PMDA drug package insert
デュロキセチンカプセル20mg「フェルゼン」
PMDA Prescription drug · ダイト株式会社 · package insert Sep 20, 2022
Key facts
| Brand names | デュロキセチンカプセル20mg「フェルゼン」, デュロキセチンカプセル30mg「フェルゼン」 |
|---|---|
| Nonproprietary names | デュロキセチン塩酸塩 |
| Companies | 製造販売元／ダイト株式会社, 販売元／株式会社フェルゼンファーマ |
| 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 | 1179052M1146, 1179052M2142 |
| Approval numbers | 30300AMX00137000, 30300AMX00138000 |
| Package insert edition | 第3版 |
| Package insert date | Sep 20, 2022 |
| PMDA document key | 400073_1179052M1146_1 |
| PMDA company code | 400073 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: