PMDA drug package insert
ソリフェナシンコハク酸塩錠2.5mg「ツルハラ」
PMDA Prescription drug · 鶴原製薬株式会社 · package insert Jun 29, 2021
Key facts
| Brand names | ソリフェナシンコハク酸塩錠2.5mg「ツルハラ」, ソリフェナシンコハク酸塩錠5mg「ツルハラ」 |
|---|---|
| Nonproprietary names | コハク酸ソリフェナシン |
| Companies | 製造販売元／鶴原製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 過活動膀胱治療剤 |
| Therapeutic category codes | 87259 |
| YJ codes | 2590011F1060, 2590011F2067 |
| Approval numbers | 30300AMX00175000, 30300AMX00174000 |
| Package insert edition | 第1版 |
| Package insert date | Jun 29, 2021 |
| PMDA document key | 460028_2590011F1060_1 |
| PMDA company code | 460028 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- No 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: