Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Date: 2012-11-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012371EN.01002601.xml










30.11.2012   


EN


Official Journal of the European Union


C 371/26





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

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

2012/C 371/04
—   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




10.10.2012


Aminocaproic acid containing medicinal products (antifibrynolitics)


See Annex I


See Annex I


12.10.2012




8.10.2012


Mometasone Furoate Sandoz and associated names


See Annex II


See Annex II


9.10.2012




10.10.2012


Tranexamic acid containing medicinal products (antifibrynolitics)


See Annex III


See Annex III


12.10.2012




8.10.2012


Baytril


See Annex IV


See Annex IV


9.10.2012






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

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


Aminocaproic acid containing medicinal products with Marketing Authorisation in the European Union











Member State
(EU/EEA)


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical form


Route of administration




ES - Spain







ROTTAPHARM, S.L.




Avda. Diagonal 67-69




08019 Barcelona




España






CAPROAMIN FIDES 4 g SOLUCIÓN INYECTABLE


4 g/10 ml


solution for injection


intravenous use




HU - Hungary







PannonPharma Kft.




Pannonpharma út 1.




7720 Pécsvárad




Hungary






Acepramin


4 g/10 ml


solution for infusion


intravenous use




PT - Portugal







Bial - Aristegui,




Produtos Farmacêuticos, S.A.




À Av. da Siderurgia Nacional Apartado 100




4745-457 S. Mamede do Coronado




Portugal






Epsicaprom 25


2 500 mg/10 ml


Solution for infusion


intravenous use







ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES











Member State
EU/EEA


Applicant


Name


Strength


Pharmaceutical form


Route of administration




Belgium







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometasone Sandoz 50 mcg/dosis neusspray, suspensie


50 microgram/dose


nasal spray, suspension


nasal use




Czech Republic







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mommox 0,05 mg/dávku


50 microgram/dose


nasal spray, suspension


nasal use




Denmark







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometasone Sandoz


50 microgram/dose


nasal spray, suspension


nasal use




Estonia







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Nasometin


50 microgram/dose


nasal spray, suspension


nasal use




Finland







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometasone furoate Sandoz


50 microgram/dose


nasal spray, suspension


nasal use




France







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






MOMETASONE Sandoz 50 microgrammes/dose, suspension pour pulvérisation nasale


50 microgram/dose


nasal spray, suspension


nasal use




Germany







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometasonfuroat Sandoz 50 Mikrogramm/Sprühstoß Nasenspray, Suspension


50 microgram/dose


nasal spray, suspension


nasal use




Greece







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometasone Furoate/Sandoz


50 microgram/dose


nasal spray, suspension


nasal use




Hungary







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometason Sandoz 50 mikrogramm/adag oldatos orrspray


50 microgram/dose


nasal spray, suspension


nasal use




Italy







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






MOMETASONE FUROATO SANDOZ 50 microgrammi/erogazione, spray nasale


50 microgram/dose


nasal spray, suspension


nasal use




Luxembourg







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometason Sandoz 50 mcg/dose spray nasale


50 microgram/dose


nasal spray, suspension


nasal use




Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometasonfuroaat Sandoz 50 microgram/dosis, neusspray, suspensie


50 microgram/dose


nasal spray, suspension


nasal use




Norway







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometasone Sandoz


50 microgram/dose


nasal spray, suspension


nasal use




Poland







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Nasometin


50 microgram/dose


nasal spray, suspension


nasal use




Portugal







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometasona Sandoz


50 microgram/dose


nasal spray, suspension


nasal use




Romania







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometazonă furoat Sandoz 50 micrograme/doza, spray nazal, suspensie


50 microgram/dose


nasal spray, suspension


nasal use




Slovak Republic







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometasone Sandoz 50 mikrogramov


50 microgram/dose


nasal spray, suspension


nasal use




Slovenia







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






FUMOMO 50 mikrogramov/vpih pršilo za nos, suspenzija


50 microgram/dose


nasal spray, suspension


nasal use




Spain







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometasona Sandoz 50 mcg/dosis suspensión para nebulización nasal


50 microgram/dose


nasal spray, suspension


nasal use




Sweden







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometasone Sandoz


50 microgram/dose


nasal spray, suspension


nasal use




United Kingdom







Sandoz B.V.




Veluwezoom 22




1327 AH Almere




P.O. box 10332




1301 AH Almere




The Netherlands






Mometasone Furoate 50 micrograms/dose, nasal spray, suspension


50 microgram/dose


nasal spray, suspension


nasal use







ANNEX III

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


Tranexamic acid containing medicinal products with Marketing Authorisation in the European Union











Member State
(EU/EEA)


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical form


Route of administration




AT - Austria







Pfizer Corporation Austria GmbH




Floridsdorfer Hauptstraße 1




A-1210 Wien




Austria






Cyklokapron - Ampullen


0,5 g/5 ml


Solution for injection


intravenous use




BE - Belgium







PFIZER S.A.N.V.




Bld de la Plaine 17




1050 Brussels




Belgium






Cyklokapron


100 mg/5 ml


Solution for injection


intravenous use




BE - Belgium







Eumedica S.A.




