PMDA drug package insert
アテキュラ吸入用カプセル低用量
PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Feb 1, 2024
Key facts
| Brand names | アテキュラ吸入用カプセル低用量, アテキュラ吸入用カプセル中用量, アテキュラ吸入用カプセル高用量 |
|---|---|
| Nonproprietary names | インダカテロール酢酸塩・モメタゾンフランカルボン酸エステル |
| Companies | 製造販売（輸入）／ノバルティスファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 喘息治療配合剤 |
| Therapeutic category codes | 87229 |
| YJ codes | 2290806G1021, 2290806G2028, 2290806G3024 |
| Approval numbers | 30200AMX00489000, 30200AMX00490000, 30200AMX00491000 |
| Package insert edition | 第5版 |
| Package insert date | Feb 1, 2024 |
| PMDA document key | 300242_2290806G1021_1 |
| PMDA company code | 300242 |
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: