OCALIVA_Obeticholic acid 10mg film coated tablets
*Company:
ADVANZ PharmaStatus:
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 23 April 2024
File name
Ocaliva-IE Adapted SPC.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 April 2024
File name
PIL.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 23 April 2024
File name
PIL.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 29 December 2023
File name
Ocaliva 5 mg and 10 mg film coated tablets.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 19 June 2023
File name
Ocaliva 5 mg and 10 mg film coated tablets_PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 27 December 2022
File name
OCALIVA_Obeticholic acid_ 5mg and 10mg film- coated tablets _SmPC_IE.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 27 December 2022
File name
OCALIVA_Obeticholic acid_ 5mg and 10mg film- coated tablets _PIL_IE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 18 November 2022
File name
OCALIVA_5mg,10mg film-coated tabs _SPC_IE.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 November 2022
File name
OCALIVA_5mg,10mg film-coated tablets _PIL_IE.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 16 August 2022
File name
OCALIV~2.PDF
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 August 2022
File name
OCALIV~1.PDF
Reasons for updating
- New PIL for new product