# C_2012224EN.01001601.xml

| 27.7.2012 | EN | Official Journal of the European Union | C 224/16 |
| --- | --- | --- | --- |

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)
  )

(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

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 |

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.

1

(2)  OJ L 311, 28.11.01, p. 1.

2

---

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

United Kingdom

Iffeza

250 mcg/10 mcg

Pressurised Inhalation Suspension

Inhalation use

---