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: Amisulpride
Active Ingredient: Amisulpride 50mg
Dosage Form: Tablet
New Zealand Sponsor: Max Health Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
   
Product: Amisulpride
Active Ingredient: Amisulpride 100mg
Dosage Form: Tablet
New Zealand Sponsor: Max Health Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
   
Product: Amisulpride
Active Ingredient: Amisulpride 200mg
Dosage Form: Tablet
New Zealand Sponsor: Max Health Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
   
Product: Amisulpride
Active Ingredient: Amisulpride 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Max Health Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
   
Product: Meclozine 12.5
Active Ingredient: Meclozine hydrochloride 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Maple Healthcare Limited
Manufacturer: RA Chem Pharma Limited, Hyderabad, India
   
Product: Meclozine 25
Active Ingredient: Meclozine hydrochloride 25mg
Dosage Form: Tablet
New Zealand Sponsor: Maple Healthcare Limited
Manufacturer: RA Chem Pharma Limited, Hyderabad, India
   
Product: Paracetamol (General sale)
Active Ingredient: Paracetamol 500mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: AA-Med NZ Limited
Manufacturer: Olive Healthcare, Daman, India
   
Product: Paracetamol (Pharmacy only)
Active Ingredient: Paracetamol 500mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: AA-Med NZ Limited
Manufacturer: Olive Healthcare, Daman, India
   
Product: Travel Relief
Active Ingredient: Meclozine hydrochloride 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Maple Healthcare Limited
Manufacturer: RA Chem Pharma Limited, Hyderabad, India
   
Product: Tysabri
Active Ingredient: Natalizumab 150mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Biogen NZ Biopharma Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany


Dated this 18th day of September 2023.

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