PMDA drug package insert
ピシバニール注射用1KE
PMDA Prescription drug · 中外製薬株式会社 · package insert Dec 9, 2022
Key facts
| Brand names | ピシバニール注射用1KE, ピシバニール注射用5KE |
|---|---|
| Nonproprietary names | 溶連菌抽出物 |
| Companies | 製造販売元／中外製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤・リンパ管腫治療剤 |
| Therapeutic category codes | 874299 |
| YJ codes | 4299400D5025, 4299400D6021 |
| Approval numbers | 21800AMX10782, 21800AMX10783 |
| Package insert edition | 第1版 |
| Package insert date | Dec 9, 2022 |
| PMDA document key | 450045_4299400D5025_1 |
| PMDA company code | 450045 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- No 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: