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C\_2005268EN.01000701.xml


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| 28.10.2005 | EN | Official Journal of the European Union | C 268/7 |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2005 to 30 September 2005

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC[(1)](#ntr1-C_2005268EN.01000701-E0001) or Article 38 of Directive 2001/82/EC[(2)](#ntr2-C_2005268EN.01000701-E0002))

(2005/C 268/03)

Issuing, maintenance or modification of a national marketing authorisation

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| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| 15.9.2005 | Lansopon | See Annex I | See Annex I | 19.9.2005 |
| 15.9.2005 | Lansoprazol HEXAL | See Annex II | See Annex II | 19.9.2005 |

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[(1)](#ntc1-C_2005268EN.01000701-E0001)  [OJ L 311, 28.11.2001, p. 67](http://publications.europa.eu/resource/oj/JOL_2001_311_R_TOC).

[(2)](#ntc2-C_2005268EN.01000701-E0002)  [OJ L 311, 28.11.2001, p. 1](http://publications.europa.eu/resource/oj/JOL_2001_311_R_TOC).

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ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

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| Member State | Marketing authorisation holder | Applicant | Invented name | Strength | Pharmaceutical form | Route of administration |
| Belgium | — | | | | --- | | HEXAL AG | | Industriestraße 25 | | DE-83607 Holzkirchen | | Lansoprazole BEXAL 15 mg gélules gastro-resistantes | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazole BEXAL 30 mg gélules gastro-resistantes | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol HEXAL | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Germany | — | | | | --- | | HEXAL AG | | Industriestraße 25 | | DE-83607 Holzkirchen | | Lansoprazol HEXAL 15 mg Hartkapseln | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol HEXAL 30 mg Hartkapseln | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Finland | | | | --- | | HEXAL AG | | Industriestraße 25 | | DE-83607 Holzkirchen | | — | Lansopon 15mg | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansopon 30 mg | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Luxembourg | — | | | | --- | | HEXAL AG | | Industriestraße 25 | | DE-83607 Holzkirchen | | Lansoprazol HEXAL 15 mg Hartkapseln | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol HEXAL 30 mg Hartkapseln | 30 mg | Gastro-resistant capsule, hard | Oral use |

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ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

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| Member State | Marketing authorisation holder | Applicant | Invented name | Strength | Pharmaceutical form | Route of administration |
| Austria | — | | | | --- | | HEXAL AG | | Industriestraße 25 | | DE-83607 Holzkirchen | | Lansohexal 15 mg — Hartkapseln | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansohexal 30 mg — Hartkapseln | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Denmark | — | | | | --- | | HEXAL AG | | Industriestraße 25 | | DE-83607 Holzkirchen | | Lansoprazol HEXAL | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol HEXAL | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Germany | — | | | | --- | | HEXAL AG | | Industriestraße 25 | | DE-83607 Holzkirchen | | Lansohexal 15 mg Hartkapseln | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansohexal 30 mg Hartkapseln | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Finland | | | | --- | | HEXAL AG | | Industriestraße 25 | | DE-83607 Holzkirchen | | — | Lansoprazol HEXAL 15mg | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol HEXAL 30 mg | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Sweden | — | | | | --- | | HEXAL AG | | Industriestraße 25 | | DE-83607 Holzkirchen | | Lansocid | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansocid | 30 mg | Gastro-resistant capsule, hard | Oral use |

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