PMDA drug package insert
パーサビブ静注透析用2.5mg
PMDA Prescription drug · 小野薬品工業株式会社 · package insert Jul 24, 2023
Key facts
| Brand names | パーサビブ静注透析用2.5mg, パーサビブ静注透析用5mg, パーサビブ静注透析用10mg |
|---|---|
| Nonproprietary names | エテルカルセチド塩酸塩 |
| Companies | 製造販売／小野薬品工業株式会社, 提携／AMGEN |
| Product type | Prescription drug |
| Therapeutic category | カルシウム受容体作動薬 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999443A1025, 3999443A2021, 3999443A3028 |
| Approval numbers | 22800AMX00721000, 22800AMX00722000, 22800AMX00723000 |
| Package insert edition | 第1版 |
| Package insert date | Jul 24, 2023 |
| PMDA document key | 180188_3999443A1025_1 |
| PMDA company code | 180188 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: