v3 · current
C. Laurent (Regulatory Affairs Lead) · 08 Apr 2024 · 2eac4ae45f04…
Confirmed at PSUR 1 review — wording aligned with QRD template v11
Each film-coated tablet contains 50 mg of veraxanib (as veraxanib hydrochloride). Excipient(s) with known effect: Each tablet contains 45 mg of lactose monohydrate and 0.15 mg of sunset yellow (E110). For the full list of excipients, see section 6.1.
v2
Dr. S. Patel (CMC Regulatory) · 12 Sept 2023 · 2eac4ae45f04…
Added colourant E110 following day 150 reformulation notification
Each film-coated tablet contains 50 mg of veraxanib (as veraxanib hydrochloride). Excipient(s) with known effect: Each tablet contains 45 mg of lactose monohydrate and 0.15 mg of sunset yellow (E110). For the full list of excipients, see section 6.1.
v1
Dr. A. Müller (MAH Medical Affairs) · 15 Mar 2023 · f0c3eed08b15…
Initial submission
Each film-coated tablet contains 50 mg of veraxanib (as veraxanib hydrochloride). Excipient with known effect: Each tablet contains 45 mg of lactose monohydrate. For the full list of excipients, see section 6.1.