Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216, Ingelheim am Rhein, Germany
Ofev 100 mg soft capsules.
Ofev 150 mg soft capsules.
| Pharmaceutical Form |
|---|
|
Soft capsule (capsule). Ofev 100 mg soft capsules: Ofev 100 mg soft capsules are peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and “100”. Ofev 150 mg soft capsules: Ofev 150 mg soft capsules are brown-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and “150”. |
Ofev 100 mg soft capsules: One soft capsule contains 100 mg nintedanib (as esilate).
Excipient with known effect: Each 100 mg soft capsule contains 1.2 mg of soya lecithin.
Ofev 150 mg soft capsules: One soft capsule contains 150 mg nintedanib (as esilate).
Excipient with known effect: Each 150 mg soft 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 Printing ink: Shellac glaze |
Ofev 100 mg soft capsules:
Ofev 100 mg soft capsules are available in the following pack-sizes:
Ofev 150 mg soft capsules:
Ofev 150 mg soft capsules are available in the following pack-sizes:
Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216, Ingelheim am Rhein, Germany
Ofev 100 mg soft capsules:
EU/1/14/979/001
EU/1/14/979/002
Ofev 150 mg soft capsules:
EU/1/14/979/003
EU/1/14/979/004
Date of first authorisation: 15 January 2015
Date of latest renewal: 23 September 2019
| Drug | Countries | |
|---|---|---|
| OFEV | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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