PMDA drug package insert
ヘムライブラ皮下注12mg
PMDA Prescription drug · 中外製薬株式会社 · package insert Feb 26, 2026
Key facts
| Brand names | ヘムライブラ皮下注12mg, ヘムライブラ皮下注30mg, ヘムライブラ皮下注60mg, ヘムライブラ皮下注90mg, ヘムライブラ皮下注105mg, ヘムライブラ皮下注150mg |
|---|---|
| Nonproprietary names | エミシズマブ（遺伝子組換え） |
| Companies | 製造販売元／中外製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗血液凝固第IXa/X因子ヒト化二重特異性モノクローナル抗体 血液凝固第VIII因子機能代替製剤 |
| Therapeutic category codes | 876349 |
| YJ codes | 6343451A6027, 6343451A1025, 6343451A2021, 6343451A3028, 6343451A4024, 6343451A5020 |
| Approval numbers | 30600AMX00261, 23000AMX00451, 23000AMX00447, 23000AMX00448, 23000AMX00449, 23000AMX00450 |
| Package insert edition | 第6版 |
| Package insert date | Feb 26, 2026 |
| PMDA document key | 450045_6343451A1025_1 |
| PMDA company code | 450045 |
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: