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: | Cold & Flu Day & Night Relief |
| Component 1: | |
| Active Ingredients: | Chlorphenamine maleate 2mg Paracetamol 500mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Film coated tablet |
| Component 2: | |
| 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: | Difflam Dry Cough + Antibacterial + Anti-Inflammatory (Blackcurrant Flavour Sugar Free) |
| Active Ingredients: | Benzydamine hydrochloride 1.5mg Cetylpyridinium chloride 1.33mg Dextromethorphan hydrobromide monohydrate 10mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Unique Pharmaceuticals Laboratories, Kadaiya, India |
| Product: | Difflam Dry Cough + Antibacterial + Anti-Inflammatory (Pineapple Lime Flavour Sugar Free) |
| Active Ingredients: | Benzydamine hydrochloride 1.5mg Cetylpyridinium chloride 1.33mg Dextromethorphan hydrobromide monohydrate 10mg |
| Dosage Form: | Lozenge |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturer: | Unique Pharmaceuticals Laboratories, Kadaiya, India |
| Product: | Ferrive (100mg/2mL) |
| Active Ingredient: | Ferric carboxymaltose 178.57mg/mL equivalent to elemental iron 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Hosur, India |
| Product: | Ferrive (500mg/10mL) |
| Active Ingredient: | Ferric carboxymaltose 178.57mg/mL equivalent to elemental iron 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Hosur, India |
| Product: | Ferrive (1000mg/20mL) |
| Active Ingredient: | Ferric carboxymaltose 178.57mg/mL equivalent to elemental iron 50mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Hosur, India |
| Product: | Haloperidol (Medicianz) |
| Active Ingredient: | Haloperidol 5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | Swiss Parenterals Limited, Ahmedabad, India |
| Product: | Haloperidol (Medsurge) |
| Active Ingredient: | Haloperidol 5mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Medsurge Pharma Limited |
| Manufacturer: | Swiss Parenterals Limited, Ahmedabad, India |
| Product: | Lacosamide-Teva |
| Active Ingredient: | Lacosamide 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Teva Pharmaceutical Works Private Limited Company, Debrecen, Hungary |
| Product: | Lacosamide-Teva |
| Active Ingredient: | Lacosamide 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Teva Pharmaceutical Works Private Limited Company, Debrecen, Hungary |
| Product: | Lacosamide-Teva |
| Active Ingredient: | Lacosamide 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Teva Pharmaceutical Works Private Limited Company, Debrecen, Hungary |
| Product: | Lacosamide-Teva |
| Active Ingredient: | Lacosamide 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Teva Pharmaceutical Works Private Limited Company, Debrecen, Hungary |
| Product: | MedEx Cold & Flu Relief PE Day & Night |
| Component 1: | |
| Active Ingredients: | Chlorphenamine maleate 2mg Paracetamol 500mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Film coated tablet |
| Component 2: | |
| 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 & Night Tablets |
| Component 1: | |
| Active Ingredients: | Chlorphenamine maleate 2mg Paracetamol 500mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Film coated tablet |
| Component 2: | |
| 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: | PharmEx Cold & Flu Relief PE Day & Night |
| Component 1: | |
| Active Ingredients: | Chlorphenamine maleate 2mg Paracetamol 500mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Film coated tablet |
| Component 2: | |
| 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: | Plerixafor |
| Active Ingredient: | Plerixafor 20mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | REX Medical Limited |
| Manufacturer: | MSN Laboratories Private Limited, Nandigama, India |
| Product: | Tofacitinib Sandoz |
| Active Ingredient: | Tofacitinib citrate 8.075mg equivalent to tofacitinib 5mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturers: | Granules India Limited, Visakhapatnam, India Haupt Pharma Amareg GmbH, Regensburg, Germany |
| Product: | Vildagliptin/Metformin (Teva) |
| Active Ingredients: | Metformin hydrochloride 850mg Vildagliptin 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Bluepharma Industria Farmaceutica S.A., Coimbra, Portugal |
| Product: | Vildagliptin/Metformin (Teva) |
| Active Ingredients: | Metformin hydrochloride 1000mg Vildagliptin 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Bluepharma Industria Farmaceutica S.A., Coimbra, Portugal |
Dated this 23rd day of March 2026.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).