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 or Article 38 of Directive 2001/82/EC)
Date: 2011-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2011383EN.01001701.xml










30.12.2011   


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







ANNEX IX

LIST OF THE NAMES, PHARMACEUTICAL FORMS, 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






Goserelin Novosis 3,6 mg Implantat


3,6 mg


implant, pre-filled syringe


subcutaneous use




Germany







Acino AG




Am Windfeld 35




83714 Miesbach




Germany






Novosis Goserelin 3,6 mg Implantat


3,6 mg


implant


subcutaneous use




United Kingdom







Acino AG




Am Windfeld 35




83714 Miesbach




Germany






Gosacin 3,6 mg Implant


3,6 mg


implant


subcutaneous use