Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Bayer AG, 51368, Leverkusen, Germany
Ventavis 10 microgram/ml nebuliser solution.
Ventavis 20 microgram/ml nebuliser solution.
| Pharmaceutical Form |
|---|
|
Nebuliser solution. Ventavis 10 microgram/ml nebuliser solution: Clear, colourless solution. Ventavis 20 microgram/ml nebuliser solution: Clear, colourless to slightly yellowish solution. |
1 ml solution contains 10 microgram iloprost (as iloprost trometamol).
Each ampoule with 1 ml solution contains 10 microgram iloprost.
Each ampoule with 2 ml solution contains 20 microgram iloprost.
1 ml solution contains 20 microgram iloprost (as iloprost trometamol).
Each ampoule with 1 ml solution contains 20 microgram iloprost.
Excipient with known effect:
Ventavis 10 microgram/ml: Each ml contains 0.81 mg ethanol 96% (equivalent to 0.75 mg ethanol).
Ventavis 20 microgram/ml: Each ml contains 1.62 mg ethanol 96% (equivalent to 1.50 mg ethanol).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Iloprost |
Iloprost is a synthetic prostacyclin analogue. After inhalation of iloprost direct vasodilatation of the pulmonary arterial bed occur with consecutive significant improvement of pulmonary artery pressure, pulmonary vascular resistance and cardiac output as well as mixed venous oxygen saturation. |
| List of Excipients |
|---|
|
Trometamol |
1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (white – yellow).
3 ml ampoules, colourless, glass type I, containing 2 ml nebuliser solution, ring coded with two coloured rings (white – pink).
Packages containing:
Multipacks containing:
Packages containing:
Multipacks containing:
1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (yellow – red).
Packages containing:
Multipacks containing:
Not all pack sizes may be marketed.
Bayer AG, 51368, Leverkusen, Germany
Ventavis 10 microgram/ml nebuliser solution:
EU/1/03/255/001
EU/1/03/255/002
EU/1/03/255/003
EU/1/03/255/004
EU/1/03/255/005
EU/1/03/255/006
EU/1/03/255/007
EU/1/03/255/008
EU/1/03/255/011
EU/1/03/255/013
Ventavis 20 microgram/ml nebuliser solution:
EU/1/03/255/009
EU/1/03/255/010
EU/1/03/255/012
EU/1/03/255/014
Date of first authorisation: 16 September 2003
Date of latest renewal: 26 August 2013
| Drug | Countries | |
|---|---|---|
| VENTAVIS | Austria, Australia, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States |
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