PMDA drug package insert
小児用レルベア50エリプタ14吸入用
PMDA Prescription drug · グラクソ・スミスクライン株式会社 · package insert Aug 23, 2024
Key facts
| Brand names | 小児用レルベア50エリプタ14吸入用, 小児用レルベア50エリプタ30吸入用, レルベア100エリプタ14吸入用, レルベア100エリプタ30吸入用, レルベア200エリプタ14吸入用, レルベア200エリプタ30吸入用 |
|---|---|
| Nonproprietary names | ビランテロールトリフェニル酢酸塩・フルチカゾンフランカルボン酸エステル |
| 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 | 喘息・COPD治療配合剤; 喘息治療配合剤 |
| Therapeutic category codes | 87229 |
| YJ codes | 2290803G5023, 2290803G6020, 2290803G1028, 2290803G3020, 2290803G2024, 2290803G4027 |
| Approval numbers | 30600AMX00146, 30600AMX00145, 22500AMX01811, 22500AMX01812, 22500AMX01813, 22500AMX01814 |
| Package insert edition | 第3版 |
| Package insert date | Aug 23, 2024 |
| PMDA document key | 340278_2290803G1028_1 |
| PMDA company code | 340278 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: