PMDA drug package insert

オメプラゾール錠10「SW」

PMDA Prescription drug · メディサ新薬株式会社 · package insert Jul 14, 2026

Key facts

Brand names オメプラゾール錠10「SW」, オメプラゾール錠20「SW」
Nonproprietary names オメプラゾール
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 プロトンポンプ・インヒビター
Therapeutic category codes 872329
YJ codes 2329022H2090, 2329022H1094
Approval numbers 21800AMZ10106000, 21600AMZ00397000
Package insert edition 第5版
Package insert date Jul 14, 2026
PMDA document key 780075_2329022H1094_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:

Browse all PMDA approved drugs and package inserts (Japan)