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: Calcipotriol/Betamethasone
Active Ingredients: Betamethasone dipropionate 0.643mg/g equivalent to betamethasone base 0.500mg/g
Calcipotriol 0.05mg/g
Dosage Form: Topical ointment
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: PLIVA Croatia Limited, Zagreb, Croatia
   
Product: Fynod
Active Ingredients: Fingolimod hydrochloride 0.56mg equivalent to fingolimod 0.5mg
Dosage Form: Capsule
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Laboratories Limited, Pithampur, India
   
Product: Glucose 10% w/v
Active Ingredient: Glucose monohydrate 110g/L equivalent to glucose 100g/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturers: Fresenius Kabi France, Louviers Cedex, France
Fresenius Kabi AG, Friedberg, Germany
   
Product: Pabrinex
Component 1:  
Active Ingredients: Pyridoxine hydrochloride 10mg/mL
Riboflavin sodium phosphate 1.016mg/mL equivalent to riboflavin 0.8mg/mL
Thiamine hydrochloride 50mg/mL
Dosage Form: Concentrate for infusion
Component 2:  
Active Ingredients: Ascorbic acid 100mg/mL
Glucose monohydrate 220mg/mL equivalent to glucose 200mg/mL
Nicotinamide 32mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Max Health Limited
Manufacturer: Haupt Pharma Wulfing GmbH, Gronau/Leine, Germany
   
Product: Paracetamol (GenericPharm) (General sale)
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Anqiu Lu’an Pharmaceutical Co Limited, Anqiu City, China
   
Product: Paracetamol (GenericPharm) (Pharmacy only)
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Anqiu Lu’an Pharmaceutical Co Limited, Anqiu City, China
   
Product: Paracetamol (MedPharm) (General sale)
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Anqiu Lu'an Pharmaceutical Co Limited, Anqiu City, China
   
Product: Paracetamol (MedPharm) (Pharmacy only)
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Anqiu Lu’an Pharmaceutical Co Limited, Anqiu City, China
   
Product: Paracetamol (MedPharm) (Prescription)
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Anqiu Lu’an Pharmaceutical Co Limited, Anqiu City, China
   
Product: Paracetamol (MedTech) (General sale)
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Anqiu Lu’an Pharmaceutical Co Limited, Anqiu City, China
   
Product: Paracetamol (MedTech) (Pharmacy only)
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Anqiu Lu’an Pharmaceutical Co Limited, Anqiu City,China
   
Product: Vizo-PF Bimatoprost
Active Ingredient: Bimatoprost 0.3mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturers: Excelvision, Annonay, France
Ionisos, Sablé-sur-Sarthe, France
   
Product: Zematane
Active Ingredient: Alitretinoin 10mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Auckland, New Zealand
   
Product: Zematane
Active Ingredient: Alitretinoin 30mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Auckland, New Zealand


Dated this 4th day of May 2022.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).