PMDA drug package insert

グアンファシン徐放錠1mg「ニプロ」

PMDA Prescription drug · ニプロ株式会社 · package insert Aug 17, 2026

Key facts

Brand names グアンファシン徐放錠1mg「ニプロ」, グアンファシン徐放錠3mg「ニプロ」
Nonproprietary names グアンファシン塩酸塩
Companies 製造販売元/ニプロ株式会社
Product type Prescription drug
Therapeutic category 注意欠陥/多動性障害治療剤 (選択的α2Aアドレナリン受容体作動薬)
Therapeutic category codes 871179
YJ codes 11790B2G1060, 11790B2G2067
Approval numbers 30800AMX00277, 30800AMX00278
Package insert edition 第1版
Package insert date Aug 17, 2026
PMDA document key 530100_11790B2G1060_1
PMDA company code 530100

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)