PMDA drug package insert
サインバルタカプセル20mg
PMDA Prescription drug · 塩野義製薬株式会社 · package insert May 20, 2026
Key facts
| Brand names | サインバルタカプセル20mg, サインバルタカプセル30mg |
|---|---|
| Nonproprietary names | デュロキセチン塩酸塩 |
| Companies | 製造販売元／塩野義製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | セロトニン・ノルアドレナリン再取り込み阻害剤 |
| Therapeutic category codes | 871179, 87119 |
| YJ codes | 1179052M1022, 1179052M2029 |
| Approval numbers | 22200AMX00230000, 22200AMX00231000 |
| Package insert edition | 第5版 |
| Package insert date | May 20, 2026 |
| PMDA document key | 340018_1179052M1022_2 |
| PMDA company code | 340018 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 Safety communications
- Yes 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: