EN Official Journal of the European Union C 77/9

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2008 to 29 February 2008

(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) )

(2008/C 77/03)

— Suspension of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 5.1.2008 Carisoprodol See Annex I See Annex I 6.2.2008 15.2.2008 Aprotinin See Annex II See Annex II 19.2.2008 15.2.2008 Simvastatin Krka See Annex III See Annex III 19.2.2008

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

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

ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Invented Name Strength Pharmaceutical form Route of administration Czech Republic EGIS Pharmaceuticals PLC Keresztúri út 30-38 H-1106 Budapest Scutamil C 150 mg carisoprodol/100 mg paracetamol Coated tablet Oral use Denmark Actavis Group hf Reykjavíkurvegur 76-78 IS-220 Hafnafjördur Somadril 350 mg Film coated tablet Oral use Finland Actavis Group hf. Reykjavíkurvegi 76-78 IS-220 Hafnafjördur Somadril Comp 200 mg carisoprodol/160 mg paracetamol/32 mg caffeine Film coated tablet Oral use Greece Uni Pharma Kleon Tsetis Pharmaceutical Laboratories ABEE 14 km National Highway Athens-Lamia GR-14564 K. Kifissia Artifar 350 mg Film coated tablet Oral use Greece Uni Pharma Kleon Tsetis Pharmaceutical Laboratories ABEE 14 km National Highway Athens-Lamia GR-14564 K. Kifissia Relacton-C 200 mg carisoprodol/300 mg paracetamol Tablet Oral use Greece Uni Pharma Kleon Tsetis Pharmaceutical Laboratories ABEE 14 km National Highway Athens-Lamia GR-14564 K. Kifissia Relacton-C 400 mg carisoprodol/600 mg paracetamol Suppository Rectal use Hungary EGIS Pharmaceuticals PLC Keresztúri út 30-38 H-1106 Budapest Scutamil-C 150 mg carisoprodol, 100 mg paracetamol Tablet Oral use Iceland Actavis Group hf. Reykjavíkurvegi 76-78 IS-220 Hafnarfjörður Somadril 350 mg Film coated tablet Oral use Iceland Actavis Group hf. Reykjavíkurvegi 76-78 IS-220 Hafnarfjörður Somadril Comp 200 mg carisoprodol/160 mg paracetamol Film coated tablet Oral use Italy TEOFARMA Srl Sede legale: via F.lli Cervi, 8 I-27010 Valle Salimbene (PV) Soma complex 140 mg carisoprodol/500 mg metamizole sodium Film coated tablet Oral use Italy TEOFARMA Srl Sede legale: via F.lli Cervi, 8 I-27010 Valle Salimbene (PV) Soma complex 600 mg carisoprodol/1 000 mg metamizole sodium Suppository Rectal use Norway Actavis Group hf. Reykjavíkurvegi 76-78 IS-220 Hafnarfjörður Somadril 350 mg Film coated tablet Oral use Slovak Republic EGIS Pharmaceuticals PLC Keresztúri út 30-38 H-1106 Budapest Scutamil C 150 mg carisoprodol/100 mg paracetamol Film coated tablet Oral use Spain Laboratorios BELMAC SA Teide, 4-planta baj. Polígono Empresarial La Marina E-28700 San Sebastian de los Reyes Madrid Mio Relax 350 mg Tablet Oral use Spain Laboratorios Rimafar Polígono industrial Malpica c, no 4 E-50057 Zaragoza Relaxibys 200 mg carisoprodol/500 mg paracetamol Tablet Oral use Sweden Actavis Group hf Reykjavíkurvegur 76-78 IS-220 Hafnafjördur Somadril 350 mg Tablet Oral use Sweden Actavis Group hf Reykjavíkurvegur 76-78 IS-220 Hafnafjördur Somadril comp. 200 mg carisoprodol/160 mg paracetamol/32 mg caffeine Tablet Oral use United Kingdom Forest Laboratories UK Limited Bourne Road Bexley Kent DA5 1NX United Kingdom Carisoma 125 mg Tablet Oral use United Kingdom Forest Laboratories UK Limited Bourne Road Bexley Kent DA5 1NX United Kingdom Carisoma 350 mg Tablet Oral use

ANNEX II LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Aprotinin containing medicinal products with marketing authorisation in the European Union Member State Marketing Authorisation Holder (Invented) Name Strength Pharmaceutical form Route of administration Austria Gerot Pharmazeutika Gesellschaft m.b.H. Arnethgasse 3 A-1160 Wien Pantinol 100 000 KIU/10 ml Solution for injection and solution for infusion Intravenous use Austria Gerot Pharmazeutika Gesellschaft m.b.H. Arnethgasse 3 A-1160 Wien Pantinol 200 000 KIU/10 ml Solution for injection and solution for infusion Intravenous use Austria Gerot Pharmazeutika Gesellschaft m.b.H. Arnethgasse 3 A-1160 Wien Pantinol 500 000 KIU/15 ml Solution for injection and solution for infusion Intravenous use Austria Bayer Austria GmbH Herbststraße 6-10 A-1160 Wien Trasylol 10 000 KIU/ml 500 000 KIU/50 ml Solution for injection and solution for infusion Intravenous use Belgium Bayer NV Avenue Louise 143 B-1050 Bruxelles Trasylol 20 000 KIU/ml Solution Intravenous use Belgium Bayer NV Avenue Louise 143 B-1050 Bruxelles Trasylol 10 000 KIU/ml Solution Intravenous use Bulgaria Gedeon Richter Plc. Gyömrői út 19-21 H-1103 Budapest Gordox 100 000 KIU Solution for injection Intravenous use Bulgaria Gedeon Richter Plc. Gyömrői út 19-21 H-1103 Budapest Gordox 500 000 KIU Solution for infusion Intravenous use Bulgaria Bayer AG D-51368 Leverkusen Trasylol 500 000 KIU/50 ml Solution for infusion Intravenous use Cyprus Bayer Hellas Abee Σορού 18-20/Sorou 18-20 GR-15125 Μαρούσι-Αθήνα GR-15125 Marousi-Athens Trasylol 500 000 KIU/50 ml Solution for infusion Intravenous use Czech Republic Spofa a. s. Poděbradská 5 CZ-180 47 Praha 9 Antilysin Spofa 55,55 Ph.Eur.U./10 ml Solution for injection Intravenous use Czech Republic Chemical Works of Gedeon Richter Ltd. Gyömrői út 19-21 H-1103 Budapest Gordox 60 Ph.Eur.U./10 ml Solution for injection Intravenous use Czech Republic Bayer HealthCare AG D-51368 Leverkusen Trasylol 500 000 KIU 70 mg Solution for infusion Intravenous use Denmark Bayer HealthCare AG D-51368 Leverkusen Trasylol 10 000 KIU/ml Solution for injection Intravenous use Estonia Gedeon Richter Ltd Gyömrői út 19-21 H-1103 Budapest Gordox 10 000 KIU/50 ml Concentrate for solution for infusion Intravenous use Finland Bayer HealthCare AG D-51368 Leverkusen Trasylol 10 000 KIU/ml Solution for injection and solution for infusion Intravenous use France Bayer Pharma SA 13, rue Jean Jaurès F-92807 Puteaux Cedex Trasylol 1 000 000 KIU/100 ml Solution for injection Intravenous use France Bayer Pharma SA 13, rue Jean Jaurès F-92807 Puteaux Cedex Trasylol 2 000 000 KIU/200 ml Solution for injection Intravenous use France Bayer Pharma SA 13, rue Jean Jaurès F-92807 Puteaux Cedex Trasylol 500 000 KIU/50 ml Solution for injection Intravenous use Germany Bayer HealthCare AG D-51368 Leverkusen Trasynin 0,5 70,0 mg/50 ml Solution for infusion Intravenous use Germany Bayer HealthCare AG D-51368 Leverkusen Trasynin 1,0 140,0 mg/100 ml Solution for infusion Intravenous use Germany Bayer HealthCare AG D-51368 Leverkusen Trasynin 2,0 280,0 mg/200 ml Solution for infusion Intravenous use Germany Bayer Vital GmbH D-51368 Leverkusen Trasylol 0,5 70,0 mg/50 ml Solution for infusion Intravenous use Germany Bayer Vital GmbH D-51368 Leverkusen Trasylol 1,0 140,0 mg/100 ml Solution for infusion Intravenous use Germany Bayer Vital GmbH D-51368 Leverkusen Trasylol 2,0 280,0 mg/200 ml Solution for infusion Intravenous use Germany EMRA-MED Arzneimittel GmbH Otto-Han-Str. 11 D-22946 Trittau Trasylol 0,5 70,0 mg/50 ml Solution for infusion Intravenous use Greece Bayer Hellas Abee Σορού 18-20/Sorou 18-20 GR-15125 Μαρούσι-Αθήνα GR-15125 Marousi-Athens Trasylol 500 000 KIU/50 ml Solution for infusion Intravenous use Hungary Bayer Hungária Kft Alkotás u. 50. H-1123 Budapest Trasylol 500 000 KIU Solution for infusion Intravenous use Hungary Richter Gedeon NyRt. Gyömrői út 19-21. H-1103 Budapest Gordox 500 000 KIU Solution for infusion Intravenous use Hungary Richter Gedeon NyRt. Gyömrői út 19-21. H-1103 Budapest Gordox 100 000 KIU Solution for injection Intravenous use Latvia Bayer Healthcare AG D-51368 Leverkusen Trasylol 0,5 10 000 KIU/ml Solution for injection Intravenous use Latvia Bayer Healthcare AG D-51368 Leverkusen Trasylol 1,0 10 000 KIU/ml Solution for injection Intravenous use Latvia Bayer Healthcare AG D-51368 Leverkusen Trasylol 2,0 10 000 KIU/ml Solution for injection Intravenous use Latvia Gedeon Richter Ltd. Gyömrői út 19-21 H-1103 Budapest Gordox 10 000 KIU/ml Solution for injection Intravenous use Lithuania Gedeon Richter Ltd. Gyömrői út 19-21 H-1103 Budapest Gordox 10 000 KIU/ml Solution for injection Intravenous use Luxembourg Bayer S.A 143, avenue Louise B-1050 Bruxelles Trasylol 500 000 KIU/50 ml Solution for injection Intravenous use/subcutaneous use Malta Bayer plc Pharmaceutical Division Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Trasylol 500 000 KIU (50 ml vial) Solution for infusion Intravenous use Malta Bayer plc Pharmaceutical Division Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Trasylol 1 000 000 KIU (100 ml vial) Solution for infusion Intravenous use Malta Bayer plc Pharmaceutical Division Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Trasylol 2 000 000 KIU (200 ml vial) Solution for infusion Intravenous use Malta Bayer plc Pharmaceutical Division Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Trasylol 10 000 KIU/ml Solution for infusion Intravenous use Netherlands Bayer B.V. Postbus 80 3640 AB Mijdrecht Nederland Trasylol 10 000 KIU/ml Solution for infusion Intravenous use Poland Przedsiębiorstwo Farmaceutyczne Jelfa S.A. ul. Wincentego Pola 21 PL-58-500 Jelenia Góra Traskolan 500 000 KIU/10 ml Solution for injection Intravenous use Poland Bayer HealthCare AG D-51368 Leverkusen Trasylol 277,8 Ph.Eur.U. Solution for infusion Intravenous use Poland Bayer HealthCare AG D-51368 Leverkusen Trasylol 555,6 Ph.Eur.U. Solution for infusion Intravenous use Poland Bayer HealthCare AG D-51368 Leverkusen Trasylol 1 111,1 Ph.Eur.U. Solution for infusion Intravenous use Portugal Bayer Portugal, S.A. PRT Rua Quinta do Pinheiro, 5 P-2794-003 Carnaxide Trasylol 500 000 KIU/50 ml Solution for infusion Intravenous use Portugal Bayer Portugal, S.A. PRT Rua Quinta do Pinheiro, 5 P-2794-003 Carnaxide Trasylol 1 000 000 KIU/100 ml Solution for infusion Intravenous use Portugal Bayer Portugal, S.A. PRT Rua Quinta do Pinheiro, 5 P-2794-003 Carnaxide Trasylol 2 000 000 KIU/200 ml Solution for infusion Intravenous use Romania Bayer HealthCare AG D-51368 Leverkusen Trasylol 500 000 KIU Solution for infusion Intravenous use Romania Gedeon Richter Ltd. Győmrői ut 19-21 H-1103 Budapest Gordox 100 000 KIU Solution for injection Intramuscular use Slovakia SPOFA a. s. Husinecká 11a CZ-130 00 Praha 3 Antilysin Spofa 100 000 KIU/10 ml Solution for injection Intravenous use Slovakia Gedeon Richter Ltd. Győmrői ut 19-21 H-1103 Budapest Gordox 100 000 KIU/10 ml Solution for injection Intravenous use Slovenia Bayer d.o.o. Bravničarjeva 13 SLO-1000 Ljubljana Trasylol 10 000 KIU/ml Solution for injection and solution for infusion Intravenous use Sweden Bayer HealthCare AG D-51368 Leverkusen Trasylol 10 000 KIU/ml Solution for injection and solution for infusion Intravenous use United Kingdom Bayer plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Trasylol 10 000 KIU/ml Solution for injection Intravenous use United Kingdom Nordic Pharma Limited Abbey House 1650 Arlington Business Park Theale, Reading Berkshire RG7 4SA United Kinddom Aprotinine 10 000 KIU/ml Solution for injection Intravenous use