Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 2014 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2014-08-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014290EN.01001001.xml










29.8.2014   


EN


Official Journal of the European Union


C 290/10





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 2014
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
2014/C 290/02
—   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




11.7.2014


Linco-Spectin 100


See Annex I


See Annex I


See Annex I


22.7.2014




22.7.2014


Domperidone


See Annex II


See Annex II


See Annex II


23.7.2014




31.7.2014


Tylosin


See Annex III


See Annex III


See Annex III


4.8.2014




—   Refusal 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




14.7.2014


Fiprex


See Annex V


See Annex V


See Annex V


15.7.2014




—   Suspension 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




14.7.2014


Fiprex


See Annex V


See Annex V


See Annex V


15.7.2014




—   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




22.7.2014


Domperidone


See Annex II


See Annex II


See Annex II


23.7.2014




11.7.2014


Caustinerf arsenical, Yranicid arsenical and other associated names


See Annex IV


See Annex IV


See Annex IV


14.7.2014






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I
LIST OF THE NAMES, PHARMACEUTICAL 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


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




Austria


Zoetis Österreich GmbH
Floridsdorfer Hauptstraße 1
1210 Vienna
Austria


Linco-Spectin forte-lösliches Pulver für Tiere


Lincomycin (as lincomycin-hydrochlorid-monohydrat) and spectinomycin (as spectinomycin sulfate)


22,2 g lincomycin and 44,5 g spectinomycin per 100 g


Powder for oral solution


Pigs
Chickens


Oral




Belgium


Zoetis Belgium SA
Rue Laid Burniat, 1
1348 Louvain-la-Neuve
Belgium


Linco-Spectin 100


Lincomycin (as lincomycin hydrochloride) and Spectinomycin (as spectinomycin sulphate)


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder for oral solution


Pigs
Chickens


Oral




Bulgaria


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


Линко-Спектин 100 разтворим прах/Linco-Spectin 100 Soluble Powder


Lincomycin (as lincomycin hydrochloride), Spectinomycin (as spectinomycin sulphate)


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder for oral solution


Pigs
Poultry — hens, chickens and turkeys


Oral




Cyprus


Zoetis Hellas SA
L. Mesogion 253- 255
15451, N. Psichico
Athens
Greece


Linco-Spectin 100 SP, Powder for oral solution for chickens


Lincomycin
Spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder for oral solution


Chickens


Oral




Czech Republic


Zoetis Česká republika, s.r.o.
Stroupežnického 17
Praha 5 150 00
Czech Republic


LINCO SPECTIN 100 plv. sol.


Lincomycin and spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder for oral solution


Pigs
Poultry


Oral




Denmark


Zoetis Finland Oy
Tietokuja 4
FI 00330 Helsinki
Finland


Linco-Spectin Vet.


Lincomycin and spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder for solution in drinking water


Pigs
Chickens


Oral




Estonia


Pfizer Manufacturing Belgium N.V.
Rijksweg 12
B-2870 Puurs
Belgium


Linco-Spectin 100 Soluble Powder


Lincomycin/Spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder for oral solution


Pigs
Poultry (broilers)


Oral




France


Zoetis
23/25 Avenue Du Docteur Lannelongue
75014 Paris
France


LINCO-SPECTIN 100


Lincomycin
spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder for oral solution


Pigs


Oral




Germany


Zoetis Deutschland GmbH
Schellingstraße 1,
D-10785 Berlin
Germany


Lincospectin Pulver zum Eingeben über das Trinkwasser für Schweine, Hühner (Broiler, Junghennen) und Puten


Lincomycin and spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder


Pigs
Chicken (broiler, pullet)
Turkey


Oral




Greece


Zoetis Hellas SA
L. Mesogion 253- 255
15451, N. Psichico
Athens
Greece


LINCO SPECTIN 100


Lincomycin and spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Pouder for oral solution


Chickens (broilers)


Oral




Hungary


Zoetis Hungary Kft.
Alkotás u. 53.
H-1123 Budapest
Hungary


Linco-Spectin 100 por belsőleges oldathoz A.U.V.


Lincomycin hydrochloride and spectinomycin sulphate


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder for oral solution


Pigs
Chickens
Turkeys


Oral




Ireland


Pfizer Healthcare Ireland Trading as Pfizer Animal Health,
Ringaskiddy,
Co. Cork
Ireland


Linco-Spectin 100 Soluble Powder


Lincomycin (as Lincomycin Hydrochloride) and Spectinomycin (as spectinomycin sulphate)


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder for oral solution. Pale yellow to light tan soluble powder


Pigs and poultry (non-layers)


Pigs: Linco-Spectin 100 Soluble Powder is formulated for administration via drinking water. A fresh solution should be prepared each day.
Poultry: For dosing via the drinking water.




Italy


ZOETIS ITALIA S.r.l.
Via Andrea Doria, 41 M
00192 Roma
Italy


LINCOSPECTIN Polvere orale per uso in acqua da bere per polli da carne e suini


LINCOMYCIN (as Hydrochloride) SPECTINOMYCIN (as Sulfate)


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Oral powder for use in drinking water


Pigs
Chickens


Oral




Latvia


Pfizer Animal Health MA EEIG
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom


Linco-Spectin 100


Lincomycin hydrochloride, spectinomycin sulfate


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Soluble powder for oral solution


Pigs
Poultry


Oral




Lithuania


Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium


Linco-Spectin 100


Lincomycin hydrochloride
Spectinomycin sulphate


33,3 g
66,7 g


Soluble Powder


Pigs
Poultry (non-layers)


Oral




Luxembourg


Zoetis Belgium SA
Rue Laid Burniat, 1
1348 Louvain-la-Neuve
Belgium


LINCO-SPECTIN 100


Lincomycin and spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder for oral solution


Pigs
Poultry


Oral




The Netherlands


Zoetis BV
Rivium Westlaan 74,
2909 LD Capelle a/d Ijssel
The Netherlands


Linco-Spectin 100


Lincomycin and spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Oral powder


Pigs
Poultry, not eggs for human consumption


oral




Poland


Zoetis Polska Sp. z o.o.
ul. Postępu 17B
02-676 Warszawa
Poland


Linco-Spectin 100 (222 g + 444 g)/1000 g, proszek do sporządzania roztworu doustnego dla świń, kur, indyków, kaczek i gołębi


Lincomycin and spectinomycin


222 g lincomycin and 444 g spectinomycin per 1  000 g


Powder for oral solution


Pigs
Chickens
Turkeys
Duck
Pigeon


Oral




Portugal


Zoetis Portugal, Lda
Lagoas Park, Edifício 10
2740-271 Porto Salvo
Portugal


LINCO-SPECTIN 100


Lincomycin and Spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Oral Powder


Pigs
Poultry (broilers, pullets and turkeys)


Oral




Romania


Pfizer Animal Health MA EEIG
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom


LINCO-SPECTIN 100


Lincomycin and spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Soluble powder


Pigs
Chickens Turkeys


Oral




Slovakia


Zoetis Česká republika, s.r.o.
Stroupežnického 17
Praha 5 150 00
Czech Republic


Linco-Spectin 100


Lincomycinum (ut Lincomycini hydrochloridum, Spectinomycinum (ut Spectinomycini sulfas tetrahydricus)


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder for oral solution


Pigs
Poultry


Oral




Slovenia


Zoetis Belgium SA,
Rue Laid Burniat 1,
1348 Louvain-la-Neuve
Belgium


LincoSpectin 100 prašek za peroralno raztopino za prašiče in perutnino


Lincomycin, Spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder for oral solution


Pigs
Poultry


Oral




Spain


Zoetis Spain, S.L.
Avda. de Europa 20B Parque empresarial La Moraleja
28108 Alcobendas, Madrid
Spain


LINCO-SPECTIN 100


Lincomycin and spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Oral powder


Pigs
Poultry


Oral




United Kingdom


Zoetis UK Limited
5th Floor, 6 St. Andrew Street
EC4A 3AE London
United Kingdom


Linco-Spectin 100 Soluble Powder, Powder for Oral Solution


Lincomycin Spectinomycin


33,3 g lincomycin and 66,7 g spectinomycin per 150 g


Powder for Oral Solution


Pigs
Poultry


Pigs: for administration via drinking water.
Poultry: for administration as the sole daily source of drinking water until consumed, followed by non-medicated water for the rest of the day, if necessary







ANNEX II
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 10MG


10 mg


tablet


oral use




Cyprus


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


domperidone


MOTILIUM ORAL SUSPENSION 1MG/ML


1 mg/ml


oral suspension


oral use




Cyprus


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


domperidone


MOTILIUM SUPPOSITORY 30MG


30 mg


suppository


rectal use




Cyprus


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


domperidone


MOTILIUM TABLETS 10MG


10 mg


tablet


oral use




Cyprus


Pierre Fabre Médicament
45 place Abel Gance
92100 Boulogne
France


domperidone


OROPERIDYS ORODISPERSIBLE TABLETS 10MG


10 mg


orodispersible tablet


oral use




Cyprus


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


domperidone


PEPTOMET FILM COATED TABLETS 10MG


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 Medicament
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 S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


10 mg


film-coated tablet


oral use




Italy


ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


60 mg


suppository


rectal use




Italy


ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


30 mg


suppository


rectal use




Italy


ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


10 mg


effervescent granules


oral use




Italy


ITALCHIMICI S.P.A. Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


1 mg/ml


suspension


oral use




Italy


ITALCHIMICI S.P.A.
Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


20 mg


film-coated tablet


oral use




Italy


ITALCHIMICI S.P.A.
Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy


Domperidone


PERIDON


20 mg


effervescent granules


oral use




Italy


Janssen-Cilag S.P.A.
Via Michelangelo buonarroti 23
20093 Cologno Monzese — Milano
Italy


Domperidone


MOTILIUM


1 mg/ml


suspension


oral use




Italy


Janssen-Cilag S.P.A.
Via Michelangelo buonarroti 23
20093 Cologno Monzese — Milano
Italy


Domperidone


MOTILIUM


10 mg


film-coated tablet


oral use




Italy


Janssen-Cilag S.P.A.
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 S.P.A.
Via Cantù 11
20092 Cinisello Balsamo — Milano — Italy


Domperidone


DOMPERIDONE GERMED


10 mg


film-coated tablet


oral use




Italy


GERMED PHARMA S.P.A.
Via Cantù 11
20092 Cinisello Balsamo — Milano — Italy


Domperidone


DOMPERIDONE GERMED


10 mg/10 ml


suspension


oral use




Italy


ABC FARMACEUTICI S.P.A.,
Corso Vittorio Emanuele II 72 , 10121 Torino
Italy


Domperidone


DOMPERIDONE ABC


10 mg


tablet


oral use




Italy


MYLAN S.P.A.
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 S.P.A.
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 S.P.A.
Via Pavia 6
20136 Milano
Italy


Domperidone


RIGES


10 mg


tablet


oral use




Italy


SANDOZ S.P.A.
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 S.P.A.
Largo Umberto Boccioni 1
21040 Origgio — Varese
Italy


Domperidone


DOMPERIDONE SANDOZ


10 mg


tablet


oral use




Italy


PENSA PHARMA S.P.A.
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 S.P.A.
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 Medicament
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 III
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State EU/EEA


Applicant/Marketing authorisation holder


Product name


INN


Strength


Pharmaceutical form


Animal species




Austria


Chevita Tierarzneimittel GmbH
Kaplanstrasse 10
4600 Wels
Austria


Chevi-Tyl 200 mg/g Arzneimittel-Vormischung zu Herstellung von Fütterungsarzneimitteln für Schweine, Hühner und Puten


Tylosin tartarate


20 g/100 g powder


Premix for medicated feeding stuff


Pigs, chicken, turkey




Austria


Chevita Tierarzneimittel GmbH
Kaplanstrasse 10
4600 Wels
Austria


Chevi-Tyl 200 mg/g Pulver zum Eingeben für Schweine, Hühner und Puten


Tylosin tartarate


20 g/100 g powder


Powder for oral solution


Pigs, chicken, turkey




Austria


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 1 g/g Granulat zum Eingeben über das Trinkwasser für Schweine, Hühner, Puten und Kälber


Tylosin


1 g tylosin (= 1,1 g tylosin tartate) per 1,1 g of granules


Granules for oral solution


Calves, pigs, chicken, turkey




Austria


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 mg/g Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine, Masthühner und Junghennen


Tylosin


100 mg tylosin as tylosin phosphate per g (= 1 00  000 IU)


Premix for medicated feeding stuff


Pigs, broilers, pullets




Austria


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 250 mg/g Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine, Masthühner und Junghennen


Tylosin


250 mg tylosin as tylosin phosphate per g (= 2 50  000 IU)


Premix for medicated feeding stuff


Pigs, broilers, pullets




Austria


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 20 mg/g Granulat zum Eingeben für Schweine


Tylosin


20 mg tylosin as tylosin phosphate per g (= 20  000 IU)


Granules for oral solution


Pigs




Austria


Richter Pharma AG
Feldgasse 19
4600 Wels
Austria


Tylan 20 mg/g — Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine


Tylosin phosphate


20 g/kg


Premix for medicated feeding stuff


Pigs




Austria


Richter Pharma AG
Feldgasse 19
4600 Wels
Austria


Tylan soluble — 1 g/g Pulver zur Herstellung einer Lösung zum Eingeben für Schweine, Hühner und Truthühner


Tylosin


110 g tylosin tartate per 110 g powder (= 100 g tylosin-activity)


Powder for oral solution


Pigs, chicken, turkeys




Austria


AniMed Service AG
Liebochstrasse 9
8143 Dobl
Austria


Tylosin-Phosphat ‘AniMed Service’ 100 mg/g — Pulver zum Eingeben für Schweine


Tylosin


100 g tylosin (as tylosin phophate) per 1  000 g powder


Powder for oral solution


Pigs




Austria


Vana GmbH
Wolfgang Schmälzlgasse 6
1020 Vienna
Austria


Vanatyl-Pulver für Tiere


Tylosin


110 g tylosin tartate per 110 g powder (= 100 g tylosin-base)


Powder for oral solution


Pigs, chicken (broiler), turkeys




Austria


AniMed Service AG
Liebochstrasse 9
8143 Dobl
Austria


Tylosintartrat PUR ‘AniMed Service’ 1 g/g — Pulver zum Eingeben für Tiere


Tylosin


1 g tylosin (as tylosin tartate) per 1 g of powder


Powder for oral solution


Cattle (calve)
Chickens
Pigs
Turkeys




Belgium


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 20 mg/g OG


Tylosin phosphate


20 mg/g
(20  000 IU)


Granules for oral solution


Pigs




Belgium


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 250 mg/g OG


Tylosin phosphate


250 mg/g
(2 50  000 IU)


Granules for oral solution


Pigs




Belgium


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 % w/w


Tylosin tartarate


1 g in 1,1 g granules
(1,1 g)


Granules for oral solution


Calves
Pigs
Chicken
Turkey




Belgium


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 mg/g Premix


Tylosin phosphate


100 mg/g
(1 00  000 IU)


Premix for medicated feeding stuff


Pigs
Broilers
Pullets




Belgium


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 250 mg/g Premix


Tylosin phosphate


250 mg/g
(2 50  000 IU)


Premix for medicated feeding stuff


Pigs
Broilers
Pullets




Belgium


Eli Lilly Benelux N.V.
Elanco Animal Health
Markiesstraat 1
1000 Brussel
Belgium


Tylan 20 Granules


Tylosin phosphate


20 mg/g
(20  000 IU)


Granules for oral solution


Pigs
Broilers
Pullets




Belgium


Eli Lilly Benelux N.V.
Elanco Animal Health
Markiesstraat 1
1000 Brussel
Belgium


Tylan 100 Granules


Tylosin phosphate


100 mg/g
(1 00  000 IU)


Granules for oral solution


Pigs
Broilers
Pullets




Belgium


Eli Lilly Benelux N.V.
Elanco Animal Health
Markiesstraat 1
1000 Brussel
Belgium


Tylan 20 Vet Premix


Tylosin phosphate


20 mg/g
(20  000 IU)


Premix for medicated feeding stuff


Pigs
Broilers
Pullets




Belgium


Eli Lilly Benelux N.V.
Elanco Animal Health
Markiesstraat 1
1000 Brussel
Belgium


Tylan 100 Vet Premix


Tylosin phosphate


100 mg/g
(1 00  000 IU)


Premix for medicated feeding stuff


Pigs
Broilers
Pullets




Belgium


Eli Lilly Benelux N.V.
Elanco Animal Health
Markiesstraat 1
1000 Brussel
Belgium


Tylan 250 Vet Premix


Tylosin phosphate


250 mg/g
(2 50  000 IU)


Premix for medicated feeding stuff


Pigs
Broilers
Pullets




Belgium


Eli Lilly Benelux N.V.
Elanco Animal Health
Markiesstraat 1
1000 Brussel
Belgium


Tylan Soluble


Tylosin tartarate


108 (100 g)/lagena
109 (1  000 g)/saccus
(1  000 mg/g)


Powder for oral solution


Calves
Pigs
Chicken
Turkey




Belgium


Kela NV (Kela Laboratoria NV)
Sint Lenaartseweg 48
2320 Hoogstraten
Belgium


Tylosine 75 % Kela


Tylosin tartarate


750 mg/g
(7 50  000 IU/g)


Powder for oral solution


Pigs
Chicken




Bulgaria


Gabrofam OOD
7002 Russe
16 Aleia Vazrajdane str., ap.42
Bulgaria


ТИЛОЗИН 60 % — БГ Водоразтворим прах


Tylosin


Tylosin tartarate 60 mg/g


Powder for oral solution


Hens and pigs




Bulgaria


Biovet JSC
39 Petar Rakov Str
4550 Peshtera
Bulgaria


TИЛОВЕТ 10 % гранули за перорално приложение за свине, прасета, пилета, пуйки, телета за угояване


Tylosin


Tylosin phosphate 100 mg/g


Granules for oral solution


Swine, pigs, chickens, turkeys, calves for fattening




Bulgaria


Biovet JSC
39 Petar Rakov Str
4550 Peshtera
Bulgaria


TИЛОВЕТ 25 % премикс за медикаментозен фураж за свине, прасета, пилета, пуйки, телета за угояване


Tylosin


Tylosin phosphate 250 mg/g


Premix for medicated feeding stuff


Swine, pigs, chickens, turkeys, calves for fattening




Bulgaria


Biovet JSC
39 Petar Rakov Str
4550 Peshtera
Bulgaria


TИЛОВЕТ 10 % премикс за медикаментозен фураж за свине, прасета, пилета, пуйки, телета за угояване


Tylosin


Tylosin phosphate 100 mg/g


Premix for medicated feeding stuff


Swine, pigs, chickens, turkeys, calves for fattening




Bulgaria


Biovet JSC
39 Petar Rakov Str
4550 Peshtera
Bulgaria


ТИЛОВЕТ пулвис водоразтворим прах за пилета, пуйки, прасета и телета


Tylosin


Tylosin tartarate 500 mg/g


Powder for oral solution


Chickens, turkeys, pigs and calves




Bulgaria


Biovet JSC
39 Petar Rakov Str
4550 Peshtera
Bulgaria


Тиловет Форте водоразтворими гранули за свине


Tylosin


200 mg/g


Granules for oral solution


Swine




Bulgaria


Pharma SIS
4 San Stefano Str.
Dobrich
Bulgaria


Оратил 100


Tylosin


108,18 g/110 g


Powder for oral solution


Chicken, turkeys and pigs




Bulgaria


Pharma SIS
4 San Stefano Str.
Dobrich
Bulgaria


Тилозин 100 премикс


Tylosin


10 g/100 g


Premix for medicated feeding stuff


Swine




Bulgaria


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 20 mg/g Орални гранули за свине


Tylosin


20 mg/g


Granules for oral solution


Swine




Bulgaria


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки


Tylosin


100 mg/g


Premix for medicated feeding stuff


Pigs, broilers and pullets




Bulgaria


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 250 mg/g премикс за медикаментозен фураж за свине, бройлери и пилета, отглеждани за носачки


Tylosin


250 mg/g


Premix for medicated feeding stuff


Pigs, broilers and pullets




Bulgaria


Pharma Vet
40 Otec Paisii Str.
Shumen
Bulgaria


Tилофарм водоразтворим прах


Tylosin


4 0 0 00  000 IU (50 g)


Powder for oral solution


Hens and pigs




Bulgaria


Zavet JSC
5 Kiril i Metodii Str.
Zavet
Bulgaria


Тилозин 50 % водоразтворим прах


Tylosin


5 00  000 IU/g


Powder for oral solution


Pigs, swine, broilers, turkeys, chicken and turkey breeders




Croatia


Medical Intertrade d.o.o.
Dr. Franje Tuđmana 3
10431, Sveta Nedelja
Croatia


Tylan Soluble


Tylosin


bottle: 100 g
bag: 1  000 g


Powder for oral solution


Chickens, turkeys, pigs




Croatia


GENERA d.d.
Svetonedeljska 2
Kalinovica, 10436 Rakov Potok
Croatia


Tilozin tartarat


Tylosin


Powder,
1 bottle: 70 g


Powder for oral solution


Chickens, turkeys, pigs




Cyprus


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 100 % Κοκκία για χορήγηση με το πόσιμο νερό για μόσχους, χοίρους, ορνίθια και ινδόρνιθες


TYLOSIN


1,1 g of granules contains 1 g of tylosin (corresponding to 1,1 g of tylosin tartrate)


Granules for oral solution


Calves, pigs, chickens, turkeys




Cyprus


Eli Lilly Regional Operations GmbH
Elanco Animal Health
Kölblgasse 8-10
1030 Vienna
Austria


TYLAN G 100 PREMIX
100 g/kg
Προμίγμα για φαρμακούχες ζωοτροφές για χοίρους.


Tylosin phosphate


100,0 g/kg


Premix for medicated feeding stuff


Pigs




Cyprus


DOX-AL ITALIA S.p.a.
Via Mascagni 6
20884 Sulbiate (MB)
Italy


TYLOSINA BMP Powder
Τylosin (from tylosin tartrate) 200 g/Kg
Φαρμακούχο πρόμιγμα σε κόκκους για χοίρους και κοτόπουλα κρεωπαραγωγής


Tylosin


200,0 g/kg


Premix for medicated feeding stuff


Swine, broilers




Czech Republic


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 % w/w granules for oral administration in drinking water for oral solution for pigs, chicken, turkey and calves


Tylosin


1 g Tylosinum (odpovídající 1,1 g Tylosini tartaras)/1,1 g


Granules for oral solution


Calves, pigs, chicken, turkey




Czech Republic


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 20 mg/g oral granules for pigs


Tylosin


Tylosinum (ut Tylosini phosphas) 20 mg v 1 g (odpovídá 20  000 IU)


Granules for oral solution


Pigs




Czech Republic


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 250 mg/g oral granules for pigs


Tylosin


Tylosinum (ut Tylosini phosphas): 250 mg/g (odpovídá 2 50  000 IU.)


Granules for oral solution


Pigs




Czech Republic


Eli Lilly Regional Operations GmbH
Elanco Animal Health
Kölblgasse 8-10
1030 Vienna
Austria


Tylan powder for oral solution


Tylosin


Tylosinum (ut tylosini tartras) 800 I.U./mg


Powder for oral solution


Chicken broilers, breeding pullets and laying hens, production pullets, turkey, pigs, calves




Czech Republic


Eli Lilly Regional Operations GmbH
Elanco Animal Health
Kölblgasse 8-10
1030 Vienna
Austria


TYLAN 100 mg/g granules for pigs


Tylosin


Tylosinum (ut phosphas) 100 mg aktivity (odpovídá 1 00  000 IU)/g


Granules for oral solution


Pigs




Czech Republic


Eli Lilly Regional Operations GmbH
Elanco Animal Health
Kölblgasse 8-10
1030 Vienna
Austria


TYLAN 100 mg/g medicated pre-mix for pigs


Tylosin


Tylosinum (ut phosphas) 100 mg aktivity (odpovídá 1 00  000 IU)/g


Premix for medicated feeding stuff


Pigs




Denmark


Elanco Animal Health A/S
Eli Lilly Danmark A/S
Lyskaer 3E, 2 tv.
2730 HERLEV
Denmark


Tylan Vet.


Tylosin


100 g/kg


Premix for medicated feeding stuff


Pig




Denmark


Elanco Animal Health A/S
Eli Lilly Danmark A/S
Lyskaer 3E, 2 tv.
2730 HERLEV
Denmark


Tylan Vet.


Tylosin


2 %


Premix for medicated feeding stuff


Pig




Denmark


Elanco Animal Health A/S
Eli Lilly Danmark A/S
Lyskaer 3E, 2 tv.
2730 HERLEV
Denmark


Tylan Vet.


Tylosin


No information available


Powder for oral solution


Pig, poultry




Denmark


Elanco Animal Health A/S
Eli Lilly Danmark A/S
Lyskaer 3E, 2 tv.
2730 HERLEV
Denmark


Tylan Vet.


Tylosin


2 %


Powder for oral solution


Pig




Denmark


Elanco Animal Health A/S
Eli Lilly Danmark A/S
Lyskaer 3E, 2 tv.
2730 HERLEV
Denmark


Tylan Vet.


Tylosin


10 %


Powder for oral solution


Pig




Denmark


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Tylmasin


Tylosin


20 mg/g


Granules for oral solution


Pig




Denmark


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Tylmasin


Tylosin


250 mg/g


Granules for oral solution


Pig




Denmark


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Tylmasin


Tylosin


1 g/g


Granules for oral solution


Calf, pig, poultry




Denmark


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Tylmasin


Tylosin


100 mg/g


Premix for medicated feeding stuff


Poultry, pig




Denmark


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Tylmasin


Tylosin


250 mg/g


Premix for medicated feeding stuff


Poultry, pig




Denmark


Ceva Animal Health A/S
Ladegårdsvej 2
DK-7100 Vejle
Denmark


Tylosin ‘Ceva’ Vet


Tylosin


No information available


Powder for oral solution


Poultry, pig




Denmark


ScanVet Animal Health A/S
Kongevejen 66
DK-3480 Fredensborg
Denmark


Tylocure


Tylosin


1 g/g


Granules for oral solution


Pig




Estonia


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 500WSP


Tylosin


500 mg/g


Powder for oral solution


Cattle, pigs, chicken, turkey




Estonia


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 1  000 mg/g granules for use in drinking water for pigs, chickens, turkeys and calves


Tylosin


1  000 mg/g


Granules for oral solution


Cattle, pigs, chicken, turkey




Finland


Elanco Animal Health A/S
Eli Lilly Danmark A/S
Lyskaer 3E, 2 tv.
2730 HERLEV
Denmark


Tylan Premix vet
20 mg/g esisekoite lääkerehua varten


Tylosin phosphate


20 mg/g


Premix for medicated feeding stuff


Pig




Finland


Elanco Animal Health A/S
Eli Lilly Danmark A/S
Lyskaer 3E, 2 tv.
2730 HERLEV
Denmark


Tylan vet jauhe oraaliliuosta varten


Tylosin tartarate


1 g oral powder contains 1 g tylosin tartrate resp 800 mg tylosin


Powder for oral solution


Pig, poultry




France


SOGEVAL
200 AVENUE DE MAYENNE
ZONE INDUSTRIELLE DES TOUCHES
53000 LAVAL
France


CONCENTRAT V007 TYLAN 100


Tylosin phosphate


20  000 IU/g


Premix for medicated feeding stuff


Pig
Poultry




France


VIRBAC
1ere avenue 2065 m L. I. D.
06516 Carros
France


AXENTYL


Tylosin tartarate


80 mg/g


Powder for oral solution


Pig




France


Lilly France S.A.S.
24 bld Vital Bouhot
CS 50004
92521 Neuilly sur Seine cedex
France


TYLAN 20 PREMIX


Tylosin phosphate


20  000 IU/g


Premix for medicated feeding stuff


Pig
Poultry




France


QALIAN
34 RUE JEAN MONNET
ZI D'ETRICHE
49500 SEGRE
France


COMPOMIX V T


Tylosin tartarate


92  000 IU/g


Powder for oral solution


Pig




France


QALIAN
34 RUE JEAN MONNET
ZI D'ETRICHE
49500 SEGRE
France


SANTAMIX TYLO 20


Tylosin phosphate


20  000 IU/g


Premix for medicated feeding stuff


Pig
Poultry




France


QALIAN
34 RUE JEAN MONNET
ZI D'ETRICHE
49500 SEGRE
France


TYLORAL


Tylosin tartarate


10 0 0 00  000 IU/sachet or jar


Powder for oral solution


Turkey
Pig
Cow
Poultry




France


QALIAN
34 RUE JEAN MONNET
ZI D'ETRICHE
49500 SEGRE


TYLOSINE BUVABLE NOE


Tylosin tartarate


10 0 0 00  000 IU/sachet


Powder for oral solution


Turkey
Pig
Cow
Poultry




France


LABORATOIRES BIOVE
3 RUE DE LORRAINE
62510 ARQUES
France


TYLOLIDE


Tylosin tartarate


10 0 0 00  000 IU/jar


Powder for oral solution


Turkey
Pig
Cow
Poultry




France


Lilly France S.A.S.
24 bld Vital Bouhot
CS 50004
92521 Neuilly sur Seine cedex
France


TYLAN SOLUBLE 100 %


Tylosin tartarate


10 0 0 00  000 IU/jar


Powder for oral solution


Pig
Cow
Poultry




France


SOGEVAL
200 AVENUE DE MAYENNE
ZONE INDUSTRIELLE DES TOUCHES
53000 LAVAL
France


SOGETYL 100 MUI POUDRE POUR SO LUTION BUVABLE POUR VEAUX PORCINS ET VOLAILLE


Tylosin tartarate


10 0 0 00  000 IU/jar


Powder for oral solution


Pig
Cow
Poultry




France


QALIAN
34 RUE JEAN MONNET
ZI D'ETRICHE
49500 SEGRE
France


TYLO 20 PM PORC VOLAILLE


Tylosin phosphate


20  000 IU/g


Premix for medicated feeding stuff


Pig
Poultry




France


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 20 G/KG PREMELANGE M EDICAMENTEUX VOLAILLE PORCS


Tylosin phosphate


20  000 IU/g


Premix for medicated feeding stuff


Pig
Poultry




France


QALIAN
34 RUE JEAN MONNET
ZI D'ETRICHE
49500 SEGRE
France


TYLOSOL 9,2


Tylosin tartarate


92  000 IU/g


Powder for oral solution


Pig




France


DELTAVIT
ZONE D'ACTIVITES DU BOIS DE TEILLAY
35150 JANZE
France


PM 21 TYLOSINE 20 PORC-VOLAILL E


Tylosin phosphate


20  000 IU/g


Premix for medicated feeding stuff


Pig
Poultry




France


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


TYLMASIN


Tylosin tartarate


10 0 0 00  000 IU/jar


Granules for oral solution


Pig
Cow
Poultry




France


LABORATORIOS MAYMO
VIA AUGUSTA 302
08017 BARCELONA
Spain


MAYLOSINE


Tylosin tartarate


No information available


Powder for oral solution


Poultry
Pig
Cattle




Germany


aniMedica GmbH
Im Südfeld 9
D-48308 Senden-Bösensell
Germany


Tylosin G 5 % AMV


Tylosin phosphate


50 g/1 kg


Premix for medicated feeding stuff


Pig




Germany


aniMedica GmbH
Im Südfeld 9
D-48308 Senden-Bösensell
Germany


Tylenterol


Tylosin phosphate


20 mg/g


Premix for medicated feeding stuff


Pig




Germany


aniMedica GmbH
Im Südfeld 9
D-48308 Senden-Bösensell
Germany


TP 10 % AMV


Tylosin phosphate


100,000 IU/g


Premix for medicated feeding stuff


Pig
chicken




Germany


aniMedica GmbH
Im Südfeld 9
D-48308 Senden-Bösensell
Germany


Klato lan


Tylosin tartarate


1  000 mg/g


Powder for oral solution


Pig
chicken




Germany


bela-pharm GmbH & Co. KG
Lohner Str. 19
D-49377 Vechta
Germany


Tylosintartrat 100 % Kompaktat


Tylosin tartarate


1  000 mg/g


Granules for oral solution


Pig
chicken




Germany


bela-pharm GmbH & Co. KG
Lohner Str. 19
D-49377 Vechta
Germany


Tylo-Suscit 100 % Kompaktat


Tylosin tartarate


1  000 mg/g


Granules for oral solution


Pig
chicken
turkey




Germany


bela-pharm GmbH & Co. KG
Lohner Str. 19
D-49377 Vechta
Germany


Tylo-Suscit 25


Tylosin tartarate


250 mg/g


Powder for oral solution


Pig
chicken




Germany


bioptivet Tierarzneimittel GmbH & Co.
Im Landwehrwinkel 22
D-59073 Hamm
Germany


Tylogran WSP, 1000 mg/g


Tylosin tartarate


1  000 mg/g


Granules for oral solution


Pig
chicken




Germany


Dopharma Research B.V.
Zalmweg 24
NL-4941 VX Raamsdonksveer
The Netherlands


TP 25 % Pulver


Tylosin phosphate


250 mg/g


Powder for oral solution


Pig




Germany


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 % w/w Granulat zum Eingeben über das Trinkwasser für Schweine, Hühner, Puten und Kälber


Tylosin tartarate


1,0 g/1,1 g


Granules for oral solution


Cattle (calf)
pig
chicken
turkey




Germany


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 250 mg/g Granulat zum Eingeben für Schweine


Tylosin


250 mg/g


Granules for oral solution


Pig




Germany


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 20 mg/g Granulat zum Eingeben für Schweine


Tylosin


20 mg/g


Granules for oral solution


Pig




Germany


KLAT-Chemie GmbH
Visbeker Str. 12
D-26197 Ahlhorn
Germany


Klato lan feed


Tylosin phosphate


1  000 mg/g


Powder for oral solution


Pig
chicken




Germany


Kon-Pharma GmbH
Senator-Bauer-Str. 34
D-30625 Hannover
Germany


Tylosintartrat 100 %


Tylosin tartarate


1 g/g


Powder for oral solution


Pig
chicken




Germany


Lilly Deutschland GmbH
Abt. Elanco Animal Health
Werner-Reimers-Straße 2-4
D-61352 Bad Homburg
Germany


Tylan Mix 2 %


Tylosin phosphate


20 g/kg


Premix for medicated feeding stuff


Pig




Germany


Lilly Deutschland GmbH
Abt. Elanco Animal Health
Werner-Reimers-Straße 2-4
D-61352 Bad Homburg
Germany


Tylan soluble


Tylosin tartarate


100 g/110 g


Powder for oral solution


Cattle(calf)
pig
chicken
turkey




Germany


Lilly Deutschland GmbH
Abt. Elanco Animal Health
Werner-Reimers-Straße 2-4
D-61352 Bad Homburg
Germany


Tylan G 25 %


Tylosin phosphate


250 mg/g


Powder for oral solution


Pig




Germany


bela-pharm GmbH & Co. KG
Lohner Str. 19
D-49377 Vechta
Germany


Tylo-Suscit 100 % Kompaktat


Tylosin tartarate


1 g/g


Granules for oral solution


Pig
chicken
turkey




Greece


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 2 %


Tylosin


20 mg/g


Granules for oral solution


Pigs




Greece


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 100 %


Tylosin


1 g


Granules for oral solution


Calves, pigs, chickens, turkeys




Greece


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 10 % premix


Tylosin


100 mg/g


Premix for medicated feeding stuff


Pigs, broilers and pullets




Greece


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMACIN 25 % premix


Tylosin


250 mg/g


Premix for medicated feeding stuff


Pigs, broilers and pullets.




Hungary


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 100 mg/g gyógypremix sertések, broilercsirkék és jércék számára A.U.V.


Tylosin phosphate


100 mg/g


Premix for medicated feeding stuff


Pigs and chickens




Hungary


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 % granulátum ivóvízbe keveréshez
sertés, házityúk, pulyka és borjú számára A.U.V.


Tylosin tartarate


100 %


Granules for oral solution


Pigs, chickens, turkeys and calves




Hungary


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 20 mg/g granulátum sertések számára A.U.V.


Tylosin phosphate


20 mg/g


Granules for oral solution


Pigs




Hungary


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 250 mg/g gyógypremix sertések, broilercsirkék és jércék számára A.U.V.


Tylosin phosphate


250 mg/g


Premix for medicated feeding stuff


Pigs and chickens




Hungary


Eli Lilly Regional Operations GmbH
Elanco Animal Health
Kölblgasse 8-10
1030 Vienna
Austria


Tylan G 100 gyógypremix A.U.V.


Tylosin phosphate


100 g/kg


Premix for medicated feeding stuff


Pigs and chickens




Hungary


Eli Lilly Regional Operations GmbH
Elanco Animal Health
Kölblgasse 8-10
1030 Vienna
Austria


Tylan vízoldékony por A.U.V.


Tylosin tartarate


100 %


Powder for oral solution


Pigs, chickens, turkeys and calves




Hungary


Kela NV (Kela Laboratoria NV)
Sint Lenaartseweg 48
2320 Hoogstraten
Belgium


TYLOSIN 75 % Kela oral por A.U.V.


Tylosin tartarate


750 mg/g


Powder for oral solution


Pigs and chickens




Ireland


Eli Lilly & Company Ltd
Elanco Animal Health
Lilly House
Priestley Road
Basingstoke, RG24 9NL
United Kingdom


Tylan G20 Premix for medicated feedingstuff


Tylosin


20 g/kg


Premix for medicated feeding stuff


Pigs




Ireland


Eli Lilly & Company Ltd
Elanco Animal Health
Lilly House
Priestley Road
Basingstoke, RG24 9NL
United Kingdom


Tylan G100 Premix


Tylosin


100 g/kg


Premix for medicated feeding stuff


Pigs




Ireland


Eli Lilly & Company Ltd
Elanco Animal Health
Lilly House
Priestley Road
Basingstoke, RG24 9NL
United Kingdom


Tylan G250 Premix for medicated feedingstuff


Tylosin


250 g/kg


Premix for medicated feeding stuff


Pigs, broilers and pullets




Ireland


Eli Lilly & Company Ltd
Elanco Animal Health
Lilly House
Priestley Road
Basingstoke, RG24 9NL
United Kingdom


Tylan G50 Premix for medicated feedingstuff


Tylosin phosphate


50 g/kg


Premix for medicated feeding stuff


Pigs




Ireland


Eli Lilly & Company Ltd
Elanco Animal Health
Lilly House
Priestley Road
Basingstoke, RG24 9NL
United Kingdom


Tylan Soluble Powder for Oral Solution


Tylosin tartarate


100 g


Powder for oral solution


Calves, pigs and poultry




Ireland


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 20 mg/g Oral Granules for pigs


Tylosin


20 mg/g


Granules for oral solution


Pigs




Ireland


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 mg/g Premix for medicated feeding stuff for pigs, broilers and pullets


Tylosin


100 mg/g


Premix for medicated feeding stuff


Pigs, broilers and pullets




Ireland


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 250 mg/g Premix for medicated feeding stuff for pigs, broilers and pullets


Tylosin


250 mg/g


Premix for medicated feeding stuff


Pigs, broilers and pullets




Ireland


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 % W/W Granules for use in Drinking Water for pigs, chickens, turkeys and calves


Tylosin tartarate


100 % w/w


Granules for oral solution


Calves, pigs, chickens, turkeys




Italy


Vetoquinol Italia
Via Piana, 265
47032 Bertinoro (FC)
Italy


ASCOTYL 200 MP


Tylosin


200 mg/g


Premix for medicated feeding stuff


Pigs, chickens




Italy


LABORATORIO VACCINOGENO PAGNINI SNC
Via A. Diaz 147/149
Portici (NA)
Italy


BRONCOTYL 100


Tylosin


100 g/kg


Premix for medicated feeding stuff


Cattle, pigs, chickens




Italy


Eli Lilly Italia S.p.A.
Via A. Gramsci, 731-733
50019 Sesto Fiorentino (IT)
Italy


NEO TYLAN G250 PREMIX


Tylosin phosphate


250 mg/g


Premix for medicated feeding stuff


Chickens,
Pigs




Italy


Sintofarm
Via P. Togliatti, 5
Guastalla (RE)
Italy


PHARMASIN 100


Tylosin


100 g/g


Granules for oral solution


Pigs, Chickens, Turkeys and Calves




Italy


DOX-AL ITALIA S.p.a.
Via Mascagni 6
20884 Sulbiate (MB)
Italy


PURTYL


Tylosin


1 g/g


Powder for oral solution


Cattle, chickens, turkeys and pigs




Italy


Medilabor
Via Cuneo, 17
Cuneo
Italy


Tilosina 10 %


Tylosin tartarate


100 g/kg


Powder for oral solution


Calves, pigs, chickens




Italy


Filozoo Srl
V. del Commercio 28/30
41012 Carpi (MO)
Italy


Tilosina 20 % Filozoo


Tylosin tartarate


200 g/kg


Powder for oral solution


Calves, chickens, pigs




Italy


Chemifarma S.p.A.
Via Don Eugenio Servadei 16
47122 Forlì, Forlì-Cesena
Italy


Tilosina 20 % Chemifarma


Tylosin tartarate


200 mg/g


Oral solution


Calves, chickens, pigs




Italy


Neofarma
Via Emilia Km.18
1854 — 47020 Longiano (FC)
Italy


Tilosina 20 % liquida Neofarma


Tylosin tartarate


200 mg/g


Oral solution


Calves, chickens, pigs




Italy


TREI
Via Affarosa, 4
42010 Rio Saliceto (RE)
Italy


Tilosina 20 % liquida TreI


Tylosin tartarate


200 mg/g


Oral solution


Calves, chickens, pigs




Italy


Chemifarma S.p.A.
Via Don Eugenio Servadei 16
47122 Forlì, Forlì-Cesena
Italy


Tilosina 20 % liquida Chemifarma


Tylosin tartarate


200 mg/g


Oral solution


Calves, chickens, pigs




Italy


LABORATORIO VACCINOGENO PAGNINI SNC
Via A. Diaz 147/149
Portici (NA)
Italy


Tilosina 20 % Pagnini


Tylosin tartarate


200 mg/g


Powder for oral solution


Calves, Pigs, Chickens-Broilers (not producing eggs for human consumption)




Italy


TREI
Via Affarosa, 4
42010 Rio Saliceto (RE)
Italy


Tilosina 20 % TreI


Tylosin tartarate


200 g/kg


Powder for oral solution


Calves, Pigs, Chickens-Broilers (not producing eggs for human consumption)




Italy


Vetoquinol Italia
Via Piana, 265
47032 Bertinoro (FC)
Italy


Tilosina 20 % Vetoquinol


Tylosin tartarate


200 mg/g


Powder for oral solution


Pigs, chickens




Italy


Filozoo Srl
V. del Commercio 28/30
41012 Carpi (MO)
Italy


Tilosina 200 premix


Tylosin


200 g/kg


Premix for medicated feeding stuff


Pigs, chickens




Italy


Ceva Salute Animale S.p.A.
Viale Colleoni, 15
20864 Agrate Brianza (MB)
Italy


Tilsol 200 liquido


Tylosin


200 g/kg


Powder for oral solution


Calves, Pigs, Chickens-Broilers, Turkeys (not producing eggs for human consumption)




Italy


Ceva Salute Animale S.p.A.
Viale Colleoni, 15
20864 Agrate Brianza (MB)
Italy


Tilsol 200 solubile


Tylosin


200 g/kg


Powder for oral solution


Calves, Pigs, Chickens-Broilers (not producing eggs for human consumption)




Italy


Eli Lilly Italia S.p.A.
Via A. Gramsci, 731-733
50019 Sesto Fiorentino (IT)
Italy


Tylan solubile


Tylosin tartarate


100 g/g


Powder for oral solution


Calves, Pigs, Herns-Broilers, Turkeys




Italy


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Tylmasin


Tylosin phosphate


250 mg/g


Premix for medicated feeding stuff


Pigs and chickens (not producing eggs for human consumption)




Italy


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Tylmasin 20 mg/g granulato per uso orale per suini


Tylosin phosphate


20 mg/g


Granules for oral solution


Pigs




Italy


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Tylmasin 250 mg/g granulato per uso orale per suini


Tylosin phosphate


250 mg/g


Granules for oral solution


Pigs




Italy


Medilabor
Via Cuneo, 17
12030 Cavallermaggiore (CN)
Italy


Tylomed 100


Tylosin phosphate


100 g/kg


Premix for medicated feeding stuff


Pigs and chickens (not producing eggs for human consumption)




Italy


DOX-AL ITALIA S.p.a.
Via Mascagni 6
20884 Sulbiate (MB)
Italy


Tyloplus 200


Tylosin


200 g/kg


Premix for medicated feeding stuff


Pigs and chickens (not producing eggs for human consumption)




Italy


Chemifarma S.p.A.
Via Don Eugenio Servadei 16
47122 Forlì, Forlì-Cesena
Italy


Tylosin 200 premix


Tylosin


200 g/kg


Premix for medicated feeding stuff


Pigs and chickens (not producing eggs for human consumption)




Italy


TREI
Via Affarosa, 4
42010 Rio Saliceto (RE)
Italy


Tylox 100 premix


Tylosin phosphate


100 g/kg


Premix for medicated feeding stuff


Pigs and chickens (not producing eggs for human consumption)




Latvia


Magnum Veterinārija SIA
Ulbrokas iela 23
Rīga, LV-1021
Latvia


Tylokel 75 MV 750 mg/g šķīdināmais pulveris iekšķīgi lietojama šķīduma pagatavošanai cūkām un mājputniem


Tylosin tartarate


750 mg/g


Powder for oral solution


Pigs and poultry




Latvia


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 500 WSP 500 mg/g ūdenī šķīstošs pulveris iekšķīgai lietošanai cūkām, liellopiem, vistām un tītariem


Tylosin tartarate


500 mg/g


Powder for oral solution


Cattle, pigs, chickens, turkey




Latvia


Vet Line SIA
M. Rāmavas 2
Valdlauči, Ķekavas pag.,LV-1076
Latvia


Macrolan WS pulveris iekšķīgai lietošanai teļiem, kazām, aitām, cūkām un mājputniem


Tylosin tartarate


1  000 mg/g


Powder for oral solution


Cattle, goats, sheep, pigs, poultry




Lithuania


bela-pharm GmbH & Co. KG
Lohner Str. 19
D-49377 Vechta
Germany


TYLO-SUSCIT 100 % Kompaktat, geriamieji milteliai


Tylosin tartarate


1  000 mg/g


Powder for oral solution


Pigs and chicken




Lithuania


Chemifarma S.p.A.
Via Don Eugenio Servadei 16
47122 Forlì, Forlì-Cesena
Italy


TILOSINA 20 % CHEMIFARMA, geriamieji milteliai


Tylosin tartarate


200 mg/g


Powder for oral solution


Non ruminating calves, pigs, poultry




Lithuania


Dopharma Research B.V.
Zalmweg 24, 4941 VX Raamsdonksveer,
the Netherlands


Tylogran WSP, granulės geriamajam tirpalui


Tylosin tartarate


1  000 mg/g


Granules for oral solution


Calves, swine, chicken, turkeys




Lithuania


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 500 mg/g vandenyje tirpūs milteliai kiaulėms, veršeliams, vištoms ir kalakutams


Tylosin tartarate


500 mg/g


Powder for oral solution


Swine, calf, chicken and turkey




Lithuania


DOX-AL ITALIA S.p.a.
Via Mascagni 6
20884 Sulbiate (MB)
Italy


TILOSINA 20 % LIQUIDA, geriamasis tirpalas


Tylosin


200 g/kg


Oral solution


Calves, swine and broilers.




Lithuania


Franvet,
Zone Industrielle d'Etriché,
49500 Segré,
France


TYLORAL, geriamieji milteliai


Tylosin tartarate


10 0 0 00  000 IU/sachet


Powder for oral solution


Poultry, swine, calves




Lithuania


DOX-AL ITALIA S.p.a.
Via Mascagni 6
20884 Sulbiate (MB)
Italy


PURTYL, geriamieji milteliai


Tylosin tartarate


1  000 mg/g


Powder for oral solution


Chicken, turkeys, swine and calves




Lithuania


Kela NV (Kela Laboratoria NV)
Sint Lenaartseweg 48
2320 Hoogstraten
Belgium


TYLOSIN 75 %, geriamieji milteliai


Tylosin tartarate


750 mg/g


Powder for oral solution


Swine, chicken




Malta


Industrial Veterinaria, S.A — INVESA
Esmeralda 19
E-08950 Esplugues de Llobregat, Barcelona
Spain


TILOSINA 100 GANADEXIL


Tylosin


100 mg/g


Powder for oral solution


Poultry, turkey, swine




The Netherlands


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 20 mg/g Orale Granules voor varkens


Tylosin phosphate


20 mg/g


Granules for oral solution


Pig




The Netherlands


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 100 mg/g premix voor gemedicineerd voer voor varkens, slachtkuikens en opfokleghennen


Tylosin phosphate


100 mg/g


Premix for medicated feeding stuff


Pig, chicken (broilers, future layers/breeders)




The Netherlands


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 % W/W Water Oplosbare Granules


Tylosin tartarate


1 g/1,1 g


Granules for oral solution


Cattle (calves), pig, chicken, turkey




The Netherlands


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 250 mg/g Orale Granules voor varkens


Tylosin phosphate


250 mg/g


Granules for oral solution


Pig




The Netherlands


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 250 mg/g premix voor gemedicineerd voer voor varkens, slachtkuikens en opfokleghennen


Tylosin phosphate


250 mg/g


Premix for medicated feeding stuff


Pig, chicken (broilers, future layers/breeders)




The Netherlands


Eli Lilly Nederland B.V.
Elanco Animal Health
Grootslag 1-5
3991 RA Houten
The Netherlands


TYLAN G250 PREMIX 25 %


Tylosin phosphate


250 g/kg


Premix for medicated feeding stuff


Pig, chicken (broilers, future layers/breeders)




The Netherlands


Eli Lilly Nederland B.V.
Elanco Animal Health
Grootslag 1-5
3991 RA Houten
The Netherlands


TYLAN W.O., poeder voor oraal gebruik bij kippen, kalkoenen, varkens en kalveren


Tylosin tartarate


Unadulterated


Powder for oral solution


Cattle (calves), pig, chicken, turkey




The Netherlands


Eli Lilly Nederland B.V.
Elanco Animal Health
Grootslag 1-5
3991 RA Houten
The Netherlands


