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: | Avren 200 |
| Active Ingredient: | Misoprostol 200mcg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | REX Medical Limited |
| Manufacturer: | Cipla Limited, Goa, India |
| Product: | Idelvion |
| Active Ingredient: | Albutrepenonacog alfa 250IU |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Idelvion |
| Active Ingredient: | Albutrepenonacog alfa 500IU |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Idelvion |
| Active Ingredient: | Albutrepenonacog alfa 1000IU |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Idelvion |
| Active Ingredient: | Albutrepenonacog alfa 2000IU |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | CSL Behring (NZ) Limited |
| Manufacturer: | CSL Behring GmbH, Marburg, Germany |
| Product: | Keytruda |
| Active Ingredient: | Pembrolizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturer: | MSD International GmbH (Ireland), Carlow, Ireland |
| Product: | Keytruda |
| Active Ingredient: | Pembrolizumab 50mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturer: | MSD International GmbH, Innishannon, Ireland |
| Product: | Lioresal Intrathecal |
| Active Ingredient: | Baclofen 2mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Delpharm Dijon, Quetigny, France |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturer: | UCB Pharma SA, Braine-l’Alleud, Belgium |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturer: | UCB Pharma SA, Braine-l’Alleud, Belgium |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturer: | UCB Pharma SA, Braine-l’Alleud, Belgium |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturer: | UCB Pharma SA, Braine-l’Alleud, Belgium |
| Product: | Vimpat |
| Active Ingredient: | Lacosamide 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturers: | UCB Pharma SA, Braine-l’Alleud, Belgium Patheon Italia SpA, Milan, Italy |
| Product: | Zaditen |
| Active Ingredient: | Ketotifen fumarate 345mcg/mL equivalent to ketotifen 250mcg/mL |
| Dosage Form: | Eye drops, solution |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Excelvision, Annonay, France |
Dated this 4th day of October 2019.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).