✨ Medicines and Veterinary Products




NEW ZEALAND GAZETTE, No. 89 β€” 6 OCTOBER 2016

Schedule

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Bemfola
Follitropin alfa 75IU
Solution for injection
Pharmbio Pty Limited
CP Pharmaceuticals Limited, Wrexham, United Kingdom

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Bemfola
Follitropin alfa 150IU
Solution for injection
Pharmbio Pty Limited
CP Pharmaceuticals Limited, Wrexham, United Kingdom

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Bemfola
Follitropin alfa 225IU
Solution for injection
Pharmbio Pty Limited
CP Pharmaceuticals Limited, Wrexham, United Kingdom

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Bemfola
Follitropin alfa 300IU
Solution for injection
Pharmbio Pty Limited
CP Pharmaceuticals Limited, Wrexham, United Kingdom

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Bemfola
Follitropin alfa 450IU
Solution for injection
Pharmbio Pty Limited
CP Pharmaceuticals Limited, Wrexham, United Kingdom

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Toujeo
Insulin glargine 300IU/mL equivalent to 10.91mg/mL
Solution for injection
Sanofi-Aventis New Zealand Limited
Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany

Dated this 2nd day of October 2016.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

2016-go5687

Notice of Application to Vary the Conditions of a Registered Trade Name Product

(Notice No. MPI 693)

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(2) of the Agricultural Compounds and Veterinary Medicines Act 1997 ("Act"), that the following variation application has been made to a registered trade name product under section 9(2) of the Act:

Trade Name: COGLAVAX

Reference: A007528

Active Ingredients:
Clostridium perfringens Types A, B, C and D; Clostridium novyi Type B; Clostridium septicum; Clostridium tetani; and Clostridium chauvoei.

Formulation Type: Aqueous suspension

Current Claim:
An adjuvanted vaccine for the protection of livestock against the following diseases: Pulpy Kidney (Clostridium perfringens Type D), Malignant Oedema (Clostridium septicum), Blackleg (Clostridium chauvoei), Black Disease (Clostridium novyi Type B) and Tetanus (Clostridium tetani).

Proposed New Claims:
A polyvalent inactivated vaccine for the prevention of Clostridial infections in cattle and sheep.

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 89





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
2 October 2016
Medicines, Distribution, Consent, Follitropin alfa, Insulin glargine
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

🌾 Notice of Application to Vary the Conditions of a Registered Trade Name Product

🌾 Primary Industries & Resources
Agricultural Compounds, Veterinary Medicines, Trade Name, Variation Application, COGLAVAX
  • Maree Zinzley, Manager Approvals Operations, Ministry for Primary Industries