Not the law itself: Notice

Address https://gelex.eu/eli/EU/notice/oj/C/2012/224/02@2012-06-30/en

Contents

1. Preamble
2. ANNEX
3. ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, ACTIVE SUBSTANCE, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
4. ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
5. ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
6. ANNEX IV LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

Issuing, maintenance or modification of a national marketing authorization Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 14/6/2012 Tilmicosin See Annex I See Annex I 18/6/2012 18/6/2012 Milaxyn plus and associated names See Annex II See Annex II 20/6/2012 28/6/2012 Flutiform and associated names See Annex III See Annex III 3/7/2012 28/6/2012 Iffeza and associated names See Annex IV See Annex IV 3/7/2012

ANNEX

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, ACTIVE SUBSTANCE, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA Marketing Authorisation Holder Name INN Strength Pharmaceutical form Animal species Austria Richter Pharma AG Feldgasse 19 A-4600 Wels AUSTRIA Pulmotil G 100 g/kg Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine und Kaninchen Tilmicosin (as phosphate) 100 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Austria Richter Pharma AG Feldgasse 19 A-4600 Wels AUSTRIA Pulmotil G 200 g/kg Arzneimittel-Vormischung zur Herstellung von Fütterungsarzneimitteln für Schweine und Kaninchen Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Belgium Eli Lilly Benelux N.V. Elanco Animal Health Rue de l'Etuve 52 Stoofstraat 52 1000 Brussel BELGIUM Pulmotil 40 VET Pre-mix Tilmicosin (as phosphate) 40 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Belgium Eli Lilly Benelux N.V. Elanco Animal Health Rue de l'Etuve 52 Stoofstraat 52 1000 Brussel BELGIUM Pulmotil 100 VET Pre-mix Tilmicosin (as phosphate) 100 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Belgium Eli Lilly Benelux N.V. Elanco Animal Health Rue de l'Etuve 52 Stoofstraat 52 1000 Brussel BELGIUM Pulmotil 100 Granules Tilmicosin (as phosphate) 100 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Belgium Eli Lilly Benelux N.V. Elanco Animal Health Rue de l'Etuve 52 Stoofstraat 52 1000 Brussel BELGIUM Pulmotil 200 VET Pre-mix Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Cyprus Eli Lilly Regional Operations GmbH Elanco Animal Health Kolblgasse 8-10 1030 Wien AUSTRIA Pulmotil pre-mix 200 g/kg ,πρόμιγμα για φαρμακούχο ζωοτροφή,για χοίρους και κoνίκλους. Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Czech Republic Eli Lilly Regional Operations GmbH Elanco Animal Health Kolblgasse 8-10 1030 Wien AUSTRIA Pulmotil 200 mg/g pre-mix pro medikaci krmiva Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Germany Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4 D-61352 Bad Homburg GERMANY Pulmotil G 40 Tilmicosin (as phosphate) 40 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Germany Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4 D-61352 Bad Homburg GERMANY Pulmotil G 100 Tilmicosin (as phosphate) 100 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Germany Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4 D-61352 Bad Homburg GERMANY Pulmotil G 20 % AMV Tilmicosin (as phospate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Denmark Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110 DK-2800 Kongens Lyngby DENMARK Pulmotil Vet. Tilmicosin (as phosphate) 40 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Denmark Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110 DK-2800 Kongens Lyngby DENMARK Pulmotil Vet. Tilmicosin (as phosphate) 100 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Denmark Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110 DK-2800 Kongens Lyngby DENMARK Pulmotil Vet. Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Greece Eli Lilly Regional Operations GmbH Elanco Animal Health Kolblgasse 8-10 1030 Wien AUSTRIA PULMOTIL 200 Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Spain ELANCO VALQUÍMICA, S.A. Avda. de la Industria 30 28108 Alcobendas Madrid SPAIN PULMOTIL G 40 Tilmicosin (as phosphate) 40 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Spain ELANCO VALQUÍMICA, S.A. Avda. de la Industria 30 28108 Alcobendas Madrid SPAIN PULMOTIL G 100 Tilmicosin (as phosphate) 100 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Spain ELANCO VALQUÍMICA, S.A. Avda. de la Industria 30 28108 Alcobendas Madrid SPAIN PULMOTIL G 200 Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits France LILLY France 13 Rue Pages 92158 Suresnes Cedex FRANCE PULMOTIL TILMICOSINE 40 PORC-LAPIN Tilmicosin (as phosphate) 40 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits France QALIAN 34 Rue Jean Monnet Zi D'Etriche 49500 Serge FRANCE SANTAMIX TILMICOSINE 40 PORCINS - LAPINS Tilmicosin (as phosphate) 40 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits France SOGEVAL 200 Route de Mayenne Zi des Touches 53000 Laval France CONCENTRAT VO 08 TILMICOSINE PORCIN-LAPIN Tilmicosin (as phosphate) 40 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Hungary Eli Lilly Regional Operations GmbH Elanco Animal Health Kolblgasse 8-10 1030 Wien AUSTRIA Pulmotil G 200 gyógypre-mix Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Ireland Eli Lilly and Company Ltd Elanco Animal Health Lilly House Priestly Road Basingstoke Hampshire RG24 9NL UNITED KINGDOM Pulmotil G40 Pre-mix for medicated feedingstuff Tilmicosin (as phosphate) 40 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Ireland Eli Lilly and Company Ltd Elanco Animal Health Lilly House Priestly Road Basingstoke Hampshire RG24 9NL UNITED KINGDOM Pulmotil G100 Pre-mix for medicated feedingstuff Tilmicosin (as phosphate) 100 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Ireland Eli Lilly and Company Ltd Elanco Animal Health Lilly House Priestly Road Basingstoke Hampshire RG24 9NL UNITED KINGDOM Pulmotil G200 Pre-mix for medicated feedingstuff Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Italy ELI LILLY ITALIA SPA VIA GRAMSCI 731/733 - SESTO FIORENTINO – FI ITALY PULMOTIL G 200 PRE-MIX Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Italy CEVA VETEM SpA via Colleoni 15 20041 Agrate Brianza (MB) ITALY MICLOZAN 200 PRE-MIX Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Netherlands Eli Lilly Nederland B.V. Elanco Animal Health Grootslag 1-5 3991 RA Houten THE NETHERLANDS PULMOTIL® G40 pre-mix voor gemedicineerd voer voor varkens Tilmicosin (as phosphate) 40 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Netherlands Eli Lilly Nederland B.V. Elanco Animal Health Grootslag 1-5 3991 RA Houten THE NETHERLANDS PULMOTIL® G100 pre-mix voor gemedicineerd voer voor varkens Tilmicosin (as phosphate) 100 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Netherlands Eli Lilly Nederland B.V. Elanco Animal Health Grootslag 1-5 3991 RA Houten THE NETHERLANDS PULMOTIL® G200 pre-mix voor gemedicineerd voer voor varkens Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Portugal Lilly Portugal – Produtos Farmacêuticos, Lda. Rua Cesário Verde, no5- piso 4 Linda-a-Pastora 2790 – 326 QUEIJAS PORTUGAL Pulmotil G40 Pré-mistura medicamentosa para alimento medicamentoso para suínos e coelhos Tilmicosin (as phosphate) 40 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Portugal Lilly Portugal – Produtos Farmacêuticos, Lda. Rua Cesário Verde, no5- piso 4 Linda-a-Pastora 2790 – 326 QUEIJAS PORTUGAL Pulmotil G100 Pré-mistura medicamentosa para alimento medicamentoso para suínos e coelhos Tilmicosin (as phosphate) 100 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Portugal Lilly Portugal – Produtos Farmacêuticos, Lda. Rua Cesário Verde, no5- piso 4 Linda-a-Pastora 2790 – 326 QUEIJAS PORTUGAL Pulmotil G200 Pré-mistura medicamentosa para alimento medicamentoso para suínos e coelhos Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Romania Eli Lilly Regional Operations GmbH Elanco Animal Health Kolblgasse 8-10 1030 Wien AUSTRIA PULMOTIL 200g/kg pre-mix Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits Slovak Republic Elli Lilly and Company Limited. Speke Operations Fleming RoadSpeke Liverpool L24 9LN UNITED KINGDOM Pulmotil G 200 pre-mix ad us.vet. Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits United Kingdom Eli Lilly and Company Ltd Elanco Animal Health Lilly House Priestly Road Basingstoke Hampshire RG24 9NL UNITED KINGDOM Pulmotil G100 Pre-mix for Medicated Feedingstuff Tilmicosin (as phosphate) 100 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits United Kingdom Eli Lilly and Company Ltd Elanco Animal Health Lilly House Priestly Road Basingstoke Hampshire RG24 9NL UNITED KINGDOM Pulmotil G200 Pre-mix for Medicated Feedingstuff Tilmicosin (as phosphate) 200 g tilmicosin per kg pre-mix Pre-mix for medicated feedingstuff Pigs, Rabbits

