NOVORAPID

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

Active ingredients

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

1
UNII 978D8U419H - SACCHAROMYCES CEREVISIAE
 

The blood glucose lowering effect of insulin aspart is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver. Insulin aspart produces a more rapid onset of action compared to soluble human insulin, together with a lower glucose concentration, as assessed within the first four hours after a meal. Insulin aspart has a shorter duration of action compared to soluble human insulin after subcutaneous injection.

 
Read more about Insulin aspart

Packages

This drug has been approved in Nigeria as follows:

Identifier Form Presentation Description Approval
A6-0207 Solution for injection NovoRapid FlexPen 100 units/mL Solution for Injection in Pre-Filled Pen INJ_SOL 100 IU/mL 3 mL x 5's (in pre-filled pen) Solution for injection. The solution is clear, colourless and aqueous 28/09/2023

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 NOVORAPID Solution for injection in vial / Cartridge / Pre-filled pen 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
A10AB05 Insulin aspart 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 A10AB05

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 12254Y, 8435Y, 8571D
BR Câmara de Regulação do Mercado de Medicamentos 526601401153416, 526601402151417, 526601801151410, 526601901156414
CA Health Products and Food Branch 02244353, 02245397, 02377209
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 26.220-03-05, 26.468-06-05
EE Ravimiamet 1045796, 1092541, 1214615, 1214637, 1214648, 1214671, 1214783, 1214794, 1351156, 1351167, 1591253, 1591264, 1591275, 1638288, 1710267
ES Centro de información online de medicamentos de la AEMPS 199119003, 199119024, 99119001, 99119009
FI Lääkealan turvallisuus- ja kehittämiskeskus 006102, 007523, 093948, 467931
FR Base de données publique des médicaments 61232223, 62278832, 65918860, 69482353
GB Medicines & Healthcare Products Regulatory Agency 143901, 146651, 146659, 195703, 262097, 32794, 32808, 32824, 376955, 376959, 379731, 379734
HK Department of Health Drug Office 46862, 55341, 60321, 60462
IE Health Products Regulatory Authority 62709, 62710, 62720, 62730, 63121, 73541
IL מִשְׂרַד הַבְּרִיאוּת 4342, 4881, 6585
IT Agenzia del Farmaco 034498016, 034498028, 034498030, 034498042, 034498055, 034498093, 034498131, 034498232, 034498244
JP 医薬品医療機器総合機構 2492415A2035, 2492415A3031, 2492415A4038, 2492415G1031, 2492415G2020, 2492415G3026, 2492415G4022, 2492415G5029, 2492415G6025
LT Valstybinė vaistų kontrolės tarnyba 1004367, 1004368, 1010935, 1029912, 1029913, 1029914, 1029916, 1029917, 1029918, 1029919, 1038361, 1060181, 1060182, 1064168, 1064169, 1064170, 1064171, 1064172, 1075477, 1076734
NG Registered Drug Product Database A6-0207
NL Z-Index G-Standaard 14305003, 14305054, 15068641
NL Z-Index G-Standaard, PRK 121355, 121495, 53880, 53902
NZ Medicines and Medical Devices Safety Authority 10732, 15621, 8563, 8564
PL Rejestru Produktów Leczniczych 100090804, 100108898, 100305469, 100312073, 100312311, 100329671
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W07268001, W07268002, W08932001, W08932002, W08932003, W12152001, W12152002, W12152003, W52654001, W52654002, W52654003, W52655001, W52655002
SG Health Sciences Authority 11394P, 12189P
TN Direction de la Pharmacie et du Médicament 5993081
TR İlaç ve Tıbbi Cihaz Kurumu 8699676770656, 8699676950669, 8699676950676
ZA Health Products Regulatory Authority 34/21.1/0160

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