PMDA drug package insert

オクトレオチド酢酸塩皮下注50μg「サンド」

PMDA Prescription drug · サンド株式会社 · package insert Aug 21, 2020

Key facts

Brand names オクトレオチド酢酸塩皮下注50μg「サンド」, オクトレオチド酢酸塩皮下注100μg「サンド」
Nonproprietary names オクトレオチド酢酸塩
Companies 製造販売/サンド株式会社
Product type Prescription drug
Therapeutic category 持続性ソマトスタチンアナログ製剤
Therapeutic category codes 872499
YJ codes 2499403A1061, 2499403A2068
Approval numbers 22200AMX00191000, 22200AMX00192000
Package insert edition 第1版
Package insert date Aug 21, 2020
PMDA document key 270428_2499403A1061_1
PMDA company code 270428

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None Safety communications
  • Yes 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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