PMDA drug package insert
ウパシタ静注透析用25μgシリンジ
PMDA Prescription drug · 株式会社三和化学研究所 · package insert Jul 11, 2022
Key facts
| Brand names | ウパシタ静注透析用25μgシリンジ, ウパシタ静注透析用50μgシリンジ, ウパシタ静注透析用100μgシリンジ, ウパシタ静注透析用150μgシリンジ, ウパシタ静注透析用200μgシリンジ, ウパシタ静注透析用250μgシリンジ, ウパシタ静注透析用300μgシリンジ |
|---|---|
| Nonproprietary names | ウパシカルセトナトリウム水和物 |
| Companies | 製造販売元／株式会社三和化学研究所, プロモーション提携／キッセイ薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | カルシウム受容体作動薬 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999460G1021, 3999460G2028, 3999460G3024, 3999460G4020, 3999460G5027, 3999460G6023, 3999460G7020 |
| Approval numbers | 30300AMX00281000, 30300AMX00282000, 30300AMX00283000, 30300AMX00284000, 30300AMX00285000, 30300AMX00286000, 30300AMX00287000 |
| Package insert edition | 第3版 |
| Package insert date | Jul 11, 2022 |
| PMDA document key | 300297_3999460G1021_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
- 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: