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OCALIVA_Obeticholic acid 5mg film coated tablets

*
Pharmacy Only: Prescription

  • Company:

    ADVANZ Pharma

  • Status:

    Updated

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Obeticholic Acid

    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 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 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