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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product: CellCept
Active Ingredient: Mycophenolate mofetil 200mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Patheon Inc, Mississauga, Canada
   
Product: CellCept
Active Ingredient: Mycophenolate mofetil 250mg
Dosage Form: Capsule
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Delpharm Milano S.r.L, Milan, Italy
   
Product: CellCept
Active Ingredient: Mycophenolate mofetil 500mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
Pierre Fabre Medicament Production, Idron, France
   
Product: CellCept
Active Ingredient: Mycophenolate mofetil 500mg
Dosage Form: Tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Recipharm Leganes S.L.U., Leganes, Spain
Delpharm Milano S.r.L, Milan, Italy


Dated this 17th day of January 2020.

DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on the 11th day of September 2013).