Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108 Freiburg, Germany, Tel.: +49 (0)761 1514-0, Fax: +49 (0)761 1514-321, E-mail: zentrale@drfalkpharma.de
Jorveza 0.2 mg/mL oral suspension.
| Pharmaceutical Form |
|---|
|
Oral suspension. Whitish, viscous suspension. |
Each mL of oral suspension contains 0.2 mg budesonide.
Each bottle of 165 mL contains 33 mg budesonide.
Excipients with known effect:
Each mL of oral suspension contains 100 mg sucrose and 0.86 mg sodium benzoate (E211).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At doses clinically equivalent to systemically acting glucocorticosteroids, budesonide gives significantly less HPA axis suppression and has a lower impact on inflammatory markers. |
| List of Excipients |
|---|
|
Sucrose |
200 mL amber glass bottle of blow moulded type III glass.
Child-resistant closure:
White ribbed cap (PP) with a colourless screw closure (HDPE) and an internal colourless flow limiter (LDPE). After first opening, the flow limiter remains in the bottle neck and enables the insertion of the oral syringe to draw the suspension.
Syringe for oral administration:
CE-certified oral syringe consisting of a colourless barrel (PP) with a colourless screw closure (HDPE) and graduations for 2.5 mL and 5 mL, and a white plunger (HDPE).
Pack size:
One bottle containing 165 mL of oral suspension with one graduated oral syringe for oral administration.
Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108 Freiburg, Germany, Tel.: +49 (0)761 1514-0, Fax: +49 (0)761 1514-321, E-mail: zentrale@drfalkpharma.de
EU/1/17/1254/012
Date of first authorisation: 08 January 2018
Date of latest renewal: 27 September 2022
| Drug | Countries | |
|---|---|---|
| JORVEZA | Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, United Kingdom |
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