Evrysdi 0.75 mg/mL powder for oral solution *
Pharmacy Only: Prescription

  • Company:

    Roche Registration GmbH
  • Status:

    No Recent Update
  • Legal 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 24 January 2022

File name

EVR_II03_PIL_18Nov2021_clean_1643044154.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 24 January 2022

File name

EVR_II03_SmPC_18Nov2021_clean_1643044039.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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)

Updated on 14 December 2021

File name

EVR_II02_SmPC_28Oct2021_clean_1639502148.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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)

Updated on 14 December 2021

File name

EVR_II02_PIL_28Oct2021_clean_1639502042.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to, or new use for medicine

Updated on 03 June 2021

File name

EVR_MAA_SmPC_26 Mar 2021_V2_1622731388.pdf

Reasons for updating

  • New SPC for medicines.ie
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 June 2021

File name

EVR_MAA_PIL_26 Mar 2021_V2_1622731328.pdf

Reasons for updating

  • New PIL for medicines.ie
  • Change to section 4 - how to report a side effect

Updated on 31 March 2021

File name

EVR_MAA_SmPC_26 Mar 2021_1617210022.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 31 March 2021

File name

EVR_MAA_PIL_26 Mar 2021_1617209998.pdf

Reasons for updating

  • New PIL for new product