PMDA drug package insert
エバステル錠10mg
PMDA Prescription drug · 住友ファーマ株式会社 · package insert Jan 24, 2025
Key facts
| Brand names | エバステル錠10mg, エバステルOD錠5mg, エバステルOD錠10mg |
|---|---|
| Nonproprietary names | エバスチン |
| Companies | 製造販売元／住友ファーマ株式会社, 提携／アルミラル,S.A.（スペイン） |
| Product type | Prescription drug |
| Therapeutic category | 持続性選択H1受容体拮抗剤 |
| Therapeutic category codes | 87449 |
| YJ codes | 4490019F2024, 4490019F3020, 4490019F4027 |
| Approval numbers | 20800AMZ00692, 21700AMZ00149, 21700AMZ00150 |
| Package insert edition | 第3版 |
| Package insert date | Jan 24, 2025 |
| PMDA document key | 400093_4490019F2024_1 |
| PMDA company code | 400093 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- No PMDA review report published
- No 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: