This document is an excerpt from the EUR-Lex website
Document 52020XC0925(05)
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)
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)
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)
PUB/2020/736
IO C 318, 25.9.2020, p. 9–12
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
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 |
ANNEX
List of medicinal products and presentations
|
Member State EU/EEA |
Applicant |
Invented Name |
Strength |
Pharmaceutical form |
Route of administration |
||||
|
Germany |
|
Budesonid SUN |
0,25 mg |
nebuliser suspension |
Inhalation use |
||||
|
Germany |
|
Budesonid SUN |
0,5 mg |
nebuliser suspension |
Inhalation use |
||||
|
Germany |
|
Budesonid SUN |
1 mg |
nebuliser suspension |
Inhalation use |
||||
|
Italy |
|
Budesonide SUN |
0,125 mg/ml |
nebuliser suspension |
Inhalation use |
||||
|
Italy |
|
Budesonide SUN |
0,25 mg/ml |
nebuliser suspension |
Inhalation use |
||||
|
Italy |
|
Budesonide SUN |
0,5 mg/ml |
nebuliser suspension |
Inhalation use |
||||
|
The Netherlands |
|
Budesonide SUN |
250 microgram/2 ml |
nebuliser suspension |
Inhalation use |
||||
|
The Netherlands |
|
Budesonide SUN |
500 microgram /2 ml |
nebuliser suspension |
Inhalation use |
||||
|
The Netherlands |
|
Budesonide SUN |
1 000 microgram/2 ml |
nebuliser suspension |
Inhalation use |
||||
|
Poland |
|
Budezonid SUN |
0,125 mg/ml |
nebuliser suspension |
Inhalation use |
||||
|
Poland |
|
Budezonid SUN |
0,25 mg/ml |
nebuliser suspension |
Inhalation use |
||||
|
Poland |
|
Budezonid SUN |
0,5 mg/ml |
nebuliser suspension |
Inhalation use |
||||
|
Spain |
|
Budesónida SUN |
0,25 mg/ml |
nebuliser suspension |
Inhalation use |
||||
|
Spain |
|
Budesónida SUN |
0,5 mg/ml |
nebuliser suspension |
Inhalation use |
||||
|
Sweden |
|
Budesonid SUN |
0,125 mg/ml |
nebuliser suspension |
Inhalation use |
||||
|
Sweden |
|
Budesonid SUN |
0,25 mg/ml |
nebuliser suspension |
Inhalation use |
||||
|
Sweden |
|
Budesonid SUN |
0,5 mg/ml |
nebuliser suspension |
Inhalation use |
||||
|
United Kingdom |
|
Budesonide |
0,125 mg/ml |
nebuliser suspension |
Inhalation use |
||||
|
United Kingdom |
|
Budesonide |
0,25 mg/ml |
nebuliser suspension |
Inhalation use |
||||
|
United Kingdom |
|
Budesonide |
0,5 mg/ml |
nebuliser suspension |
Inhalation use |