PMDA drug package insert
ペマジール錠4.5mg
PMDA Prescription drug · インサイト・バイオサイエンシズ・ジャパン合同会社 · package insert Oct 10, 2023
Key facts
| Brand names | ペマジール錠4.5mg |
|---|---|
| Nonproprietary names | ペミガチニブ |
| Companies | 製造販売元／インサイト・バイオサイエンシズ・ジャパン合同会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤/FGFR阻害剤 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291072F1024 |
| Approval numbers | 30300AMX00259000 |
| Package insert edition | 第5版 |
| Package insert date | Oct 10, 2023 |
| PMDA document key | 150892_4291072F1024_1 |
| PMDA company code | 150892 |
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: