PMDA drug package insert

クラフォラン注射用0.5g

PMDA Prescription drug · サノフィ株式会社 · package insert Jun 9, 2025

Key facts

Brand names クラフォラン注射用0.5g, クラフォラン注射用1g
Nonproprietary names セフォタキシムナトリウム
Companies 製造販売元/サノフィ株式会社
Product type Prescription drug
Therapeutic category セフェム系抗生物質
Therapeutic category codes 876132
YJ codes 6132409D1050, 6132409D2056
Approval numbers 21800AMX10712, 21800AMX10713
Package insert edition 第2版
Package insert date Jun 9, 2025
PMDA document key 780069_6132409D1050_1
PMDA company code 780069

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:

Browse all PMDA approved drugs and package inserts (Japan)