PMDA drug package insert
コセルゴカプセル10mg
PMDA Prescription drug · アレクシオンファーマ合同会社 · package insert Oct 1, 2026
Key facts
| Brand names | コセルゴカプセル10mg, コセルゴカプセル25mg |
|---|---|
| Nonproprietary names | セルメチニブ硫酸塩 |
| Companies | 製造販売元／アレクシオンファーマ合同会社 |
| Product type | Prescription drug |
| Therapeutic category | 神経線維腫症1型治療剤（MEK阻害剤） |
| Therapeutic category codes | 874299 |
| YJ codes | 4299004M1025, 4299004M2021 |
| Approval numbers | 30400AMX00430000, 30400AMX00431000 |
| Package insert edition | 第6版 |
| Package insert date | Oct 1, 2026 |
| PMDA document key | 870056_4299004M1025_1 |
| PMDA company code | 870056 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes Risk management plan (RMP)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMDA approved drugs and package inserts (Japan)
Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.
Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date: