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: Emend IV
Active Ingredient: Fosaprepitant dimeglumine 257.6mg
Dosage Form: Powder for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: DSM Pharmaceuticals Inc, North Carolina, United States of America
Product: Nurofen Sinus Pain PE (General Sale)
Active Ingredients: Ibuprofen 200mg
Phenylephrine hydrochloride 5mg equivalent to Phenylephrine 4.1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottinghamshire, United Kingdom
Product: Nurofen Sinus Pain PE (Pharmacy Only)
Active Ingredients: Ibuprofen 200mg
Phenylephrine hydrochloride 5mg equivalent to Phenylephrine 4.1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottinghamshire, United Kingdom
Product: Orencia
Active Ingredient: Abatacept 262.5mg
Dosage Form: Powder for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Product: Penembact
Active Ingredient: Meropenem trihydrate 570.5mg equivalent to Meropenem 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: InterPharma (NZ) Limited
Manufacturer: Venus Remedies Limited/India, Baddi (H.P), India
Product: Penembact
Active Ingredient: Meropenem trihydrate 1141mg equivalent to Meropenem 1000mg
Dosage Form: Powder for injection
New Zealand Sponsor: InterPharma (NZ) Limited
Manufacturer: Venus Remedies Limited/India, Baddi (H.P), India
Product: Robitussin Mucus Relief Double Action
Active Ingredients: Bromhexine hydrochloride 0.8mg/mL
Guaifenesin 20mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Interphil Laboratories Inc, Laguna, Philippines
Product: Tacrolimus Sandoz
Active Ingredient: Tacrolimus monohydrate 0.511mg equivalent to Tacrolimus 0.5mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Private Limited, Navi Mumbai, India
Product: Tacrolimus Sandoz
Active Ingredient: Tacrolimus monohydrate 1.022mg equivalent to Tacrolimus 1mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Private Limited, Navi Mumbai, India
Product: Tacrolimus Sandoz
Active Ingredient: Tacrolimus monohydrate 5.11mg equivalent to Tacrolimus 5mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Private Limited, Navi Mumbai, India
Dated this 19th day of October 2011.
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).