PMDA drug package insert

ファモチジン錠10mg「TCK」

PMDA Prescription drug · 辰巳化学株式会社 · package insert Sep 30, 2026

Key facts

Brand names ファモチジン錠10mg「TCK」, ファモチジン錠20mg「TCK」
Nonproprietary names ファモチジン
Companies 製造販売元/辰巳化学株式会社
Product type Prescription drug
Therapeutic category H2受容体拮抗剤
Therapeutic category codes 872325
YJ codes 2325003F1245, 2325003F2250
Approval numbers 21800AMZ10303000, 21800AMX10343000
Package insert edition 第2版
Package insert date Sep 30, 2026
PMDA document key 400278_2325003F1245_1
PMDA company code 400278

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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