Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 2014 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2014-10-31
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014386EN.01001401.xml










31.10.2014   


EN


Official Journal of the European Union


C 386/14





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 2014
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
2014/C 386/03
—   Issuing, maintenance or modification of a national marketing authorisation











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




1.9.2014


Domperidone


See Annex I


See Annex I


See Annex I


2.9.2014




4.9.2014


Diacerein


See Annex II


See Annex II


See Annex II


8.9.2014




18.9.2014


Anagrelide


anagrelide


Not applicable


Not applicable


19.9.2014




30.9.2014


Emergency contraceptives — levonorgestrel


See Annex III


See Annex III


See Annex III


1.10.2014




1.9.2014


Baytril (Art. 34)


See Annex IV


See Annex IV


See Annex IV


2.9.2014




1.9.2014


Baytril (Art. 35)


See Annex V


See Annex V


See Annex V


2.9.2014




—   Revocation of a national marketing authorisation











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




1.9.2014


Domperidone


See Annex I


See Annex I


See Annex I


2.9.2014






(1)  OJ L 311, 28.11.01, p. 67.


(2)  OJ L 311, 28.11.01, p. 1.



ANNEX I
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States











Member State
(in EEA)


Marketing authorisation holder


INN


Invented name


Strength


Pharmaceutical form


Route of administration




Austria


Janssen-Cilag Pharma GmbH
Vorgartenstraße 206b
1020 Wien
Austria


Domperidone


Motilium 10 mg — Filmtabletten


10 mg


film-coated tablet


oral use




Austria


Janssen-Cilag Pharma GmbH
Vorgartenstraße 206b
1020 Wien
Austria


Domperidone


Motilium 1 mg/ml — Suspension zum Einnehmen


1 mg/ml


oral suspension


oral use




Austria


Janssen-Cilag Pharma GmbH
Vorgartenstraße 206b
1020 Wien
Austria


Domperidone


Motilium 10 mg — Zäpfchen


10 mg


suppository


rectal use




Austria


Janssen-Cilag Pharma GmbH
Vorgartenstraße 206b
1020 Wien
Austria


Domperidone


Motilium 30 mg — Zäpfchen


30 mg


suppository


rectal use




Austria


Janssen-Cilag Pharma GmbH
Vorgartenstraße 206b
1020 Wien
Austria


Domperidone


Motilium 60 mg — Zäpfchen


60 mg


suppository


rectal use




Belgium


Teva Pharma Belgium N.V.
Laarstraat 16
2610 Wilrijk
Belgium


Domperidone maleate


Domperidon teva


10 mg


film-coated tablet


oral use




Belgium


Eurogenerics N.V.
Heizel Esplanade b22
1020 Brussels
Belgium


Domperidone maleate


Domperidone EG


10 mg


tablet


oral use




Belgium


Eurogenerics N.V.
Heizel Esplanade b22
1020 Brussels
Belgium


Domperidone


Domperidone instant EG


10 mg


orodispersible tablet


oral use




Belgium


Mylan BVBA/SPRL
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium


Domperidone maleate


Domperidone mylan


10 mg


film-coated tablet


oral use




Belgium


Apotex NV
Av Etienne Demunter 5/8
1090 Brussels
Belgium


Domperidone maleate


Domperitop


10 mg


film-coated tablet


oral use




Belgium


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone maleate


Motilium


1 mg/ml


oral suspension


oral use




Belgium


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone maleate


Motilium


10 mg


film-coated tablet


oral use




Belgium


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium


10 mg


suppository


rectal use




Belgium


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium


10 mg


effervescent granules


oral use




Belgium


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium


10 mg


film-coated tablet


oral use




Belgium


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium


1 mg/ml


oral suspension


oral use




Belgium


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium


30 mg


suppository


rectal use




Belgium


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium


60 mg


suppository


rectal use




Belgium


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium instant


10 mg


orodispersible tablet


oral use




Belgium


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


Oroperidys


10 mg


orodispersible tablet


oral use




Belgium


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Cinnarizine/
Domperidone maleate


Touristil


20 mg/
19 mg


tablet


oral use




Belgium


Kela Pharma nv
Industriepark 68
9100 Sint-Niklaas
Belgium


Domperidone maleate


Zilium


10 mg


tablet


oral use




Bulgaria


Johnson & Johnson D.O.O
Smartinska cesta 53
1000 Ljubljana
Slovenia


Domperidone


Motilium


10 mg


film-coated tablet


oral use




Bulgaria


Medochemie Ltd.
1-10 Astronafton Str.+ Limassol
3505
Cyprus


Domperidone


Costi


10 mg


tablet


oral use




Cyprus


MEDOCHEMIE LTD
1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos
Cyprus


Domperidone


COSTI TABLETS 10 MG


10 mg


tablet


oral use




Cyprus


Janssen-Cilag International NV
Turnhoutseweg 30
B-2340, Beerse
Belgium


Domperidone


MOTILIUM ORAL SUSPENSION 1 MG/ML


1 mg/ml


oral suspension


oral use




Cyprus


Janssen-Cilag International NV
Turnhoutseweg 30
B-2340, Beerse
Belgium


Domperidone


MOTILIUM SUPPOSITORY 30 MG


30 mg


suppository


rectal use




Cyprus


Janssen-Cilag International NV
Turnhoutseweg 30
B-2340, Beerse
Belgium


Domperidone


MOTILIUM TABLETS 10 MG


10 mg


tablet


oral use




Cyprus


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


OROPERIDYS ORODISPERSIBLE TABLETS 10 MG


10 mg


orodispersible tablet


oral use




Cyprus


REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos,
Cyprus


Domperidone


PEPTOMET FILM COATED TABLETS 10 MG


10 mg


tablet


oral use




Czech Republic


Janssen-Cilag s.r.o.
Karla Engliše 3201/6
150 00 Praha 5 — Smíchov
Czech Republic


Domperidone


Motilium


10 mg


film-coated tablet


oral use




Czech Republic


Pierre Fabre Médicament
45 Place Abel Gance
92654 Boulogne Cedex
France


Domperidone


Oroperidys 10 mg


10 mg


orodispersible tablet


oral use




Denmark


Janssen-Cilag (TIBOTEC)
Hammerbakken 19
3460 Birkeroed
Denmark


Domperidone


Motilium


10 mg


film-coated tablet


oral use




Denmark


Janssen-Cilag (TIBOTEC)
Hammerbakken 19
3460 Birkeroed
Denmark


Domperidone


Motilium


30 mg


suppository


rectal use




Denmark


Alternova A/S
Lodhusvej 11
4230 Skaelskoer
Denmark


Domperidone


Domperidon ‘Alternova’


10 mg


tablet


oral use




Estonia


Actavis Group Hf
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Domperidone


Domperidon Actavis


10 mg


tablet


oral use




Estonia


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


Oroperidys 10 mg


10 mg


orodispersible tablet


oral use




France


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


BIPERIDYS 20 mg, comprimé pelliculé sécable


20 mg


film-coated tablet


oral use




France


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


BIPERIDYSFLASH 20 mg, comprimé orodispersible


20 mg


orodispersible tablet


oral use




France


ACTAVIS FRANCE
La Boursidière Centre d'Affaires
92357 Le Plessis Robinson
France


Domperidone


DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


BIOGARAN
15, boulevard Charles de Gaulle
92700 Colombes
France


Domperidone


DOMPERIDONE ALMUS 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


ALTER
3, avenue de la Baltique
ZI de Courtaboeuf
91140 Villebon Sur Yvette
FRANCE


Domperidone


DOMPERIDONE ALTER 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


ARROW GENERIQUES
26, avenue Tony Garnier
69007 Lyon
France


Domperidone


DOMPERIDONE ARROW 1 mg/ml, suspension buvable


1 mg/ml


oral suspension


oral use




France


ARROW GENERIQUES
26, avenue Tony Garnier
69007 Lyon
France


Domperidone


DOMPERIDONE ARROW 10 mg, comprimé orodispersible


10 mg


orodispersible tablet


oral use




France


ARROW GENERIQUES
26, avenue Tony Garnier
69007 Lyon
France


Domperidone


DOMPERIDONE ARROW 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


AUROBINDO PHARMA FRANCE
22-26 rue des Gaudines
78100 Saint-Germain-en-Laye
France


Domperidone


DOMPERIDONE AUROBINDO 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


BIOGARAN
15, boulevard Charles de Gaulle
92700 Colombes
France


Domperidone


DOMPERIDONE BIOGARAN 10 mg, comprimé orodispersible


10 mg


orodispersible tablet


oral use




France


BIOGARAN
15, boulevard Charles de Gaulle
92700 Colombes
France


Domperidone


DOMPERIDONE BIOGARAN 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


BIOGARAN
15, boulevard Charles de Gaulle
92700 Colombes
France


Domperidone


DOMPERIDONE BIOGARAN 20 mg, comprimé pelliculé sécable.


20 mg


film-coated tablet


oral use




France


CRISTERS
22 quai Gallieni
92150 Suresnes
France


Domperidone


DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible


10 mg


orodispersible tablet


oral use




France


EG LABO — LABORATOIRES EUROGENERICS
‘Le Quintet’ — bâtiment A
12, rue Danjou
92517 Boulogne Billancourt Cedex
France


Domperidone


DOMPERIDONE EG 10 mg, comprimé orodispersible


10 mg


orodispersible tablet


oral use




France


EG LABO — LABORATOIRES EUROGENERICS
‘Le Quintet’ — bâtiment A
12, rue Danjou
92517 Boulogne Billancourt Cedex
France


Domperidone


DOMPERIDONE EG 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


EG LABO — LABORATOIRES EUROGENERICS
‘Le Quintet’ — bâtiment A
12, rue Danjou
92517 Boulogne Billancourt Cedex
France


Domperidone


DOMPERIDONE EG 20 mg, comprimé pelliculé sécable.


20 mg


film-coated tablet


oral use




France


SUBSTIPHARM DEVELOPPEMENT
8, rue Bellini
75116 Paris
France


Domperidone


DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.


20 mg


film-coated tablet


oral use




France


SUBSTIPHARM
8, rue Bellini
75116 Paris
France


Domperidone


DOMPERIDONE GERDA 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


MYLAN SAS
117, allée des Parcs
69800 Saint-Priest
France


Domperidone


DOMPERIDONE MYLAN 10 mg, comprimé orodispersible


10 mg


orodispersible tablet


oral use




France


MYLAN SAS
117, allée des Parcs
69800 Saint-Priest
France


Domperidone


DOMPERIDONE MYLAN 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


MYLAN SAS
117, allée des Parcs
69800 Saint-Priest
France


Domperidone


DOMPERIDONE MYLAN 20 mg, comprimé pelliculé sécable.


20 mg


film-coated tablet


oral use




France


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


DOMPERIDONE PIERRE FABRE 10 mg, comprimé orodispersible


10 mg


orodispersible tablet


oral use




France


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


DOMPERIDONE PIERRE FABRE 20 mg, comprimé pelliculé sécable


20 mg


film-coated tablet


oral use




France


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


DOMPERIDONE PIERRE FABRE MEDICAMENT 10 mg, comprimé orodispersible


10 mg


orodispersible tablet


oral use




France


QUALIMED (LYON)
117, allée des Parcs
69800 Saint-Priest
France


Domperidone


DOMPERIDONE QUALIMED 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


RATIOPHARM (ALLEMAGNE)
Graf Arco Strasse 3
89079 Ulm
Germany


Domperidone


DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible


10 mg


orodispersible tablet


oral use




France


RATIOPHARM (ALLEMAGNE)
Graf Arco Strasse 3
89079 Ulm
Germany


Domperidone


DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


Ranbaxy Pharmacie Génériques
11-15 Quai Dion Bouton
92800 Puteaux
France


Domperidone


DOMPERIDONE RPG 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


SANDOZ
49, avenue Georges Pompidou
92300 Levallois-Perret
France


Domperidone


DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible


10 mg


orodispersible tablet


oral use




France


SANDOZ
49, avenue Georges Pompidou
92300 Levallois-Perret
France


Domperidone


DOMPERIDONE SANDOZ 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


SANDOZ
49, avenue Georges Pompidou
92300 Levallois-Perret
France


Domperidone


DOMPERIDONE SANDOZ 20 mg, comprimé pelliculé sécable.


20 mg


film-coated tablet


oral use




France


SUBSTIPHARM DEVELOPPEMENT
8, rue Bellini
75116 Paris
France


Domperidone


DOMPERIDONE SG-PHARM 20 mg, comprimé pelliculé sécable.


20 mg


film-coated tablet


oral use




France


SUBSTIPHARM DEVELOPPEMENT
8, rue Bellini
75116 Paris
France


Domperidone


DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable


20 mg


film-coated tablet


oral use




France


TEVA SANTE
110, Esplanade du Général de Gaulle
92931 Paris La Défense Cedex
France


Domperidone


DOMPERIDONE TEVA 10 mg, comprimé orodispersible


10 mg


orodispersible tablet


oral use




France


TEVA SANTE
110, Esplanade du Général de Gaulle
92931 Paris La Défense Cedex
France


Domperidone


DOMPERIDONE TEVA 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


TEVA SANTE
110, Esplanade du Général de Gaulle
92931 Paris La Défense Cedex
France


Domperidone


DOMPERIDONE TEVA 20 mg, comprimé pelliculé sécable


20 mg


film-coated tablet


oral use




France


Sanofi-Aventis France
1-13, boulevard Romain Rolland
75014 Paris
France


Domperidone


DOMPERIDONE ZENTIVA 10 mg, comprimé orodispersible


10 mg


orodispersible tablet


oral use




France


Sanofi-Aventis France
1-13, boulevard Romain Rolland
75014 Paris
France


Domperidone


DOMPERIDONE ZENTIVA 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


Sanofi-Aventis France
1-13, boulevard Romain Rolland
75014 Paris
France


Domperidone


DOMPERIDONE ZENTIVA 20 mg, comprimé pelliculé sécable.


20 mg


film-coated tablet


oral use




France


ZYDUS FRANCE
25, rue des Peupliers
ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers
92000 Nanterre
France


Domperidone


DOMPERIDONE ZYDUS 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


Janssen-Cilag
1, rue Camille Desmoulins
TSA 91003
92787 Issy-les-Moulineaux Cedex 9
France


Domperidone


MOTILIUM 1 mg/ml, suspension buvable


1 mg/ml


oral suspension


oral use




France


Janssen-Cilag
1, rue Camille Desmoulins
TSA 91003
92787 Issy-les-Moulineaux Cedex 9
France


Domperidone


MOTILIUM 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




France


Janssen-Cilag
1, rue Camille Desmoulins
TSA 91003
92787 Issy-les-Moulineaux Cedex 9
France


Domperidone


MOTILIUM 10 mg, granulés effervescents en sachet-dose


10 mg


effervescent granules


oral use




France


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


OROPERIDYS 10 mg, comprimé orodispersible


10 mg


orodispersible tablet


oral use




France


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


PERIDYS 1 mg/ml, suspension buvable


1 mg/ml


oral suspension


oral use




France


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


PERIDYS 10 mg, comprimé pelliculé


10 mg


film-coated tablet


oral use




Germany


1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany


Domperidonemaleat


Domperidon — 1 A Pharma 10 mg Tabletten


12,72 mg


tablet


oral use




Germany


AbZ Pharma GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany


Domperidonemaleat


Domperidon-CT 10 mg Filmtabletten


12,73 mg


film-coated tablet


oral use




Germany


AbZ Pharma GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany


Domperidonemaleat


Domperidon AbZ 10 mg Filmtabletten


12,73 mg


film-coated tablet


oral use




Germany


Accord Healthcare Limited
Sage House, 319, Pinner Road
HA1 4HF North Harrow, Middlesex
United Kingdom


Domperidonemaleat


Domperidon Accord 10 mg Tabletten


12,72 mg


tablet


oral use




Germany


ALIUD PHARMA GmbH
Gottlieb-Daimler-Str. 19
89150 Laichingen
Germany


Domperidonemaleat


Domperidon AL 10 mg Tabletten


12,72 mg


tablet


oral use




Germany


Betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany


Domperidonemaleat


Domperidon beta 10 mg Tabletten


12,72 mg


tablet


oral use




Germany


HEXAL AG
Industriestr. 25
83607 Holzkirchen
Germany


Domperidonemaleat


Domperidom Hexal 10 mg Tabletten


12,72 mg


tablet


oral use




Germany


RATIOPHARM GmbH
Graf Arco Strasse 3
89079 Ulm
Germany


Domperidonemaleat


Domperidon-ratiopharm 10 mg Filmtabletten


12,73 mg


film-coated tablet


oral use




Germany


Stadapharm GmbH
Stadastr. 2-18
61118 Bad Vilbel
Germany


Domperidonemaleat


Domperidon STADA 10 mg Tabletten


12,72 mg


tablet


oral use




Germany


Takeda GmbH
Byk-Gulden-Str. 2
78467 Konstanz
Germany


Domperidone


Motilium Tropfen


10 mg


oral drops, suspension


oral use




Germany


Takeda GmbH
Byk-Gulden-Str. 2
78467 Konstanz
Germany


Domperidone


Motilium


10 mg


tablet


oral use




Germany


TEVA GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany


Domperidonemaleat


Domperidon-TEVA 10 mg Filmtabletten


12,73 mg


film-coated tablet


oral use




Germany


TEVA GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany


Domperidonemaleat


Domidon 10 mg Filmtabletten


12,73 mg


film-coated tablet


oral use




Greece


JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA
Epidarvou 4 & Aigialeias
Maroussi 15125
Athens,
Greece


Domperidone


CILROTON


10 mg


film-coated tablet


oral use




Greece


JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA
Epidarvou 4 & Aigialeias
Maroussi 15125
Athens,
Greece


Domperidone


CILROTON


5 mg/5 ml


oral solution


oral use




Greece


PIERRE FABRE MEDICINES SA
Messogeion 350, Agia Paraskevi 15341
Athens,
Greece


Domperidone


OROPERIDYS


10 mg


orodispersible tablet


oral use




Hungary


Extractum Pharma zRT. Megyeri út 64. Budapest H-1044 Hungary


Domperidone


Domperidon-EP 10 mg tabletta


10 mg


tablet


oral use




Hungary


Janssen-Cilag Kft.
Tó park
H-2045 Törökbálint
Hungary


Domperidone


Motilium 10 mg filmtabletta


10 mg


film-coated tablet


oral use




Ireland


McNeil Healthcare (Ireland) Limited
Airton Road
Tallaght
Dublin 24
Ireland


Domperidone


Motilium Fastmelts 10 mg Tablets


10 mg


tablet


oral use




Ireland


McNeil Healthcare (Ireland) Limited
Airton Road
Tallaght
Dublin 24
Ireland


Domperidone


Motilium 10 mg Film-Coated Tablets


10 mg


tablet


oral use




Ireland


McNeil Healthcare (Ireland) Limited
Airton Road
Tallaght
Dublin 24
Ireland


Domperidone


Motilium 10 mg Suppositories


10 mg


suppository


rectal use




Ireland


McNeil Healthcare (Ireland) Limited
Airton Road
Tallaght
Dublin 24
Ireland


Domperidone


Motilium 30 mg Suppositories


30 mg


suppository


rectal use




Ireland


McNeil Healthcare (Ireland) Limited
Airton Road
Tallaght
Dublin 24
Ireland


Domperidone


Motilium 60 mg Suppositories


60 mg


suppository


rectal use




Ireland


McNeil Healthcare (Ireland) Limited
Airton Road
Tallaght
Dublin 24
Ireland


Domperidone


Motilium 1 mg/ml Oral Suspension


1 mg/ml


oral suspension


oral use




Ireland


McNeil Healthcare (Ireland) Limited
Airton Road
Tallaght
Dublin 24
Ireland


Domperidone


Motilium Rx 10 mg Film-coated Tablets


10 mg


film-coated tablet


oral use




Ireland


Rowex Ltd
Bantry
Co Cork
Ireland


Domperidone


DOMERID 10 mg Tablets.


10 mg


tablet


oral use




Ireland


Rowex Ltd
Bantry
Co Cork
Ireland


Domperidone


Domerid Relief 10 mg Tablets.


10 mg


tablet


oral use




Italy


ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


10 mg


film-coated tablet


oral use




Italy


ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


60 mg


suppository


rectal use




Italy


ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


30 mg


suppository


rectal use




Italy


ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


10 mg


effervescent granules


oral use




Italy


ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


1 mg/ml


suspension


oral use




Italy


ITALCHIMICI SpA
Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


20 mg


film-coated tablet


oral use




Italy


ITALCHIMICI SpA
Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


20 mg


effervescent granules


oral use




Italy


Janssen-Cilag SpA
Via Michelangelo buonarroti 23
20093 Cologno Monzese — Milano
Italy


Domperidone


MOTILIUM


1 mg/ml


suspension


oral use




Italy


Janssen-Cilag SpA
Via Michelangelo buonarroti 23
20093 Cologno Monzese — Milano
Italy


Domperidone


MOTILIUM


10 mg


film-coated tablet


oral use




Italy


Janssen-Cilag SpA
Via Michelangelo buonarroti 23
20093 Cologno Monzese — Milano
Italy


Domperidone


MOTILIUM


10 mg


effervescent granules


oral use




Italy


DR. REDDY'S S.R.L.
Via Fernanda Wittgens 3 — 20123 Milano
Italy


Domperidone


DOMPERIDONE DR. REDDY'S


10 mg


tablet


oral use




Italy


DR. REDDY'S S.R.L.
Via Fernanda Wittgens 3 — 20123 Milano
Italy


Domperidone


DOMPERIDONE DR. REDDY'S


100 mg/100 ml


syrup


oral use




Italy


GIULIANI S.P.A
Via Palagi 2 20129 Milano
Italy


Domperidone


DIGESTIVO GIULIANI


5 mg


effervescent granules


oral use




Italy


GIULIANI S.P.A
Via Palagi 2
20129 Milano
Italy


Domperidone


DIGESTIVO GIULIANI


5 mg


chewable tablet


oral use




Italy


GIULIANI S.P.A
Via Palagi 2
20129 Milano
Italy


Domperidone


DIGESTIVO GIULIANI


10 mg


film-coated tablet


oral use




Italy


TEVA ITALIA S.R.L.
Via Messina 38
20154 Milano
Italy


Domperidone


DOMPERIDONE TEVA


10 mg


film-coated tablet


oral use




Italy


GERMED PHARMA SpA
Via Cantù 11
20092 Cinisello Balsamo — Milano — Italy


Domperidone


DOMPERIDONE GERMED


10 mg


film-coated tablet


oral use




Italy


GERMED PHARMA SpA
Via Cantù 11
20092 Cinisello Balsamo — Milano — Italy


Domperidone


DOMPERIDONE GERMED


10 mg/10 ml


suspension


oral use




Italy


ABC FARMACEUTICI SpA,
Corso Vittorio Emanuele II 72, 10121 Torino
Italy


Domperidone


DOMPERIDONE ABC


10 mg


tablet


oral use




Italy


MYLAN SpA
Via Vittor Pisani 20
20124 Milano
Italy


Domperidone


DOMPERIDONE MYLAN GENERICS


10 mg


tablet


oral use




Italy


FG S.R.L.
Via San Rocco 6 -
85033 Episcopia Potenza
Italy


Domperidone


DOMPERIDONE FG


10 mg


tablet


oral use




Italy


EG SpA
Via Domenico Scarlatti 31
20124 Milano
Italy


Domperidone


DOMPERIDONE EG


10 mg


tablet


oral use




Italy


LABORATORI ALTER S.R.L.
Via Egadi 7
20144 Milano
Italy


Domperidone


DOMPERIDONE ALTER


10 mg


tablet


oral use




Italy


CRINOS SpA
Via Pavia 6
20136 Milano
Italy


Domperidone


RIGES


10 mg


tablet


oral use




Italy


SANDOZ SpA
Largo Umberto Boccioni 1
21040 Origgio — Varese
Italy


Domperidone


PYNINAT


10 mg


tablet


oral use




Italy


DOC GENERICI S.R.L.
Via Manunzio 7
20124 Milano
Italy


Domperidone


DOMPERIDONE DOC GENERICI


10 mg


tablet


oral use




Italy


ALMUS S.R.L.
Via Cesarea 11/10
16121 Genova
Italy


Domperidone


DOMPERIDONE ALMUS


10 mg


tablet


oral use




Italy


FARMAKOPEA S.P.A
Via Cavriana 14
20134 Milano
Italy


Domperidone


DALIA


10 mg


effervescent tablet


oral use




Italy


SANDOZ SpA
Largo Umberto Boccioni 1
21040 Origgio — Varese
Italy


Domperidone


DOMPERIDONE SANDOZ


10 mg


tablet


oral use




Italy


PENSA PHARMA SpA
Via Ippolito Rossellini 12
20124 Milano
Italy


Domperidone


DOMPERIDONE PENSA


10 mg


effervescent tablet


oral use




Italy


FARMAKOPEA S.P.A
Via Cavriana 14
20134 Milano
Italy


Domperidone


GERDI


5 mg


effervescent tablet


oral use




Italy


FARMAKOPEA S.P.A
Via Cavriana 14
20134 Milano
Italy


Domperidone


GERDI


5 mg


effervescent granules


oral use




Italy


CRINOS SpA
Via Pavia 6
20136 Milano
Italy


Domperidone


RAXAR


10 mg


orodispersible tablet


oral use




Italy


PIERRE FABRE PHARMA S.R.L. Via Winckelmann 1 20146 Milano
Italy


Domperidone


NEOPERIDYS


10 mg


orodispersible tablet


oral use




Italy


SOFAR S.p.a. Via Firenze, 40 20060 Trezzano Rosa — Milano
Italy


Domperidone Maleato


PERMOTIL


10 mg


tablet


oral use




Italy


ANGENERICO S.p.a.
Via Nocera Umbra 75, 00181 Roma
Italy


Domperidone Maleato


DOMPERIDONE ANGENERICO


10 mg


tablet


oral use




Latvia


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


Oroperidys 10 mg orodispersible tablets


10 mg


orodispersible tablet


oral use




Latvia


UAB ‘Johnson & Johnson’
Geležinio Vilko g. 18A
LT-08104 Vilnius
Lithuania


Domperidone


Motilium 10 mg film-coated tablets


10 mg


film-coated tablet


oral use




Latvia


Actavis Group Hf
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Domperidone


Domperidon Actavis 10 mg tablets


10 mg


tablet


oral use




Lithuania


Actavis Group Hf
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Domperidone


Domperidon Actavis


10 mg


tablet


oral use




Lithuania


Torrent Pharma GmbH
Sudwestpark 50
Nurnberg D-90449
Germany


Domperidone


Domstal


10 mg


tablet


oral use




Lithuania


UAB ‘Johnson & Johnson’
Geležinio Vilko g. 18A
LT-08104 Vilnius
Lithuania


Domperidone


Motilium


10 mg


film-coated tablet


oral use




Lithuania


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


Oroperidys


10 mg


orodispersible tablet


oral use




Luxembourg


Eurogenerics SA esplanade heysel b22 1020 bruxelles
Belgium


Domperidone (maleate)


Domperidone EG-10


10 mg


tablet


oral use




Luxembourg


Eurogenerics SA esplanade heysel b22
1020 bruxelles
Belgium


Domperidone


Domperidone EG-10


10 mg


orodispersible tablet


oral use




Luxembourg


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium Domperidone Base


10 mg


coated tablet


oral use




Luxembourg


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium Instant-10


10 mg


orodispersible tablet


oral use




Luxembourg


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone (maleate)


Motilium-10


10 mg


coated tablet


oral use




Luxembourg


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium pediatrie


1 mg/ml


oral suspension


oral use




Luxembourg


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium-1 mg/ml


1 mg/ml


oral suspension


oral use




Luxembourg


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium-10 supp


10 mg


suppository


rectal use




Luxembourg


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium-30 supp


30 mg


suppository


rectal use




Luxembourg


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Domperidone


Motilium-60 supp


60 mg


suppository


rectal use




Luxembourg


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


Oroperidys


10 mg


orodispersible tablet


oral use




Luxembourg


Johnson & Johnson Consumer N.V.
Antwerpseweg 15-17
2340 Beerse
Belgium


Cinnarizine/Domperidone (maleate)


Touristil


20 mg/
15 mg


tablet


oral use




Malta


Actavis Group Hf
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Domperidone


Domperidon Actavis


10 mg


tablet


oral use




Malta


Medochemie Limited
PO Box 51409
Limassol CY-3505
Cyprus


Domperidone


Costi 10 mg Film coated tablets


10 mg


film-coated tablet


oral use




Malta


Janssen-Cilag International NV
Turnhoutseweg 30
B-2340, Beerse
Belgium


Domperidone


motilium 1 mg/ml oral suspension


1 mg/ml


oral suspension


oral use




Malta


Janssen-Cilag International NV
Turnhoutseweg 30
B-2340, Beerse
Belgium


Domperidone


motilium 10 mg film coated tablets


10 mg


film-coated tablet


oral use




Malta


Janssen-Cilag International NV
Turnhoutseweg 30
B-2340, Beerse
Belgium


Domperidone


motilium 30 mg Suppositories


30 mg


suppository


rectal use




Poland


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


Domperidone


Oroperidys


10 mg


orodispersible tablet


oral use




Portugal


Laboratório Medinfar — Produtos Farmacêuticos, S.A.
Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova
2700-547 Amadora
Portugal


Domperidone


Cinet


10 mg


tablet


oral use




Portugal


Laboratório Medinfar — Produtos Farmacêuticos, S.A.
Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova
2700-547 Amadora
Portugal


Domperidone


Cinet


10 mg


dispersible tablet


oral use




Portugal


Laboratório Medinfar — Produtos Farmacêuticos, S.A.
Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova
2700-547 Amadora
Portugal


Domperidone


Cinet


1 mg/ml


oral suspension


oral use




Portugal


Actavis A/S Sucursal
Rua Virgílio Correia, 11 — A
1600-219 Lisboa
Portugal


Domperidone


Domperidona Actavis


10 mg


tablet


oral use




Portugal


Baldacci — Portugal, S.A.
Rua Cândido de Figueiredo, 84-B
1549-005 Lisboa
Portugal


Domperidone


Domperidona Baldacci


10 mg


film-coated tablet


oral use




Portugal


Ciclum Farma Unipessoal, Lda.
Quinta da Fonte, Rua Vitor Câmara, 2 — Edifício D. Amélia, Piso 1, Ala B
2770-229 Paço de Arcos
Portugal


Domperidone


Domperidona Ciclum


10 mg


tablet


oral use




Portugal


GP — Genéricos Portugueses, Lda.
Rua Henrique Paiva Couceiro, 29 — Venda Nova
2700-451 Amadora
Portugal


Domperidone


Domperidona GP


10 mg


tablet


oral use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Domperidone


Domperidona Generis


10 mg


film-coated tablet


oral use




Portugal


Germed Farmacêutica, Lda.
Rua Alto do Montijo, 13 — 1o Dto — Edifício Monsanto
2790-012 Portela de Carnaxide
Portugal


Domperidone


Domperidona Germed


10 mg


film-coated tablet


oral use




Portugal


Labesfal Genéricos, S.A.
Avenida Dr. Afonso Costa, 1370
3465-051 Campo de Besteiros
Portugal


Domperidone


Domperidona Labesfal


10 mg


tablet


oral use




Portugal


Mylan, Lda.
Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C — 7.3 e 7.4
1990-095 Lisboa
Portugal


Domperidone


Domperidona Mylan


10 mg


film-coated tablet


oral use




Portugal


Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.
Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo
Portugal


Domperidone


Domperidona Ratiopharm


10 mg


film-coated tablet


oral use




Portugal


ToLife — Produtos Farmacêuticos, S.A.
Avenida do Forte, 3 — Edificio Suécia III, Piso 1
2794-093 Carnaxide
Portugal


Domperidone


Domperidona ToLife


10 mg


tablet


oral use




Portugal


Wynn Industrial Pharma, S.A.
Rua Tierno Galvan, Torre 3, 16o Piso, Amoreiras
1070-274 Lisboa
Portugal


Domperidone


Domperidona Wynn


10 mg


tablet


oral use




Portugal


Johnson & Johnson, Lda.
Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo
2730-055 Barcarena
Portugal


Domperidone


Motilium


1 mg/ml


oral suspension


oral use




Portugal


Johnson & Johnson, Lda.
Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo
2730-055 Barcarena
Portugal


Domperidone


Motilium


10 mg


film-coated tablet


oral use




Portugal


Johnson & Johnson, Lda.
Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo
2730-055 Barcarena
Portugal


Domperidone


Motilium


10 mg


effervescent granules


oral use




Portugal


Johnson & Johnson, Lda.
Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo
2730-055 Barcarena
Portugal


Domperidone


Motilium Rapid


10 mg


orodispersible tablet


oral use




Portugal


Laboratórios Azevedos — Indústria Farmacêutica, S.A.
Edifícios Azevedos — Estrada Nacional 117-2, Alfragide
2614-504 Amadora
Portugal


Domperidone


Remotil


10 mg


tablet


oral use




Romania


S.C. TERAPIA S.A.
Str. Fabricii nr. 124, Cluj Napoca,
Romania


DOMPERIDONE


MOTILIUM 10 mg


10 mg


film-coated tablet


oral use




Romania


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


DOMPERIDONE


OROPERIDYS 10 mg


10 mg


orodispersible tablet


oral use




Slovak Republic


Pierre Fabre Médicament
45 Place Abel Gance
92654 Boulogne Cedex
France


Domperidone


OROPERIDYS 10 mg


10 mg


tablet


oral use




Slovak Republic


Medochemie Ltd.
1-10 Constantinoupoleos St.
P.O. Box: 51409
3505 Limassol Cyprus


Domperidone


COSTI


10 mg


tablet


oral use




Slovenia


KRKA, tovarna zdravil, d.d., Novo mesto
Šmarješka cesta 6 8501 Novo mesto Slovenia


Domperidone


Tametil 10 mg filmsko obložene tablete


10 mg


film-coated tablet


oral use




Spain


LABORATORIOS DR. ESTEVE, S.A.
Avda. Mare de Déu de Montserrat, 221
08041 Barcelona
Spain


Domperidone


Motilium 30 mg supositorios niños


30 mg


suppository


rectal use




Spain


LABORATORIOS DR. ESTEVE, S.A.
Avda. Mare de Déu de Montserrat, 221
08041 Barcelona
Spain


Domperidone


Motilium 10 mg comprimidos recubiertos con película


10 mg


film-coated tablet


oral use




Spain


LABORATORIOS DR. ESTEVE, S.A.
Avda. Mare de Déu de Montserrat, 221
08041 Barcelona
Spain


Domperidone


Motilium 1 mg/ml suspensión oral


1 mg/ml


oral suspension


oral use




Spain


Janssen-Cilag, S.A.
Po de Las Doce Estrellas, 5-7
28042 Madrid
Spain


Domperidone


Nauzelin 1 mg/ml suspensión oral


1 mg/ml


oral suspension


oral use




Spain


Janssen-Cilag, S.A.
Po de Las Doce Estrellas, 5-7
28042 Madrid
Spain


Domperidone


Nauzelin 10 mg comprimidos recubiertos con película


10 mg


film-coated tablet


oral use




Spain


ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain


Domperidone


Domperidona Gamir 10 mg cápsulas duras


10 mg


capsule, hard


oral use




Spain


ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain


Domperidone


Domperidona Gamir 1 mg/ml suspensión oral


1 mg/ml


oral suspension


oral use




Spain


PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3-bajos
Valencia 46015 Spain


Domperidone maleate


Domperidona Pensa 10 mg comprimidos EFG


12,72 mg


tablet


oral use




Spain


Pierre Fabre Médicament
45 place Abel Gance
F-92100 Boulogne
France


Domperidone


Orosperidys 10 mg comprimidos bucodispersables


10 mg


orodispersible tablet


oral use




The Netherlands


Johnson & Johnson Consumer B.V.
Rooseveltweg 15
1314 SJ Almere
The Netherlands


Domperidone


Motilium filmomhulde tabletten 10 mg


10 mg


film-coated tablet


oral use




The Netherlands


Johnson & Johnson Consumer B.V.
Rooseveltweg 15
1314 SJ Almere
The Netherlands


Domperidone


Motilium suspensie voor oraal gebruik 1 mg/ml


1 mg/ml


oral suspension


oral use




The Netherlands


Johnson & Johnson Consumer B.V.
Rooseveltweg 15
1314 SJ Almere
The Netherlands


Domperidone


Motilium zetpillen voor zuigelingen 10 mg


10 mg


suppository


rectal use




The Netherlands


Johnson & Johnson Consumer B.V.
Rooseveltweg 15
1314 SJ Almere
The Netherlands


Domperidone


Motilium zetpillen voor kinderen 30 mg


30 mg


suppository


rectal use




The Netherlands


Johnson & Johnson Consumer B.V.
Rooseveltweg 15
1314 SJ Almere
The Netherlands


Domperidone


Motilium zetpillen voor volwassenen 60 mg


60 mg


suppository


rectal use




The Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands


Domperidone


Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg


10 mg


suppository


rectal use




The Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands


Domperidone


Domperidon 30 PCH voor kinderen, zetpillen 30 mg


30 mg


suppository


rectal use




The Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands


Domperidone


Domperidon 60 PCH voor volwassenen, zetpillen 60 mg


60 mg


suppository


rectal use




The Netherlands


Johnson & Johnson Consumer B.V.
Rooseveltweg 15
1314 SJ Almere
The Netherlands


Domperidone


Domperidon JJC filmomhulde tabletten 10 mg


10 mg


film-coated tablet


oral use




The Netherlands


Johnson & Johnson Consumer B.V.
Rooseveltweg 15
1314 SJ Almere
The Netherlands


Domperidone


Domperidon JJC zetpillen voor volwassenen 60 mg


60 mg


suppository


rectal use




The Netherlands


Johnson & Johnson Consumer B.V.
Rooseveltweg 15
1314 SJ Almere
The Netherlands


Domperidone


Domperidon JJC zetpillen voor kinderen 30 mg


30 mg


suppository


rectal use




The Netherlands


Johnson & Johnson Consumer B.V.
Rooseveltweg 15
1314 SJ Almere
The Netherlands


Domperidone


Domperidon JJC zetpillen voor zuigelingen 10 mg


10 mg


suppository


rectal use




The Netherlands


Samenwerkende Apothekers Nederland B.V.
Kralingseweg 201
3062 CE Rotterdam
The Netherlands


Domperidone


Domperidon 30 mg zetpillen Samenwerkende Apothekers


30 mg


suppository


rectal use




The Netherlands


Samenwerkende Apothekers Nederland B.V.
Kralingseweg 201
3062 CE Rotterdam
The Netherlands


Domperidone


Domperidon 60 mg zetpillen Samenwerkende Apothekers, zetpillen


60 mg


suppository


rectal use




The Netherlands


Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
The Netherlands


Domperidone


Domperidon Mylan 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Pharmacin B.V.
Molenvliet 103
3335 LH Zwijndrecht
The Netherlands


Domperidone


Domperidon Pharmacin 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands


Domperidone


Domperidon 10 PCH, filmomhulde tabletten 10 mg


10 mg


film-coated tablet


oral use




The Netherlands


Accord Healthcare Ltd
Sage House, 319 Pinner Road
HA1 4 HF North Harrow, Middlesex
United Kingdom


Domperidone


Domperidon Accord 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Healthypharm B.V.
Nieuwe Donk 3
4879 AC Etten-Leur
The Netherlands


Domperidone


Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Leidapharm B.V.
Archimedesweg 2
2333 CN Leiden
The Netherlands


Domperidone


Domperidon 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Stada Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany


Domperidone


Domperidon STADA 10 mg tabletten


10 mg


tablet


oral use




The Netherlands


Actavis B.V.
Baarnsche Dijk 1
3741 LN Baarn
The Netherlands


Domperidone


Domperidon Actavis 10 mg, omhulde tabletten


10 mg


coated tablet


oral use




The Netherlands


Centrafarm B.V.
Nieuwe Donk 3
4879 AC Etten-Leur
The Netherlands


Domperidone


Domperidon CF 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands


Domperidone


Domperidon PCH 10, filmomhulde tabletten 10 mg


10 mg


film-coated tablet


oral use




The Netherlands


Wise Pharmaceuticals Ltd.
Hamwells Business Park Unit No7, Hardicker Street
M19 2RB Manchester
United Kingdom


Domperidone


Domperidon 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Marel B.V.
Archimedesweg 2
2333 CN Leiden
The Netherlands


Domperidone


Kruidvat Domperidon 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands


Domperidone


Domperidon Sandoz 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Sofar S.p.A.
Via Firenze 40
20060 Trezzano Rosa (MI)
Italy


Domperidone


Domperidon Sofar 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Bellwood Pharmaceuticals Ltd.
First Floor 69, St. Patricks Road
Dalkey, Co. Dublin
Ireland


Domperidone


Domperidon Bellwood 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Faribérica, Productos Farmacêuticos, SA
Estrada da Luz, 90-9o CDE
1600-160 Lissabon
Portugal


Domperidone


Domperidon Faribérica 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Actavis Nordic A/S
Ornegardsvej 16
2820 Gentofte
Denmark


Domperidone


Domperidon Actavis 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Mediq Farma B.V.
Hertogswetering 159
3543 AS Utrecht
The Netherlands


Domperidone


Domperidon Mdq 10 mg, tabletten


10 mg


tablet


oral use




The Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands


Domperidone


Domperidon 10 mg PCH, tabletten


10 mg


tablet


oral use




The Netherlands


Samenwerkende Apothekers Nederland B.V.
Kralingseweg 201
3062 CE Rotterdam
The Netherlands


Domperidone


Domperidon 10 mg tabletten Samenwerkende Apothekers


10 mg


tablet


oral use




The Netherlands


Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands


Domperidone


Domperidon 10 mg Pharmachemie, tabletten


10 mg


tablet


oral use




The Netherlands


KELA Pharma nv
Industriepark West 68
9100 Sint-Niklaas
Belgium


Domperidone


Domperidon Kela 10 mg, tabletten


10 mg


tablet


oral use




United Kingdom


Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stoke-on-Trent, Staffordshire ST3 7UN
United Kingdom


Domperidone maleate


Domperidone 10 mg Tablets


10 mg


tablet


oral use




United Kingdom


Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG,
United Kingdom


Domperidone maleate


Domperidone Tablets 10 mg


10 mg


coated tablet


oral use




United Kingdom


Co-Pharma Limited
Unit 4, Metro Centre
Tolpits Lane, Watford
Hertfordshire
WD18 9SS
United Kingdom


Domperidone maleate


Domperidone 10 mg Tablets


10 mg


tablet


oral use




United Kingdom


Manx Healthcare Limited
Taylor Group House
Wedgnock Lane
Warwick
CV34 5YA
United Kingdom


Domperidone maleate


Domperidone 10 mg Tablets


10 mg


tablet


oral use




United Kingdom


McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
United Kingdom


Domperidone maleate


Motilium 10


10 mg


tablet


oral use




United Kingdom


McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
United Kingdom


Domperidone maleate


Motilium Instants


10 mg


orodispersible tablet


oral use




United Kingdom


Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD,
United Kingdom


Domperidone maleate


Domperidone 10 mg Tablets


10 mg


tablet


oral use




United Kingdom


Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS,
United Kingdom


Domperidone


Domperidone 1 mg/ml Oral Suspension


5 mg


oral suspension


oral use




United Kingdom


Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS
United Kingdom


Domperidone maleate


Motilium 10 mg Film-coated Tablets


10 mg


film-coated tablet


oral use




United Kingdom


Bristol Laboratories Limited
Unit 3, Canalside
Northbridge Road, Berkhamsted
Hertfordshire
HP4 1EG
United Kingdom


Domperidone maleate


Domperidone 10 mg Tablets


10 mg


tablet


oral use




United Kingdom


Focus Pharmaceuticals Limited
Unit 5, Faraday Court
First Avenue, Centrum 100
Burton Upon Trent, Staffordshire
DE14 2WX
United Kingdom


Domperidone maleate


Domperidone 10 mg Tablets


10 mg


tablet


oral use




United Kingdom


Medreich plc,
Warwick House, Plane Tree Crescent, Feltham TW13 7HF
United Kingdom


Domperidone maleate


Domperidone 10 mg Tablets


10 mg


tablet


oral use




United Kingdom


Wockhardt UK Limited
Ash Road North
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom


Domperidone maleate


Domperidone 10 mg Tablets


10 mg


film-coated tablet


oral use




United Kingdom


Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co. Roscommon,
Ireland


Domperidone maleate


Domperidone 10 mg Tablets


10 mg


film-coated tablet


oral use







ANNEX II
List of the names, pharmaceutical form, strength 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


TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG
2355 Wiener Neudorf
Austria


ARTROLYT 50 mg Kapseln


50 mg


capsule, hard


oral use




Austria


TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG
2355 Wiener Neudorf
Austria


VERBORIL 50 mg Kapseln


50 mg


capsule, hard


oral use




Czech Republic


TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG
2355 Wiener Neudorf
Austria


ARTRODAR


50 mg


capsule, hard


oral use




France


NEGMA
10, rue Paul Dautier
78140 Vélizy Villacoublay
France


ART 50 mg, gélule


50 mg


capsule, hard


oral use




France


ACTAVIS GROUP (ISLANDE)
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland


DIACEREINE ACTAVIS 50 mg, gélule


50 mg


capsule, hard


oral use




France


ARROW GENERIQUES
26, avenue Tony Garnier
69007 Lyon
France


DIACEREINE ARROW 50 mg, gélule


50 mg


capsule, hard


oral use




France


BIOGARAN
15, boulevard Charles de Gaulle
92700 Colombes
France


DIACEREINE BIOGARAN 50 mg, gélule


50 mg


capsule, hard


oral use




France


CRISTERS
22 quai Gallieni
92150 Suresnes
France


DIACEREINE CRISTERS 50 mg, gélule


50 mg


capsule, hard


oral use




France


EG LABO — LABORATOIRES EUROGENERICS
‘Le Quintet’ — bâtiment A
12, rue Danjou
92517 Boulogne Billancourt Cedex
France


DIACEREINE EG 50 mg, gélule


50 mg


capsule, hard


oral use




France


EVOLUPHARM
rue Irène Caron
Zone Industrielle d'Auneuil
60390 Auneuil
France


DIACEREINE EVOLUGEN 50 mg, gélule


50 mg


capsule, hard


oral use




France


MAZAL PHARMACEUTIQUE
11, rue Rontgen
BP 1309
29103 Quimper
France


DIACEREINE MAZAL 50 mg, gélule


50 mg


capsule, hard


oral use




France


MYLAN SAS
117, allée des Parcs
69800 Saint-Priest
France


DIACEREINE MYLAN 50 mg, gélule


50 mg


capsule, hard


oral use




France


NEGMA
10, rue Paul Dautier
78140 Vélizy Villacoublay
France


DIACEREINE NEGMA 50 mg, gélule


50 mg


capsule, hard


oral use




France


LABORATOIRES PHARMA 2000
10 rue Paul Dautier
78140 Vélizy Villacoublay
France


DIACEREINE PHARMA 2000 50 mg, gélule


50 mg


capsule, hard


oral use




France


RANBAXY PHARMACIE GENERIQUES
11-15 Quai de Dion Bouton
92800 Puteaux
France


DIACEREINE RANBAXY 50 mg, gélule


50 mg


capsule, hard


oral use




France


TEVA SANTE
110, Esplanade du Général de Gaulle
92931 Paris La Défense Cedex
France


DIACEREINE RATIOPHARM 50 mg, gélule


50 mg


capsule, hard


oral use




France


BIOGARAN
15, boulevard Charles de Gaulle
92700 Colombes
France


DIACEREINE REF 50 mg, gélule


50 mg


capsule, hard


oral use




France


SANDOZ
49, avenue Georges Pompidou
92300 Levallois-Perret
France


DIACEREINE SANDOZ 50 mg, gélule


50 mg


capsule, hard


oral use




France


SUBSTIPHARM DEVELOPPEMENT
24, rue Erlanger
75016 Paris
FRANCE


DIACEREINE SUBSTIPHARM 50 mg, gélule


50 mg


capsule, hard


oral use




France


TEVA SANTE
110, Esplanade du Général de Gaulle
92931 Paris La Défense Cedex
France


DIACEREINE TEVA 50 mg, gélule


50 mg


capsule, hard


oral use




France


SANOFI AVENTIS FRANCE
1-13, boulevard Romain Rolland
75014 Paris
France


DIACEREINE ZENTIVA 50 mg, gélule


50 mg


capsule, hard


oral use




France


ZYDUS FRANCE
25, rue des Peupliers
ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers
92000 Nanterre
France


DIACEREINE ZYDUS 50 mg, gélule


50 mg


capsule, hard


oral use




France


MAZAL PHARMACEUTIQUE
11, rue Rontgen
BP 1309
29103 Quimper
France


MAZART 50 mg, gélule


50 mg


capsule, hard


oral use




France


NIVERPHARM
10 rue Paul Dautier
78140 Vélizy Villacoublay
France


ZONDAR 50 mg, gélule


50 mg


capsule, hard


oral use




Greece


ANGELINI PHARMA HELLAS
Achaias and Troizinias, Nea Kifissia 14564, Athens
Greece


VERBORIL


50 mg


capsule, hard


oral use




Greece


AURORA PHARMACEUTICALS S.A.
Evrou 4 and Messinias 2,
Gerakas 15344
Greece


ARTHROREIN


50 mg


capsule, hard


oral use




Greece


VOCATE Pharmaceuticals S.A.,
Gounari 150, Glyfada 16674 Athens
Greece


ARTHROFAR


50 mg


capsule, hard


oral use




Greece


RAFARM AEBE
korinthou 12, Neo Psychiko, 15451
Greece


IDEALITE


50 mg


capsule, hard


oral use




Greece


HELP ABEE
Valaoritou 10, Metamorfosi, Attikis, 14452
Greece


INFLABION


50 mg


capsule, hard


oral use




Greece


BROS EPE
Avgis & Gallinis 15, n. Kifissia, 14564
Greece


REUMANISAL


50 mg


capsule, hard


oral use




Greece


FARMEDIA A.E.
Athinas 22 & Apollonos
Gerakas, Attikis, 15344
Greece


OSTIREIN


50 mg


capsule, hard


oral use




Greece


GENEPHARM A.E.
18th km Marathonos Avenue, Pallini, Attikis, 15351
Greece


MYOBLOC


50 mg


capsule, hard


oral use




Greece


PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS
Dilou 9, Peristeri, Attikis, 12134
Greece


DIACEREIN/PROEL


50 mg


capsule, hard


oral use




Greece


NORMA HELLAS A.E.
Menandrou 54, Athens, 10431
Greece


DIACEREIN/NORMA


50 mg


capsule, hard


oral use




Greece


S.M. Pharmaceutical Products Ltd,
Agiou Orous 43-45 Piraeus 18545
Greece


DESEREIN


50 mg


capsule, hard


oral use




Greece


PROTON PHARMA
Achaias 4 and Trizoinias,
Nea Kifissia 14564
Greece


DIACERIL


50 mg


capsule, hard


oral use




Italy


ABIOGEN PHARMA S.p.A.
Via Meucci 36
56121 Ospedaletto — Pisa
Italy


FISIODAR


50 mg


capsule, hard


oral use




Portugal


Neo-Farmacêutica, S.A.
Av. D. João II,
Lote 1.02.2.1 D-2o

1990-090 Lisboa
Portugal


Artrolyt


50 mg


capsule, hard


oral use




Slovak Republic


TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG
2355 Wiener Neudorf
Austria


ARTRODAR


50 mg


capsule, hard


oral use




Spain


ROTTAPHARM S.L. Avda. Diagonal, 67-69 08019 Barcelona ESPAÑA


GLIZOLAN 50 mg cápsulas


50 mg


capsule, hard


Oral use




Spain


NEGMA-LERADS Immeuble Strasbourg Avenue de L'Europe Toussus-le-Noble Magny-les Hameaux Cedex F-78771 France


ARTRIZAN 50 mg cápsulas


50 mg


capsule, hard


Oral use




Spain


LACER S.A. Sardenya, 350 08025 Barcelona Spain


GALAXDAR 50 mg cápsulas


50 mg


capsule, hard


Oral use




Spain


LABORATORIOS NORMON S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain


DIACEREINA NORMON 50 mg cápsulas duras EFG


50 mg


capsule, hard


Oral use




Spain


IBERMEDGEN S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain


DIACEREINA PANLUETOL 50 mg cápsulas duras EFG


50 mg


capsule, hard


Oral use




Spain


MG PHARMA
8, Rue Bellini 75116 Paris France


REINART 50 mg cápsulas duras EFG


50 mg


capsule, hard


Oral use







ANNEX III
List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States

Levonorgestrel-containing emergency contraceptive medicinal products











Member State
(in EEA)


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




Austria


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Postinor 1  500 Mikrogramm-Tablette


1,5 mg


Tablet


Oral use




Austria


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Vikela 750 Mikrogramm- Tabletten


0,75 mg


Tablet


Oral use




Austria


Laboratoire HRA Pharma
15. rue Béranger
FR-75003 Paris
France


Vikela 1,5 Milligramm-Tablette


1,5 mg


Tablet


Oral use




Austria


Velvian Germany GmbH
Carl-Zeiss-Ring 9
85737 Ismaning
Germany


Velafam 1,5 mg Tabletten


1,5 mg


Tablet


Oral use




Austria


Velvian Germany GmbH
Carl-Zeiss-Ring 9
85737 Ismaning
Germany


Velafam 750 Mikrogramm Tabletten


0,75 mg


Tablet


Oral use




Belgium


Sandoz N.V.
Telecom Gardens
Medialaan 40
1800 Vilvoorde
Belgium


Levodonna


1,5 mg


Tablet


Oral use




Belgium


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


0,75 mg


Tablet


Oral use




Belgium


Laboratoire HRA Pharma
15. rue Béranger
FR-75003 Paris
France


Norlevo


1,5 mg


Tablet


Oral use




Belgium


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Postinor


1,5 mg


Tablet


Oral use




Belgium


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Postinor


0,75 mg


Tablet


Oral use




Bulgaria


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Escapelle


1,5 mg


Tablet


Oral use




Bulgaria


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Ramonna


1,5 mg


Tablet


Oral use




Bulgaria


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Postinor-Duo


0,75 mg


Tablet


Oral use




Bulgaria


Laboratorios Leon Farma SA
Poligono Industrial Navatejera,
La Vallina s/n,
24008 Villaquilambre, Leon
Spain


Etiyone


1,5 mg


Tablet


Oral use




Bulgaria


Laboratorios Leon Farma SA
Poligono Industrial Navatejera,
La Vallina s/n,
24008 Villaquilambre, Leon
Spain


Melkidos


0,75 mg


Tablet


Oral use




Croatia


Arenda d.o.o.,
Medarska ulica 56b
Zagreb 10090
Croatia


Vikela 1,5 mg tableta


1,5 mg


Tablet


Oral use




Croatia


Sandoz d.o.o.
Maksimirska 120
Zagreb 10000
Croatia


Escapelle


1,5 mg


Tablet


Oral use




Cyprus


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


0,75 mg


Tablet


Oral use




Cyprus


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


1,5 mg


Tablet


Oral use




Czech Republic


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Escapelle


1,5 mg


Tablet


Oral use




Czech Republic


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Postinor-2


0,75 mg


Tablet


Oral use




Czech Republic


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Ramonna


1,5 mg


Tablet


Oral use




Czech Republic


Egis Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest
Hungary


Egianti 0,75 mg


0,75 mg


Tablet


Oral use




Czech Republic


Laboratorios León Farma S.A.
Calle La Vallina s/n
Polígono Industrial Navatejera
24008 — Navatejera — León
Spain


Nopregy 1,5 mg tablety


1,5 mg


Tablet


Oral use




Denmark


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


0,75 mg


Tablet


Oral use




Denmark


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


1,5 mg


Tablet


Oral use




Denmark


Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 København S
Denmark


Levodonna


1,5 mg


Tablet


Oral use




Estonia


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


RAMONNA


1,5 mg


Tablet


Oral use




Estonia


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


ESCAPELLE


1,5 mg


Tablet


Oral use




Estonia


Orivas UAB
J.Jasinskio 16B
LT-01112 Vilnius
Lithuania


LEVIDON


0,75 mg


Tablet


Oral use




Estonia


Sandoz Pharmaceuticals Verovškova 57
1000 Ljubljana
Slovenia


LEVODONNA


1,5 mg


Tablet


Oral use




Estonia


Actavis Group PTC ehf
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


LEVONORGESTREL ACTAVIS


0,75 mg


Tablet


Oral use




Estonia


Orivas UAB
J.Jasinskio 16B
LT-01112 Vilnius
Lithuania


ELISTREL


1,5 mg


Tablet


Oral use




Finland


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


0,75 mg


Tablet


Oral use




Finland


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


1,5 mg


Tablet


Oral use




France


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


ANTHIA 750 microgrammes, comprimé


0,75 mg


Tablet


Oral use




France


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


LEVONORGESTREL BIOGARAN 1  500 microgrammes, comprimé


1,5 mg


Tablet


Oral use




France


MYLAN SAS
117, allée des Parcs
69800 Saint-Priest
France


LEVONORGESTREL MYLAN 1,5 mg, comprimé


1,5 mg


Tablet


Oral use




France


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


NORLEVO 1,5 mg, comprimé


1,5 mg


Tablet


Oral use




France


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


NORLEVO 750 microgrammes, comprimé


0,75 mg


Tablet


Oral use




France


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


VIKELA 1,5 mg, comprimé


1,5 mg


Tablet


Oral use




France


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


VIKELA 750 microgrammes, comprimé


0,75 mg


Tablet


Oral use




Germany


VELVIAN Germany GmbH
Carl-Zeiss-Ring 9
85737 Ismaning
Germany


Navela 0,75 mg Tabletten


0,75 mg


Tablet


Oral use




Germany


VELVIAN Germany GmbH
Carl-Zeiss-Ring 9
85737 Ismaning
Germany


Navela 1,5 mg Tabletten


1,5 mg


Tablet


Oral use




Germany


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


PiDaNa 1,5 mg Tablette


1,5 mg


Tablet


Oral use




Germany


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Postinor 1  500 Mikrogramm Tablette


1,5 mg


Tablet


Oral use




Germany


Hexal Aktiengesellschaft
Industriestr. 25
83607 Holzkirchen
Germany


unofem HEXAL 1,5 mg Tabletten


1,5 mg


Tablet


Oral use




Germany


Laboratorios Leon Farma, SA
Poligono Industrial Navatejera
C/La Vallina s/n
24008 Navatejera — Villaquilambre
Spain


Etiyone 1  500 Mikrogramm Tabletten


1,5 mg


Tablet


Oral use




Greece


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


NORLEVO


0,75 mg


Tablet


Oral use




Greece


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


NORLEVO


1,5 mg


Tablet


Oral use




Greece


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


POSTINOR


1,5 mg


Tablet


Oral use




Hungary


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Escapelle


1,5 mg


Tablet


Oral use




Hungary


Egis Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest
Hungary


Empil 0,75 mg tabletta


0,75 mg


Tablet


Oral use




Hungary


Actavis Group PTC ehf Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Helibona


1,5 mg


Tablet


Oral use




Hungary


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Rigesoft


0,75 mg


Tablet


Oral use




Iceland


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


1,5 mg


Tablet


Oral use




Iceland


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


0,75 mg


Tablet


Oral use




Iceland


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Postinor


1,5 mg


Tablet


Oral use




Ireland


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Levonelle 1  500 microgram Tablet


1,5 mg


Tablet


Oral use




Ireland


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


NORLEVO 750 micrograms tablet


0,75 mg


Tablet


Oral use




Ireland


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


NORLEVO 1,5 mg tablet


1,5 mg


Tablet


Oral use




Ireland


Laboratorios Leon Farma, S.A.
C/Roa de la Vega 15, 1
24008 Leon
Spain


Tyedra 1  500 micrograms tablet


1,5 mg


Tablet


Oral use




Italy


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


NORLEVO


0,75 mg


Tablet


Oral use




Italy


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


NORLEVO


1,5 mg


Tablet


Oral use




Italy


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


LONEL


1,5 mg


Tablet


Oral use




Latvia


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Escapelle 1,5 mg tablets


1,5 mg


Tablet


Oral use




Latvia


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Ramonna 1  500micrograms tablets


1,5 mg


Tablet


Oral use




Latvia


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Postinor-Duo 750 micrograms tablets


0,75 mg


Tablet


Oral use




Latvia


UAB ‘Orivas’
J. Jasinskio g. 16B
LT- 01112 Vilnius
Lithuania


Elistrel 1  500 micrograms tablets


1,5 mg


Tablet


Oral use




Latvia


UAB ‘Orivas’
J. Jasinskio g. 16B
LT- 01112 Vilnius
Lithuania


Levidon 750 micrograms tablets


0,75 mg


Tablet


Oral use




Latvia


Actavis Group PTC ehf
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Levonorgestrel Actavis 750 micrograms tablets


0,75 mg


Tablet


Oral use




Lithuania


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


ESCAPELLE


1,5 mg


Tablet


Oral use




Lithuania


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


RAMONNA


1,5 mg


Tablet


Oral use




Lithuania


UAB ‘Orivas’
J. Jasinskio g. 16B
LT- 01112 Vilnius
Lithuania


Elistrel


1,5 mg


Tablet


Oral use




Lithuania


UAB ‘Orivas’
J. Jasinskio g. 16B
LT- 01112 Vilnius
Lithuania


Levidon


0,75 mg


Tablet


Oral use




Lithuania


UAB Inteli Generics Nord
Šeimyniškių 3
LT-09312 Vilnius
Lithuania


Avodele


0,75 mg


Tablet


Oral use




Lithuania


UAB Inteli Generics Nord
Šeimyniškių 3
LT-09312 Vilnius
Lithuania


Avodele


1,5 mg


Tablet


Oral use




Lithuania


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


POSTINOR-DUO


0,75 mg


Tablet


Oral use




Luxembourg


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


0,75 mg


Tablet


Oral use




Luxembourg


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


1,5 mg


Tablet


Oral use




Luxembourg


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Postinor


0,75 mg


Tablet


Oral use




Luxembourg


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Postinor


1,5 mg


Tablet


Oral use




Norway


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


NORLEVO


0,75 mg


Tablet


Oral use




Norway


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


NORLEVO


1,5 mg


Tablet


Oral use




Norway


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


POSTINOR


1,5 mg


Tablet


Oral use




Norway


Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 København S
Denmark


Isteranda


1,5 mg


Tablet


Oral use




Poland


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Escapelle tabletka 1  500 mikrogramów


1,5 mg


Tablet


Oral use




Poland


Gedeon Richter Polska Sp. z o.o.
5 Ks. J. Poniatowskiego Street
05-825 Grodzisk Mazowiecki
Poland


Ramonna


1,5 mg


Tablet


Oral use




Portugal


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


0,75 mg


Tablet


Oral use




Portugal


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


1,5 mg


Tablet


Oral use




Portugal


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Postinor


1,5 mg


Tablet


Oral use




Romania


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


ESCAPELLE


1,5 mg


Tablet


Oral use




Romania


Gedeon Richter Romania S.A.
Str. Cuza-Vodă nr. 99-105 Târgu Mureş 540306
Romania


RAMONNA


1,5 mg


Tablet


Oral use




Romania


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


POSTINOR-2 750 micrograme


0,75 mg


Tablet


Oral use




Slovak Republic


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


ESCAPELLE


1,5 mg


Tablet


Oral use




Slovak Republic


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Ramona


1,5 mg


Tablet


Oral use




Slovak Republic


Egis Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest
Hungary


EGIANTI 0,75 mg tablety


0,75 mg


Tablet


Oral use




Slovak Republic


Actavis Group PTC ehf
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Helibona 1,5 mg


1,5 mg


Tablet


Oral use




Slovenia


Gedeon Richter Plc.
Gyömrői út 19-21.
H-1103 Budapest
Hungary


Escapelle 1,5 mg tableta


1,5 mg


Tablet


Oral use




Slovenia


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris France


NORLEVO 1,5 mg tableta


1,5 mg


Tablet


Oral use




Slovenia


Gedeon Richter Plc.
Gyömrői út 19-21.
H-1103 Budapest
Hungary


Ramonna 1,5 mg tableta


1,5 mg


Tablet


Oral use




Spain


CHIESI ESPAÑA, S.A.
Plaça d'Europa, 41-43 planta 10
08908 L'Hospitalet de Llobregat (Barcelona)
Spain


Norlevo 750 microgramos comprimidos


0,75 mg


Tablet


Oral use




Spain


CHIESI ESPAÑA, S.A.
Plaça d'Europa, 41-43 planta 10
08908 L'Hospitalet de Llobregat (Barcelona)
Spain


Norlevo 1  500 microgramos comprimido


1,5 mg


Tablet


Oral use




Spain


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Postinor 1  500 microgramos comprimido


1,5 mg


Tablet


Oral use




Spain


Actavis Group PTC ehf
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland


Julirona 1,5 mg comprimido EFG


1,5 mg


Tablet


Oral use




Sweden


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


0,75 mg


Tablet


Oral use




Sweden


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo


1,5 mg


Tablet


Oral use




Sweden


Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 København S
Denmark


Levodonna


1,5 mg


Tablet


Oral use




Sweden


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Postinor


1,5 mg


Tablet


Oral use




The Netherlands


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo, tabletten 0,75 mg


0,75 mg


Tablet


Oral use




The Netherlands


Laboratoire HRA Pharma
15, rue Béranger
FR-75003 Paris
France


Norlevo 1,5 mg, tabletten


1,5 mg


Tablet


Oral use




The Netherlands


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Postinor 1  500 microgram, tablet


1,5 mg


Tablet


Oral use




The Netherlands


Perryment Ltd
42-46 High street
Esher, KT10 9QY Surrey
United Kingdom


Vikela, tabletten 750 microgram


0,75 mg


Tablet


Oral use




United Kingdom


Sandoz Limited
Frimley Business Park
Frimley, Camberley
Surrey GU16 7SR
United Kingdom


Isteranda 1,5 mg Tablets


1,5 mg


Tablet


Oral use




United Kingdom


Gedeon Richter Plc.
Gyömröí út 19-21
HU-1103 Budapest
Hungary


Upostelle 1  500 Microgram Tablets


1,5 mg


Tablet


Oral use




United Kingdom


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Levonelle-2 750 Microgram Tablet


0,75 mg


Tablet


Oral use




United Kingdom


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Levonelle 1  500Microgram Tablet


1,5 mg


Tablet


Oral use




United Kingdom


Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom


Levonelle One Step 1  500 Microgram Tablet/Boots Emergency Contraceptive 1,5 mg Tablet


1,5 mg


Tablet


Oral use




United Kingdom


Laboratorios Leon Farma SA
Calle La Vallina S/N
Poligono Industrial Navatejera
Navatejera, Leon E-24008
Spain


Melkine 1,5 mg Tablet


1,5 mg


Tablet


Oral use







ANNEX IV
List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States











Member State EU/EEA


Marketing authorisation holder


Product name


INN


Strength


Pharmaceutical form


Animal species




Austria


Bayer Austria GmbH
Herbststraße 6-10
1160 Wien
Austria


Baytril 25 mg/ml — Injektionslösung für Tiere


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, rabbits, rodents (excluded: guinea pigs, hamster), exotic animals (reptiles, avian species), pigs (piglet, pigs < 30 kg bw)




Austria


Bayer Austria GmbH
Herbststraße 6-10
1160 Wien
Austria


Baytril 50 mg/ml — Injektionslösung für Tiere


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, pigs, calves




Austria


Bayer Austria GmbH
Herbststraße 6-10
1160 Wien
Austria


Baytril 100 mg/ml — Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem (Machelen)
Belgium


Baytril 2,5 %


Enrofloxacin


25 mg/ml


Solution for injection


Cats, dogs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem (Machelen)
Belgium


Baytril Piglet


Enrofloxacin


25 mg/ml


Solution for injection


Pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem (Machelen)
Belgium


Baytril 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem (Machelen)
Belgium


Baytril 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem (Machelen)
Belgium


Baytril Swine


Enrofloxacin


100 mg/ml


Solution for injection


Pigs




Bulgaria


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Байтрил 5 % инжективен разтвор


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Cyprus


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


BAYTRIL INJECTION 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Czech Republic


BAYER s.r.o.
Siemensova 2717/4
155 00 Praha 5
Czech Republic


BAYTRIL 2,5 % (w/v) injekční roztok


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Czech Republic


BAYER s.r.o.
Siemensova 2717/4
155 00 Praha 5
Czech Republic


BAYTRIL 5 % (w/v) injekční roztok


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, pigs, calves




Denmark


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril Vet.


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, cats, cattle, poultry, pigs




Denmark


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril Vet.


Enrofloxacin


100 mg/ml


Solution for injection


Dogs, cats, cattle
poultry, pigs




Finland


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril 5 % inj.


Enrofloxacin


50 mg/ml


Solution for injection


Cats, dogs, sheep, cattle, pigs, goats




Finland


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril 10 % inj.


Enrofloxacin


100 mg/ml


Solution for injection


Sheep, cattle, pigs, goats




France


Bayer Sante
220 Avenue de la Recherche
59120 Loos
France


BAYTRIL 2,5 %


Enrofloxacin


25 mg/ml


Solution for injection


Pigs




France


Bayer Sante
220 Avenue de la Recherche
59120 Loos
France


BAYTRIL 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




France


Bayer Sante
220 Avenue de la Recherche
59120 Loos
France


BAYTRIL 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Bayer Vital GmbH
Kaiser-Wilhelm-Allee
D-51373 Leverkusen
Germany


Baytril — Das Original - 2,5 % Injektionslösung für Hunde, Katzen, Schweine und Kaninchen


Enrofloxacin


25 mg/ml


Solution for injection


Pig, rabbits, dogs, cats




Germany


Bayer Vital GmbH
Kaiser-Wilhelm-Allee
D-51373 Leverkusen
Germany


Baytril — Das Original — 5 % Injektionslösung


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dogs




Germany


Bayer Vital GmbH
Kaiser-Wilhelm-Allee
D-51373 Leverkusen
Germany


Baytril — Das Original — 10 % Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Greece


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


BAYTRIL 2,5 % inj.sol


Enrofloxacin


25 mg/ml


Solution for injection


Dogs




Greece


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


BAYTRIL 5 % inj.sol


Enrofloxacin


50 mg/ml


Solution for injection


Calves, cattle, pigs, dogs




Hungary


Bayer Hungária Kft.
Alkotás u. 50
1123 Budapest
Hungary


Baytril 2,5 % injekció A.U.V.


Enrofloxacin


25 mg/ml


Solution for injection


Pigs, rabbit, dogs, cats, exotic animals (mammals, birds, reptiles)




Hungary


Bayer Hungária Kft.
Alkotás u. 50
1123 Budapest
Hungary


Baytril 5 % injekció A.U.V.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Hungary


Bayer Hungária Kft.
Alkotás u. 50
1123 Budapest
Hungary


Baytril 10 % injekció A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Iceland


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, poultry, dogs, cats




Iceland


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


100 mg/ml


Solution for injection


Calves, pigs, poultry, dogs, cats




Ireland


Bayer Limited
Animal Health Division
The Atrium
Blackthorn Road
Dublin 18
Ireland


Baytril 2,5 % Solution for Injection


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Ireland


Bayer Limited
Animal Health Division
The Atrium
Blackthorn Road
Dublin 18
Ireland


Baytril 5 % Solution for Injection


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Ireland


Bayer Limited
Animal Health Division
The Atrium
Blackthorn Road
Dublin 18
Ireland


Baytril 10 % Solution for Injection


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Italy


Bayer S.p.A.
Viale Certosa, 130
20156 Milano
Italy


Baytril


Enrofloxacin


25 mg/ml and
50 mg/ml


Solution for injection


Cattle, dogs, sheep, goats, cats, rabbits, pigs




Italy


Bayer S.p.A.
Viale Certosa, 130
20156 Milano
Italy


Baytril 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, sheep, goats




Norway


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


25 mg/ml


Solution for injection


Pigs, cattle, dogs, cats




Norway


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


100 mg/ml


Solution for injection


Pigs, cattle, dogs, cats




Poland


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril 2,5 % inj., 25 mg/ml roztwór do wstrzykiwań dla psów i kotów


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Poland


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Portugal


Bayer Portugal S.A.
Rua Quinta do Pinheiro, 5
2794-003 Carnaxide
Portugal


BAYTRIL 2,5 % solução injectável


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Portugal


Bayer Portugal S.A.
Rua Quinta do Pinheiro, 5
2794-003 Carnaxide
Portugal


Baytril 5 % solução injectável


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, cattle, pigs




Portugal


Bayer Portugal S.A.
Rua Quinta do Pinheiro, 5
2794-003 Carnaxide
Portugal


Baytril 10 % solução injectável


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


Bayer Health Care AG
D-51368 Leverkusen
Germany


Baytril 5 %


Enrofloxacin


50 mg/ml


solution for injection


Calves, pigs, dogs




Romania


Bayer Health Care AG
D-51368 Leverkusen
Germany


Baytril 10 %


Enrofloxacin


100 mg/ml


solution for injection


Cattle, pigs




Slovakia


Bayer s.r.o.
Litvínovská 609/3
190 21 Praha 9
Czech Republic


Baytril 2,5 %


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Slovakia


Bayer s.r.o.
Litvínovská 609/3
190 21 Praha 9
Czech Republic


Baytril 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, pigs, calves




Slovenia


Bayer d.o.o.
Bravničarjeva 13
Ljubljana
Slovenia


Baytril® 5 % raztopina za injiciranje


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Slovenia


Bayer d.o.o.
Bravničarjeva 13
Ljubljana
Slovenia


Baytril® 10 % raztopina za injiciranje


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


Bayer Hispania S.L.
Avda Baix LLObregat, 3-5
08970, Saint Joan Despí
Barcelona
Spain


Baytril 2,5 % solución inyectable


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats and other exotic species (rodents, rabbits, cage birds and reptiles (snakes, turtles and iguana))




Spain


Bayer Hispania S.L.
Avda Baix LLObregat, 3-5
08970, Saint Joan Despí
Barcelona
Spain


Baytril 5 % solución inyectable


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, cattle, pigs




Spain


Bayer Hispania S.L.
Avda Baix LLObregat, 3-5
08970, Saint Joan Despí
Barcelona
Spain


Baytril 10 % solución inyectable


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Sweden


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril®vet


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, pigs, cattle, cats




Sweden


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril®vet


Enrofloxacin


100 mg/ml


Solution for injection


Dogs, pigs, cattle, cats




The Netherlands


Bayer BV
Energieweg 1
3641 RT Mijdrecht
The Netherlands


Baytril Piglet 25 mg/ml inspuitbare oplossing


Enrofloxacin


25 mg/ml


Solution for injection


Pigs




The Netherlands


Bayer BV
Energieweg 1
3641 RT Mijdrecht
The Netherlands


BAYTRIL 2,5 % INJEKTIEVLOEISTOF


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




The Netherlands


Bayer BV
Energieweg 1
3641 RT Mijdrecht
The Netherlands


BAYTRIL 5 % INJECTIEOPLOSSING


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




The Netherlands


Bayer BV
Energieweg 1
3641 RT Mijdrecht
The Netherlands


BAYTRIL 5 % INJEKTIEVLOEISTOF


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




The Netherlands


Bayer BV
Energieweg 1
3641 RT Mijdrecht
The Netherlands


BAYTRIL 10 % INJECTIEOPLOSSING


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Bayer BV
Energieweg 1
3641 RT Mijdrecht
The Netherlands


BAYTRIL INJEKTIEVLOEISTOF 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Pigs, cattle




United Kingdom


Bayer plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA
United Kingdom


Baytril 2,5 % Solution for Injection


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats and exotic animals (small mammals, reptiles and avian species)




United Kingdom


Bayer plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA
United Kingdom


Baytril 5 % Solution for Injection


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




United Kingdom


Bayer plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA
United Kingdom


Baytril 10 % Solution for Injection


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs







ANNEX V
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States











Member State EU/EEA


Applicant/Marketing Authorisation Holder


Product name


INN


Strength


Pharmaceutical form


Animal species




Austria


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 25, 25 mg/ml Injektionslösung für Hunde, Katzen, Schweine und Kaninchen


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, pigs, rabbits




Austria


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 50, 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (Calves), pigs, dogs




Austria


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 100, 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Austria


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml Injektionslösung für Tiere


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Austria


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Austria


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


Enrodexil, 100 mg/ml, Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Austria


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 50 mg/ml Injektionslösung für Kälber, Schweine und Hunde


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Austria


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Austria


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Unisol 100 mg/ml, Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Austria


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Austria


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


BAYTRIL PIGLET


Enrofloxacin


25 mg/ml


Solution for injection


Pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


BAYTRIL 2,5 %


Enrofloxacin


25 mg/ml


Solution for injection


Cats, dogs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


BAYTRIL 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


BAYTRIL SWINE


Enrofloxacin


100 mg/ml


Solution for injection


Pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


BAYTRIL 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle




Belgium


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


FENOFLOX 50 MG/ML


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Belgium


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


FENOFLOX 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


EMDOKA bvba
John Lijsenstraat 16
B-2321 Hoogstraten
Belgium


FLOXADIL 50 MG/ML


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Belgium


EMDOKA bvba
John Lijsenstraat 16
B-2321 Hoogstraten
Belgium


FLOXADIL 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 25 MG/ML


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Belgium


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 50 MG/ML


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Belgium


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


ENRODEXIL 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


ROXACIN 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


COLMYC 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


Vandenbussche Farma Service
Brusselsesteenweg 396
1980 Eppegem
Belgium


FLOXAVET 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Belgium


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


DORAFLOX 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


UNISOL 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Bulgaria


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Байтрил 5 % инжективен разтвор


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Bulgaria


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


Ганадексил 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dogs




Bulgaria


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


Роксацин БГ инжективен


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Bulgaria


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


Ценеровиг — 10 ГБ Инж.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, dogs




Bulgaria


Laboratorios Hipra S.A.
Avda. La Selva, 135
17170 Amer
Girona
Spain


Хипралона Енро — И


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Bulgaria


Laboratorios Syva S.A.
Parroco Pablo Diez, 49 — 57
24010 Leon
Spain


Сиваквинол — 100 Инжекционен разтвор


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Bulgaria


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Кинофлокс 100 mg/ml инжекционен разтвор за говеда и свине


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Bulgaria


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Колмик 100 мг/мл инжекционен разтвор за говеда и свине


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Cyprus


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril 5 %, Ενέσιμο διάλυμα για μόσχους, χοίρους και σκύλους


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Czech Republic


Bayer s.r.o.
Siemensova 2717/4
155 00 Praha 5
Czech Republic


BAYTRIL 2,5 % (w/v) injekční roztok
Přípravek s indikačním omezením


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Czech Republic


BAYER s.r.o.
Siemensova 2717/4
155 00 Praha 5
Czech Republic


BAYTRIL 5 % (w/v) injekční roztok
Přípravek s indikačním omezením


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, pigs, calves




Czech Republic


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml injekční roztok pro psy, kočky a exotická zvířata


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats exotic animals (small mammals, reptiles and birds)




Czech Republic


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml injekční roztok pro skot, prasata, psy a kočky


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Czech Republic


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml injekční roztok pro skot a prasata


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Czech Republic


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 50 mg/ml injekční roztok


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, pigs, calves




Czech Republic


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 100 mg/ml injekční roztok


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Czech Republic


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


ROXACIN 100 mg/ml injekční roztok


Enrofloxacin


100 mg/ml


Solution for injection


Pigs and calves




Denmark


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril Vet


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, cattle, poultry, cats, pigs




Denmark


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril Vet


Enrofloxacin


100 mg/ml


Solution for injection


Dogs, cattle, poultry, cats, pigs




Denmark


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, cattle, poultry, cats, pigs




Estonia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Estonia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Estonia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Estonia


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


Ganadexil Enrofloxacina 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dogs




Estonia


Laboratorios Hipra S.A.
Avda. La Selva, 135
17170 Amer
Girona
Spain


Hipralona Enro-I


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Estonia


Vetoquinol Biowet Sp z o.o.
13/14 Kosynierów Gdyńskich St.
66-400 Gorzów Wlkp.
Poland


Enrobioflox5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dogs




Finland


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


50 mg/ml


Solution for injection


Cats, dogs, sheep, cattle, pigs, goats




Finland


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox vet


Enrofloxacin


50 mg/ml


Solution for injection


Cats, dogs, cattle, pigs




France


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


ENROCARE 25 MG/ML INJECTABLE POUR CHIENS CHATS ET NAC


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




France


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


ENROCARE 50 MG/ML INJECTABLE POUR BOVINS PORCINS CHIENS ET CHATS


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




France


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


ENROCARE 100 MG/ML INJECTABLE POUR BOVINS ET PORCINS


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




France


Bayer Sante
220 Avenue de la Recherche
59120 LOOS
France


BAYTRIL 2,5 % SOLUTION INJECTABLE


Enrofloxacin


25 mg/ml


Solution for injection


Cattle, pigs, dogs




France


Bayer Sante
220 Avenue de la Recherche
59120 LOOS
France


BAYTRIL 5 % SOLUTION INJECTABLE


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




France


Bayer Sante
220 Avenue de la Recherche
59120 LOOS
France


BAYTRIL 10 % SOLUTION INJECTABLE


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




France


BIOLIS
21 Montee De La Garde
69340 Francheville
France


QUINOTRYL 50 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCIN S


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




France


BIOLIS
21 Montee De La Garde
69340 Francheville
France


QUINOTRYL 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCI NS


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




France


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


CHANENRO 50 MG/ML SOLUTION INJECTABLE POUR BOVINS, PORCINS, CHIENS ET CHATS


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




France


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


FLOXIBAC 50 MG/ML SOLUTION INJECTABLE POUR BOVINS, PORCINS, CHIENS ET CHATS


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




France


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


CHANENRO 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCIN S


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




France


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


FLOXIBAC 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCIN S


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Albrecht GmbH
Hauptstr. 6-8
D-88326 Aulendorf
Germany


Enro-Sleecol 50 mg/ml


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


Albrecht GmbH
Hauptstr. 6-8
D-88326 Aulendorf
Germany


Enro-Sleecol 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 25


Enrofloxacin


25 mg/ml


Solution for injection


Pigs, rabbits, dogs, cats




Germany


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 50


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 100


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril — Das Original - 2,5 % Injektionslösung für Hunde, Katzen, Schweine und Kaninchen


Enrofloxacin


25 mg/ml


Solution for injection


Pigs, rabbits, dogs, cats




Germany


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril — Das Original — 5 % Injektionslösung


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril — Das Original — 10 % Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Calluna Pharma bvba
Treslong 34
B-2322 Hoogstraaten
Belgium


Enrofloxacin 2,5 % WDT, Injektionslösung


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Germany


Calluna Pharma bvba
Treslong 34
B-2322 Hoogstraaten
Belgium


Enrofloxacin 5 % WDT, Injektionslösung


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


Calluna Pharma bvba
Treslong 34
B-2322 Hoogstraaten
Belgium


Enrofloxacin 10 % WDT, Injektionslösung


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Germany


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


Enrodexil 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


Roxacin 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Medistar Arzneimittel-Vertrieb GmbH
Lüdinghauser Str. 23
D-59387 Ascheberg
Germany


Enrostar 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


Medistar Arzneimittel-Vertrieb GmbH
Lüdinghauser Str. 23
D-59387 Ascheberg
Germany


Enrostar 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Serumwerk Bernburg AG
Hallesche Landstr. 105b
D-06406 Bernburg
Germany


Ursofloxacin 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


Serumwerk Bernburg AG
Hallesche Landstr. 105b
D-06406 Bernburg
Germany


Ursofloxacin 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc 100 mg/ml Inyectable


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Doraflox 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Unisol


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Germany


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Greece


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril 2,5 %


Enrofloxacin


25 mg/ml


Solution for injection


Dogs




Greece


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs




Greece


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


FLOXIBAC 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Greece


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


FLOXIBAC 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Greece


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROFLOXACIN/HEALTHCARE


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




Greece


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROFLOXACIN/HEALTHCARE


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Greece


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROFLOXACIN/HEALTHCARE


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Greece


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


ENRODEXIL


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Greece


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


COLMYC


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Greece


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


DORAFLOX


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Bayer Hungária Kft.
Alkotás u. 50.
1123 Budapest
Hungary


Baytril 2,5 % injekció A.U.V.


Enrofloxacin


25 mg/ml


Solution for injection


Pigs, rabbits, dogs, cats, exotic animals (mammals, birds, reptiles)




Hungary


Bayer Hungária Kft.
Alkotás u. 50.
1123 Budapest
Hungary


Baytril 5 % injekció A.U.V.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Hungary


Bayer Hungária Kft.
Alkotás u. 50.
1123 Budapest
Hungary


Baytril 10 % injekció A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml injekció szarvasmarha, sertés, kutya és macska részére A.U.V.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Hungary


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml injekció szarvasmarha és sertés részére A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml injekció kutyák, macskák és egzotikus állatok részére A.U.V.


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Hungary


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml injekció szarvasmarha, sertés, kutya és macska részére A.U.V.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Hungary


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml injekció szarvasmarha és sertés részére A.U.V


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


ENRODEXIL 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 5 % injekció A.U.V.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, sheep, goats




Hungary


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 10 % injekció A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Laboratorios Syva S.A.
Parroco Pablo Diez, 49-57
24010 Leon
Spain


Syvaquinol 100 injekció A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc 100 mg/ml injekció szarvasmarha és sertés részére A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


DORAFLOX 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


LANFLOX 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Iceland


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril vet.


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, poultry dogs, cats




Iceland


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril vet.


Enrofloxacin


100 mg/ml


Solution for injection


Calves, pigs, poultry dogs, cats




Ireland


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Enrocare 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats and exotic animals (small mammals, reptiles and avian species)




Ireland


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Enrocare 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs weighing more than 25 kg, dogs, cats




Ireland


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs weighing more than 25 kg




Ireland


Bayer Limited
The Atruim
Blackthorn Road
Dublin 18
Ireland


Baytril 2,5 % Solution for Injection


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Ireland


Bayer Limited
The Atruim
Blackthorn Road
Dublin 18
Ireland


Baytril 5 % Solution for Injection


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Ireland


Bayer Limited
The Atruim
Blackthorn Road
Dublin 18
Ireland


Baytril 10 % Solution for Injection


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Ireland


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Ireland


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml Solution for injection for dogs, cats and exotic animals


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Ireland


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml Solution for injection for cattle, pigs, dogs and cats


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Ireland


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml Solution for injection for cattle and pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Global Vet Health SL
c/Capcanes, no 12-bajos
Poligon Agro-Reus
Reus 43206
Spain


Quinoflox 100 mg/ml solution for injection for cattle and pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


ENRODEXIL 100 mg/ml solution for injection for cattle and pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 50 mg/ml solution for injection for calves, pigs and dogs


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Ireland


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 100 mg/ml solution for injection for cattle and pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


ROXACIN 100 mg/ml solution for injection for cattle and pig


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Doraflox 100 mg/ml solution for injection for cattle and pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Unisol 100 mg/ml solution for injection for cattle and pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 50 mg/ml solution for injection for cattle, pigs, dogs and cats.
Enrofloxacin.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Ireland


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 100 mg/ml solution for injection for cattle and pigs
Enrofloxacin


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Italy


Bayer SpA
Viale Certosa, 130
20156 Milano
Italy


Baytril


Enrofloxacin


25 mg/ml and 50 mg/ml


Solution for injection


Cattle, dogs, sheep, goats, cats, rabbits, pigs




Italy


Bayer SpA
Viale Certosa, 130
20156 Milano
Italy


Baytril 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, sheep, goats




Italy


CEVA Salute Animale
viale Colleoni, 15
20864 Agrate Brianza (MB)
Italy


CEVAFLOX iniettabile, 100 mg/ml, soluzione iniettabile per bovini, ovini, suini


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, sheep




Italy


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


GELLIFLOX 100 mg/ml (or 50 mg/ml) soluzione iniettabile per bovini e suini


Enrofloxacin


100 mg/ml (or 50 mg/ml)


Solution for injection


Cattle, pigs




Italy


Drugs Italia srl
Via G. Puecher, 8
20037 Paderno Dugnano (MI)
Italy


EFLOXIN soluzione iniettabile


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, sheep




Italy


Fatro s.p.a.
Via Emilia, 285
Ozzano Emilia (BO)
Italy


VALEMAS 10 (or 5) 100 mg/ml (or 50 mg/ml) soluzione iniettabile per bovini, ovi-caprini e suini


Enrofloxacin


100 mg/ml (or 50 mg/ml)


Solution for injection


Cattle, pigs, sheep, goats




Italy


Friulchem
via San Marco, 23
33099 Vivaro (PN)
Italy


TENOTRIL 100 mg/ml soluzione iniettabile epr bovini, suini, ovicaprini


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, sheep, goats




Italy


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


ENRODEXIL 100 mg/ml soluzione iniettabile per bovini e suini


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Italy


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


ROXACIN 100 mg/ml soluzione iniettabile per bovini e suini


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Italy


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


COLMYC 100 mg/ml soluzione iniettabile


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Italy


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


LANFLOX 100 mg/ml soluzione iniettabile per bovini e suini


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Latvia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




Latvia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Latvia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Lithuania


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 25 mg/ml, injekcinis tirpalas šunims, katėms ir egzotiniams gyvūnams


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Lithuania


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 50 mg/ml, injekcinis tirpalas galvijams, kiaulėms, šunims ir katėms


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Lithuania


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 100 mg/ml, injekcinis tirpalas galvijams ir kiaulėms


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Lithuania


Vetoquinol Biowet Sp z o.o.
13/14 Kosynierów Gdyńskich St.
66-400 Gorzów Wlkp.
Poland


ENROBIOFLOX 5 %, injekcinis tirpalas galvijams, kiaulėms ir šunims


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Luxembourg


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Floxadil 25 mg/ml Injektionsl! osung für Hunde, katzen und exotische Tiere


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and birds)




Luxembourg


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Floxadil 50 mg/ml Injektionslösung fürRinder, Schweine, Hunde und Katzen


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs >25kg, dogs, cats




Luxembourg


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Floxadil 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs >25kg




Luxembourg


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


Baytril piglet 25 mg/ml


Enrofloxacin


25 mg/ml


Solution for injection


Pigs




Luxembourg


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


Baytril 2,5 %


Enrofloxacin


25 mg/ml


Solution for injection


Cats, dogs




Luxembourg


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


Baytril 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Luxembourg


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


Baytril 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle




Luxembourg


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


Baytril Swine 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Pigs




Luxembourg


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml solution injectable pour bovins, porcins, chiens et chats


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Luxembourg


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml solution injectable pour bovins et porcins


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Luxembourg


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc injectable Bovins Porcins


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Malta


Farmcare Ltd
Florence A triq il Fran
Qormi
Malta


Baytril 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Malta


Industrial Veterinaria, S.A
Esmeralda, 19,
08950 Esplugues de Llobreget
Barcelona
Spain


Ganadexil Enrofloxacino 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Malta


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


Roxacin injection


Enrofloxacin


100 mg/ml


Solution for injection


Pigs




Malta


Laboratorios Syva S.A.
Parroco Pablo Diez, 49-57
24010 Leon
Spain


Syvaquinol 25 %


Enrofloxacin


25 mg/ml


Solution for injection


Calves, piglets, dogs




Malta


Laboratorios Syva S.A.
Parroco Pablo Diez, 49-57
24010 Leon
Spain


Syvaquinol 100 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Norway


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


25 mg/ml


Solution for injection


Pigs, cattle, dogs, cats




Norway


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


100 mg/ml


Solution for injection


Pigs, cattle, dogs, cats




Norway


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Poland


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril 2,5 % inj., 25 mg/ml roztwór do wstrzykiwań dla psów i kotów


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Poland


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Poland


Biowet Puławy Sp. z o.o.
2 Arciucha Str.
24-100
Puławy
Poland


Enflocyna inj, 100 mg/ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Poland


Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.
6 Grójecka Str.
05-651 Drwalew
Poland


Enrofloksacyna 10 % inj., 100 mg/ml roztwór do wstrzykiwań dla bydła


Enrofloxacin


100 mg/ml


Solution for injection


Cattle




Poland


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml roztwór do wstrzykiwań dla psów, kotów i zwierząt egzotycznych


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




Poland


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg roztwór do wstrzykiwań dla bydła, świń, psów i kotów


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Poland


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Poland


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


Enrodexil, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Poland


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Poland


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


Roxacin, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Poland


PFO ‘Vetos-Farma’ Sp. z o.o.
21 Dzierżoniowska Str.
58-260
Bielawa
Poland


Enrofloxacyna 5 % iniekcja, enrofloxacyna 5 g/100ml, roztwór dla bydła, świń, psów i kotów


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Poland


PFO ‘Vetos-Farma’ Sp. z o.o.
21 Dzierżoniowska Str.
58-260
Bielawa
Poland


Enrofloxacyna 10 % iniekcja, enrofloksacyna 10 g/100 ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Poland


Pharmagal, s.r.o.
Murgasova 5
949 01, Nitra
Slovakia


Enrogal 50 mg/ml roztwór do wstrzykiwań


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Poland


Przedsiębiorstwo Wielobranżowe VET-AGRO Sp. z o.o.
32 Gliniana Str.
20-616
Lublin
Poland


Enrocin 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Poland


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc 100 mg/ml roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Poland


Vetoquinol Biowet Sp z o.o.
13/14 Kosynierów Gdyńskich St.
66-400 Gorzów Wlkp.
Poland


Enrobioflox 5 % Injectio, 50 mg/ml roztwór do wstrzykiwań dla świń, bydła i psów


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Poland


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Lanflox, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Bayer PORTUGAL S.A.
Rua Quinta do Pinheiro, 5
2794-003 Carnaxide
Portugal


BAYTRIL 2,5 % solução injectável


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Portugal


Bayer PORTUGAL S.A.
Rua Quinta do Pinheiro, 5
2794-003 Carnaxide
Portugal


Baytril 5 % solução injectável


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, cattle and pigs




Portugal


Bayer PORTUGAL S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal


Baytril 10 % solução injectável


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml solução injectável para bovinos, suínos, cães e gatos


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Portugal


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 50 mg/ml solução injetável para bovinos, suínos, cães e gatos


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Portugal


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml solução injectável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 100 mg/ml solução injectável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


ESTEVE FARMA, LDA
Av. Do Forte, 3
Edifício Suécia II
Piso 4A
2794-044 Carnaxide
Portugal


ALSIR 25 mg/ml solução injectável para Cães e Gatos


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Portugal


ESTEVE FARMA, LDA
Av. Do Forte, 3
Edifício Suécia II
Piso 4A
2794-044 Carnaxide
Portugal


ALSIR 50Mmg/ml Solução Injectável


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Portugal


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml Solução injectável para cães, gatos e animais exóticos


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic Animals (small mammals, reptiles and avian species)




Portugal


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml Solução injectável para bovinos, suínos, cães e gatos


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Portugal


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml solução injectável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Global Vet Health SL
c/Capcanes, no 12-bajos
Poligon Agro-Reus
Reus 43206
Spain


Quinoflox 100 mg/ml solução injetável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


ROXACIN 100 mg/ml solução injectável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc 100 mg/ml Solução injectável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


LANFLOX 100 mg/ml solução injectável para bovinos e suínos.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


ENRODEXIL 100 mg/ml solução injectável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


CENAVISA SA LABORATORIOS
Cami Pedra Estela s/n
43205 REUS
Spain


CENAMICINA 10 PLUS


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, dogs




Romania


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 25 mg/ml


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




Romania


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 50 mg/ml


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Romania


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pig




Romania


Global Vet Health SL
c/Capcanes, no 12-bajos
Poligon Agro-Reus
Reus 43206
Spain


QUINOFLOX 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


GANADEXIL ENROFLOXACINA
5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs,




Romania


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROXIL 50 mg/ml


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, goats, sheep, dogs




Romania


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROXIL 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


Laboratorios Hipra S.A.
Avda. La Selva, 135
17170 Amer
Girona
Spain


HIPRALONA ENRO I


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs




Romania


Laboratorios Syva S.A.
Parroco Pablo Diez, 49-57
24010 Leon
Spain


SYVAQUINOL 100 injectable


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


LABORATORIOS VELVIAN S.L
C/Vitoria 9, 2 B
09004
Burgos
Spain


ENRODEXIL 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


PASTEUR
Filiala Filipesti SRL
Str. Principala nr. 944
Filipestii de Padure
Jud. Prahova
Romania


Enrofloxacina 5 % injectable solution


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, sheep, goats, pigs, dogs, cats




Romania


PASTEUR
Filiala Filipesti SRL
Str. Principala nr. 944
Filipestii de Padure
Jud. Prahova
Romania


Enrofloxacina 10 % injectable solution


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, sheep, goats, pigs, dogs, cats




Romania


S.C. ROMVAC COMPANY S.A.
Şos. Centurii, nr. 7
Voluntari
Romania


Enrofloxarom 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, sheep, pigs, dogs




Romania


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc 100 mg/ml inyectable solution


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


DORAFLOX 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovakia


Bayer s.r.o.
Litvínovská 609/3
190 21 Praha 9
Czech Republic


Baytril 2,5 % inj. ad us. vet.


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Slovakia


Bayer s.r.o.
Litvínovská 609/3
190 21 Praha 9
Czech Republic


Baytril 5 % (w/v) injekčný roztok


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, pigs, calves




Slovakia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml injekčný roztok pre psy, mačky a exotické živočíchy


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




Slovakia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml injekčný roztok pre hovädzí dobytok, ošípané, psy a mačky


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Slovakia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml injekčný roztok


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovakia


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 5 % inj. ad us. vet.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, sheep, goats, pigs, dogs




Slovakia


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 10 % inj. ad us. vet.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovakia


Laboratorios Hipra S.A.
Avda. La Selva, 135
17170 Amer
Girona
Spain


Hipralona Enro — I 50 mg/ml injekčný roztok


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Slovakia


Pharmagal, s.r.o.
Murgasova 5
949 01, Nitra
Slovakia


Enrogal 50 mg/ml injekčný roztok


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Slovenia


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 25, 25 mg/ml raztopina za injiciranje za pse, mačke, prašiče in kunce


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, pigs, rabbits




Slovenia


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


ENROTRON 50, 50 mg/ml raztopina za injiciranje za govedo (teleta), prašiče in pse


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dogs




Slovenia


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


ENROTRON 100, 100 mg/ml raztopina za injiciranje za govedo in prašiče


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovenia


Bayer d.o.o.
Bravničarjeva 13
Ljubljana
Slovenia


Baytril® 5 % raztopina za injiciranje


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Slovenia


Bayer d.o.o.
Bravničarjeva 13
Ljubljana
Slovenia


Baytril® 10 % raztopina za injiciranje


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovenia


GENERA Slovenia d.o.o.
Dunajska 51
1000 Ljubljana
Slovenia


VETOFLOK 10 % raztopina za injiciranje


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovenia


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROXIL 50 mg/ml raztopina za injiciranje za govedo, ovce, koze, prašiče in pse


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, sheep, goats, pigs, dogs




Slovenia


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROX 100 mg/ml raztopina za injiciranje za govedo in prašiče


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovenia


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROXIL 100 mg/ml raztopina za injiciranje za govedo in prašiče


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


Hifarmax, Produtos e serviços veterinários, Lda
Av. Marechal Craveiro Lopes no96 R/C
Dto 2775-696 Carcavelos
Portugal


ENROCILL 50 mg/ml solución inyectable para bovino, porcino y perros


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Spain


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


ENRODEXIL 100 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


ROXACIN 100 mg/ml SOLUCION INYECTABLE


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


Laboratorios Dr. Esteve, S.A.
Avda. Mare de Déu de Montserrat, 221
08041 Barcelona
Spain


ALSIR 2,5 % SOLUCION INYECTABLE


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Spain


Laboratorios Dr. Esteve, S.A.
Avda. Mare de Déu de Montserrat, 221
08041 Barcelona
Spain


ALSIR 5 % SOLUCION INYECTABLE


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Spain


Laboratorios Dr. Esteve, S.A.
Avda. Mare de Déu de Montserrat, 221
08041 Barcelona
Spain


ALSIR 100 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


QUINOLCEN 100 mg/ml SOLUCION INYECTABLE


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


FLOXAVEX 100 mg/ml SOLUCION INYECTABLE


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


LANFLOX 100 mg/ml SOLUCION INYECTABLE


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Sweden


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril® vet.


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, pigs, cattle, cats




Sweden


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril® vet.


Enrofloxacin


100 mg/ml


Solution for injection


Dog, pigs, cattle, cats




Sweden


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox vet


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Floxadil 25 mg/ml, oplossing voor injectie voor honden, katten en exotische dieren


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




The Netherlands


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Floxadil 50 mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




The Netherlands


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Floxadil 100 mg/ml, oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands


BAYTRIL 2,5 % INJEKTIEVLOEISTOF


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




The Netherlands


Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands


Baytril Piglet 25 mg/ml inspuitbare oplossing


Enrofloxacin


25 mg/ml


Solution for injection


Pigs




The Netherlands


Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands


BAYTRIL 5 % INJEKTIEVLOEISTOF


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




The Netherlands


Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands


BAYTRIL 5 % INJECTIEOPLOSSING


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, dogs, pigs




The Netherlands


Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands


BAYTRIL INJEKTIEVLOEISTOF 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands


BAYTRIL 10 % INJECTIEOPLOSSING


Enrofloxacin


100 mg/ml


Solution for injection


Pigs, cattle




The Netherlands


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml Oplossing voor injectie


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




The Netherlands


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml Oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml, oplossing voor injectie


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, cage birds, reptiles




The Netherlands


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




The Netherlands


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml, oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROXIL Oplossing voor injectie 50 mg/ml voor kalveren, varkens en honden


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




The Netherlands


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROXIL 100 MG/ML SOLUTION FOR INJECTION


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


Roxacin 100 mg/ml, oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Romikim Farma SL
Gran Via Carlos III, 98,6
8027 Barcelona
Spain


Enrodexil 100 mg/ml oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc 100 mg/ml injectieoplossing voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Doraflox 100 mg/ml, oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Unisol 100 mg/ml, oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox Oplossing voor injectie 50 mg/ml voor runderen, varkens, honden en katten


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




The Netherlands


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox Oplossing voor injectie 100 mg/ml voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Animalcare Ltd
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Enrocare 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals


Enrofloxacin


25 mg/ml


Solution for injection


Cage birds, cats, dogs, exotic animals, reptiles, small mammals




United Kingdom


Animalcare Ltd
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Enrocare 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats


Enrofloxacin


50 mg/ml


Solution for injection


Cats, cattle, dogs, pigs




United Kingdom


Animalcare Ltd
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Bayer plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
United Kingdom


Baytril 2,5 % Solution for Injection


Enrofloxacin


25 mg/ml


Solution for injection


Cage birds, cats, dogs, exotic animals, reptiles, small mammals




United Kingdom


Bayer plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
United Kingdom


Baytril 5 % Solution for Injection


Enrofloxacin


50 mg/ml


Solution for injection


Cats, cattle, dogs, pigs




United Kingdom


Bayer plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
United Kingdom


Baytril 10 % Solution for Injection


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats


Enrofloxacin


50 mg/ml


Solution for injection


Cats, cattle, dogs, pigs




United Kingdom


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats


Enrofloxacin


50 mg/ml


Solution for injection


Cats, cattle, dogs, Pigs




United Kingdom


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals


Enrofloxacin


25 mg/ml


Solution for injection


Cage birds, cats, dogs, exotic animals, reptiles, small mammals




United Kingdom


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats


Enrofloxacin


50 mg/ml


Solution for injection


Cats, cattle, dogs, pigs




United Kingdom


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Global Vet Health SL
c/Capcanes, no 12-bajos
Poligon Agro-Reus
Reus 43206
Spain


Quinoflox 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


Enrodexil 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 50 mg/ml Solution for Injection for Calves, Pigs and Dogs


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, dogs, pigs




United Kingdom


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Doraflox 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Unisol 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats Enrofloxacin


Enrofloxacin


50 mg/ml


Solution for injection


Cats, cattle, dogs, pigs




United Kingdom


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 100 mg/ml Solution for Injection for Cattle and Pigs Enrofloxacin


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs