✨ Medicines Classification and Trade Name Registration




NEW ZEALAND GAZETTE, No. 88 β€” 13 AUGUST 2015

Pembrolizumab
Pirfenidone
Piperacetam
Pramiracetam
Ranolazine
Recombinant human Epidermal Growth Factor
Rolipram (and its stereoisomers)
Rolziracetam
Secukinumab
Seletracetam (and its stereoisomers)
Suvorexant

Schedule 2

Restricted Medicines

Ketoprofen; in solid dose form containing 25 milligrams or less per dose form in packs of not more than 30 capsules or tablets

Schedule 3

Pharmacy-only Medicines

Azelastine; in preparations for nasal use containing 0.15% azelastine hydrochloride or less; in topical eye preparations containing 0.05% or less

Bilastine; in divided solid dosage forms for oral use containing 20 milligrams or less for the treatment of the symptoms of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria when sold in a pack containing not more than 30 dosage units

Macrogols; in preparations for oral use as a liquid concentrate for laxative use

Medicines for General Sale

Please note that the following medicines are now available for general sale.

Efmoroctocog alfa
Simoctocog alfa

Dated this 10th day of August 2015.

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

2015-go4783


Notice of Application to Register a Trade Name Product (Notice No. MPI 513)

Maree Zinzley, Manager Approvals Operations of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, gives notice, under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 ("the Act"), that the following application has been made to register a trade name product under section 9(1) of the Act:

Trade Name: Phenobarbital Injection

Reference: A11144

Active Ingredient and Concentration:
Phenobarbital sodium 1ml ampoule 200mg

Formulation Type: Aqueous solution

General Use Claim:
Intravenous phenobarbital sodium is indicated for the emergency control of convulsions, and other situations where anticonvulsant therapy may be required in an intensive care situation.

Any person may make a written submission to the director-general concerning this application.

Under sections 16 and 17 of the Act, a written submission:



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2015, No 88





✨ LLM interpretation of page content

πŸ₯ Classification of Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
10 August 2015
Medicines, Prescription, Restricted, Pharmacy-only, General Sale, Ministry of Health
  • Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🌾 Notice of Application to Register a Trade Name Product

🌾 Primary Industries & Resources
Trade Name Registration, Phenobarbital Injection, Agricultural Compounds, Veterinary Medicines, Ministry for Primary Industries
  • Maree Zinzley, Manager Approvals Operations, Ministry for Primary Industries