Winston Churchilllaan 67




1180 Brussels




Belgium






Exacyl 500


500 mg/5 ml


Solution for injection


intravenous use




CY - Cyprus







MEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, P.O.BOX 51409,




3505 LEMESOS, CYPRUS






AZEPTIL INJECTION 500 MG/5 ML


500 MG/5 ML


INJECTION


intravenous use




CY - Cyprus







MEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, P.O.BOX 51409,




505 LEMESOS, CYPRUS






AZEPTIL INJECTION 250 MG/5 ML


250 MG/5 ML


INJECTION


intravenous use




CZ - Czech Republic







Sanofi-Aventis, s.r.o., Evropská 846/176a,




160 00 Praha 6, Czech Republic






Exacyl


100 mg/ml


Solution for injection


intravenous use




DE - Germany







Pharmacia GmbH




Linkstr. 10




D-10785 Berlin






Cyklokapron-Injektionslösung


500 mg/5 ml


Solution for injection


intravenous use




DK - Denmark







Pfizer ApS,




Lautrupvang 8,




DK-2750 Ballerup, Denmark






Tranexamsyre ‘Pfizer’


100 mg/ml


Solution for injection


intravenous use




EL - Greece







A. NIKOLAKOPOULOS A.E.




GALATSIOU AVENUE 115, Athens 11146






TRANSAMIN


500 MG/5 ML


Solution for Injection or infusion


intravenous use




ES - Spain







ROTTAPHARM S.L.




Avda. Diagonal 67-69




08019 Barcelona




España






AMCHAFIBRIN
500 mg SOLUCIÓN INYECTABLE


500 mg/5 ml


solution for injection


intravenous use




ET - Estonia







Pfizer Enterprises SARL Round-Point du Kirchberg




51, Avenue J.F. Kennedy




L-1855 Luxembourg






CYKLOKAPRON


100 mg/ml


solution for injection


intravenous use




FI - Finland







Oy Leiras Finland Ab




Paciuksenkatu 21




PL 1406




00101 Helsinki




Finland






CAPRILON


100 mg/ml


Solution for injection


intravenous use




FR - France







Sanofi Aventis France




1-13, bd Romain Rolland




75014 Paris




France






Exacyl 0,5 g/5 ml I.V., solution injectable


0,5 g/5 ml


solution for injection


intravenous use




HU - Hungary







sanofi-aventis Zrt.




Tó u. 1-5.




1045 Budapest, Hungary






Exacyl


0,5 g/5 ml


solution for injection


intravenous use




IE - Ireland







Pharmacia Ireland Ltd,




9 Riverwalk, National Digital Park,




Citywest Business Campus,




Dublin 24




Ireland






Cyklokapron 500 mg/5 ml solution for injection or infusion


100 mg/ml


Solution for injection


intravenous use




IS - Iceland







Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup,




Denmark






Tranexamsyre ‘Pfizer’


100 mg/ml


Solution for injection


intravenous use




IT - Italy







Rottapharm S.p.A.




Via Valosa di Sopra, 9




20052 Monza - Italy






UGUROL


500 mg/5 ml


solution for injection


intravenous use




IT - Italy







Istituto Farmacobiologico Malesci S.p.A.




Via Lungo l'Ema 7




50015 Bagno a Ripoli (Firenze)




Italy






TRANEX


500 mg/5 ml


solution for injection


intravenous use




IT - Italy







Bioindutria Laboratorio Italiano Medicinali spa




Via De Ambrosiis, 2




15067 Novi Ligure Alessandria




Italy






ACIDO TRANEXAMICO BIOINDUTRIA L.I.M.


500 mg/5 ml


solution for injection


intravenous use




LU - Luxembourg







Eumedica SA




67, Avenue Winston Churchill




B-1180 Bruxelles






EXACYL


500 mg/5 ml


solution for injection


intravenous use




LU - Luxembourg







PFIZER S.A.N.V.




Bld de la Plaine 17




1050 Brussels




Belgium






Cyklokapron


100 mg/ml


Solution for injection


Intravenous use




NL - Netherlands







Pfizer B.V.




Rivium Westlaan 142




2909 LD, Capelle a/d Ijssel






Cyklokapron, oplossing voor injectie 100 mg/ml


100 mg/ml


solution for injection


intravenous use




NO - Norway







Pfizer AS




Postboks 3




1324 Lysaker Norway






CYKLOKAPRON


100 mg/ml


injection for solution


intravenous use




PL - Poland







Warszawskie Zakłady Farmaceutyczne POLFA S.A.




22/24 karolkowa st.




01-207 Warsaw, Poland






Exacyl


100 mg/ml


solution for infusion


intravenous use




PL - Poland







Sanofi-Aventis France




Boulevard Romain Rolland 1-13,




F-75014 Paris, France






Exacyl


100 mg/ml


solution for infusion


intravenous use




SE - Sweden







Pfizer AB




191 90 Sollentuna




Sweden






Cyklokapron


100 mg/ml


Solution for injection


intravenous use




UK - United Kingdom







Pharmacia Limited




Walton Oaks, Dorking Road, Tadworth




Surrey KT20 7NS




United Kingdom






CYKLOKAPRON INJECTION 500 MG/ML


500 mg/ml


Solution for Injection


intravenous use







ANNEX IV

Condition of the marketing authorisations

The National Competent Authorities shall ensure that the following condition is fulfilled by the marketing authorisation holders:






—


The marketing authorisation holders should substantiate the dosing regimen in rabbits taking into account the current MIC distribution for the target pathogens, the variability in pharmacokinetics resulting from administration of enrofloxacin via the drinking water to groups of rabbits under field conditions and with the goal to ensure sustainable effective treatment.










—


Residue depletion studies should be provided for any proposed new dosage regimen. A shorter or lower dose regimen than the current 10 mg/kg for 5 days needs to be substantiated by new clinical data.




The results of those studies should be provided to the relevant Authorities for assessment not later than 18 months after the Commission Decision on this referral procedure.