JP19 changes · Drug substance (API) · モンテルカストナトリウム
The Montelukast Sodium monograph in the Japanese Pharmacopoeia 19th Edition (JP19): revised monograph. What changed, what to check before 30 September 2027, and links to the official text.
Last updated: 2026-09-27 · source: MHLW / PMDA (PDL1.0), edited and translated
| Monograph | Montelukast Sodium モンテルカストナトリウム |
|---|---|
| Type | Drug substance (API) |
| Change in JP19 | Revised monograph |
| Items changed | Chemical names of related substances |
| JP18 title | モンテルカストナトリウム (JP18) |
| In force | 10 April 2026 (JP19, MHLW Notification No. 193) |
days left until the JP19 transition period ends on 30 September 2027
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As of 2026-10-02: 363 days left. The number updates in your browser (Japan time).
Our own summary from comparing the JP18 and JP19 Japanese texts (MHLW PDFs) and the official change list, 2026-09-27. Check the official text.
General points, not regulatory advice for your product.
The official Montelukast Sodium monograph is in the Japanese JP19 text (free PDF). The English JP19 is not out yet; PMDA says within a year of publication. We do not reproduce the monograph.
出典：厚生労働省「第十九改正日本薬局方の制定等について」（医薬発0410第1号）、日本薬局方部会資料、厚生労働省「日本薬局方」ページの第十九改正・第十八改正日本薬局方、PMDA「第十九改正日本薬局方の概要」等を加工・翻訳して Japan Pharma Regulatory Brief が作成。
Used under the Public Data License 1.0 (PDL1.0) (compatible with CC BY 4.0). All English on this page is an unofficial translation or our own summary; the Japanese originals prevail.
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