✨ Medicines and Trade Name Registration
NEW ZEALAND GAZETTE, No. 37 — 6 APRIL 2017
Product: Ketamine
Active Ingredient: Ketamine hydrochloride 11.53mg/mL equivalent to 10mg/mL ketamine
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This renewed consent is valid for two years from 5 May 2017.
Product: RiaSTAP
Active Ingredient: Fibrinogen 900mg – 1300mg
Dosage Form: Powder for injection
New Zealand Sponsor: CSL Behring (NZ) Limited
Manufacturer: CSL Behring GmbH, Marburg, Germany
Note: This renewed consent is valid for two years from 12 May 2017.
Dated this 3rd day of April 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
2017-go1672
Notice of Application to Register a Trade Name Product (Notice No. MPI 737)
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: Poulvac Bron Vic S
Reference: A011427
Active Ingredient and Concentration: Infectious bronchitis virus (Vic S strain; ≥10³․⁰ EID50)
Formulation Type: Aqueous suspension
General Use Claim: A live vaccine for the prevention of infectious bronchitis in poultry.
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:
ACVM Group, Ministry for Primary Industries, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.
The applicant’s address for service is:
Pacificvet Limited, 3 Hickory Place, Christchurch 8841. Postal Address: PO Box 16129, Hornby, Christchurch.
Dated at Wellington this 4th day of April 2017.
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NZ Gazette 2017, No 37
✨ LLM interpretation of page content
🏥
Renewal of Provisional Consent to the Distribution of Medicines
(continued from previous page)
🏥 Health & Social Welfare3 April 2017
Medicines, Provisional Consent, Renewal, Ketamine, RiaSTAP, Biomed Limited, CSL Behring
- CHRIS JAMES, Group Manager, Medsafe, Ministry of Health
🌾 Notice of Application to Register a Trade Name Product
🌾 Primary Industries & Resources4 April 2017
Trade Name Registration, Poulvac Bron Vic S, Agricultural Compounds, Veterinary Medicines, Poultry Vaccine
- Maree Zinzley, Manager Approvals Operations, Ministry for Primary Industries