Evrysdi 0.75 mg/mL powder for oral solution *

  • 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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

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