Skilarence 120 mg gastro-resistant tablets
*Company:
Almirall LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
File name
IE_IEDMF_2400001_revised IE_EM 1 Mar 24.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Updated with AE reports received of PML
Updated on 03 March 2022
File name
ie-spc-skilarence-30and120mg-21.02.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
EMA approval of renewal procedure resulting in editorial changes throughout package leaflet. Also further emphasis in section 2, warnings and precaustions in regards to stomach and inteestinal problems potentially causing a reduction in the effectiveness of oral contraceptive methods.
Updated on 03 March 2022
File name
ie-spc-skilarence-30and120mg-21.02.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMA approval of Renewal Application resulting in mainly editorial changes throughout the SmPC in line with the QRD template.
Updated on 15 October 2020
File name
Skilarence - 30 mg Package leaflet 10.2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Additional side effect with frequency unknown: herpes zoster
Updated on 30 January 2019
File name
Skilarence -30 mg packageleaflet-0617.pdf
Reasons for updating
- New PIL for new product