✨ Consent to Distribution of New Medicines




10 DECEMBER 2009 NEW ZEALAND GAZETTE, No. 183

4429

Product: Seroquel XR
Active Ingredient: Quetiapine fumarate 460.5mg equivalent to quetiapine free base 400mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of America
AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom

Dated this 4th day of December 2009.

ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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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 medicine set out in the Schedule hereto:

Schedule

Product: A-Bendroflumethiazide
Active Ingredient: Bendroflumethiazide 5mg
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India

Product: A-Bendroflumethiazide
Active Ingredient: Bendroflumethiazide 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India

Product: Bendroflumethiazide
Active Ingredient: Bendroflumethiazide 5mg
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India

Product: Bendroflumethiazide
Active Ingredient: Bendroflumethiazide 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India

Product: Duro-Tuss Chesty Cough Sugar Free Lemon
Active Ingredients: Bromhexine hydrochloride 8mg
Cetylpyridinium chloride, anhydrous 1.33mg
Dosage Form: Lozenge
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Nestle Australia Limited, Blacktown, NSW, Australia

Product: I-Bendroflumethiazide
Active Ingredient: Bendroflumethiazide 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India

Product: I-Bendroflumethiazide
Active Ingredient: Bendroflumethiazide 5mg
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India

Product: Nurofen Zavance (general sales)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Banner Pharmacaps Europe BV, Tilburg, The Netherlands



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2009, No 183





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
4 December 2009
Medicines, Approval, Distribution, Seroquel XR, Quetiapine
  • Anthony Hill, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Approval, Distribution, A-Bendroflumethiazide, Bendroflumethiazide, Duro-Tuss, I-Bendroflumethiazide, Nurofen Zavance