PMDA drug package insert
ジェムザール注射用200mg
PMDA Prescription drug · 日本イーライリリー株式会社 · package insert Oct 10, 2025
Key facts
| Brand names | ジェムザール注射用200mg, ジェムザール注射用1g |
|---|---|
| Nonproprietary names | ゲムシタビン塩酸塩 |
| Companies | 製造販売元／日本イーライリリー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 代謝拮抗性抗悪性腫瘍剤 |
| Therapeutic category codes | 874224 |
| YJ codes | 4224403D1030, 4224403D2037 |
| Approval numbers | 21300AMY00405, 21300AMY00404 |
| Package insert edition | 第4版 |
| Package insert date | Oct 10, 2025 |
| PMDA document key | 530471_4224403D1030_1 |
| PMDA company code | 530471 |
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: