PMDA drug package insert

グリメピリド錠0.5mg「フェルゼン」

PMDA Prescription drug · 株式会社フェルゼンファーマ · package insert Dec 26, 2023

Key facts

Brand names グリメピリド錠0.5mg「フェルゼン」, グリメピリド錠1mg「フェルゼン」, グリメピリド錠3mg「フェルゼン」
Nonproprietary names グリメピリド
Companies 製造販売元/株式会社フェルゼンファーマ
Product type Prescription drug
Therapeutic category スルホニルウレア系経口血糖降下剤
Therapeutic category codes 873961
YJ codes 3961008F3325, 3961008F1365, 3961008F2361
Approval numbers 23000AMX00299000, 23000AMX00297000, 23000AMX00298000
Package insert edition 第1版
Package insert date Dec 26, 2023
PMDA document key 671940_3961008F1365_1
PMDA company code 671940

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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