PIL - Mycophenolate mofetil 500 mg powder for concentrate for solution for infusion: Change history
View Patient Information Leaflet (PIL - Mycophenolate mofetil 500 mg powder for concentrate for solution for infusion)
Last updated on this site: 02 May 2024
Description of update: The following change(s) has been notified:
Type IA (B.III.1.a.2) to update the certificate of suitability from already approved supplier, Biocon from revision R1-CEP 2010-162-Rev 05 to R1-CEP 2010-162-Rev 06.
Type IA (B.III.1.a.2) to update the certificate of suitability from already approved supplier, Biocon from revision R1-CEP 2010-162-Rev 06 to R1-CEP 2010-162-Rev 07.
Type IA (B.III.1.a.2) to update the certificate of suitability from already approved supplier, Biocon from revision R1-CEP 2010-162-Rev 07 to CEP 2010-162-Rev 08.
Type IA (A.7) deletion of Accord Healthcare B.V. Utrecht, Winthontlaan 200 3526 KV at Utrecht, Netherland as batch release site only.
PIL section updated: 6 (for A.7 change).
No changes to SmPC.
RMS approval date: 25/04/2024.
Last updated on this site: 02 May 2024
Description of update: The following change(s) has been notified:
Type IA (B.III.1.a.2) to update the certificate of suitability from already approved supplier, Biocon from revision R1-CEP 2010-162-Rev 05 to R1-CEP 2010-162-Rev 06.
Type IA (B.III.1.a.2) to update the certificate of suitability from already approved supplier, Biocon from revision R1-CEP 2010-162-Rev 06 to R1-CEP 2010-162-Rev 07.
Type IA (B.III.1.a.2) to update the certificate of suitability from already approved supplier, Biocon from revision R1-CEP 2010-162-Rev 07 to CEP 2010-162-Rev 08.
Type IA (A.7) deletion of Accord Healthcare B.V. Utrecht, Winthontlaan 200 3526 KV at Utrecht, Netherland as batch release site only.
PIL section updated: 6 (for A.7 change).
No changes to SmPC.
RMS approval date: 25/04/2024.
-
Changes: (Updated: 02 May 2024)
Description of update: The following change(s) has been notified:
Type IA (B.III.1.a.2) to update the certificate of suitability from already approved supplier, Biocon from revision R1-CEP 2010-162-Rev 05 to R1-CEP 2010-162-Rev 06.
Type IA (B.III.1.a.2) to update the certificate of suitability from already approved supplier, Biocon from revision R1-CEP 2010-162-Rev 06 to R1-CEP 2010-162-Rev 07.
Type IA (B.III.1.a.2) to update the certificate of suitability from already approved supplier, Biocon from revision R1-CEP 2010-162-Rev 07 to CEP 2010-162-Rev 08.
Type IA (A.7) deletion of Accord Healthcare B.V. Utrecht, Winthontlaan 200 3526 KV at Utrecht, Netherland as batch release site only.
PIL section updated: 6 (for A.7 change).
No changes to SmPC.
RMS approval date: 25/04/2024.
-
Changes: (Updated: 21 Sep 2022)
Initial upload