PMDA drug package insert
シムビコートタービュヘイラー30吸入
PMDA Prescription drug · アストラゼネカ株式会社 · package insert Feb 3, 2025
Key facts
| Brand names | シムビコートタービュヘイラー30吸入, シムビコートタービュヘイラー60吸入 |
|---|---|
| Nonproprietary names | ブデソニド・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 | ドライパウダー吸入式喘息・COPD治療配合剤 |
| Therapeutic category codes | 87229 |
| YJ codes | 2290801G1029, 2290801G2025 |
| Approval numbers | 22100AMX02249, 22100AMX02250 |
| Package insert edition | 第2版 |
| Package insert date | Feb 3, 2025 |
| PMDA document key | 670227_2290801G1029_1 |
| PMDA company code | 670227 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: