PMDA drug package insert

パキシル錠5mg

PMDA Prescription drug · グラクソ・スミスクライン株式会社 · package insert Dec 23, 2025

Key facts

Brand names パキシル錠5mg, パキシル錠10mg, パキシル錠20mg
Nonproprietary names パロキセチン塩酸塩水和物
Companies 製造販売元/グラクソ・スミスクライン株式会社
Product type Prescription drug
Therapeutic category 選択的セロトニン再取り込み阻害剤
Therapeutic category codes 871179
YJ codes 1179041F3028, 1179041F1025, 1179041F2021
Approval numbers 22200AMX00408, 21200AMY00200, 21200AMY00201
Package insert edition 第4版
Package insert date Dec 23, 2025
PMDA document key 340278_1179041F1025_2
PMDA company code 340278

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes 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)