PMDA drug package insert
フィコンパ錠2mg
PMDA Prescription drug · エーザイ株式会社 · package insert Oct 22, 2025
Key facts
| Brand names | フィコンパ錠2mg, フィコンパ錠4mg, フィコンパ細粒1% |
|---|---|
| Nonproprietary names | ペランパネル水和物 |
| Companies | 製造販売元／エーザイ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗てんかん剤 |
| Therapeutic category codes | 871139 |
| YJ codes | 1139014F1022, 1139014F2029, 1139014C1026 |
| Approval numbers | 22800AMX00379000, 22800AMX00380000, 30200AMX00024000 |
| Package insert edition | 第6版 |
| Package insert date | Oct 22, 2025 |
| PMDA document key | 170033_1139014F1022_1 |
| PMDA company code | 170033 |
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: