Alunbrig
Product Information *
Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateActive Ingredients :
This medicinal product is subject to additional monitoring.
*Additional information is available upon request
Legal Category:
Product subject to medical prescription which may be renewed (B)
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 18 February 2021
File name
Alunbrig SmPC IRE 15.09.2020_1613641338.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 7: MAH Address Update
Updated on 18 February 2021
File name
Alunbrig PIL IRE 11.12.2020_1613641280.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 20 October 2020
File name
Alunbrig SmPC IRE 06.07.2020_1603204973.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 6.3 Shelf Life - Extension of shelf-life of finished product from 2 years to 3 years for 90 and 180 mg film-coated tablets
File name
Alunbrig Patient Alert Card Ireland_1598023446.pdf
Reasons for updating
- Add New Doc
Updated on 20 April 2020
File name
Alunbrig SmPC IRE 01.04.2020_1587393492.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The following changes have been made to the SmPC:
|
Section |
Changes |
|
4.1 Therapeutic indications
|
New frontline indication added: Addition of the Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. |
|
4.2 Posology and method of administration |
Table 2 Elevation of CPK adverse reaction amended
|
|
4.4 Special warnings and precautions for use |
Creatine phosphokinase (CPK) elevation subsection amended
|
|
4.5 Interaction with other medicinal products and other forms of interaction |
|
|
4.8 Undesirable effects |
The following subsections have been updated:
|
|
5.1 Pharmacodynamic properties |
Addition of ALTA 1L clinical trial data
|
|
5.2 Pharmacokinetic properties |
The following subsections have been updated:
|
|
10. date of the revision of the text |
1 April 2020 |
Updated on 20 April 2020
File name
Alunbrig PIL IRE 01.04.2020_1587393290.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 26 March 2019
File name
Brigatinib PIL IRE 18.12.2018_1546957654.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 08 January 2019
File name
Brigatinib PIL IRE 18.12.2018_1546957654.pdf
Reasons for updating
- New PIL for new product
Updated on 08 January 2019
File name
Brigatinib SmPC IRE 18.12.2018_1546957607.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
08.01.2019 = Two variations were approved on 18th December for Alunbrig - to add a 28 tablet pack size for 30 mg strength and to add the starter pack