FY2026 Drug Precaution Revisions for Biologics
Summary
PMDA published FY2026 precaution revisions for 6 drugs/biologics on April 21, 2026. Revised products include infliximab and etanercept (both with biosimilars), calcium chloride hydrate (injection), calcium gluconate hydrate, avelumab, and regorafenib hydrate. Each revision includes a PRECAUTIONS document and Summary of Investigation.
What changed
PMDA posted new precaution revisions for six pharmaceutical products on April 21, 2026. The revisions cover infliximab and etanercept (both with biosimilars), calcium chloride hydrate injection, calcium gluconate hydrate, avelumab, and regorafenib hydrate. Each product listing links to the revised PRECAUTIONS document and a Summary of Investigation.
Pharmaceutical companies marketing these products in Japan and healthcare providers prescribing or administering them should review the updated precaution documents. The revisions may reflect new safety information identified through PMDA's post-market investigation process.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
日本語ページはこちら
| Date | Nonproprietary name | Detailed information on revisions of PRECAUTIONS
(from MHLW) | Summary of
investigation results
(from PMDA)
Reference article note)
(if applicable) |
| --- | --- | --- | --- |
| April 21, 2026 | - Infliximab
(genetical recombination) and biosimilars
- Etanercept
(genetical recombination) and biosimilars | PRECAUTIONS
[26.5 KB] | Summary of Investigation
[73.8 KB] |
| - Calcium chloride hydrate (injection) | PRECAUTIONS
[32.4 KB] | Summary of Investigation
[131 KB] | |
| - Calcium gluconate hydrate | PRECAUTIONS
[31.4 KB] | Summary of Investigation
[131 KB] | |
| - Avelumab
(genetical recombination) | PRECAUTIONS
[25.6 KB] | Summary of Investigation
[79.8 KB] | |
| - Regorafenib hydrate | PRECAUTIONS
[25.6 KB] | Summary of Investigation
[78.6 KB] | |
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