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Intended for UK patients and members of the public

Relugolix 120 mg film-coated tablets

Relugolix Tablets

Medicines showing this symbol are subject to additional monitoring. This will allow quick identification of new safety information. Please click here for more information.

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

Relugolix 120 mg film-coated tablets

Medicines showing this symbol are subject to additional monitoring. This will allow quick identification of new safety information. Please click here for more information.

PL Number:
PLGB 0142/1272
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • View Patient Information Leaflet (PIL- Relugolix 120 mg film-coated tablets)

    Last updated on this site: 01 Apr 2026

    Description of update:

    Submission of CSR 049 study as post authorisation measures for Orgovyx® 120 mg film-coated tablets.

    Based on the data provided, updates to SmPC section 4.5 are proposed with consequential updates to the leaflet.

    Additionally, we have taken the opportunity to update SmPC sections 4.8 and 5.1. In section 4.8, the frequency for the adverse event myocardial infarction has been updated to uncommon. 

     

    Date of approval: 24/03/2026

    SmPC sections updated: 4.5, 4.8, 5.1 and 10.

    View change history
  • View Summary of Product Characteristics (SmPC - Orgovyx® 120 mg film-coated tablets, Relugolix 120 mg film-coated tablets (Great Britain))

    Last updated on this site: 01 Apr 2026

    Description of update:

    Submission of CSR 049 study as post authorisation measures for Orgovyx® 120 mg film-coated tablets.

    Based on the data provided, updates to SmPC section 4.5 are proposed with consequential updates to the leaflet.

    Additionally, we have taken the opportunity to update SmPC sections 4.8 and 5.1. In section 4.8, the frequency for the adverse event myocardial infarction has been updated to uncommon. 

     

    Date of approval: 24/03/2026

    SmPC sections updated: 4.5, 4.8, 5.1 and 10.

    View change history

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

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