Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2016 to 30 November 2016 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2016-12-30
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2016490EN.01001001.xml










30.12.2016   


EN


Official Journal of the European Union


C 490/10





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2016 to 30 November 2016
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2016/C 490/02)
—   Issuing, maintenance or modification 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 authorisation


Member State concerned


Date of notification




11.11.2016


Clenil and associated names — Art 30


beclometasone dipropionate


See Annex


See Annex


14.11.2016






(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


Marketing authorisation holder
company name, address


(Invented) Name


Strength


Pharmaceutical form


Route of administration




France


Chiesi S.A.
11 Avenue Dubonnet, 92400 Courbevoie
France


Beclospin


400 μG/ML


Nebuliser Suspension


Inhalation use




France


Chiesi S.A.
11 Avenue Dubonnet, 92400 Courbevoie
France


Beclospin


800 μG/2 ML


Nebuliser Suspension


Inhalation use




Germany


Chiesi Gmbh
Gasstraße. 6
22761 Hamburg
Germany


Sanasthmax


400 μG/ML


Nebuliser Suspension


Inhalation use




Greece


Chiesi Hellas A.E.B.E.
89, Karamanli Str,
151 25, Maroussi, Athens,
Greece


Becloneb


400 μG/ML


Nebuliser Suspension


Inhalation use




Greece


Chiesi Hellas A.E.B.E.
89, Karamanli Str,
151 25, Maroussi, Athens,
Greece


Becloneb


800 μG/2 ML


Nebuliser Suspension


Inhalation use




Greece


Chiesi Hellas A.E.B.E.
89, Karamanli Str,
151 25, Maroussi, Athens,
Greece


Beclospin


400 μG/ML


Nebuliser Suspension


Inhalation use




Greece


Chiesi Hellas A.E.B.E.
89, Karamanli Str,
151 25, Maroussi, Athens,
Greece


Beclospin


800 μG/2 ML


Nebuliser Suspension


Inhalation use




Ireland


Chiesi Farmaceutici S.P.A.
Via Palermo, 26/A,
43122 Parma,
Italy


Becloneb


800 μG/2 ML


Nebuliser Suspension


Inhalation use




Ireland


Chiesi Farmaceutici S.P.A.
Via Palermo, 26/A,
43122 Parma,
Italy


Becloneb


400 μG/ML


Nebuliser Suspension


Inhalation use




Ireland


Chiesi Farmaceutici S.P.A.
Via Palermo, 26/A,
43122 Parma,
Italy


Beclospin


800 μG/2 ML


Nebuliser Suspension


Inhalation use




Ireland


Chiesi Farmaceutici S.P.A.
Via Palermo, 26/A,
43122 Parma,
Italy


Beclospin


400 μG/ML


Nebuliser Suspension


Inhalation use




Italy


Master Pharma S.R.L.
Via Giacomo Chiesi, 1,
43122 Parma
Italy


Becloneb


800 μG/2 ML


Nebuliser Suspension


Inhalation use




Italy


Chiesi Farmaceutici S.P.A.
Via Palermo, 26/A,
43122 Parma,
Italy


Clenil


800 μG/2 ML


Nebuliser Suspension


Inhalation use