Evrysdi 0.75 mg/mL powder for oral solution

*
Pharmacy Only: Prescription
  • Company:

    Roche Registration GmbH
  • Status:

    Updated
  • 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 21 March 2024

File name

Evrysdi_II21_SmPC_01Feb2024.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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 18 January 2024

File name

EVR-EN-II17+II18-110124-Clean-CD_SmPC_1.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 18 January 2024

File name

EVR-EN-II17+II18-110124-Clean-CD_PL_1.pdf

Reasons for updating

  • Change to date of revision

Updated on 24 August 2023

File name

EVR-EN-VII05-140823-Clean-CD-1_PL.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 24 August 2023

File name

EVR-EN-VII05-140823-Clean-CD-1_SmPC.pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 22 August 2023

File name

EVR-EN-VII05-140823-Clean-CD_SmPC_1.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 22 August 2023

File name

EVR-EN-VII05-140823-Clean-CD_PL_1.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - what the product looks like and pack contents
  • Change to date of revision

Updated on 26 May 2023

File name

Evrysdi_II11_SmPC_20Apr2023.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 10 - Date of revision of the text

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

Updated on 23 March 2023

File name

EVR-EN-Art61.3-180123-Clean_PL_1.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 22 June 2022

File name

EVR_IB06_PIL_dated 17Jun2022.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 22 June 2022

File name

EVR_IB06_SmPC_dated 17Jun2022.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 24 January 2022

File name

EVR_II03_PIL_18Nov2021_clean.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.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.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.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.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.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.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.pdf

Reasons for updating

  • New PIL for new product