PMDA drug package insert

ファモチジン錠10「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Mar 27, 2026

Key facts

Brand names ファモチジン錠10「サワイ」, ファモチジン錠20「サワイ」, ファモチジン細粒2%「サワイ」, ファモチジン散10%「サワイ」
Nonproprietary names ファモチジン
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category H2受容体拮抗剤
Therapeutic category codes 872325
YJ codes 2325003F1040, 2325003F2055, 2325003B2045, 2325003B1065
Approval numbers 21400AMZ00346000, 21400AMZ00347000, 21400AMZ00345000, 21600AMZ00150000
Package insert edition 第1版
Package insert date Mar 27, 2026
PMDA document key 300119_2325003B1065_1
PMDA company code 300119

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:

Browse all PMDA approved drugs and package inserts (Japan)