PMDA drug package insert
ドグマチール錠100mg
PMDA Prescription drug · 日医工株式会社 · package insert May 20, 2025
Key facts
| Brand names | ドグマチール錠100mg, ドグマチール錠200mg |
|---|---|
| Nonproprietary names | スルピリド |
| Companies | 製造販売元／日医工株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 精神・情動安定剤 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179016F1124, 1179016F2090 |
| Approval numbers | 15400AMZ00253000, 15400AMZ00254000 |
| Package insert edition | 第6版 |
| Package insert date | May 20, 2025 |
| PMDA document key | 530169_1179016F1124_4 |
| PMDA company code | 530169 |
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: