Skilarence 120 mg gastro-resistant tablets *
Pharmacy Only: Prescription

  • Company:

    Almirall Limited
  • Status:

    No Recent Update
  • Legal 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

Updated on 03 March 2022

File name

ie-spc-skilarence-30and120mg-21.02_1646327649.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_1646325677.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_1602777135.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_1548784544.pdf

Reasons for updating

  • New PIL for new product