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:
Laboratoires Juvise PharmaceuticalsStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 09 March 2026
File name
ema-combined-h-5163-en-clean-SmPC-renewal.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Renewal procedure approved. Removal of black triangle as part of the procedure.
Updated on 09 March 2026
File name
ema-combined-h-5163-en-clean-PIL-renewal.pdf
Reasons for updating
- Removal of Black Inverted Triangle
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Renewal procedure approved. Black triangle removed as part of procedure.
Updated on 18 September 2025
File name
Ponvory PIL_Feb 2025.pdf
Reasons for updating
- XPIL Created
Updated on 07 March 2025
File name
Ponvory PIL_Feb 2025.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 07 March 2025
File name
Ponvory SmPC_Feb 2025.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Ponvory-RMM Patient Guide A5 00756 17-12.pdf
Reasons for updating
- Replace File
File name
Ponvory-RMM Prescribers checklist 00725 17-12.pdf
Reasons for updating
- Replace File
File name
Ponvory-RMM Pregnancy card A6 00787 17-12.pdf
Reasons for updating
- Replace File
Updated on 24 December 2024
File name
ema-combined-h-5163-en-SmPC-clean-IE.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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 December 2024
File name
ema-combined-h-5163-en-PIL-clean-IE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to date of revision
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 Patient Guide A5.pdf
Reasons for updating
- Add New Doc
File name
Ponvory-RMM Prescribers checklist.pdf
Reasons for updating
- Add New Doc
File name
Ponvory-RMM Pregnancy card A6.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)
Laboratoires Juvise Pharmaceuticals
Address:
149 boulevard Bataille de Stalingrad, 69100 Villeurbanne, FranceMedical Information E-mail:
pv@juvise.comMedical Information Direct Line:
+33 4 26 29 40 00