PMDA drug package insert
リンデロン坐剤0.5mg
PMDA Prescription drug · シオノギファーマ株式会社 · package insert Mar 23, 2026
Key facts
| Brand names | リンデロン坐剤0.5mg, リンデロン坐剤1.0mg |
|---|---|
| Nonproprietary names | ベタメタゾン |
| Companies | 製造販売元／シオノギファーマ株式会社, 販売元／塩野義製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 合成副腎皮質ホルモン剤 |
| Therapeutic category codes | 872454 |
| YJ codes | 2454700J1028, 2454700J2024 |
| Approval numbers | 15600AMZ00693000, 15600AMZ00695000 |
| Package insert edition | 第4版 |
| Package insert date | Mar 23, 2026 |
| PMDA document key | 343018_2454700J1028_2 |
| PMDA company code | 343018 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: