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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
| Product: | Admed Levetiracetam |
| Active Ingredient: | Levetiracetam 250mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AdiraMedica Pty Limited |
| Manufacturers: | Cipro Pharmaceuticals, Hyderabad, India Sunglow Lifescience Private Limited, Kattankulam, India |
| Product: | Admed Levetiracetam |
| Active Ingredient: | Levetiracetam 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AdiraMedica Pty Limited |
| Manufacturers: | Cipro Pharmaceuticals, Hyderabad, India Sunglow Lifescience Private Limited, Kattankulam, India |
| Product: | Admed Levetiracetam |
| Active Ingredient: | Levetiracetam 750mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AdiraMedica Pty Limited |
| Manufacturers: | Cipro Pharmaceuticals, Hyderabad, India Sunglow Lifescience Private Limited, Kattankulam, India |
| Product: | Admed Levetiracetam |
| Active Ingredient: | Levetiracetam 1000mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AdiraMedica Pty Limited |
| Manufacturers: | Cipro Pharmaceuticals, Hyderabad, India Sunglow Lifescience Private Limited, Kattankulam, India |
| Product: | FLUCELVAX QUAD |
| Active Ingredient: | Influenza vaccine, inactivated, split virion 60mcg |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturers: | CSL Behring GmbH, Marburg, Germany Seqirus Inc., North Carolina, United States of America |
| Product: | Lenvima |
| Active Ingredient: | Lenvatinib mesilate 4.9mg equivalent to lenvatinib 4mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Patheon Inc, Mississauga, Canada |
| Product: | Lenvima |
| Active Ingredient: | Lenvatinib mesilate 12.25mg equivalent to lenvatinib 10mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Eisai New Zealand Limited |
| Manufacturers: | Eisai Co Limited, Kakamigahara-shi, Japan Patheon Inc, Mississauga, Canada |
| Product: | Paracetamol & Ibuprofen (Pams) |
| Active Ingredients: | Ibuprofen 200mg Paracetamol 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | REX Medical Limited |
| Manufacturers: | Milan Laboratories (India) Pvt Limited, Mumbai, India |
| Product: | Winglore (50mg/10mL) |
| Active Ingredient: | Ipilimumab 5mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Baxter Pharmaceutical Solutions LLC, Indiana, United States of America Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico |
| Product: | Winglore (200mg/40mL) |
| Active Ingredient: | Ipilimumab 5mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Baxter Pharmaceutical Solutions LLC, Indiana, United States of America Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico |
| Product: | Yervoy (50mg/10mL) |
| Active Ingredient: | Ipilimumab 5mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Baxter Pharmaceutical Solutions LLC, Indiana, United States of America Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico |
| Product: | Yervoy (200mg/40mL) |
| Active Ingredient: | Ipilimumab 5mg/mL |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Bristol-Myers Squibb (NZ) Limited |
| Manufacturers: | Baxter Pharmaceutical Solutions LLC, Indiana, United States of America Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico |
Dated this 21st day of March 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).