# C_2009231EN.01001801.xml

| 25.9.2009 | EN | Official Journal of the European Union | C 231/18 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/18

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 July 2009 to 31 July 2009

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
   (1)
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
   (2)
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council

1

or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council

2

)

2009/C 231/04

—   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 | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 2.7.2009 | Nymusa | Chiesi Farmaceutici SpA |
| Via Palermo 26/A |
| 43100 Parma PR |
| ITALIA |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

2.7.2009

Nymusa

Chiesi Farmaceutici SpA

Via Palermo 26/A

43100 Parma PR

ITALIA

This Decision is addressed to the Member States

3.7.2009

20.7.2009

Instanyl

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1 |
| 4000 Roskilde |
| DANMARK |

Nycomed Danmark ApS

Langebjerg 1

4000 Roskilde

DANMARK

This Decision is addressed to the Member States

22.7.2009

—   Suspension of a national marketing authorisation

Suspension of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 14.7.2009 | Prokanazol | See Annex I | See Annex I | 15.7.2009 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

14.7.2009

Prokanazol

See Annex I

See Annex I

15.7.2009

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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 I

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S)/MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Czech Republic | PRO.MED.CS Praha a.s. |
| Telčská 1 |
| 140 00 Prague 4 |
| CZECH REPUBLIC |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Czech Republic

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

CZECH REPUBLIC

Prokanazol

100 mg

Hard capsules

Oral use

Latvia

| PRO.MED.CS Praha a.s. |
| --- |
| Telčská 1 |
| 140 00 Prague 4 |
| CZECH REPUBLIC |

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

CZECH REPUBLIC

Prokanaz 100 mg cietās kapsulas

100 mg

Hard capsules

Oral use

Lithuania

| PRO.MED.CS Praha a.s. |
| --- |
| Telčská 1 |
| 140 00 Prague 4 |
| CZECH REPUBLIC |

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

CZECH REPUBLIC

Prokanaz

100 mg

Hard capsules

Oral use

Poland

| PRO.MED.CS Praha a.s. |
| --- |
| Telčská 1 |
| 140 00 Prague 4 |
| CZECH REPUBLIC |

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

CZECH REPUBLIC

Prokanazol

100 mg

Hard capsules

Oral use

Slovak Republic

| PRO.MED.CS Praha a.s. |
| --- |
| Telčská 1 |
| 140 00 Prague 4 |
| CZECH REPUBLIC |

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

CZECH REPUBLIC

Prokanazol

100 mg

Hard capsules

Oral use

Slovenia

| PRO.MED.CS Praha a.s. |
| --- |
| Telčská 1 |
| 140 00 Prague 4 |
| CZECH REPUBLIC |

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

CZECH REPUBLIC

Prokanazol 100 mg trde kapsule

100 mg

Hard capsules

Oral use

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