PMDA drug package insert
プレガバリンOD錠25mg「DSEP」
PMDA Prescription drug · 第一三共エスファ株式会社 · package insert May 17, 2024
Key facts
| Brand names | プレガバリンOD錠25mg「DSEP」, プレガバリンOD錠75mg「DSEP」, プレガバリンOD錠150mg「DSEP」 |
|---|---|
| Nonproprietary names | プレガバリン |
| Companies | 製造販売／第一三共エスファ株式会社, 販売提携／第一三共株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 疼痛治療剤（神経障害性疼痛・線維筋痛症） |
| Therapeutic category codes | 871190 |
| YJ codes | 1190017F1037, 1190017F2033, 1190017F3030 |
| Approval numbers | 30200AMX00829, 30200AMX00830, 30200AMX00831 |
| Package insert edition | 第1版 |
| Package insert date | May 17, 2024 |
| PMDA document key | 430773_1190017F1037_1 |
| PMDA company code | 430773 |
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: