PMDA drug package insert
フルティフォーム50エアゾール56吸入用
PMDA Prescription drug · 杏林製薬株式会社 · package insert Sep 12, 2025
Key facts
| Brand names | フルティフォーム50エアゾール56吸入用, フルティフォーム50エアゾール120吸入用, フルティフォーム125エアゾール56吸入用, フルティフォーム125エアゾール120吸入用 |
|---|---|
| Nonproprietary names | フルチカゾンプロピオン酸エステル・ホルモテロールフマル酸塩水和物 |
| Companies | 製造販売元／杏林製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 喘息治療配合剤 |
| Therapeutic category codes | 87229 |
| YJ codes | 2290802G1023, 2290802G3026, 2290802G2020, 2290802G4022 |
| Approval numbers | 22500AMX01797000, 22500AMX01799000, 22500AMX01798000, 22500AMX01800000 |
| Package insert edition | 第7版 |
| Package insert date | Sep 12, 2025 |
| PMDA document key | 231099_2290802G1023_2 |
| PMDA company code | 231099 |
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: