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:
Active Ingredient:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

DP-Atorvastatin
Atorvastatin calcium trihydrate 10.845mg
equivalent to atorvastatin 10mg
Coated tablet
CARSL Consulting
Sun Pharmaceutical Industries Limited, Paonta Sahib, India

Product:
Active Ingredient:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

DP-Atorvastatin
Atorvastatin calcium trihydrate 21.69mg
equivalent to atorvastatin 20mg
Coated tablet
CARSL Consulting
Sun Pharmaceutical Industries Limited, Paonta Sahib, India

Product:
Active Ingredient:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

DP-Atorvastatin
Atorvastatin calcium trihydrate 43.38mg
equivalent to atorvastatin 40mg
Coated tablet
CARSL Consulting
Sun Pharmaceutical Industries Limited, Paonta Sahib, India

Product:
Active Ingredient:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

DP-Atorvastatin
Atorvastatin calcium trihydrate 86.76mg
equivalent to atorvastatin 80mg
Coated tablet
CARSL Consulting
Sun Pharmaceutical Industries Limited, Paonta Sahib, India

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Erelzi
Etanercept 25mg
Solution for injection
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Erelzi
Etanercept 50mg
Solution for injection
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Erelzi (Pre-filled Auto-Injector)
Etanercept 50mg
Solution for injection
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland

Product:
Active Ingredient:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Naloxone Juno
Naloxone hydrochloride dihydrate 440mcg/mL
equivalent to naloxone hydrochloride 400mcg/mL
Solution for injection
Juno Pharmaceuticals NZ Limited
L.Molteni & C. dei F. lli Alitti Societa di Esercizio S.p.A., Scandicci, Italy

Product:
Active Ingredient:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Naloxone Juno Neonatal
Naloxone hydrochloride dihydrate 22mcg/mL
equivalent to naloxone hydrochloride 20mcg/mL
Solution for injection
Juno Pharmaceuticals NZ Limited
L.Molteni & C. dei F. lli Alitti Societa di Esercizio S.p.A., Scandicci, Italy

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Solifenacin Succinate
Solifenacin succinate 5mg equivalent to solifenacin 3.8mg
Film coated tablet
Max Health Limited
Intas Pharmaceuticals Limited, Sanand, India

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Solifenacin Succinate
Solifenacin succinate 10mg equivalent to solifenacin 7.5mg
Film coated tablet
Max Health Limited
Intas Pharmaceuticals Limited, Sanand, India

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Spinraza
Nusinersen 12mg equivalent to nusinersen heptadecasodium 12.6mg
Solution for injection
Biogen NZ Biopharma Limited
Patheon Italia SpA, Frosinone, Italy
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Dated this 17th day of August 2018.

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