PMDA drug package insert

ファモチジンOD錠10mg「ケミファ」

PMDA Prescription drug · シオノケミカル株式会社 · package insert Dec 15, 2025

Key facts

Brand names ファモチジンOD錠10mg「ケミファ」, ファモチジンOD錠20mg「ケミファ」
Nonproprietary names ファモチジン
Companies 製造販売元/シオノケミカル株式会社, 販売元/日本薬品工業株式会社
Product type Prescription drug
Therapeutic category H2受容体拮抗剤
Therapeutic category codes 872325
YJ codes 2325003F3205, 2325003F4228
Approval numbers 22400AMX00889000, 22400AMX00890000
Package insert edition 第1版
Package insert date Dec 15, 2025
PMDA document key 340409_2325003F3205_2
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:

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