PMDA drug package insert
サブリル散分包500mg
PMDA Prescription drug · サノフィ株式会社 · package insert Jul 28, 2023
Key facts
| Brand names | サブリル散分包500mg |
|---|---|
| Nonproprietary names | ビガバトリン |
| Companies | 製造販売元／サノフィ株式会社, 販売元／アルフレッサ ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗てんかん剤 |
| Therapeutic category codes | 871139 |
| YJ codes | 1139013B1026 |
| Approval numbers | 22800AMX00376 |
| Package insert edition | 第1版 |
| Package insert date | Jul 28, 2023 |
| PMDA document key | 780069_1139013B1026_1 |
| PMDA company code | 780069 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: