✨ Medicines and Trade Name Registration
NEW ZEALAND GAZETTE, No. 8 — 29 JANUARY 2015
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: Amiodarone Alphapharm
Active Ingredient: Amiodarone hydrochloride 50mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Teoranta, County Galway, Ireland
Product: m-Nystatin
Active Ingredient: Nystatin 100000IU/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Madhya Pradesh, India
Dated this 22nd day of January 2015.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
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Notice of Application to Register a Trade Name Product (Notice No. MPI 451)
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: Veraflox 25 mg/mL Oral Suspension for Cats
Reference: A11156
Active Ingredients and Concentrations:
Pradofloxacin 25mg/mL
Formulation Type: Aqueous Suspension
General Use Claim:
Treatment of:
- infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).
- wound infections and abscesses caused by susceptible strains of Pasteurella multocida and the Staphylococcus intermedius group (including S. pseudintermedius).
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; and
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; and
b. where requests for copies of the public information relating to the application can be sent; and
c. where public information relating to the application can be viewed; and
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NZ Gazette 2015, No 8
✨ LLM interpretation of page content
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Consent to the Distribution of New Medicines
(continued from previous page)
🏥 Health & Social Welfare22 January 2015
Medicine Distribution, Amiodarone, m-Nystatin, Medsafe
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
🌾 Notice of Application to Register a Trade Name Product
🌾 Primary Industries & ResourcesTrade Name Registration, Veraflox, Agricultural Compounds, Veterinary Medicines
- Maree Zinzley, Manager Approvals Operations of the Ministry for Primary Industries