SmPC - Orgovyx® 120 mg film-coated tablets, Relugolix 120 mg film-coated tablets (Great Britain): Change history

To update sections 4.2 and 4.5 of the SmPC to add information on "Combination with other medicines for advanced hormone-sensitive prostate cancer" based on clinical studies and literature. In addition, to introduce editorial changes to sections 4.8 and 5.1 of the SmPC.

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.

SmPC Sections updated: 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.

Description of update:

To register updates to sections 4.1, 4.2, 4.5 and 5.1 of the SmPC to reflect the addition of new therapeutic indications: Treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy, and Neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer. Consequently, the PIL has also been updated. The RMP has also been updated to version 2.0.

SmPC Sections updated: 4.1, 4.2, 4.5, 5.1 and 10.

Description of update: To update section 4.5 of the SmPC based on final results from study MVT-601-9039; this is an In vitro Interaction Study of Relugolix with human OATP2B1 Uptake Transporter.

SmPC sections updated: 4.5 and 10.

Description of update: To assess the sufficiency of dose separation to mitigate absorption-mediated increases in exposure to Relugolix resulting from inhibition of intestinal P-gp by Azithromycin as post authorisation measures for Orgovyx® 120 mg film-coated tablets.

SmPC sections updated – 4.5 and 10

No update to artwork