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 are set out in the Schedule hereto:
| Product: | Comirnaty LP.8.1 (MDV) |
| Active Ingredient: | SARS-CoV-2 spike protein (mRNA) LP.8.1 0.033mg/mL equivalent to 10mcg/0.3mL dose |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium |
| Product: | Comirnaty LP.8.1 (SDV) |
| Active Ingredient: | SARS-CoV-2 spike protein (mRNA) LP.8.1 0.033mg/mL equivalent to 10mcg/0.3mL dose |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium |
| Product: | Comirnaty LP.8.1 |
| Active Ingredient: | SARS-CoV-2 spike protein (mRNA) LP.8.1 0.033mg/mL equivalent to 3mcg/0.3mL dose |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium |
| Product: | Comirnaty LP.8.1 (MDV) |
| Active Ingredient: | SARS-CoV-2 spike protein (mRNA) LP.8.1 0.1mg/mL equivalent to 30mcg/0.3mL dose |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium |
| Product: | Comirnaty LP.8.1 (PFS) |
| Active Ingredient: | SARS-CoV-2 spike protein (mRNA) LP.8.1 0.1mg/mL equivalent to 30mcg/0.3mL dose |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium |
| Product: | Itovebi |
| Active Ingredient: | Inavolisib 3mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland |
| Product: | Itovebi |
| Active Ingredient: | Inavolisib 9mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland |
| Product: | Osenvelt |
| Active Ingredient: | Denosumab 70mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Patheon Italia S.p.A, Milan, Italy |
| Product: | Relfydess |
| Active Ingredient: | Botulinum toxin type A 100U/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Q-Med AB, Uppsala, Sweden |
| Product: | Sacubitril/Valsartan 24/26 |
| Active Ingredients: | Sacubitril sodium 25.6mg equivalent to sacubitril 24.3mg Valsartan disodium 28.3mg equivalent to valsartan 25.7mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Devatis Limited |
| Manufacturer: | Deva Holding AS, Tekirdag, Turkey |
| Product: | Sacubitril/Valsartan 49/51 |
| Active Ingredients: | Sacubitril sodium 51.2mg equivalent to sacubitril 48.60mg Valsartan disodium 56.59mg equivalent to valsartan 51.40mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Devatis Limited |
| Manufacturer: | Deva Holding AS, Tekirdag, Turkey |
| Product: | Sacubitril/Valsartan 97/103 |
| Active Ingredients: | Sacubitril sodium 102.39mg equivalent to sacubitril 97.20mg Valsartan disodium 113.18mg equivalent to valsartan 102.80mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Devatis Limited |
| Manufacturer: | Deva Holding AS, Tekirdag, Turkey |
| Product: | Stoboclo |
| Active Ingredient: | Denosumab 60mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Product: | Thiamine-REX |
| Active Ingredient: | Thiamine hydrochloride 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Maple Healthcare Limited |
| Manufacturer: | Sri Krishna Pharmaceuticals Limited, Hyderabad, India |
Dated this 28th day of October 2025.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).