PMDA drug package insert
ジクロフェナクナトリウム坐剤12.5mg「ゼリア」
PMDA Prescription drug · 京都薬品工業株式会社 · package insert Oct 16, 2024
Key facts
| Brand names | ジクロフェナクナトリウム坐剤12.5mg「ゼリア」, ジクロフェナクナトリウム坐剤25mg「ゼリア」, ジクロフェナクナトリウム坐剤50mg「ゼリア」 |
|---|---|
| Nonproprietary names | ジクロフェナクナトリウム |
| Companies | 製造販売元／京都薬品工業株式会社, 発売元／ゼリア新薬工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 鎮痛・解熱・抗炎症剤 |
| Therapeutic category codes | 871147 |
| YJ codes | 1147700J1219, 1147700J2274, 1147700J3300 |
| Approval numbers | 30100AMX00108000, 30100AMX00099000, 30100AMX00109000 |
| Package insert edition | 第2版 |
| Package insert date | Oct 16, 2024 |
| PMDA document key | 230099_1147700J1219_1 |
| PMDA company code | 230099 |
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: