Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010 (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: 2010-04-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing, medicinal product, pharmaceutical industry








C_2010111EN.01001601.xml










30.4.2010   


EN


Official Journal of the European Union


C 111/16





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010

(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)
)

2010/C 111/03
—   Issuing, maintenance or modification of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




20.1.2010


Extraneal


See Annex I


See Annex I


22.1.2010




26.1.2010


Antiadiposo — iodocasein/thiamine nitrate


See Annex II


See Annex II


27.1.2010




25.1.2010


Poulvac Bursa Plus and associated names


See Annex III


See Annex III


26.1.2010




8.1.2010


Revlimid







Celgene Europe Limited




Riverside House




Riverside Walk




Windsor




Berkshire




SL4 1NA




UNITED KINGDOM






This Decision is addressed to the Member States


11.1.2010




29.1.2010


Urorec







Recordati Ireland Ltd.




Raheens East




Ringaskiddy Co. Cork




IRELAND






This Decision is addressed to the Member States


1.2.2010




29.1.2010


Silodyx







Recordati Ireland Ltd.




Raheens East




Ringaskiddy Co. Cork




IRELAND






This Decision is addressed to the Member States


1.2.2010







—   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




29.1.2010


Teicoplanin Hospira and associated names


See Annex IV


See Annex IV


2.2.2010







—   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




27.1.2010


APPM Respipharm


See Annex V


See Annex V


28.1.2010






(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 MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State EU/EEA


Marketing autorisation Holder


Invented Name


Strength


Pharmaceutical form


Route of administration




Austria







Baxter Vertriebs GmbH




Landstraßer Hauptstraße 99/Top2A




1031 Wien




ÖSTERREICH






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




Belgium







Baxter S.A.




Boulevard R. Branquart 80




7680 Lessines




BELGIQUE/BELGIË






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




Denmark







Baxter A/S




Gydevang 43




3450 Allerød




DANMARK






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




Finland







Baxter Oy




P.O. Box 270




Valimotie 15A




FI-00381 Helsinski




SUOMI/FINLAND






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




France







Baxter S.A.S




6 av. Louis Pasteur




78310 Maurepas




FRANCE






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




Germany







Baxter Deutschland GmbH




Edissontrasse 3—4




85716 Unterschleissheim




DEUTSCHLAND






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




Greece







Diophar A.E.




Kiphissias 368




152 33 Halandri Athens




GREECE






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




Ireland







Baxter Healthcare Ltd




Caxton Way




Thetford




IP24 3SE




UNITED KINGDOM






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




Italy







Baxter S.p.A.




Piazzale dell’Industria 20




00144 Roma RM




ITALIA






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




Luxembourg







Baxter S.A.




Boulevard R. Branquart 80




7680 Lessines




BELGIQUE/BELGIË






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




Netherlands







Baxter B.V




Kobaltweg 49




3542 CE Utrecht




NEDERLAND






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




Portugal







Baxter Médico Farmacêutica Lda




Sintra Business Park




Zona Industrial da Abrunheira




Edificio 10




2710-089 Sintra




PORTUGAL






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




Spain







Baxter S.L




Poligono Industrial Sector 14




C/ Pouet de Camilo, 2




46394 Ribarroja del Turia (Valencia)




ESPAÑA






Extraneal


Icodextrina 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




Sweden







Baxter AB




Box 63




SE-164 94 Kista




SVERIGE






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use




United Kingdom







Baxter Healthcare Ltd




Caxton Way




Thetford




IP24 3SE




UNITED KINGDOM






Extraneal


Icodextrin 7,5 %


Solution for peritoneal dialysis


Intraperitoneal use







ANNEX II

LIST OF THE INVENTED NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES (EEA)


Iodocasein/thiamine containing medicinal products with marketing authorisation in the European Union











Member State


Marketing Authorisation Holder


Invented Name


Strength


Pharmaceutical Form


Route of administration




Italy







TEOFARMA SRL




Via Fratelli Cervi 8




Valle Salimbene




27010 Pavia PV




ITALIA






ANTIADIPOSO


125 mg + 12,33 mg


Coated tablet


Oral use







ANNEX III

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














Member State


Applicant/Marketing Authorisation Holder


Invented name


Pharmaceutical form


Strength


Animal species


Route of administration


Recommended dose


Withdrawal period
(meat)




Belgium


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Bulgaria


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Czech Republic


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Denmark


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Estonia


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Spain


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Germany


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Greece


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Hungary


Fort Dodge Animal Health


Poulvac Bursa Plus vakcina A.U.V.


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Ireland


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Italy


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Latvia


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Lithuania


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




The Netherlands


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Poland


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Portugal


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Romania


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Slovakia


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




Slovenia


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days




United Kingdom


Fort Dodge Animal Health


Poulvac Bursa Plus


lyophilisate for suspension in drinking water


Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose


Chickens from 10 days of age


For oral administration in drinking water


One dose from 10 days of age


Zero days







ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES













Member State EU/EEA


Marketing Authorisation Holder


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration


Content (concentration)




Austria


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanin Hospira 200 mg
Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung


200 mg


Powder and solvent for solution for injection or infusion


Intravenous use (injection or infusion)
Intramuscular use


200 mg/vial
(66,7 mg/ml)




Austria


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanin Hospira 400 mg
Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung


400 mg


Powder and solvent for solution for injection or infusion


Intravenous use (injection or infusion)
Intramuscular use


400 mg/vial
(133,4 mg/ml)




Germany


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanin Mayne Hospira 200 mg
Trockensubstanz


200 mg


Powder and Solvent for Solution for Injection or Infusion


Intravenous use (injection or infusion)
Intramuscular use


200 mg/vial




Germany


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanin Mayne Hospira 400 mg
Trockensubstanz


400 mg


Powder and Solvent for Solution for Injection or Infusion


Intravenous use (injection or infusion)
Intramuscular use


400 mg/vial




Ireland


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanin 200 mg
Powder and Solvent for Solution for Injection or Infusion


200 mg


Powder and Solvent for Solution for Injection or Infusion


Intravenous use (injection or infusion)
Intramuscular use


200 mg/vial




Ireland


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanin 400 mg
Powder and Solvent for Solution for Injection or Infusion


400 mg


Powder and Solvent for Solution for Injection or Infusion


Intravenous use (injection or infusion)
Intramuscular use


400 mg/vial




Italy


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanina Hospira


200 mg


Powder and Solvent for Solution for Injection or Infusion


Intravenous use (injection or infusion)
Intramuscular use


200 mg/vial




Italy


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanina Hospira


400 mg


Powder and Solvent for Solution for Injection or Infusion


Intravenous use (injection or infusion)
Intramuscular use


400 mg/vial




Portugal


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanina Hospira 200 mg
Pó e solvente para solução injectável ou solução para perfusão


200 mg


Powder and Solvent for Solution for Injection or Infusion


Intravenous use (injection or infusion)
Intramuscular use


200 mg/vial




Portugal


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanina Hospira 400 mg
Pó e solvente para solução injectável ou solução para perfusão


400 mg


Powder and Solvent for Solution for Injection or Infusion


Intravenous use (injection or infusion)
Intramuscular use


400 mg/vial




Spain


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanina Hospira 200 mg
Polvo y disolvente para solución inyectable o para perfusión


200 mg


Powder and Solvent for Solution for Injection or Infusion


Intravenous use (injection or infusion)
Intramuscular use


200 mg/vial




Spain


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanina Hospira 400 mg
Polvo y disolvente para solución inyectable o para perfusión


400 mg


Powder and Solvent for Solution for Injection or Infusion


Intravenous use (injection or infusion)
Intramuscular use


400 mg/vial




United Kingdom


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanin 200 mg
Powder and Solvent for Solution for Injection or Infusion


200 mg


Powder and Solvent for Solution for Injection or Infusion


Intravenous use


200 mg/vial




United Kingdom


 







Hospira UK Limited




Queensway




Royal Leamington Spa




Warwickshire




CV31 3RW




UNITED KINGDOM






Teicoplanin 400 mg
Powder and Solvent for Solution for Injection or Infusion


400 mg


Powder and Solvent for Solution for Injection or Infusion


Intravenous use


400 mg/vial







ANNEX V

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, WITHDRAWAL PERIOD AND APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES














Member State


Applicant or Marketing Authorisation Holder


Invented name


Pharmaceutical form


Strength


Animal species


Frequency and route of administration


Recommended dose


Withdrawal period




Slovak Republic (1)








Pharmagal Bio, s.r.o.




Murgašova 5




949 01 Nitra




SLOVENSKO/SLOVAKIA






APPM Respipharm


Suspension for injection


Strains of Actinobacillus pleuropneumoniae producing Apx I, Apx II and Apx III toxins:






 



Actinobacillus pleuropneumoniae

serotype 2 ≥ 4,8 log2
 (2)











 



Actinobacillus pleuropneumoniae

serotype 9 ≥ 5,2 log2
 (2)











 



Actinobacillus pleuropneumoniae

serotype 11 ≥ 4,9 log2
 (2)











 



Pasteurella multocida

serotype A ≥ 2,1 log2
 (2)







Pigs


Intramuscularly deep into the neck muscle.






 


Pregnant sows:






 


Primary vaccination: First injection 4-5 weeks before expected farrowing.
Second injection at least 2 weeks before expected farrowing.










 


Booster: One injection 2-3 weeks before each farrowing.














 


Weaned piglets:






 


First injection: At the age of 6-8 weeks.










 


Revaccination: After 14-21 days.
















 


Pregnant sows:
Vaccine dose: 3 ml










 


Weaned piglets:
Vaccine dose: 2 ml






Zero days




Spain







Pharmagal Bio, s.r.o.




Murgašova 5




949 01 Nitra




SLOVENSKO/SLOVAKIA






APPM Respipharm


Suspension for injection


Strains of Actinobacillus pleuropneumoniae producing Apx I, Apx II and Apx III toxins:






 



Actinobacillus pleuropneumoniae

serotype 2 ≥ 4,8 log2
 (2)











 



Actinobacillus pleuropneumoniae

serotype 9 ≥ 5,2 log2
 (2)











 



Actinobacillus pleuropneumoniae

serotype 11 ≥ 4,9 log2
 (2)











 



Pasteurella multocida

serotype A ≥ 2,1 log2
 (2)







Pigs


Intramuscularly deep into the neck muscle.






 


Pregnant sows:






 


Primary vaccination: First injection 4-5 weeks before expected farrowing.
Second injection at least 2 weeks before expected farrowing.










 


Booster: One injection 2-3 weeks before each farrowing.














 


Weaned piglets:






 


First injection: At the age of 6-8 weeks.










 


Revaccination: After 14-21 days.
















 


Pregnant sows:
Vaccine dose: 3 ml










 


Weaned piglets:
Vaccine dose: 2 ml






Zero days




Poland


Pharmagal Bio, s.r.o.
Murgašova 5
949 01 Nitra
SLOVENSKO/SLOVAKIA


APPM Respipharm


Suspension for injection


Strains of Actinobacillus pleuropneumoniae producing Apx I, Apx II and Apx III toxins:






 



Actinobacillus pleuropneumoniae

serotype 2 ≥ 4,8 log2
 (2)











 



Actinobacillus pleuropneumoniae

serotype 9 ≥ 5,2 log2
 (2)











 



Actinobacillus pleuropneumoniae

serotype 11 ≥ 4,9 log2
 (2)











 



Pasteurella multocida

serotype A ≥ 2,1 log2
 (2)







Pigs


Intramuscularly deep into the neck muscle.






 


Pregnant sows:






 


Primary vaccination: First injection 4-5 weeks before expected farrowing.
Second injection at least 2 weeks before expected farrowing.










 


Booster: One injection 2-3 weeks before each farrowing.














 


Weaned piglets:






 


First injection: At the age of 6-8 weeks.










 


Revaccination: After 14-21 days.
















 


Pregnant sows:
Vaccine dose: 3 ml










 


Weaned piglets:
Vaccine dose: 2 ml






Zero days






(1)  Marketing Authorisation granted.

(2)  Mean titre of agglutination antibodies after vaccination in rabbits.