PMDA drug package insert

ニセルゴリン錠5mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Aug 23, 2024

Key facts

Brand names ニセルゴリン錠5mg「サワイ」, ニセルゴリン細粒1%「サワイ」
Nonproprietary names ニセルゴリン
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category 脳循環・代謝改善剤
Therapeutic category codes 87219
YJ codes 2190021F1437, 2190021C1058
Approval numbers 22400AMX00140000, 22400AMX00139000
Package insert edition 第1版
Package insert date Aug 23, 2024
PMDA document key 300119_2190021C1058_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:

Browse all PMDA approved drugs and package inserts (Japan)