Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
Kinpeygo 4 mg modified-release hard capsules.
| Pharmaceutical Form |
|---|
|
Modified-release hard capsule. 19 mm white coated opaque capsules printed with “CAL10 4MG” in black ink. |
Each modified-release hard capsule contains budesonide 4 mg.
Excipient(s) with known effect: Each capsule contains 230 mg of sucrose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Budesonide |
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 |
|---|
|
Capsule content: Sugar spheres (sucrose and corn starch) Capsule shell: Hypromellose Printing ink: Shellac |
White high density polyethylene (HDPE) bottle with a white polypropylene (PP) child-resistant closure with an induction seal.
Pack sizes: 1 bottle containing 120 modified-release hard capsules and multipacks containing 360 (3 packs of 120) modified-release hard capsules.
Not all pack sizes may be marketed.
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
EU/1/22/1657/001
EU/1/22/1657/002
Date of first authorisation: 15 July 2022
| Drug | Countries | |
|---|---|---|
| KINPEYGO | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Romania |
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