PMDA drug package insert
リンスパッド点滴静注用1000mg
PMDA Prescription drug · 株式会社オーファンパシフィック · package insert Feb 2, 2023
Key facts
| Brand names | リンスパッド点滴静注用1000mg |
|---|---|
| Nonproprietary names | 乾燥濃縮人α１－プロテイナーゼインヒビター |
| Companies | 選任外国製造医薬品等製造販売業者／株式会社オーファンパシフィック, 外国製造医薬品等特例承認取得者／Grifols Therapeutics LLC（米国） |
| Product type | Prescription drug |
| Therapeutic category | 血漿分画製剤 |
| Therapeutic category codes | 876343 |
| YJ codes | 6343456D1024 |
| Approval numbers | 30300AMI00001000 |
| Package insert edition | 第2版 |
| Package insert date | Feb 2, 2023 |
| PMDA document key | 181251_6343456D1024_1 |
| PMDA company code | 181251 |
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: