PMDA drug package insert
エピルビシン塩酸塩注射液10mg/5mL「NK」
PMDA Prescription drug · 日本化薬株式会社 · package insert Nov 1, 2023
Key facts
| Brand names | エピルビシン塩酸塩注射液10mg/5mL「NK」, エピルビシン塩酸塩注射液50mg/25mL「NK」 |
|---|---|
| Nonproprietary names | エピルビシン塩酸塩 |
| Companies | 製造販売元／日本化薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗腫瘍性抗生物質製剤 |
| Therapeutic category codes | 874235 |
| YJ codes | 4235404A1040, 4235404A2047 |
| Approval numbers | 22100AMX00361, 22100AMX00362 |
| Package insert edition | 第1版 |
| Package insert date | Nov 1, 2023 |
| PMDA document key | 530191_4235404A1040_1 |
| PMDA company code | 530191 |
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: