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: | Imbruvica |
| Active Ingredient: | Ibrutinib 140mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturers: | Catalent CTS Inc, Missouri, United States of America Cilag AG, Schaffhausen, Switzerland |
| Note: The application received 17 April 2020 is for changes to the contraindications, warnings and precautions. | |
| Product: | Imbruvica |
| Active Ingredient: | Ibrutinib 140mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturers: | Catalent CTS Inc, Missouri, United States of America Cilag AG, Schaffhausen, Switzerland |
| Note: The application received 30 April 2020 is for changes to the dosage regimen for Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma (CLL/SLL). | |
| Product: | Imbruvica |
| Active Ingredient: | Ibrutinib 140mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Catalent CTS Inc, Missouri, United States of America |
| Note: The application received 17 April 2020 is for changes to the contraindications, warnings and precautions. | |
| Product: | Imbruvica |
| Active Ingredient: | Ibrutinib 140mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Catalent CTS Inc, Missouri, United States of America |
| Note: The application received 30 April 2020 is for changes to the dosage regimen for Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma (CLL/SLL). | |
| Product: | Imbruvica |
| Active Ingredient: | Ibrutinib 280mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Catalent CTS Inc, Missouri, United States of America |
| Note: The application received 17 April 2020 is for changes to the contraindications, warnings and precautions. | |
| Product: | Imbruvica |
| Active Ingredient: | Ibrutinib 280mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Catalent CTS Inc, Missouri, United States of America |
| Note: The application received 30 April 2020 is for changes to the dosage regimen for Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma (CLL/SLL). | |
| Product: | Imbruvica |
| Active Ingredient: | Ibrutinib 420mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Catalent CTS Inc, Missouri, United States of America |
| Note: The application received 17 April 2020 is for changes to the contraindications, warnings and precautions. | |
| Product: | Imbruvica |
| Active Ingredient: | Ibrutinib 420mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Catalent CTS Inc, Missouri, United States of America |
| Note: The application received 30 April 2020 is for changes to the dosage regimen for Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma (CLL/SLL). | |
| Product: | Imbruvica |
| Active Ingredient: | Ibrutinib 560mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Catalent CTS Inc, Missouri, United States of America |
| Note: The application received 17 April 2020 is for changes to the contraindications, warnings and precautions. | |
| Product: | Imbruvica |
| Active Ingredient: | Ibrutinib 560mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Catalent CTS Inc, Missouri, United States of America |
| Note: The application received 30 April 2020 is for changes to the dosage regimen for Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma (CLL/SLL). | |
Dated this 20th day of October 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).