PMDA drug package insert
コバールトリイ静注用250
PMDA Prescription drug · バイエル薬品株式会社 · package insert Oct 22, 2025
Key facts
| Brand names | コバールトリイ静注用250, コバールトリイ静注用500, コバールトリイ静注用1000, コバールトリイ静注用2000, コバールトリイ静注用3000 |
|---|---|
| Nonproprietary names | オクトコグ ベータ（遺伝子組換え） |
| Companies | 製造販売元／バイエル薬品株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝子組換え型血液凝固第Ⅷ因子製剤 |
| Therapeutic category codes | 876349 |
| YJ codes | 6343447D1025, 6343447D2021, 6343447D3028, 6343447D4024, 6343447D5020 |
| Approval numbers | 22800AMX00392000, 22800AMX00393000, 22800AMX00394000, 22800AMX00395000, 22800AMX00396000 |
| Package insert edition | 第4版 |
| Package insert date | Oct 22, 2025 |
| PMDA document key | 630004_6343447D1025_1 |
| PMDA company code | 630004 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: