PMDA drug package insert

クラビット錠250mg

PMDA Prescription drug · 第一三共株式会社 · package insert May 20, 2025

Key facts

Brand names クラビット錠250mg, クラビット錠500mg, クラビット細粒10%
Nonproprietary names レボフロキサシン水和物
Companies 製造販売元/第一三共株式会社
Product type Prescription drug
Therapeutic category 広範囲経口抗菌製剤
Therapeutic category codes 876241
YJ codes 6241013F2020, 6241013F3027, 6241013C2024
Approval numbers 22100AMX00648, 22100AMX00649, 22100AMX00650
Package insert edition 第2版
Package insert date May 20, 2025
PMDA document key 430574_6241013C2024_1
PMDA company code 430574

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes 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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