PMDA drug package insert

ナファモスタットメシル酸塩注射用10mg「NIG」

PMDA Prescription drug · 日医工岐阜工場株式会社 · package insert Feb 1, 2026

Key facts

Brand names ナファモスタットメシル酸塩注射用10mg「NIG」, ナファモスタットメシル酸塩注射用50mg「NIG」, ナファモスタットメシル酸塩注射用100mg「NIG」
Nonproprietary names ナファモスタットメシル酸塩
Companies 製造販売元/日医工岐阜工場株式会社, 販売元/日医工株式会社
Product type Prescription drug
Therapeutic category 蛋白分解酵素阻害剤
Therapeutic category codes 873999
YJ codes 3999407D1343, 3999407D2358, 3999407D3192
Approval numbers 23100AMX00066, 23100AMX00067, 23100AMX00068
Package insert edition 第3版
Package insert date Feb 1, 2026
PMDA document key 581120_3999407D1343_1
PMDA company code 581120

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)