PIL - Tranexamic acid 100mg/ml solution for injection: Change history
View Patient Information Leaflet (PIL - Tranexamic acid 100mg/ml solution for injection)
Last updated on this site: 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.
PIL sections updated: Heading, 1, 2, 3, 4 and 6.
Last updated on this site: 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.
PIL sections updated: Heading, 1, 2, 3, 4 and 6.
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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.
PIL sections updated: Heading, 1, 2, 3, 4 and 6.
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Changes: (Updated: 22 Sep 2022)
Initial upload