Evrysdi 0.75 mg/mL powder for oral solution
*Company:
Roche Registration GmbHStatus:
No Recent UpdateLegal 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 26 August 2024
File name
SmPC_Evrysdi_II-0022-II-0025_25Jul2024.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 August 2024
File name
PIL_Evrysdi_II-0022-II-0025_25Jul2024.pdf
Reasons for updating
- Change to date of revision
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
Roche Registration GmbH
Address:
3004 Lake Drive, Citywest, Naas Road, Dublin 24Medical Information E-mail:
ireland.druginfo@roche.comTelephone:
+353 1 469 0700Fax:
+353 1 469 0791