PMDA drug package insert
アマリール0.5mg錠
PMDA Prescription drug · サノフィ株式会社 · package insert Jul 22, 2024
Key facts
| Brand names | アマリール0.5mg錠, アマリール1mg錠, アマリール3mg錠 |
|---|---|
| Nonproprietary names | グリメピリド |
| Companies | 製造販売元／サノフィ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | スルホニルウレア系経口血糖降下剤 |
| Therapeutic category codes | 873961 |
| YJ codes | 3961008F3023, 3961008F1020, 3961008F2027 |
| Approval numbers | 22100AMX02339, 21100AMZ00635, 21100AMZ00636 |
| Package insert edition | 第2版 |
| Package insert date | Jul 22, 2024 |
| PMDA document key | 780069_3961008F1020_1 |
| PMDA company code | 780069 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: