New Zealand Gazette – 2008 – No. 152

Page 4029

✨ Medicines Consent and Classification

2 OCTOBER 2008 NEW ZEALAND GAZETTE, No. 152 4029

Product: Pantocid I.V.
Active Ingredient: Pantoprazole sodium sesquihydrate 45.12mg equivalent to pantoprazole 40.0mg
Dosage Form: Powder for injection
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: Sun Pharmaceutical Industries Limited, Halol, Gujarat, India

Product: Temodal
Active Ingredient: Temozolomide 140mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Orion Pharma, Turku, Finland

Product: Temodal
Active Ingredient: Temozolomide 180mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Orion Pharma, Turku, Finland

Dated this 26th day of September 2008.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

Product: Ursofalk
Active Ingredient: Ursodeoxycholic acid 250mg
Dosage Form: Capsule
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Losan Pharma GmbH, Neuenburg, Germany

Note: This renewed consent is valid for two years from 28 October 2008.

Dated this 26th day of September 2008.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (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, Mark Richards, Acting Deputy Director-General, Sector Accountability and Funding Directorate, 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 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.

Schedule 1
Prescription Medicines

Agomelatine
Alpha₁-proteinase inhibitor
Cadmium
Dapoxetine
Etravirine
Idursulfase
Iron; for injection except in parenteral nutrition replacement preparations
Lenalidomide
Maraviroc
Miglustat
Panitumumab
Sugammadex
Tocilizumab
Zonisamide

Gazette.govt.nz — NZ Gazette 2008, No 152

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

Domain🏥 Health & Social Welfare
Dated26 September 2008
KeywordsMedicines, Distribution, Consent, New Zealand
👩‍💼 Officials

Mark Richards, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Renewal of Provisional Consent to the Distribution of a Medicine

Domain🏥 Health & Social Welfare
Dated26 September 2008
KeywordsMedicines, Distribution, Consent, Renewal, New Zealand
👩‍💼 Officials

Mark Richards, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Classification of Medicines

Domain🏥 Health & Social Welfare
Dated26 September 2008
KeywordsMedicines, Classification, Prescription, Pharmacy-only
👩‍💼 Officials

Mark Richards, Acting Deputy Director-General, Sector Accountability and Funding Directorate

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