Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany
Vargatef 100 mg soft capsules.
Vargatef 150 mg soft capsules.
| Pharmaceutical Form |
|---|
|
Soft capsule (capsule). Vargatef 100 mg soft capsules: Peach-coloured, opaque, oblong soft-gelatin capsules (approx. 16 × 6 mm) marked on one side with the Boehringer Ingelheim company symbol and “100”. Vargatef 150 mg soft capsules: Brown-coloured, opaque, oblong soft-gelatin capsule (approx. 18 × 7 mm) marked on one side with the Boehringer Ingelheim company symbol and “150”. |
Each soft capsule contains 100 mg nintedanib (as esilate).
Excipients with known effect: Each capsule contains 1.2 mg of soya lecithin.
Each soft capsule contains 150 mg nintedanib (as esilate).
Excipients with known effect: Each capsule contains 1.8 mg of soya lecithin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Nintedanib |
Nintedanib is a triple angiokinase inhibitor blocking vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR α and β) and fibroblast growth factor receptors (FGFR 1-3) kinase activity. Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signalling which is crucial for the proliferation and survival of endothelial as well as perivascular cells (pericytes and vascular smooth muscle cells). |
| List of Excipients |
|---|
|
Capsule content: Triglycerides, medium-chain Capsule shell: Gelatin |
Aluminium/aluminium blisters containing 10 capsules each.
Pack-sizes: 60 or 120 capsules, or multipack of 120 (2 × 60) capsules (2 cartons of 60 capsules each, wrapped in plastic foil).
Pack-size: 60 capsules.
Not all pack-sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany
Vargatef 100 mg soft capsules:
EU/1/14/954/001
EU/1/14/954/002
EU/1/14/954/003
Vargatef 150 mg soft capsules:
EU/1/14/954/004
Date of first authorisation: 21 November 2014
Date of latest renewal: 26 August 2019
| Drug | Countries | |
|---|---|---|
| VARGATEF | Austria, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom |
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