PMDA drug package insert
レスプレン錠5mg
PMDA Prescription drug · 太陽ファルマ株式会社 · package insert Oct 27, 2025
Key facts
| Brand names | レスプレン錠5mg, レスプレン錠20mg, レスプレン錠30mg |
|---|---|
| Nonproprietary names | エプラジノン塩酸塩 |
| Companies | 製造販売元／太陽ファルマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 鎮咳・気道粘液溶解剤 |
| Therapeutic category codes | 872249 |
| YJ codes | 2249001F1030, 2249001F2079, 2249001F3032 |
| Approval numbers | 21300AMZ00456, 21300AMZ00457, 15300AMZ00856 |
| Package insert edition | 第2版 |
| Package insert date | Oct 27, 2025 |
| PMDA document key | 431010_2249001F1030_3 |
| PMDA company code | 431010 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: