Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2009 to 30 April 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Date: 2009-05-29
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market








C_2009121EN.01001401.xml










29.5.2009   


EN


Official Journal of the European Union


C 121/14





Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2009 to 30 April 2009

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

2009/C 121/04
—   Issuing, maintenance or modification of a national marketing authorisation










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




17.4.2009


Thelin







Encysive (UK) Limited




Alder Castle House




10 Noble Street




London




EC2V 7QJ




UNITED KINGDOM






This Decision is addressed to the Member States


21.4.2009




30.4.2009


Alpha2-adrenoreceptor agonist (romifidine, xylazine, detomidine or medetomidine)


See Annex I


See Annex I


5.5.2009






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

COUNTRY, PRODUCT INVENTED NAME, ACTIVE SUBSTANCE, MARKETING AUTHORISATION NUMBER, MARKETING AUTHORISATION HOLDER CONCERNED BY THE PROCEDURE










Country


Product invented name


Active substance


Marketing Authorisation number


Marketing Authorisation Holder




AT


Rompun


Xylazine


14840


Bayer Austria GmbH




AT


Chanazine 2 %


Xylazine


8-00448







Chanelle Pharmaceuticals Manufacturing Ltd.




Dublin Road




Loughrea




Co. Galway




IRELAND








AT


Domosedan


Detomidine


8-00128







Pfizer Animal Health BV




Postbus 37




2900 AA Capell a/d Ijssel




THE NETHERLANDS








AT


Domitor


Medetomidine


8-00144







Pfizer Animal Health BV




Postbus 37




2900 AA Capell a/d Ijssel




THE NETHERLANDS








BE


Rompun 2 %


Xylazine hydrochloride


0187IS0155F012







BAYER N.V.




Louizalaan 143




1050 Brussel




BELGIUM








BE


Rompun Droge Stof


Xylazine hydrochloride


0187IS0120F012







BAYER N.V.




Louizalaan 143




1050 Brussel




BELGIUM








BE


Domosedan 10 mg/ml


Dnretomidine hydrochloride


0419IS0001F012







PFIZER ANIMAL HEALTH S.A.




Rue Laid Burniat 1




1348 Louvain-La-Neuve




BELGIUM








BE


Domitor 1 mg/ml


Medetomidine hydrochloride


0419IS0003F012







PFIZER ANIMAL HEALTH S.A.




Rue Laid Burniat 1




1348 Louvain-La-Neuve




BELGIUM








BE


Sedivet 10 mg/ml


Romifidine hydrochloride


0205IS0127F012







SCS BOEHRINGER INGELHEIM COMM.V




Vesalius Science Park




Avenue Ariane 16




1200 Bruxelles




BELGIUM








CY


Sedivet 1 % Solution for injection 10 mg/ml


Romifidine


CY004V-E


Boehringer Ingelheim Vetmedica GmbH




CZ


Domitor


Medetomidine hydrochloride


96/731/96-C







Pfizer Animal Health S.A.




Rue Laid Burniat 1




1348 Louvain-la-Neuve




BELGIUM








CZ


Xylazine 2 % Alfasan


Xylazine hydrochloride


96/025/00-C







ALFASAN INTERNATIONAL B.V.




P.O. BOX 78




3440 AB Woerden




THE NETHERLANDS








CZ


Sedivet 1 %


Romifidine hydrochloride


96/039/01-C







BOEHRINGER INGELHEIM VETMEDICA GMBH




Binger Strasse 173




55216 Ingelheim am Rhein




GERMANY








CZ


Domosedan inj.


Detomidine hydrochloride


96/730/96-C







Pfizer Animal Health S.A.




Rue Laid Burniat 1




1348 Louvain-la-Neuve




BELGIUM








DE


Sedivet


Romifidine hydrochloride


23715.00.00







BOEHRINGER INGELHEIM VETMEDICA GMBH




Binger Str. 173




55218 Ingelheim




GERMANY








DE


Rompun TS


Xylazine hydrochloride


6293723.00.00







Bayer Vital Gmbh




51368 Leverkusen




GERMANY








DE


Rompun 2 %


Xylazine hydrochloride


6293841.00.00







Bayer Vital GmbH




51368 Leverkusen




GERMANY








DE


Domosedan


Detomidine hydrochloride


15912.00.00







Pfizer GmbH




Pfizerstr. 1




76139 Karlsruhe




GERMANY








DE


Domitor


Medetomidine hydrochloride


32457.00.00







Pfizer GmbH




Pfizerstr. 1




76139 Karlsruhe




GERMANY








DE


Xylazin 2 %


Xylazine hydrochloride


6324464.00.00







CEVA TIERGESUNDHEIT GmbH




Kanzlerstr. 4




40472 Düsseldorf




GERMANY








DK


Sedivet Vet.


Romifidine


14896







Boehringer Ingelheim Vetmedica GmbH




Binger Str. 173




55218 Ingelheim




GERMANY








DK


Rompun Vet.


Xylazine


05669


Bayer A/S
Bayer HealthCare




ES


Rompun


Xylazine


7532 A


Química Farmacéutica Bayer




ES


Sedivet


Romifidine


1107 ESP







Boehringer Ingelheim España S.A.




Prat de la Riva s/n.




08190 Sant Cugat del Valles




Barcelona




SPAIN








ES


Domosedan


Detomidine hydrochloride


9059 I







Pfizer S.A.




Avda. Europa, 20 B




Parque Empresarial La Moraleja




28108 Alcobendas (Madrid)




SPAIN








ES


Domitor


Medetomidine hydrochloride


933 ESP







Pfizer S.A.




Avda. Europa, 20 B




Parque Empresarial La Moraleja




28108 Alcobendas (Madrid)




SPAIN








FI


Rompun vet


Xylazine hydrochloride


6047







Bayer HealthCare AG




Animal Health Division




51368 Leverkusen




GERMANY








FI


Domosedan


Detomidine hydrochloride


8546







Orion oyj




P.O. Box 65




02201 Espoo




FINLAND








FI


Domitor vet


Medetomidine hydrochloride


9501







Orion oyj




P.O. Box 65




02201 Espoo




FINLAND








FR


Rompun 2 %


Xylazine chlorhydrate


255


BAYER SANTE




FR


Rompun Lyophilise


Xylazine chlorhydrate


8061


BAYER SANTE




FR


Domosedan


Detomidine chlorhydrate


10076


PFIZER




FR


Sedivet


Romifidine Chlorhydrate


11004


BOEHRINGER INGELHEIM FRANCE




FR


Domitor


Medetomidine Chlorhydrate


10718


PFIZER




GR


Domitor


Medetomidine


46335/06-12-00


PFIZER HELLAS




GR


Rompun 2 %


Xylazine


19605/23-06-93


ALAPIS




GR


Chanazine


Xylazine


11188/30-03-99


FARMAZAC SYNVET




GR


Sedivet


Romifidine


44613/22-11-00


BOEHRINGER INGELHEIM VETMEDICA GMBH. GERMANY




HU


Rompun


Xylazine


411/1991.







Bayer Hungária Ltd.




1123 Budapest




Alkotás u. 50




HUNGARY








HU


Domosedan


Detomodine hydrochloride


2079/2006.







Pfizer Co. Ltd.




1123 Budapest




Alkotás u. 53




HUNGARY








HU


Domitor


Medetomidine hydrochloride


891/1999.







Pfizer Co. Ltd.




1123 Budapest




Alkotás u. 53




HUNGARY








HU


Primazin 2 % injection


Xylazine


743/1997.







Alfasan International B.V.




3449 JA Woerden




THE NETHERLANDS








IE


Sedivet


Romifidine


10007/023/001







Boehringer Ingelheim Ltd




Ellesfield Avenue Bracknell




Berkshire RG12 8YS




UNITED KINGDOM








IE


Chanazine 2 % Solution for Injection


Xylazine


10987/030/001







Chanelle Pharmaceuticals Manufacturing Ltd.




Loughrea




Co. Galway




IRELAND








IE


Chanazine 10 % Solution for Injection


Xylazine


10987/031/001







Chanelle Pharmaceuticals Manufacturing Ltd.




Loughrea




Co. Galway




IRELAND








IE


Domosedan Injection


Detomidine hydrochloride


10019/025/001







Pfizer Animal Health




Ringaskiddy




Co. Cork




IRELAND








IE


Domitor Injection


Medetomodine hydrochloride


10019/026/001







Pfizer Animal Health




Ringaskiddy




Co. Cork




IRELAND








IS


Domosedan, vet.


Detomidine


890003







Orion Corporation




Orionintie 1




FUB-0220 Espoo




FINLAND








IS


Chanazine 2 %, vet.


Xylazine


IS/2/01/003/02







Icepharma hf.




Lynhálsi 13




110 Reykjavík




ICELAND








IS


Chanazine 10 %, vet.


Xylazine


IS/2/01/003/01







Icepharma hf.




Lynhálsi 13




110 Reykjavík




ICELAND








IS


Rompun, vet.


Xylazine


691254







Bayer HealthCare AG




Animal Health Division




51368 Leverkusen




GERMANY








IT


Sedivet


Romifidine


102196







Boehringer Ingelheim




Località Prulli 103/c




50066 Regello




FINLAND








IT


Rompum


Xylazine


100390032







Bayer




Viale Certosa 130




20156 Milano




ITALY








IT


Rompum 2 %


Xylazine


100390018







Bayer




Viale Certosa 130




20156 Milano




ITALY








IT


Domosedan


Detomidine


100102


Orion




IT


Domitor


Medetomidine


100103


Orion Corporation animal health




LV


Xylazine 2 %


Xylazine


NRP/VFP-00544-05







Alfasan International B.V.




Kuipersweg 9




P.O. Box 78




NL-3440 AB Woerden




THE NETHERLANDS








LV


Domitor


Medetomidine


NRP/VFP-01453-07







Alfasan International B.V.




Kuipersweg 9




P.O. Box 78




NL-3440 AB Woerden




THE NETHERLANDS








NL


Sedivet


Romifidine


7232







Boehringer Ingelheim




Postbus 8037




1802 KA Alkmaar




THE NETHERLANDS








NL


Xylalin


Xylazine


3886







CEVA Santé BV




Tiendweg 8c




2671 SB Naaldwijk




THE NETHERLANDS








NL


Rompun droog


Xylazine


5407







Bayer BV Animal Health




Postbus 80




3640 AB Mijdrecht




THE NETHERLANDS








NL


Rompun


Xylazine


5409







Bayer BV Animal Health




Postbus 80




3640 AB Mijdrecht




THE NETHERLANDS








NL


Xylazine 5'+mg


Xylazine


7695







Dopharma Research BV




Postbus 205




4940 AE Raamsdonksveer




THE NETHERLANDS








NL


Aescoket Plus


Xylazine, Ketamine, Atropine


7986







Aesculaap BV




Mijlstraat 35




5281 LJ Boxtel




THE NETHERLANDS








NL


Sedazine 20 Inj.


Xylazine


8066







A.S.T. Farma BV




Willeskop 206a




4321 GW Oudewater




THE NETHERLANDS








NL


Rompun 2 % Injectievloeistof


Xylazine


8210







Bayer BV Animal Health




Postbus 80




3640 AB Mijdrecht




THE NETHERLANDS








NL


A.A. Xylazine P.I.


Xylazine


9759







CEVA Santé BV




Tiendweg 8c




2671 SB Naaldwijk




THE NETHERLANDS








NL


Xylazine 20 Inj.


Xylazine


10080







Kepro BV




Maadgenburgstraat 38




7421 ZE Deventer




THE NETHERLANDS








NL


Xylasan 2 % Pro Inj.


Xylazine


10253







Alfasan Nederland BV




Postbus 78




3440 AB Woerden




THE NETHERLANDS








NL


Chanazine 2 %


Xylazine


7756







Chanelle Pharmaceuticals Manufacturing Ltd.




Dublin Road




Loughrea




Co. Galway




IRELAND








NL


Domosedan


Detomidine


2973







Pfizer Animal Health BV




Postbus 37




2900 AA Capell a/d Ijssel




THE NETHERLANDS








NL


Domosedan


Detomidine


9713







Equi Products Holland BV




Hermelijnkoog 44




1822 CB Alkmaar




THE NETHERLANDS








NL


Domosedan


Detomidine


10032







Equi Products Holland BV




Hermelijnkoog 44




1822 CB Alkmaar




THE NETHERLANDS








NL


Domosedan


Detomidine


10131







Equi Products Holland BV




Hermelijnkoog 44




1822 CB Alkmaar




THE NETHERLANDS








NL


Domosedan


Detomidine


10295







Novivet BV




Albert Cuyplaan 2B




7482 JA Haaksbergen




THE NETHERLANDS








NL


Domosedan


Detomidine


10403







Wirtz Farma BV




Albert Cuyplaan 2B




7482 JA Haaksbergen




THE NETHERLANDS








NL


Domitor


Medetomidine


7823







Pfizer Animal Health BV




Postbus 37




2900 AA Capell a/d Ijssel




THE NETHERLANDS








NL


Domitor


Medetomidine


10354







Wirtz Farma BV




Albert Cuyplaan 2B




7482 JA Haaksbergen




THE NETHERLANDS








NO


Sedivet vet


Romifidine


0000/7913







Boehringer Ingelheim Vetmedica GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




GERMANY








NO


Rompun vet


Xylazine


0000/05588







Bayer Healthcare AG




Animal Health Division




51368 Leverkusen




GERMANY








PL


Sedivet 1 %


Romifidine


P-1257/02







Boehringer Ingelheim Vetmedica GmbH




Binger Str. 173




55218 Ingelheim




GERMANY








PL


Domosedan


Detomidine hydrochloride


P3-0505/98







Orion Corporation Orion Pharma




Tengstromink 8




Box 65




Turku 0101




FINLAND








PL


Domitor


Medetomidine hydrochloride


P2-0118/95







Orion Corporation Orion Pharma




Tengstromink 8




Box 65




Turku 0101




FINLAND








PT


Romidys 1 mg/ml Solução Injectável para cães e gatos


Romifidine


51498







Virbac S.A.




1ère avenue




2065 m, L.I.D.




06516 Carros Cedex




FRANCE








PT


Domitor


Medetomidine


50855P







Laboratórios Pzifer




AS Laboratórios Pfizer




Lda Lagoas Park




Edifício 10




2740-271 Porto Salvo




PORTUGAL








PT


Domosedan


Detomidine


50820P







Laboratórios Pzifer




AS Laboratórios Pfizer




Lda Lagoas Park




Edifício 10




2740-271 Porto Salvo




PORTUGAL








PT


Chanazine 2 %


Xylazine


51188







Agrovete




Organização Técnica Agro Pecuária




S.A R. Alto B Vista Pavilhão 40 Agualva-Cacém




2735-340 Agualva, Cacém




Lisbon




PORTUGAL








PT


Rompun


Xylazine


4770







Bayer Portugal




S.A Rua da Quinta do Pinheiro 5




2794-003 Carnaxide




PORTUGAL








RO


Xylazine 2 % xylazine


Xylazine


161895/3 of 6.12.2002 (expired)







ALFASAN INTERNATIONAL B.V.




Kuipersweg 9




3449 Ja Woerden




THE NETHERLANDS








RO


Domosedan


Detomidine


221972/2 of 23.1.2004 (valid until 23.1.2009)







PFIZER GLOBAL MANUFACTURING




Rue Laid Burniat 1




1348 Louvain La Nueve




BELGIUM




(Variation IA,1 – pending





Pfizer Animal Health MA EEIG




Ramsgate Road




Sandwich




Kent CT13 9NJ




UNITED KINGDOM)








RO


Domitor


Medetomidine


221972/3 of 23.1.2004 (valid until 23.1.2009)







PFIZER GLOBAL MANUFACTURING




Rue Laid Burniat 1




1348 Louvain La Nueve




BELGIUM




(Variation IA,1 – pending





Pfizer Animal Health MA EEIG




Ramsgate Road




Sandwich




Kent CT13 9NJ




UNITED KINGDOM)








SE


Sedivet vet.


Romifidine hydrochloride


11753







Boehringer Ingelheim Vetmedica GmbH




Binger Str. 173




55218 Ingelheim




GERMANY








SE


Rompun vet.


Xylazine hydrochloride


8534


Bayer HealthCare AG




SE


Domosedan vet.


Detomidine hydrochloride


10243







Orion Corporation




Box 65




02101 Esbo




FINLAND








SE


Domitor vet.


Medetomidine hydrochloride


10574







Orion Corporation




Box 65




02101 Esbo




FINLAND








SK


Chanazine 2 %


Xylazine


96/174/00-S







Chanelle Pharmaceuticals Manufacturing Ltd.




Dublin Road




Loughrea




Co. Galway




IRELAND








SL


Chanazine 2 %


Xylazine


323-03-8/01-42







VET4VET




Gerbičeva 50




1000 Ljubljana




SLOVENIA








SL


Domitor


Medetomidine


5363-783/2005







Pfizer Luxembourg SARL PFIZER




podružnica Ljubljana




Letališka 3 c




1000 Ljubljana




SLOVENIA








SL


Domosedan


Detomodine


5363-959/2004







Pfizer Luxembourg SARL PFIZER




podružnica Ljubljana




Letališka 3 c




1000 Ljubljana




SLOVENIA








UK


Sedivet 10 mg/ml Solution for Injection


Romifidine


00015/4033







Boehringer Ingelheim Ltd




Ellesfield Avenue




Bracknell




Berkshire RG12 8YS




UNITED KINGDOM








UK


Domosedan 10 mg/ml Injection


Detomidine hydrochloride


03649/4000







Orion Corporation Orion Pharma




Tengstromink 8




Box 65




Turku 20101




FINLAND








UK


Domosedan 10 mg/ml Injection


Detomidine hydrochloride


24939/4001







Globalmed Ltd




Ground Floor




134 Church Hill




Loughton




Essex IG10 1LH




UNITED KINGDOM








UK


Domosedan 10 mg/ml Injection


Detomidine hydrochloride


20860/4005







Quvera Ltd




Unit 8




Brember Road




Harrow




Middlesex HA2 8AX




UNITED KINGDOM








UK


Domitor 1 mg/ml Solution for Injection


Medetomidine hydrochloride


03649/4001







Orion Corporation Orion Pharma




Tengstromink 8




Box 65




Turku 20101




FINLAND








UK


Domitor Injection (Strength 1 mg/ml)


Medetomidine hydrochloride


20860/4002







Quvera Ltd




Unit 8




Brember Road




Harrow




Middlesex HA2 8AX




UNITED KINGDOM








UK


Chanazine 10 % Solution for Injection


Xylazine


11990/4006







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool L1 9HZ




UNITED KINGDOM








UK


Chanazine 2 % Solution for Injection


Xylazine


11990/4005







Chanelle Animal Health Ltd




7 Rodney Street




Liverpool L1 9HZ




UNITED KINGDOM








UK


Rompun 2 % w/v Solution for Injection


Xylazine


00010/4093







Bayer plc




Animal Health Division




Bayer House




Strawberry Hill




Newbury




Berkshire RG14 1JA




UNITED KINGDOM