EN Official Journal of the European Union C 350/30

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 October 2013

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )

2013/C 350/03

— Issuing, maintenance or modification 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 2.10.2013 Suifertil 4 mg/ml See Annex I See Annex I 3.10.2013 9.10.2013 Methylphenidate Hexal See Annex II See Annex II 11.10.2013 9.10.2013 Methylphenidate Sandoz See Annex III See Annex III 10.10.2013 18.10.2013 Dexadreson 2 mg/ml See Annex IV See Annex IV 21.10.2013 18.10.2013 Micotil 300 See Annex V See Annex V 21.10.2013 31.10.2013 Sandimmun See Annex VI See Annex VI 4.11.2013 31.10.2013 Sandimmun Neoral See Annex VII See Annex VII 4.11.2013





— 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 11.10.2013 Ketoconazole See Annex VIII See Annex VIII 14.10.2013

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

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

ANNEX I LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES Member State EU/EEA Applicant Name INN Strength Pharmaceutical form Animal species Route of administration Austria aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany Suifertil 4 mg/ml Lösung zum Eingeben für Schweine Altrenogest 4 mg/ml Oral solution Pigs (sexually mature gilts) For oral use as a top-dressing France aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany Synchroplan 4 mg/ml solution buvable porcins Altrenogest 4 mg/ml Oral solution Pigs (sexually mature gilts) For oral use as a top-dressing Germany aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany Suifertil 4 mg/ml Oral Solution for Pigs Altrenogest 4 mg/ml Oral solution Pigs (sexually mature gilts) For oral use as a top-dressing Hungary aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany Suifertil 4 mg/ml belsőleges oldat sertések részére A.U.V. Altrenogest 4 mg/ml Oral solution Pigs (sexually mature gilts) For oral use as a top-dressing The Netherlands aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany Suifertil 4 mg/ml orale oplossing voor varkens Altrenogest 4 mg/ml Oral solution Pigs (sexually mature gilts) For oral use as a top-dressing Poland aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany Suifertil 4 mg/ml Oral Solution for Pigs Altrenogest 4 mg/ml Oral solution Pigs (sexually mature gilts) For oral use as a top-dressing Romania aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany Suifertil 4 mg/ml Oral Solution for Pigs Altrenogest 4 mg/ml Oral solution Pigs (sexually mature gilts) For oral use as a top-dressing Spain aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany Suifertil 4 mg/ml solución oral para porcino Altrenogest 4 mg/ml Oral solution Pigs (sexually mature gilts) For oral use as a top-dressing United Kingdom aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany Suifertil 4 mg/ml Oral Solution for Pigs Altrenogest 4 mg/ml Oral solution Pigs (sexually mature gilts) For oral use as a top-dressing

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder company name, address Applicant company name, address (Invented) Name Strength Pharmaceutical form Route of administration Denmark Hexal A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate ‘Hexal’ 18 mg Prolonged-release tablet Oral use Denmark Hexal A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate ‘Hexal’ 36 mg Prolonged-release tablet Oral use Denmark Hexal A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate ‘Hexal’ 54 mg Prolonged-release tablet Oral use Germany Hexal A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidathydrochlorid HEXAL 18 mg Retardtabletten 18 mg Prolonged-release tablet Oral use Germany Hexal A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidathydrochlorid HEXAL 36 mg Retardtabletten 36 mg Prolonged-release tablet Oral use Germany Hexal A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidathydrochlorid HEXAL 54 mg Retardtabletten 54 mg Prolonged-release tablet Oral use Ireland Rowex Ltd Bantry Co. Cork Ireland Metidate XL 54 mg Prolonged-Release Tablets 54 mg Prolonged-release tablet Oral use Ireland Rowex Ltd Bantry Co. Cork Ireland Metidate XL 18 mg Prolonged-Release Tablets 18 mg Prolonged-release tablet Oral use Ireland Rowex Ltd Bantry Co. Cork Ireland Metidate XL 36 mg Prolonged-Release Tablets 36 mg Prolonged-release tablet Oral use

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder company name, address Applicant company name, address (Invented) Name Strength Pharmaceutical form Route of administration Belgium Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylfenidaat Sandoz 18 mg tabletten met verlengde afgifte 18 mg Prolonged-release tablet Oral use Belgium Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylfenidaat Sandoz 36 mg tabletten met verlengde afgifte 36 mg Prolonged-release tablet Oral use Belgium Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylfenidaat Sandoz 54 mg tabletten met verlengde afgifte 54 mg Prolonged-release tablet Oral use Cyprus Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria Methylphenidate Sandoz 18 mg Prolonged-release tablet Oral use Cyprus Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria Methylphenidate Sandoz 36 mg Prolonged-release tablet Oral use Cyprus Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria Methylphenidate Sandoz 54 mg Prolonged-release tablet Oral use Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate ‘Sandoz’ 18 mg Prolonged-release tablet Oral use Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate ‘Sandoz’ 36 mg Prolonged-release tablet Oral use Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate ‘Sandoz’ 54 mg Prolonged-release tablet Oral use Finland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate Sandoz 18 mg Prolonged-release tablet Oral use Finland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate Sandoz 36 mg Prolonged-release tablet Oral use Finland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate Sandoz 54 mg Prolonged-release tablet Oral use France Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Méthylphénidate Sandoz LP 18 mg, comprimé à liberation prolongée 18 mg Prolonged-release tablet Oral use France Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Méthylphénidate Sandoz LP 36 mg, comprimé à libération prolongée 36 mg Prolonged-release tablet Oral use France Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Méthylphénidate Sandoz LP 54 mg, comprimé à librétaion prolongée 54 mg Prolonged-release tablet Oral use Germany Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidathydrochlorid - 1 A Pharma 18 mg Retardtabletten 18 mg Prolonged-release tablet Oral use Germany Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidathydrochlorid - 1 A Pharma 36 mg Retardtabletten 36 mg Prolonged-release tablet Oral use Germany Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidathydrochlorid - 1 A Pharma 54 mg Retardtabletten 54 mg Prolonged-release tablet Oral use Iceland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate Sandoz, 18 mg, forðatöflur 18 mg Prolonged-release tablet Oral use Iceland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate Sandoz, 36 mg, forðatöflur 36 mg Prolonged-release tablet Oral use Iceland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate Sandoz, 54 mg, forðatöflur 54 mg Prolonged-release tablet Oral use Luxembourg Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylfenidaat Sandoz 18 mg comprimé à libération prolongée 18 mg Prolonged-release tablet Oral use Luxembourg Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylfenidaat Sandoz 36 mg comprimé à libération prolongée 36 mg Prolonged-release tablet Oral use Luxembourg Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylfenidaat Sandoz 54 mg comprimé à libération prolongée 54 mg Prolonged-release tablet Oral use Malta Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Matoride XL 18 mg Prolonged-release Tablets 18 mg Prolonged-release tablet Oral use Malta Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Matoride XL 36 mg Prolonged-release Tablets 36 mg Prolonged-release tablet Oral use Malta Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Matoride XL 54 mg Prolonged-release Tablets 54 mg Prolonged-release tablet Oral use Norway Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate Sandoz 18 mg depottabletter 18 mg Prolonged-release tablet Oral use Norway Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate Sandoz 36 mg depottabletter 36 mg Prolonged-release tablet Oral use Norway Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate Sandoz 54 mg depottabletter 54 mg Prolonged-release tablet Oral use Poland Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria Difumenil 18 mg Prolonged-release tablet Oral use Poland Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria Difumenil 36 mg Prolonged-release tablet Oral use Poland Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria Difumenil 54 mg Prolonged-release tablet Oral use Portugal Sandoz Farmacêutica Lda. Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15 2710-693 Sintra Portugal Metilfenidato Sandoz 18 mg Prolonged-release tablet Oral use Portugal Sandoz Farmacêutica Lda. Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15 2710-693 Sintra Portugal Metilfenidato Sandoz 36 mg Prolonged-release tablet Oral use Portugal Sandoz Farmacêutica Lda. Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15 2710-693 Sintra Portugal Metilfenidato Sandoz 54 mg Prolonged-release tablet Oral use Spain Sandoz Farmacéutica, S.A. Centro Empresarial Osa Mayor Avda Osa Mayor no 4 28023 – Aravaca, Madrid Spain Metilfenidato Sandoz 18 mg comprimidos de liberación prolongada EFG 18 mg Prolonged-release tablet Oral use Spain Sandoz Farmacéutica, S.A. Centro Empresarial Osa Mayor Avda Osa Mayor no 4 28023 – Aravaca, Madrid Spain Metilfenidato Sandoz 36 mg comprimidos de liberación prolongada EFG 36 mg Prolonged-release tablet Oral use Spain Sandoz Farmacéutica, S.A. Centro Empresarial Osa Mayor Avda Osa Mayor no 4 28023 – Aravaca, Madrid Spain Metilfenidato Sandoz 54 mg comprimidos de liberación prolongada EFG 54 mg Prolonged-release tablet Oral use Sweden Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate Sandoz 18 mg Prolonged-release tablet Oral use Sweden Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate Sandoz 36 mg Prolonged-release tablet Oral use Sweden Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylphenidate Sandoz 54 mg Prolonged-release tablet Oral use The Netherlands Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylfenidaat HCl Sandoz retard 18 mg, tabletten met verlengde afgifte 18 mg Prolonged-release tablet Oral use The Netherlands Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylfenidaat HCl Sandoz retard 36 mg, tabletten met verlengde afgifte 36 mg Prolonged-release tablet Oral use The Netherlands Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Methylfenidaat HCl Sandoz retard 54 mg, tabletten met verlengde afgifte 54 mg Prolonged-release tablet Oral use United Kingdom Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Matoride XL 18 mg Prolonged-release Tablets 18 mg Prolonged-release tablet Oral use United Kingdom Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Matoride XL 36 mg Prolonged-release Tablets 36 mg Prolonged-release tablet Oral use United Kingdom Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Matoride XL 54 mg Prolonged-release Tablets 54 mg Prolonged-release tablet Oral use

ANNEX IV LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Applicant/marketing authorisation holder Name INN Strength Pharmaceutical form Animal species Austria Intervet GmbH Siemensstraße 107 AT-1210 Wien AUSTRIA Hexadreson 2 mg/ml Injektionslösung für Pferde, Rinder, Schweine, Hunde Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Austria Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS Rapidexon 2 mg/ml Injektionslösung für Pferde, Rinder, Schweine, Katzen und Hunde Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Belgium Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS RAPIDEXON 2 MG/ML SOLUTION INJECTABLE Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Belgium Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer THE NETHERLANDS DEXA-JECT 2 MG/ML oplossing voor injectie voor runderen, paarden, varkens, honden en katten Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Cyprus Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS DEXADRESON INJECTION 2 MG/ML Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Czech republic Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS Dexadreson, 2 mg/ml Injekční roztok Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Czech republic Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS RAPIDEXON 2 mg/ml injekční roztok Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Denmark Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS Dexadreson Vet Dexamethasone 2 mg/ml Solution for injection Cattle, horses Denmark Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer THE NETHERLANDS Dexaject Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Denmark Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS Rapidexon Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Finland Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS Rapidexon vet Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats France Intervet Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRANCE Dexadreson Dexamethasone 2 mg/ml Solution for injection Cattle, horses, goat, pigs, dogs and cats. France Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS Rapidexon 2 mg/ml solution injectable Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats France Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS Cortadex 2 mg/ml solution injectable pour bovins, porcins, chiens et chats Dexamethasone 2 mg/ml Solution for injection Cattle, pigs, dogs and cats France Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer THE NETHERLANDS Dexa-ject 2 mg/ml solution injectable pour bovins, chevaux, porcins, chiens et chats Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Germany Intervet Deutschland GmbH Feldstr. 1a D-85716 Unterschleißheim GERMANY Hexadreson Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Germany Albrecht GmbH Hauptstr. 6-8 88326 Aulendorf GERMANY Rapidexon Albrecht 2 mg/ml Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Germany Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer THE NETHERLANDS Dexa-ject 2 mg/ml Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Greece Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS DEXADRESON Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Greece Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS RAPIDEXON Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Hungary Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS Dexadreson injekció A.U.V. Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Hungary Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer THE NETHERLANDS Dexa-ject 2 mg/ml injekció szarvasmarhák, lovak, sertések, kutyák és macskák részére A.U.V. Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Hungary Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS Rapidexon 2 mg/ml injekció A.U.V. Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Iceland Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer THE NETHERLANDS Dexaject Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Ireland Intervet Ireland Ltd. Magna Drive, Magna Business Park Citywest Road Dublin 24 IRELAND Dexadresson 2 mg/ml solution for injection Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Ireland Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS Rapidexon 2 mg/ml solution for injection Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Ireland Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer THE NETHERLANDS Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Italy Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS Dexadreson Dexamethasone 2 mg/ml Solution for injection Cattle, horses, goat, pigs, dogs and cats. Latvia Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS Dexacortin Dexamethasone 2 mg/ml Solution for injection Cattle, pigs, dogs and cats Lithuania Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS DEXACORTIN 2 mg/ml solution for injection for cattle, swine, dogs and cats Dexamethasone 2 mg/ml Solution for injection Cattle, pigs, dogs and cats Lithuania Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS RAPIDEXON 2 mg/ml, solution for injection Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Lithuania Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer THE NETHERLANDS DEXA-JECT 2 mg/ml solution for injection for cattle, horse, pigs, dogs and cats Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats The Netherlands Intervet Nederland B.V. p.o. box 50 5830 AB Boxmeer THE NETHERLANDS Dexadreson Dexamethasone 2 mg/ml Solution for injection Cattle The Netherlands Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS Rapidexon Dexamethasone 2 mg/ml Solution for injection Cattle The Netherlands Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS Rapidexon Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats The Netherlands Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer THE NETHERLANDS Dexa-ject Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Norway Intervet AB Box 7121 192 07 Sollentuna SWEDEN Dexadreson vet. Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Poland Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS DEXACORTIN 2 mg/ml roztwór do wstrzykiwań dla bydła, świń, psów i kotów Dexamethasone 2 mg/ml Solution for injection Cattle, pigs, dogs and cats. Poland Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS RAPIDEXON 2 mg/ml roztwór do wstrzykiwań Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Poland Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer THE NETHERLANDS Dexa-ject 2 mg/ml roztwór do wstrzykiwań dla bydła, koni, świń, psów i kotów Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Portugal Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS Rapidexon 2 mg/ml, solução injectável Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Portugal Intervet Portugal – Saúde Animal, Lda Rua Agualva dos Açores n.o 16 2735-557 Agualva-Cacém, PORTUGAL Dexacortin 2 mg/ml solução injectável para bovinos, suínos, cães e gatos Dexamethasone 2 mg/ml Solution for injection Cattle, pigs, dogs and cats Romania Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS DEXADRESON Dexamethasone 2 mg/ml Solution for injection Cattle, horses, goat, pigs, dogs and cats Slovakia Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS Dexadreson 2 mg/ml injekčný roztok Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Slovakia Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS Rapidexon 2 mg/ml injekčný roztok Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Slovenia Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS RAPIDEXON 2 mg/ml raztopina za injiciranje Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Slovenia Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS DEXACORTIN 2 mg/ml, raztopina za injiciranje za govedo, prašiče, pse in mačke Dexamethasone 2 mg/ml Solution for injection Cattle, pigs, dogs and cats Spain Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS Rapidexon 2 mg/ml solución inyectable Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Spain S.P. Veterinaria, S.A. Ctra. Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona SPAIN Dexavex Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Spain Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer THE NETHERLANDS Dexa-ject 2 mg/ml Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats Sweden Intervet AB Box 7121 192 07 Sollentuna SWEDEN Dexadreson vet. Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats United Kingdom Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ UNITED KINGDOM Dexadreson 2 mg/ml Solution for Injection Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats United Kingdom Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer THE NETHERLANDS Dexa-ject 2 mg/ml Solution for Injection for Cattle, Horses, Pigs, Dogs and Cats Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats United Kingdom Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel THE NETHERLANDS Rapidexon 2 mg/ml Solution for Injection Dexamethasone 2 mg/ml Solution for injection Cattle, horses, pigs, dogs and cats

ANNEX V LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Name INN Strength Pharmaceutical form Animal species Route of administration Austria Richter Pharma AG Feldgasse 19 4600 Wels AUSTRIA Micotil 300 mg/ml - Injektionslösung für Rinder Tilmicosin 300 mg/ml Solution for injection Cattle Subcutaneous injection Belgium ELI LILLY BENELUX N.V. Division Elanco Animal Health Stoofstraat 52 1000 Brussel BELGIUM Micotil 300 mg/ml Tilmicosin 300 mg/ml Solution for injection Cattle, sheep Subcutaneous injection Czech Republic EIi Lílly Regional Operations GmbH Elanco Animal Health Kölblgasse 8-10 1030 Wien AUSTRIA Micotil 300 mg/ml injekční roztok pro skot (telata, mladý skot) Tilmicosin 300 mg/ml Solution for injection Cattle Subcutaneous injection Germany Lilly Deutschland GmbH Teichweg 3 35396 Gießen GERMANY Micotil 300 Tilmicosin 300 mg/ml Solution for injection Cattle Subcutaneous injection France LILLY FRANCE 13 Rue Pages 92158 Suresnes Cedex FRANCE MICOTIL 300 Tilmicosin 300 mg/ml Solution for injection Cattle Subcutaneous injection Greece Eli Lilly Regional Operations GesmbH Elanco Animal Health Kölblgasse 8-10 1030 Vienna AUSTRIA MICOTIL 300 Tilmicosin 300 mg/ml Solution for injection Cattle, sheep Subcutaneous injection Spain ELANCO VALQUÍMICA S.A, Avenida de la Industria 30 28108 Alcobendas Madrid SPAIN Micotil 300 Tilmicosin 300 mg/ml Solution for injection Cattle Subcutaneous injection Hungary Eli Lilly Regional Operations GmbH Elanco Animal Health Kölblgasse 8-10 1030 Vienna AUSTRIA Micotil 300 injekció Tilmicosin 300 mg/ml Solution for injection Cattle Subcutaneous injection Ireland Eli Lilly and Company Ltd Priestley Road Basingstoke Hampshire RG24 9NL UNITED KINGDOM Micotil 300 mg/ml Solution for Injection Tilmicosin 300 mg/ml Solution for injection Cattle, sheep Subcutaneous injection Italy ELI LILLY ITALIA S.p.A. Via A. Gramsci, 731/733 Sesto Fiorentino ITALY Micotil 300 Tilmicosin 300 mg/ml Solution for injection Cattle, sheep rabbit Subcutaneous injection The Netherlands Eli Lilly Nederland B.V./Elanco AnimalHealth Grootslag 1-5 3991 RA Houten THE NETHERLANDS MICOTIL 300 INJECTIE Tilmicosin 300 mg/ml Solution for injection Cattle, sheep Subcutaneous injection Portugal Lilly Portugal – Produtos Farmacêuticos, Lda. Rua Cesário Verde, 5 – piso 4 Linda-a-Pastora 2790-326 QUEIJAS PORTUGAL Micotil 300 mg/ml solução injectável Tilmicosin 300 mg/ml Solution for injection Cattle Subcutaneous injection United Kingdom Eli Lilly & Company Ltd Elanco Animal Health Lilly House Priestley Road Basingstoke RG24 9NL UNITED KINGDOM Micotil 300 mg/ml Solution for Injection Tilmicosin 300 mg/ml Solution for injection Cattle, sheep Subcutaneous injection

ANNEX VI LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Invented Name Strength Pharmaceutical form Route of administration Content (concentration) Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 AT-1020 Wien Austria Sandimmun 50 mg – Konzentrat zur Infusionsbereitung 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Belgium N.V. Novartis Pharma S.A. Medialaan 40, bus 1 B-1800 Vilvoorde Belgium SANDIMMUN 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Czech Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Prague 4 - Nusle Czech Republic Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 Copenhagen Denmark Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Finland Novartis Finland OY Metsänneidonkuja 10 FI-02130 Espoo Finland Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml France Novartis Pharma S.A.S. 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France SANDIMMUN 25 mg Capsule, soft Oral use France Novartis Pharma S.A.S. 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France SANDIMMUN 50 mg Capsule, soft Oral use France Novartis Pharma S.A.S. 2- 4, rue Lionel Terray 92500 RUEIL-MALMAISON, France SANDIMMUN 100 mg Capsule, soft Oral use France Novartis Pharma S.A.S. 2- 4, rue Lionel Terray 92500 RUEIL-MALMAISON, France SANDIMMUN 100 mg/ml Oral solution Oral use 100 mg/ml France Novartis Pharma S.A.S. 2- 4, rue Lionel Terray 92500 RUEIL-MALMAISON, France SANDIMMUN 50 mg/ml Solution for infusion Intravenous use 50 mg/ml Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 25 mg Weichkapseln 25 mg Capsule, soft Oral use Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 100 mg Weichkapseln 100 mg Capsule, soft Oral use Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 100 mg/ml Lösung zum Einnehmen 100 mg/ml Oral solution Oral use 100 mg/ml Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Immunosporin 25 mg Weichkapseln 25 mg Capsule, soft Oral use Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Immunosporin 50 mg Weichkapseln 50 mg Capsule, soft Oral use Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Immunosporin 100 mg Weichkapseln 100 mg Capsule, soft Oral use Greece Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens Greece SANDIMMUN 250 mg/5 ml amp Concentrate for solution for infusion Intravenous use 50 mg/ml Greece Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens Greece SANDIMMUN 50 mg/ml amp Concentrate for solution for infusion Intravenous use 50 mg/ml Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út 43-47 H-1114 Budapest Hungary Sandimmun 50 mg/ml koncentrátum oldatos infúzióhoz 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Iceland Novartis Healthcare A/S Edward Thomsens Vej 14 2003 Köbenhavn S Denmark Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun 25 mg Capsule, soft Oral use Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun 50 mg Capsule, soft Oral use Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun 100 mg Capsule, soft Oral use Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun 100 mg/ml Oral Solution Oral use 100 mg/ml Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun 50 mg/1 ml Concentrate for solution for infusion Intravenous