PMDA drug package insert
イムノブラダー膀注用80mg
PMDA Prescription drug · 日本ビーシージー製造株式会社 · package insert Aug 24, 2026
Key facts
| Brand names | イムノブラダー膀注用80mg, イムノブラダー膀注用40mg |
|---|---|
| Nonproprietary names | 乾燥ＢＣＧ膀胱内用（日本株） |
| Companies | 製造販売元／日本ビーシージー製造株式会社, 発売元／日本化薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | その他の生物学的製剤; 抗悪性腫瘍剤 |
| Therapeutic category codes | 876391 |
| YJ codes | 6391700X4026, 6391700X3020 |
| Approval numbers | 21400AMZ00619000, 21400AMZ00618000 |
| Package insert edition | 第4版 |
| Package insert date | Aug 24, 2026 |
| PMDA document key | 530331_6391700X3020_2 |
| PMDA company code | 530331 |
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: