PMDA drug package insert
ソマトロピンBS皮下注5mg「サンド」シュアパル
PMDA Prescription drug · サンド株式会社 · package insert Aug 19, 2026
Key facts
| Brand names | ソマトロピンBS皮下注5mg「サンド」シュアパル, ソマトロピンBS皮下注10mg「サンド」シュアパル |
|---|---|
| Nonproprietary names | ソマトロピン（遺伝子組換え） |
| Companies | 製造販売／サンド株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝子組換え天然型ヒト成長ホルモン製剤 |
| Therapeutic category codes | 872412 |
| YJ codes | 2412402A3033, 2412402A4030 |
| Approval numbers | 22700AMX00728000, 22700AMX00729000 |
| Package insert edition | 第3版 |
| Package insert date | Aug 19, 2026 |
| PMDA document key | 270428_2412402A3033_1 |
| PMDA company code | 270428 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: