Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2012 to 30 June 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2012-07-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012224EN.01001601.xml










27.7.2012   


EN


Official Journal of the European Union


C 224/16





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2012 to 30 June 2012

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

2012/C 224/02
—   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






(1)  OJ L 311, 28.11.01, p. 67.

(2)  OJ L 311, 28.11.01, p. 1.


ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, 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