✨ Medicine Distribution Consents




4444 NEW ZEALAND GAZETTE, No. 155 13 OCTOBER 2011

Consent to the Distribution of New Related Products

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new related products set out in the Schedule hereto:

Schedule

Product: Bonvit Psyllium Husk Natural Orange Flavour
Active Ingredient: Ispaghula husk 48.4%w/w
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Crombie and Price Limited
Manufacturer: DFC Pharmamed Pty Limited, Thornleigh, Australia

Product: Bonvit Psyllium Husk Natural Orange Flavour Sugar Free
Active Ingredient: Ispaghula husk 95.75%w/w
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Crombie and Price Limited
Manufacturer: DFC Pharmamed Pty Limited, Thornleigh, Australia

Product: Bonvit Psyllium Husk Powder Smooth Texture
Active Ingredient: Ispaghula husk 100%w/w
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Crombie and Price Limited
Manufacturer: DFC Pharmamed Pty Limited, Thornleigh, Australia

Product: Bonvit Psyllium Husks
Active Ingredient: Ispaghula husk 100%w/w
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Crombie and Price Limited
Manufacturer: DFC Pharmamed Pty Limited, Thornleigh, Australia

Dated this 6th day of October 2011.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, 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 medicines set out in the Schedule hereto:

Schedule

Product: Auro-Ondansetron 4
Active Ingredient: Ondansetron hydrochloride dihydrate 4.986mg equivalent to Ondansetron 4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India

Product: Auro-Ondansetron 8
Active Ingredient: Ondansetron hydrochloride dihydrate 9.972mg equivalent to Ondansetron 8mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India

Product: Gilenya
Active Ingredient: Fingolimod hydrochloride 0.56mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Product: Olanzapine FC
Active Ingredient: Olanzapine 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Pharmathen SA, Attikis, Greece
Oman Pharmaceutical Products Company LLC, Salalah, Oman

Product: Olanzapine FC
Active Ingredient: Olanzapine 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Pharmathen SA, Attikis, Greece
Oman Pharmaceutical Products Company LLC, Salalah, Oman



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 155





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
6 October 2011
Medicines, Approval, Bonvit Psyllium Husk, Ispaghula husk
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
6 October 2011
Medicines, Approval, Auro-Ondansetron, Gilenya, Olanzapine FC
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health