Reclassification

6.1

Famciclovir (Famvir, Novartis)

This is a company submission (pdf document, 2044KB) for the reclassification of 500 milligram famciclovir tablets from prescription medicine to restricted medicine when sold in packs of three tablets for the treatment of recurrent Herpes labialis (cold sores).

6.2

Guaiphenesin (Mucinex, Reckitt Benkiser)

This is a company submission (pdf document, 523KB) ( for the reclassification from prescription medicine to general sales medicine of 600 milligram and 1200 milligram modified release guaiphenesin tablets for use as an expectorant to help relieve chest congestion. Guaiphenesin is currently a general sale medicine when for oral use in medicines containing 2% or less or 200 mg or less per dose form.

6.3

Pantoprazole (Somac 20 mg enteric coated tablet, Nycomed)

This is a company submission (pdf document, 279KB) for the reclassification from prescription medicine to restricted medicine of pantoprazole 20 milligram enteric coated tablets, in packs containing not more than 14 days supply, for the symptomatic relief of heartburn, acid regurgitation and other symptoms associated with gastro-oesophageal reflux disease (GORD) in patients aged 18 and over.

6.4

Zolmitriptan (Zomig nasal spray, AstraZeneca)

This is a company submission (pdf document, 426KB) for the reclassification from prescription medicine to restricted medicine of one prefilled nasal spray device containing 5 milligrams of zolmitriptan for the acute treatment of migraine with or without aura.

6.5

Analogues of Sildenafil, Vardenafil and Tadalafil

This is a Medsafe submission (pdf document, 1567KB) requesting that analogues of sildenafil, vardenafil and tadalafil be classified as prescription medicines. The parent compounds are already classified as prescription medicines.
Sildenafil, vardenafil and tadalafil and their analogues act as inhibitors of phosphodiesterase type 5. Therefore, the submission also requests that phosphodiesterase type 5 inhibitors be classified as prescription medicines. This is intended to cover any other compounds that have similar activity.

7

New Medicines for Classification

8

Harmonisation of New Zealand and Australian Schedules

8.1

New chemical entities which are not yet classified in New Zealand

8.2

Recommendations made by the NDPSC to the MCC in October 2008

No unresolved recommendations.

9

For the Next Meeting

10

General Business