use 50 mg/ml Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom SANDIMMUN 25 mg Capsule, soft Oral use Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom SANDIMMUN 50 mg Capsule, soft Oral use Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom SANDIMMUN 100 mg Capsule, soft Oral use Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom SANDIMMUN 100 mg/ml Oral solution Oral use 100 mg/ml Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom SANDIMMUN 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Luxembourg Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 25 mg Weichkapseln 25 mg Capsule, soft Oral use Luxembourg Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 100 mg Weichkapseln 100 mg Capsule, soft Oral use Luxembourg Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 100 mg/ml Lösung zum Einnehmen 100 mg/ml Oral solution Oral use 100 mg/ml Luxembourg Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Netherlands Novartis Pharma B.V. Raapopseweg 1 6824 DP Arnhem The Netherlands Sandimmune, concentraat voor oplossing voor intraveneuze infusie 50 mg/ml 50 mg/ml Concentrate for solution for intravenous infusion Intravenous use 50 mg/ml Norway Novartis Norge AS Nydalen Alle 37A P.O Box 4284 Nydalen, N-0401 Oslo Norway Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Poland Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous 50 mg/ml Portugal Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P-2710-444 Sintra Portugal Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Slovak Republic Novartis s.r.o. Na Pankráci 1724/129 Prague 140 00 Czech Republic Sandimmun 50 mg/ml 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Slovenia Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 50 mg/ml koncentrat za raztopino za infundiranje 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Spain Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes, 764 E-08013 Barcelona Spain Sandimmun 50 mg/ml concentrado para solución para perfusión 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Spain Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes, 764 E-08013 Barcelona Spain Sandimmun 250 mg/5 ml concentrado para solución para perfusión 250 mg/5 ml Concentrate for solution for infusion Intravenous use 50 mg/ml Sweden Novartis Sverige AB Kemistvägen 1B / Box 1150 SE-183 11 Täby Sweden Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom SANDIMMUN Soft Gelatin Capsules 25 mg 25 mg Capsule, soft Oral use United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom SANDIMMUN Soft Gelatin Capsules 50 mg 50 mg Capsule, soft Oral use United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom SANDIMMUN Soft Gelatin Capsules 100 mg 100 mg Capsule, soft Oral use United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom SANDIMMUN Oral Solution 100 mg/ml Oral solution Oral use 100 mg/ml United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom SANDIMMUN Concentrate for Solution for Infusion 50 mg/ml 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml

ANNEX VII LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Invented Name Strength Pharmaceutical form Route of administration Content (concentration) Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 AT-1020 Wien Austria Sandimmun - Neoral 10 mg Kapseln 10 mg Capsule, soft Oral use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 AT-1020 Wien Austria Sandimmun - Neoral 25 mg Kapseln 25 mg Capsule, soft Oral use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 AT-1020 Wien Austria Sandimmun - Neoral 50 mg Kapseln 50 mg Capsule, soft Oral use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 AT-1020 Wien Austria Sandimmun - Neoral 100 mg Kapseln 100 mg Capsule, soft Oral use Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 AT-1020 Wien Austria Sandimmun - Neoral 100 mg/ml - Trinklösung 100 mg/ml Oral solution Oral use 100 mg/ml Belgium N.V. Novartis Pharma S.A. Medialaan 40, B-1800 Vilvoorde Belgium Neoral - Sandimmun 10 mg 10 mg Capsule Oral use Belgium N.V. Novartis Pharma S.A. Medialaan 40, B-1800 Vilvoorde Belgium Neoral-Sandimmun 100 mg 100 mg Capsule Oral use Belgium N.V. Novartis Pharma S.A. Medialaan 40, B-1800 Vilvoorde Belgium Neoral - Sandimmun 25 mg 25 mg Capsule Oral use Belgium N.V. Novartis Pharma S.A. Medialaan 40, B-1800 Vilvoorde Belgium Neoral - Sandimmun 50 mg 50 mg Capsule Oral use Belgium N.V. Novartis Pharma S.A. Medialaan 40, B-1800 Vilvoorde Belgium Neoral-Sandimmun 100 mg/ml 100 mg/ml Oral solution Oral use 100 mg/ml Bulgaria Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg Germany Sandimmun Neoral 25 mg capsule 25 mg Capsule, soft Oral use Bulgaria Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg Germany Sandimmun Neoral 50 mg capsule 50 mg Capsule, soft Oral use Bulgaria Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg Germany Sandimmun Neoral 100 mg capsule 100 mg Capsule, soft Oral use Bulgaria Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg Germany Sandimmun Neoral 100 mg/ml oral solution 100 mg/ml Oral solution Oral use 100 mg/ml – 50 ml Cyprus Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun Neoral 25 mg 25 mg Capsule, soft Oral use Cyprus Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun Neoral 50 mg 50 mg Capsule, soft Oral use Cyprus Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun Neoral 100 mg 100 mg Capsule, soft Oral use Cyprus Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun Neoral Oral Solution 100 mg/ ml 100 mg/ml Oral Solution Oral use 100 mg/ml Czech Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Prague 4 - Nusle Czech Republic Sandimmun Neoral 25 mg 25 mg Capsule, soft Oral use Czech Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Prague 4 - Nusle Czech Republic Sandimmun Neoral 50 mg 50 mg Capsule, soft Oral use Czech Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Prague 4 - Nusle Czech Republic Sandimmun Neoral 100 mg 100 mg Capsule, soft Oral use Czech Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Prague 4 - Nusle Czech Republic Sandimmun Neoral 100 mg/ml 100 mg/ml Oral solution Oral use 100 mg/ml Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 Copenhagen Denmark Sandimmun Neoral 10 mg Capsule, soft Oral use Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 Copenhagen Denmark Sandimmun Neoral 25 mg Capsule, soft Oral use Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 Copenhagen Denmark Sandimmun Neoral 50 mg Capsule, soft Oral use Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 Copenhagen Denmark Sandimmun Neoral 100 mg Capsule, soft Oral use Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 Copenhagen Denmark Sandimmun Neoral 100 mg/ml Oral solution Oral use 100 mg/ml Estonia Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finland Sandimmun Neoral 25 mg Capsule, soft Oral use Estonia Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finland Sandimmun Neoral 50 mg Capsule, soft Oral use Estonia Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finland Sandimmun Neoral 100 mg Capsule, soft Oral use Finland Novartis Finland OY Metsänneidonkuja 10 FI-02130 Espoo Finland Sandimmun Neoral 25 mg Capsule, soft Oral use Finland Novartis Finland OY Metsänneidonkuja 10 FI-02130 Espoo Finland Sandimmun Neoral 50 mg Capsule, soft Oral use Finland Novartis Finland OY Metsänneidonkuja 10 FI-02130 Espoo Finland Sandimmun Neoral 100 mg Capsule, soft Oral use Finland Novartis Finland OY Metsänneidonkuja 10 FI-02130 Espoo Finland Sandimmun Neoral 100 mg/ml Oral solution Oral use 100 mg/ml France Novartis Pharma S.A.S. 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France NEORAL 10 mg Capsule, soft Oral use France Novartis Pharma S.A.S. 2- 4, rue Lionel Terray 92500 RUEIL-MALMAISON, France NEORAL 25 mg Capsule, soft Oral use France Novartis Pharma S.A.S. 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France NEORAL 50 mg Capsule, soft Oral use France Novartis Pharma S.A.S. 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France NEORAL 100 mg Capsule, soft Oral use France Novartis Pharma S.A.S. 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France NEORAL 100 mg/ml Oral solution Oral use 100 mg/ml Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Optoral 10 mg Weichkapseln 10 mg Capsule, soft Oral use Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Optoral 25 mg Weichkapseln 25 mg Capsule, soft Oral use Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Optoral 50 mg Weichkapseln 50 mg Capsule, soft Oral use Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Optoral 100 mg Weichkapseln 100 mg Capsule, soft Oral use Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Optoral 100 mg/ml Lösung zum Einnehmen 100 mg/ml Oral solution Oral use 100 mg/ml Greece Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens Greece SANDIMMUN NEORAL 25 mg/cap Capsule, soft Oral use Greece Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens Greece SANDIMMUN NEORAL 50 mg/cap Capsule, soft Oral use Greece Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens Greece SANDIMMUN NEORAL 100 mg/cap Capsule, soft Oral use Greece Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens Greece SANDIMMUN NEORAL 500 mg/5 ml Oral solution Oral use 100 mg/ml Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út 43-47 H-1114 Budapest Hungary Sandimmun Neoral 10 mg lágy kapszula 10 mg Capsule, soft Oral use Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út 43-47 H-1114 Budapest Hungary Sandimmun Neoral 25 mg lágy kapszula 25 mg Capsule, soft Oral use Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út 43-47 H-1114 Budapest Hungary Sandimmun Neoral 50 mg lágy kapszula 50 mg Capsule, soft Oral use Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út 43-47 H-1114 Budapest Hungary Sandimmun Neoral 100 mg lágy kapszula 100 mg Capsule, soft Oral use Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út 43-47 H-1114 Budapest Hungary Sandimmun Neoral 100 mg/ml belsőleges oldat 100 mg/ml Oral solution Oral use 100 mg/ml Iceland Novartis Healthcare A/S Edward Thomsens Vej 14 2003 Köbenhavn S Denmark Sandimmun Neoral 25 mg Capsule, soft Oral use Iceland Novartis Healthcare A/S Edward Thomsens Vej 14 2003 Köbenhavn S Denmark Sandimmun Neoral 50 mg Capsule, soft Oral use Iceland Novartis Healthcare A/S Edward Thomsens Vej 14 2003 Köbenhavn S Denmark Sandimmun Neoral 100 mg Capsule, soft Oral use Iceland Novartis Healthcare A/S Edward Thomsens Vej 14 2003 Köbenhavn S Denmark Sandimmun Neoral 100 mg/ml Oral solution Oral use 100 mg/ml Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Neoral 