PMDA drug package insert

ニルバジピン錠2mg「NIG」

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

Key facts

Brand names ニルバジピン錠2mg「NIG」, ニルバジピン錠4mg「NIG」
Nonproprietary names ニルバジピン
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 高血圧治療剤
Therapeutic category codes 872149
YJ codes 2149022F1117, 2149022F2130
Approval numbers 23000AMX00529, 23000AMX00530
Package insert edition 第2版
Package insert date Feb 1, 2026
PMDA document key 581120_2149022F1117_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:

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