v3 · current
C. Laurent (Regulatory Affairs Lead) · 08 Apr 2024 · 1d89e557bc56…
Confirmed unchanged at PSUR 1 review
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant use of strong CYP3A4 inducers (see section 4.5).
v2
Dr. A. Müller (MAH Medical Affairs) · 12 Sept 2023 · 1d89e557bc56…
No change required following Day 120 assessment
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant use of strong CYP3A4 inducers (see section 4.5).
v1
Dr. A. Müller (MAH Medical Affairs) · 15 Mar 2023 · 1d89e557bc56…
Initial submission
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant use of strong CYP3A4 inducers (see section 4.5).