PMDA drug package insert
クレセンバカプセル40mg
PMDA Prescription drug · 旭化成セラピューティクス株式会社 · package insert Apr 1, 2026
Key facts
| Brand names | クレセンバカプセル40mg, クレセンバカプセル100mg |
|---|---|
| Nonproprietary names | イサブコナゾニウム硫酸塩 |
| Companies | 製造販売元／旭化成セラピューティクス株式会社, 提携先／Basilea Pharmaceutica International Ltd, Allschwil |
| Product type | Prescription drug |
| Therapeutic category | 深在性真菌症治療剤 |
| Therapeutic category codes | 876179 |
| YJ codes | 6179003M2028, 6179003M1021 |
| Approval numbers | 30600AMX00260000, 30400AMX00448000 |
| Package insert edition | 第5版 |
| Package insert date | Apr 1, 2026 |
| PMDA document key | 100898_6179003M1021_1 |
| PMDA company code | 100898 |
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: