New Zealand Gazette – 2014 – No. 65

Page 1853

✨ Medicines Notices

19 JUNE 2014

NEW ZEALAND GAZETTE, No. 65

1853

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 set out in the Schedule hereto:

Schedule

Product: Tafinlar

Active Ingredient: Dabrafenib mesilate 59.25mg equivalent to Dabrafenib 50mg

Dosage Form: Capsule

New Zealand Sponsor: GlaxoSmithKline (NZ) Limited

Manufacturers: GlaxoSmithKline (Canada) Inc, Ontario, Canada
Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom

Product: Tafinlar

Active Ingredient: Dabrafenib mesilate 88.88mg equivalent to Dabrafenib 75mg

Dosage Form: Capsule

New Zealand Sponsor: GlaxoSmithKline (NZ) Limited

Manufacturers: GlaxoSmithKline (Canada) Inc, Ontario, Canada
Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom

Dated this 13th day of June 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 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
Aclidinium bromide
Afamelanotide
Afatanib dimaleate
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
Amyl nitrite; except when sold to a person who holds a controlled substances licence (issued under section 95B of the Hazardous Substances and New Organisms Act 1996) authorising the person to possess cyanide; except when sold to an exempt laboratory covered by a Hazardous Substances and New Organisms Act 1996 approved code of practice
Apixaban
Articaine; except when used as a local anaesthetic in practice by a dental therapist registered with the Dental Council
Asenapine
Axitinib
Azelastine; except when specified elsewhere in this notice
Belatacept
Belimumab
Bendamustine hydrochloride
Besifloxacin hydrochloride
Besifloxacine
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
Collagenase clostridium histolyticum
Crizotinib
Crofelemer

Gazette.govt.nz — NZ Gazette 2014, No 65

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 (continued from previous page)

Domain🏥 Health & Social Welfare
Dated13 June 2014
KeywordsMedicines Act 1981, New Medicines, Distribution Consent, Tafinlar, Dabrafenib
👩‍💼 Officials

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health

🏥 Classification of Medicines

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

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

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