PMDA drug package insert
シナジス筋注液50mg
PMDA Prescription drug · アストラゼネカ株式会社 · package insert Mar 26, 2024
Key facts
| Brand names | シナジス筋注液50mg, シナジス筋注液100mg |
|---|---|
| Nonproprietary names | パリビズマブ（遺伝子組換え） |
| Companies | 製造販売元／アストラゼネカ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗RSウイルスヒト化モノクローナル抗体製剤 |
| Therapeutic category codes | 87625 |
| YJ codes | 6250404A1020, 6250404A2026 |
| Approval numbers | 22400AMX01366, 22400AMX01365 |
| Package insert edition | 第3版 |
| Package insert date | Mar 26, 2024 |
| PMDA document key | 670227_6250404A1020_3 |
| PMDA company code | 670227 |
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: