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Intended for UK patients and members of the public

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Tranexamic Acid Solution

Active Ingredients

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Tranexamic acid 100mg/ml solution for injection

PL Number:
20075/0451
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Discontinued

Product Documentation

  • 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

    PIL sections updated: 1, 2, 3, 4, 6 and HCP section

  • 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

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

General FAQs

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