PMDA drug package insert
オルベスコ50μgインヘラー112吸入用
PMDA Prescription drug · 帝人ファーマ株式会社 · package insert May 11, 2020
Key facts
| Brand names | オルベスコ50μgインヘラー112吸入用, オルベスコ100μgインヘラー56吸入用, オルベスコ100μgインヘラー112吸入用, オルベスコ200μgインヘラー56吸入用 |
|---|---|
| Nonproprietary names | シクレソニド |
| Companies | 製造販売元／帝人ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 吸入ステロイド喘息治療剤 |
| Therapeutic category codes | 87229 |
| YJ codes | 2290702G1025, 2290702G4024, 2290702G2021, 2290702G3028 |
| Approval numbers | 21900AMY00025000, 22300AMX00438000, 21900AMY00026000, 21900AMY00028000 |
| Package insert edition | 第1版 |
| Package insert date | May 11, 2020 |
| PMDA document key | 470310_2290702G1025_1 |
| PMDA company code | 470310 |
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: