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
Product: Olanzapine FC
Active Ingredient: Olanzapine 7.5mg
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 10mg
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 15mg
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 20mg
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 ODT
Active Ingredient: Olanzapine 5mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Pharmathen SA, Attikis, Greece
Oman Pharmaceutical Products Company LLC, Salalah, Oman
Product: Olanzapine ODT
Active Ingredient: Olanzapine 10mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Pharmathen SA, Attikis, Greece
Oman Pharmaceutical Products Company LLC, Salalah, Oman
Product: Olanzapine ODT
Active Ingredient: Olanzapine 15mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Pharmathen SA, Attikis, Greece
Oman Pharmaceutical Products Company LLC, Salalah, Oman
Product: Olanzapine ODT
Active Ingredient: Olanzapine 20mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Pharmathen SA, Attikis, Greece
Oman Pharmaceutical Products Company LLC, Salalah, Oman
Product: Ondansetron Tabs Pfizer
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: Ondansetron Tabs Pfizer
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: Sudafed Nasal Decongestant
Active Ingredient: Oxymetazoline hydrochloride 0.05%w/v
Dosage Form: Nasal spray solution
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Aspen Pharma Pty Limited, Dandenong, 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).