PMDA drug package insert
オメプラゾール錠10mg「ケミファ」
PMDA Prescription drug · シオノケミカル株式会社 · package insert Jul 14, 2026
Key facts
| Brand names | オメプラゾール錠10mg「ケミファ」, オメプラゾール錠20mg「ケミファ」 |
|---|---|
| Nonproprietary names | オメプラゾール |
| Companies | 製造販売元／シオノケミカル株式会社, 販売元／日本ケミファ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | プロトンポンプ・インヒビター |
| Therapeutic category codes | 872329 |
| YJ codes | 2329022H2163, 2329022H1191 |
| Approval numbers | 22400AMX00749000, 22400AMX00748000 |
| Package insert edition | 第7版 |
| Package insert date | Jul 14, 2026 |
| PMDA document key | 340409_2329022H1191_1 |
| PMDA company code | 340409 |
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: