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: | Benedo |
| Active Ingredient: | Liraglutide 6mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Sun Pharmaceutical Industries Limited, Halol, India |
| Product: | Berinert IV |
| Active Ingredient: | Human C1-Esterase Inhibitor 500IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Berinert IV |
| Active Ingredient: | Human C1-Esterase Inhibitor 1500IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Berinert SC |
| Active Ingredient: | Human C1-Esterase Inhibitor 2000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Berinert SC |
| Active Ingredient: | Human C1-Esterase Inhibitor 3000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Ferric Carboxymaltose (100mg/2mL) |
| Active Ingredient: | Ferric carboxymaltose 185mg/mL equivalent to iron 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | PLIVA Croatia Limited., Zagreb, Croatia |
| Product: | Ferric Carboxymaltose (500mg/10mL) |
| Active Ingredient: | Ferric carboxymaltose 185mg/mL equivalent to iron 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | PLIVA Croatia Limited., Zagreb, Croatia |
| Product: | Ferric Carboxymaltose (1000mg/20mL) |
| Active Ingredient: | Ferric carboxymaltose 185mg/mL equivalent to iron 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | PLIVA Croatia Limited., Zagreb, Croatia |
| Product: | Flucelvax |
| Active Ingredients: | Influenza virus A (H1N1) haemagglutinin 15mcg Influenza virus A (H3N2) haemagglutinin 15mcg Influenza virus B (Victoria) haemagglutinin 15mcg |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturers: | Rovi Pharma Industrial Services, S.A., Madrid, Spain CSL Behring GmbH, Marburg, Germany Seqirus Inc., North Carolina, United States of America |
| Product: | IXIFI |
| Active Ingredient: | Infliximab 100mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium |
| Product: | Liraglutide RBX |
| Active Ingredient: | Liraglutide 6mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Sun Pharmaceutical Industries Limited, Halol, India |
| Product: | Liraglutide SUN |
| Active Ingredient: | Liraglutide 6mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Sun Pharmaceutical Industries Limited, Halol, India |
| Product: | Nintedanib Sandoz |
| Active Ingredient: | Nintedanib esilate 120.4mg equivalent to nintedanib 100mg |
| Dosage Form: | Liquid filled capsule |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturer: | Lotus Pharmaceutical Co Limited, Nantou City, Taiwan |
| Product: | Nintedanib Sandoz |
| Active Ingredient: | Nintedanib esilate 180.6mg equivalent to nintedanib 150mg |
| Dosage Form: | Liquid filled capsule |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturer: | Lotus Pharmaceutical Co Limited, Nantou City, Taiwan |
| Product: | Saphnelo |
| Active Ingredient: | Anifrolumab 150mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | AstraZeneca Limited |
| Manufacturer: | AstraZeneca Nijmegen B.V., Nijmegen, Netherlands |
| Product: | Zantac 150 |
| Active Ingredient: | Ranitidine hydrochloride 168mg equivalent to ranitidine 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Strides Pharma Science Limited, Puducherry, India |
| Product: | Zantac 300 |
| Active Ingredient: | Ranitidine hydrochloride 336mg equivalent to ranitidine 300mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Strides Pharma Science Limited, Puducherry, India |
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).