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 0.5 mg orodispersible tablets.
Jorveza 1 mg orodispersible tablets.
| Pharmaceutical Form |
|---|
|
Orodispersible tablet. Jorveza 0.5 mg orodispersible tablets: White, round, biplane orodispersible tablets, with a diameter of 7.1 mm and height of 2.2 mm. They are debossed with "0.5" on one side. Jorveza 1 mg orodispersible tablets: White, round, biplane orodispersible tablets, with a diameter of 7.1 mm and height of 2.2 mm. |
Each orodispersible tablet contains 0.5 mg of budesonide.
Excipient with known effect:
Each 0.5 mg orodispersible tablet contains 26 mg sodium.
Each orodispersible tablet contains 1 mg of budesonide.
Excipient with known effect:
Each 1 mg orodispersible tablet contains 26 mg sodium.
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 |
|---|
|
Jorveza 0.5 mg and 1 mg orodispersible tablets: Disodium hydrogen citrate |
Alu/Alu-blister.
Jorveza 0.5 mg orodispersible tablets:
Pack sizes of 20, 60, 90, 100 or 200 orodispersible tablets.
Jorveza 1 mg orodispersible tablets:
Pack sizes of 20, 30, 60, 90, 100 or 200 orodispersible tablets.
Not all pack sizes may be marketed.
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 1 mg orodispersible tablets:
EU/1/17/1254/001
EU/1/17/1254/002
EU/1/17/1254/003
EU/1/17/1254/004
EU/1/17/1254/005
EU/1/17/1254/006
Jorveza 0.5 mg orodispersible tablets:
EU/1/17/1254/007
EU/1/17/1254/008
EU/1/17/1254/009
EU/1/17/1254/010
EU/1/17/1254/011
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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