EN Official Journal of the European Union C 383/17

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2011 to 31 October 2011

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

2011/C 383/02

— 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 7.10.2011 Norvasc and associated names See Annex I See Annex I 10.10.2011 20.10.2011 Synulox Lactating Cow Art 34 See Annex II See Annex II 21.10.2011 13.9.2011 Dexrazoxane - Art 31 See Annex III See Annex III 15.9.2011 2.9.2011 Diflucan and associated names - Art 30 See Annex IV See Annex IV 5.9.2011 24.10.2011 Dexamethasone Alapis - Art 29 See Annex V See Annex V 25.10.2011





— Refusal 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 22.9.2011 Canazole Clotrimazole Cream 1 % w/w - Art. 29 See Annex VI See Annex VI 23.9.2011





— 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 22.9.2011 Canazole Clotrimazole Cream 1 % w/w - Art. 29 See Annex VI See Annex VI 23.9.2011 16.9.2011 Goserelin cell pharm 3,6 mg Implantat and associated names See Annex VII See Annex VII 20.9.2011 16.9.2011 Novimp 3,6 mg Implantat and associated names - Ref. Art.36 See Annex VIII See Annex VIII 19.9.2011 16.9.2011 Novosis Goserelin 3,6 mg Implantat and associated names See Annex IX See Annex IX 19.9.2011

(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 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 Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 A - 1210 Wien Austria Norvasc 5 mg - Tabletten 5 mg Tablet Oral use Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 A - 1210 Wien Austria Norvasc 10 mg - Tabletten 10 mg Tablet Oral use Belgium Pfizer SA Boulevard de la Plaine 17, B-1050 Brussels Belgium Amlor 5 mg Capsule, Hard Oral use Belgium Pfizer SA Boulevard de la Plaine 17, B-1050 Brussels Belgium Amlor 10 mg Capsule, Hard Oral use Bulgaria Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 5 mg Tablet Oral use Bulgaria Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 10 mg Tablet Oral use Cyprus Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece Norvasc 5 mg Capsule, Hard Oral use Cyprus Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece Norvasc 10 Capsule, Hard Oral use Denmark Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Denmark Norvasc 5 mg Tablet Oral use Denmark Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Denmark Norvasc 10 mg Tablet Oral use Denmark Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Denmark Amlodipine Pfizer 5 mg Tablet Oral use Denmark Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Denmark Amlodipine Pfizer 10 mg Tablet Oral use Estonia Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 5 mg Tablet Oral use Estonia Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 10 mg Tablet Oral use Finland Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland Norvasc 5 mg Tablet Oral use Finland Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland Norvasc 10 mg Tablet Oral use France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France Amlor 5 mg Capsule, Hard Oral use France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France Amlor 10 mg Capsule, Hard Oral use Germany Pfizer Pharma GmbH, Linkstraße 10 10785 Berlin, Germany Norvasc 5 mg 5 mg Tablet Oral use Germany Pfizer Pharma GmbH, Linkstraße 10 10785 Berlin, Germany Norvasc 10 mg 10 mg Tablet Oral use Greece Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece Norvasc 5 mg Capsule, Hard Oral use Greece Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece Norvasc 10 mg Capsule, Hard Oral use Hungary Pfizer KFT, Budapest, Alkotás u. 53 1123 Hungary Norvasc 5 mg Tablet Oral use Hungary Pfizer KFT, Budapest, Alkotás u. 53 1123 Hungary Norvasc 10 mg Tablet Oral use Iceland Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Denmark Norvasc 5 mg Tablet Oral use Iceland Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Denmark Norvasc 10 mg Tablet Oral use Ireland Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Istin 5 mg Tablet Oral use Ireland Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Istin 10 mg Tablet Oral use Ireland Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Amlodipine besilate 5 mg tablets 5 mg Tablet Oral use Ireland Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Amlodipine besilate 10 mg tablets 10 mg Tablet Oral use Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina – Italy Norvasc 5 mg Tablet Oral use Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina, Italy Norvasc 10 mg Tablet Oral use Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina, Italy Monopina 5 mg Tablet Oral use Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina – Italy Monopina 10 mg Tablet Oral use Latvia Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom Norvasc 5 mg tabletes 5 mg Tablet Oral use Latvia Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom Norvasc 10 mg tabletes 10 mg Tablet Oral use Lithuania Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 5 mg Tablet Oral use Lithuania Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 10 mg Tablet Oral use Lithuania Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 5 mg Capsule, Hard Oral use Lithuania Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 10 mg Capsule, Hard Oral use Luxembourg Pfizer SA Boulevard de la Plaine 17 B-1050 Brussels, Belgium Amlor 5 mg Capsule, Hard Oral use Luxembourg Pfizer SA Boulevard de la Plaine 17 B-1050 Brussels, Belgium Amlor 10 mg Capsule, Hard Oral use Malta Pfizer Hellas S.A. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece Istin 5 mg Tablet Oral use Malta Pfizer Hellas S.A. 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece Istin 10 mg Tablet Oral use Netherlands Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands Norvasc 5 5 mg Tablet Oral use Netherlands Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands Norvasc 10 10 mg Tablet Oral use Norway Pfizer AS Pb. 3 1324 Lysaker Norway Norvasc 5 mg Tablet Oral use Norway Pfizer AS Pb. 3 1324 Lysaker Norway Norvasc 10 mg Tablet Oral use Poland Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 5 mg Tablet Oral use Poland Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 10 mg Tablet Oral use Portugal Laboratorios Pfizer, Lda., Lagoas Park, Edifício 10, 2740-271 Porto Salvo, Portugal Norvasc 5 mg Tablet Oral use Portugal Laboratorios Pfizer, Lda., Lagoas Park, Edifício 10, 2740-271 Porto Salvo, Portugal Norvasc 10 mg Tablet Oral use Romania Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 5 mg capsule 5 mg Capsule, Hard Oral use Romania Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 10 mg capsule 10 mg Capsule, Hard Oral use Romania Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 5 mg 5 mg Tablet Oral use Romania Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 10 mg 10 mg Tablet Oral use Slovak Republic Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 5 mg Tablet Oral use Slovak Republic Pfizer Europe MA EEIG, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Norvasc 10 mg Tablet Oral use Slovenia Pfizer Luxembourg SARL, 51, Avenue J. F. Kennedy, L-1855 Luxembourg Norvasc 5 mg tablete 5 mg Tablet Oral use Slovenia Pfizer Luxembourg SARL, 51, Avenue J. F. Kennedy, L-1855 Luxembourg Norvasc 10 mg tablete 10 mg Tablet Oral use Spain PFIZER, S.A. Av. De Europa, 20-B Parque Empresarial “La Moraleja” 28108 ALCOBENDAS Madrid, Spain Norvas 5 mg comprimidos 5 mg Tablet Oral use Spain PFIZER, S.A. Av. De Europa, 20-B Parque Empresarial “La Moraleja” 28108 ALCOBENDAS Madrid, Spain Norvas 10 mg comprimidos 10 mg Tablet Oral use Spain PHARMACIA GRUPO PFIZER, S.L. Av. De Europa, 20-B Parque Empresarial “La Moraleja” 28108 ALCOBENDAS Madrid, Spain Amlodipino Pharmacia 5 mg comprimidos 5 mg Tablet Oral use Spain PHARMACIA GRUPO PFIZER, S.L. Av. De Europa, 20-B Parque Empresarial “La Moraleja” 28108 ALCOBENDAS Madrid, Spain Amlodipino Pharmacia 10 mg comprimidos 10 mg Tablet Oral use Sweden Pfizer AB 19190 Sollentuna Sweden Norvasc 5 mg Tablet Oral use Sweden Pfizer AB 191 90 Sollentuna Sweden Norvasc 10 mg Tablet Oral use United Kingdom Pfizer Limited, Ramsgate Road, Sandwich, United Kingdom Istin 5 mg Tablet Oral use United Kingdom Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Istin 10 mg Tablet Oral use

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, WITHDRAWAL PERIOD, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing Authorisation Holder Name INN Strengths Pharmaceutical form Animal species Withdrawal period (meat and milk) Austria Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria Synulox comp - Injektoren für Kühe Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat and offal: 4 days, milk: 3 days Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Bulgaria Pfizer Animal Health MA EEIG Ramstage Road Sandwich Kent CT13 9NJ United Kingdom Synulox Lactating Cow Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat: 7 days Milk: 60 hours In combination with SYNULOX RTU: Meat: 42 days. Milk: 60 hours. Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Cyprus PFIZER HELLAS AE Mesogeion Ave. 243 154 51 Neo Psichiko Athens Greece SYNULOX LC Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Edible tissues: 4 days Milk: 72 Hours Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Czech Republic Pfizer, spol. s r.o. Veterinární divize – Anumal Health Stroupežnického 17 150 00 Praha 5 Czech Republic SYNULOX LC 260 mg intramam. suspension for cattle Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat: 7 days Milk 84 hours (7 milkings) Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg France PFIZER 23/25 Avenue Du Docteur Lannelongue 75014 Paris France SYNULOX INTRAMAMMAIRE Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat: 7 days Milk: 2 days Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Greece PFIZER HELLAS A.E Mesogion Av 242 154 51 N. Psichiko Greece SYNULOX LC Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat: 3 days Milk: 72 hours Clavulanic acid (as potassium clavulanate) 10 mg Prednisolone 50 mg Hungary Pfizer Kft. Budapest Alkotás u. 53. 1123 Hungary SYNULOX LC tőgyinfúzió Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Edible tissues: 4 days Milk: 60 hours Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Ireland Pfizer Healthcare Ireland, Trading as Pfizer Animal Health Ringaskiddy County Cork Ireland Synulox Lactating Cow Intramammary suspension. Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat and offal: 7 Days Milk: 60 Hours Meat: 7 days Milk (cows milked twice daily): 60 hours (i.e. at the 5th milking) after the last treatment. When any other milking routine is followed milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk for human consumption may only be taken at the 8th milking). In combination with SYNULOX RTU: Meat: 42 days. Milk: 80 hours. Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Italy PFIZER ITALIA Via Valbiondone 113 00188 Roma Italy SYNULOX ENDOMAMMARIO Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat: 4 days Milk: 108 hours Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Latvia Pfizer Animal Health MA EEIG Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom Synulox LC Suspensija ievadīšanai tesmenī laktējošām govīm Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat: 7 days Milk (cows milked twice daily): 60 hours (i.e. at the 5th milking) after the last treatment. When any other milking routine is followed milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk for human consumption may only be taken at the 8th milking). In combination with SYNULOX RTU: Meat: 42 days. Milk: 60 hours. Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Lithuania Pfizer Animal Health MA EEIG Ramstage Road Sandwich Kent CT13 9NJ United Kingdom SYNULOX LC, intramaminė suspensija Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat: 7 days Milk: 60 hours In combination with SYNULOX RTU: Meat: 42 days. Milk: 60 hours. Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Norway Pfizer Oy Animal Health Tietokuja 4 00330 Helsinki Finland Synulox comp. vet Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary emulsion Cattle Meat: 6 days Milk: 5 days Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Poland Pfizer Trading Polska Sp. z o. o. ul. Rzymowskiego 34 02-697 Warszawa Poland SYNULOX L.C. (200 mg + 50 mg + 10 mg)/3 g, zawiesina dowymieniowa, bydło Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat and offal: 4 days Milk: 60 hours Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Portugal Laboratórios Pfizer, Lda Lagoas Park -Edifício 10 Porto Salvo 2470 Oeiras Portugal SYNULOX LC suspensão intramamária para bovinos em lactação Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat and offal: 14 days Milk: 2 days Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Romania Pfizer Animal Health MA EEIG Ramstage Road Sandwich Kent CT13 9NJ United Kingdom SYNULOX LC, amoxicilină, acid clavulanic, prednisolon, suspensie intramamara pentru vaci in lactatie Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat and offal: 7 days Milk: 60 hours In combination with SYNULOX RTU: Meat: 42 days. Milk: 14 days. Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Slovak Republic Pfizer Luxembourg SARL, o.z. Pfizer AH Pribinova 25 811 09 Bratislava Slovak Republic Synulox LC 260 mg intramammary suspension Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat: 7 days Milk: 84 hours (7 milkings) Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Slovenia PFIZER Luxembourg SARL 51,Avenue J.F.Kennedy 1855 Luxembourg SYNULOX LC intramamarna suspenzija za krave v laktaciji Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat and offal: 7 days Milk: 60 hours Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg Spain PFIZER, S.A. Avd. Europa 20-B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain SYNULOX LC Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat: 7 days Milk: 60 hours or 5 milking Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg The Netherlands Pfizer Rivium Westlaan 142 2909 LD Capelle a/d Ijssel The Netherlands Avuloxil Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat: 7 days Milk: 4 days Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg United Kingdom Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Synulox Lactating Cow Intramammary Suspension Amoxicillin (as amoxicillin trihydrate) 200 mg Intramammary suspension Cattle Meat: 7 days Milk (cows milked twice daily): 60 hours (i.e. at the 5th milking) after the last treatment. When any other milking routine is followed milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk for human consumption may only be taken at the 8th milking). In combination with SYNULOX RTU: Meat: 42 days. Milk: 60 hours. Clavulanic acid (as potassium clavulanate) 50 mg Prednisolone 10 mg

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 Product name Strength Pharmaceutical form Route of administration Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A 1020 Wien Austria Cardioxane 500 mg - Pulver zur Herstellung einer Infusionslösung 500 mg Powder for solution for infusion Intravenous use Austria CYATHUS EXQUIRERE Pharmaforschungs GmbH Rudolfsplatz 2/8 1010 Wien Austria Cyrdanax 20 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung 20 mg Powder for solution for infusion Intravenous use Austria CYATHUS EXQUIRERE Pharmaforschungs GmbH Rudolfsplatz 2/8 1010 Wien Austria Enaxozar 20 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung 20 mg Powder for solution for infusion Intravenous use Czech Republic Novartis s.r.o. GEMINI, budova B Na Pankráci 1724 / 129 CZ-140 00 Praha 4 Czech Republic Cardioxane 500 mg Powder for solution for injection Intravenous use Czech Republic CYATHUS EXQUIRERE Pharmaforschungs GmbH Rudolfsplatz 2/8 1010 Wien Austria Cyrdanax 20 mg/ml prášek pro přípravu infuzního roztoku 20 mg Powder for solution for injection Intravenous use Germany Novartis Pharma GmbH Roonstr. 25 D-90429 Nürnberg Germany CARDIOXANE 500 mg, Pulver zur Herstellung einer Infusionslösung 500 mg Powder for solution for infusion Intravenous (not otherwise specified) Germany CYATHUS EXQUIRERE Pharmaforschungs GmbH Rudolfsplatz 2/8 1010 Wien Austria Cyrdanax 20 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung 20 mg Powder for solution for injection Intravenous use Germany CYATHUS EXQUIRERE Pharmaforschungs GmbH Rudolfsplatz 2/8 1010 Wien Austria Enaxozar 20 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung 20 mg Powder for solution for injection Intravenous use Denmark Novartis Healthcare A/S, Lyngbyvej 172 DK-2100 Copenhagen Ø Denmark Cardioxane 500 mg Powder for solution for infusion Intravenous use Greece NOVARTIS (HELLAS) A.E.B.E. 12 km National Highway No 1 Metamorfosi Attikis 14451 Greece CARDIOXANE 500 mg/vial Powder for solution for infusion Intravenous use Spain NOVARTIS FARMACEUTICA, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona Spain CARDIOXANE 500 mg polvo para solucion para perfusion 500 mg Powder for solution for infusion Intravenous use Finland Novartis Finland Oy, Metsänneidonkuja 10 02130 Espoo Finland Cardioxane 500 mg powder for solution for infusion Intravenous use France NOVARTIS PHARMA SAS 2-4, rue Lionel Terray 92500 Rueil-Malmaison FRANCE CARDIOXANE 500 mg, poudre pour solution pour perfusion 500 mg powder for solution for infusion Intravenous use France CYATHUS EXQUIRERE Pharmaforschungs GmbH Rudolfsplatz 2/8 1010 Wien Austria DEXRAZOXANE CYATHUS 20 mg/ml, poudre pour solution pour perfusion 20 mg Powder for solution for injection Intravenous use Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út 43-47. (Bartók-Ház, V. em.) 1114 Budapest Hungary CARDIOXANE 500 mg Powder for solution for infusion Intravenous use Hungary CYATHUS EXQUIRERE Pharmaforschungs GmbH Rudolfsplatz 2/8 1010 Wien Austria Procard 20 mg/ml Por oldatos infúzióhoz 20 mg Powder for solution for injection Intravenous use Ireland MAH: Novartis Pharmaceuticals UK, Frimley Business Park, Frimley, Camberley, Surrey Gu16 7SR United Kingdom Mailing address: Novartis Ireland Ltd Beech House, Beech Hill Office Campus Clonskeagh Dublin 4 Ireland Cardioxane 500 mg Powder for solution for infusion Intravenous use Italy Novartis Farma spa Largo Umberto Boccioni, 121040 Origgio- Varese Italy CARDIOXANE 500 mg powder for solution for infusion Intravenous use Lithuania Novartis Finland Oy Metsänneidonkuja 10 FI-02130 Espoo Finland Cardioxane 500 mg Powder for solution for infusion Intravenous use Luxembourg NOVARTIS PHARMA GMBH 25 ROONSTRASSE 90429 NUERNBERG Germany CARDIOXANE 500 mg POWDER FOR SOLUTION FOR INFUSION Intravenous use Netherlands Novartis Pharma B.V. Raapopseweg 1 6824 DP ARNHEM The Netherlands Cardioxane 500 mg 500 mg powder for solution for infusion Intravenous use Norway Novartis Norge AS Postboks 237 Okern 0510 Oslo Norway Cardioxane 500 mg Powder for solution for infusion injection Poland Novartis Pharma GmbH Roonstarsse 25 D-90429 Nürnberg Germany Cardioxane 500 mg powder for solution for infusion Intravenous use Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Rua do Centro Empresarial, Edifício 8, Quinta da Beloura 2710-444 Sintra Portugal Cardioxane 500 mg powder for solution for infusion Intravenous use Romania CYATHUS EXQUIRERE Pharmaforschungs GmbH Rudolfsplatz 2/8 1010 Wien Austria CYRDANAX 20 mg/ml 20 mg/ml powder for solution for infusion Intravenous use Slovakia Novartis s.r.o. GEMINI, budova B Na Pankráci 1724 / 129 CZ-140 00 Praha 4 Czech Republic CARDIOXANE 500 mg powder for solution for infusion Intravenous use United Kingdom Novartis Pharmaceuticals UK Limted Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Cardioxane 500 mg powder for solution for infusion Intravenous use

ANNEX IV 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 Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 1210 Wien Austria Diflucan 50 mg - Kapseln 50 mg Capsule, Hard Oral use N/A Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 1210 Wien Austria Diflucan 100 mg - Kapseln 100 mg Capsule, Hard Oral use N/A Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 1210 Wien Austria Diflucan 150 mg - Kapseln 150 mg Capsule, Hard Oral use N/A Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 1210 Wien Austria Fungata 150 mg - Kapsel 150 mg Capsule, Hard Oral use N/A Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 1210 Wien Austria Diflucan 200 mg - Kapseln 200 mg Capsule, Hard Oral use N/A Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 1210 Wien Austria Diflucan 50 mg/5 ml - Trockensaft 50 mg/5 ml Powder for oral Suspension Oral use 10 mg/ml Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 1210 Wien Austria Diflucan 200 mg/5 ml - Trockensaft 200 mg/5 ml Powder for oral Suspension Oral use 40 mg/ml Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 1210 Wien Austria Diflucan 100 mg - Infusionsflaschen 100 mg/50 ml Solution for Infusion Intravenous use 2 mg/ml Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 1210 Wien Austria Diflucan 200 mg - Infusionsflaschen 200 mg/100 ml Solution for Infusion Intravenous use 2 mg/ml Austria Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstrasse 1 1210 Wien Austria Diflucan 400 mg - Infusionsflaschen 400 mg/200 ml Solution for Infusion Intravenous use 2 mg/ml Belgium Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 50 mg Capsule, Hard Oral use N/A Belgium Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 100 mg Capsule, Hard Oral use N/A Belgium Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 150 mg Capsule, Hard Oral use N/A Belgium Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 200 mg Capsule, Hard Oral use N/A Belgium Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 50 mg/5 ml Powder for Suspension Oral use 10 mg/ml Belgium Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 200 mg/5 ml Powder for Suspension Oral use 40 mg/ml Belgium Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 200 mg/100 ml Solution for Infusion Intravenous use 2 mg/ml Belgium Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 400 mg/200 ml Solution for Infusion Intravenous use 2 mg/ml Bulgaria Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 50 mg Capsule, Hard Oral use N/A Bulgaria Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 150 mg Capsule, Hard Oral use N/A Bulgaria Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Cyprus Pfizer Hellas A. E. 243, Messoghion Ave. 154 51 Νeo Psychiko Athens Greece Fungustatin 150 mg Capsule, Hard Oral use N/A Cyprus Pfizer Hellas A. E. 243, Messoghion Ave. 154 51 Νeo Psychiko Athens Greece Fungustatin 100 mg/50 ml Solution for Infusion Intravenous use 2 mg/ml Czech Republic Pfizer. s r.o. Stroupežnického 17 150 00 Prague 5 Czech Republic Diflucan 50 mg 50 mg Capsule, Hard Oral use N/A Czech Republic Pfizer. s r.o., Stroupežnického 17 150 00 Prague 5 Czech Republic Diflucan 100 mg 100 mg Capsule, Hard Oral use N/A Czech Republic Pfizer. s r.o., Stroupežnického 17 150 00 Prague 5 Czech Republic Diflucan 150 mg 150 mg Capsule, Hard Oral use N/A Czech Republic Pfizer. s r.o., Stroupežnického 17 150 00 Prague 5 Czech Republic Diflucan I.V. 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Denmark Pfizer ApS, Lautrupvang 8 2750 Ballerup Denmark Diflucan 50 mg Capsule, Hard Oral use N/A Denmark Pfizer ApS, Lautrupvang 8 2750 Ballerup Denmark Diflucan 150 mg Capsule, Hard Oral use N/A Denmark Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Diflucan 200 mg Capsule, Hard Oral use N/A Denmark Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Diflucan 10 mg/ml Powder for Suspension Oral use 10 mg/ml Denmark Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Diflucan 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Estonia Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 150 mg 150 mg Capsule, Hard Oral use N/A Estonia Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 2 mg/ml 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Finland Pfizer Oy Tietokuja 4 00330 Helsinki Finland Diflucan 50 mg Capsule, Hard Oral use N/A Finland Pfizer Oy Tietokuja 4 00330 Helsinki Finland Diflucan 100 mg Capsule, Hard Oral use N/A Finland Pfizer Oy Tietokuja 4 00330 Helsinki Finland Diflucan 150 mg Capsule, Hard Oral use N/A Finland Pfizer Oy Tietokuja 4 00330 Helsinki Finland Diflucan 10 mg/ml Powder for Oral Suspension Oral use 10 mg/ml Finland Pfizer Oy Tietokuja 4 00330 Helsinki, Finland Diflucan 40 mg/ml Powder for Oral Suspension Oral use 40 mg/ml Finland Pfizer Oy, Tietokuja 4 00330 Helsinki Finland Diflucan 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France Fluconazole Pfizer 50 mg Capsule, Hard Oral use N/A France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France Triflucan 50 mg Capsule, Hard Oral use N/A France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France Fluconazole Pfizer 100 mg Capsule, Hard Oral use N/A France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France Triflucan 100 mg Capsule, Hard Oral use N/A France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France Fluconazole Pfizer 150 mg Capsule, Hard Oral use N/A France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France Fluconazole Pfizer 200 mg Capsule, Hard Oral use N/A France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France Triflucan 200 mg Capsule, Hard Oral use N/A France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France Fluconazole Pfizer 50 mg/5 ml Powder for Oral Suspension Oral use 10 mg/ml France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France Triflucan 50 mg/5 ml Powder for Oral Suspension Oral use 10 mg/ml France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France Triflucan 200 mg/5 ml Powder for Oral Suspension Oral use 40 mg/ml France Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014 Paris France Triflucan 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Diflucan 50 mg Capsule, Hard Oral use N/A Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Diflucan Derm 50 mg Capsule, Hard Oral use N/A Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Diflucan 100 mg Capsule, Hard Oral use N/A Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Diflucan 200 mg Capsule, Hard Oral use N/A Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Fungata 150 mg Capsule, Hard Oral use N/A Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Diflucan Trockensaft 50 mg/5 ml Powder for Suspension Oral use 10 mg/ml Germany Pfizer Pharma GmbH, Linkstraße 10 10785 Berlin Germany Diflucan i.v.-100 mg 100 mg/50 ml Solution for Infusion Intravenous use 2 mg/ml Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Diflucan i.v.-200 mg 200 mg/100 ml Solution for Infusion Intravenous use 2 mg/ml Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Diflucan i.v.-400 mg 400 mg/200 ml Solution for Infusion Intravenous use 2 mg/ml Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Diflucan Derm Saft 5 mg/ml Syrup Oral use 5 mg/ml Germany Pfizer Pharma GmbH Linkstraße 10 10785 Berlin Germany Diflucan Saft 5 mg/ml Syrup Oral use 5 mg/ml Greece Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko Athens Greece Fungustatin 50 mg Capsule, Hard Oral use N/A Greece Pfizer Hellas A. E. 243, Messoghion Ave., 154 51 Νeo Psychiko Athens Greece Fungustatin 100 mg Capsule, Hard Oral use N/A Greece Pfizer Hellas A. E. 243, Messoghion Ave. 154 51 Νeo Psychiko, Athens Greece Fungustatin 150 mg Capsule, Hard Oral use N/A Greece Pfizer Hellas A. E. 243, Messoghion Ave. 154 51 Νeo Psychiko Athens Greece Fungustatin 200 mg Capsule, Hard Oral use N/A Greece Pfizer Hellas A. E. 243, Messoghion Ave. 154 51 Νeo Psychiko Athens Greece Fungustatin 50 mg/5 ml Powder for Suspension Oral use 10 mg/ml Greece Pfizer Hellas A. E. 243, Messoghion Ave. 154 51 Νeo Psychiko Athens Greece Fungustatin 200 mg/5 ml Powder for Suspension Oral use 40 mg/ml Greece Pfizer Hellas A. E. 243, Messoghion Ave. 154 51 Νeo Psychiko Athens Greece Fungustatin 100 mg/50 ml Solution for Infusion Intravenous use 2 mg/ml Greece Pfizer Hellas A. E. 243, Messoghion Ave. 154 51 Νeo Psychiko Athens Greece Fungustatin 200 mg/100 ml Solution for Infusion Intravenous use 2 mg/ml Greece Pfizer Hellas A. E. 243, Messoghion Ave. 154 51 Νeo Psychiko Athens Greece Fungustatin 50 mg/25 ml Solution for Infusion Intravenous use 2 mg/ml Hungary Pfizer KFT 1123 Budapest Alkotás u. 53. Hungary Diflucan 50 mg kemény kapszula 50 mg Capsule, Hard Oral use N/A Hungary Pfizer KFT 1123 Budapest Alkotás u. 53. Hungary Diflucan 100 mg kemény kapszula 100 mg Capsule, Hard Oral use N/A Hungary Pfizer KFT 1123 Budapest Alkotás u. 53 Hungary Diflucan 150 mg kemény kapszula 150 mg Capsule, Hard Oral use N/A Hungary Pfizer KFT 1123 Budapest Alkotás u. 53. Hungary Diflucan 200 mg kemény kapszula 200 mg Capsule, Hard Oral use N/A Hungary Pfizer KFT 1123 Budapest Alkotás u. 53. Hungary Diflucan 10 mg/ml por belsőleges szuszpenzióhoz 50 mg/5 ml Powder for Oral suspension Oral use 10 mg/ml Hungary Pfizer KFT 1123 Budapest Alkotás u. 53. Hungary Diflucan 40 mg/ml por belsőleges szuszpenzióhoz 200 mg/5 ml Powder for Oral Suspension Oral use 40 mg/ml Hungary Pfizer KFT 1123 Budapest, Alkotás u. 53. Hungary Diflucan 2 mg/ml oldatos infúzió 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Iceland Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Diflucan 50 mg Capsule, Hard Oral use N/A Iceland Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Diflucan 150 mg Capsule, Hard Oral use N/A Iceland Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Diflucan 200 mg Capsule, Hard Oral use N/A Iceland Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Diflucan 10 mg/ml Powder for Suspension Oral use 10 mg/ml Iceland Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark Diflucan 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Ireland Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 50 mg Capsule, Hard Oral use N/A Ireland Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 150 mg Capsule, Hard Oral use N/A Ireland Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 200 mg Capsule, Hard Oral use N/A Ireland Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 50 mg/5 ml Powder for Suspension Oral use 10 mg/ml Ireland Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 200 mg/5 ml Powder for Suspension Oral use 40 mg/ml Ireland Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 200 mg/100 ml Solution for Infusion Intravenous use 2 mg/ml Ireland Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 50 mg/25 ml Solution for Infusion Intravenous use 2 mg/ml Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Diflucan 50 mg Capsule, Hard Oral use N/A Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Diflucan 100 mg Capsule, Hard Oral use N/A Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Diflucan 150 mg Capsule, Hard Oral use N/A Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Diflucan 200 mg Capsule, Hard Oral use N/A Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Diflucan 50 mg/5 ml Powder for Suspension Oral use 10 mg/ml Italy Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy Diflucan 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Latvia Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 50 mg kapsulas 50 mg Capsule, Hard Oral use N/A Latvia Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 150 mg kapsulas 150 mg Capsule, Hard Oral use N/A Latvia Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 2 mg/ml šķīdums infūzijām 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Lithuania Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 50 mg Capsule, Hard Oral use N/A Lithuania Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 100 mg Capsule, Hard Oral use N/A Lithuania Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 150 mg Capsule, Hard Oral use N/A Lithuania Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Luxembourg Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 50 mg Capsule, Hard Oral use N/A Luxembourg Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 100 mg Capsule, Hard Oral use N/A Luxembourg Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 150 mg Capsule, Hard Oral use N/A Luxembourg Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 200 mg Capsule, Hard Oral use N/A Luxembourg Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 50 mg/5 ml Powder for Suspension Oral use 10 mg/ml Luxembourg Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 200 mg/5 ml Powder for Suspension Oral use 40 mg/ml Luxembourg Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 200 mg/100 ml Solution for Infusion Intravenous use 2 mg/ml Luxembourg Pfizer SA Boulevard de la Plaine 17 1050 Brussels Belgium Diflucan 400 mg/200 ml Solution for Infusion