PMDA drug package insert
ソグルーヤ皮下注5mg
PMDA Prescription drug · ノボ ノルディスク ファーマ株式会社 · package insert Jun 19, 2026
Key facts
| Brand names | ソグルーヤ皮下注5mg, ソグルーヤ皮下注10mg, ソグルーヤ皮下注15mg |
|---|---|
| Nonproprietary names | ソマプシタン（遺伝子組換え） |
| Companies | 製造販売元／ノボ ノルディスク ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 長時間作用型ヒト成長ホルモンアナログ製剤 |
| Therapeutic category codes | 872412 |
| YJ codes | 2412403G1020, 2412403G2026, 2412403G3022 |
| Approval numbers | 30300AMX00025000, 30300AMX00026000, 30500AMX00131000 |
| Package insert edition | 第4版 |
| Package insert date | Jun 19, 2026 |
| PMDA document key | 620023_2412403G1020_1 |
| PMDA company code | 620023 |
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: