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: Bosvate
Active Ingredient: Bisoprolol fumarate 1.25mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Chanelle Medical Limited, County Galway, Ireland
Product: Bosvate
Active Ingredient: Bisoprolol fumarate 3.75mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Chanelle Medical Limited, County Galway, Ireland
Product: Bosvate
Active Ingredient: Bisoprolol fumarate 7.5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Chanelle Medical Limited, County Galway, Ireland
Product: Ceftriaxone
Active Ingredient: Ceftriaxone sodium 0.596g equivalent to Ceftriaxone 0.5g
Dosage Form: Powder for injection
New Zealand Sponsor: Deva Holdings NZ Limited
Manufacturer: Deva Holding A.S., Tekirdag, Turkey
Product: Ceftriaxone
Active Ingredient: Ceftriaxone sodium 1.193g equivalent to Ceftriaxone 1.0g
Dosage Form: Powder for injection
New Zealand Sponsor: Deva Holdings NZ Limited
Manufacturer: Deva Holding A.S., Tekirdag, Turkey
Product: Cold & Flu Relief + Decongestant DAY + NIGHT
Day Tablet
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Night Tablet
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Maharashtra, India
Product: DBLT Zoledronic Acid Concentrate for Infusion
Active Ingredient: Zoledronic acid monohydrate 4.3mg equivalent to Zoledronic acid 4mg
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Inc, North Carolina, United States of America
Product: Endyarid
Active Ingredients: Atropine sulfate 0.025mg
Diphenoxylate hydrochloride 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Drug Houses of Australia Private Limited, Singapore
Product: Gastro-Soothe Forte
Active Ingredient: Hyoscine butylbromide 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Sigma Laboratories Limited, Goa, India
Product: Granisetron-AFT
Active Ingredient: Granisetron hydrochloride 1.12mg/mL equivalent to Granisetron 1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Qilu Pharmaceutical Co Limited, Shandong Province, China
Product: OMEPRAZOLE ACTAVIS 10
Active Ingredient: Omeprazole 10mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
Product: OMEPRAZOLE ACTAVIS 20
Active Ingredient: Omeprazole 20mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
Product: OMEPRAZOLE ACTAVIS 40
Active Ingredient: Omeprazole 40mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
Product: Oxycodone Immediate Release Capsules
Active Ingredient: Oxycodone hydrochloride 5mg equivalent to Oxycodone 4.48mg
Dosage Form: Capsule
New Zealand Sponsor: InterPharma (NZ) Limited
Manufacturers: Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria
Product: Oxycodone Immediate Release Capsules
Active Ingredient: Oxycodone hydrochloride 10mg equivalent to Oxycodone 8.96mg
Dosage Form: Capsule
New Zealand Sponsor: InterPharma (NZ) Limited
Manufacturers: Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria
Product: Oxycodone Immediate Release Capsules
Active Ingredient: Oxycodone hydrochloride 20mg equivalent to Oxycodone 17.93mg
Dosage Form: Capsule
New Zealand Sponsor: InterPharma (NZ) Limited
Manufacturers: Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria
Product: Rulide D
Active Ingredient: Roxithromycin 50mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Winthrop Industrie, Compiegne, France
Product: Ziprasidone Actavis
Active Ingredient: Ziprasidone hydrochloride 21.72mg equivalent to Ziprasidone 20mg
Dosage Form: Capsule
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturers: Actavis ehf, Hafnarfjordur, Iceland
Actavis Limited, Zejtun, Malta
Product: Ziprasidone Actavis
Active Ingredient: Ziprasidone hydrochloride 43.44mg equivalent to Ziprasidone 40mg
Dosage Form: Capsule
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturers: Actavis ehf, Hafnarfjordur, Iceland
Actavis Limited, Zejtun, Malta
Product: Ziprasidone Actavis
Active Ingredient: Ziprasidone hydrochloride 65.16mg equivalent to Ziprasidone 60mg
Dosage Form: Capsule
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturers: Actavis ehf, Hafnarfjordur, Iceland
Actavis Limited, Zejtun, Malta
Product: Ziprasidone Actavis
Active Ingredient: Ziprasidone hydrochloride 86.88mg equivalent to Ziprasidone 80mg
Dosage Form: Capsule
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturers: Actavis ehf, Hafnarfjordur, Iceland
Actavis Limited, Zejtun, Malta
Product: Zusdone
Active Ingredient: Ziprasidone hydrochloride 21.72mg equivalent to Ziprasidone 20mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Actavis ehf, Hafnarfjordur, Iceland
Product: Zusdone
Active Ingredient: Ziprasidone hydrochloride 43.44mg equivalent to Ziprasidone 40mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Actavis ehf, Hafnarfjordur, Iceland
Product: Zusdone
Active Ingredient: Ziprasidone hydrochloride 65.16mg equivalent to Ziprasidone 60mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Actavis ehf, Hafnarfjordur, Iceland
Product: Zusdone
Active Ingredient: Ziprasidone hydrochloride 86.88mg equivalent to Ziprasidone 80mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Actavis ehf, Hafnarfjordur, Iceland
Dated this 15th day of August 2014.
SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).