PMDA drug package insert
ゾニサミドOD錠25mgTRE「フェルゼン」
PMDA Prescription drug · 株式会社フェルゼンファーマ · package insert Jun 14, 2024
Key facts
| Brand names | ゾニサミドOD錠25mgTRE「フェルゼン」, ゾニサミドOD錠50mgTRE「フェルゼン」 |
|---|---|
| Nonproprietary names | ゾニサミド |
| Companies | 製造販売元／株式会社フェルゼンファーマ |
| Product type | Prescription drug |
| Therapeutic category | パーキンソン病治療薬・レビー小体型認知症に伴うパーキンソニズム治療薬（レボドパ賦活剤） |
| Therapeutic category codes | 871169 |
| YJ codes | 1169015F2170, 1169015F3177 |
| Approval numbers | 30600AMX00082000, 30600AMX00083000 |
| Package insert edition | 第2版 |
| Package insert date | Jun 14, 2024 |
| PMDA document key | 671940_1169015F2170_1 |
| PMDA company code | 671940 |
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: