PMDA drug package insert
グラクティブ錠12.5mg
PMDA Prescription drug · 小野薬品工業株式会社 · package insert Oct 1, 2026
Key facts
| Brand names | グラクティブ錠12.5mg, グラクティブ錠25mg, グラクティブ錠50mg, グラクティブ錠100mg |
|---|---|
| Nonproprietary names | シタグリプチンリン酸塩水和物 |
| Companies | 製造販売／小野薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 選択的DPP-4阻害剤; －糖尿病用剤－ |
| Therapeutic category codes | 873969 |
| YJ codes | 3969010F4025, 3969010F1026, 3969010F2022, 3969010F3029 |
| Approval numbers | 22500AMX01784000, 22100AMX02261000, 22100AMX02260000, 22100AMX02262000 |
| Package insert edition | 第7版 |
| Package insert date | Oct 1, 2026 |
| PMDA document key | 180188_3969010F1026_1 |
| PMDA company code | 180188 |
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: