PMDA drug package insert
ロキソニンテープ50mg
PMDA Prescription drug · リードケミカル株式会社 · package insert Mar 5, 2025
Key facts
| Brand names | ロキソニンテープ50mg, ロキソニンテープ100mg |
|---|---|
| Nonproprietary names | ロキソプロフェンナトリウム水和物 |
| Companies | 製造販売元／リードケミカル株式会社, 販売元／第一三共株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 経皮吸収型鎮痛・抗炎症剤 |
| Therapeutic category codes | 872649 |
| YJ codes | 2649735S2024, 2649735S3020 |
| Approval numbers | 22000AMX00446, 22000AMX00447 |
| Package insert edition | 第3版 |
| Package insert date | Mar 5, 2025 |
| PMDA document key | 850028_2649735S2024_1 |
| PMDA company code | 850028 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: