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: | Afluria Quad |
| Active Ingredients: | Influenza virus A/Michigan/45/2015 (H1N1) pdm09 – like strain 15mcg Influenza virus A/Switzerland/8060/2017 (H3N2) – like strain 15mcg Influenza virus B/Colorado/06/2017 – like strain 15mcg Influenza virus B/Phuket/3073/2013 – like strain 15mcg |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturer: | Seqirus Pty Limited, Melbourne, Australia |
| Product: | Levlen ED |
| Active Ingredients: | Ethinylestradiol 30mcg Levonorgestrel 150mcg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturers: | Bayer AG, Berlin, Germany Bayer Weimar GmbH und Co KG, Weimar, Germany |
| Product: | Microgynon 20 ED |
| Active Ingredients: | Ethinylestradiol 20mcg Levonorgestrel 100mcg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturers: | Bayer AG, Berlin, Germany Bayer Weimar GmbH und Co KG, Weimar, Germany |
| Product: | Microgynon 50 ED |
| Active Ingredients: | Ethinylestradiol 0.05mg Levonorgestrel 0.125mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturers: | Bayer AG, Berlin, Germany Bayer Weimar GmbH und Co KG, Weimar, Germany |
| Product: | Yasmin |
| Active Ingredients: | Drospirenone 3mg Ethinylestradiol 30mcg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturers: | Bayer Weimar GmbH und Co KG, Weimar, Germany Bayer AG, Leverkusen, Germany |
| Product: | Yaz |
| Active Ingredients: | Drospirenone 3mg Ethinylestradiol betadex clathrate 0.02mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturers: | Bayer Weimar GmbH und Co KG, Weimar, Germany Bayer AG, Leverkusen, Germany |
Dated this 12th day of December 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).