PMDA drug package insert

キネダック錠50mg

PMDA Prescription drug · アルフレッサ ファーマ株式会社 · package insert Jun 27, 2024

Key facts

Brand names キネダック錠50mg
Nonproprietary names エパルレスタット
Companies 製造販売/アルフレッサ ファーマ株式会社
Product type Prescription drug
Therapeutic category アルドース還元酵素阻害剤
Therapeutic category codes 873999
YJ codes 3999013F1231
Approval numbers 21700AMZ00653
Package insert edition 第2版
Package insert date Jun 27, 2024
PMDA document key 530258_3999013F1231_2
PMDA company code 530258

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)