SOTYKTU 6 mg film coated tablets
*Company:
Bristol-Myers Squibb Pharma EEIGStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)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 19 May 2026
File name
ie-sotyktu-pil-clean-30Apr26.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
30 April 2026: EMA approved the treatment of SOTYKTU, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy.
Updated on 19 May 2026
File name
ie-sotyktu-spc-clean-30Apr26.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
30 April 2026: EMA approved the treatment of SOTYKTU, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy.
Updated on 14 April 2026
File name
ie-sotyktu-spc-clean-10Apr26.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
10-April-2026: Update to the SOTYKTU EU Product Information with data on excretion into human milk. Sections 4.6 and 5.2 were updated
Updated on 17 July 2024
File name
ie-spc-clean-sotyktu (03Jul24).pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 May 2024
File name
ie-spc-clean-sotyktu (23Apr24).pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to section 5.1 - Pharmacodynamic properties - the ATC code has been updated.
Change to section 10 - Date of revision of the text
Updated on 28 February 2024
File name
ie-pil-Sotyktu (24Mar23).pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New Patient Information Leaflet for a new medicinal product
Updated on 20 February 2024
File name
ie-spc-clean (24Mar23).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
New SmPC for a new medicinal product SOTYKTU (deucravacitinib).
Updated on 20 February 2024
File name
ie-spc-clean (24Mar23).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
New SmPC for a new medicinal product SOTYKTU (deucravacitinib).
Bristol-Myers Squibb Pharma EEIG
Address:
Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, IrelandMedical Information E-mail:
medical.information@bms.comTelephone:
+353 1 483 3625Medical Information Direct Line:
Freephone 1 800 749 749Stock Availability:
bmscustomer-service.chester@bms.com