β¨ 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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β¨ LLM interpretation of page content
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social Welfare1 April 2016
Medicines, Distribution, Consent, Medicines Act 1981
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Renewal of Provisional Consent to the Distribution of Medicines
π₯ Health & Social Welfare1 April 2016
Medicines, Renewal, Provisional Consent, Medicines Act 1981
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
NZ Gazette 2016, No 29