SmPC - Riluzole 50mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Riluzole 50mg Film-coated Tablets)
Last updated on this site: 27 Mar 2023
Variation Description: To update section 4.8 of the SPC in line with PRAC recommendations (EMEA/H/C/PSUSA/00002645/202112) to include the ADR ‘rash’ with a frequency ‘Not known’. Consequentially, the PIL has been updated.
SmPC sections updated – 4.8 and 10.
View Summary of Product Characteristics (SmPC - Riluzole 50mg Film-coated Tablets)
Last updated on this site: 27 Mar 2023
Variation Description: To update section 4.8 of the SPC in line with PRAC recommendations (EMEA/H/C/PSUSA/00002645/202112) to include the ADR ‘rash’ with a frequency ‘Not known’. Consequentially, the PIL has been updated.
SmPC sections updated – 4.8 and 10.
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Changes: (Updated: 27 Mar 2023)
Variation Description: To update section 4.8 of the SPC in line with PRAC recommendations (EMEA/H/C/PSUSA/00002645/202112) to include the ADR ‘rash’ with a frequency ‘Not known’. Consequentially, the PIL has been updated.
SmPC sections updated – 4.8 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload