Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2012 to 31 December 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2013-01-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013024EN.01000801.xml










25.1.2013   


EN


Official Journal of the European Union


C 24/8





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2012 to 31 December 2012

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

2013/C 24/02
—   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




17.12.2012


HIPRALONA ENRO-S and its generics


See Annex I


See Annex I


19.12.2012




6.12.2012


Prefluce+l and associated names


See Annex II


See Annex II


10.12.2012







—   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




20.12.2012


Loraxin


See Annex III


See Annex III


21.12.2012




10.12.2012


Cilazapril Teva and associated names


See Annex IV


See Annex IV


12.12.2012






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State
EU/EEA


Applicant/Marketing Authorisation Holder


Name


INN


Strength


Pharmaceutical form


Animal species




Belgium







GLOBAL VET HEALTH SL




C/Capçanes




no 12-bajos




Polígono Agro-Reus




43206 Reus




SPAIN






QUINOFLOX 100 mg/ml


Enrofloxacin


100 mg/ml


Oral solution


Chickens (Broilers, replacement chickens, broiler breeders), Rabbits




Cyprus







LABORATORIOS KARIZOO, S.A.




Polígono Industrial La Borda




Mas Pujades, 11-12




08140 Caldes de Montbui




Barcelona




SPAIN






K-Flox 100 mg/ml Πόσιμο διάλυμα για ορνίθια κρεοπαραγωγής και κουνέλια


Enrofloxacin


100 mg/ml


Oral solution


Chickens (broilers), Rabbits




Spain







LABORATORIOS HIPRA,




S.A.Avda.




La Selva,135




17170 Amer




SPAIN






HIPRALONA ENRO - S


Enrofloxacin


100 mg/ml


Oral solution


Poultry (Chicken and Turkeys), Rabbits




Spain







UNIVERSAL FARMA, S.L.




Gran Via Carlos III 98 - 7a





08028 Barcelona




SPAIN






LEVOFLOK® 100 mg/ml Oral solution for chickens and rabbits


Enrofloxacin


100 mg/ml


Oral solution


Chickens, Rabbits




Spain







LABORATORIOS KARIZOO, S.A.




Polígono Industrial La Borda




Mas Pujades, 11-12




08140 Caldes de Montbui




Barcelona




SPAIN






K-FLOX 100 mg/ml Oral Solution for chickens and rabbits.


Enrofloxacin


100 mg/ml


Oral solution


Chickens, Rabbits




Spain







Global Vet Health, SL




Capcanes, 12 bajos




Poligono Agro-Reus




43206 Reus




SPAIN






QUINOFLOX 100 mg/ml


Enrofloxacin


100 mg/ml


Oral solution


Chickens, Rabbits




Spain







SP VETERINARIA




Ctra.Reus-Vinyols, Km,




43330 Ruidoms




SPAIN






COLMYC -C


Enrofloxacin


100 mg/ml


Oral solution


Poultry (Chicken and Turkeys), Rabbits




France







GLOBAL VET HEALTH SL




c/Capçanes, no 12-bajos.




Polígon Agro-Reus.




43206 Reus




SPAIN






Quinoflox 100 mg/ml solution for use in drinking water, chicken and rabbits


Enrofloxacin


100 mg/ml


Oral solution


Chickens (Broilers, replacement chickens, broiler breeders), Rabbits




Italy







GLOBAL VET HEALTH, S.L.




Capsanes, 12 - Polígono Agro-Reus




E-43206 - REUS (Tarragona)




SPAIN






QUINOLCEN


Enrofloxacin


100 mg/ml


Oral solution


Chickens, Rabbits




Italy







LABORATORIOS KARIZOO, S.A.




Polígono Industrial La Borda




Mas Pujades, 11-12




08140 – CALDES DE MONTBUI (Barcelona)




SPAIN






K-FLOX 100 mg/ml


Enrofloxacin


100 mg/ml


Oral solution


Chickens, Rabbits




Italy







VETPHARMA ANIMAL HEALTH, S.L.




Les Corts, 23




08028 – BARCELONA




SPAIN






NIFLOX 100 mg/ml


Enrofloxacin


100 mg/ml


Oral solution


Chickens, Rabbits




Poland







Medivet S.A.




Szkolna 17




63-100 Śrem




POLAND






MEDOXIL ORAL 100 mg/ml roztwór doustny dla kur i królików


Enrofloxacinum


100 mg/ml


Oral solution


Chickens, Rabbits




Portugal







GLOBAL VET HEALTH SL




C/Capçanes




no 12-bajos




Polígono Agro-Reus




43206 Reus




SPAIN






Quinoflox 100 mg/ml solução para administração na água de bebida para frangos e coelhos


Enrofloxacin


100 mg


Oral solution


Chickens (Broilers, replacement chickens, broiler breeders) and rabbits




Portugal







VETPHARMA ANIMAL HEALTH, S.L.




Les Corts, 23




08028 Barcelona




SPAIN






LEVOFLOK® 100 mg/ml Solução oral para frangos de carne e coelhos


Enrofloxacin


100 mg


Oral solution


Chickens (broilers), Rabbits




Portugal







LABORATORIOS KARIZOO, S.A.




Polígono Industrial La Borda




Mas Pujades, 11-12




08140 Caldes de Montbui




Barcelona




SPAIN






K-FLOX 100 mg/ml Solução oral para frangos de carne e coelhos


Enrofloxacin


100 mg


Oral solution


Chickens (broilers), Rabbits




Portugal







Prodivet-Zn,Nutrição e Comércio de Produtos Químicos




Farmacêuticos e Cosméticos




SA Av. Infante D. Henrique no 333 H 3o Piso Esc.




411800-282 Lisboa




PORTUGAL






Prodirox 100 mg/ml solução oral para frangos e coelhos


Enrofloxacin


100 mg


Oral solution


Chickens (broilers), Rabbits




Portugal







VETLIMA




Sociedade Distr. Produtos Agro-Pecuários LDA.




Centro Empresarial da Rainha




Lote 27




2050-501 Vila Nova Da Rainha




PORTUGAL






VETAFLOX 100 mg/ml solução oral para frangos de engorda e coelhos


Enrofloxacin


100 mg


Oral solution


Chickens (broilers), Rabbits




United Kingdom







Global Vet Health S.L.




Calle Capcanes




n12 Bajos




Poligono Agro-Reus




43206 Reus




SPAIN






Quinoflox 100 mg/ml Solution for Use in Drinking Water, Chicken and Rabbits


Enrofloxacin


100 mg/ml


Oral solution


Chickens, Rabbits







ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State
(in EEA)


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical form


Route of administration




Austria







Baxter AG




Industriestrasse 67




Vienna 1221




Austria






Preflucel Injektionssuspen sion in einer Fertigspritze


15 micrograms haemagglutinin of each of the 3 specified strains as determined by WHO per 0,5 ml dose


suspension for injection in a pre-filled syringe


intramuscular use




Belgium







Baxter S.A.




Bd René Branquart 80




7860 Lessines




Belgium






Preflucel


15 μg-0,5 ml


suspension for injection


intramuscular use




Czech Republic







Baxter AG




Industriestrasse 67




Vienna 1221




Austria






PREFLUCEL


0,5 ml per dose


suspension for injection


intramuscular use




Denmark







Baxter A/S




Gydevang 43




DK-3450 Allerød




Denmark






Preflucel


15 microgram


suspension for injection in a prefilled syringe


intramuscular use




Finland







Baxter Oy




Tammasaarenkatu 1




PL 119




00181 Helsinki




Finland






Preflucel


15 mikrog HA/0,5 ml
15 mikrog HA/0,5 ml
15 mikrog HA/0,5 ml


suspension for injection in pre-filled syringe


intramuscular use




Germany







Baxter Deutschland GmbH




Edisonstraße 4




85716 Unterschleißheim




Germany






PREFLUCEL


15 μgHA
15 μgHA
15 μgHA


suspension for injection in prefilled syringe


intramuscular use




Ireland







Baxter Healthcare Limited




Caxton Way




Thetford




Norfolk IP24 3SE




United Kingdom






Preflucel suspension for injection in a pre- filled syringe


15 microgram


suspension for injection


intramuscular use




Italy







Baxter S.p.A.




Piazzale dell'Industria 20




Rome 00144




Italy






PREFLUCELL


15 micrograms


suspension for injection in a pre-filled syringe


intramuscular use




Norway







Baxter AS




Gjerdrums vei 11




N-0484 Oslo




Norway






Preflucel


15 μg hemagglutinin of each of the 3 influenza virus strains


suspension for injection in a pre-filled syringe


intramuscular use




Poland







Baxter Polska Sp. z o.o.




Kruczkowskiego 8




00-380 Warszawa




Poland






Preflucel


A/California/07/2009 (H1N1)-
15 micrograms HA A/Perth/16/2009 (H3N2) like strain used (A/Victoria/210/2009)-
15 micrograms HA B/Brisbane/60/2008 (B)-
15 micrograms HA/HA**
per 0,5 ml dose


suspension for injection in a pre-filled syringe


intramuscular use




Portugal







Baxter Médico-Farmacêutica,




Lda.




Zona Industrial da Abrunheira




Edifício 10




Sintra Business Park




2710-089 Sintra




Portugal






Preflucel


A/California/7/2009 (H1N1) - like virus →
0,015 mg A/Perth/16/2009 (H3N2) - like virus →
0,015 mg
B/Brisbane/60/2008 →
0,015 mg


suspension for injection in a pre-filled syringe


intramuscular Use




Spain







Baxter, S.L.




Polígono Industrial Sector 14




Pouet de Camilo, 2




Ribarroja del Turia




Valencia 46394




Spain






PREFLUCEL SUSPENSION INYECTABLE EN JERINGA PRECARGADA


A/California/07/2009 (H1N1)-
15 micrograms HA; A/Perth/16/2009 (H3N2) like strain used: (A/Victoria/210/2009)-
15 micrograms HA; B/Brisbane/60/2008 (B)-
15 micrograms HA, per 0,5 ml dose


suspension for injection in prefilled syringe


intramuscular use




Sweden







Baxter Medical AB




Torshamnsgatan 35




Box 63




164 94 Kista




Sweden






Preflucel


(NA)


solution for injection, pre filled syringe


intramuscular use




The Netherlands







Baxter B.V.




Kobaltweg 49




3542 CE Utrecht




The Netherlands






Preflucel
2011/2012, suspensie voor injectie 0,5 ml


0,5 ml per dose


suspension for injection


intramuscular use




United Kingdom







Baxter Healthcare Limited




Caxton Way




Thetford




Norfolk IP24 3SE




United Kingdom






Preflucel


15 mcg hemagglutinin of each of the 3 influenza virus strains


suspension for injection in a pre-filled syringe


intramuscular use







ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State
EU/EEA


Marketing authorisation holder


Applicant


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Czech Republic


 







Vitabalans Oy




Varastokatu 8




13500 Hämeenlinna




Finland






Loratadine Vitabalans 10 mg tablety


10 mg


tablet


oral use




Denmark


 







Vitabalans Oy




Varastokatu 8




13500 Hämeenlinna




Finland






Loraxin


10 mg


tablet


oral use




Estonia


 







Vitabalans Oy




Varastokatu 8




13500 Hämeenlinna




Finland






Loratadine Vitabalans


10 mg


tablet


oral use




Finland







Vitabalans Oy




Varastokatu 8




13500 Hämeenlinna




Finland











Vitabalans Oy




Varastokatu 8




13500 Hämeenlinna




Finland






Loraxin


10 mg


tablet


oral use




Hungary


 







Vitabalans Oy




Varastokatu 8




13500 Hämeenlinna




Finland






Loraxin


10 mg


tablet


oral use




Latvia


 







Vitabalans Oy




Varastokatu 8




13500 Hämeenlinna




Finland






Loratadine Vitabalans 10 mg tabletes


10 mg


tablet


oral use




Lithuania


 







Vitabalans Oy




Varastokatu 8




13500 Hämeenlinna




Finland






Loraxin


10 mg


tablet


oral use




Norway


 







Vitabalans Oy




Varastokatu 8




13500 Hämeenlinna




Finland






Loratadine Vitabalans


10 mg


tablet


oral use




Poland


 







Vitabalans Oy




Varastokatu 8




13500 Hämeenlinna




Finland






Loratadine Vitabalans


10 mg


tablet


oral use




Slovak Republic


 







Vitabalans Oy




Varastokatu 8




13500 Hämeenlinna




Finland






Loratadine Vitabalans 10 mg


10 mg


tablet


oral use




Slovenia


 







Vitabalans Oy




Varastokatu 8




13500 Hämeenlinna




Finland






Loratadine Vitabalans 10 mg tablete


10 mg


tablet


oral use




Sweden


 







Vitabalans Oy




Varastokatu 8




13500 Hämeenlinna




Finland






Loratadine Vitabalans


10 mg


tablet


oral use







ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM, 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







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






Cilazapril TEVA 0,5 mg Filmtabletten


0,5 mg


Film-coated tablet


Oral use




Austria







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






Cilazapril TEVA 2,5 mg Filmtabletten


2,5 mg


Film-coated tablet


Oral use




Austria







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






Cilazapril TEVA 5 mg Filmtabletten


5,0 mg


Film-coated tablet


Oral use




Czech Republic







Teva Pharmaceuticals CR, s.r.o.




Radlická 3185/1c




150 00 Praha 5,




Czech Republic






CILAZAPRIL TEVA 5 MG


5 mg


Film-coated tablet


Oral use




Czech Republic







Teva Pharmaceuticals CR, s.r.o.




Radlická 3185/1c




150 00 Praha 5,




Czech Republic






CILAZAPRIL TEVA 2,5 MG


2,5 mg


Film-coated tablet


Oral use




France







TEVA SANTE




110 ESPLANADE DU GENERAL DE GAULLE




92931 PARIS LA DEFENSE CEDEX




FRANCE






CILAZAPRIL TEVA
1 mg, comprimé pelliculé sécable


1 mg


Film-coated tablet


Oral use




France







TEVA SANTE




110 ESPLANADE DU GENERAL DE GAULLE




92931 PARIS LA DEFENSE CEDEX




FRANCE






CILAZAPRIL TEVA 0,5 mg, comprimé pelliculé sécable


0,5 mg


Film-coated tablet


Oral use




France







TEVA SANTE




110 ESPLANADE DU GENERAL DE GAULLE




92931 PARIS LA DEFENSE CEDEX




FRANCE






CILAZAPRIL TEVA 2,5 mg, comprimé pelliculé sécable


2,5 mg


Film-coated tablet


Oral use




Poland







123ratio Sp. z o.o.




ul. Emilii Plater 53




00-113 Warsaw




Poland






Cilazaprilum 123ratio


1 mg


Film-coated tablet


Oral use




Poland







123ratio Sp. z o.o.




ul. Emilii Plater 53




00-113 Warsaw




Poland






Cilazaprilum 123ratio


2,5 mg


Film-coated tablet


Oral use




Poland







123ratio Sp. z o.o.




ul. Emilii Plater 53




00-113 Warsaw




Poland






Cilazaprilum 123ratio


5 mg


Film-coated tablet


Oral use




Spain







TEVA PHARMA, S.L.U.




C/Anabel Segura, 11




Edificio Albatros B, 1a planta




28108 Alcobendas (Madrid)




Spain






CILAZAPRIL TEVA 1 mg comprimidos recubiertos con película EFG


1 mg


Film-coated tablet


Oral use




Spain







TEVA PHARMA, S.L.U.




C/Anabel Segura, 11




Edificio Albatros B, 1a planta




28108 Alcobendas (Madrid)




Spain






CILAZAPRIL TEVA 5 mg comprimidos recubiertos con película EFG


5 mg


Film-coated tablet


Oral use




Spain







TEVA PHARMA, S.L.U.




C/Anabel Segura, 11




Edificio Albatros B, 1a planta




28108 Alcobendas (Madrid)




Spain






CILAZAPRIL TEVA 2,5 mg comprimidos recubiertos con película EFG


2,5 mg


Film-coated tablet


Oral use




United Kingdom







Teva UK Ltd,




Brampton Road,




Hampden Park,




Eastbourne,




BN22 9AG,




United Kingdom






Cilazapril 0,5 mg tablets


0,5 mg


Tablet


Oral use




United Kingdom







Teva UK Ltd,




Brampton Road,




Hampden Park,




Eastbourne,




BN22 9AG,




United Kingdom






Cilazapril 1 mg tablets


1 mg


Tablet


Oral use




United Kingdom







Teva UK Ltd,




Brampton Road,




Hampden Park,




Eastbourne,




BN22 9AG,




United Kingdom






Cilazapril 2,5 mg tablets


2,5 mg


Tablet


Oral use




United Kingdom







Teva UK Ltd,




Brampton Road,




Hampden Park,




Eastbourne,




BN22 9AG,




United Kingdom






Cilazapril 5 mg tablets


5 mg


Tablet


Oral use