PMDA drug package insert
ビレーズトリエアロスフィア56吸入
PMDA Prescription drug · アストラゼネカ株式会社 · package insert Aug 19, 2024
Key facts
| Brand names | ビレーズトリエアロスフィア56吸入, ビレーズトリエアロスフィア120吸入 |
|---|---|
| Nonproprietary names | ブデソニド・グリコピロニウム臭化物・ホルモテロールフマル酸塩水和物 |
| Companies | 製造販売元／アストラゼネカ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | COPD治療配合剤 |
| Therapeutic category codes | 87229 |
| YJ codes | 2290805G1027, 2290805G2023 |
| Approval numbers | 30100AMX00002, 30100AMX00003 |
| Package insert edition | 第5版 |
| Package insert date | Aug 19, 2024 |
| PMDA document key | 670227_2290805G1027_1 |
| PMDA company code | 670227 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: