PMDA drug package insert
シベノール錠50mg
PMDA Prescription drug · トーアエイヨー株式会社 · package insert Oct 1, 2025
Key facts
| Brand names | シベノール錠50mg, シベノール錠100mg |
|---|---|
| Nonproprietary names | シベンゾリンコハク酸塩 |
| Companies | 製造販売元／トーアエイヨー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 不整脈治療剤 |
| Therapeutic category codes | 872129 |
| YJ codes | 2129007F1020, 2129007F2027 |
| Approval numbers | 20200AMZ00947000, 20200AMZ00946000 |
| Package insert edition | 第5版 |
| Package insert date | Oct 1, 2025 |
| PMDA document key | 480008_2129007F1020_4 |
| PMDA company code | 480008 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: