| EMA number | EMEA/H/C/004319 |
| ATC code | L04AB04 |
| Authorisation | 10 November 2017 |
| Withdrawn | 15 January 2019 |
| Revision | 2 |
Please refer to section 4.1 of the Summary of product characteristics in the product information document.
HULIO β MYLAN PHARMS INC, approved 2025-02-05 (BLA761154).
547,369 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System β they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.