PMDA drug package insert

フルボキサミンマレイン酸塩錠25mg「タカタ」

PMDA Prescription drug · 高田製薬株式会社 · package insert Jun 13, 2024

Key facts

Brand names フルボキサミンマレイン酸塩錠25mg「タカタ」, フルボキサミンマレイン酸塩錠50mg「タカタ」, フルボキサミンマレイン酸塩錠75mg「タカタ」
Nonproprietary names フルボキサミンマレイン酸塩
Companies 製造販売元/高田製薬株式会社
Product type Prescription drug
Therapeutic category 選択的セロトニン再取り込み阻害剤(SSRI)
Therapeutic category codes 871179
YJ codes 1179039F1150, 1179039F2156, 1179039F3152
Approval numbers 22200AMX00416, 22200AMX00417, 22200AMX00420
Package insert edition 第3版
Package insert date Jun 13, 2024
PMDA document key 400186_1179039F1150_1
PMDA company code 400186

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 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)