PMDA drug package insert
ストレンジック皮下注12mg
PMDA Prescription drug · アレクシオンファーマ合同会社 · package insert Jul 7, 2022
Key facts
| Brand names | ストレンジック皮下注12mg, 0.3mL, ストレンジック皮下注18mg, 0.45mL, ストレンジック皮下注28mg, 0.7mL, ストレンジック皮下注40mg, 1mL, ストレンジック皮下注80mg, 0.8mL |
|---|---|
| Nonproprietary names | アスホターゼ アルファ（遺伝子組換え） |
| Companies | 製造販売元／アレクシオンファーマ合同会社 |
| Product type | Prescription drug |
| Therapeutic category | 低ホスファターゼ症治療剤 |
| Therapeutic category codes | 87395 |
| YJ codes | 3959418A1021, 3959418A2028, 3959418A3024, 3959418A4020, 3959418A5027 |
| Approval numbers | 22700AMX00702000, 22700AMX00703000, 22700AMX00704000, 22700AMX00705000, 22700AMX00706000 |
| Package insert edition | 第3版 |
| Package insert date | Jul 7, 2022 |
| PMDA document key | 870056_3959418A1021_1 |
| PMDA company code | 870056 |
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: