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: Hulio (20mg/0.4mL)
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Viatris Limited
Manufacturer: Terumo Yamaguchi D&D Corporation, Yamaguchi, Japan
   
Product: Hulio (40mg/0.8mL)
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Viatris Limited
Manufacturer: Terumo Yamaguchi D&D Corporation, Yamaguchi, Japan
   
Product: Hulio (40mg/0.8mL Pen)
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Viatris Limited
Manufacturer: Terumo Yamaguchi D&D Corporation, Yamaguchi, Japan
   
Product: Tadalafil Sandoz
Active Ingredient: Tadalafil 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
   
Product: Tadalafil Sandoz
Active Ingredient: Tadalafil 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
   
Product: Tadalafil Sandoz
Active Ingredient: Tadalafil 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India


Dated this 28th day of September 2021.

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