Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Publication Date
15 Aug 2024

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2024-go3992

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: Daptomycin-AFT
Active Ingredient: Daptomycin 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Qilu Pharmaceutical (Hainan) Co Limited, Haikou, China
   
Product: Furosemide-AFT
Active Ingredient: Furosemide 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Private Joint Stock Company “Pharmaceutical firm Darnytsia”, Kiev, Ukraine
   
Product: Parecoxib-AFT
Active Ingredient: Parecoxib sodium 42.36mg equivalent to parecoxib 40mg
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Qilu Pharmaceutical (Hainan) Co Limited, Haikou, China
   
Product: VAXNEUVANCE
Active Ingredients: Pneumococcal polysaccharide serotype 1 2mcg
Pneumococcal polysaccharide serotype 14 2mcg
Pneumococcal polysaccharide serotype 18C 2mcg
Pneumococcal polysaccharide serotype 19A 2mcg
Pneumococcal polysaccharide serotype 19F 2mcg
Pneumococcal polysaccharide serotype 22F 2mcg
Pneumococcal polysaccharide serotype 23F 2mcg
Pneumococcal polysaccharide serotype 3 2mcg
Pneumococcal polysaccharide serotype 33F 2mcg
Pneumococcal polysaccharide serotype 4 2mcg
Pneumococcal polysaccharide serotype 5 2mcg
Pneumococcal polysaccharide serotype 6A 2mcg
Pneumococcal polysaccharide serotype 6B 4mcg
Pneumococcal polysaccharide serotype 7F 2mcg
Pneumococcal polysaccharide serotype 9V 2mcg
Dosage Form: Suspension for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: MSD International GmbH t/a MSD Ireland (Carlow), Carlow, Ireland


Dated this 12th day of August 2024.

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