23 DECEMBER 2010 NEW ZEALAND GAZETTE, No. 179 4449

Product: Rivastigmine
Active Ingredient: Rivastigmine tartrate 4.8mg
Dosage Form: Capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India

Product: Rivastigmine
Active Ingredient: Rivastigmine tartrate 7.2mg
Dosage Form: Capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India

Product: Rivastigmine
Active Ingredient: Rivastigmine tartrate 9.6mg
Dosage Form: Capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India

Product: SMOFlipid
Active Ingredients: Fish oil 30g
Medium-chain triglycerides 60g
Olive oil 50g
Soya oil 60g
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Fresenius Kabi AB, Uppsala, Sweden

Dated this 20th day of December 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).

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Authorisation of a Specified Biotechnical Procedure

I, Tony Ryall, Minister of Health, pursuant to section 96C(4) of the Medicines Act 1981 (“the Act”), hereby vary the conditional authorisation, issued under section 96C(1) of the Act to Living Cell Technologies Limited (LCT) and dated the 22nd day of June 2009*, to conduct a clinical trial involving xenotransplantation.

That authorisation is hereby varied in the following respects:

1. The protocol is amended as follows:
   1.1 LCT is allowed to increase the number of participants in the study to 14.
   1.2 LCT is allowed to create a fourth treatment arm where four participants are administered 5,000 IEQ/kg.
   1.3 LCT is allowed to transfer two current participants who have yet to receive any treatment, from the third treatment arm into the fourth treatment arm.

2. Condition added:
   2.1 LCT will, prior to implementing the amended protocol, provide Medsafe with evidence that the Northern X Regional Ethics committee has considered and approved LCT’s proposed amendments contained in its application to Medsafe dated 15 November 2010.

All previous conditions instituted in the authorisation issued to LCT and published in the New Zealand Gazette dated 25 June 2009* remain in effect for the period that the clinical trial has been approved by the Northern X Regional Ethics Committee, unless sooner varied or revoked, pursuant to section 96C(4) of the Act.

Dated this 8th day of December 2010.

HON TONY RYALL, Minister of Health.

*New Zealand Gazette, 25 June 2009, No. 94, page 2111

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New Zealand Public Health and Disability Act 2000

Breast Prosthesis Service Payments Notice (Amendment No. 1)

Pursuant to sections 88(1) and (3) of the New Zealand Public Health and Disability Act 2000, the Crown, acting by and through the Ministry of Health, gives the following notice.

Notice

1. Title—(1) This notice is the Breast Prosthesis Service Payments Notice (Amendment No. 1).
   (2) In this notice, the Breast Prosthesis Service Payments Notice1, in force on 31 March 2005, is called the “principal notice”.

2. Commencement—This notice comes into force on 16 December 2010.

3. Amendment—Part D of the principal notice is amended as follows:
   (a) By omitting “$600” in every place where it appears and substituting “$613.33”.
   (b) By omitting “$1,200” in every place where it appears and substituting “$1,226.66”.

4. Statement of reasons for departure from terms and conditions of the principal notice for purposes of section 89(5) of the New Zealand Public Health and Disability Act 2000—The terms and conditions in this notice depart from the terms and conditions in the principal notice to increase the entitlements for breast prosthesis services by 2.22% to account for an increase in the goods and services tax rate.