PMDA drug package insert

ファモチジンOD錠10mg「TBP」

PMDA Prescription drug · 東菱薬品工業株式会社 · package insert Sep 14, 2026

Key facts

Brand names ファモチジンOD錠10mg「TBP」, ファモチジンOD錠20mg「TBP」
Nonproprietary names ファモチジン
Companies 製造販売元/東菱薬品工業株式会社, 販売元/株式会社ビオメディクス
Product type Prescription drug
Therapeutic category H2受容体拮抗剤
Therapeutic category codes 872325
YJ codes 2325003F3248, 2325003F4260
Approval numbers 22600AMX00657000, 22600AMX00656000
Package insert edition 第3版
Package insert date Sep 14, 2026
PMDA document key 480143_2325003F3248_2
PMDA company code 480143

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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