PMDA drug package insert

ニルバジピン錠2mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Mar 15, 2024

Key facts

Brand names ニルバジピン錠2mg「サワイ」, ニルバジピン錠4mg「サワイ」
Nonproprietary names ニルバジピン
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category Ca拮抗剤
Therapeutic category codes 872149
YJ codes 2149022F1087, 2149022F2105
Approval numbers 22500AMX00947000, 22500AMX00948000
Package insert edition 第1版
Package insert date Mar 15, 2024
PMDA document key 300119_2149022F1087_1
PMDA company code 300119

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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