PIL - Mycophenolate Mofetil 500 mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL - Mycophenolate Mofetil 500 mg Film-coated Tablets)
Last updated on this site: 30 Nov 2023
Description of update: To update SmPC sections 4.6, 4.8, 5.1, 5.2 and 5.3 and leaflet section 2 and 3 in-line with the information of reference product (Cellcept 500mg Film-Coated Tablets, MAH: Roche Registration GmbH, Germany; EU procedure number: EMEA/H/C/000082).
PIL sections updated: Title, 1, 2, 3 and 6.
Last updated on this site: 30 Nov 2023
Description of update: To update SmPC sections 4.6, 4.8, 5.1, 5.2 and 5.3 and leaflet section 2 and 3 in-line with the information of reference product (Cellcept 500mg Film-Coated Tablets, MAH: Roche Registration GmbH, Germany; EU procedure number: EMEA/H/C/000082).
PIL sections updated: Title, 1, 2, 3 and 6.
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Changes: (Updated: 30 Nov 2023)
Description of update: To update SmPC sections 4.6, 4.8, 5.1, 5.2 and 5.3 and leaflet section 2 and 3 in-line with the information of reference product (Cellcept 500mg Film-Coated Tablets, MAH: Roche Registration GmbH, Germany; EU procedure number: EMEA/H/C/000082).
PIL sections updated: Title, 1, 2, 3 and 6.
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Changes: (Updated: 03 Jul 2023)
Description of update: The following changes have been notified:
Type IA (A.7) variation for deletion of Astron Research Limited, 2nd & 3rd floor, Sage House, 319 Pinner Road, Harrow, HA1 4HF, United Kingdom and ALS Laboratories (UK) Limited 2 Bartholomews Walk, Cambridgeshire Business Park, Ely CB7 4ZE, United Kingdom as Batch testing site.
Type IAIN (B.II.b.2.c.1) variation for replacement of Accord Healthcare Limited, Ground floor, Sage house, 319 Pinner road, Harrow, Middlesex, HA1 4 HF, United Kingdom with LABORATORI FUNDACIO DAU C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona 08040, Spain as Batch release site.
Type IA (A.5.b) variation for change in the name of batch control/testing site from Wessling Hungary Kft., Anonymus utca 6., Budapest 1045, Hungary to Eurofins Analytical Services Hungary Kft., Anonymus utca 6, Budapest, 1045, Hungary.
PIL sections updated: 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload