PMDA drug package insert
メキニスト錠0.5mg
PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Feb 19, 2026
Key facts
| Brand names | メキニスト錠0.5mg, メキニスト錠2mg, メキニスト小児用ドライシロップ4.7mg |
|---|---|
| Nonproprietary names | トラメチニブ ジメチルスルホキシド付加物 |
| Companies | 製造販売（輸入）／ノバルティスファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤; MEK阻害剤 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291047F1026, 4291047F2022, 4291047R1022 |
| Approval numbers | 22800AMX00374000, 22800AMX00375000, 30600AMX00240000 |
| Package insert edition | 第8版 |
| Package insert date | Feb 19, 2026 |
| PMDA document key | 300242_4291047F1026_1 |
| PMDA company code | 300242 |
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: