PMDA drug package insert

ファモチジンOD錠10mg「オーハラ」

PMDA Prescription drug · 大原薬品工業株式会社 · package insert Oct 9, 2026

Key facts

Brand names ファモチジンOD錠10mg「オーハラ」, ファモチジンOD錠20mg「オーハラ」
Nonproprietary names ファモチジン
Companies 製造販売元/大原薬品工業株式会社
Product type Prescription drug
Therapeutic category H2受容体拮抗剤
Therapeutic category codes 872325
YJ codes 2325003F3213, 2325003F4236
Approval numbers 22500AMX00356000, 22500AMX00357000
Package insert edition 第1版
Package insert date Oct 9, 2026
PMDA document key 180095_2325003F3213_1
PMDA company code 180095

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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