e
6.2 Incompatibilities
Not applicable
6.3 Shelf life
4 years
6.4 Special precautions for storage
Store in the original pouch until ready for use in order to protect from light and moisture.
This medicinal product does not require any special temperature storage conditions.
6.5 Nature and contents of container
The white inhaler (housing) is molded from a medical-grade polycarbonate.
Each inhaler is provided in a sealed, multilaminate aluminum foil pouch. ADASUVE 9.1 mg is supplied in a carton of 1 or 5 units.
Not all pack-sized may be marketed.
6.6 Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
Ferrer Internacional, S.A.
Gran Vía Carlos III, 94
08028- Barcelona
España
8. Marketing authorisation number(s)
EU/1/13/823/002 (5 single-dose inhalers)
EU/1/13/823/004 (1 single-dose inhaler)
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 20 February 2013
Date of latest renewal: 15 January 2018
10. Date of revision of the text
01/2018
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
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