PMDA drug package insert

パキシルCR錠6.25mg

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CR錠6.25mg, パキシルCR錠12.5mg, パキシルCR錠25mg
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 1179041G3023, 1179041G1020, 1179041G2027
Approval numbers 23000AMX00612, 22400AMX00045, 22400AMX00046
Package insert edition 第3版
Package insert date Dec 23, 2025
PMDA document key 340278_1179041G1020_1
PMDA company code 340278

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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