PMDA drug package insert
ルボックス錠25
PMDA Prescription drug · アッヴィ合同会社 · package insert Jul 23, 2026
Key facts
| Brand names | ルボックス錠25, ルボックス錠50, ルボックス錠75 |
|---|---|
| Nonproprietary names | フルボキサミンマレイン酸塩 |
| Companies | 製造販売元／アッヴィ合同会社 |
| Product type | Prescription drug |
| Therapeutic category | 選択的セロトニン再取り込み阻害剤（SSRI） |
| Therapeutic category codes | 871179 |
| YJ codes | 1179039F1036, 1179039F2032, 1179039F3039 |
| Approval numbers | 21100AMZ00427000, 21100AMZ00428000, 22000AMX00965000 |
| Package insert edition | 第7版 |
| Package insert date | Jul 23, 2026 |
| PMDA document key | 112130_1179039F1036_3 |
| PMDA company code | 112130 |
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: