1
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Welcome
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2
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Apologies
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3
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Confirmation of the minutes of the 51st
meeting held on Tuesday 8 april 2014
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4
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Declaration of conflicts of interest
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5
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Matters arising
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5.1
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Objections to recommendations made at
the 51st meeting
No valid objections have been received.
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5.2
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Reclassification of rizatriptan from
prescription medicine to restricted medicine following a recommendation
at the 43rd meeting
At the 43rd meeting on 13 April 2010, the Committee recommended
that rizatriptan 5 mg wafers should be reclassified from prescription
medicine to restricted medicine for the acute treatment of migraine
with or without aura.
The current classification of rizatriptan is:
- prescription medicine; except when specified elsewhere in
this schedule
- restricted medicine; for oral use in medicines for the acute
relief of migraine attacks with or without aura in patients
who have a stable, well-established pattern of symptoms, when
in wafers containing 5 milligrams or less per wafer and when
sold in a pack containing not more than 2 wafers approved by
the Minister or the Director-General for distribution as a restricted
medicine.
The Committee noted at the last meeting that, since this reclassification,
the company had not produced an approved pack.
The Committee will discuss potential options.
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6
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Submissions for reclassification
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6.1
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Beclomethasone – proposed reclassification
from pharmacy-only medicine to general sale medicine
(Beconase Allergy & Hayfever 12 Hour, Pharmaceutical Solutions)
This is a company submission
(Adobe Acrobat document, 2032 KB, 24 pages) for the reclassification
of beclomethasone, in aqueous nasal sprays delivering up to 50 micrograms
per actuation when the maximum recommended daily dose is no greater
than 400 micrograms (200 micrograms per nostril) in a pack containing
200 actuations or less, from pharmacy-only medicine to general sale
medicine for the treatment or prophylaxis of allergic rhinitis in
adults and children over 12 years of age.
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6.2
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Omeprazole - proposed reclassification
from pharmacy-only medicine to general sale medicine
(Losec, Bayer New Zealand Limited)
This is a company submission
(Adobe Acrobat document, 990 KB, 52 pages) for the reclassification
of omeprazole, in solid dose form containing 10 mg or less, from
pharmacy-only medicine to general sale medicine for the short-term
symptomatic relief of gastric reflux-like symptoms in sufferers
aged 18 years and older.
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6.3
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Paracetamol in combination with phenylephrine
(Maxiclear Sinus and Pain Relief and Maxiclear Cold and Flu Relief,
AFT Pharmaceuticals)
This is a
company submission (Adobe Acrobat document, 1650 KB, 22 pages)
for the reclassification of paracetamol in combination with phenylephrine
in packs containing:
- any number of solid dose units containing paracetamol 500
mg in combination with more than 2.5 mg phenylephrine per dose
unit from general sale or pharmacy-only medicine to restricted
medicine
- more than 20 solid dose units containing paracetamol 500
mg in combination with 2.5 mg phenylephrine or less per dose
unit to remain a pharmacy-only medicine
- 20 or less solid dose units containing paracetamol 500 mg
in combination with 2.5 mg phenylephrine or less per dose unit
to remain a general sale medicine
- any number of sachets of powder containing 1000 mg paracetamol
in combination with more than 5 mg phenylephrine per sachet
from general sale or pharmacy-only medicine to restricted medicine
- more than 10 sachets of powder containing 1000 mg paracetamol
in combination with 5 mg phenylephrine or less per sachet to
remain a pharmacy-only medicine
- 10 or fewer sachets of powder containing 1000 mg paracetamol
in combination with 5 mg phenylephrine or less per sachet to
remain a general sale medicine.
Confidential information has been redacted by the company.
Secretary’s note – For the paracetamol and phenylephrine combinations
stated to remain as general sale or pharmacy-only medicine, it has
been assumed that the combination also complies with the relevant
requirements for phenylephrine (eg, a product containing phenylephrine
cannot be general sale if it is indicated for the treatment of the
symptoms of cough and cold in children aged 6-12 years).
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7
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New medicines for classification
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8
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Harmonisation of the New Zealand and
Australian schedules
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8.1
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New chemical entities which are not yet
classified in New Zealand
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8.2
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Decisions by the Secretary to the Department
of Health and Aging in Australia (or the Secretary's Delegate)
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8.2.1
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Decisions by the Delegate - April 2014
Decisions also included under agenda item 8.1.
- Esopmeprazole
A new Schedule 3 (restricted
medicine) entry should be created for esomeprazole in oral preparations
containing 20 mg or less per dosage unit for the relief of heartburn
and other symptoms of gastro-oesophageal reflux disease, in
packs containing not more than 14 days’ supply.
- Macrogols
A new Schedule 2 (pharmacy-only
medicine) entry should be created for macrogols in preparations
for oral use as a liquid concentrate for laxative use.
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8.2.2
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Decisions by the Delegate - May 2014
No harmonisation decisions relevant to the Committee were made
by the Delegate.
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8.2.3
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Decisions by the Delegate - July 2014
Decisions also included under agenda item 8.1.
- Naproxen
A new Schedule 3 (restricted
medicine) entry should be created for naproxen when in a modified
release dosage form of 600 mg or less of naproxen per dosage
unit in packs of 16 or less dosage units when labelled not for
the treatment of children under 12 years of age.
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8.2.4
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Decisions by the Delegate - August 2014
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No harmonisation decisions relevant to the Committee were made
by the Delegate. |
9
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Agenda items for the next meeting
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10
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General business
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11
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Date of next meeting
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