PMDA drug package insert

プラミペキソール塩酸塩錠0.125mg「JG」

PMDA Prescription drug · 日本ジェネリック株式会社 · package insert Sep 3, 2026

Key facts

Brand names プラミペキソール塩酸塩錠0.125mg「JG」, プラミペキソール塩酸塩錠0.5mg「JG」
Nonproprietary names プラミペキソール塩酸塩水和物
Companies 製造販売元/日本ジェネリック株式会社
Product type Prescription drug
Therapeutic category ドパミン作動性パーキンソン病治療剤; レストレスレッグス症候群治療剤
Therapeutic category codes 871169, 87119
YJ codes 1169012F1073, 1169012F2070
Approval numbers 22500AMX00203000, 22500AMX00204000
Package insert edition 第5版
Package insert date Sep 3, 2026
PMDA document key 580591_1169012F1073_1
PMDA company code 580591

At a glance

  • 1–9 Package insert revisions
  • 10–99 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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