1600 NEW ZEALAND GAZETTE, No. 55 17 MAY 2012

Product: RexAir HFA Inhaler
Active Ingredients:
Fluticasone propionate 0.05mg
Salmeterol xinafoate 0.0363mg equivalent to Salmeterol 0.025mg
Dosage Form:
Aerosol inhaler, metered dose
New Zealand Sponsor:
REX Medical Limited
Manufacturer:
Cipla Limited, Goa, India

Product: RexAir HFA Inhaler
Active Ingredients:
Fluticasone propionate 0.125mg
Salmeterol xinafoate 0.0363mg equivalent to Salmeterol 0.025mg
Dosage Form:
Aerosol inhaler, metered dose
New Zealand Sponsor:
REX Medical Limited
Manufacturer:
Cipla Limited, Goa, India

Product: RexAir HFA Inhaler
Active Ingredients:
Fluticasone propionate 0.25mg
Salmeterol xinafoate 0.0363mg equivalent to Salmeterol 0.025mg
Dosage Form:
Aerosol inhaler, metered dose
New Zealand Sponsor:
REX Medical Limited
Manufacturer:
Cipla Limited, Goa, India

Dated this 10th day of May 2012.

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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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 16.
   1.2 LCT is allowed to increase the number of participants in the treatment arm where participants are administered 20,000 IEQ/kg to a total of 4.

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 26 March 2012.

All previous conditions instituted in the authorisation issued to LCT and published in the New Zealand Gazette, 25 June 2009, No. 94, page 2111, 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 22nd day of April 2012.

HON TONY RYALL, Minister of Health.

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Internal Affairs

Marriage Act 1955

Marriage (Approval of Organisations) Notice No. 11

Pursuant to the Marriage Act 1955, the Registrar-General of Marriages hereby gives notice as follows.

Notice

1. This notice may be cited as the Marriage (Approval of Organisations) Notice No. 11.
2. The organisation specified in the Schedule hereto is hereby declared to be an approved organisation for the purpose of the Marriage Act 1955.

Schedule
Tree of Life Church.

Dated at Wellington this 17th day of May 2012.

B. E. CLARKE, Registrar-General.

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Marriage (Approval of Organisations) Notice No. 12

Pursuant to the Marriage Act 1955, the Registrar-General of Marriages hereby gives notice as follows.

Notice

1. This notice may be cited as the Marriage (Approval of Organisations) Notice No. 12.
2. The organisation specified in the Schedule hereto is hereby declared to be an approved organisation changing its name for the purpose of the Marriage Act 1955.

Schedule
House of Breakthrough Palmerston North (formerly Highbury Church Incorporated).

Dated at Wellington this 17th day of May 2012.

B. E. CLARKE, Registrar-General.

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Marriage Celebrants for 2012 Notice No. 36

Pursuant to the provisions of section 11 of the Marriage Act 1955, the following addresses of marriage celebrants within