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