Gazette.govt.nzPursuant 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:
Schedule
| Product: | Calcipotriol/Betamethasone Sandoz 50/500 |
| Active Ingredients: | Betamethasone dipropionate 0.643mg/g equivalent to betamethasone 0.50mg/g Calcipotriol monohydrate 0.0522mg/g equivalent to calcipotriol 0.050mg/g |
| Dosage Form: | Topical ointment |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Salutas Pharma GmbH, Sulzetal Ortsteil Osterweddingen, Germany |
| Product: | Erlotinib |
| Active Ingredient: | Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Alchemy Health Limited |
| Manufacturer: | Remedica Limited, Limassol, Cyprus |
| Product: | Erlotinib |
| Active Ingredient: | Erlotinib hydrochloride 54.63mg equivalent to erlotinib 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Alchemy Health Limited |
| Manufacturer: | Remedica Limited, Limassol, Cyprus |
| Product: | Erlotinib |
| Active Ingredient: | Erlotinib hydrochloride 109.27mg equivalent to erlotinib 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Alchemy Health Limited |
| Manufacturer: | Remedica Limited, Limassol, Cyprus |
| Product: | Erlotinib |
| Active Ingredient: | Erlotinib hydrochloride 163.9mg equivalent to erlotinib 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Alchemy Health Limited |
| Manufacturer: | Remedica Limited, Limassol, Cyprus |
| Product: | Febrex (General sale) |
| Active Ingredient: | Paracetamol 500mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Miro Healthcare Limited |
| Manufacturer: | Indoco Remedies Limited, Verna, India |
| Product: | Febrex (Pharmacy only) |
| Active Ingredient: | Paracetamol 500mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Miro Healthcare Limited |
| Manufacturer: | Indoco Remedies Limited, Verna, India |
| Product: | Febrex (Prescription) |
| Active Ingredient: | Paracetamol 500mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Miro Healthcare Limited |
| Manufacturer: | Indoco Remedies Limited, Verna, India |
| Product: | PediPPI |
| Active Ingredient: | Omeprazole 2mg/mL |
| Dosage Form: | Powder for oral suspension |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturer: | Xeolas Pharmaceuticals Limited, Dublin, Ireland |
| Product: | PediPPI |
| Active Ingredient: | Omeprazole 4mg/mL |
| Dosage Form: | Powder for oral suspension |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturer: | Xeolas Pharmaceuticals Limited, Dublin, Ireland |
| Product: | Vebulis |
| Active Ingredient: | Iloprost 0.01mg/mL |
| Dosage Form: | Solution for inhalation |
| New Zealand Sponsor: | Devatis Limited |
| Manufacturer: | Deva Holding AS, Kartepe, Turkey |
| Product: | Zeposia (Combination product) |
| Component 1 | |
| Active Ingredient: | Ozanimod 0.23mg equivalent to ozanimod hydrochloride 0.25mg |
| Dosage Form: | Capsule |
| Component 2 | |
| Active Ingredient: | Ozanimod 0.46mg equivalent to ozanimod hydrochloride 0.5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Celgene Limited |
| Manufacturers: | Patheon Inc, Mississauga, Canada Celgene International Sarl, Boudry, Switzerland |
| Product: | Zeposia |
| Active Ingredient: | Ozanimod 0.92mg equivalent to ozanimod hydrochloride 1mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Celgene Limited |
| Manufacturers: | Patheon Inc, Mississauga, Canada Celgene International Sarl, Boudry, Switzerland |
Dated this 10th day of May 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).