Evrysdi 0.75 mg/mL powder for oral solution * Pharmacy Only: Prescription
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 24 August 2023
File name
64e70b9435042.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 24 August 2023
File name
64e70b1959f18.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
64e4ba9f23760.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
64e4b9fcb2e37.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
6470b64ce9978.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
641c7597abd68.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 22 June 2022
File name
62b308f1b18c3.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
62b30873c45a2.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_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