✨ Medicines and Agricultural Compounds
NEW ZEALAND GAZETTE, No. 101 — 10 NOVEMBER 2016
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Leuprorelin Sandoz
Leuprorelin acetate 3.78mg equivalent to leuprorelin 3.6mg
Subcutaneous implant
Novartis New Zealand Limited
EVER Pharma Jena GmbH, Jena, Germany
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Leuprorelin Sandoz
Leuprorelin acetate 5.25mg equivalent to leuprorelin 5mg
Subcutaneous implant
Novartis New Zealand Limited
EVER Pharma Jena GmbH, Jena, Germany
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Lynparza
Olaparib 50mg
Capsule
AstraZeneca Limited
Patheon Pharmaceuticals Inc, Ohio, United States of America
Dated this 4th day of November 2016.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
2016-go6316
Notice of Application to Register a Trade Name Product (Notice No. MPI 698)
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: CLiK Extra Spray-On
Reference: A011384
Active Ingredient and Concentration:
Dicyclanil* 65g/L
Formulation Type: Aqueous suspension
General Use Claim:
For the control by prevention of blowfly strike for up to 22 weeks in sheep.
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
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:
39
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✨ LLM interpretation of page content
🏥 Consent to the distribution of new medicines
🏥 Health & Social Welfare4 November 2016
Medicines, Leuprorelin Sandoz, Lynparza, Medsafe, Ministry of Health
- CHRIS JAMES, Group Manager, Medsafe, Ministry of Health
🌾 Notice of Application to Register a Trade Name Product
🌾 Primary Industries & ResourcesAgricultural Compounds, Veterinary Medicines, CLiK Extra Spray-On, MPI
- Maree Zinzley, Manager Approvals Operations, Ministry for Primary Industries
NZ Gazette 2016, No 101