Ponvory 2 mg, 3 mg, 4 mg, 5 mg, 6 mg , 7 mg, 8 mg, 9 mg , 10 mg, 20 mg film-coated tablets
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
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 02 September 2024
File name
EN_Ponvory_SmPC_clean_July 2024.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/005163/II/0013 - update of section 4.4 of the SmPC to include language on the potential risk of IRIS associated with PML and its management
Updated on 27 March 2024
File name
EN_Ponvory_SPC_clean_Feb 2024.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of 4.5 - DDI with carbamazepine.
Updated on 27 March 2024
File name
EN_Ponvory_PIL_clean_Feb 2024.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Local representative contact information update (addition of contact e-mail address)
Updated on 18 July 2023
File name
EN_Ponvory_SPC_clean_July 2023.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 July 2023
File name
EN_Ponvory_PIL_clean_July 2023.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 30 March 2022
File name
EN-Ponvory-20220315-SmPC-clean.pdf
Reasons for updating
- Introduction of new pack/pack size
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Ponvory-RMM Pregnancy card A6.pdf
Reasons for updating
- Add New Doc
File name
Ponvory-RMM Prescribers checklist.pdf
Reasons for updating
- Add New Doc
File name
Ponvory-RMM Patient Guide A5.pdf
Reasons for updating
- Add New Doc
Updated on 06 December 2021
File name
IRE_NI_SPC-Ponvory-clean 19May2021-black triangle.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)