Skilarence 30 mg gastro-resisistant tablets *
Pharmacy Only: Prescription

  • Company:

    Almirall Limited
  • Status:

    No Recent Update
  • Legal 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.

EDM Updated on 10 November 2021

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.

EDM Updated on 18 November 2019

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.

EDM Updated on 13 February 2019

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