PIL- Rocuronium bromide 10 mg/ml solution for injection/infusion in pre-filled syringe: Change history
View Patient Information Leaflet (PIL- Rocuronium bromide 10 mg/ml solution for injection/infusion in pre-filled syringe)
Last updated on this site: 17 Mar 2026
Description of update: To update sections 4.4 and 4.8 of the SPC and PIL in line with PRAC recommendation (PSUSA/0002656/202502) to add a warning regarding hypertensive crisis in patients with known or latent phaeochromocytoma, and to add information on hypersensitivity reactions for sugammadex-rocuronium complex.
Date of approval: 10/03/2026
PIL sections updated: 2, 4 and 6
Last updated on this site: 17 Mar 2026
Description of update: To update sections 4.4 and 4.8 of the SPC and PIL in line with PRAC recommendation (PSUSA/0002656/202502) to add a warning regarding hypertensive crisis in patients with known or latent phaeochromocytoma, and to add information on hypersensitivity reactions for sugammadex-rocuronium complex.
Date of approval: 10/03/2026
PIL sections updated: 2, 4 and 6
-
Changes: (Updated: 17 Mar 2026)
Description of update: To update sections 4.4 and 4.8 of the SPC and PIL in line with PRAC recommendation (PSUSA/0002656/202502) to add a warning regarding hypertensive crisis in patients with known or latent phaeochromocytoma, and to add information on hypersensitivity reactions for sugammadex-rocuronium complex.
Date of approval: 10/03/2026
PIL sections updated: 2, 4 and 6
-
Changes: (Updated: 27 May 2025)
New Product launch