PIL- Ambrisentan Accord 5mg, 10mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL- Ambrisentan Accord 5mg, 10mg Film-coated Tablets)
Last updated on this site: 20 May 2024
Description of update:
This notification is submitted to amend the packaging components without the need to amend the SmPC. Changes notified are as follows:
To remove references to EIRE on the PIL as this is no longer a packshare.
PIL sections updated: 4 and 6.
Last updated on this site: 20 May 2024
Description of update:
This notification is submitted to amend the packaging components without the need to amend the SmPC. Changes notified are as follows:
To remove references to EIRE on the PIL as this is no longer a packshare.
PIL sections updated: 4 and 6.
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Changes: (Updated: 20 May 2024)
Description of update:
This notification is submitted to amend the packaging components without the need to amend the SmPC. Changes notified are as follows:
To remove references to EIRE on the PIL as this is no longer a packshare.
PIL sections updated: 4 and 6.
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Changes: (Updated: 25 May 2023)
Administrative update only; no changes to file.
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Changes: (Updated: 25 May 2023)
Description of update: The proposed change is: C.I.2. a) Implementation of change(s) for which no new additional data is required to be submitted by the MAH. Adaptation of the PI to reference product Volibris. (EMEA/H/C/000839)
PIL sections updated: 1, 2, 3, 4, 6.
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Changes: (Updated: 06 Feb 2023)
Website administration update
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Changes: (Updated: 20 Sep 2022)
initial upload