Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Allertyne
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Drug Houses of Australia Private Limited, Singapore
Product: AS-Paclitaxel
Active Ingredient: Paclitaxel 6mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: GN-Paclitaxel
Active Ingredient: Paclitaxel 6mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Imodium Capsules (Pharmacy Only)
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag, Val de Reuil, France
Product: Imodium Capsules (General Sales)
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag, Val de Reuil, France
Product: Paclitox
Active Ingredient: Paclitaxel 6mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Vinorelbine
Active Ingredient: Vinorelbine tartrate 13.85mg/mL equivalent to Vinorelbine 10mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Ltd, Goa, India
Dated this 14th day of February 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).