TYLAN 100 PREMIX 10 %


Tylosin phosphate


100 g/kg


Premix for medicated feeding stuff


Pig, chicken (broilers, future layers/breeders)




The Netherlands


Eli Lilly Nederland B.V.
Elanco Animal Health
Grootslag 1-5
3991 RA Houten
The Netherlands


TYLAN 2 % TOPDRESSING


Tylosin phosphate


20 g/kg


Powder for oral solution


Pig




The Netherlands


Eli Lilly Nederland B.V.
Elanco Animal Health
Grootslag 1-5
3991 RA Houten
The Netherlands


TYLAN 20 PREMIX 2 %


Tylosin phosphate


20 g/kg


Premix for medicated feeding stuff


Pig, chicken (broilers, future layers/breeders)




The Netherlands


Dopharma Reasearch B.V.
Zalmweg 24
4941 VX Raamsdonkveer
The Netherlands


TYLOGRAN WSP


Tylosin tartarate


Unadulterated


Powder for oral solution


Cattle (calves), pig, chicken, turkey




The Netherlands


Eli Lilly Nederland B.V.
Elanco Animal Health
Grootslag 1-5
3991 RA Houten
The Netherlands


Tylosinetartraat 100 %


Tylosin tartarate


Unadulterated


Powder for oral solution


Cattle (calves), pig, chicken (broilers, future layers/breeders), turkey




Poland


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 mg/g Premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych


Tylosin phosphate


100 mg/g


Premix for medicated feeding stuff


Pigs, Broilers and Pullets




Poland


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 20 mg/g granulat doustny dla świń


Tylosin phosphate


20 mg/g


Granules for oral solution


Pigs




Poland


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 250 mg/g premiks do sporządzania paszy leczniczej dla świń, brojlerów i młodych kur rzeźnych


Tylosin phosphate


250 mg/g


Premix for medicated feeding stuff


Pigs, Broilers and Pullets




Poland


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 250 mg/g granulat doustny dla świń


Tylosin phosphate


250 mg/g


Granules for oral solution


Pigs




Poland


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 1 g/g granulat do podania w wodzie do picia dla świń, cieląt, kur i indyków


Tylosin tartarate


1 g/g


Granules for oral solution


Calves, pigs, chickens, turkeys




Poland


Ceva Salute Animale S.p.A.
Viale Colleoni, 15
20864 Agrate Brianza (MB)
Italy


Tilsol 200, 200 g/1000 g


Tylosin


200 g/1  000 g


Powder for oral solution


Chicken, pig




Poland


Eli Lilly Regional Operations GmbH
Elanco Animal Health
Kölblgasse 8-10
1030 Vienna
Austria


Tylan Soluble Powder


Tylosin


1  000 g/kg


Powder for oral solution


Chicken, turkey, pig, cattle




Poland


Eli Lilly Regional Operations GmbH
Elanco Animal Health
Kölblgasse 8-10
1030 Vienna
Austria


Tylan G 100 Premix


Tylosin


100 mg/kg


Premix for medicated feeding stuff


Pigs




Poland


P.F.H.U. ‘Veta’ Mariusz Hołownia
Kownaty 74
18-421 Kownaty
Poland


Tylo-Kel 75 proszek do sporządzania roztworu doustnego dla kur i świń


Tylosin tartarate


750 mg/g


Powder for oral solution


Chicken, pig




Poland


Przedsiębiorstwo Farmaceutyczne Okoniewscy ‘VETOS FARMA’ Sp. z o.o.
ul. Dzierżoniowska 21
58-260 Bielawa
Poland


FARMATYL, tylozyny winian 1000 g/kg proszek do sporządzania roztworu doustnego dla kur, indyków i świń


Tylosin tartarate


1  000 g/kg


Powder for oral solution


Turkey, hen, pig




Poland


Vetoquinol Biowet Sp. z o.o.
ul. Kosynierów Gdyńskich 13-14
66-400 Gorzów Wielkopolski
Poland


Tylbian, 110 mg/g


Tylosin tartarate


110 mg/g


Granules for oral solution


Hen
turkey
pig
cattle




Portugal


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 g/g Grânulos para administração na água de bebida para suínos, galinhas e frangos, perús e vitelos.


Tylosin


1,1 g of granules contains 1 g of tylosin


Granules for oral solution


Calves, pigs, chickens, turkeys




Portugal


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 250 mg/g Pré-mistura para alimento medicamentoso para suínos, galinhas e frangos de engorda


Tylosin


250 mg per g. (equivalent to 2 50  000 IU)


Premix for medicated feeding stuff


Pigs, broilers and pullets




Portugal


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 mg/g Pré-mistura medicamentosa para alimento medicamentoso para suínos, frangos de engorda e galinhas


Tylosin


100 mg per g. (equivalent to 1 00  000 IU)


Premix for medicated feeding stuff


Pigs, broilers and pullets




Portugal


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 20 mg/g Grânulos Orais para suínos


Tylosin


20 mg per g (equivalent to 20  000 IU)


Granules for oral solution


Pigs




Portugal


REPRESENTAGRO — REPRESENTAÇOES LDA
Estrada da Lapa 1
2665-507 Venda do Pinheiro
Portugal


ORATIL 100 P, pó para solução oral para suínos, frangos e perus


Tylosin


1  000 mg


Powder for oral solution


Pigs, broilers, turkeys




Portugal


PRODIVET, Comércio de Produtos Químicos, Farmacêuticos e Cosméticos, SA
Av. Infante D. Henrique no 333-H 3o piso Esc. 41
1800-282 Lisboa
Portugal


PRODITYL, Pó para solução oral para administração na água de bebida para suínos, frangos e perus


Tylosin


1,1 g


Powder for oral solution


Pigs, broilers, turkeys




Portugal


Ceva Saúde Animal Produtos Farmacêuticos e Imunológicos, Lda.
Rua Doutor António Loureiro Borges, 9/9A — 9oA
Miraflores, 1495-131 Algés
Portugal


TILPLUS 100 PÓ para solução oral para suínos, frangos e perus


Tylosin


100 g


Powder for oral solution


Pigs, broilers, turkeys




Portugal


Lilly Portugal — Produtos Farmaceuticos, Lda.
Torre Occidente
Rua Galileu Galilei, n.o 2
Piso 7 fração A/D,
1500-392 Lisboa
Portugal


Tylan 100 g/Kg Pré mistura medicamentosa para alimento medicamentoso para suínos e frangos de carne, reprodutoras e poedeiras


Tylosin


100 g/kg


Premix for medicated feeding stuff


Pigs, broilers, chickens




Portugal


Lilly Portugal — Produtos Farmaceuticos, Lda.
Torre Occidente
Rua Galileu Galilei, n.o 2
Piso 7 fração A/D,
1500-392 Lisboa
Portugal


Tylan 20 g/Kg Pré mistura medicamentosa para alimento medicamentoso para suínos e frangos de carne, reprodutoras e poedeiras


TYLOSIN


20 g/kg


Premix for medicated feeding stuff


Pigs, broilers, chickens




Portugal


Lilly Portugal — Produtos Farmaceuticos, Lda.
Torre Occidente
Rua Galileu Galilei, n.o 2
Piso 7 fração A/D,
1500-392 Lisboa
Portugal


Tylan 250 g/Kg Pré mistura medicamentosa para alimento medicamentoso para Suínos e frangos de carne


TYLOSIN


250 g/kg


Premix for medicated feeding stuff


Pigs, broilers, chickens




Portugal


Lilly Portugal — Produtos Farmaceuticos, Lda.
Torre Occidente
Rua Galileu Galilei, n.o 2
Piso 7 fração A/D,
1500-392 Lisboa
Portugal


TYLAN PÓ SOLÚVEL


TYLOSIN


100 g per bottle


Powder for oral solution


Pigs, broilers, turkeys




Portugal


ZOOPAN Produtos Pecuários S.A.
Rua da Liberdade, no 77
2050-023 Aveiras de Baixo
Portugal


TYLOSIN 750 mg/g Pó oral para administração na água de bebida para suínos e frangos


TYLOSIN


750 mg/g


Powder for oral solution


Pigs, broilers




Romania


S.C. PASTEUR -FILIALA FILIPESTI
Str. Principala, nr. 944
Filipestii de Padure, Jud. Prahova
Romania


Tilozina 100


Tylosin phosphate


10 g/100 g


Premix for medicated feeding stuff


Poultry, pigs




Romania


S.C. PASTEUR -FILIALA FILIPESTI
Str. Principala, nr. 944
Filipestii de Padure, Jud. Prahova
Romania


Tilozina


Tylosin tartarate


0,58 g/g


Powder for oral solution


Cattle, pigs, poultry




Romania


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 250 mg/g


Tylosin phosphate


250 mg/g


Premix for medicated feeding stuff


Pigs, broilers and pullets




Romania


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 mg/g


Tylosin phosphate


100 mg/g


Premix for medicated feeding stuff


Pigs, broilers and pullets




Romania


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 20 mg/g


Tylosin phosphate


20 mg/g


Granules for oral solution


Pigs




Romania


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 %


Tylosin tartarate


1 g/g


Granules for oral solution


Calves, pigs, poultry




Romania


Eli Lilly Regional Operations GmbH
Elanco Animal Health
Kölblgasse 8-10
1030 Vienna
Austria


Tylan G 100 g/kg


Tylosin phosphate


100 g/kg


Premix for medicated feeding stuff


Pigs




Romania


Crida Pharm SRL
str. Intrarea Vagonetului nr.2, bl.101, ap.47, parter, sector 6
Bucharest
Romania


Tylosin 60 %


Tylosin tartarate


60 g/100 g


Powder for oral solution


Pigs, broilers




Romania


SC Delos Impex 96 SRLStr
Horia, Closca si Crisan, Otopeni
judetul Ilfov
Romania


Tilodem 50


Tylosin tartarate


500 mg/g


Powder for oral solution


Pigs, poultry (broilers, breeding broilers, laying hens, replacement pullets)




Romania


SC Delos Impex 96 SRLStr
Horia, Closca si Crisan, Otopeni
judetul Ilfov
Romania


Tilosin 10 %


Tylosin tartarate


100 mg/g


Powder for oral solution


Pigs, poultry




Romania


Chemifarma S.p.A.
Via Don Eugenio Servadei 16
47122 Forlì, Forlì-Cesena
Italy


Tilosina 20 % Chemifarma


Tylosin tartarate


20 g/100 g


Powder for oral solution


Cattle, pigs, poultry (broilers, turkeys)




Romania


Anupco LTd.
Crockatt Road
Lady Lane Industrial Estate, Hadleigh
Ipswich, Suffolk, IP7 6RD
United Kingdom


Tylosin 75


Tylosin tartarate


825 mg/g


Powder for oral solution


Pigs, poultry (chicken, turkey)




Romania


Kela NV (Kela Laboratoria NV)
Sint Lenaartseweg 48
2320 Hoogstraten
Belgium


Tylosin 75 % Kela


Tylosin tartarate


750 mg/g


Powder for oral solution


Pigs, poultry




Slovakia


Pharmagal spol. s.r.o.
Murgašova 5
949 01 Nitra
Slovakia


RESETYL prášok na perorálny roztok


Tylosin tartarate


1  000 g/1  100 g


Powder for oral solution


Chickens (broilers, pullets, laying hens), turkeys, pigs, calves




Slovakia


Eli Lilly Regional Operations GmbH
Elanco Animal Health
Kölblgasse 8-10
1030 Vienna
Austria


TYLAN vodorozpustný prášok


Tylosin tartarate


1  000 g/1  100 g


Powder for oral solution


Chickens (broilers, pullets, laying hens), turkeys, pigs, calves




Slovakia


Eli Lilly Regional Operations GmbH
Elanco Animal Health
Kölblgasse 8-10
1030 Vienna
Austria


TYLAN 100 mg/g premix


Tylosin phosphate


100 mg/g


Premix for medicated feeding stuff


Pigs




Slovenia


IRIS Mednarodna trgovina d.o.o.,
Cesta v Gorice 8
1000 Ljubljana
Slovenia


TYLAN SOLUBLE prašek za peroralno raztopino za prašiče, kokoši in purane


Tylosin


100 g


Powder for oral solution


Pigs, chicken, turkey




Spain


Elanco Valquímica, S.A.
Avda. de la Industria, no 30
Polígono Industrial de Alcobendas
28108 Alcobendas (Madrid)
Spain


TRELACON G 250 PREMEZCLA


Tylosin


250 mg/g


Premix for medicated feeding stuff


Pigs, poultry




Spain


Elanco Valquímica, S.A.
Avda. de la Industria, no 30
Polígono Industrial de Alcobendas
28108 Alcobendas (Madrid)
Spain


TRELACON G 50 PREMEZCLA


Tylosin


50 mg/g


Premix for medicated feeding stuff


Pigs, poultry




Spain


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 100 MG/G PREMEZCLA MEDICAMENTOSA PARA PORCINO POLLOS DE ENGORDE


Tylosin


100 mg/g


Premix for medicated feeding stuff


Pigs, broilers, pullets




Spain


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 250 MG/G PREMEZCLA MEDICAMENTOSA PARA PORCINO POLLOS DE ENGORDE


Tylosin phosphate


250 mg/g


Premix for medicated feeding stuff


Pigs, broilers, pullets




Spain


S.P. VETERINARIA, S.A.
CTRA. REUS-VINYOLS, KM.4,1.
RIUDOMS (Tarragona)
Spain


HIDROTIL POLVO ORAL


Tylosin tartarate


100 g/100 g


Powder for oral solution


Broilers, layer hens and future layer pullets turkeys, pigs and cattle (claves)




Spain


Elanco Valquímica, S.A.
Avda. de la Industria, no 30
Polígono Industrial de Alcobendas
28108 Alcobendas (Madrid)
Spain


TRELACON G 20 G/KG PREMEZCLA MEDICAMENTOSA


Tylosin phosphate


20 mg/g


Premix for medicated feeding stuff


Pigs, broilers and replacement pullets




Spain


Elanco Valquímica, S.A.
Avda. de la Industria, no 30
Polígono Industrial de Alcobendas
28108 Alcobendas (Madrid)
Spain


TRELACON G 100 G/KG PREMEZCLA MEDICAMENTOSA


Tylosin phosphate


100 mg/g


Premix for medicated feeding stuff


Pigs, broilers and replacement pullets




Spain


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 1G/G GRANULADO PARA ADMINISTRACIÓN EN AGUA DE BEBIDA


Tylosin tartarate


1 g/g


Granules for oral solution


Pigs, calves, chickens, turkeys




Spain


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


PHARMASIN 20 MG/G GRANULADO ORAL PARA PORCINO


Tylosin phosphate


20 mg/g


Granules for oral solution


Pigs




Spain


Elanco Valquímica, S.A.
Avda. de la Industria, no 30
Polígono Industrial de Alcobendas
28108 Alcobendas (Madrid)
Spain


TAILAN


Tylosin


1 g/g


Powder for oral solution


Pigs, poultry (broilers, pullets, layers and turkeys), bovine (pre-ruminants calves).




Spain


S.P. VETERINARIA, S.A.
Ctra. Reus-Vinyols, km.4,1.
Riudoms (Tarragona)
Spain


ORATIL — 100


Tylosin tartarate


1 g/g


Powder for oral solution


Pigs, chickens, turkeys, calves




Spain


INDUSTRIAL VETERINARIA, S.A.
Esmeralda 19.
08950 Esplugues de Llobregat (Barcelona)
Spain


TILOSINA 100 GANADEXIL


Tylosin tartarate


1 g/g


Powder for oral solution


Pigs, chickens, turkeys




Spain


MEVET, S. A.U.
Polígono Industrial El Segre
parcela 409-410.
25191 Lérida
Spain


TILOVALL PREMEZCLA


Tylosin phosphate


20 mg/g


Premix for medicated feeding stuff


Pigs, poultry and cattle




Spain


LABORATORIOS CALIER, S.A.
BARCELONÉS, 26.
08520 Les Franqueses del Valles (Barcelona)
Spain


GANAMIX TILOSINA 10 % PREMEZCLA


Tylosin phosphate


10 mg/g


Premix for medicated feeding stuff


Pigs, poultry and cattle




Spain


LABORATORIOS HIPRA, S.A.
Avda. La Selva, 135.
17170 Amer (Girona)
Spain


HIPRAMIX-TIL


Tylosin phosphate


20 mg/g


Premix for medicated feeding stuff


Pigs, poultry and cattle




Spain


ANDRES PINTALUBA, S.A.
Pol. Industrial Agro-Reus
c/Prudenci Bertrana 5.
43206 Reus (Tarragona)
Spain


APSAMIX TILOSINA 10 %


Tylosin phosphate


10 mg/g


Premix for medicated feeding stuff


Pigs, poultry and cattle




Spain


MEVET, S. A.U.
Polígono Industrial El Segre
parcela 409-410.
25191 Lérida
Spain


TILOVALL POLVO


Tylosin tartarate


1 g/g


Powder for oral solution


Porcine, chickens, calves




Spain


SUPER’S DIANA, S.L.
Ctra. C-17, km 17.
08150 Parets del Valles (Barcelona)
Spain


TILOSAN


Tylosin phosphate


20 mg/g


Premix for medicated feeding stuff


Pigs




Sweden


Elanco Animal Health A/S
Eli Lilly Danmark A/S
Lyskaer 3E, 2 tv.
2730 HERLEV
Denmark


Tylan vet.


Tylosin


0,83


Powder for oral solution


Pigs and domestic birds




Sweden


Elanco Animal Health A/S
Eli Lilly Danmark A/S
Lyskaer 3E, 2 tv.
2730 HERLEV
Denmark


Tylan vet.


Tylosin


0,02


Premix for medicated feeding stuff


Pigs




Sweden


Elanco Animal Health A/S
Eli Lilly Danmark A/S
Lyskaer 3E, 2 tv.
2730 HERLEV
Denmark


Tylan vet.


Tylosin


0,1


Premix for medicated feeding stuff


Pigs




United Kingdom


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 mg/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets


Tylosin


100 mg/g


Premix for medicated feeding stuff


Pigs
Poultry




United Kingdom


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 100 % w/w Granules for Use in Drinking Water for Pigs, Chickens, Turkeys and Calves


Tylosin


100 % w/w


Granules for oral solution


Cattle
Chickens
Pigs
Turkey




United Kingdom


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 20 mg/g Oral Granules for Pigs


Tylosin


20 mg/mg


Premix for medicated feeding stuff


Pigs




United Kingdom


Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium


Pharmasin 250 mg/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets


Tylosin


250 mg/g


Premix for medicated feeding stuff


Pigs
Poultry




United Kingdom


Eli Lilly & Company Ltd
Elanco Animal Health
Lilly House
Priestley Road
Basingstoke, RG24 9NL
United Kingdom


Tylan G20 Premix for Medicated Feedingstuff


Tylosin


2,00 % w/w


Premix for medicated feeding stuff


Pigs




United Kingdom


Eli Lilly & Company Ltd
Lilly House
Priestley Road
Basingstoke, RG24 9NL
United Kingdom


Tylan G250 Premix for Medicated Feedingstuff


Tylosin


25 % w/w


Premix for medicated feeding stuff


Chickens
Pigs




United Kingdom


Eli Lilly & Company Ltd
Lilly House
Priestley Road
Basingstoke, RG24 9NL
United Kingdom


Tylan G50 Premix for Medicated Feedingstuff


Tylosin


5,00 % w/w


Premix for medicated feeding stuff


Pigs




United Kingdom


Eli Lilly & Company Ltd
Lilly House
Priestley Road
Basingstoke, RG24 9NL
United Kingdom


Tylan Soluble Powder for Oral Solution


Tylosin


10 % w/w


Powder for oral solution


Cattle
Chickens
Pigs
Turkeys







ANNEX IV
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


INN


Invented name


Strength


Pharmaceutical Form


Route of administration




Estonia


Septodont
58, rue du Pont de Creteil
94100 Saint-Maur-
Des-Fosses
France


Ephedrine hydrochloride
arsenous anhydride
lidocaine


CAUSTINERF ARSENICAL


1 g, 30 g, 30 g


Dental paste


Topical use




France


Septodont
58, rue du Pont de Creteil
94100 Saint-Maur-
Des-Fosses
France


Ephedrine hydrochloride
arsenous anhydride
lidocaine


CAUSTINERF ARSENICAL, pâte pour usage dentaire


1 g, 30 g, 30 g


Dental paste


Topical use




France


ATO ZIZINE
69, rue de Wattignies
BP 50018
75560 Paris Cedex 12
France


Ephedrine hydrochloride
arsenous anhydride
lidocaine


YRANICID ARSENICAL, pâte pour usage dentaire


1 g, 30 g, 30 g


Dental paste


Topical use




Italy


Giovanni Ogna E Figli S.p.A.
Viale Zara 23
20159 Milano
Italy


Ephedrine hydrochloride
arsenous anhydride
lidocaine


PASTA ARSENICALE NORMALE


1 g, 30 g, 30 g


Dental paste


Topical use




Latvia


Septodont
58, rue du Pont de Creteil
94100 Saint-Maur-
Des-Fosses
France


Ephedrine hydrochloride
arsenous anhydride
lidocaine


Caustinerf arsenical pasta lietošanai zobārstniecībā


1 g, 30 g, 30 g


Dental paste


Topical use




Lithuania


Septodont
58, rue du Pont de Creteil
94100 Saint-Maur-
Des-Fosses
France


Ephedrine hydrochloride
arsenous anhydride
lidocaine


Caustinerf Arsenical


1 g, 30 g, 30 g


Dental paste


Topical use







ANNEX V
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES












Member State EU/EEA


Applicant/Marketing authorisation holder


Name


INN


Strength


Pharmaceutical form


Route of administration


Animal species




Austria (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex CAT 52,5 mg Lösung zum Auftropfen für Katzen


Fipronil


52,5 mg


Spot-on solution


Spot-on use


Cats




Austria (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex S 75 mg Lösung zum Auftropfen für Hunde


Fipronil


75 mg


Spot-on solution


Spot-on use


Dogs




Austria (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex M 150 mg Lösung zum Auftropfen für Hunde


Fipronil


150 mg


Spot-on solution


Spot-on use


Dogs




Austria (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex L 300 mg Lösung zum Auftropfen für Hunde


Fipronil


300 mg


Spot-on solution


Spot-on use


Dogs




Austria (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex XL 412,5 mg Lösung zum Auftropfen für Hunde


Fipronil


412,5 mg


Spot-on solution


Spot-on use


Dogs




Belgium


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex CAT 52,5 mg spot-on oplossing voor katten


Fipronil


52,5 mg


Spot-on solution


Spot-on use


Cats




Belgium


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex S 75 mg spot-on oplossing voor honden


Fipronil


75 mg


Spot-on solution


Spot-on use


Dogs




Belgium


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex M 150 mg spot-on oplossing voor honden


Fipronil


150 mg


Spot-on solution


Spot-on use


Dogs




Belgium


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex L 300 mg spot-on oplossing voor honden


Fipronil


300 mg


Spot-on solution


Spot-on use


Dogs




Belgium


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex XL 412,5 mg spot-on oplossing voor honden


Fipronil


412,5 mg


Spot-on solution


Spot-on use


Dogs




Czech Republic (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex CAT 52,5 mg roztok pro nakapání na kůži spot-on pro kočky


Fipronil


52,5 mg


Spot-on solution


Spot-on use


Cats




Czech Republic (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex S 75 mg roztok pro nakapání na kůži spot-on pro psy


Fipronil


75 mg


Spot-on solution


Spot-on use


Dogs




Czech Republi (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex M 150 mg roztok pro nakapání na kůži spot-on pro psy


Fipronil


150 mg


Spot-on solution


Spot-on use


Dogs




Czech Republic (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex L 300 mg roztok pro nakapání na kůži spot-on pro psy


Fipronil


300 mg


Spot-on solution


Spot-on use


Dogs




Czech Republic (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex XL 412,5 mg roztok pro nakapání na kůži spot-on pro psy


Fipronil


412,5 mg


Spot-on solution


Spot-on use


Dogs




Denmark


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex CAT 52,5 mg spot-on løsning for katte


Fipronil


52,5 mg


Spot-on solution


Spot-on use


Cats




Denmark


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex S 75 mg spot-on løsning for hunde


Fipronil


75 mg


Spot-on solution


Spot-on use


Dogs




Denmark


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex M 150 mg spot-on løsning for hunde


Fipronil


150 mg


Spot-on solution


Spot-on use


Dogs




Denmark


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex L 300 mg spot-on løsning for hunde


Fipronil


300 mg


Spot-on solution


Spot-on use


Dogs




Denmark


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex XL 412,5 mg spot-on løsning for hunde


Fipronil


412,5 mg


Spot-on solution


Spot-on use


Dogs




Greece


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex CAT 52,5 mg Διάλυμα για επίχυση σε σημείο (spot-on) για γάτες


Fipronil


52,5 mg


Spot-on solution


Spot-on use


Cats




Greece


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex S 75 mg Διάλυμα για επίχυση σε σημείο (spot-on) για σκύλους


Fipronil


75 mg


Spot-on solution


Spot-on use


Dogs




Greece


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex M 150 mg Διάλυμα για επίχυση σε σημείο (spot-on) για σκύλους


Fipronil


150 mg


Spot-on solution


Spot-on use


Dogs




Greece


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex L 300 mg Διάλυμα για επίχυση σε σημείο (spot-on) για σκύλους


Fipronil


300 mg


Spot-on solution


Spot-on use


Dogs




Greece


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex XL 412,50 mg Διάλυμα για επίχυση σε σημείο (spot-on) για σκύλους


Fipronil


412,5 mg


Spot-on solution


Spot-on use


Dogs




Ireland


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex CAT 52,5 mg spot-on solution for cats


Fipronil


52,5 mg


Spot-on solution


Spot-on use


Cats




Ireland


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex S 75 mg spot-on solution for dogs


Fipronil


75 mg


Spot-on solution


Spot-on use


Dogs




Ireland


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex M 150 mg spot-on solution for dogs


Fipronil


150 mg


Spot-on solution


Spot-on use


Dogs




Ireland


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex L 300 mg spot-on solution for dogs


Fipronil


300 mg


Spot-on solution


Spot-on use


Dogs




Ireland


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex XL 412,5 mg spot-on solution for dogs


Fipronil


412,5 mg


Spot-on solution


Spot-on use


Dogs




Italy


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex CAT 52,5 mg soluzione spot-on per gatti


Fipronil


52,5 mg


Spot-on solution


Spot-on use


Cats




Italy


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex S 75 mg soluzione spot-on per cani


Fipronil


75 mg


Spot-on solution


Spot-on use


Dogs




Italy


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex M 150 mg soluzione spot-on per cani


Fipronil


150 mg


Spot-on solution


Spot-on use


Dogs




Italy


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex L 300 mg soluzione spot-on per cani


Fipronil


300 mg


Spot-on solution


Spot-on use


Dogs




Italy


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex XL 412,5 mg soluzione spot-on per cani


Fipronil


412,5 mg


Spot-on solution


Spot-on use


Dogs




The Netherlands (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex CAT 52,5 mg spot-on oplossing voor katten


Fipronil


52,5 mg


Spot-on solution


Spot-on use


Cats




The Netherlands (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex S 75 mg spot-on oplossing voor honden


Fipronil


75 mg


Spot-on solution


Spot-on use


Dogs




The Netherlands (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex M 150 mg spot-on oplossing voor honden


Fipronil


150 mg


Spot-on solution


Spot-on use


Dogs




The Netherlands (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex L 300 mg spot-on oplossing voor honden


Fipronil


300 mg


Spot-on solution


Spot-on use


Dogs




The Netherlands (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex XL 412,5 mg spot-on oplossing voor honden


Fipronil


412,5 mg


Spot-on solution


Spot-on use


Dogs




Spain (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex GATOS 52,5 mg solución spot-on para gatos


Fipronil


52,5 mg


Spot-on solution


Spot-on use


Cats




Spain (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex75 mg solución spot-on para perros pequeños


Fipronil


75 mg


Spot-on solution


Spot-on use


Dogs




Spain (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex 150 mg solución spot-on para perros medianos


Fipronil


150 mg


Spot-on solution


Spot-on use


Dogs




Spain (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex 300 mg solución spot-on para perros grandes


Fipronil


300 mg


Spot-on solution


Spot-on use


Dogs




Spain (1)



VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex 412,5 mg solución spot-on para perros muy grandes


Fipronil


412,5 mg


Spot-on solution


Spot-on use


Dogs




Slovak Republic


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex CAT 52,5 mg na vonkajšiu aplikáciu na kožu mačiek


Fipronil


52,5 mg


Spot-on solution


Spot-on use


Cats




Slovak Republic


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex S 75 mg na vonkajšiu aplikáciu na kožu pre psov


Fipronil


75 mg


Spot-on solution


Spot-on use


Dogs




Slovak Republic


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex M 150 mg na vonkajšiu aplikáciu na kožu pre psov


Fipronil


150 mg


Spot-on solution


Spot-on use


Dogs




Slovak Republic


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex L 300 mg na vonkajšiu aplikáciu na kožu pre psov


Fipronil


300 mg


Spot-on solution


Spot-on use


Dogs




Slovak Republic


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex XL 412,5 mg na vonkajšiu aplikáciu na kožu pre psov


Fipronil


412,5 mg


Spot-on solution


Spot-on use


Dogs




United Kingdom


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex CAT 52,5 mg spot-on solution for cats


Fipronil


52,5 mg


Spot-on solution


Spot-on use


Cats




United Kingdom


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex S 75 mg spot-on solution for dogs


Fipronil


75 mg


Spot-on solution


Spot-on use


Dogs




United Kingdom


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex M 150 mg spot-on solution for dogs


Fipronil


150 mg


Spot-on solution


Spot-on use


Dogs




United Kingdom


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex L 300 mg spot-on solution for dogs


Fipronil


300 mg


Spot-on solution


Spot-on use


Dogs




United Kingdom


VET-AGRO TRADING Sp. z o.o.
Mełgiewska str. 18,
20-234 Lublin,
Poland


Fiprex XL 412.5 mg spot-on solution for dogs


Fipronil


412,5 mg


Spot-on solution


Spot-on use


Dogs






(1)  Marketing authorisation granted