PMDA drug package insert

オメプラゾール錠10mg「TSU」

PMDA Prescription drug · 鶴原製薬株式会社 · package insert Jul 14, 2026

Key facts

Brand names オメプラゾール錠10mg「TSU」, オメプラゾール錠20mg「TSU」
Nonproprietary names オメプラゾール
Companies 製造販売元/鶴原製薬株式会社
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 2329022H2139, 2329022H1140
Approval numbers 22300AMX00051000, 21700AMZ00099000
Package insert edition 第4版
Package insert date Jul 14, 2026
PMDA document key 460028_2329022H1140_1
PMDA company code 460028

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:

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