This brand name is authorized in Nigeria. It is also authorized in Austria, Croatia, Cyprus, Estonia, France, Germany, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Singapore, Spain, Tunisia, Turkey, UK.
The drug INSULATARD contains one active pharmaceutical ingredient (API):
1
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UNII
1Y17CTI5SR - INSULIN HUMAN
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The blood glucose lowering effect of insulin 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. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| A6-0073 | Suspension for injection | Insulatard® 100 IU/ml vial INJ_SUSP 180 IU/mL 1x10ml | 10/30/2024 17:37:22 Insulatard® 100 IU/ml vial. Human Insulin A6-0073 suspension for injection Subcutaneous Insulatard® vial (100 IU/ml) 1 vial contains 10 ml equivalent to 1,000 international units. 1 ml suspension contains 100 international units isophane (NPH) insulin human (equivalent to 3.5 mg). 1 vial contains 10 ml equivalent to 1,000 international units 1x10ml POM Novo Nordisk Pharma Ltd Nigeria 4TH floor, GIL Building, Ashabi Cole Street, off CIPM Avenue, Central Business District, Alausa, Ikeja Lagos Nigeria Novo Nordisk A/S Novo Nordisk A/S Novo Allé DK-2880 Bagsværd, Denmark Denmark 27/08/2021 26/08/2026 No A10AC01 | 27/08/2021 |
| A6-0450 | Suspension for injection | Insulatard FlexPen 100 IU INJ_SUSP 300 units/3 mL 3 mL x 5's (in pre-filled multidose disposable pen) | Suspension for injection. The suspension is cloudy, white and aqueous | 03/10/2022 |
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| INSULATARD Suspension for injection | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| A10AB01 | Insulin (human) | A Alimentary tract and metabolism → A10 Drugs used in diabetes → A10A Insulins and analogues → A10AB Insulins and analogues for injection, fast-acting |
| A10AC01 | Insulin (human) | A Alimentary tract and metabolism → A10 Drugs used in diabetes → A10A Insulins and analogues → A10AC Insulins and analogues for injection, intermediate-acting |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| DE | Bundesinstitut für Arzneimittel und Medizinprodukte | 00022958, 00022964, 00115039, 00115335, 00292161, 00579916, 00702251, 01825487, 01825493, 05039656, 05039722, 06430776, 06430807, 09012708, 10206091 |
| EE | Ravimiamet | 1202757, 1202768, 1202779, 1202780, 1202791, 1202803, 1202814, 1202847, 1202858, 1202869, 1202870, 1202881, 1202892 |
| ES | Centro de información online de medicamentos de la AEMPS | 02233003, 02233014 |
| FR | Base de données publique des médicaments | 60423446, 62457123, 67248825, 69704932 |
| GB | Medicines & Healthcare Products Regulatory Agency | 32562, 32616, 32640 |
| IE | Health Products Regulatory Authority | 61786, 71512, 71580 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 2576, 664 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1029202, 1029203, 1029204, 1029205, 1029206, 1029207, 1029208, 1029209, 1029210, 1029211, 1029212, 1029213, 1029214, 1029215, 1029216, 1029217, 1029218 |
| NG | Registered Drug Product Database | A6-0073, A6-0450 |
| NL | Z-Index G-Standaard | 14815974, 14815982, 14994658, 14996839 |
| NL | Z-Index G-Standaard, PRK | 105716, 29998, 34851 |
| PL | Rejestru Produktów Leczniczych | 100030920, 100030943, 100030966, 100103174, 100311033 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W03713002, W03713003, W03714001, W03714002, W03714003, W13941001, W13941002, W13941003, W52580001, W52580002, W52580003, W52581002, W52581003, W52581004, W52582002, W52582003, W52582004 |
| SG | Health Sciences Authority | 08654P, 08655P |
| TN | Direction de la Pharmacie et du Médicament | 5993017, 5993026 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699676770489, 8699676950416 |
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