PMDA drug package insert

シルデナフィル錠25mgVI「キッセイ」

PMDA Prescription drug · キッセイ薬品工業株式会社 · package insert Dec 6, 2023

Key facts

Brand names シルデナフィル錠25mgVI「キッセイ」, シルデナフィル錠50mgVI「キッセイ」
Nonproprietary names シルデナフィルクエン酸塩
Companies 製造販売元/キッセイ薬品工業株式会社
Product type Prescription drug
Therapeutic category 勃起不全治療剤
Therapeutic category codes 87259
YJ codes 259000AF1075, 259000AF2098
Approval numbers 22600AMX00930000, 22600AMX00931000
Package insert edition 第3版
Package insert date Dec 6, 2023
PMDA document key 230034_259000AF1075_1
PMDA company code 230034

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:

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