Skilarence 30 mg gastro-resisistant tablets
*Company:
Almirall LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)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 of PML.
Updated on 03 March 2022
File name
ie-spc-skilarence-30and120mg-21.02.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
EMC approval of renewal application resutling in mainly editorial changes in line with QRD template.
Updated on 03 March 2022
File name
m1.3.1.package-leaflet-skilarence30mg-02.2022.pdf
Reasons for updating
- Change to information about pregnancy or lactation
Free text change information supplied by the pharmaceutical company
EMA approval of renewal procedure resulting in mainly editorial changes in line with QRD template. Further emphasis on in section 2, warnings and precautions, in regards to stomach and intestinal problems potentially causing a reduction in the effectiveness of oral contraceptive methods.
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 15 October 2020
File name
Skilarence -30 amd 120 mg SmPC-10.2020.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 - additional side effect - Herpes zoster
Removal of astericks to indicate that the following side effects have also been reported for Skilarence:
PML, abdominal distention, allergic skin reaction, proteinuria, renal failure, serum creatininine increased.
Updated on 22 August 2019
File name
SmPC - Skilarence 30 and 120 mg-072019.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of 70 and 120 tablet pack size for the 30 mg strength.
Updated on 30 January 2019
File name
Skilarence -30 mg packageleaflet-0617.pdf
Reasons for updating
- New PIL for new product