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Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of a New Medicine

Publication Date
1 Oct 2024

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2024-go4994
Title
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File Type and Size
PDF (36 KB)

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product: Syndrex
Component 1:  
Active Ingredients: Pyridoxine hydrochloride 10mg/mL
Riboflavin sodium phosphate 1mg/mL equivalent to riboflavin 0.8mg/mL
Thiamine hydrochloride 50mg/mL
Dosage Form: Concentrate for infusion
Component 2:  
Active Ingredients: Ascorbic acid 100mg/mL
Glucose monohydrate 220mg/mL equivalent to glucose 200mg/mL
Nicotinamide 32mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Max Health Limited
Manufacturer: Farmak JSC, Kyiv, Ukraine

Note: This consent is given subject to the following conditions:
  1. Provisional consent is granted for two years to address an urgent shortage in the market and only applies to batch number 90624. Additional batches may only be marketed or distributed by mutual agreement with Medsafe.
  2. The medicine may only be marketed or distributed when no other infusion concentrate of water-soluble vitamins B and C (thiamine hydrochloride, riboflavin, pyridoxine hydrochloride, ascorbic acid, nicotinamide, and glucose) with consent under section 20 of the medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations.
Note: This consent is valid for two years from the date of publication of this notice.


Dated this 30th day of September 2024.

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