PMDA drug package insert

ボルタレンサポ12.5mg

PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Oct 22, 2024

Key facts

Brand names ボルタレンサポ12.5mg, ボルタレンサポ25mg, ボルタレンサポ50mg
Nonproprietary names ジクロフェナクナトリウム
Companies 製造販売/ノバルティスファーマ株式会社
Product type Prescription drug
Therapeutic category 鎮痛・解熱・抗炎症剤
Therapeutic category codes 871147
YJ codes 1147700J1057, 1147700J2061, 1147700J3084
Approval numbers 15600AMZ01040000, 15600AMZ01041000, 15600AMZ01042000
Package insert edition 第2版
Package insert date Oct 22, 2024
PMDA document key 300242_1147700J1057_2
PMDA company code 300242

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)