PMDA drug package insert

ケーワン錠5mg

PMDA Prescription drug · エーザイ株式会社 · package insert Apr 10, 2023

Key facts

Brand names ケーワン錠5mg
Nonproprietary names フィトナジオン
Companies 製造販売元/エーザイ株式会社
Product type Prescription drug
Therapeutic category ビタミンK1剤
Therapeutic category codes 87316
YJ codes 3160001F1320
Approval numbers 21900AMX00662000
Package insert edition 第1版
Package insert date Apr 10, 2023
PMDA document key 170033_3160001F1320_1
PMDA company code 170033

At a glance

  • 1–9 Package insert revisions
  • 1–9 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)