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: Donepezil Hydrochloride
Active Ingredient: Donepezil hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Donepezil Hydrochloride
Active Ingredient: Donepezil hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Meterol HFA Inhaler
Active Ingredient: Salmeterol xinafoate 0.0363mg equivalent to salmeterol 0.025mg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Product: Paroxetine
Active Ingredient: Paroxetine hydrochloride 22.21mg equivalent to Paroxetine 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Paroxetine
Active Ingredient: Paroxetine hydrochloride 33.32mg equivalent to Paroxetine 30mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Pioglitazone Hydrochloride
Active Ingredient: Pioglitazone hydrochloride 16.54mg equivalent to pioglitazone 15mg
Dosage Form: Tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Pioglitazone Hydrochloride
Active Ingredient: Pioglitazone hydrochloride 33.07mg equivalent to pioglitazone 30mg
Dosage Form: Tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Pioglitazone Hydrochloride
Active Ingredient: Pioglitazone hydrochloride 49.61mg equivalent to pioglitazone 45mg
Dosage Form: Tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: SalAir HFA Inhaler
Active Ingredient: Salbutamol sulfate 0.12mg equivalent to salbutamol 100mcg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturers: Cipla Limited, Goa, India
Medispray Laboratories Pvt Limited, Goa, India
Dated this 18th day of January 2012.
DR PAT TUOHY, Acting 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).