PMDA drug package insert
スピンラザ髄注12mg
PMDA Prescription drug · バイオジェン・ジャパン株式会社 · package insert Nov 12, 2025
Key facts
| Brand names | スピンラザ髄注12mg, スピンラザ髄注28mg, スピンラザ髄注50mg |
|---|---|
| Nonproprietary names | ヌシネルセンナトリウム |
| Companies | 製造販売元／バイオジェン・ジャパン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 脊髄性筋萎縮症治療剤 |
| Therapeutic category codes | 87119 |
| YJ codes | 1190403A1022, 1190403A2029, 1190403A3025 |
| Approval numbers | 22900AMX00587, 30700AMX00217, 30700AMX00218 |
| Package insert edition | 第6版 |
| Package insert date | Nov 12, 2025 |
| PMDA document key | 630499_1190403A1022_1 |
| PMDA company code | 630499 |
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: