APIDRA

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Nigeria, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

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 more about Insulin glulisine

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
APIDRA Solution for injection	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

ATC Group		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)
AU	Pharmaceutical Benefits Scheme	12268Q, 1921D, 9224L
BR	Câmara de Regulação do Mercado de Medicamentos	502814501158316, 502814502154314, 502814504157310, 576720020052217, 576720020052317, 576720020052417
CA	Health Products and Food Branch	02279460, 02279479, 02294346
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	26.645-10-05
EE	Ravimiamet	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
ES	Centro de información online de medicamentos de la AEMPS	04285001, 04285008, 04285032
FI	Lääkealan turvallisuus- ja kehittämiskeskus	019777, 019814, 078632
FR	Base de données publique des médicaments	62679768, 64684582, 65554613
GB	Medicines & Healthcare Products Regulatory Agency	121447, 299601, 374289, 375909, 381167, 95284, 95289
HK	Department of Health Drug Office	56757
IE	Health Products Regulatory Authority	53489, 69335, 69376, 69398
IL	מִשְׂרַד הַבְּרִיאוּת	4984, 6164
JP	医薬品医療機器総合機構	2492418A1024, 2492418A2020, 2492418G1027
LT	Valstybinė vaistų kontrolės tarnyba	1004316, 1004813, 1027377, 1027378, 1027379, 1027380, 1027381, 1027382, 1027383, 1027385, 1027386, 1027387, 1027388, 1027405, 1027406, 1027407, 1027409, 1027410, 1027411, 1027412
NG	Registered Drug Product Database	A6-0366
Switch country to Nigeria in order to find specific presentations of APIDRA
NL	Z-Index G-Standaard	15008991
NL	Z-Index G-Standaard, PRK	77704, 77712, 77720
NZ	Medicines and Medical Devices Safety Authority	12283, 13106
PL	Rejestru Produktów Leczniczych	100126577, 100127275
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	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
SG	Health Sciences Authority	13108P, 13432P
TN	Direction de la Pharmacie et du Médicament	1823024
TR	İlaç ve Tıbbi Cihaz Kurumu	8699809950658, 8699809950665
US	FDA, National Drug Code	0088-2500, 0088-2502
ZA	Health Products Regulatory Authority	A38/21.1/0506