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Mamber State EU/EEA Marketing authorisation holder Name INN/Strength Pharmaceutical form Animal species Austria Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus Tabletten für Hunde Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Austria Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus Tabletten für Hunde Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Belgium Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus Tabletten für Hunde Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Belgium Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus Tabletten für Hunde Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Belgium Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus Tabletten für Hunde Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Bulgaria Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus таблетки за кучета Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Bulgaria Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus таблетки за кучета Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Bulgaria Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus таблетки за кучета Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Cyprus Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus Δισκία Για Σκύλους Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Czech Republic Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus tablety pro psy Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Czech Republic Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus tablety pro psy Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Czech Republic Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus tablety pro psy Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Denmark Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Denmark Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Estonia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus tabletid koertele Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Estonia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus tabletid koertele Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Finland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus 50 mg/144 mg/150 mg tablet Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Finland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus 50 mg/144 mg/150 mg tablet Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Finland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus 50 mg/144 mg/150 mg tablet Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs France Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Milaxyn comprimé pour chiens Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs France Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Strantel comprimé pour chiens Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs France Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazical comprimé pour chiens Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs France Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Voxical comprimé pour chiens Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Germany Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Tabletten für Hunde Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Germany Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Tabletten für Hunde Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Germany Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Strantel Tabletten für Hunde Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Greece Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel plus Δισκία Για Σκύλους Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Greece Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel plus Δισκία Για Σκύλους Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Greece Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel plus Δισκία Για Σκύλους Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Hungary Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus tabletta kutyák részére A.U.V Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Hungary Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus tabletta kutyák részére A.U.V Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Hungary Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus tabletta kutyák részére A.U.V Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Iceland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus töflur fyrir hunda Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Iceland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus töflur fyrir hunda Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Ireland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus tablets for dogs Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Ireland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus tablets for dogs Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Ireland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Milaxyn Plus tablets for dogs Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Ireland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazical Plus tablets for dogs Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Ireland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus tablets for dogs Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Ireland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Strantel Plus tablets for dogs Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Ireland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Voxical Plus tablets for dogs Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Italy Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Canitel Plus compresse per cani Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Italy Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus compresse per cani Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Italy Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel compresse per cani Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Latvia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel tablets Tabletes suņiem Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Latvia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel tablets Tabletes suņiem Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Latvia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel tablets Tabletes suņiem Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Lithuania Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus tabletės šunims Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Lithuania Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus tabletės šunims Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Lithuania Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus tabletės šunims Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Luxembourg Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus tabletten voor honden Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Luxembourg Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus tabletten voor honden Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Netherlands Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus tabletten voor honden Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Netherlands Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus tabletten voor honden Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Netherlands Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus tabletten voor honden Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Norway Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Vet Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Norway Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Vet Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Poland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus tabletki dla psów Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Poland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus tabletki dla psów Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Poland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus tabletki dla psów Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Portugal Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus Comprimidos para cães Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Portugal Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus Comprimidos para cães Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Portugal Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus Comprimidos para cães Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Romania Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus Comprimate pentru câini Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Romania Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus Comprimate pentru câini Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Romania Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus Comprimate pentru câini Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Slovakia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus tablety pre psov Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Slovakia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus tablety pre psov Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Slovakia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus tablety pre psov Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Slovenia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel Plus tablete za pse Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Slovenia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel Plus tablete za pse Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Slovenia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel Plus tablete za pse Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Spain Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel comprimidos para perros Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Spain Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel comprimidos para perros Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Spain Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel comprimidos para perros Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Sweden Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Exitel vet. 150 mg/144 mg/50 mg tablett för hund Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs Sweden Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Strantel vet. 150 mg/144 mg/50 mg tablett för hund Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs United Kingdom Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Cazitel plus tablets for dogs Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs United Kingdom Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Easimax plus tablets for dogs Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs United Kingdom Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea Co. Galway Ireland Prazitel plus tablets for dogs Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate) Febantel 150 mg Tablet Dogs

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

Member State EU/EEA Applicant company name, address (Invented) Name Strength Pharmaceutical form Route of administration Austria Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® Flutiform 50 Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Austria Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® Flutiform 125 Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Austria Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® Flutiform 250 Mikrogramm/10 Mikrogramm pro Sprühstoß Druckgasinhalation 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Belgium Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® Flutiform 50 mcg/5 mcg, aërosol, suspensie 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Belgium Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® Flutiform 125 mcg/5 mcg, aërosol, suspensie 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Belgium Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® Flutiform 250 mcg/10 mcg, aërosol, suspensie 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Bulgaria Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Bulgaria Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Bulgaria Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cyprus Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cyprus Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cyprus Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Czech Republic Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Czech Republic Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Czech Republic Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Denmark Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Denmark Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Denmark Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Finland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Finland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Finland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use France Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use France Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use France Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Germany Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Germany Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Germany Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Iceland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Iceland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Iceland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Ireland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Ireland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Ireland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Italy Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiformo® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Italy Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiformo® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Italy Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiformo® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Luxembourg Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Luxembourg Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Luxembourg Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Netherlands Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® Flutiform 50 microgram/5 microgram/dosis aërosol, suspensie 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Netherlands Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® Flutiform 125 microgram/5 microgram/dosis aërosol, suspensie 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Netherlands Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® Flutiform 250 microgram/10 microgram/dosis aërosol, suspensie 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Norway Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Norway Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Norway Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Poland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Poland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Poland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Portugal Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Portugal Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Portugal Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Romania Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® Flutiform 50 micrograme/5 micrograme suspensie de inhalat presurizată 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Romania Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® Flutiform 125 micrograme/5 micrograme suspensie de inhalat presurizată 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Romania Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® Flutiform 250 micrograme/10 micrograme suspensie de inhalat presurizată 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Slovak Republic Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50/5 μg 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Slovak Republic Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125/5 μg 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Slovak Republic Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250/10 μg 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Sweden Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Sweden Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Sweden Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flutiform® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use United Kingdom Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flofera® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use United Kingdom Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flofera® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use United Kingdom Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Flofera® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use

ANNEX IV LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

Member State EU/EEA Applicant company name, address (Invented) Name Strengths Pharmaceutical form Route of administration Austria Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Austria Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Austria Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 Mikrogramm/10 Mikrogramm pro Sprühstoß Druckgasinhalation 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Belgium Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg, aërosol, suspensie 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Belgium Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg, aërosol, suspensie 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Belgium Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg, aërosol, suspensie 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Bulgaria Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Bulgaria Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Bulgaria Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Cyprus Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cyprus Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Cyprus Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Czech Republic Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Czech Republic Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Czech Republic Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Denmark Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Denmark Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Denmark Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Finland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Finland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Finland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use France Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use France Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use France Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Germany Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Germany Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Germany Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Iceland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Iceland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Iceland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Ireland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Ireland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Ireland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Italy Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Italy Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Italy Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Luxembourg Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Luxembourg Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Luxembourg Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Netherlands Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 microgram/5 microgram/dosis aërosol, suspensie 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Netherlands Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 microgram/5 microgram/dosis aërosol, suspensie 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Netherlands Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 microgram/10 microgram/dosis aërosol, suspensie 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Norway Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffera® 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Norway Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffera® 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Norway Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffera® 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Poland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Poland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Poland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Portugal Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Portugal Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Portugal Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Romania Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 micrograme/5 micrograme suspensie de inhalat presurizată 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Romania Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 micrograme/5 micrograme suspensie de inhalat presurizată 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Romania Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 micrograme/10 micrograme suspensie de inhalat presurizată 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Slovak Republic Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50/5 μg 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Slovak Republic Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125/μg 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Slovak Republic Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250/10 μg 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use Sweden Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Sweden Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use Sweden Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use United Kingdom Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 50 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use United Kingdom Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 125 mcg/5 mcg Pressurised Inhalation Suspension Inhalation use United Kingdom Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Iffeza 250 mcg/10 mcg Pressurised Inhalation Suspension Inhalation use

Versions

1. 2012-06-30