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: Alpha-Amoxi
Active Ingredient(s): Amoxycillin (trihydrate) 31.2854mg/mL equivalent to 25mg/mL anhydrous amoxycillin
Dosage Form: Granules for oral suspension
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Alpha-Amoxi
Active Ingredient(s): Amoxycillin (trihydrate) 62.5708mg/mL equivalent to 50.0mg/mL anhydrous amoxicillin
Dosage Form: Granules for oral suspension
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Lovir
Active Ingredient(s): Aciclovir 250mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Biologici Italia Laboratoires Srl, Novate Milanese, Milan, Italy
Product: Testosterone
Active Ingredient(s): Testosterone 200mg
Dosage Form: Subcutaneous implant
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Organon (Ireland) Limited, Swords, Co. Dublin, Ireland
Dated this 23rd day of April 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).