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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 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.

  • 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.

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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