PMDA drug package insert
コルスバ静注透析用シリンジ17.5μg
PMDA Prescription drug · 丸石製薬株式会社 · package insert Dec 13, 2023
Key facts
| Brand names | コルスバ静注透析用シリンジ17.5μg, コルスバ静注透析用シリンジ25.0μg, コルスバ静注透析用シリンジ35.0μg |
|---|---|
| Nonproprietary names | ジフェリケファリン酢酸塩 |
| Companies | 製造販売元／丸石製薬株式会社, 販売元／キッセイ薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 静注透析そう痒症改善剤 |
| Therapeutic category codes | 87129 |
| YJ codes | 1290402G1026, 1290402G2022, 1290402G3029 |
| Approval numbers | 30500AMX00248, 30500AMX00249, 30500AMX00250 |
| Package insert edition | 第2版 |
| Package insert date | Dec 13, 2023 |
| PMDA document key | 730119_1290402G1026_1 |
| PMDA company code | 730119 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: