PMDA drug package insert

ラフチジン錠5mg「日医工」

PMDA Prescription drug · 日医工株式会社 · package insert Jun 20, 2024

Key facts

Brand names ラフチジン錠5mg「日医工」, ラフチジン錠10mg「日医工」
Nonproprietary names ラフチジン
Companies 製造販売元/日医工株式会社
Product type Prescription drug
Therapeutic category H2受容体拮抗剤
Therapeutic category codes 872325
YJ codes 2325006F1117, 2325006F2113
Approval numbers 22400AMX01259000, 22400AMX01260000
Package insert edition 第1版
Package insert date Jun 20, 2024
PMDA document key 530169_2325006F1117_1
PMDA company code 530169

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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