PMDA drug package insert
シロスタゾール錠50mg「サワイ」
PMDA Prescription drug · 沢井製薬株式会社 · package insert Mar 27, 2026
Key facts
| Brand names | シロスタゾール錠50mg「サワイ」, シロスタゾール錠100mg「サワイ」, シロスタゾールOD錠50mg「サワイ」, シロスタゾールOD錠100mg「サワイ」 |
|---|---|
| Nonproprietary names | シロスタゾール |
| Companies | 製造販売元／沢井製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗血小板剤 |
| Therapeutic category codes | 873399 |
| YJ codes | 3399002F1265, 3399002F2288, 3399002F3039, 3399002F4035 |
| Approval numbers | 22300AMX01227000, 22300AMX01226000, 22500AMX00292000, 22500AMX00291000 |
| Package insert edition | 第2版 |
| Package insert date | Mar 27, 2026 |
| PMDA document key | 300119_3399002F1265_1 |
| PMDA company code | 300119 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: