New Zealand Gazette – 2017 – No. 13

Page 53

✨ Medicines and Trade Name Registration



NEW ZEALAND GAZETTE, No. 13 — 9 FEBRUARY 2017

not more than 14 days’ supply; except in medicines containing 300 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than seven days’ supply

Medicines for General Sale

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

Benzydamine; for oromucosal or topical use

Efmoroctocog alfa

Lignocaine; for external use and in throat sprays in medicines containing 2% or less; in throat lozenges in medicines containing 30 milligrams or less per dose form

Loratadine; in divided solid dosage forms for oral use containing 10 milligrams or less per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer’s original pack containing not more than ten days’ supply

Simoctocog alfa

Ranitidine; in medicines containing 300 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than seven days’ supply

Dated this 7th day of February 2017.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health.

2017-go565

Notice of Application to Register a Trade Name Product (Notice No. MPI 721)

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 ("Act"), that the following application has been made to register a trade name product under section 9(1) of the Act:

Trade Name: TRI-SOLFEN Topical Anaesthetic & Antiseptic Solution

Reference: A011409

Active Ingredients and Concentrations:

  • Lignocaine (as hydrochloride) 40.6g/L
  • Bupivacaine (as hydrochloride) 4.2g/L
  • Adrenaline (as acid tartrate) 24.8mg/L
  • Cetrimide 5.0g/L

Formulation Type: Aqueous solution

General Use Claim:

Topical Anaesthetic and Antiseptic Solution.

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:

a. must state in full the reasons for making the submission;

b. may state any decision sought on that application; and

c. must be received by the director-general no later than 30 working days after the date of notification in the New Zealand Gazette.

Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant’s information.

The following address is:

a. where submissions on this application are to be sent;

b. where requests for copies of the public information relating to the application can be sent;

c. where public information relating to the application can be viewed; and

d. the director-general’s address for service:

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Online Sources for this page:

Gazette.govt.nz — PDF NZ Gazette 2017, No 13




✨ LLM interpretation of page content

🏥 Medicines for General Sale (continued from previous page)

🏥 Health & Social Welfare
7 February 2017
General sale medicines, Benzydamine, Efmoroctocog alfa, Lignocaine, Loratadine, Simoctocog alfa, Ranitidine
  • CHRIS JAMES, Group Manager, Medsafe, Ministry of Health

🌾 Notice of Application to Register a Trade Name Product

🌾 Primary Industries & Resources
Trade name registration, TRI-SOLFEN, Agricultural Compounds and Veterinary Medicines Act 1997, MPI, Lignocaine, Bupivacaine, Adrenaline, Cetrimide
  • Maree Zinzley, Manager Approvals Operations, Ministry for Primary Industries