New Zealand Gazette – 2014 – No. 15

Page 335

✨ Medicines Notices

7 FEBRUARY 2014 NEW ZEALAND GAZETTE, No. 15 335

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: Dexmethsone
Active Ingredient: Dexamethasone sodium phosphate 4.4mg equivalent to dexamethasone phosphate 4.0mg
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Agila Specialties Pvt Limited, Bangalore, India

Product: m-Mycophenolate
Active Ingredient: Mycophenolate mofetil 250mg
Dosage Form: Capsule
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Alkem Laboratories Limited, Himachal Predesh, India

Product: m-Mycophenolate
Active Ingredient: Mycophenolate mofetil 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Alkem Laboratories Limited, Himachal Predesh, India

Dated this 31st day of January 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

Aclidinium bromide

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

Articaine; except when used as a local anaesthetic in practice by a dental therapist registered with the Dental Council

Bendamustine hydrochloride

Besifloxacin hydrochloride

Crizotinib

Dabrafenib mesilate

Diphtheria, tetanus and pertussis (acellular, component) vaccine; except when administered in a single dose to a person 18 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health

Enobosarm

Ghrelin

Hexarelin

Human growth hormone secretagogues

Insulin-like growth factors; except where specified elsewhere in the schedule

Ipamorelin

Loteprednol etabonate

Melanocyte stimulating compounds

Meningococcal vaccine; except when administered to a person 16 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who

Gazette.govt.nz — NZ Gazette 2014, No 15

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✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

Domain🏥 Health & Social Welfare
Dated31 January 2014
KeywordsMedicines, Distribution, Consent, Dexmethsone, Mycophenolate
👩‍💼 Officials

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health

🏥 Classification of Medicines

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

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

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