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:
| Product: | Dabigatran etexilate ADVZ |
| Active Ingredient: | Dabigatran etexilate mesylate 86.48mg equivalent to dabigatran etexilate 75mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a Mercury Pharma (NZ) |
| Manufacturer: | Optimus Pharma Pvt. Limited, Patancheru, India |
| Product: | Dabigatran etexilate ADVZ |
| Active Ingredient: | Dabigatran etexilate mesylate 126.83mg equivalent to dabigatran etexilate 110mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a Mercury Pharma (NZ) |
| Manufacturer: | Optimus Pharma Pvt. Limited, Patancheru, India |
| Product: | Dabigatran etexilate ADVZ |
| Active Ingredient: | Dabigatran etexilate mesylate 172.95mg equivalent to dabigatran etexilate 150mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a Mercury Pharma (NZ) |
| Manufacturer: | Optimus Pharma Pvt. Limited, Patancheru, India |
| Product: | Ivermectin ADVZ |
| Active Ingredient: | Ivermectin 3mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a Mercury Pharma (NZ) |
| Manufacturer: | Europeenne De Pharmacotechnie - Europhartech, Lempdes, France |
| Product: | Nicorette QuickMist Mouthspray |
| Active Ingredient: | Nicotine 13.6mg/mL |
| Dosage Form: | Oral spray |
| New Zealand Sponsor: | JNTL Consumer Health (New Zealand) Limited |
| Manufacturer: | McNeil AB, Helsingborg, Sweden |
| Product: | Prasugrel Lupin |
| Active Ingredient: | Prasugrel 5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Lupin NZ Limited |
| Manufacturers: | Jetpharma SA, Balerna, Switzerland Neuraxpharm Pharmaceuticals, S.L., Barcelona, Spain |
| Product: | Prasugrel Lupin |
| Active Ingredient: | Prasugrel 10mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Lupin NZ Limited |
| Manufacturers: | Jetpharma SA, Balerna, Switzerland Neuraxpharm Pharmaceuticals, S.L., Barcelona, Spain |
| Product: | Pyridostigmine Bromide JAMP |
| Active Ingredient: | Pyridostigmine bromide 60mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | JAMP Pharma New Zealand Limited |
| Manufacturers: | Medinfar Manufacturing S.A., Sebal, Portugal Acme Generics Pvt. Limited, Tehsil Nalagarh, India |
| Product: | Rennie |
| Active Ingredients: | Calcium carbonate 680mg Magnesium carbonate 80mg |
| Dosage Form: | Chewable tablet |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturer: | PT Bayer Indonesia, Depok, Indonesia |
| Product: | Tremfya (pre-filled syringe) |
| Active Ingredient: | Guselkumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Cilag AG, Schaffhausen, Switzerland |
| Product: | Tremfya (pre-filled pen) |
| Active Ingredient: | Guselkumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Cilag AG, Schaffhausen, Switzerland |
| Product: | Tremfya (vial) |
| Active Ingredient: | Guselkumab 10mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Cilag AG, Schaffhausen, Switzerland |
| Product: | Vabysmo |
| Active Ingredient: | Faricimab 120mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
Dated this 26th day of June 2026.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).