PMDA drug package insert

トラネキサム酸注250mg/5mL「日新」

PMDA Prescription drug · 日新製薬株式会社 · package insert Jan 31, 2024

Key facts

Brand names トラネキサム酸注250mg/5mL「日新」, トラネキサム酸注1000mg/10mL「日新」
Nonproprietary names トラネキサム酸
Companies 製造販売元/日新製薬株式会社
Product type Prescription drug
Therapeutic category 抗プラスミン剤
Therapeutic category codes 873327, 87449
YJ codes 3327401A1160, 3327401A4274
Approval numbers 22600AMX00894, 22600AMX00895
Package insert edition 第1版
Package insert date Jan 31, 2024
PMDA document key 530113_3327401A1160_1
PMDA company code 530113

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)