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: | Bi-Gesic (General sale) |
| Active Ingredients: | Ibuprofen 200mg Paracetamol 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | REX Medical Limited |
| Manufacturer: | Milan Laboratories (India) Pvt Limited, Mumbai, India |
| Product: | Bi-Gesic (Pharmacy only) |
| Active Ingredients: | Ibuprofen 200mg Paracetamol 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | REX Medical Limited |
| Manufacturer: | Milan Laboratories (India) Pvt Limited, Mumbai, India |
| Product: | Biofreeze Pain Relieving Gel |
| Active Ingredient: | Levomenthol 35mg/g |
| Dosage Form: | Topical gel |
| New Zealand Sponsor: | Sports Health Limited |
| Manufacturer: | Span Contract Packaging Inc, South Carolina, United States of America |
| Product: | Biofreeze Pain Relieving Roll-on Gel |
| Active Ingredient: | Levomenthol 35mg/g |
| Dosage Form: | Topical gel |
| New Zealand Sponsor: | Sports Health Limited |
| Manufacturer: | Span Contract Packaging Inc, South Carolina, United States of America |
| Product: | Carglumic Acid Waymade |
| Active Ingredient: | Carglumic acid 200mg |
| Dosage Form: | Dispersible tablet |
| New Zealand Sponsor: | Te Arai BioFarma Limited |
| Manufacturer: | Apothecon Pharmaceuticals Pvt. Limited, Vadodara, India |
| Product: | Contrave 8/90 |
| Active Ingredients: | Bupropion hydrochloride 90mg equivalent to bupropion 78mg Naltrexone hydrochloride 8mg equivalent to naltrexone 7.2mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | iNova Pharmaceuticals (New Zealand) Limited |
| Manufacturers: | Patheon Inc, Ontario, Canada Sanofi Winthrop Industrie, Tours, France |
| Product: | Diarrhoea Relief |
| Active Ingredient: | Loperamide hydrochloride 2mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | PSM Healthcare Limited trading as API Consumer Brands |
| Manufacturer: | Adcock Ingram Limited - A Medreich Group Company, Anekal, India |
| Product: | Fibrinox |
| Active Ingredient: | Enoxaparin sodium 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Rovi Pharma Industrial Services, Madrid, Spain |
| Product: | Fibrinox Forte |
| Active Ingredient: | Enoxaparin sodium 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Rovi Pharma Industrial Services, Madrid, Spain |
| Product: | Fosrenol |
| Active Ingredient: | Lanthanum carbonate hydrate 954mg equivalent to elemental lanthanum 500mg |
| Dosage Form: | Chewable tablet |
| New Zealand Sponsor: | Takeda New Zealand Limited |
| Manufacturer: | Hamol Limited, Nottingham, United Kingdom |
| Product: | Fosrenol |
| Active Ingredient: | Lanthanum carbonate hydrate 1431mg equivalent to elemental lanthanum 750mg |
| Dosage Form: | Chewable tablet |
| New Zealand Sponsor: | Takeda New Zealand Limited |
| Manufacturer: | Hamol Limited, Nottingham, United Kingdom |
| Product: | Fosrenol |
| Active Ingredient: | Lanthanum carbonate hydrate 1431mg equivalent to elemental lanthanum 750mg |
| Dosage Form: | Oral powder |
| New Zealand Sponsor: | Takeda New Zealand Limited |
| Manufacturer: | Catalent Germany Schorndorf GmbH, Schorndorf, Germany |
| Product: | Fosrenol |
| Active Ingredient: | Lanthanum carbonate hydrate 1908mg equivalent to elemental lanthanum 1000mg |
| Dosage Form: | Oral powder |
| New Zealand Sponsor: | Takeda New Zealand Limited |
| Manufacturer: | Catalent Germany Schorndorf GmbH, Schorndorf, Germany |
| Product: | Fosrenol |
| Active Ingredient: | Lanthanum carbonate hydrate 1908mg equivalent to elemental lanthanum 1000 mg |
| Dosage Form: | Chewable tablet |
| New Zealand Sponsor: | Takeda New Zealand Limited |
| Manufacturer: | Hamol Limited, Nottingham, United Kingdom |
| Product: | Haylor Syrup |
| Active Ingredient: | Loratadine 1mg/mL |
| Dosage Form: | Syrup |
| New Zealand Sponsor: | Boucher & Muir (New Zealand) Limited t/a BNM Group |
| Manufacturer: | YSP Industries (M) Sdn. Bhd., Kajang, Malaysia |
| Product: | Macrobid |
| Active Ingredients: | Nitrofurantoin 25mg Nitrofurantoin monohydrate 80.7mg |
| Dosage Form: | Modified release capsule |
| New Zealand Sponsor: | Te Arai BioFarma Limited |
| Manufacturer: | Norwich Pharmaceuticals Inc, New York, United States of America |
| Product: | Naltrexone |
| Active Ingredient: | Naltrexone hydrochloride 50mg equivalent to naltrexone 45.2mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Haupt Pharma Wolfratshausen GmbH, Wolfratshausen, Germany |
| Product: | Paracetamol & Ibuprofen (General sale) |
| Active Ingredients: | Ibuprofen 200mg Paracetamol 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | REX Medical Limited |
| Manufacturer: | Milan Laboratories (India) Pvt Limited, Mumbai, India |
| Product: | Paracetamol & Ibuprofen (Pharmacy only) |
| Active Ingredients: | Ibuprofen 200mg Paracetamol 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | REX Medical Limited |
| Manufacturer: | Milan Laboratories (India) Pvt Limited, Mumbai, India |
| Product: | Spectaril |
| Active Ingredients: | Clotrimazole 1%w/w Hydrocortisone acetate 1%w/w |
| Dosage Form: | Topical cream |
| New Zealand Sponsor: | Nova Pharmaceuticals NZ Limited |
| Manufacturer: | Mepro Pharmaceuticals Private Limited, Wadhwan City, India |
Dated this 29th day of September 2020.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).