Tibsovo
*Company:
Servier Laboratories Ireland LtdStatus:
UpdatedLegal Category:
Product subject to restricted prescription (C)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 10 March 2026
File name
Tibsovo 250mg Pil - Cl.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 03 March 2026
File name
Tibsovo 250mg SmPC-CL.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
- Change in ATC code from L01XM62 to L01XM02;
- Change in the Summary of product Characteristics intended to improve the comprehension of the posology by HCPs 4.2
- Update of section 4.5 of the SmPC to include atazanavir as an example of a drug–drug interaction with Ivosidenib
- update SmPC section 5.1
- Section 4.4: correction of “See section 4.5” to “See section 4.2”
- Section 5.1: Correction of a typo in the date in notes from Table 5
- Section 10: correction of website address
Updated on 17 January 2024
File name
Tibsovo PIL.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 17 January 2024
File name
Tibsovo SmPC.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 restricted prescription (C)
Updated on 09 June 2023
File name
Tibsovo SmPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to restricted prescription (C)
File name
Tibsovo PAC.pdf
Reasons for updating
- Add New Doc
Updated on 11 May 2023
File name
Tibsovo SmPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 11 May 2023
File name
Tibsovo PIL.pdf
Reasons for updating
- New PIL for new product
Servier Laboratories Ireland Ltd
Address:
1st Floor, Building Two, The Green Dublin Airport Central , Dublin Airport, Swords, Co. Dublin, K67 E2H3Medical Information E-mail:
medicalinformation-dublin@servier.comTelephone:
+353 1 663 8110Fax:
+353 1 663 8120