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並前往https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-maximum-shelf-life-sterile-products-human-use-after-first-opening-following_en.pdf

NfG on Maximum shelf-life for sterile products for human use

MAXIMUM SHELF-LIFE FOR STERILE PRODUCTS FOR HUMAN. USE AFTER FIRST OPENING OR FOLLOWING RECONSTITUTION. DISCUSSION IN THE QUALITY WORKING PARTY (QWP).

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