SmPC - Tranexamic acid 100mg/ml Solution for Injection: Change history
View Summary of Product Characteristics (SmPC - Tranexamic acid 100mg/ml Solution for Injection)
Last updated on this site: 04 Dec 2025
Description of update: To submit Type IB (C.I.2.a) variation to update sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 5.1, 5.2, 5.3, 6.6 of the SmPC and sections 1, 2, 3 and 4 of the PIL in line with information of reference product (Cyklokapron 100 mg/mL solution for injection/infusion, DCP procedure number: NO/H/0309/001; MAH: Pfizer Limited) along with minor editorial changes. In addition; there are formatting and editorial updates to the PIL, and additional information regarding method of administration was added to the Carton and Ampoule Label.
Date of approval: 26/11/2025
SmPC sections updated: Index, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 5.1, 5.2, 5.3, 6.6 and 10
Last updated on this site: 04 Dec 2025
Description of update: To submit Type IB (C.I.2.a) variation to update sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 5.1, 5.2, 5.3, 6.6 of the SmPC and sections 1, 2, 3 and 4 of the PIL in line with information of reference product (Cyklokapron 100 mg/mL solution for injection/infusion, DCP procedure number: NO/H/0309/001; MAH: Pfizer Limited) along with minor editorial changes. In addition; there are formatting and editorial updates to the PIL, and additional information regarding method of administration was added to the Carton and Ampoule Label.
Date of approval: 26/11/2025
SmPC sections updated: Index, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 5.1, 5.2, 5.3, 6.6 and 10
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Changes: (Updated: 04 Dec 2025)
Description of update: To submit Type IB (C.I.2.a) variation to update sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 5.1, 5.2, 5.3, 6.6 of the SmPC and sections 1, 2, 3 and 4 of the PIL in line with information of reference product (Cyklokapron 100 mg/mL solution for injection/infusion, DCP procedure number: NO/H/0309/001; MAH: Pfizer Limited) along with minor editorial changes. In addition; there are formatting and editorial updates to the PIL, and additional information regarding method of administration was added to the Carton and Ampoule Label.
Date of approval: 26/11/2025
SmPC sections updated: Index, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 5.1, 5.2, 5.3, 6.6 and 10
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Changes: (Updated: 20 May 2024)
Description of update:
To submit Type IB (C.I.2.a) variation application to update SmPC sections 4.4, 4.6 and 4.8 and leaflet sections 2, 3 and 4 in line with information of reference product (Cyklokapron 100 mg/mL solution for injection/infusion, DCP/MRP procedure number: NO/H/0309/001; MAH: Pfizer Limited). In addition, SmPC section 1 has been updated to add the title ‘Summary of product characteristics’, SmPC section 4.8 and the PIL have been updated in line with QRD guidelines.
SmPC Sections updated: 1, 4.4, 4.6, 4.8 and 10.
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Changes: (Updated: 22 Sep 2022)
Initial upload