✨ Medicine Consent Notices




NEW ZEALAND GAZETTE, No. 29 β€” 7 APRIL 2016

Product:
Active Ingredients:
Cardioplegia Solution A
Calcium chloride 0.176g/L
Magnesium chloride 3.25g/L
Potassium chloride 1.19g/L
Sodium chloride 6.43g/L

Dosage Form:
Solution

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturer:
Baxter Healthcare Pty Limited, Sydney, Australia

Product:
Active Ingredient:
Levomepromazine Hydrochloride
Levomepromazine hydrochloride 25mg/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Max Health Limited

Manufacturer:
CP Pharmaceuticals Limited, Wrexham, United Kingdom

Product:
Active Ingredient:
Sodium Valproate 100mg/mL Solution for Injection or Infusion
Sodium valproate 100mg/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Max Health Limited

Manufacturer:
CP Pharmaceuticals Limited, Wrexham, United Kingdom

Product:
Active Ingredient:
Zoledronic Acid
Zoledronic acid monohydrate 0.8528mg/mL
equivalent to zoledronic acid 0.8mg/mL

Dosage Form:
Concentrate for infusion

New Zealand Sponsor:
Max Health Limited

Manufacturer:
Hameln Pharmaceuticals GmbH, Hameln, Germany

Dated this 1st day of April 2016.

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

2016-go1872

Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:
Gutron
Midodrine hydrochloride 2.5mg

Dosage Form:
Tablet

New Zealand Sponsor:
Douglas Pharmaceuticals Limited

Manufacturer:
Takeda GmbH, Oranienburg, Germany

Note: This renewed consent is valid for two years from 30 April 2016.

Product:
Active Ingredient:
Gutron
Midodrine hydrochloride 5mg

Dosage Form:
Tablet

New Zealand Sponsor:
Douglas Pharmaceuticals Limited

Manufacturer:
Takeda GmbH, Oranienburg, Germany

Note: This renewed consent is valid for two years from 30 April 2016.

Product:
Active Ingredient:
Loniten
Minoxidil 10mg

Dosage Form:
Tablet

New Zealand Sponsor:
Pfizer New Zealand Limited

Manufacturer:
Patheon Inc, Ontario, Canada

Note: This renewed consent is valid for one year from 14 April 2016.

Dated this 1st day of April 2016.

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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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 29





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
1 April 2016
Medicines, Distribution, Consent, Medicines Act 1981
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of Medicines

πŸ₯ Health & Social Welfare
1 April 2016
Medicines, Renewal, Provisional Consent, Medicines Act 1981
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health