Alunbrig
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
File name
Alunbrig Patient Alert Card v3 IE and NI-clean.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Changes:
- Removal of black triangle information
- Addition of Takeda adverse event reporting info as per aRMM SOP
Updated on 15 August 2023
File name
Alunbrig (brigatinib) PIL Ireland JUL2023.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The black triangle and associated wording have been removed
Updated on 15 August 2023
File name
ie-alunbrig-SmPC-clean-renewal.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 black triangle and associated wording have been removed.
Undesirable effects and overdose updated.
File name
Alunbrig Patient Alert Card Ireland July 2022.pdf
Reasons for updating
- Replace File
Updated on 10 May 2022
File name
Alunbrig SmPC Ireland 17.02.2022 V2.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Minor correction of 2 errors in Table 4. Efficacy results in ALTA IL (ITT population)
Updated on 24 February 2022
File name
Alunbrig SmPC Ireland 17.02.2022.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic 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
Section 5.1 updated with the ALTA-1L trial final efficacy data
Section 10 date of revision amended to 17 Feb 2022
Updated on 31 January 2022
File name
Alunbrig SmPC Ireland 27.01.2022.pdf
Reasons for updating
- 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 5.1 - Pharmacodynamic 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
Section 4.4 wording added for dose modifications of brigatinib if concomitant use of moderate CYP3A inducers cannot be avoided. Addition of sodium section.
Section 4.5 wording added for dose modifications of brigatinib if concomitant use of moderate CYP3A inducers cannot be avoided. Data also added into the CYP3A substrates section for midazolam.
Section 5.1 ATC code changed to L01ED04
Section 10 Date revised to 27 January 2022
Updated on 31 January 2022
File name
Alunbrig PIL Ireland Jan 2022.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Section 2 Warnings and precautions - wording added for sodium.
Section 6 Marketing authorisation holder - Contact details amended for several countries including Ireland
Updated on 17 January 2022
File name
Alunbrig SmPC IRE 13.01.2022.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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 4.4 Special warning and precautions for use: addition photosensitivity and photodermatosis wording
Section 4.8 Undesirable effects: Table 3 clarifying footnotes updated to include a footnote for photosensitivity reaction. New adverse reaction section added for photosensitivity and photodermatosis
Updated on 17 January 2022
File name
Alunbrig PIL Ireland Jan 2022.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 18 February 2021
File name
Alunbrig SmPC IRE 15.09.2020.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.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.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.pdf
Reasons for updating
- Add New Doc
Updated on 20 April 2020
File name
Alunbrig SmPC IRE 01.04.2020.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.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.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 08 January 2019
File name
Brigatinib PIL IRE 18.12.2018.pdf
Reasons for updating
- New PIL for new product
Updated on 08 January 2019
File name
Brigatinib SmPC IRE 18.12.2018.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