PMDA drug package insert
ノルディトロピン フレックスプロ注 5mg
PMDA Prescription drug · ノボ ノルディスク ファーマ株式会社 · package insert Sep 10, 2025
Key facts
| Brand names | ノルディトロピン フレックスプロ注 5mg, ノルディトロピン フレックスプロ注 10mg, ノルディトロピン フレックスプロ注 15mg |
|---|---|
| Nonproprietary names | ソマトロピン（遺伝子組換え） |
| Companies | 製造販売業者等／ノボ ノルディスク ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト成長ホルモン(遺伝子組換え)製剤 |
| Therapeutic category codes | 872412 |
| YJ codes | 2412402P6027, 2412402P7023, 2412402P8020 |
| Approval numbers | 22200AMX00390000, 22200AMX00391000, 22200AMX00392000 |
| Package insert edition | 第3版 |
| Package insert date | Sep 10, 2025 |
| PMDA document key | 620023_2412402P6027_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
- 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: