PMDA drug package insert

ファモチジンOD錠10mg「テバ」

PMDA Prescription drug · T'sファーマ株式会社 · package insert Sep 29, 2026

Key facts

Brand names ファモチジンOD錠10mg「テバ」, ファモチジンOD錠20mg「テバ」
Nonproprietary names ファモチジン
Companies 製造販売元/T'sファーマ株式会社, 販売/武田薬品工業株式会社
Product type Prescription drug
Therapeutic category H2受容体拮抗剤
Therapeutic category codes 872325
YJ codes 2325003F3221, 2325003F4244
Approval numbers 22500AMX00455, 22500AMX00456
Package insert edition 第5版
Package insert date Sep 29, 2026
PMDA document key 400813_2325003F3221_1
PMDA company code 400813

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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