Skilarence 30 mg gastro-resisistant tablets

*
Pharmacy Only: Prescription
  • Company:

    Almirall Limited
  • Status:

    Updated
  • 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

EDM Updated on 12 March 2024

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