PMDA drug package insert
エポジン注シリンジ1500
PMDA Prescription drug · 中外製薬株式会社 · package insert Jan 24, 2020
Key facts
| Brand names | エポジン注シリンジ1500, エポジン注シリンジ3000 |
|---|---|
| Nonproprietary names | エポエチン ベータ（遺伝子組換え） |
| Companies | 製造販売元／中外製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝子組換えヒトエリスロポエチン製剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999413G2031, 3999413G3038 |
| Approval numbers | 21300AMZ00604, 21300AMZ00605 |
| Package insert edition | 第1版 |
| Package insert date | Jan 24, 2020 |
| PMDA document key | 450045_3999413G2031_1 |
| PMDA company code | 450045 |
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: