PMDA drug package insert
トラディアンス配合錠AP
PMDA Prescription drug · 日本ベーリンガーインゲルハイム株式会社 · package insert Oct 23, 2025
Key facts
| Brand names | トラディアンス配合錠AP, トラディアンス配合錠BP |
|---|---|
| Nonproprietary names | エンパグリフロジン・リナグリプチン配合剤 |
| Companies | 製造販売元／日本ベーリンガーインゲルハイム株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 選択的SGLT2阻害薬; 胆汁排泄型選択的DPP-4阻害薬配合剤; －2型糖尿病治療剤－ |
| Therapeutic category codes | 873969 |
| YJ codes | 3969108F1027, 3969108F2023 |
| Approval numbers | 23000AMX00806000, 23000AMX00807000 |
| Package insert edition | 第6版 |
| Package insert date | Oct 23, 2025 |
| PMDA document key | 650168_3969108F1027_1 |
| PMDA company code | 650168 |
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: