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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