PMDA drug package insert
エムパベリ皮下注1080mg
PMDA Prescription drug · Swedish Orphan Biovitrum Japan株式会社 · package insert Aug 24, 2026
Key facts
| Brand names | エムパベリ皮下注1080mg |
|---|---|
| Nonproprietary names | ペグセタコプラン |
| Companies | 製造販売元／Swedish Orphan Biovitrum Japan株式会社, 発売元／旭化成セラピューティクス株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 補体（C3）阻害剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999470A1022 |
| Approval numbers | 30500AMX00117000 |
| Package insert edition | 第7版 |
| Package insert date | Aug 24, 2026 |
| PMDA document key | 371336_3999470A1022_1 |
| PMDA company code | 371336 |
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: