β¨ Medicines Distribution Consent
NEW ZEALAND GAZETTE, No. 135 β 10 DECEMBER 2015
Product:
Day Tablet
Active Ingredients:
Ethics Cold & Flu Combo (Combination Product)
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Night Tablet
Active Ingredients:
Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form:
Film coated tablet
Product:
Lozenge
Active Ingredients:
Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Dosage Form:
Lozenge
New Zealand Sponsor:
Multichem NZ Limited
Manufacturers:
Cipla Limited, District Raigad, India
Cipla Limited, District Solan, India
Product:
Praxbind
Active Ingredient:
Idarucizumab 50mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Boehringer Ingelheim (NZ) Limited
Manufacturer:
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product:
Vit.D3
Active Ingredient:
Colecalciferol 1.25mg equivalent to 50,000IU
Dosage Form:
Soft gelatin capsule
New Zealand Sponsor:
Multichem NZ Limited
Manufacturer:
Geltec Private Limited, Bangalore, India
Product:
Xigduo XR
Active Ingredients:
Dapagliflozin propanediol monohydrate 12.3mg equivalent to Dapagliflozin 10mg
Metformin hydrochloride 500mg
Dosage Form:
Modified release tablet
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer:
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Product:
Xigduo XR
Active Ingredients:
Dapagliflozin propanediol monohydrate 12.3mg equivalent to Dapagliflozin 10mg
Metformin hydrochloride 1000mg
Dosage Form:
Modified release tablet
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer:
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Product:
Xigduo XR
Active Ingredients:
Dapagliflozin propanediol monohydrate 6.15mg equivalent to Dapagliflozin 5mg
Metformin hydrochloride 1000mg
Dosage Form:
Modified release tablet
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer:
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
Dated this 4th day of December 2015.
SARAH READER, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
2015-go7192
Consent to the Distribution of New Medicines
Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
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β¨ LLM interpretation of page content
π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare4 December 2015
Medicines Act 1981, New Medicines, Distribution Consent, Day Tablet, Night Tablet, Lozenge, Praxbind, Vit.D3, Xigduo XR
- SARAH READER, Acting Group Manager, Medsafe, Ministry of Health
NZ Gazette 2015, No 135