PMDA drug package insert
ステミラック注
PMDA Regenerative medical product · ニプロ株式会社 · package insert Sep 1, 2025
Key facts
| Brand names | ステミラック注 |
|---|---|
| Nonproprietary names | ヒト（自己）骨髄由来間葉系幹細胞 |
| Companies | 製造販売元／ニプロ株式会社 |
| Product type | Regenerative medical product |
| Package insert date | Sep 1, 2025 |
| PMDA document key | 530100_4900401X1026_A_01 |
| PMDA company code | 530100 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: