PMDA drug package insert
ビームゲン注0.25mL
PMDA Prescription drug · KMバイオロジクス株式会社 · package insert Dec 19, 2022
Key facts
| Brand names | ビームゲン注0.25mL, ビームゲン注0.5mL |
|---|---|
| Nonproprietary names | 組換え沈降Ｂ型肝炎ワクチン |
| Companies | 製造販売元／KMバイオロジクス株式会社, 販売元／Meiji Seika ファルマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ウイルスワクチン類 |
| Therapeutic category codes | 876313 |
| YJ codes | 6313402A1073, 6313402A2070 |
| Approval numbers | 22500AMX01249, 22500AMX01250 |
| Package insert edition | 第4版 |
| Package insert date | Dec 19, 2022 |
| PMDA document key | 261976_6313402A1073_6 |
| PMDA company code | 261976 |
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: