SmPC - Indometacin Capsules BP 50mg: Change history
View Summary of Product Characteristics (SmPC - Indometacin Capsules BP 50mg)
Last updated on this site: 25 Mar 2024
Description of update: To update 4.3, 4.4, 4.5, 4.6, 4.8, 4.9(50mg), 5.1 and 5.3 of the SmPC in line with the QRD update following reference product comparison with Indocid Capsules 50mg (PL 39699/012, 013; MAH: Aspen Pharma Trading Limited). Consequently, the PIL has been updated. Additional QRD updates throughout the SPC and PIL. Including updates to section headings in SPC section 1, 4.1, 6.6, 7, 8 and 9.
SmPC Sections updated: 1, 4.1, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9(50mg), 5.1, 5.3, 6.6, 7, 8, 9 and 10.
Last updated on this site: 25 Mar 2024
Description of update: To update 4.3, 4.4, 4.5, 4.6, 4.8, 4.9(50mg), 5.1 and 5.3 of the SmPC in line with the QRD update following reference product comparison with Indocid Capsules 50mg (PL 39699/012, 013; MAH: Aspen Pharma Trading Limited). Consequently, the PIL has been updated. Additional QRD updates throughout the SPC and PIL. Including updates to section headings in SPC section 1, 4.1, 6.6, 7, 8 and 9.
SmPC Sections updated: 1, 4.1, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9(50mg), 5.1, 5.3, 6.6, 7, 8, 9 and 10.
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Changes: (Updated: 25 Mar 2024)
Description of update: To update 4.3, 4.4, 4.5, 4.6, 4.8, 4.9(50mg), 5.1 and 5.3 of the SmPC in line with the QRD update following reference product comparison with Indocid Capsules 50mg (PL 39699/012, 013; MAH: Aspen Pharma Trading Limited). Consequently, the PIL has been updated. Additional QRD updates throughout the SPC and PIL. Including updates to section headings in SPC section 1, 4.1, 6.6, 7, 8 and 9.
SmPC Sections updated: 1, 4.1, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9(50mg), 5.1, 5.3, 6.6, 7, 8, 9 and 10.
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Changes: (Updated: 27 Jul 2023)
Variation Description: To register section 3.2.P.7 Container Closure System for 20μ Aluminium/250μ PVC blister packaging and to remove reference to the heat seal lacquer from section 6.5 of the SmPC.
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Changes: (Updated: 15 Feb 2023)
Single Variation
Variation type: IB C.I.3.z
Variation Description:
To update section 4.6 of the SmPC to bring in line with PRAC recommendations for all systemic NSAIDs use during pregnancy. Consequently, the PIL has been updated.
Additional typographical updates in the PIL and spelling correction of ‘corticosteriods’ to ‘corticosteroids’.
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Changes: (Updated: 20 Sep 2022)
Initial upload