PIL- Lamivudine 300 mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL- Lamivudine 300 mg Film-coated Tablets)
Last updated on this site: 27 Jun 2024
To update the PIL mock-ups to consolidate updates from two variations:
NL/H/2661/001-003/IB/020 SmPC and PIL update in line with reference Epivir
UK-only IA variation to add manufacturing site Accord Healthcare Ltd.
No other changes have been introduced.
Last updated on this site: 27 Jun 2024
To update the PIL mock-ups to consolidate updates from two variations:
NL/H/2661/001-003/IB/020 SmPC and PIL update in line with reference Epivir
UK-only IA variation to add manufacturing site Accord Healthcare Ltd.
No other changes have been introduced.
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Changes: (Updated: 27 Jun 2024)
To update the PIL mock-ups to consolidate updates from two variations:
NL/H/2661/001-003/IB/020 SmPC and PIL update in line with reference Epivir
UK-only IA variation to add manufacturing site Accord Healthcare Ltd.
No other changes have been introduced.
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Changes: (Updated: 11 Apr 2024)
Description of update: Updates to SmPC sections 4.4 and 4.8 to align with the reference product (Epivir150 mg/ 300 mg film-coated tablets; EU procedure number: EU/1/96/015; MAH: ViiV Healthcare BV, Netherlands). The PIL has been updated accordingly including spelling and grammatical changes.
PIL sections updated: 2, 3, 4, 5 and 6.
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Changes: (Updated: 27 Feb 2024)
Description of update:
1. To register the addition of Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as Batch control testing site.
2. To register the addition of Accord Healthcare Limited, Edgefield Avenue, Newcastle Upon Tyne, NE3 3NB, United Kingdom as Secondary packaging site.
3. To register the addition of Accord Healthcare Limited, Sage house, 319 Pinner road, North Harrow, Middlesex, HA1 4HF United Kingdom as Batch release and importation site.
Consequently, the PIL is updated.
PIL sections updated: 6 only.
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Changes: (Updated: 20 Sep 2022)
initial upload