Intravenous use 2 mg/ml Malta Pfizer Hellas S.A. 243, Messoghion Ave. 154 51 Νeo Psychiko Athens Greece Diflucan 50 mg/25 ml Solution for Infusion Intravenous use 2 mg/ml Malta Pfizer Hellas S.A. 243, Messoghion Ave. 154 51 Νeo Psychiko Athens Greece Diflucan 200 mg/100 ml Solution for Infusion Intravenous use 2 mg/ml Netherlands Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands Diflucan 50 50 mg Capsule Oral use N/A Netherlands Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands Diflucan 100 100 mg Capsule Oral use N/A Netherlands Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands Diflucan 150 150 mg Capsule Oral use N/A Netherlands Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands Diflucan 200 200 mg Capsule Oral use N/A Netherlands Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands Diflucan suspensie 50 50 mg/5 ml Powder for Suspension Oral use 10 mg/ml Netherlands Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands Diflucan suspensie 200 200 mg/5 ml Powder for Suspension Oral use 40 mg/ml Netherlands Pfizer bv Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands Diflucan I.V. 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Norway Pfizer AS Pb. 3 1324 Lysaker Norway Diflucan 50 mg Capsule, Hard Oral use N/A Norway Pfizer AS Pb. 3 1324 Lysaker Norway Diflucan 100 mg Capsule, Hard Oral use N/A Norway Pfizer AS Pb. 3 1324 Lysaker Norway Diflucan 150 mg Capsule, Hard Oral use N/A Norway Pfizer AS Pb. 3 1324 Lysaker Norway Diflucan 200 mg Capsule, Hard Oral use N/A Norway Pfizer AS Pb. 3 1324 Lysaker Norway Diflucan 50 mg/5 ml Powder for Oral Suspension Oral use 10 mg/ml Norway Pfizer AS Pb. 3 1324 Lysaker Norway Diflucan 200 mg/5 ml Powder for Oral Suspension Oral use 40 mg/ml Norway Pfizer AS Pb. 3 1324 Lysaker Norway Diflucan 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Poland Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 50 mg Capsule, Oral use N/A Poland Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 150 mg Capsule, Oral use N/A Poland Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Portugal Laboratorios Pfizer, Lda. Lagoas Park Edifício 10 2740-271 Porto Salvo Portugal Diflucan 50 mg Capsule, Hard Oral use N/A Portugal Laboratorios Pfizer, Lda. Lagoas Park Edifício 10 2740-271 Porto Salvo Portugal Diflucan 100 mg Capsule, Hard Oral use N/A Portugal Laboratorios Pfizer, Lda. Lagoas Park Edifício 10 2740-271 Porto Salvo Portugal Diflucan 150 mg Capsule, Hard Oral use N/A Portugal Laboratorios Pfizer, Lda., Lagoas Park Edifício 10 2740-271 Porto Salvo Portugal Diflucan 200 mg Capsule, Hard Oral use N/A Portugal Laboratorios Pfizer, Lda. Lagoas Park Edifício 10 2740-271 Porto Salvo Portugal Diflucan 10 mg/ml Powder for oral Suspension Oral use 10 mg/ml Portugal Laboratorios Pfizer, Lda. Lagoas Park Edifício 10 2740-271 Porto Salvo Portugal Diflucan 40 mg/ml Powder for oral Suspension Oral use 40 mg/ml Portugal Laboratorios Pfizer, Lda. Lagoas Park Edifício 10 2740-271 Porto Salvo Portugal Diflucan 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Romania Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ, United Kingdom Diflucan 50 mg 50 mg Capsule, Hard Oral use N/A Romania Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 150 mg 150 mg Capsule, Hard Oral use N/A Romania Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 50 mg/5 ml 50 mg/5 ml Powder for oral Suspension Oral use 10 mg/ml Romania Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 2 mg/ml 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Slovak Republic Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 50 mg 50 mg Capsule Oral use N/A Slovak Republic Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 100 mg 100 mg Capsule Oral use N/A Slovak Republic Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 150 mg 150 mg Capsule Oral use N/A Slovak Republic Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan P.O.S. 50 mg/5 ml 50 mg/5 ml Powder for Oral Suspension Oral use 10 mg/ml Slovak Republic Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan P.O.S. 200 mg/5 ml 200 mg/5 ml Powder for Oral Suspension Oral use 40 mg/ml Slovak Republic Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan IV 2 mg/ml 2 mg/ml Solution for Intravenous Infusion Intravenous use 2 mg/ml Slovenia Pfizer Luxembourg SARL 51, Avenue J. F. Kennedy L-1855 Luxembourg, Luxembourg Diflucan 50 mg trde kapsule 50 mg Capsule, Hard Oral use N/A Slovenia Pfizer Luxembourg SARL 51, Avenue J. F. Kennedy L-1855 Luxembourg, Luxembourg Diflucan 100 mg trde kapsule 100 mg Capsule, Hard Oral use N/A Slovenia Pfizer Luxembourg SARL 51, Avenue J. F. Kennedy L-1855 Luxembourg, Luxembourg Diflucan 150 mg trde kapsule 150 mg Capsule, Hard Oral use N/A Slovenia Pfizer Luxembourg SARL 51, Avenue J. F. Kennedy L-1855 Luxembourg, Luxembourg Diflucan 10 mg/ ml prašek za peroralno suspenzijo 10 mg/ml Powder for Suspension Oral use 10 mg/ml Slovenia Pfizer Luxembourg SARL 51, Avenue J. F. Kennedy L-1855 Luxembourg, Luxembourg Diflucan 40 mg/ml prašek za peroralno suspenzijo 40 mg/ml Powder for Suspension Oral use 40 mg/ml Slovenia Pfizer Luxembourg SARL 51, Avenue J. F. Kennedy L-1855 Luxembourg, Luxembourg Diflucan 2 mg/ml raztopina za infundiranje 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Spain Vinci Farma, S.A. (Grupo Pfizer) Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Diflucan 50 mg cápsulas duras 50 mg Capsule, Hard Oral use N/A Spain Vinci Farma, S.A. (Grupo Pfizer) Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Diflucan 100 mg cápsulas duras 100 mg Capsule, Hard Oral use N/A Spain Vinci Farma, S.A. (Grupo Pfizer) Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Diflucan 150 mg cápsulas duras 150 mg Capsule, Hard Oral use N/A Spain Vinci Farma, S.A. (Grupo Pfizer) Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Diflucan 200 mg cápsulas duras 200 mg Capsule, Hard Oral use N/A Spain Vinci Farma, S.A. (Grupo Pfizer) Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Diflucan 50 mg/5 ml polvo para suspensión oral 50 mg/5 ml Powder for Suspension Oral use 10 mg/ml Spain Vinci Farma, S.A. (Grupo Pfizer) Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Diflucan 200 mg/5 ml polvo para suspensión oral 200 mg/5 ml Powder for Suspension Oral use 40 mg/ml Spain Vinci Farma, S.A. (Grupo Pfizer) Avda. de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain Diflucan 2 mg/ml solución para perfusión 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml Sweden Pfizer AB 191 90 Sollentuna Sweden Diflucan 50 mg Capsule, Hard Oral use N/A Sweden Pfizer AB 191 90 Sollentuna Sweden Diflucan 100 mg Capsule, Hard Oral use N/A Sweden Pfizer AB 191 90 Sollentuna Sweden Diflucan 150 mg Capsule, Hard Oral use N/A Sweden Pfizer AB 191 90 Sollentuna Sweden Diflucan 200 mg Capsule, Hard Oral use N/A Sweden Pfizer AB 191 90 Sollentuna Sweden Diflucan 10 mg/ml Powder for Suspension Oral use 10 mg/ml Sweden Pfizer AB 191 90 Sollentuna Sweden Diflucan 40 mg/ml Powder for Suspension Oral use 40 mg/ml Sweden Pfizer AB 191 90 Sollentuna Sweden Diflucan 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml United Kingdom Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 50 mg Capsule, Hard Oral use N/A United Kingdom Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 150 mg Capsule, Hard Oral use N/A United Kingdom Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 200 mg Capsule, Hard Oral use N/A United Kingdom Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 50 mg/5 ml Powder for Suspension Oral use 10 mg/ml United Kingdom Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 200 mg/5 ml Powder for Suspension Oral use 40 mg/ml United Kingdom Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Diflucan 2 mg/ml Solution for Infusion Intravenous use 2 mg/ml

ANNEX V LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATIONS, APPLICANTS IN THE MEMBER STATES Member State EU/EEA Applicant (Invented) Name Strength Pharmaceutical form Route of administration Content (concentration) Belgium Alapis S.A., 2 Aftokratoros Nikolaou street, 17671 Athens, Greece Dexamethasone Alapis 0,4 mg/ml Oral solution Oral use 1 Bottle × 150 ml Bulgaria Alapis Bulgaria Ltd., 29, Atanas Dukov Str. 1407, Sofia, Bulgaria Dexamethasone Alapis 0,4 mg/ml Oral solution Oral use 1 Bottle × 150 ml Cyprus Alapis S.A., 2 Aftokratoros Nikolaou street, 17671 Athens, Greece Dexamethasone Alapis 0,4 mg/ml Oral solution Oral use 1 Bottle × 150 ml Germany Alapis S.A., 2 Aftokratoros Nikolaou street, 17671 Athens, Greece Dexamethasone Alapis 0,4 mg/ml Oral solution Oral use 1 Bottle × 150 ml Greece Alapis S.A., 2 Aftokratoros Nikolaou street, 17671 Athens, Greece Dexamethasone Alapis 0,4 mg/ml Oral solution Oral use 1 Bottle × 150 ml Malta Alapis S.A., 2 Aftokratoros Nikolaou street, 17671 Athens, Greece Dexamethasone Alapis 0,4 mg/ml Oral solution Oral use 1 Bottle × 150 ml Portugal Alapis S.A., 2 Aftokratoros Nikolaou street, 17671 Athens, Greece Dexamethasone Alapis 0,4 mg/ml Oral solution Oral use 1 Bottle × 150 ml Romania Alapis Romania s.r.l. Strada Leordeni nr. 13, Bragadiru, Jud.IIfov, 077025, Romania Dexamethasone Alapis 0,4 mg/ml Oral solution Oral use 1 Bottle × 150 ml United Kingdom Alapis S.A., 2 Aftokratoros Nikolaou street, 17671 Athens, Greece Dexamethasone Alapis 0,4 mg/ml Oral solution Oral use 1 Bottle × 150 ml

ANNEX VI LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Applicant (Invented) Name Strength Pharmaceutical form Route of administration Content (concentration) Ireland Pinewood Laboratories Limited, Ballmacarbry, Clonmel, Co. Tipperary, Ireland Canazole Clotrimazole Cream 1 % w/w 1 % w/w Cream Cutaneous Use 100 mg/ml United Kingdom Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland Canazole Clotrimazole Cream 1 % w/w 1 % w/w Cream Cutaneous Use 100 mg/ml

ANNEX VII LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCT, 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 Austria STADA Arzneimittel GmbH, Muthgasse 36, A-1190 Wien Austria Novogos 3,6 mg Implantat 3,6 mg implant, pre-filled syringe subcutaneous use Germany Cell Pharm GmbH Theodor-Heuss-Str. 52 61118 Bad Vilbel Germany Goserelin cell pharm 3,6 mg Implantat 3,6 mg implant subcutaneous use United Kingdom Genus Pharmaceuticals, Park View House, 65 London Road, Newbury, Berkshire RG14 1JN United Kingdom Novgos 3,6 mg Implant 3,6 mg implant subcutaneous use

ANNEX VIII LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Invented name Strength Pharmaceutical form Route of administration Austria Acino AG Am Windfeld 35 83714 Miesbach Germany Novimp 3,6 mg Implantat 3,6 mg implant, pre-filled syringe subcutaneous use Germany Acino AG Am Windfeld 35 83714 Miesbach Germany Novimp 3,6 mg Implantat 3,6 mg implant subcutaneous use United Kingdom Acino AG Am Windfeld 35 83714 Miesbach Germany Novimp 3,6 mg Implant 3,6 mg implant subcutaneous use