PIL- Metformin SR 500mg Prolonged release Tablets: Change history
View Patient Information Leaflet (PIL- Metformin SR 500mg Prolonged release Tablets)
Last updated on this site: 25 Sep 2023
Description of update:
1 x Type IA, A.7 - Administrative change - Deletion of manufacturing sites, date of arrival 31.7.2023, application nr. 627609/2023: deletion of Accord Healthcare Limited, Ground floor, Sage house, 319 Pinner road, Harrow, Middlesex, HA1 4 HF, United Kingdom as Batch release & importation site, deletion of Wessling Hungary Kft, Budapest, Fóti út 56, 1047, Hungary as Batch release site, deletion of Astron Research Limited, 2nd & 3rd floor, Sage House, 319 Pinner Road, Harrow, HA1 4HF, United Kingdom and Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as Batch testing site.
1 x Type IAin, B.II.b.1.b - Replacement or addition of a manufacturing site for the FP - Primary packaging site, date of arrival 31.7.2023, application nr. 627610/2023: replacement of Accord Healthcare Limited, Unit C & D, Homefield Business Park, Homefield Road, Haverhill, CB9 8QP, United Kingdom with Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as Primary packaging site.
1 x Type IAin, B.II.b.1.a - Secondary packaging site, date of arrival 31.7.2023, application nr. 627611/2023: replacement of Accord Healthcare Limited, Unit C & D, Homefield Business Park, Homefield Road, Haverhill, CB9 8QP, United Kingdom with Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as Secondary packaging site.
1 x Type IA, A.5.b - Change in the name and/or address of a manufacturer/importer of the finished product (including batch release or quality control testing sites) - The activities for which the manufacturer/importer is responsible do not include batch release, date of arrival 31.7.2023, application nr. 627612/2023: change in approved finished product manufacturer address of Intas Pharmaceuticals Limited.
1 x Type IA, A.5.b - Change in the name and/or address of a manufacturer/importer of the finished product (including batch release or quality control testing sites) - The activities for which the manufacturer/importer is responsible do not include batch release, date of arrival 31.7.2023, application nr. 627613/2023: 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: 2, 4 and 6.
Last updated on this site: 25 Sep 2023
Description of update:
1 x Type IA, A.7 - Administrative change - Deletion of manufacturing sites, date of arrival 31.7.2023, application nr. 627609/2023: deletion of Accord Healthcare Limited, Ground floor, Sage house, 319 Pinner road, Harrow, Middlesex, HA1 4 HF, United Kingdom as Batch release & importation site, deletion of Wessling Hungary Kft, Budapest, Fóti út 56, 1047, Hungary as Batch release site, deletion of Astron Research Limited, 2nd & 3rd floor, Sage House, 319 Pinner Road, Harrow, HA1 4HF, United Kingdom and Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as Batch testing site.
1 x Type IAin, B.II.b.1.b - Replacement or addition of a manufacturing site for the FP - Primary packaging site, date of arrival 31.7.2023, application nr. 627610/2023: replacement of Accord Healthcare Limited, Unit C & D, Homefield Business Park, Homefield Road, Haverhill, CB9 8QP, United Kingdom with Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as Primary packaging site.
1 x Type IAin, B.II.b.1.a - Secondary packaging site, date of arrival 31.7.2023, application nr. 627611/2023: replacement of Accord Healthcare Limited, Unit C & D, Homefield Business Park, Homefield Road, Haverhill, CB9 8QP, United Kingdom with Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as Secondary packaging site.
1 x Type IA, A.5.b - Change in the name and/or address of a manufacturer/importer of the finished product (including batch release or quality control testing sites) - The activities for which the manufacturer/importer is responsible do not include batch release, date of arrival 31.7.2023, application nr. 627612/2023: change in approved finished product manufacturer address of Intas Pharmaceuticals Limited.
1 x Type IA, A.5.b - Change in the name and/or address of a manufacturer/importer of the finished product (including batch release or quality control testing sites) - The activities for which the manufacturer/importer is responsible do not include batch release, date of arrival 31.7.2023, application nr. 627613/2023: 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: 2, 4 and 6.
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Changes: (Updated: 25 Sep 2023)
Description of update:
1 x Type IA, A.7 - Administrative change - Deletion of manufacturing sites, date of arrival 31.7.2023, application nr. 627609/2023: deletion of Accord Healthcare Limited, Ground floor, Sage house, 319 Pinner road, Harrow, Middlesex, HA1 4 HF, United Kingdom as Batch release & importation site, deletion of Wessling Hungary Kft, Budapest, Fóti út 56, 1047, Hungary as Batch release site, deletion of Astron Research Limited, 2nd & 3rd floor, Sage House, 319 Pinner Road, Harrow, HA1 4HF, United Kingdom and Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as Batch testing site.
1 x Type IAin, B.II.b.1.b - Replacement or addition of a manufacturing site for the FP - Primary packaging site, date of arrival 31.7.2023, application nr. 627610/2023: replacement of Accord Healthcare Limited, Unit C & D, Homefield Business Park, Homefield Road, Haverhill, CB9 8QP, United Kingdom with Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as Primary packaging site.
1 x Type IAin, B.II.b.1.a - Secondary packaging site, date of arrival 31.7.2023, application nr. 627611/2023: replacement of Accord Healthcare Limited, Unit C & D, Homefield Business Park, Homefield Road, Haverhill, CB9 8QP, United Kingdom with Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as Secondary packaging site.
1 x Type IA, A.5.b - Change in the name and/or address of a manufacturer/importer of the finished product (including batch release or quality control testing sites) - The activities for which the manufacturer/importer is responsible do not include batch release, date of arrival 31.7.2023, application nr. 627612/2023: change in approved finished product manufacturer address of Intas Pharmaceuticals Limited.
1 x Type IA, A.5.b - Change in the name and/or address of a manufacturer/importer of the finished product (including batch release or quality control testing sites) - The activities for which the manufacturer/importer is responsible do not include batch release, date of arrival 31.7.2023, application nr. 627613/2023: 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: 2, 4 and 6.
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Changes: (Updated: 31 Jul 2023)
Variation Description:
Type IB, 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 (to update SPC section 4.6 and relevant section of PIL).
Type IB, 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 (to update SPC section 5.1)
PIL sections updated - 2, 4, 6.
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Changes: (Updated: 06 Dec 2022)
Update to PIL in line with update to SmPC for this product
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Changes: (Updated: 21 Sep 2022)
initial upload