PIL - Mycophenolic acid 360mg Gastro-resistant Tablets: Change history
View Patient Information Leaflet (PIL - Mycophenolic acid 360mg Gastro-resistant Tablets)
Last updated on this site: 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.
PIL sections updated: 2, 3, 4, 6.
Last updated on this site: 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.
PIL sections updated: 2, 3, 4, 6.
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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.
PIL sections updated: 2, 3, 4, 6.
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Changes: (Updated: 09 Feb 2023)
Description of update: Type IA group variation application as per below mentioned changes for Mycophenolic Acid Accord Healthcare 180 mg and 360 mg gastro-resistant tablets:
1) Type IA (A.7) variation for deletion of Accord Healthcare Limited, Ground floor, Sage house, 319 Pinner road, Harrow, HA1 4 HF, United Kingdom as Batch release site, 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 and deletion of Accord Healthcare Limited, Unit C & D, Homefield Business Park, Homefield Road, Haverhill, CB9 8QP, United Kingdom as Primary and Secondary packaging site.
2) Type IAIN (B.II.b.1.b) variation for addition of Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as Primary Packaging site.
Type IAIN (B.II.b.2.c.2) variation for addition of STADA Arzneimittel AG, Stadastraße 2-18, 61118 Bad Vilbel, Germany as Batch testing & Batch release site.
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Changes: (Updated: 21 Sep 2022)
Initial upload