PMDA drug package insert

バルネチール錠50

PMDA Prescription drug · 共和薬品工業株式会社 · package insert Oct 15, 2024

Key facts

Brand names バルネチール錠50, バルネチール錠100, バルネチール錠200, バルネチール細粒50%
Nonproprietary names スルトプリド塩酸塩
Companies 製造販売元/共和薬品工業株式会社
Product type Prescription drug
Therapeutic category ベンズアミド系抗精神病剤
Therapeutic category codes 871179
YJ codes 1179032F1026, 1179032F2022, 1179032F3029, 1179032C1046
Approval numbers 20100AMZ00028, 20100AMZ00029, 20100AMZ00030, 21900AMX01637
Package insert edition 第3版
Package insert date Oct 15, 2024
PMDA document key 672173_1179032C1046_6
PMDA company code 672173

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:

Browse all PMDA approved drugs and package inserts (Japan)