Skyclarys 50mg Hard Capsules
*Company:
Biogen Idec (Ireland) LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 01 September 2026
File name
IE PIL lactation.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to section 2 to include test relating to results of lactation study
Updated on 01 September 2026
File name
IE SmPC lactation.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to sections 4.6 and 5.2 to include data from lactation study.
Updated on 04 August 2026
File name
IE SmPC carcinogenicity.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to section 5.3 to include text on repeat-dose toxicity and updated carcinogenicity text. This is due to the completion of a 2-year rat carcinogenicity study.
Updated on 19 March 2026
File name
IE SmPC shelf-life update Mar 26.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
New SmPC
Updated on 19 March 2026
File name
IE PIL Mar 26.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL
Biogen Idec (Ireland) Ltd
Address:
United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, IrelandMedical Information E-mail:
MedInfoUKI@biogen.comMedical Information Direct Line:
1800 812 719