PIL - Vascalpha 5mg, 10mg Prolonged-release Tablets: Change history

Last updated on this site: 16 Aug 2023

Description of update:

1) Update to SmPC section 4.4 and PIL to align excipient information for lactose with the latest EC Excipient Guidelines (version 10.2).

2) Update to SmPC section 5.1 to bring pharmacotherapeutical group naming in line with the WHO ATC Index.

3) Update to SmPC section 6.6, 8 and 10 headings in line with the QRD template.

4) The product description has been updated in PIL section 6 to align with SmPC section 3.

5) Editorial updates to SmPC sections 4.4, 5.1, 5.3 and PIL.

6) QRD updates to the PIL.

PIL sections updated: Title, 1, 2, 3, 4, 5, 6.

Changes: (Updated: 16 Aug 2023)

Description of update:
1) Update to SmPC section 4.4 and PIL to align excipient information for lactose with the latest EC Excipient Guidelines (version 10.2).
2) Update to SmPC section 5.1 to bring pharmacotherapeutical group naming in line with the WHO ATC Index.
3) Update to SmPC section 6.6, 8 and 10 headings in line with the QRD template.
4) The product description has been updated in PIL section 6 to align with SmPC section 3.
5) Editorial updates to SmPC sections 4.4, 5.1, 5.3 and PIL.
6) QRD updates to the PIL.
PIL sections updated: Title, 1, 2, 3, 4, 5, 6.
Changes: (Updated: 14 Aug 2023)

Website administration update only- no changes to file.
Changes: (Updated: 21 Sep 2022)

Initial upload

Changes: (Updated: 16 Aug 2023)