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: Cold & Flu Relief + Decongestant
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Maharashtra, India
Product: INLYTA
Active Ingredient: Axitinib 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
Product: INLYTA
Active Ingredient: Axitinib 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
Product: Lemsip Max Sinus + Pain Relief Hot Drink
Active Ingredients: Paracetamol 1000mg
Phenylephrine hydrochloride 12.2mg equivalent to Phenylephrine 10mg
Dosage Form: Powder for oral solution
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom
Product: Lemsip Sinus + Pain Relief Capsules
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 6.1mg equivalent to Phenylephrine 5mg
Dosage Form: Powder filled capsule
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturers: Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom
Perrigo UK Limited, Devon, United Kingdom
Product: Nasal Decongestant
Active Ingredient: Phenylephrine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Maharashtra, India
Product: Onyban Nail-Aid
Active Ingredient: Amorolfine hydrochloride 6.4% w/w equivalent to Amorolfine 5% w/w
Dosage Form: Nail lacquer
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Chanelle Medical Limited, County Galway, Ireland
Product: VitA-POS
Active Ingredient: Retinol palmitate 0.138mg/g equivalent to Vitamin A 250 lU/g
Dosage Form: Eye ointment
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Ursapharm Arzneimittel GmbH, Saarbrucken, Germany
Product: Yasmin Plus
Active Tablet:
Active Ingredients: Drospirenone 3mg
Ethinylestradiol 30mcg
Levomefolate calcium 451mcg equivalent to Folic acid 400mcg
Dosage Form: Tablet
Placebo Tablet:
Active Ingredient: Levomefolate calcium 451mcg equivalent to Folic acid 400mcg
Dosage Form: Tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Weimar GmbH und Co KG, Weimar, Germany
Product: Your Pharmacy Loratadine Tablets
Active Ingredient: Loratadine 9.999mg
Dosage Form: Tablet
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: L Perrigo Company, Michigan, United States of America
Dated this 10th day of April 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).