SmPC- Baclofen Tablets BP 10mg: Change history
View Summary of Product Characteristics (SmPC- Baclofen Tablets BP 10mg)
Last updated on this site: 25 Sep 2024
To update sections 4.4 to add warnings of Encephalopathy. To update 4.8 to include Encephalopathy in SOC nervous system disorders in frequency not known. Aswell as an update to section 4.9 to include Encephalopathy and Generalised slowing on EEG in the symptoms of overdose all in line with PSUSA/00000294/202309. The PIL has been updated accordingly
Last updated on this site: 25 Sep 2024
To update sections 4.4 to add warnings of Encephalopathy. To update 4.8 to include Encephalopathy in SOC nervous system disorders in frequency not known. Aswell as an update to section 4.9 to include Encephalopathy and Generalised slowing on EEG in the symptoms of overdose all in line with PSUSA/00000294/202309. The PIL has been updated accordingly
-
Changes: (Updated: 25 Sep 2024)
To update sections 4.4 to add warnings of Encephalopathy. To update 4.8 to include Encephalopathy in SOC nervous system disorders in frequency not known. Aswell as an update to section 4.9 to include Encephalopathy and Generalised slowing on EEG in the symptoms of overdose all in line with PSUSA/00000294/202309. The PIL has been updated accordingly
-
Changes: (Updated: 31 May 2023)
Description of update: 1) To register section 3.2.P.7 of the dossier to reflect details of the blister packaging material. 2) To remove reference to the heat seal lacquer from section 6.5 of the SmPC.
There have been no changes to the blister packaging material itself, only an update in the supporting dossier details. There are no changes to the leaflet and labelling text.
SmPC section(s) updated– 6.5, 10
No changes to artwork
-
Changes: (Updated: 20 Dec 2022)
SmPC sections updated – 4.4, 4.9 and 10
-
Changes: (Updated: 20 Sep 2022)
Initial upload