PMDA drug package insert
ビプレッソ徐放錠50mg
PMDA Prescription drug · 共和薬品工業株式会社 · package insert Jan 14, 2026
Key facts
| Brand names | ビプレッソ徐放錠50mg, ビプレッソ徐放錠150mg |
|---|---|
| Nonproprietary names | クエチアピンフマル酸塩 |
| Companies | 製造販売元／共和薬品工業株式会社, 提携／AstraZeneca UK Ltd |
| Product type | Prescription drug |
| Therapeutic category | 双極性障害のうつ症状治療薬 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179042G1025, 1179042G2021 |
| Approval numbers | 22900AMX00579, 22900AMX00580 |
| Package insert edition | 第7版 |
| Package insert date | Jan 14, 2026 |
| PMDA document key | 672173_1179042G1025_2 |
| PMDA company code | 672173 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None 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: