SmPC - Trimethoprim Tablets BP 200mg: Change history
View Summary of Product Characteristics (SmPC - Trimethoprim Tablets BP 200mg)
Last updated on this site: 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
Last updated on this site: 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
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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
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Changes: (Updated: 21 Mar 2023)
Variation Description: To update sections 4.4, 4.5, 4.6, 4.8 and 5.2 of the SmPC in line with the reference product, Trimethoprim 100mg Tablets (PL 06453/0043, MAH: Athlone Laboratories Limited) dated 16th June 2022. Consequently, the PIL has been updated. In addition, section 2 of the SmPC has been updated to follow the standard QRD wording at the request of the MHRA.
SmPC sections updated – 2, 4.4, 4.5, 4.6, 4.8, 5.2 and 10.
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Changes: (Updated: 22 Sep 2022)
Initial upload