PMDA drug package insert
ミネブロ錠1.25mg
PMDA Prescription drug · 第一三共株式会社 · package insert Dec 17, 2024
Key facts
| Brand names | ミネブロ錠1.25mg, ミネブロ錠2.5mg, ミネブロ錠5mg, ミネブロOD錠1.25mg, ミネブロOD錠2.5mg, ミネブロOD錠5mg |
|---|---|
| Nonproprietary names | エサキセレノン |
| Companies | 製造販売元／第一三共株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 選択的ミネラルコルチコイド受容体ブロッカー |
| Therapeutic category codes | 872149 |
| YJ codes | 2149049F1027, 2149049F2023, 2149049F3020, 2149049F4026, 2149049F5022, 2149049F6029 |
| Approval numbers | 23100AMX00011, 23100AMX00012, 23100AMX00013, 30400AMX00161, 30400AMX00160, 30400AMX00159 |
| Package insert edition | 第7版 |
| Package insert date | Dec 17, 2024 |
| PMDA document key | 430574_2149049F1027_1 |
| PMDA company code | 430574 |
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: