PMDA drug package insert
エヌジェンラ皮下注24mgペン
PMDA Prescription drug · ファイザー株式会社 · package insert Jul 14, 2026
Key facts
| Brand names | エヌジェンラ皮下注24mgペン, エヌジェンラ皮下注60mgペン |
|---|---|
| Nonproprietary names | ソムアトロゴン（遺伝子組換え） |
| Companies | 製造販売元／ファイザー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 長時間作用型遺伝子組換えヒト成長ホルモン製剤 |
| Therapeutic category codes | 872412 |
| YJ codes | 2412404G1024, 2412404G2020 |
| Approval numbers | 30400AMX00006, 30400AMX00007 |
| Package insert edition | 第3版 |
| Package insert date | Jul 14, 2026 |
| PMDA document key | 672212_2412404G1024_1 |
| PMDA company code | 672212 |
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: