PMDA drug package insert
レグテクト錠333mg
PMDA Prescription drug · 日本新薬株式会社 · package insert Aug 18, 2020
Key facts
| Brand names | レグテクト錠333mg |
|---|---|
| Nonproprietary names | アカンプロサートカルシウム |
| Companies | 製造販売元／日本新薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | アルコール依存症 断酒補助剤 |
| Therapeutic category codes | 87119 |
| YJ codes | 1190022H1020 |
| Approval numbers | 22500AMX00874000 |
| Package insert edition | 第1版 |
| Package insert date | Aug 18, 2020 |
| PMDA document key | 530263_1190022H1020_1 |
| PMDA company code | 530263 |
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: