PMDA drug package insert
オキサリプラチン点滴静注液50mg「DSEP」
PMDA Prescription drug · 第一三共エスファ株式会社 · package insert Feb 13, 2025
Key facts
| Brand names | オキサリプラチン点滴静注液50mg「DSEP」, オキサリプラチン点滴静注液100mg「DSEP」, オキサリプラチン点滴静注液200mg「DSEP」 |
|---|---|
| Nonproprietary names | オキサリプラチン |
| Companies | 製造販売元／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 | 抗悪性腫瘍剤 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291410A1070, 4291410A2076, 4291410A3064 |
| Approval numbers | 22600AMX01090, 22600AMX01091, 22700AMX00517 |
| Package insert edition | 第2版 |
| Package insert date | Feb 13, 2025 |
| PMDA document key | 430773_4291410A1070_1 |
| PMDA company code | 430773 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes 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: