This brand name is authorized in Australia, Cyprus, Spain, Finland, France, Ireland, Israel, Japan, Netherlands, Singapore, Turkey, United Kingdom, United States

Active ingredients

The drug ABSTRAL contains one active pharmaceutical ingredient (API):

1 Fentanyl

Fentanyl is a potent µ-opioid analgesic with rapid onset of analgesia and short duration of action. Its primary therapeutic actions are analgesia and sedation and is approximately 100-fold more potent than morphine as an analgesic. Secondary effects of fentanyl on central nervous system (CNS), respiratory and gastro-intestinal function are typical of opioid analgesics and are considered to be class effects.

Read about Fentanyl

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
ABSTRAL Sublingual tablet Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
N02AB03 Fentanyl N Nervous system → N02 Analgesics → N02A Opioids → N02AB Phenylpiperidine derivatives
Discover more medicines within N02AB03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 10600X, 10601Y, 10602B, 10603C, 10604D, 10606F, 10607G, 10608H, 10610K, 10611L, 10612M, 10613N
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 70501, 70502, 70504, 70507, 70508, 70511
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 029211, 029222, 029255, 029277, 029300, 029311, 029335, 029357
Country: FR Base de données publique des médicaments Identifier(s): 60282999, 61464150, 61578296, 63451714, 67144513, 68336954
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 149484, 149485, 149488, 149491, 149495, 149496, 149500, 149501, 149505, 149506
Country: IE Health Products Regulatory Authority Identifier(s): 10880, 10881, 10882, 10883, 10884, 10885, 10886, 10887, 10888, 10889, 10890, 10891
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 7242, 7243, 7244, 7245, 7610
Country: JP 医薬品医療機器総合機構 Identifier(s): 8219001F1020, 8219001F2026, 8219001F3022
Country: NL Z-Index G-Standaard, PRK Identifier(s): 98175, 98183, 98191, 98205, 98213, 98221
Country: SG Health Sciences Authority Identifier(s): 15147P, 15148P, 15149P, 15150P, 15151P, 15152P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699538055600, 8699538055617, 8699538055624, 8699538055631
Country: US FDA, National Drug Code Identifier(s): 42358-100, 42358-200

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