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: | AdiraMedica Ibuprofen (General sale) |
Active Ingredient: | Ibuprofen sodium dihydrate 256mg equivalent to ibuprofen 200mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | AdiraMedica Pty Limited |
Manufacturer: | Sunglow Lifescience Private Limited, Kattankulam Village, India |
Product: | AdiraMedica Ibuprofen (Pharmacy only) |
Active Ingredient: | Ibuprofen sodium dihydrate 256mg equivalent to ibuprofen 200mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | AdiraMedica Pty Limited |
Manufacturer: | Sunglow Lifescience Private Limited, Kattankulam Village, India |
Product: | Colgate Total Whole Mouth Health |
Active Ingredients: | Colloidal silicon dioxide 50mg/g Sodium fluoride 3.2mg/g Zinc citrate trihydrate 5mg/g Zinc oxide 10mg/g |
Dosage Form: | Oral paste |
New Zealand Sponsor: | Colgate-Palmolive Limited (NZ) |
Manufacturer: | Colgate-Palmolive (Thailand) Limited, Chonburi, Thailand |
Product: | Fingolimod |
Active Ingredient: | Fingolimod hydrochloride 0.56mg equivalent to fingolimod 0.5mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
Manufacturer: | Teva Pharmaceutical Industries Limited, Kfar Saba, Israel |
Product: | Glycoprep-O Kit (Combination Product) |
Component 1: | |
Active Ingredient: | Bisacodyl 5mg |
Dosage Form: | Tablet |
Component 2: | |
Active Ingredients: | Citric acid 14.3gMagnesium carbonate monohydrate 7.2g |
Dosage Form: | Powder for oral solution |
Component 3: | |
Active Ingredients: | Macrogol 3350 52.9g Potassium chloride 740mg Sodium chloride 2.6g Sodium sulfate 5.6g |
Dosage Form: | Oral powder |
New Zealand Sponsor: | Fresenius Kabi New Zealand Limited |
Manufacturers: | Probiotec Pharma Pty Limited, Melbourne, Australia Remedica Limited, Limassol, Cyprus |
Product: | Ibuprofen (Pharmacy Health) (General sale) |
Active Ingredient: | Ibuprofen sodium dihydrate 256mg equivalent to ibuprofen 200mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | AdiraMedica Pty Limited |
Manufacturer: | Sunglow Lifescience Private Limited, Kattankulam Village, India |
Product: | Ibuprofen (Pharmacy Health) (Pharmacy only) |
Active Ingredient: | Ibuprofen sodium dihydrate 256mg equivalent to ibuprofen 200mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | AdiraMedica Pty Limited |
Manufacturer: | Sunglow Lifescience Private Limited, Kattankulam Village, India |
Product: | Maxiclear Nasal Spray |
Active Ingredient: | Xylometazoline hydrochloride 1mg/mL |
Dosage Form: | Nasal spray solution |
New Zealand Sponsor: | AFT Pharmaceuticals Ltd |
Manufacturer: | Basic Pharma Manufacturing BV, Geleen, Netherlands |
Product: | Midodrine Hydrochloride (Medicianz) |
Active Ingredient: | Midodrine hydrochloride 2.5mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Medicianz Healthcare Limited |
Manufacturer: | Apex Laboratories Private Limited, Kanchipuram, India |
Product: | Midodrine Hydrochloride (Medsurge) |
Active Ingredient: | Midodrine hydrochloride 2.5mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Medicianz Healthcare Limited |
Manufacturer: | Apex Laboratories Private Limited, Kanchipuram, India |
Product: | Midodrine Hydrochloride (Medicianz) |
Active Ingredient: | Midodrine hydrochloride 5mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Medicianz Healthcare Limited |
Manufacturer: | Apex Laboratories Private Limited, Kanchipuram, India |
Product: | Midodrine Hydrochloride (Medsurge) |
Active Ingredient: | Midodrine hydrochloride 5mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Medicianz Healthcare Limited |
Manufacturer: | Apex Laboratories Private Limited, Kanchipuram, India |
Product: | Oncaspar |
Active Ingredient: | Pegaspargase 3750U |
Dosage Form: | Powder for injection |
New Zealand Sponsor: | Servier Laboratories NZ Limited |
Manufacturer: | Lyophilization Services of New England Inc, New Hampshire, United States of America |
Product: | Posaconazole JUNO |
Active Ingredient: | Posaconazole 100mg |
Dosage Form: | Modified release tablet |
New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
Manufacturer: | AET Laboratories Private Limited, Gaddapotharam Village, India |
Product: | RINVOQ |
Active Ingredient: | Upadacitinib hemihydrate 30.7mg equivalent to upadacitinib 30mg |
Dosage Form: | Modified release tablet |
New Zealand Sponsor: | AbbVie Limited |
Manufacturer: | AbbVie Ireland NL B.V., Sligo, Ireland |
Product: | Symdeko 100/150 |
Component 1: | |
Active Ingredients: | Ivacaftor 150mg Tezacaftor 100mg |
Dosage Form: | Film coated tablet |
Component 2: | |
Active Ingredient: | Ivacaftor 150mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
Manufacturers: | Patheon Pharmaceuticals Inc, Ohio, United States of America Aesica Queenborough Limited, Queenborough, United Kingdom Vertex Pharmaceutical Incorporated, Massachusetts, United States of America |
Dated this 14th day of January 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).