Section Version History

Section 6.1 — List of excipients

← Veraxanib 50 mg film-coated tablets

3 versions recorded. Append-only — each version is immutable once written.

v3 · current
C. Laurent (Regulatory Affairs Lead) · 08 Apr 2024 · 456804b37266…
Confirmed unchanged at PSUR 1 review
Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate. Film coat: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, sunset yellow aluminium lake (E110).
v2
Dr. S. Patel (CMC Regulatory) · 12 Sept 2023 · 456804b37266…
Confirmed following CMC Day 70 assessment — no change
Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate. Film coat: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, sunset yellow aluminium lake (E110).
v1
Dr. A. Müller (MAH Medical Affairs) · 15 Mar 2023 · 456804b37266…
Initial submission
Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate. Film coat: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, sunset yellow aluminium lake (E110).