New Zealand Gazette – 2014 – No. 107

Page 2993

✨ Medicines Notices

4 SEPTEMBER 2014 NEW ZEALAND GAZETTE, No. 107

2993

Dated this 29th day of August 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Arrow - Iloprost

Active Ingredient: Iloprost 0.1mg/mL equivalent to Iloprost trometamol 0.134mg/mL

Dosage Form: Concentrate for infusion

New Zealand Sponsor: Actavis New Zealand Limited

Manufacturer: IBN Savio Srl, Genoa, Italy

Product: Prevenar 13

Active Ingredients:

Pneumococcal Polysaccharide serotype 6A 2.2mcg
Pneumococcal Polysaccharide type 1 2.2mcg
Pneumococcal Polysaccharide type 14 2.2mcg
Pneumococcal Polysaccharide type 18C 2.2mcg
Pneumococcal Polysaccharide type 19A 2.2mcg
Pneumococcal Polysaccharide type 19F 2.2mcg
Pneumococcal Polysaccharide type 23F 2.2mcg
Pneumococcal Polysaccharide type 3 2.2mcg
Pneumococcal Polysaccharide type 4 2.2mcg
Pneumococcal Polysaccharide type 5 2.2mcg
Pneumococcal Polysaccharide type 6B 4.4mcg
Pneumococcal Polysaccharide type 7F 2.2mcg
Pneumococcal Polysaccharide type 9V 2.2mcg

Dosage Form: Suspension for injection

New Zealand Sponsor: Pfizer New Zealand Limited

Manufacturers:

Pfizer Ireland Pharmaceuticals, Dublin, Ireland
Baxter BioPharma Solutions LLC, Indiana, United States of America
Wyeth Pharmaceuticals Inc, New York, United States of America

Dated this 29th day of August 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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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 that the medicines listed in Schedule 1 to this notice are classified as prescription 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

Avanafil
Empagliflozin
Ledipasvir
Riociguat

Dated this 27th day of August 2014.

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

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Gazette.govt.nz — NZ Gazette 2014, No 107

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
Dated29 August 2014
KeywordsMedicines Act 1981, Distribution Consent, Arrow - Iloprost, Prevenar 13, Medsafe
👩‍💼 Officials

Stewart Jessamine, Group Manager, Medsafe, Ministry of Health

🏥 Classification of Medicines

Domain🏥 Health & Social Welfare
Dated27 August 2014
KeywordsMedicines Act 1981, Prescription Medicines, Avanafil, Empagliflozin, Ledipasvir, Riociguat
👩‍💼 Officials

Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

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