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 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).