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: Apo-Famciclovir
Active Ingredient: Famciclovir 125mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Famciclovir
Active Ingredient: Famciclovir 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Famciclovir (Prescription)
Active Ingredient: Famciclovir 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Famciclovir (Restricted)
Active Ingredient: Famciclovir 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: m-Montelukast
Active Ingredient: Montelukast sodium 4.15mg equivalent to montelukast 4mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Pharmathen SA, Attikis, Greece
Oman Pharmaceutical Products Company LLC, Salalah, Oman
Product: m-Montelukast
Active Ingredient: Montelukast sodium 5.188mg equivalent to montelukast 5mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Pharmathen SA, Attikis, Greece
Oman Pharmaceutical Products Company LLC, Salalah, Oman
Product: m-Montelukast
Active Ingredient: Montelukast sodium 10.4mg equivalent to montelukast 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: Voltaren Emulgel 12 Hourly
Active Ingredient: Diclofenac diethylamine 2.32% equivalent to diclofenac 2%
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Novartis Consumer Health SA, Nyon, Switzerland
Dated this 27th day of June 2013.
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).