Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Date: 2009-09-25
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market








C_2009231EN.01003001.xml










25.9.2009   


EN


Official Journal of the European Union


C 231/30





Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 2009

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
 (1)
or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
 (2)
)

2009/C 231/06
—   Issuing, maintenance or modification of a national marketing authorisation










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




3.8.2009


Fenflor


See Annex I


See Annex I


5.8.2009




3.8.2009


Shotaflor


See Annex II


See Annex II


5.8.2009




—   Suspension of a national marketing authorisation










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




6.8.2009


Loratadine Sandoz 10


See Annex III


See Annex III


7.8.2009






(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 PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER/APPLICANT IN THE MEMBER STATES












Member State


Applicant/Marketing Authorisation Holder


Invented name


Pharmaceutical form


Strength


Animal species


Frequency and route of administration




Austria







Gosmore Ltd




9 Pitch and Pay Lane




Sneyd Park




Bristol




UNITED KINGDOM






Fenflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Belgium







Gosmore Ltd




9 Pitch and Pay Lane




Sneyd Park




Bristol




UNITED KINGDOM






Fenflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Germany







Gosmore Ltd




9 Pitch and Pay Lane




Sneyd Park




Bristol




UNITED KINGDOM






Fenflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




France







Gosmore Ltd




9 Pitch and Pay Lane




Sneyd Park




Bristol




UNITED KINGDOM






Fenflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Ireland







Gosmore Ltd




9 Pitch and Pay Lane




Sneyd Park




Bristol




UNITED KINGDOM






Fenflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Italy







Gosmore Ltd




9 Pitch and Pay Lane




Sneyd Park




Bristol




UNITED KINGDOM






Fenflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Poland







Gosmore Ltd




9 Pitch and Pay Lane




Sneyd Park




Bristol




UNITED KINGDOM






Fenflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Portugal







Gosmore Ltd




9 Pitch and Pay Lane




Sneyd Park




Bristol




UNITED KINGDOM






Fenflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Spain







Gosmore Ltd




9 Pitch and Pay Lane




Sneyd Park




Bristol




UNITED KINGDOM






Fenflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




The Netherlands







Gosmore Ltd




9 Pitch and Pay Lane




Sneyd Park




Bristol




UNITED KINGDOM






Fenflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




United Kingdom







Gosmore Ltd




9 Pitch and Pay Lane




Sneyd Park




Bristol




UNITED KINGDOM






Fenflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart







ANNEX II

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












Member State


Applicant/Marketing
Authorisation Holder


Invented name


Pharmaceutical form


Strength


Animal species


Frequency and route of administration




Austria







Virbac S.A.




1ère avenue 2065 m L.I.D




06516 Carros Cedex




FRANCE






Shotaflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Belgium







Virbac S.A.




1ère avenue 2065 m L.I.D




06516 Carros Cedex




FRANCE






Shotaflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Denmark







Virbac S.A.




1ère avenue 2065 m L.I.D




06516 Carros Cedex




FRANCE






Shotaflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Germany







Virbac S.A.




1ère avenue 2065 m L.I.D




06516 Carros Cedex




FRANCE






Shotaflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




France







Virbac S.A.




1ère avenue 2065 m L.I.D




06516 Carros Cedex




FRANCE






Shotaflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Greece







Virbac S.A.




1ère avenue 2065 m L.I.D




06516 Carros Cedex




FRANCE






Shotaflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Ireland







Virbac S.A.




1ère avenue 2065 m L.I.D




06516 Carros Cedex




FRANCE






Shotaflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Italy







Virbac S.A.




1ère avenue 2065 m L.I.D




06516 Carros Cedex




FRANCE






Shotaflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Portugal







Virbac S.A.




1ère avenue 2065 m L.I.D




06516 Carros Cedex




FRANCE






Shotaflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




Spain







Virbac S.A.




1ère avenue 2065 m L.I.D




06516 Carros Cedex




FRANCE






Shotaflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




The Netherlands







Virbac S.A.




1ère avenue 2065 m L.I.D




06516 Carros Cedex




FRANCE






Shotaflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart




United Kingdom







Virbac S.A.




1ère avenue 2065 m L.I.D




06516 Carros Cedex




FRANCE






Shotaflor 300 mg/ml solution for injection for cattle


Solution for injection


300 mg/ml


Cattle


Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart







ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS 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




Austria







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




AUSTRIA






 


Lictyn 10 mg — Tabletten


10 mg


Tablet


Oral use




Bulgaria


 







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




THE NETHERLANDS






Loratadin Sandoz


10 mg


Tablet


Oral use




Czech Republic


 







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




THE NETHERLANDS






Loratadin Sandoz 10 mg tablety


10 mg


Tablet


Oral use




Denmark







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




AUSTRIA






 


Loratadin Sandoz


10 mg


Tablet


Oral use




Estonia


 







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




THE NETHERLANDS






Lomilan


10 mg


Tablet


Oral use




Finland







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




AUSTRIA






 


Loratadin Sandoz 10 mg


10 mg


Tablet


Oral use




France


 







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




THE NETHERLANDS






Loratadine Sandoz Conseil 10 mg comprimé


10 mg


Tablet


Oral use




Germany







Sandoz Pharmaceuticals GmbH




Raiffeisenstr. 11




83607 Holzkirchen




GERMANY






 


Loratadin Sandoz 10 mg Tabletten


10 mg


Tablet


Oral use




Greece







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




AUSTRIA






 


Tirlor


10 mg


Tablet


Oral use




Hungary


 







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




THE NETHERLANDS






Loratadin Sandoz 10 mg tabletta


10 mg


Tablet


Oral use




Italy


 







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




THE NETHERLANDS






Loratadina Hexal AG 10 mg compresse


10 mg


Tablet


Oral use




Latvia


 







Sandoz B.V.




Verovskova 57




SI-1000 Ljubljana




SLOVENIA






Lomilan 10 mg tabletes


10 mg


Tablet


Oral use




Lithuania


 







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




THE NETHERLANDS






Lomilan


10 mg


Tablet


Oral use




Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




THE NETHERLANDS






 


Loratadine Sandoz 10, tabletten 10 mg


10 mg


Tablet


Oral use




Norway







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




AUSTRIA






 


Loratadin Sandoz 10 mg


10 mg


Tablet


Oral use




Poland


 







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




THE NETHERLANDS






Flonidan tab


10 mg


Tablet


Oral use




Portugal







Sandoz Farmacêutica, Lda.




PRT Alameda da Beloura




Edifício 1, 2.o — Escritório 15




2710-693 Sintra




PORTUGAL






 


Loratadina Sandoz 10 mg Comprimidos


10 mg


Tablet


Oral use




Romania


 







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




THE NETHERLANDS






Loratadina Sandoz 10 mg comprimate


10 mg


Tablet


Oral use




Slovak Republic


 







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




THE NETHERLANDS






Flonidan 10 mg tablety


10 mg


Tablet


Oral use




Slovenia


 







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




THE NETHERLANDS






Florin 10 mg tablete


10 mg


Tablet


Oral use




Spain







Sandoz Farmacéutica, S.A.




Gran Via de los Corts Catalanes, 764




08013 Barcelona




SPAIN






 


Loratadina Genpril 10 mg Comprimidos EFG


10 mg


Tablet


Oral use




Sweden







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




AUSTRIA






 


Loratadin Sandoz 10 mg


10 mg


Tablet


Oral use




United Kingdom







Sandoz Limited




Woolmer way




Bordon, Hants




GU35 9QE




UNITED KINGDOM






 


Loratadine 10 mg Tablets


10 mg


Tablet


Oral use