PMDA drug package insert
シタグリプチン錠12.5mg「サワイ」
PMDA Prescription drug · メディサ新薬株式会社 · package insert Aug 17, 2026
Key facts
| Brand names | シタグリプチン錠12.5mg「サワイ」, シタグリプチン錠25mg「サワイ」, シタグリプチン錠50mg「サワイ」, シタグリプチン錠100mg「サワイ」 |
|---|---|
| Nonproprietary names | シタグリプチンリン酸塩 |
| Companies | 製造販売元／メディサ新薬株式会社, 発売元／沢井製薬株式会社 |
| 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 | 39690B2F4028, 39690B2F1029, 39690B2F2025, 39690B2F3021 |
| Approval numbers | 30500AMX00207000, 30500AMX00206000, 30500AMX00205000, 30500AMX00204000 |
| Package insert edition | 第1版 |
| Package insert date | Aug 17, 2026 |
| PMDA document key | 780075_39690B2F1029_1 |
| PMDA company code | 780075 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- No 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: