PMDA drug package insert
ダルベポエチン アルファBS注5μgシリンジ「三和」
PMDA Prescription drug · 株式会社三和化学研究所 · package insert Jun 17, 2025
Key facts
| Brand names | ダルベポエチン アルファBS注5μgシリンジ「三和」, ダルベポエチン アルファBS注10μgシリンジ「三和」, ダルベポエチン アルファBS注15μgシリンジ「三和」, ダルベポエチン アルファBS注20μgシリンジ「三和」, ダルベポエチン アルファBS注30μgシリンジ「三和」, ダルベポエチン アルファBS注40μgシリンジ「三和」, ダルベポエチン アルファBS注60μgシリンジ「三和」, ダルベポエチン アルファBS注120μgシリンジ「三和」, ダルベポエチン アルファBS注180μgシリンジ「三和」 |
|---|---|
| Nonproprietary names | ダルベポエチン アルファ（遺伝子組換え） |
| Companies | 製造販売（輸入）元／株式会社三和化学研究所 |
| Product type | Prescription drug |
| Therapeutic category | 持続型赤血球造血刺激因子製剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999454G1026, 3999454G2022, 3999454G3029, 3999454G4025, 3999454G5021, 3999454G6028, 3999454G7024, 3999454G8020, 3999454G9027 |
| Approval numbers | 30100AMX00262000, 30100AMX00263000, 30100AMX00264000, 30100AMX00265000, 30100AMX00266000, 30100AMX00267000, 30100AMX00268000, 30100AMX00269000, 30100AMX00270000 |
| Package insert edition | 第3版 |
| Package insert date | Jun 17, 2025 |
| PMDA document key | 300297_3999454G1026_1 |
| PMDA company code | 300297 |
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: