# C_2016490EN.01001001.xml

| 30.12.2016 | EN | Official Journal of the European Union | C 490/10 |
| --- | --- | --- | --- |

30.12.2016

EN

Official Journal of the European Union

C 490/10

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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))

1

2

(2016/C 490/02)

—   Issuing, maintenance or modification of a national marketing authorisation

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 |

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

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(1)  OJ L 311, 28.11.2001, p. 67.

1

(2)  OJ L 311, 28.11.2001, p. 1.

2

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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 |

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

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