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Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use

Sabumalin and associated names

Product name: Sabumalin and associated names
Also marketed in the EU under the name(s): Sabumalin, SalbuLEK, Salbutamol Lek, Salbutamol Sandoz
Active substance: salbutamol
Indication: Symptomatic treatment of reversible bronchoconstriction due to bronchial asthma and chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. Prophylaxis of exercise and allergen induced asthma.
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
16/03/2009 Referral EMEA/H/A-29/990 (2009)1969 of 12/03/2009
16/07/2009 Corrigendum (2009)1969 cor of 15/07/2009