New Zealand Gazette – 2013 – No. 85

Page 2288

✨ Medicine Notices

2288 NEW ZEALAND GAZETTE, No. 85 4 JULY 2013

Product: Apo-Famciclovir
Active Ingredient: Famciclovir 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada

Product: Apo-Famciclovir (Prescription)
Active Ingredient: Famciclovir 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada

Product: Apo-Famciclovir (Restricted)
Active Ingredient: Famciclovir 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada

Product: m-Montelukast
Active Ingredient: Montelukast sodium 4.15mg equivalent to montelukast 4mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Pharmathen SA, Attikis, Greece
Oman Pharmaceutical Products Company LLC, Salalah, Oman

Product: m-Montelukast
Active Ingredient: Montelukast sodium 5.188mg equivalent to montelukast 5mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Pharmathen SA, Attikis, Greece
Oman Pharmaceutical Products Company LLC, Salalah, Oman

Product: m-Montelukast
Active Ingredient: Montelukast sodium 10.4mg equivalent to montelukast 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Pharmathen SA, Attikis, Greece
Oman Pharmaceutical Products Company LLC, Salalah, Oman

Product: Voltaren Emulgel 12 Hourly
Active Ingredient: Diclofenac diethylamine 2.32% equivalent to diclofenac 2%
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Novartis Consumer Health SA, Nyon, Switzerland

Dated this 27th day of June 2013.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
(pursuant to delegation given by the Minister of Health on 6 July 2001).

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Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981, I, Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health, acting under delegated authority, hereby declare the following:

The medicines listed in Schedule 1 to this notice are classified as prescription medicines.
The medicines listed in Schedule 2 to this notice are classified as restricted medicines.
The medicines listed in Schedule 3 to this notice are classified as pharmacy-only medicines.

Every reference to a medicine in this notice applies whether the medicine is synthetic in origin or is from biological or mineral sources.

Unless specific reference is made otherwise, every reference applies also to medicines that are:

(a) preparations and admixtures containing any proportion of any substance listed in the notice.

(b) salts and esters of any substance listed in the notice.

(d) salts or oxides of elements listed in the notice.

Unless specific reference is made otherwise, every reference to a medicine applies:

(i) if the medicine is in an injection or eye preparation, to any concentration of that medicine; and

(ii) if the medicine is not in an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.

Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using the free acid, base, alcohol or element unless specifically stated otherwise.

Gazette.govt.nz — NZ Gazette 2013, No 85

Parliament House (depicted) was completed in 1918 and remains the primary seat of Parliament.

✨ LLM interpretation of page content

🏥 Consent to Distribution of Apo-Famciclovir Medicine (continued from previous page)

Domain🏥 Health & Social Welfare
Dated27 June 2013
KeywordsMedicines, Distribution, Apo-Famciclovir, Famciclovir
👩‍💼 Officials

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Classification of Medicines

Domain🏥 Health & Social Welfare
Dated27 June 2013
KeywordsMedicines, Classification, Prescription, Restricted, Pharmacy-only
👩‍💼 Officials

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

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27 issues of The New Zealand Advertiser and Bay of Islands Gazette (1840) were sourced from Papers Past (public domain).
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