APIDRA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Insulin glulisine
UNII 7XIY785AZD - INSULIN GLULISINE

Insulin glulisine is a recombinant human insulin analogue that is equipotent to regular human insulin. Insulin glulisine has a more rapid onset of action and a shorter duration of action than regular human insulin.

Read about Insulin glulisine

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
APIDRA Solution for injection European Medicines Agency (EU) 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
A10AB06 Insulin glulisine A Alimentary tract and metabolism → A10 Drugs used in diabetes → A10A Insulins and analogues → A10AB Insulins and analogues for injection, fast-acting
Discover more medicines within A10AB06

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): 12268Q, 1921D, 9224L
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 502814501158316, 502814502154314, 502814504157310, 576720020052217, 576720020052317, 576720020052417
Country: CA Health Products and Food Branch Identifier(s): 02279460, 02279479, 02294346
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 26.645-10-05
Country: EE Ravimiamet Identifier(s): 1201329, 1201330, 1201341, 1201352, 1201363, 1201374, 1201385, 1201396, 1201408, 1201419, 1201420, 1201431, 1201442, 1201453, 1201464, 1201475, 1201486, 1201497, 1201509, 1201510, 1294365, 1294376, 1294387, 1294398, 1294400, 1294411, 1294422, 1294433, 1316528, 1316539, 1316540, 1316551, 1316562, 1316573, 1316584, 1316595
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 04285001, 04285008, 04285032
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 019777, 019814, 078632
Country: FR Base de données publique des médicaments Identifier(s): 62679768, 64684582, 65554613
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 121447, 299601, 374289, 375909, 381167, 95284, 95289
Country: HK Department of Health Drug Office Identifier(s): 56757
Country: IE Health Products Regulatory Authority Identifier(s): 53489, 69335, 69376, 69398
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 4984, 6164
Country: JP 医薬品医療機器総合機構 Identifier(s): 2492418A1024, 2492418A2020, 2492418G1027
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1004316, 1004813, 1027377, 1027378, 1027379, 1027380, 1027381, 1027382, 1027383, 1027385, 1027386, 1027387, 1027388, 1027405, 1027406, 1027407, 1027409, 1027410, 1027411, 1027412
Country: NL Z-Index G-Standaard Identifier(s): 15008991
Country: NL Z-Index G-Standaard, PRK Identifier(s): 77704, 77712, 77720
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 12283, 13106
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100126577, 100127275
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W41737001, W41737002, W41737003, W41737004, W41739001, W41739002, W41739003, W41739004, W41739005, W41739006, W41739007, W41739008, W41740001, W41740002, W41740003, W41740004, W41740005, W41740006, W41740007, W41740008, W42280001, W42280002, W42280003, W42280004, W42280005, W42280006, W42280007, W42280008, W52538001, W52538002, W52538003, W52538004, W52538005, W52538006, W52538007, W52538008
Country: SG Health Sciences Authority Identifier(s): 13108P, 13432P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 1823024
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699809950658, 8699809950665
Country: US FDA, National Drug Code Identifier(s): 0088-2500, 0088-2502
Country: ZA Health Products Regulatory Authority Identifier(s): A38/21.1/0506

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