Update of the safety information for a medicinal product containing darolutamide based on the results of the signal review by the Pharmacovigilance Risk Assessment Committee (PRAC) at the meeting of June 08 – 11, 2026

In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.

08 – 11 June 2026

Having considered the available data in EudraVigilance, in particular the cumulative review provided and additional data on the time to onset of adverse reactions (time to onset), PRAC decided that the registration certificate holder of the medicinal product Nubeqa (Bayer AG) must submit an application to amend the instructions for medical use as indicated below (new text is underlined).

“Adverse reactions” section

Table 1

The following adverse reaction should be added to SOC “Skin and subcutaneous tissue disorders” with the frequency “not known”:

Angioedema ^{g, h}

^g Includes laryngeal edema, lip edema, facial edema, and tongue edema

^h Spontaneous reports received during post-registration surveillance

TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE RELEVANT APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT AVAILABLE AT THE FOLLOWING LINKS: