Notice Title

Consent to the Distribution of New Medicines

Publication Date
21 Aug 2025

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2025-go4547
Title
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File Type and Size
PDF (31 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 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: ILARIS
Active Ingredient: Canakinumab 150mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
   
Product: Leqvio
Active Ingredient: Inclisiran sodium 200mg/mL equivalent to inclisiran 189mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Corden Pharma SpA, Caponago, Italy
Novartis Pharmaceutical Manufacturing GmbH, Langkampfen, Austria
   
Product: Lidocaine Gel 2%
Active Ingredient: Lidocaine hydrochloride monohydrate 2.2%w/w
Dosage Form: Topical gel
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Orion Laboratories Pty Limited t/a Evaris Pharma, Perth, Australia
   
Product: Mucosoothe
Active Ingredient: Lidocaine hydrochloride monohydrate 21.3mg/mL equivalent to lidocaine hydrochloride 2%w/v
Dosage Form: Oral topical gel
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Orion Laboratories Pty Limited t/a Evaris Pharma, Perth, Australia
   
Product: Ozempic (2mg/1.5mL)
Active Ingredient: Semaglutide 1.34mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Hillerod, Denmark
   
Product: Ozempic (4mg/3mL)
Active Ingredient: Semaglutide 1.34mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Hillerod, Denmark
Novo Nordisk Pharmaceutical Industries, North Carolina, United States of America
   
Product: Perrigo Surgi-Prep C Pink
Active Ingredients: Chlorhexidine gluconate 26.625g/L
Ethanol 586.98g/L
Dosage Form: Topical solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Orion Laboratories Pty Limited t/a Evaris Pharma, Perth, Australia
   
Product: Perrigo Surgi-Prep C Red
Active Ingredients: Chlorhexidine gluconate 26.625g/L
Ethanol 586.98g/L
Dosage Form: Topical solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Orion Laboratories Pty Limited t/a Evaris Pharma, Perth, Australia
   
Product: Perrigo Surgi-Prep C+ Pink
Active Ingredients: Chlorhexidine gluconate 106.5g/L
Ethanol 586.95g/L
Dosage Form: Topical solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Orion Laboratories Pty Limited t/a Evaris Pharma, Perth, Australia
   
Product: Perrigo Surgi-Prep C+ Red
Active Ingredients: Chlorhexidine gluconate 106.5g/L
Ethanol 586.98g/L
Dosage Form: Topical solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Orion Laboratories Pty Limited t/a Evaris Pharma, Perth, Australia
   
Product: Riodine Antiseptic Solution
Active Ingredient: Povidone-iodine 100mg/mL equivalent to iodine 1.0%w/v
Dosage Form: Topical solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Orion Laboratories Pty Limited t/a Evaris Pharma, Perth, Australia
   
Product: Ritemvia (100mg/10mL)
Active Ingredient: Rituximab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Celltrion Healthcare New Zealand Limited
Manufacturer: Celltrion Inc., Incheon, South Korea
   
Product: Ritemvia (500mg/50mL)
Active Ingredient: Rituximab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Celltrion Healthcare New Zealand Limited
Manufacturer: Celltrion Inc., Incheon, South Korea
   
Product: Truxima (100mg/10mL)
Active Ingredient: Rituximab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Celltrion Healthcare New Zealand Limited
Manufacturer: Celltrion Inc., Incheon, South Korea
   
Product: Truxima (500mg/50mL)
Active Ingredient: Rituximab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Celltrion Healthcare New Zealand Limited
Manufacturer: Celltrion Inc., Incheon, South Korea
   
Product: Wegovy
Active Ingredient: Semaglutide 0.68mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Hovedstaden, Denmark
Novo Nordisk A/S, Hillerod, Denmark
   
Product: Wegovy (0.5mg FlexTouch)
Active Ingredient: Semaglutide 1.34mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Hovedstaden, Denmark
Novo Nordisk A/S, Hillerod, Denmark
   
Product: Wegovy (1mg FlexTouch)
Active Ingredient: Semaglutide 1.34mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Hovedstaden, Denmark
Novo Nordisk A/S, Hillerod, Denmark
   
Product: Wegovy
Active Ingredient: Semaglutide 2.27mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Hovedstaden, Denmark
Novo Nordisk A/S, Hillerod, Denmark
   
Product: Wegovy
Active Ingredient: Semaglutide 3.2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Hovedstaden, Denmark
Novo Nordisk A/S, Hillerod, Denmark


Dated this 15th 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).