New Zealand Gazette – 2010 – No. 134

Page 3396

✨ Medicines Notices

NEW ZEALAND GAZETTE, No. 134
30 SEPTEMBER 2010

Product:
Apo-Risperidone
Active Ingredient:
Risperidone 3mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Apotex NZ Limited
Manufacturers:
Apotex Inc, Etobicoke, Ontario, Canada
Apotex Inc, Weston, Ontario, Canada

Product:
Apo-Risperidone
Active Ingredient:
Risperidone 4mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Apotex NZ Limited
Manufacturers:
Apotex Inc, Etobicoke, Ontario, Canada
Apotex Inc, Weston, Ontario, Canada

Product:
Kaletra
Active Ingredients:
Lopinavir 80mg/mL
Ritonavir 20mg/mL
Dosage Form:
Oral solution
New Zealand Sponsor:
Abbott Laboratories (NZ) Limited
Manufacturer:
Aesica Queensborough Limited, Kent, United Kingdom

Product:
Kaletra
Active Ingredients:
Lopinavir 200mg
Ritonavir 50mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Abbott Laboratories (NZ) Limited
Manufacturer:
Abbott GmbH & Co. KG, Ludwigshafen, Germany

Product:
Kaletra
Active Ingredients:
Lopinavir 100mg
Ritonavir 25mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Abbott Laboratories (NZ) Limited
Manufacturer:
Abbott GmbH & Co. KG, Ludwigshafen, Germany

Dated this 22nd day of September 2010.

JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

go7542

Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981, I, Janice Wilson, Deputy Director-General, Population Health Directorate, Ministry of Health, acting under delegated authority, hereby declare the following:

The medicine listed in Schedule 2 to this notice is classified as a restricted medicine.
The medicine listed in Schedule 3 to this notice is classified as a pharmacy-only medicine.

This notice shall come into force on 4 October 2010.

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.

Schedule 2

Restricted Medicine

Codeine; in medicines for oral use, containing not more than 15 milligrams of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of codeine, when combined with one or more active ingredients, in such a way that the substance cannot be recovered by readily applicable means or in a yield which would constitute a risk to health, for use as an analgesic and when sold in a pack of not more than five days’ supply, approved by the Minister or the Director-General for distribution as a restricted medicine.

Gazette.govt.nz — NZ Gazette 2010, No 134

The General Assembly Library (on the right) was completed in 1899 and survived the 1907 fire. Now the oldest remaining original Parliament building, still used as the Parliamentary Library.

✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

Domain🏥 Health & Social Welfare
Dated22 September 2010
KeywordsMedicines, Distribution, Apo-Risperidone, Kaletra, Risperidone, Lopinavir, Ritonavir
👩‍💼 Officials

Janice Wilson, Deputy Director-General, Population Health Directorate, Ministry of Health

🏥 Classification of Medicines

Domain🏥 Health & Social Welfare
Dated4 October 2010
KeywordsMedicines, Classification, Restricted Medicine, Pharmacy-Only Medicine, Codeine
👩‍💼 Officials

Janice Wilson, Deputy Director-General, Population Health Directorate, Ministry of Health

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Additional Sources

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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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