PIL - Hydroxychloroquine Sulfate 200mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL - Hydroxychloroquine Sulfate 200mg Film-coated Tablets)
Last updated on this site: 27 Feb 2024
Description of update:
IB, B.II.f.1.b.1 – To extend the shelf-life of the finished product packed in PVC/aluminium foil blister, from 2 years to 3 years, based on available real time data. SmPC Section 6.3 affected.
IB, B.II.f.1.e - To register a change to the stability protocol - to amend post-approval stability protocol by reducing testing schedule at the long term condition and by adding testing at the accelerated condition. Section 5 of the PIL has been updated.
PIL sections updated: 5 & 6.
Last updated on this site: 27 Feb 2024
Description of update:
IB, B.II.f.1.b.1 – To extend the shelf-life of the finished product packed in PVC/aluminium foil blister, from 2 years to 3 years, based on available real time data. SmPC Section 6.3 affected.
IB, B.II.f.1.e - To register a change to the stability protocol - to amend post-approval stability protocol by reducing testing schedule at the long term condition and by adding testing at the accelerated condition. Section 5 of the PIL has been updated.
PIL sections updated: 5 & 6.
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Changes: (Updated: 27 Feb 2024)
Description of update:
IB, B.II.f.1.b.1 – To extend the shelf-life of the finished product packed in PVC/aluminium foil blister, from 2 years to 3 years, based on available real time data. SmPC Section 6.3 affected.
IB, B.II.f.1.e - To register a change to the stability protocol - to amend post-approval stability protocol by reducing testing schedule at the long term condition and by adding testing at the accelerated condition. Section 5 of the PIL has been updated.
PIL sections updated: 5 & 6.
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Changes: (Updated: 26 Jun 2023)
Variation Description:
Update to SPC sections 4.4, 4.6 and 4.8, and PIL in line with PRAC recommended wording (DK/H/PSUFU/00001693/202104) for hepatotoxicity, hepatitis B reactivation, and tetragenicity.
Additionally, the PIL has been updated to shorten the product name throughout, as well as simplification of the serious side effects list in section 4, and additional batch release sites have been removed from the PIL.
PIL sections updated – Introduction, index, 1, 2, 3, 4, 5 and 6.
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Changes: (Updated: 20 Sep 2022)
Initial upload