EN Official Journal of the European Union C 78/20

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) or Article 38 of Directive 2001/82/EC (2))

(2006/C 78/04)

— Issuing, maintenance or modification of a national marketing authorisation

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

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

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

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

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