PMDA drug package insert
ミルセラ注シリンジ12.5μg
PMDA Prescription drug · 中外製薬株式会社 · package insert Apr 10, 2023
Key facts
| Brand names | ミルセラ注シリンジ12.5μg, ミルセラ注シリンジ25μg, ミルセラ注シリンジ50μg, ミルセラ注シリンジ75μg, ミルセラ注シリンジ100μg, ミルセラ注シリンジ150μg, ミルセラ注シリンジ200μg, ミルセラ注シリンジ250μg |
|---|---|
| Nonproprietary names | エポエチン ベータ ペゴル（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 | 持続型赤血球造血刺激因子製剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999432G8024, 3999432G1020, 3999432G2026, 3999432G3022, 3999432G4029, 3999432G5025, 3999432G6021, 3999432G7028 |
| Approval numbers | 23000AMX00442, 22300AMX00543, 22300AMX00544, 22300AMX00546, 22300AMX00545, 22300AMX00553, 22300AMX00527, 22300AMX00528 |
| Package insert edition | 第2版 |
| Package insert date | Apr 10, 2023 |
| PMDA document key | 450045_3999432G1020_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: