Vyepti concentrate for solution for infusion 100 mg (300 mg not marketed)
*Company:
Lundbeck (Ireland) LimitedStatus:
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 November 2024
File name
IE_Vyepti_100_mg_and_300_mg_conc_for_sol_for_inf_PIL_Portrait_-_REG_00196081.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 18 October 2024
File name
IE SPC.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 October 2024
File name
IE-XI PIL.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 5 - how to store or dispose
Updated on 11 December 2023
File name
IE_SPC.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 December 2023
File name
IE-XI_PIL.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 - what the product looks like and pack contents
- Introduction of new strength
Updated on 02 December 2022
File name
IE Vyepti SPC.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 December 2022
File name
IE-SPC.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 December 2022
File name
IE-XI_Vyepti PIL.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 18 July 2022
File name
IE-XI Vyepti PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 18 July 2022
File name
IE-SPC.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 June 2022
File name
IE Vyepti SPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 June 2022
File name
IE-XI Vyepti PIL.pdf
Reasons for updating
- New PIL for new product