β¨ 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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β¨ LLM interpretation of page content
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Classification of Medicines
(continued from previous page)
π₯ Health & Social Welfare10 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
πΎ Notice of Application to Register a Trade Name Product
πΎ Primary Industries & ResourcesTrade Name Registration, Phenobarbital Injection, Agricultural Compounds, Veterinary Medicines, Ministry for Primary Industries
- Maree Zinzley, Manager Approvals Operations, Ministry for Primary Industries
NZ Gazette 2015, No 88