Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AMMTeK, 8 rue Campagne Première, 75014 Paris, France, Tel: +33 (0)6 74 29 38 14
AMGLIDIA 0.6 mg/mL oral suspension.
AMGLIDIA 6 mg/mL oral suspension.
| Pharmaceutical Form |
|---|
|
Oral suspension. White suspension. |
AMGLIDIA 0.6 mg/mL oral suspension: Each mL contains 0.6 mg glibenclamide.
AMGLIDIA 6 mg/mL oral suspension: Each mL contains 6 mg glibenclamide.
Excipient(s) with known effect: Each mL contains 2.8 mg of sodium and 5 mg of benzoate (E211). For the full list of excipients, see section 6.1
| Active Ingredient | Description | |
|---|---|---|
| Glibenclamide |
Glibenclamide, a second-generation, short half-life sulphonylurea, is a hypoglycaemic agent that reduces blood-glucose by stimulating insulin release by the pancreas. Sulphonylureas act on pancreatic beta-cells by inhibiting ATP-sensitive potassium channels. |
| List of Excipients |
|---|
|
Hydroxyethylcellulose |
Brown glass bottle (type III) with a child-resistant closure (polypropylene screw cap with polyethylene capsule inside) in a carton containing a 1 mL or 5 ml graduated oral syringe of LDPE and polypropylene depending on the presentation prescribed and an adaptor (LDPE) to be plugged on the bottle after opening for the syringe.
The 1 mL oral syringe is thin and small while the 5 mL syringe is thick and long.
Pack sizes:
One bottle of 30 ml suspension and one oral syringe of 1 mL packed in an individual bag and one syringe adaptor.
One bottle of 30 ml suspension and one oral syringe of 5 mL packed in an individual bag and one syringe adaptor.
AMMTeK, 8 rue Campagne Première, 75014 Paris, France, Tel: +33 (0)6 74 29 38 14
EU/1/18/1279/001
EU/1/18/1279/002
EU/1/18/1279/003
EU/1/18/1279/004
Date of first authorisation: 24 May 2018
| Drug | Countries | |
|---|---|---|
| AMGLIDIA | Austria, Estonia, France, Croatia, Ireland, Lithuania, Poland, United Kingdom |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
