PMDA drug package insert
スペリア内用液8%
PMDA Prescription drug · 久光製薬株式会社 · package insert Dec 22, 2023
Key facts
| Brand names | スペリア内用液8% |
|---|---|
| Nonproprietary names | フドステイン |
| Companies | 製造販売元／久光製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 気道分泌細胞正常化剤 |
| Therapeutic category codes | 872233 |
| YJ codes | 2233004S1031 |
| Approval numbers | 21600AMZ00424000 |
| Package insert edition | 第1版 |
| Package insert date | Dec 22, 2023 |
| PMDA document key | 650034_2233004S1031_2 |
| PMDA company code | 650034 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: