Skilarence 30 mg gastro-resisistant tablets * Pharmacy Only: Prescription
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
Updated on 03 March 2022
File name
ie-spc-skilarence-30and120mg-21.02_1646327396.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_1646327145.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.
File name
Skilarence (dimethyl fumrate) RMM Ireland_1636556611.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Owing to the transition to a new internal document management system and part of our periodic review of documents within the system, the job code and date of preparation on the last page of the leaflet has been updated. No other changes have been made.
Updated on 15 October 2020
File name
Skilarence - 30 mg Package leaflet 10.2020_1602776997.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_1602776870.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.
File name
UKIEDMF3983(1) 57954-Almirall Skilarence HPG ROI 4pp A5 - Aug 2019 hi-res_1574091473.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update of email address for queries
Updated on 22 August 2019
File name
SmPC - Skilarence 30 and 120 mg-072019_1566486456.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.
File name
Almirall Skilarence HPG ROI 4pp A5 - Jan 2019 24.01 PROOF_1548869477.pdf
Reasons for updating
- Add New Doc
Updated on 30 January 2019
File name
Skilarence -30 mg packageleaflet-0617_1548784544.pdf
Reasons for updating
- New PIL for new product