PMDA drug package insert
オラビ錠口腔用50mg
PMDA Prescription drug · ネクセラファーマジャパン株式会社 · package insert Apr 1, 2024
Key facts
| Brand names | オラビ錠口腔用50mg |
|---|---|
| Nonproprietary names | ミコナゾール |
| Companies | 製造販売元／ネクセラファーマジャパン株式会社, 発売元／久光製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 口腔粘膜付着型 口腔咽頭カンジダ症治療剤 |
| Therapeutic category codes | 87629 |
| YJ codes | 6290704D1026 |
| Approval numbers | 23000AMX00799000 |
| Package insert edition | 第4版 |
| Package insert date | Apr 1, 2024 |
| PMDA document key | 150923_6290704D1026_2 |
| PMDA company code | 150923 |
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: