New Zealand Gazette – 2013 – No. 172

Page 4705

✨ Medicine Approvals and Classifications

19 DECEMBER 2013

NEW ZEALAND GAZETTE, No. 172

4705

Product: Omnitrope
Active Ingredient: Somatropin 3.33mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz GmbH, Tyrol, Austria

Product: Omnitrope
Active Ingredient: Somatropin 6.67mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz GmbH, Tyrol, Austria

Product: Omnitrope
Active Ingredient: Somatropin 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz GmbH, Tyrol, Austria

Product: Phenercalm
Active Ingredient: Promethazine hydrochloride 1mg/mL
Dosage Form: Elixir
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Drug Houses of Australia Private Limited, Singapore

Dated this 16th day of December 2013.

SARAH READER, Acting 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 the following:

The medicines listed in Schedule 1 to this notice are classified as prescription medicines.
The medicines listed in Schedule 2 to this notice are classified as restricted 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

5-aminolevulinic acid
Abiraterone acetate
Afamelanotide
Aflibercept
Alogliptin
Amorolfine; except when specified elsewhere in this notice; except in preparations for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board
Apixaban
Asenapine
Axitinib
Azelastine; except when specified elsewhere in this notice
Belatacept
Belimumab
Boceprevir
Cabazitaxel
Canagliflozin
Catumaxomab
Ceftaroline fosamil
Cholera vaccine; except in the form of an oral liquid containing Vibrio cholerae when sold in a pharmacy by a registered pharmacist
Clotrimazole; except in medicines for vaginal or external use
Cobicistat
Crofelemer
Cyclizine; except when specified elsewhere in this notice
Dapagliflozin propanediol
Degarelix
Denosumab
Diclofenac; in preparations for the treatment of solar keratosis; except when specified elsewhere in this notice;

Gazette.govt.nz — NZ Gazette 2013, No 172

Parliament House (depicted) was completed in 1918 and remains the primary seat of Parliament.

✨ LLM interpretation of page content

🏥 Approval of Omnitrope and Phenercalm Medicines

Domain🏥 Health & Social Welfare
Dated16 December 2013
KeywordsMedicine, Solution for injection, Somatropin, Elixir, Promethazine hydrochloride, Novartis, Sandoz, Actavis
👩‍💼 Officials

SARAH READER, Acting Group Manager, Medsafe, Ministry of Health

🏥 Classification of Medicines

Domain🏥 Health & Social Welfare
KeywordsMedicines Act 1981, Prescription medicines, Restricted medicines, Pharmacy-only medicines, Classification
👩‍💼 Officials

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

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