Zeposia 0.23 mg, 0.46 mg and 0.92 mg hard capsules
*Company:
Bristol-Myers Squibb Pharma EEIGStatus:
No Recent UpdateLegal 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
File name
IRE Ozanimod HCP Cover Letter - Final.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
This letter describes the recent updates made to one of the educational materials for Zeposia (ozanimod) - the Prescriber's Checklist.
File name
ZEPOSIA Prescriber Checklist IRE Version 2.0.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Updates made to the ozanimod Prescriber's Checklist in in May 2023 reflect changes to the Summary of Product Characteristics (SPC) for ozanimod in relation to dosing in patients with mild or moderate chronic hepatic impairment ( Child-Pugh class A or B).
Updated on 30 March 2023
File name
2023 03 24 IE Zeposia PIL _clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
update PIL section 3 in order to add a dose adjustment after completion of the dose escalation regimen in patients with mild or moderate chronic hepatic impairment (Child-Pugh class A or B).
Updated on 30 March 2023
File name
2023 03 24 IE Zeposia_SmPC_ clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to SmPC sections 4.2 and 5.2 in order to add a dose adjustment after completion of the dose escalation regimen in patients with mild or moderate chronic hepatic impairment (Child-Pugh class A or B) based on the final results from study RPC-1063-CP-004 (Phase I, multicenter, open-label study to evaluate the effect of mild or moderate hepatic impairment on the multiple-dose pharmacokinetics of ozanimod).
File name
Zeposia (ozanimod) Patient Caregiver Guide IRE V2.0 Jan 2022.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Version 2 - Updated following approval of new indication
File name
Zeposia (ozanimod) Pregnancy-Specific Patient Reminder Card IRE v2.0 Jan 2022.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Version 2 - Updated following approval of new indication
Updated on 30 March 2022
File name
2021 11_ IE ZEPOSIA PIL_ a_clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Correction of spelling/typing errors
- Change to improve clarity and readability
File name
ZEPOSIA Patient Caregiver Guide IRE V1_Final_Nov 2021.pdf
Reasons for updating
- Add New Doc
File name
ZEPOSIA Pregnancy-Specific Patient Reminder Card IRE V1_Final_Nov2021.pdf
Reasons for updating
- Add New Doc
File name
ZEPOSIA Prescriber's Checklist IRE V1_Final_Nov2021.pdf
Reasons for updating
- Add New Doc
Updated on 04 January 2022
File name
2021 11_ IE ZEPOSIA PIL_ clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Updated on 26 November 2021
File name
2021 11 18 IE ZEPOSIA SmPC.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 November 2021
File name
2021 11 18 IE ZEPOSIA PIL_ clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
extension of indication in UC and BCRP inhibitors
Updated on 14 October 2021
File name
2021 09 02 IE ZEPOSIA SmPC_clean.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 14 October 2021
File name
2021 09 02 IE ZEPOSIA PIL_clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL