PMDA drug package insert
シスプラチン点滴静注10mg「マルコ」
PMDA Prescription drug · 日医工ファーマ株式会社 · package insert Sep 24, 2025
Key facts
| Brand names | シスプラチン点滴静注10mg「マルコ」, シスプラチン点滴静注25mg「マルコ」, シスプラチン点滴静注50mg「マルコ」 |
|---|---|
| Nonproprietary names | シスプラチン |
| Companies | 製造販売元／日医工ファーマ株式会社, 販売元／日医工株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291401A1119, 4291401A2115, 4291401A3111 |
| Approval numbers | 22100AMX01616000, 22100AMX01617000, 22100AMX01618000 |
| Package insert edition | 第2版 |
| Package insert date | Sep 24, 2025 |
| PMDA document key | 580825_4291401A1119_3 |
| PMDA company code | 580825 |
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: