✨ 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

60



Next Page →



Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2015, No 135





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
4 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