Section Version History

Section 6.3 — Shelf life

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

v3 · current
C. Laurent (Regulatory Affairs Lead) · 08 Apr 2024 · 8df9515fb458…
Confirmed unchanged at PSUR 1 review
36 months.
v2
Dr. S. Patel (CMC Regulatory) · 12 Sept 2023 · 8df9515fb458…
Confirmed following 36-month real-time stability data; no change needed
36 months.
v1
Dr. A. Müller (MAH Medical Affairs) · 15 Mar 2023 · 8df9515fb458…
Initial submission — based on 24-month real-time stability data
36 months.