25 mg Capsule, soft Oral use Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Neoral 50 mg Capsule, soft Oral use Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Neoral 100 mg Capsule, soft Oral use Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Neoral 100 mg/ml Oral solution Oral use 100 mg/ml Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom Sandimmun Neoral 10 mg Capsule, soft Oral use Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom Sandimmun Neoral 25 mg Capsule, soft Oral use Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom Sandimmun Neoral 50 mg Capsule, soft Oral use Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom Sandimmun Neoral 100 mg Capsule, soft Oral use Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom Sandimmun Neoral 100 mg/ml Oral solution Oral use 100 mg/ml Latvia Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finland Sandimmun Neoral 25 mg mīkstās kapsulas 25 mg Capsule, soft Oral use Latvia Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finland Sandimmun Neoral 50 mg mīkstās kapsulas 50 mg Capsule, soft Oral use Latvia Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finland Sandimmun Neoral 100 mg mīkstās kapsulas 100 mg Capsule, soft Oral use Lithuania Novartis Finland Oy Metsänneidonkuja 10 FIN-02130 Espoo Finland Sandimmun Neoral 25 mg Capsule, soft Oral use Lithuania Novartis Finland Oy Metsänneidonkuja 10 FIN-02130 Espoo, Finland Sandimmun Neoral 50 mg Capsule, soft Oral use Lithuania Novartis Finland Oy Metsänneidonkuja 10 FIN-02130 Espoo Finland Sandimmun Neoral 100 mg Capsule, soft Oral use Luxembourg Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Optoral 10 mg Weichkapseln 10 mg Capsule, soft Oral use Luxembourg Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Optoral 25 mg Weichkapseln 25 mg Capsule, soft Oral use Luxembourg Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Optoral 50 mg Weichkapseln 50 mg Capsule, soft Oral use Luxembourg Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Optoral 100 mg Weichkapseln 100 mg Capsule, soft Oral use Luxembourg Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Optoral 100 mg/ml Lösung zum Einnehmen 100 mg/ml Oral solution Oral use 100 mg/ml Malta Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun Neoral 25 mg Capsule, soft Oral use Malta Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun Neoral 100 mg Capsule, soft Oral use Malta Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun Neoral 100 mg/ml Oral Solution Oral use 100 mg/ml Netherlands Novartis Pharma B.V. Raapopseweg 1 6824 DP Arnhem The Netherlands Neoral 25 mg, capsules 25 mg Capsule, soft Oral use Netherlands Novartis Pharma B.V. Raapopseweg 1 6824 DP Arnhem The Netherlands Neoral 100 mg, capsules 100 mg Capsule, soft Oral use Netherlands Novartis Pharma B.V. Raapopseweg 1 6824 DP Arnhem The Netherlands Neoral 100 mg/ml, drank 100 mg/ml Oral Solution Oral use 100 mg/ml Norway Novartis Norge AS Nydalen Alle 37A P.O Box 4284 Nydalen, N-0401 Oslo Norway Sandimmun Neoral 25 mg Capsule, soft Oral use Norway Novartis Norge AS Nydalen Alle 37A P.O Box 4284 Nydalen, N-0401 Oslo Norway Sandimmun Neoral 50 mg Capsule, soft Oral use Norway Novartis Norge AS Nydalen Alle 37A P.O Box 4284 Nydalen, N-0401 Oslo Norway Sandimmun Neoral 100 mg Capsule, soft Oral use Norway Novartis Norge AS Nydalen Alle 37A P.O Box 4284 Nydalen, N-0401 Oslo Norway Sandimmun Neoral 100 mg/ml Oral solution Oral use 100 mg/ml Poland Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Neoral 10 mg Capsule, soft Oral use Poland Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Neoral 25 mg Capsule, soft Oral use Poland Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Neoral 50 mg Capsule, soft Oral use Poland Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Neoral 100 mg Capsule, soft Oral use Poland Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun Neoral 100 mg/ml Oral solution Oral use 100 mg/ml Portugal Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P-2710-444 Sintra Portugal Sandimmun Neoral 25 mg Capsule, soft Oral use Portugal Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P-2710-444 Sintra Portugal Sandimmun Neoral 50 mg Capsule, soft Oral use Portugal Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P-2710-444 Sintra Portugal Sandimmun Neoral 100 mg Capsule, soft Oral use Portugal Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P-2710-444 Sintra Portugal Sandimmun Neoral 100 mg/ml Oral solution Oral use 100 mg/ml Romania Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany SANDIMMUN NEORAL capsule moi, 25 mg 25 mg Capsule, soft Oral use Romania Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany SANDIMMUN NEORAL,capsule moi, 50 mg 50 mg Capsule, soft Oral use Romania Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany SANDIMMUN NEORAL, solutie orala, 100 mg/ml 100 mg/ml Oral solution Oral use 100 mg/ml Slovak Republic Novartis s.r.o. Na Pankráci 1724/129 Prague 140 00 Czech Republic Sandimmun Neoral 25 mg 25 mg Capsule, soft Oral use Slovak Republic Novartis s.r.o. Na Pankráci 1724/129 Prague 140 00 Czech Republic Sandimmun Neoral 50 mg 50 mg Capsule, soft Oral use Slovak Republic Novartis s.r.o. 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