Medicine Distribution and Classification




18 AUGUST 2011 NEW ZEALAND GAZETTE, No. 127 3591

Dated this 10th day of August 2011.

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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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: Brilinta
Active Ingredient: Ticagrelor 90mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Södertälje, Sweden

Product: Codral Relief Max Strength Cold & Flu + Decongestant
Active Ingredients: Paracetamol 1000mg
Phenylephrine hydrochloride 12.2mg
Dosage Form: Powder
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Wrafton Laboratories Limited, Devon, United Kingdom

Product: Duro-Tuss Phenylephrine PE Chesty Cough & Nasal Decongestant
Active Ingredients: Bromhexine hydrochloride 0.08%w/v
Phenylephrine hydrochloride 0.067%w/v
Dosage Form: Oral solution
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: iNova Pharmaceuticals (Australia) Pty Limited, Thornleigh, Australia

Product: Onbrez Breezhaler
Active Ingredient: Indacaterol maleate 0.194mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Product: Onbrez Breezhaler
Active Ingredient: Indacaterol maleate 0.389mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Product: Your Pharmacy Cold & Flu Hot Drink PE
Active Ingredients: Paracetamol 1000mg
Phenylephrine hydrochloride 12.2mg
Dosage Form: Powder
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Wrafton Laboratories Limited, Devon, United Kingdom

Product: Your Pharmacy Paediatric Paracetamol Suspension
Active Ingredient: Paracetamol 2%w/w
Dosage Form: Oral solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

Dated this 10th day of August 2011.

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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Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981, I, 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.



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 127





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
10 August 2011
Medicines Act, Distribution Consent, Brilinta, Codral Relief Max Strength Cold & Flu + Decongestant, Duro-Tuss Phenylephrine PE Chesty Cough & Nasal Decongestant, Onbrez Breezhaler, Your Pharmacy Cold & Flu Hot Drink PE, Your Pharmacy Paediatric Paracetamol Suspension
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Classification of Medicines

🏥 Health & Social Welfare
10 August 2011
Medicines Act, Prescription Medicines, Classification
  • Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health