PMDA drug package insert
ボックスゾゴ皮下注用0.4mg
PMDA Prescription drug · BioMarin Pharmaceutical Japan株式会社 · package insert Aug 17, 2026
Key facts
| Brand names | ボックスゾゴ皮下注用0.4mg, ボックスゾゴ皮下注用0.56mg, ボックスゾゴ皮下注用1.2mg |
|---|---|
| Nonproprietary names | ボソリチド（遺伝子組換え） |
| Companies | 製造販売業者／BioMarin Pharmaceutical Japan株式会社, 製造業者／BioMarin International Limited, Ireland |
| Product type | Prescription drug |
| Therapeutic category | 軟骨無形成症治療薬 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999465D1028, 3999465D2024, 3999465D3020 |
| Approval numbers | 30400AMX00212000, 30400AMX00213000, 30400AMX00214000 |
| Package insert edition | 第8版 |
| Package insert date | Aug 17, 2026 |
| PMDA document key | 641173_3999465D1028_1 |
| PMDA company code | 641173 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: