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: | CandaDerm 1 Day Thrush Pessary |
| Active Ingredient: | Clotrimazole 500mg |
| Dosage Form: | Pessary |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Bliss GVS Pharma Limited, Palghar, India |
| Product: | CandaDerm 6 Day Thrush Pessary |
| Active Ingredient: | Clotrimazole 100mg |
| Dosage Form: | Pessary |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Bliss GVS Pharma Limited, Palghar, India |
| Product: | Feryxa (100mg/2mL) |
| Active Ingredient: | Ferric carboxymaltose 180mg/mL equivalent to iron 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturers: | IDT Biologika GmbH, Dessau-Rosslau, Germany Siegfried Hameln GmbH, Hameln, Germany |
| Product: | Feryxa (500mg/10mL) |
| Active Ingredient: | Ferric carboxymaltose 180mg/mL equivalent to iron 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturers: | IDT Biologika GmbH, Dessau-Rosslau, Germany Siegfried Hameln GmbH, Hameln, Germany |
| Product: | Feryxa (1000mg/20mL) |
| Active Ingredient: | Ferric carboxymaltose 180mg/mL equivalent to iron 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturers: | IDT Biologika GmbH, Dessau-Rosslau, Germany Siegfried Hameln GmbH, Hameln, Germany |
| Product: | Flucloxacillin Eugia |
| Active Ingredient: | Flucloxacillin sodium monohydrate 544mg equivalent to flucloxacillin 500mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | EUGIA SEZ Private Limited, Mahabubnagar, India |
| Product: | Flucloxacillin Eugia |
| Active Ingredient: | Flucloxacillin sodium monohydrate 1088mg equivalent to flucloxacillin 1000mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | EUGIA SEZ Private Limited, Mahabubnagar, India |
| Product: | Folic Acid |
| Active Ingredient: | Folic acid 5mg equivalent to folic acid hydrate 5.46mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Maple Healthcare Limited |
| Manufacturer: | Sri Krishna Pharmaceuticals Limited, Shamshabad, India |
| Product: | Folic Acid Maple |
| Active Ingredient: | Folic acid 5mg equivalent to Folic acid hydrate 5.46mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Maple Healthcare Limited |
| Manufacturer: | Sri Krishna Pharmaceuticals Limited, Shamshabad, India |
| Product: | I-Losartan potassium and Hydrochlorothiazide |
| Active Ingredients: | Hydrochlorothiazide 12.5mg Losartan potassium 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Ipca-Paracetamol |
| Active Ingredient: | Paracetamol 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Losartan Potassium and Hydrochlorothiazide |
| Active Ingredients: | Hydrochlorothiazide 12.5mg Losartan potassium 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Maxiclear Day and Night |
| Component 1: | |
| Active Ingredients: | Paracetamol 500mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Film coated tablet |
| Component 2: | |
| Active Ingredients: | Chlorphenamine maleate 2mg Paracetamol 500mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturers: | XL Laboratories Pvt. Limited, Bhiwadi, India |
| Product: | MedEx Cold & Flu Relief PE |
| Active Ingredients: | Paracetamol 500mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Medreich Limited, Bengaluru, India |
| Product: | Medreich Cold & Flu Relief PE Day Tablets (Pharmacy only) |
| Active Ingredients: | Paracetamol 500mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Medreich Limited, Bengaluru, India |
| Product: | Medreich Cold & Flu Relief PE Day Tablets (General sale) |
| Active Ingredients: | Paracetamol 500mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Medreich Limited, Bengaluru, India |
| Product: | Medreich Cold & Flu Relief PE Night tablets |
| Active Ingredients: | Chlorphenamine maleate 2mg Paracetamol 500mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Medreich Limited, Bengaluru, India |
| Product: | Mounjaro (KwikPen) |
| Active Ingredient: | Tirzepatide 4.17mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturers: | Eli Lilly and Company Inc, Indiana, United States of America Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Product: | Mounjaro (Pre-filled Pen) |
| Active Ingredient: | Tirzepatide 5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | BSP Pharmaceuticals SpA, Latina Scalo, Italy |
| Product: | Mounjaro (Vial) |
| Active Ingredient: | Tirzepatide 5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | Eli Lilly Italia SpA, Florence, Italy |
| Product: | Mounjaro (KwikPen) |
| Active Ingredient: | Tirzepatide 8.33mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | BSP Pharmaceuticals SpA, Latina Scalo, Italy |
| Product: | Mounjaro (Pre-filled Pen) |
| Active Ingredient: | Tirzepatide 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturers: | Eli Lilly and Company Inc, Indiana, United States of America Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Product: | Mounjaro (Vial) |
| Active Ingredient: | Tirzepatide 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturers: | Eli Lilly and Company Inc, Indiana, United States of America Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Product: | Mounjaro (KwikPen) |
| Active Ingredient: | Tirzepatide 12.5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | BSP Pharmaceuticals SpA, Latina Scalo, Italy |
| Product: | Mounjaro (Pre-filled Pen) |
| Active Ingredient: | Tirzepatide 15mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | Eli Lilly Italia SpA, Florence, Italy |
| Product: | Mounjaro (Vial) |
| Active Ingredient: | Tirzepatide 15mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturers: | Eli Lilly and Company Inc, Indiana, United States of America Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Product: | Mounjaro (KwikPen) |
| Active Ingredient: | Tirzepatide 16.67mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | BSP Pharmaceuticals SpA, Latina Scalo, Italy |
| Product: | Mounjaro (Pre-filled Pen) |
| Active Ingredient: | Tirzepatide 20mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | Eli Lilly Italia SpA, Florence, Italy |
| Product: | Mounjaro (Vial) |
| Active Ingredient: | Tirzepatide 20mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturers: | Eli Lilly and Company Inc, Indiana, United States of America Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Product: | Mounjaro (Kwik Pen) |
| Active Ingredient: | Tirzepatide 20.83mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | BSP Pharmaceuticals SpA, Latina Scalo, Italy |
| Product: | Mounjaro (KwikPen) |
| Active Ingredient: | Tirzepatide 25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturers: | Eli Lilly and Company Inc, Indiana, United States of America Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
| Product: | Mounjaro (Pre-filled Pen) |
| Active Ingredient: | Tirzepatide 25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | BSP Pharmaceuticals SpA, Latina Scalo, Italy |
| Product: | Mounjaro (Vial) |
| Active Ingredient: | Tirzepatide 25mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | Eli Lilly Italia SpA, Florence, Italy |
| Product: | Mounjaro (Pre-filled Pen) |
| Active Ingredient: | Tirzepatide 30mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | Eli Lilly Italia SpA, Florence, Italy |
| Product: | Mounjaro (Vial) |
| Active Ingredient: | Tirzepatide 30mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturer: | Eli Lilly Italia SpA, Florence, Italy |
| Product: | Paracetamol Quiphen |
| Active Ingredient: | Paracetamol 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Ipca Pharma (NZ) Pty Limited |
| Manufacturer: | Ipca Laboratories Limited, Silvassa, India |
| Product: | Pharmacor Ticagrelor |
| Active Ingredient: | Ticagrelor 90mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacor Limited |
| Manufacturer: | Alkem Laboratories Limited, Nalagarh, India |
| Product: | PharmEx Cold & Flu Relief PE |
| Active Ingredient: | Paracetamol 500mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Medreich Limited, Bengaluru, India |
| Product: | Platexa |
| Active Ingredient: | Ticagrelor 90mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacor Limited |
| Manufacturer: | Alkem Laboratories Limited, Nalagarh, India |
| Product: | Plerixafor Eugia |
| Active Ingredient: | Plerixafor 20mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Eugia Pharma Specialities Limited, Malkajgiri, India |
| Product: | Sonaflam |
| Active Ingredient: | Naproxen sodium 275mg equivalent to naproxen 250mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturer: | Cipla Limited, District Raigad, India Medispray Laboratories Pvt Limited, Satara, India |
| Product: | Topreloc-XL |
| Active Ingredient: | Metoprolol succinate 23.75mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacor Limited |
| Manufacturer: | Alkem Laboratories Limited, Daman, India |
| Product: | Topreloc-XL |
| Active Ingredient: | Metoprolol succinate 47.5mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacor Limited |
| Manufacturer: | Alkem Laboratories Limited, Daman, India |
| Product: | Topreloc-XL |
| Active Ingredient: | Metoprolol succinate 95mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacor Limited |
| Manufacturer: | Alkem Laboratories Limited, Daman, India |
| Product: | Topreloc-XL |
| Active Ingredient: | Metoprolol succinate 190mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacor Limited |
| Manufacturer: | Alkem Laboratories Limited, Daman, India |
Dated this 19th day of December 2025.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).