Notice Title

Consent to the Distribution of New Medicines

Publication Date
28 Aug 2025

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2025-go4762
Title
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File Type and Size
PDF (27 KB)

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 are set out in the Schedule hereto:

Schedule

Product: AndroForte 5
Active Ingredient: Testosterone 50mg/mL
Dosage Form: Transdermal cream
New Zealand Sponsor: Alchemy Health Limited
Manufacturer: Orion Laboratories Pty Limited t/a Evaris Pharma, Perth, Australia
   
Product: Fulvestrant Accord
Active Ingredient: Fulvestrant 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
   
Product: Fulvestrant SXP
Active Ingredient: Fulvestrant 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Southern XP Pty Limited
Manufacturer: Sichuan Huiyu Pharmaceutical Company Limited, Neijiang, China
   
Product: Glyceryl Trinitrate (Medicianz)
Active Ingredient: Glyceryl trinitrate 1mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Bioindustria Laboratorio Italiano Medicinali SpA, Novi Ligure AL, Italy
   
Product: Glyceryl Trinitrate (Medsurge)
Active Ingredient: Glyceryl trinitrate 1mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Bioindustria Laboratorio Italiano Medicinali SpA, Novi Ligure AL, Italy
   
Product: Lemsip Max Decongestant Cold & Flu Hot Drink
Active Ingredient: Paracetamol 1000mg Phenylephrine hydrochloride 12.2mg equivalent to phenylephrine 10mg
Dosage Form: Powder for oral solution
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, United Kingdom
   
Product: Medreich Promethazine
Active Ingredient: Promethazine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medreich New Zealand Limited
Manufacturer: Medreich Limited, Bangalore, India
   
Product: Medreich Promethazine
Active Ingredient: Promethazine hydrochloride 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medreich New Zealand Limited
Manufacturer: Medreich Limited, Bangalore, India
   
Product: Medreich Rosuvastatin
Active Ingredient: Rosuvastatin calcium 5.21mg equivalent to rosuvastatin 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medreich New Zealand Limited
Manufacturer: Medreich Limited, Bangalore, India
   
Product: Medreich Rosuvastatin
Active Ingredient: Rosuvastatin calcium 10.42mg equivalent to rosuvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medreich New Zealand Limited
Manufacturer: Medreich Limited, Bangalore, India
   
Product: Medreich Rosuvastatin
Active Ingredient: Rosuvastatin calcium 20.84mg equivalent to rosuvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medreich New Zealand Limited
Manufacturer: Medreich Limited, Bangalore, India
   
Product: Medreich Rosuvastatin
Active Ingredient: Rosuvastatin calcium 41.68mg equivalent to rosuvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medreich New Zealand Limited
Manufacturer: Medreich Limited, Bangalore, India
   
Product: Paracetamol For Children 1 Month to 5 Years
Active Ingredient: Paracetamol 24mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Noumed Pharmaceuticals Limited
Manufacturer: Gracure Pharmaceuticals Limited, Bhiwadi, India


Dated this 25th day of August 2025.

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