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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

Orgovyx 120mg 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

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

  • CCC-AccordUK-00142-017

    IB grouped variation via IRP route:

    1.) IB, B.II.e.1.b.1 – Register a change in the immediate packaging of the finished product; addition of a new container 30's count blister pack with shelf life of 48 months.

    2.) IB, B.II.e.1.b.1 – Register a change in the immediate packaging of the finished product; addition of a new container 90's count blister pack with shelf life of 48 months.

    3.) IAin, B.II.e.5.a.1 – Register addition of a new pack size of 90's

    HDPE bottle.

    4.) IA, B.II.b.5.b – Register addition of blister leak test as a new in-process test applied during the manufacture of the finished product.

    5.) IB, B.II.f.1.b.1 – Register an extension to the shelf life of the HDPE bottle for the finished product as packed for sale from 36 months to 48 months when stored below 30˚C.

  • Description of update: To register the addition of the generic name "Relugolix 120 mg film-coated tablets".

    Consequently, sections 1, 4.1, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.5, 6.6 and 10 of the SPC have been updated, aswell as the label and leaflet.

    PIL sections updated: Intro and sections 1, 2, 3, 4, 5 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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