PMDA drug package insert
レボレード錠12.5mg
PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Nov 22, 2024
Key facts
| Brand names | レボレード錠12.5mg, レボレード錠25mg |
|---|---|
| Nonproprietary names | エルトロンボパグ オラミン |
| Companies | 製造販売／ノバルティスファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 経口造血刺激薬/トロンボポエチン受容体作動薬 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999028F1025, 3999028F2021 |
| Approval numbers | 22200AMX00960000, 22200AMX00961000 |
| Package insert edition | 第2版 |
| Package insert date | Nov 22, 2024 |
| PMDA document key | 300242_3999028F1025_2 |
| 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: