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C\_2006078EN.01002001.xml


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| 31.3.2006 | EN | Official Journal of the European Union | C 78/20 |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2006 to 28 February 2006

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC[(1)](#ntr1-C_2006078EN.01002001-E0001) or Article 38 of Directive 2001/82/EC[(2)](#ntr2-C_2006078EN.01002001-E0002))

(2006/C 78/04)

—   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 |
| 21.2.2006 | Lanzoprazol ratiopharm | See Annex I | See Annex I | 23.2.2006 |
| 21.2.2006 | Lansoprazol ABZ-Pharma | See Annex II | See Annex II | 23.2.2006 |
| 21.2.2006 | Lansoprazol CT-Arzneimittel | See Annex III | See Annex III | 23.2.2006 |

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[(1)](#ntc1-C_2006078EN.01002001-E0001)  [OJ L 311, 28.11.2001, p. 67](http://publications.europa.eu/resource/oj/JOL_2001_311_R_TOC).

[(2)](#ntc2-C_2006078EN.01002001-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 HOLDER IN THE MEMBER STATES

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| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| Austria | — | | | | --- | | ratiopharm Arzneimittel Vertriebs-GmbH | | Albert-Schweitzer-G. 3 | | A-1140 Wien | | Lansoprazol ‘ratiopharm’ 15 mg Kapseln | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol ‘ratiopharm’ 30 mg Kapseln | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Belgium | — | | | | --- | | ratiopharm Belgium | | Rue Saint-Lambert 14 | | B-1120 Bruxelles/Brussel | | Lansoprazol-ratiopharm 15 mg gelules gastro-résistante | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol-ratiopharm 30 mg gelules gastro-résistante | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Denmark | — | | | | --- | | ratiopharm GmbH | | Graf-Arco-Straße 3 | | D-89079 Ulm | | Lantrolix 15 mg enterokapsler, hårde | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lantrolix 30 mg enterokapsler, hårde | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Finland | | | | --- | | ratiopharm GmbH | | Graf-Arco-Straße 3 | | D-89079 Ulm | | — | Lansoprazol ratiopharm 15 mg | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol ratiopharm 30 mg | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Germany | — | | | | --- | | ratiopharm GmbH | | Graf-Arco-Straße 3 | | D-89079 Ulm | | Lansoprazol-ratiopharm 15 mg Hartkapseln | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol-ratiopharm 30 mg Hartkapseln | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Italy | — | | | | --- | | ratiopharm GmbH | | Graf-Arco-Straße 3 | | D-89079 Ulm | | Lansoprazolo ratiopharm 15 mg capsule di gelatina dura | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazolo ratiopharm 30 mg capsule di gelatina dura | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Luxembourg | — | | | | --- | | ratiopharm GmbH | | Graf-Arco-Straße 3 | | D-89079 Ulm | | Lansoprazol-ratiopharm 15 mg Hartkapseln | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol-ratiopharm 30 mg Hartkapseln | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Portugal | — | | | | --- | | ratiopharm Lda, Portugal | | Edifício Tejo, 6.o piso | | Rua Quinta do Pinheiro | | P-2790-143 Carnaxide | | Lansoprazol ratiopharm 15 mg cápsulas gastro-resistentes | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol ratiopharm 30 mg cápsulas gastro-resistentes | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Sweden | — | | | | --- | | ratiopharm GmbH | | Graf-Arco-Straße 3 | | D-89079 Ulm | | Sopranix 15 mg, enterokapsler, hårda | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Sopranix 30 mg, enterokapsler, hårda | 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 HOLDER IN THE MEMBER STATES

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| --- | --- | --- | --- | --- | --- | --- |
| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| Finland | | | | --- | | ratiopharm GmbH | | Graf-Arco-Str. 3 | | D-89075 Ulm | | — | Lansoprazol AbZ-Pharma 15 mg | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol AbZ-Pharma 30 mg | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Germany | — | | | | --- | | ratiopharm GmbH | | Graf-Arco-Str. 3 | | D-89075 Ulm | | Lansoprazol AbZ 15 mg Hartkapseln | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol AbZ 30 mg Hartkapseln | 30 mg | Gastro-resistant capsule, hard | Oral use |

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ANNEX III

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

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| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| Finland | | | | --- | | ratiopharm GmbH | | Graf-Arco-Straße 3 | | D-89079 Ulm | | — | Lansoprazol CT-Arzneimittel 15 mg | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol CT-Arzneimittel 30 mg | 30 mg | Gastro-resistant capsule, hard | Oral use |
| Germany | — | | | | --- | | ratiopharm GmbH | | Graf-Arco-Straße 3 | | D-89079 Ulm | | Lansoprazol-CT 15 mg Hartkapseln | 15 mg | Gastro-resistant capsule, hard | Oral use |
| Lansoprazol-CT 30 mg Hartkapseln | 30 mg | Gastro-resistant capsule, hard | Oral use |

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