SmPC - Dapsone Tablets BP 100mg: Change history
View Summary of Product Characteristics (SmPC - Dapsone Tablets BP 100mg)
Last updated on this site: 26 May 2023
Variation type: IB, B.II.e.1.z
Variation Description:
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: 26 May 2023
Variation type: IB, B.II.e.1.z
Variation Description:
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: 26 May 2023)
Variation type: IB, B.II.e.1.z
Variation Description:
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: 24 Apr 2023)
Variation Description:
To update sections 1, 2, 4.1, 4.4, 4.5, 4.6, 5.1, 7, 8, 9 of the SmPC in line with the excipients guideline and QRD template. Consequently, the PIL has been updated.
Inclusion of pharmacotherapeutic group and ATC code in section 5.1 of the SmPC.
SmPC sections updated – 1, 2, 4.1, 4.4, 4.5, 4.6, 5.1, 7, 8, 9 and 10.
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Changes: (Updated: 20 Sep 2022)
Initial upload