SmPC - Mycophenolic acid 360mg Gastro-resistant Tablets: Change history
View Summary of Product Characteristics (SmPC - Mycophenolic acid 360mg Gastro-resistant Tablets)
Last updated on this site: 04 Dec 2025
Description of update: To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.2, 5.3 of the SmPC and PIL in-line with the information of the reference product (Myfortic 180 mg, 360 mg gastro-resistant tablets; MAH: Novartis Pharma SAS, France; EU procedure number: FR/H/0239/001-002/DC). Section 4.4 of the SmPC and section 2 of the leaflet have been updated with excipient warning in line with Annex to the European Commission guideline on `Excipients in the labelling and package leaflet of medicinal products for human use'. Furthermore, section 6.6 of the SmPC has been updated with the instructions for handling of the medicinal product and with the QRD changes.
Date of approval: 07/11/2025
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.2, 5.3, 6.6 and 10
Last updated on this site: 04 Dec 2025
Description of update: To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.2, 5.3 of the SmPC and PIL in-line with the information of the reference product (Myfortic 180 mg, 360 mg gastro-resistant tablets; MAH: Novartis Pharma SAS, France; EU procedure number: FR/H/0239/001-002/DC). Section 4.4 of the SmPC and section 2 of the leaflet have been updated with excipient warning in line with Annex to the European Commission guideline on `Excipients in the labelling and package leaflet of medicinal products for human use'. Furthermore, section 6.6 of the SmPC has been updated with the instructions for handling of the medicinal product and with the QRD changes.
Date of approval: 07/11/2025
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.2, 5.3, 6.6 and 10
-
Changes: (Updated: 04 Dec 2025)
Description of update: To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.2, 5.3 of the SmPC and PIL in-line with the information of the reference product (Myfortic 180 mg, 360 mg gastro-resistant tablets; MAH: Novartis Pharma SAS, France; EU procedure number: FR/H/0239/001-002/DC). Section 4.4 of the SmPC and section 2 of the leaflet have been updated with excipient warning in line with Annex to the European Commission guideline on `Excipients in the labelling and package leaflet of medicinal products for human use'. Furthermore, section 6.6 of the SmPC has been updated with the instructions for handling of the medicinal product and with the QRD changes.
Date of approval: 07/11/2025
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.2, 5.3, 6.6 and 10
-
Changes: (Updated: 09 Aug 2024)
Update of the SmPC section 4.6 to implement the wording agreed by PRAC following the outcome of the PSUR procedure PSUSA/10550/202305.
-
Changes: (Updated: 12 Jun 2023)
Description of update: C.I.2.a Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/ biosimilar medicinal products following assessment of the same change for the reference product. Implementation of change(s) for which no new additional data is required to be submitted by the MAH.
SmPC sections updated: 4.6, 4.7, 4.8, 10.
-
Changes: (Updated: 21 Sep 2022)
Initial upload