PMDA drug package insert

サルポグレラート塩酸塩錠50mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Feb 29, 2024

Key facts

Brand names サルポグレラート塩酸塩錠50mg「サワイ」, サルポグレラート塩酸塩錠100mg「サワイ」
Nonproprietary names サルポグレラート塩酸塩
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category 5-HT2ブロッカー
Therapeutic category codes 873399
YJ codes 3399006F1182, 3399006F2189
Approval numbers 22100AMX02132000, 22100AMX02133000
Package insert edition 第1版
Package insert date Feb 29, 2024
PMDA document key 300119_3399006F1182_1
PMDA company code 300119

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)