Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2020 to 31 August 2020 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2020-09-25
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2020318EN.01000901.xml










25.9.2020   


EN


Official Journal of the European Union


C 318/9






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2020 to 31 August 2020
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2020/C 318/02)
—   Refusal of a national marketing authorisation











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




19.8.2020


Budesonide SUN and associated names


budesonide


See Annex


See Annex


20.8.2020






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.




ANNEX
List of medicinal products and presentations










Member State EU/EEA


Applicant


Invented Name


Strength


Pharmaceutical form


Route of administration




Germany







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonid SUN


0,25  mg


nebuliser suspension


Inhalation use




Germany







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonid SUN


0,5  mg


nebuliser suspension


Inhalation use




Germany







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonid SUN


1 mg


nebuliser suspension


Inhalation use




Italy







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonide SUN


0,125  mg/ml


nebuliser suspension


Inhalation use




Italy







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonide SUN


0,25  mg/ml


nebuliser suspension


Inhalation use




Italy







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonide SUN


0,5  mg/ml


nebuliser suspension


Inhalation use




The Netherlands







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonide SUN


250 microgram/2 ml


nebuliser suspension


Inhalation use




The Netherlands







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonide SUN


500 microgram /2 ml


nebuliser suspension


Inhalation use




The Netherlands







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonide SUN


1 000  microgram/2 ml


nebuliser suspension


Inhalation use




Poland







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budezonid SUN


0,125  mg/ml


nebuliser suspension


Inhalation use




Poland







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budezonid SUN


0,25  mg/ml


nebuliser suspension


Inhalation use




Poland







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budezonid SUN


0,5  mg/ml


nebuliser suspension


Inhalation use




Spain







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesónida SUN


0,25  mg/ml


nebuliser suspension


Inhalation use




Spain







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesónida SUN


0,5  mg/ml


nebuliser suspension


Inhalation use




Sweden







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonid SUN


0,125  mg/ml


nebuliser suspension


Inhalation use




Sweden







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonid SUN


0,25  mg/ml


nebuliser suspension


Inhalation use




Sweden







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonid SUN


0,5  mg/ml


nebuliser suspension


Inhalation use




United Kingdom







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonide


0,125  mg/ml


nebuliser suspension


Inhalation use




United Kingdom







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonide


0,25  mg/ml


nebuliser suspension


Inhalation use




United Kingdom







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87




2132 JH Hoofddorp




The Netherlands






Budesonide


0,5  mg/ml


nebuliser suspension


Inhalation use