PMDA drug package insert
エンクラッセ62.5μgエリプタ7吸入用
PMDA Prescription drug · グラクソ・スミスクライン株式会社 · package insert Jul 11, 2024
Key facts
| Brand names | エンクラッセ62.5μgエリプタ7吸入用, エンクラッセ62.5μgエリプタ30吸入用 |
|---|---|
| Nonproprietary names | ウメクリジニウム臭化物 |
| Companies | 製造販売元/グラクソ・スミスクライン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 長時間作用性吸入気管支拡張剤 |
| Therapeutic category codes | 872259 |
| YJ codes | 2259714G1028, 2259714G2024 |
| Approval numbers | 22700AMX00633, 22700AMX00634 |
| Package insert edition | 第4版 |
| Package insert date | Jul 11, 2024 |
| PMDA document key | 340278_2259714G1028_1 |
| PMDA company code | 340278 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None 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: