# C_2012078EN.01001001.xml

| 16.3.2012 | EN | Official Journal of the European Union | C 78/10 |
| --- | --- | --- | --- |

16.3.2012

EN

Official Journal of the European Union

C 78/10

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2012 to 31 January 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 78/02

—   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 |
| --- | --- | --- | --- | --- |
| 13.1.2012 | Cephalosporins | See Annex I | See Annex I | 18.1.2012 |
| 20.1.2012 | Nimesulide | See Annex II | See Annex II | 23.1.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

13.1.2012

Cephalosporins

See Annex I

See Annex I

18.1.2012

20.1.2012

Nimesulide

See Annex II

See Annex II

23.1.2012

---

(1)  OJ L 311, 28.11.2001, p. 67.

1

(2)  OJ L 311, 28.11.2001, p. 1.

2

---

ANNEX I

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

| Member State EU/EEA | Applicant/Marketing Authorisation Holder | Name | Active substance | Strength | Pharmaceutical form | Animal species |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Intervet GmbH |
| Siemensstraße 107 |
| 1210 Wien |
| AUSTRIA |

Member State EU/EEA

Applicant/Marketing Authorisation Holder

Name

Active substance

Strength

Pharmaceutical form

Animal species

Austria

Intervet GmbH

Siemensstraße 107

1210 Wien

AUSTRIA

Cobactan 2,5 % w/v Injektionssuspension für Rinder und Schweine

Cefquinome

25 mg/ml

Suspension for injection

Cattle, pigs

Austria

| Intervet GmbH |
| --- |
| Siemensstraße 107 |
| 1210 Wien |
| AUSTRIA |

Intervet GmbH

Siemensstraße 107

1210 Wien

AUSTRIA

COBACTAN LA 7,5 % - Injektionssupension für Rinder

Cefquinome

75 mg/ml

Suspension for injection

Cattle

Austria

| Intervet GmbH |
| --- |
| Siemensstraße 107 |
| 1210 Wien |
| AUSTRIA |

Intervet GmbH

Siemensstraße 107

1210 Wien

AUSTRIA

Cobactan 4,5 % Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Pferde und Rinder

Cefquinome

45 mg/ml

Powder and solvent for solution for injection

Cattle, horses

Austria

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Rinder und Schweine

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Austria

| Vetoquinol Österreich GmbH |
| --- |
| Zehetnergasse 24 |
| 1140 Wien |
| AUSTRIA |

Vetoquinol Österreich GmbH

Zehetnergasse 24

1140 Wien

AUSTRIA

Ceftiocyl 50 mg/ml, Injektionssuspension für Rinder und Schweine

Ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Austria

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL 50 mg/ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Rinder und Schweine

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Austria

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL RTU 50 mg/ml Injektionssuspensiuon für Rinder und Schweine

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Austria

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 mg/ml Injektionssuspension für Schweine und Rinder

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Austria

| Pfizer Corporation Austria GmbH |
| --- |
| Floridsdorfer Hauptstraße 1 |
| 1210 Wien |
| AUSTRIA |

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

1210 Wien

AUSTRIA

Excenel - Pulver zur Herstellung einer Injektionslösung für Tiere

Ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, pigs

Austria

| Pfizer Corporation Austria GmbH |
| --- |
| Floridsdorfer Hauptstraße 1 |
| 1210 Wien |
| AUSTRIA |

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

1210 Wien

AUSTRIA

Excenel RTU 50 mg/ml Injektionssuspension für Schweine und Rinder

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Austria

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

READYCEF 50 mg/ml Injektionssuspension für Schweine und Rinder

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Austria

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef Pulver zur Herstellung einer Injektionslösung für Rinder und Schweine

Ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, pigs

Belgium

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 2,5 %

Cefquinome (as sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 4,5 %

Cefquinome (as sulfate)

45 mg/ml

Powder and solvent for solution for injection

Cattle, Horses (adult and foal) and (adult and calf)

Belgium

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA 7,5 %

Cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

Belgium

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

ACTIONIS 50 MG/ML

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL 50 MG/ML

Ceftiofur (as sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Belgium

| VETOQUINOL N.V./S.A. |
| --- |
| Kontichsesteenweg 42 |
| 2630 Aartselaar |
| BELGIUM |

VETOQUINOL N.V./S.A.

Kontichsesteenweg 42

2630 Aartselaar

BELGIUM

CEFTIOCYL 50 MG/ML

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

CEFTIOSAN

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Pigs weighing up to 125 kg.

Cattle

Belgium

| CEVA Santé Animale NV/SA |
| --- |
| Metrologielaan 6 |
| 1130 Brussel |
| BELGIUM |

CEVA Santé Animale NV/SA

Metrologielaan 6

1130 Brussel

BELGIUM

CEVAXEL 50MG/ML

Ceftiofur (as sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Belgium

| CEVA Santé Animale NV/SA |
| --- |
| Metrologielaan 6 |
| 1130 Brussel |
| BELGIUM |

CEVA Santé Animale NV/SA

Metrologielaan 6

1130 Brussel

BELGIUM

CEVAXEL-RTU 50 MG/ML

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 MG/ML

Ceftiofur (as sodium)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Pfizer Animal Health s.a. |
| --- |
| Rue Laid Burniat 1 |
| B-1348 Louvain La Neuve |
| BELGIUM |

Pfizer Animal Health s.a.

Rue Laid Burniat 1

B-1348 Louvain La Neuve

BELGIUM

EXCENEL

Ceftiofur (as sodium)

50 mg/ml

Powder for Solution for Injection

Cattle, pigs

Belgium

| Pfizer Animal Health s.a. |
| --- |
| Rue Laid Burniat 1 |
| B-1348 Louvain La Neuve |
| BELGIUM |

Pfizer Animal Health s.a.

Rue Laid Burniat 1

B-1348 Louvain La Neuve

BELGIUM

EXCENEL RTU

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

READYCEF 50 MG/ML

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Continental Farmaceutica, S.L. |
| --- |
| Parque Empresarial La Moraleja |
| Avenida de Europa 20-B |
| E-28108 Madrid, Alcobendas |
| SPAIN |

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPAIN

TRULEVA RTU

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

VIRBACEF Poudre pour solution injectable pour bovins et porcins

Ceftiofur (as sodium)

50 mg/ml

Powder for Solution for Injection

Cattle, pigs

Bulgaria

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Цефтиомакс 50 mg/ml инжекционна суспензия за едри преживни животни и свине

Ceftiofur

50mg/ml

Suspension for injection

Cattle, pigs

Bulgaria

| Ceva Animal Health Bulgaria EOOD |
| --- |
| 26 Elemag Str., ent. B, app. 1 |
| 1113 Sofia |
| BULGARIA |

Ceva Animal Health Bulgaria EOOD

26 Elemag Str., ent. B, app. 1

1113 Sofia

BULGARIA

Севаксел-РТУ 50 мг/мл, суспенсия за инжектиране при говеда и свине

Ceftiofur

50mg/ml

Suspension for injection

Cattle, pigs

Bulgaria

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Ефикур 50 мг/мл инжекционна суспензия за свине и говеда

Ceftiofur

50mg/ml

Suspension for injection

Cattle, pigs

Bulgaria

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Цефтиозан 50 мг/мл инжекционна суспензия за свине и говеда

Ceftiofur

50mg/ml

Suspension for injection

Cattle, pigs

Bulgaria

| Interchemie werken "De Adelaar" BV |
| --- |
| Horsterweg 26A |
| 5811 AC Castenray |
| THE NETHERLANDS |

Interchemie werken "De Adelaar" BV

Horsterweg 26A

5811 AC Castenray

THE NETHERLANDS

Цефтионел-50-ceftiofur base(50mg/ml), инжекционна суспензия за говеда и свине

Ceftiofur

50mg/kg

Suspension for injection

Cattle, pigs

Bulgaria

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Кобактан ЛА 7,5 % инжективна суспензия за говеда

Cefquinome

75mg/ml

Suspension for injection

Cattle

Bulgaria

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Кобактан 2,5 %

Cefquinome

25 mg/ml

Suspension for injection

Cattle, pigs

Cyprus

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50mg/ml Σκόνη και διαλύτης για ενέσιμο διάλυμα για βοοειδή και χοίρους

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Cyprus

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur 50mg/ml ενέσιμο διάλυμα για χοίρους και βοοειδή

Ceftiofur (as hydrochloride)

50 mg/ml

Injectable suspension

Cattle, pigs

Cyprus

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 2,5 %

Cefquinome (as sulfate)

25 mg/ml

Injectable suspension

Cattle

Cyprus

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 %

Cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

Czech Republic

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml powder and solvent for solution for njection for cattle and pigs.

Ceftiofurum (ut Ceftiofurum natricum)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Czech Republic

| Vetoquinol s.r.o. |
| --- |
| Zámečnická 411 |
| CZ - 288 02 Nymburk |
| CZECH REPUBLIC |

Vetoquinol s.r.o.

Zámečnická 411

CZ - 288 02 Nymburk

CZECH REPUBLIC

Ceftiocyl 50 mg/ml suspension for injection for cattle and pigs

Ceftiofurum (ut hydrochloridum)

50 mg/ml

Suspension for injection

Cattle, pigs

Czech Republic

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Ceftiomax 50 mg/ml suspension for injection for pigs and cattle

Ceftiofurum (ut Ceftiofuri hydrochloridum)

50 mg/ml

Suspension for injection

Cattle, pigs

Czech Republic

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL 50 mg/ml powder and solvent for solution for njection for cattle and pigs.

Ceftiofurum (ut natricum)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Czech Republic

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR

50 mg/ml suspension for injection for pigs and cattle

Ceftiofurum (ut hydrochloridum)

50 mg/ml

Suspension for injection

Cattle, pigs

Czech Republic

| Pfizer s.r.o. |
| --- |
| Stroupežnického 17 |
| 150 00 Praha 5 |
| CZECH REPUBLIC |

Pfizer s.r.o.

Stroupežnického 17

150 00 Praha 5

CZECH REPUBLIC

Excenel 50 mg/ml freeze-dried powder for solution for injection

Ceftiofurum (ut natricum)

50 mg/ml

Freeze-dried powder for solution for injection

Cattle, pigs, horses

Czech Republic

| Pfizer s.r.o. |
| --- |
| Stroupežnického 17 |
| 150 00 Praha 5 |
| CZECH REPUBLIC |

Pfizer s.r.o.

Stroupežnického 17

150 00 Praha 5

CZECH REPUBLIC

EXCENEL RTU inj

Ceftiofurum (ut hydrochloridum)

50 mg/ml

Suspension for injection

Cattle, pigs

Czech Republic

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef powder for solution for injection for cattle and pigs

Ceftiofurum (ut Ceftiofurum natricum)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Czech Republic

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 2,5 % inj

Cefquinomum (ut sulfas)

25 mg/ml

Injection

Cattle, pigs

Czech Republic

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 % suspension for injection for cattle

Cefquinomum (ut sulfas)

75 mg/ml

Suspension for injection

Cattle

Denmark

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan Vet.

cefquinome

75 mg/ml

Solution for injection, suspension

Cattle

Denmark

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan Vet.

cefquinome

25mg/ml

Solution for injection, suspension

Cattle, pigs

Denmark

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan Vet.

cefquinome

45 mg/ml

Powder and solvent for injections for solution

Horses

Denmark

| Vetoquinol scandinavia AB |
| --- |
| Torggatan 2 |
| Box 9 |
| SE-26521 Åstorp |
| SWEDEN |

Vetoquinol scandinavia AB

Torggatan 2

Box 9

SE-26521 Åstorp

SWEDEN

Ceftiocyl

Ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Denmark

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur Vet.

ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Denmark

| Pfizer Oy, Animal Health |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health

Tietokuja 4

FI-00330 Helsinki

FINLAND

Excenel Vet.

ceftiofur

50 mg/ml

Solution for injection, suspension

Cattle, pigs

Denmark

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan

Ceftiofur

50 mg/ml

Solution for injection, suspension

Cattle, pigs

Denmark

| Pfizer Oy, Animal Health |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health

Tietokuja 4

FI-00330 Helsinki

FINLAND

Excenel Vet.

Ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, pigs

Denmark

| Pfizer Oy, Animal Health |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health

Tietokuja 4

FI-00330 Helsinki

FINLAND

Excenel Vet.

Ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, pigs

Estonia

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan 50mg/ml

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Estonia

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

Cevaxel

Ceftiofur (as sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Estonia

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

Cevaxel-RTU

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Estonia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 2,5 %

Cefquinome (as sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs

Estonia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 %

Cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

Estonia

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Ceftiomax

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Estonia

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur

Ceftiofur (as Ceftiofur Hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Estonia

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Estonia

| Pfizer Manufacturing Belgium N,V./S.A. |
| --- |
| Rijksweg 12 |
| B-2870 Puurs |
| BELGIUM |

Pfizer Manufacturing Belgium N,V./S.A.

Rijksweg 12

B-2870 Puurs

BELGIUM

Excenel RTU

Ceftiofur (as Ceftiofur Hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Estonia

| Vetoquinol S.A. |
| --- |
| Magny-Vernois |
| 70200 Lure |
| FRANCE |

Vetoquinol S.A.

Magny-Vernois

70200 Lure

FRANCE

Ceftiocyl

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Finland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL VET 50 mg/ml

Ceftiofurum natricum

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

France

| PFIZER HOLDING France |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANCE |

PFIZER HOLDING France

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCE

EXCENEL 1 G

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Powder for solution for injection.

Cattle, horses, pigs

France

| PFIZER HOLDING France |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANCE |

PFIZER HOLDING France

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCE

EXCENEL 4 G

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Powder for solution for injection.

Cattle, horses, pigs

France

| INTERVET |
| --- |
| Rue Olivier De Serres |
| Angers Technopole |
| 49070 Beaucouze |
| FRANCE |

INTERVET

Rue Olivier De Serres

Angers Technopole

49070 Beaucouze

FRANCE

COBACTAN 2,5 %

Cefquinome (sous forme de sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs, calves

France

| PFIZER HOLDING France |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANCE |

PFIZER HOLDING France

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCE

EXCENEL RTU

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA 7,5 %

Cefquinome (sous forme de sulfate)

75 mg/ml

Suspension for injection

Cattle

France

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN IV IM 4,5 %

Cefquinome (sous forme de sulfate)

45 mg/ml

Powder and solvent for solution for injection.

Horses

France

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL 50 MG/ML

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Powder and solvent for solution for injection.

Cattle, pigs

France

| INTERVET |
| --- |
| Rue Olivier De Serres |
| Angers Technopole |
| 49070 Beaucouze |
| FRANCE |

INTERVET

Rue Olivier De Serres

Angers Technopole

49070 Beaucouze

FRANCE

COBACTAN 4,5 % PS

Cefquinome (sous forme de sulfate)

45 mg/ml

Powder and solvent for solution for injection.

Cattle, horses

France

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL 50 MG/ML

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

France

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

VIRBACEF POUDRE POUR SOLUTION INJECTABLE POUR BOVINS ET PORCINS

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Powder for solution for injection.

Cattle, pigs

France

| Vetoquinol S.A. |
| --- |
| Magny-Vernois |
| 70200 Lure |
| FRANCE |

Vetoquinol S.A.

Magny-Vernois

70200 Lure

FRANCE

CEFTIOCYL 50 MG/ML SUSPENSION INJECTABLE POUR BOVINS ET PORCINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

READYCEF 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL-RTU 50 MG/ML SUSPENSION INJECTABLE POUR BOVINS ET PORCINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Continental Farmaceutica, S.L. |
| --- |
| Parque Empresarial La Moraleja |
| Avenida de Europa 20-B |
| E-28108 Madrid, Alcobendas |
| SPAIN |

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPAIN

TRULEVA RTU 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection.

Cattle, pigs

France

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

CEFTIOSAN 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

ACTIONIS 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Laboratorios Maymó, S.A. |
| --- |
| Vía Augusta, 302 |
| 08017. Barcelona |
| SPAIN |

Laboratorios Maymó, S.A.

Vía Augusta, 302

08017. Barcelona

SPAIN

CEMAY 50 MG/ML SUSPENSION INJECTABLE POUR PORCS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Pigs

Germany

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

Actionis 50 mg/ml Injektionssuspension

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| CEVA Tiergesundheit GmbH |
| --- |
| Kanzlerstr. 4 |
| D-40472 Düsseldorf |
| GERMANY |

CEVA Tiergesundheit GmbH

Kanzlerstr. 4

D-40472 Düsseldorf

GERMANY

CEVAXEL-RTU

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| Intervet Deutschland GmbH |
| --- |
| Feldstr. 1a |
| D-85716 Unterschleißheim |
| GERMANY |

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

GERMANY

Cobactan LA 7,5 %

cefquinome sulfate

75 mg/ml

Suspension for injection

Cattle

Germany

| Laboratorios Maymó S.A. |
| --- |
| Calle Ferro 9, Poligono Industrial Can Pelegri |
| E-08755 Castellbisbal (Barcelona) |
| SPAIN |

Laboratorios Maymó S.A.

Calle Ferro 9, Poligono Industrial Can Pelegri

E-08755 Castellbisbal (Barcelona)

SPAIN

CEMAY 50 mg/ml

ceftiofur HCl

50 mg/ml

Suspension for injection

Pigs

Germany

| Intervet Deutschland GmbH |
| --- |
| Feldstr. 1a |
| D-85716 Unterschleißheim |
| GERMANY |

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

GERMANY

Cobactan 2,5 %

cefquinome sulfate

25 mg/ml

Suspension for injection

Cattle, pigs

Germany

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan, 50 mg/ml, injectable suspension for cattle and pigs

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| Vetoquinol GmbH |
| --- |
| Parkstr. 10 |
| D-88212 Ravensburg |
| GERMANY |

Vetoquinol GmbH

Parkstr. 10

D-88212 Ravensburg

GERMANY

CEFTIOCYL

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml

ceftiofur sodium

50 mg/ml

Powder and solvent for reconstitution

Cattle, pigs

Germany

| Intervet Deutschland GmbH |
| --- |
| Feldstr. 1a |
| D-85716 Unterschleißheim |
| GERMANY |

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

GERMANY

Cobactan 4,5 %

cefquinome sulfate

45 mg/ml

Powder and solvent for reconstitution

Cattle, horses

Germany

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Readycef 50 mg/ml Injektionssuspension für Schweine und Rinder

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| CEVA Tiergesundheit GmbH |
| --- |
| Kanzlerstr. 4 |
| D-40472 Düsseldorf |
| GERMANY |

CEVA Tiergesundheit GmbH

Kanzlerstr. 4

D-40472 Düsseldorf

GERMANY

CEVAXEL 50 mg/ml

ceftiofur sodium

50 mg/ml

Powder and solvent for reconstitution

Cattle, pigs

Germany

| Intervet Deutschland GmbH |
| --- |
| Feldstr. 1a |
| D-85716 Unterschleißheim |
| GERMANY |

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

GERMANY

Cobactan IV 4,5 % Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Pferde

cefquinome sulfate

45 mg/ml

Powder and solvent for reconstitution

Horses

Germany

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| GERMANY |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GERMANY

Excenel 1g Pulver zur Herstellung einer Injektionslösung für Schweine und Rinder

ceftiofur sodium

50 mg/ml

Powder

Cattle, pigs

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| GERMANY |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GERMANY

Excenel 4g

ceftiofur sodium

50 mg/ml

Powder

Cattle, pigs

Germany

| Pfizer GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| GERMANY |

Pfizer GmbH

Linkstr. 10

D-10785 Berlin

GERMANY

Excenel RTU

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| Continental Farmaceutica, S.L. |
| --- |
| Parque Empresarial La Moraleja |
| Avenida de Europa 20-B |
| E-28108 Madrid, Alcobendas |
| SPAIN |

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPAIN

Truleva RTU

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Greece

| INTERVET HELLAS AE |
| --- |
| Ag Dimitriou Str 63, Alimos |
| 174 55 Athens |
| GREECE |

INTERVET HELLAS AE

Ag Dimitriou Str 63, Alimos

174 55 Athens

GREECE

COBACTAN

Cefquinome sulphate

25 mg/ml

Inj.sol.

Cattle, pigs

Greece

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 4,5 %

Cefquinome sulphate

45 mg/ml

Powder and solvent for solution for injection

Horses, foals, cattle, calves

Greece

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA

Cefquinome sulphate

75 mg/ml

Suspension for injection

Cattle

Greece

| CEVA HELLAS |
| --- |
| Ag. Nikolaou 15 |
| 17455 Alimos |
| GREECE |

CEVA HELLAS

Ag. Nikolaou 15

17455 Alimos

GREECE

CEVAXEL

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Greece

| CEVA HELLAS |
| --- |
| Ag. Nikolaou 15 |
| 17455 Alimos |
| GREECE |

CEVA HELLAS

Ag. Nikolaou 15

17455 Alimos

GREECE

CEVAXEL-RTU, for cattle and pigs

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Greece

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Greece

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

VIRBACEF σκόνη για ενέσιμο διάλυμα για βοοειδή και χοίρους

Ceftiofur

50 mg/ml

Powder for Solution for Injection

Cattle, pigs

Greece

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

READYCEF

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Greece

| PFIZER HELLAS AE |
| --- |
| Messogeion Ave 243. |
| Neo Psychiko |
| GR-154 51 |
| GREECE |

PFIZER HELLAS AE

Messogeion Ave 243.

Neo Psychiko

GR-154 51

GREECE

EXCENEL

CEFTIOFUR

50 mg/ml

Ppowder for injection

Cattle, pigs

Greece

| PFIZER HELLAS AE |
| --- |
| Messogeion Ave 243. |
| Neo Psychiko |
| GR-154 51 |
| GREECE |

PFIZER HELLAS AE

Messogeion Ave 243.

Neo Psychiko

GR-154 51

GREECE

EXCENEL PTU

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Greece

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR

Ceftiofur (as Ceftiofur Hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Hungary

| Pfizer Co. Ltd. |
| --- |
| Budapest |
| Alkotás u. 54. |
| H-1123 |
| HUNGARY |

Pfizer Co. Ltd.

Budapest

Alkotás u. 54.

H-1123

HUNGARY

Excenel SP injekció

Ceftiofur Sodium

50 mg/ml

Sterile powder for injection

Water for parenteral use

Cattle, pigs

Hungary

| Pfizer Co. Ltd. |
| --- |
| Budapest |
| Alkotás u. 54. |
| H-1123 |
| HUNGARY |

Pfizer Co. Ltd.

Budapest

Alkotás u. 54.

H-1123

HUNGARY

Excenel RTU injekció

Ceftiofur Hydrochloride

50 mg/ml

Injection

Cattle, pigs

Hungary

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 2,5 % injekció

Cefquinom sulphate

25 mg/ml

Injection

Cattle, pigs

Hungary

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan IV 4,5 % injekció

Cefquinom sulphate

45 mg/ml

Injection

Cattle, horses

Hungary

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 % injekció

Cefquinom sulphate

75 mg/ml

Injection

Cattle

Hungary

| Ceva Phylaxia Co. Ltd. |
| --- |
| Budapest |
| Szállás u. 5. |
| H-1107 |
| HUNGARY |

Ceva Phylaxia Co. Ltd.

Budapest

Szállás u. 5.

H-1107

HUNGARY

Cevaxel RTU 50 mg/ml szuszpenziós injekció szarvasmarha és sertés részére

Ceftiofur Hydrochloride

50 mg/ml

Injection

Cattle, pigs

Hungary

| Ceva Phylaxia Co. Ltd. |
| --- |
| Budapest |
| Szállás u. 5. |
| H-1107 |
| HUNGARY |

Ceva Phylaxia Co. Ltd.

Budapest

Szállás u. 5.

H-1107

HUNGARY

Cevaxel 50 mg/ml por és oldószer injekcióhoz szarvasmarha és sertés részére

Ceftiofur Sodium

50 mg/ml

Sterile powder for injection

Water for parenteral use

Cattle, pigs

Hungary

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Ceftiomax 50 mg/ml injekció sertés és szarvasmarha részére

Ceftiofur Hydrochloride

50 mg/ml

Injection

Cattle, pigs

Hungary

| Vetoquinol S.A. |
| --- |
| Magny-Vernois |
| 70200 Lure |
| FRANCE |

Vetoquinol S.A.

Magny-Vernois

70200 Lure

FRANCE

Ceftiocyl 50 mg/ml injekció szarvasmarhák és sertések részére

Ceftiofur Hydrochloride

50 mg/ml

Injection

Cattle, pigs

Hungary

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur 50 mg/ml injekció szarvasmarhák és sertések részére

Ceftiofur Hydrochloride

50 mg/ml

Injection

Cattle, pigs

Iceland

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur vet.

Ceftiofurum INN

50 mg/ml

Suspension for injection

Cattle, pigs

Ireland

| Pfizer Healthcare Ireland (Trading as Pfizer Animal Health) |
| --- |
| Ringaskiddy Co. Cork |
| IRELAND |

Pfizer Healthcare Ireland (Trading as Pfizer Animal Health)

Ringaskiddy Co. Cork

IRELAND

Excenel RTU, 50 mg/ml, suspension for injection for pigs and cattle

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for Injection

Cattle, pigs

Ireland

| Pfizer Healthcare Ireland (Trading as Pfizer Animal Health) |
| --- |
| Ringaskiddy Co. Cork |
| IRELAND |

Pfizer Healthcare Ireland (Trading as Pfizer Animal Health)

Ringaskiddy Co. Cork

IRELAND

Excenel 1 g Sterile Powder for Solution for Injection

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Ireland

| Pfizer Healthcare Ireland (Trading as Pfizer Animal Health) |
| --- |
| Ringaskiddy Co. Cork |
| IRELAND |

Pfizer Healthcare Ireland (Trading as Pfizer Animal Health)

Ringaskiddy Co. Cork

IRELAND

Excenel 4 g Sterile Powder for Solution for Injection

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Ireland

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 mg/ml suspension for injection for pigs and cattle

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Pigs, cattle

Ireland

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef Powder for Solution for Injection for cattle and pigs.

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Ireland

| Vetoquinol UK Limited |
| --- |
| Vetoquinol House |
| Great Slade |
| Buckingham Industrial Park |
| Buckingham |
| MK18 1PA |
| UNITED KINGDOM |

Vetoquinol UK Limited

Vetoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

UNITED KINGDOM

Ceftiocyl 50 mg/ml, suspension for injection for cattle and pigs.

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Ireland

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL-RTU 50 mg/ml, suspension for injection for cattle and pigs

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Ireland

| Intervet Ireland Ltd. |
| --- |
| Magna Drive |
| Magna Business Park |
| Citywest Road |
| Dublin 24 |
| IRELAND |

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

IRELAND

Cobactan 2,5 % w/v Suspension for Injection

Cefquinome sulfate

25 mg/ml

Suspension for injection

Cattle, pigs

Ireland

| Intervet Ireland Ltd. |
| --- |
| Magna Drive |
| Magna Business Park |
| Citywest Road |
| Dublin 24 |
| IRELAND |

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

IRELAND

Cobactan LA 7,5 % suspension for injection for cattle

Cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

Ireland

| Intervet Ireland Ltd. |
| --- |
| Magna Drive |
| Magna Business Park |
| Citywest Road |
| Dublin 24 |
| IRELAND |

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

IRELAND

Cobactan 4,5 % powder and solvent for solution for injection for horse and cattle

Cefquinome (as sulfate)

45 mg/ml

Powder and solvent for solution for injection.

Horses (adult and foal), cattle (adult and calf)

Ireland

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan 50 mg/ml suspension for injection for pigs and cattle

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Pigs weighing up to 125 kg.

Cattle

Ireland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for Cattle and Pigs.

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Italy

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL

Ceftiofur chlorhidrate

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Vetoquinol S.A. |
| --- |
| Magny-Vernois |
| 70200 Lure |
| FRANCE |

Vetoquinol S.A.

Magny-Vernois

70200 Lure

FRANCE

CEFTIOCYL

Ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

CEFTIOMAX

Ceftiofur chlorhidrate

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

CEFTIOSAN

Ceftiofur chlorhidrate

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Laboratorios Maymó, S.A. |
| --- |
| Vía Augusta, 302 |
| 08017. Barcelona |
| SPAIN |

Laboratorios Maymó, S.A.

Vía Augusta, 302

08017. Barcelona

SPAIN

CEMAY

Ceftiofur chlorhidrate

50 mg/ml

Suspension for injection

Pigs

Italy

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

ACTIONIS

Ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Ceva Vetem SpA |
| --- |
| Via Colleoni 15 |
| 20041 Agrate Brianza (MB) |
| ITALY |

Ceva Vetem SpA

Via Colleoni 15

20041 Agrate Brianza (MB)

ITALY

CEVAXEL

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL RTU

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| PFIZER ITALIA SRL |
| --- |
| Via Valbondione, 113 |
| 00188 Roma |
| ITALY |

PFIZER ITALIA SRL

Via Valbondione, 113

00188 Roma

ITALY

EXCENEL

Sodium ceftiofur

50 mg/ml

Powder for injection

Cattle, pigs, horses

Italy

| PFIZER ITALIA SRL |
| --- |
| Via Valbondione, 113 |
| 00188 Roma |
| ITALY |

PFIZER ITALIA SRL

Via Valbondione, 113

00188 Roma

ITALY

EXCENEL RTU

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Fatro Spa |
| --- |
| Via Emilia 285 |
| 40064 Ozzano Dell'Emilia (BO) |
| ITALY |

Fatro Spa

Via Emilia 285

40064 Ozzano Dell'Emilia (BO)

ITALY

WONDERCEF

Ceftiofur sodium

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Italy

| Continental Farmaceutica, S.L. |
| --- |
| Parque Empresarial La Moraleja |
| Avenida de Europa 20-B |
| E-28108 Madrid, Alcobendas |
| SPAIN |

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPAIN

TRULEVA

Ceftiofur chlorhidrate

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Continental Farmaceutica, S.L. |
| --- |
| Parque Empresarial La Moraleja |
| Avenida de Europa 20-B |
| E-28108 Madrid, Alcobendas |
| SPAIN |

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPAIN

TRULEVA

Ceftiofur chlorhidrate

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| INTERVET ITALIA SRL |
| --- |
| Via Nettunense Km 20,300. |
| 04011 Aprilia (LT) |
| ITALY |

INTERVET ITALIA SRL

Via Nettunense Km 20,300.

04011 Aprilia (LT)

ITALY

COBACTAN

Cefquinome sulphate

25 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN IV IM 4,5 %

Cefquinome sulphate

No information available

Suspension for injection

Cattle, horses

Italy

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA 7,5 %

Cefquinome sulphate

No information available

Suspension for injection

Cattle

Latvia

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil

ceftiofur sodium

50 mg/ml

Powder for solution for injection

Cattle, pigs

Latvia

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL

ceftiofur sodium

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Latvia

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Ceftiomax

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Latvia

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

Cevaxel-RTU

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Latvia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 2,5 %

cefquinome

25 mg/ml

Suspension for injection

Cattle, pigs

Latvia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 %

cefquinome

75 mg/ml

Suspension for injection

Cattle

Latvia

| Pfizer Animal Health |
| --- |
| Boulevard de la Paine 17 |
| B-1050 Brussels |
| BELGIUM |

Pfizer Animal Health

Boulevard de la Paine 17

B-1050 Brussels

BELGIUM

Excenel RTU

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Latvia

| Pfizer Animal Health |
| --- |
| Boulevard de la Paine 17 |
| B-1050 Brussels |
| BELGIUM |

Pfizer Animal Health

Boulevard de la Paine 17

B-1050 Brussels

BELGIUM

Excenel Sterile Powder

ceftiofur sodium

50 mg/ml

Powder for solution for injection

Cattle, pigs

Latvia

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Latvia

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 2,5 %, injekcinė suspensija

Cefquinome (as sulphate)

25 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA 7,5 %, injekcinė suspensija

Cefquinome (as sulphate)

75 mg/ml

Suspension for injection

Cattle

Lithuania

| Pfizer Manufacturing Belgium N,V./S.A. |
| --- |
| Rijksweg 12 |
| B-2870 Puurs |
| BELGIUM |

Pfizer Manufacturing Belgium N,V./S.A.

Rijksweg 12

B-2870 Puurs

BELGIUM

EXCENEL, milteliai injekciniam tirpalui ruošti

Ceftiofur (as sodium)

50 mg/ml

Powder for solution for injection

Cattle, pigs, one-day-old chickens

Lithuania

| Pfizer Manufacturing Belgium N,V./S.A. |
| --- |
| Rijksweg 12 |
| B-2870 Puurs |
| BELGIUM |

Pfizer Manufacturing Belgium N,V./S.A.

Rijksweg 12

B-2870 Puurs

BELGIUM

EXCENEL RTU, injekcinė suspensija

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 mg/ml injekcinė ceftiofuro suspensija kiaulėms ir galvijams

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL 50 mg/ml, milteliai ir tirpiklis injekciniam tirpalui ruošti

Ceftiofur (as sodium)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Lithuania

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL RTU, injekcinė suspensija

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL 50 mg/ml, milteliai ir tirpiklis injekciniam tirpalui ruošti

Ceftiofur (as sodium)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Lithuania

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Ceftiomax 50 mg/ml injekcinė suspensija kiaulėms ir galvijams

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Interchemie werken "De Adelaar" BV |
| --- |
| Horsterweg 26A |
| 5811 AC Castenray |
| THE NETHERLANDS |

Interchemie werken "De Adelaar" BV

Horsterweg 26A

5811 AC Castenray

THE NETHERLANDS

CEFTIONEL-50, injekcinė suspensija galvijams ir kiaulėms

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Pigs weighing up to 125 kg, cattle

Poland

| Pfizer Trading Polska Sp. z o.o. |
| --- |
| ul. Rzymowskiego 34 |
| 02-697 Warszawa |
| POLAND |

Pfizer Trading Polska Sp. z o.o.

ul. Rzymowskiego 34

02-697 Warszawa

POLAND

Excenel Ceftiofur (w postaci Ceftiofuru sodowego) 50 mg/ml, proszek do sporządzania roztworu do wstrzykiwań

Ceftiofurum

50 mg/ml

Powder for solution for injection

Cattle, horses, pigs

Poland

| Pfizer Trading Polska Sp. z o.o. |
| --- |
| ul. Rzymowskiego 34 |
| 02-697 Warszawa |
| POLAND |

Pfizer Trading Polska Sp. z o.o.

ul. Rzymowskiego 34

02-697 Warszawa

POLAND

Excenel RTU

Ceftiofurum

50 mg/ml

Suspention for injection

Cattle, pigs

Poland

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Ceftiomax 50 mg/ml zawiesina do wstrzykiwań dla świń i bydła

Ceftiofuri hydrochloridum

50 mg/ml

Suspention for injection

Cattle, pigs

Poland

| Ceva Animal Health Polska Sp. z o.o. |
| --- |
| ul. Okrzei 1A |
| 03-715 Warszawa |
| POLAND |

Ceva Animal Health Polska Sp. z o.o.

ul. Okrzei 1A

03-715 Warszawa

POLAND

Cevaxel 50 mg/ml proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań dla bydła i świń

Ceftiofurum

50 mg/ml

Powder and solution for solution for injection

Cattle, pigs

Poland

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur 50 mg/ml zawiesina do wstrzykiwań dla świń i bydła

Ceftiofurum

50 mg/ml

Suspention for injection

Cattle, pigs

Poland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefur 50 mg/ml proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań dla bydła i świń

Ceftiofurum natricum

50 mg/ml

Powder and solution for solution for injection

Cattle, pigs

Poland

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

Vetoquinol Biowet Sp. z o.o

ul. Kosynierów Gdyńskich 13-14

66-400 Gorzów Wielkopolski

POLAND

Ceftiocyl 50 mg/ml, zawiesina do wstrzykiwań dla bydła i świń

Ceftiofur as hydrochloride

50 mg/ml

Suspention for injection

Cattle, pigs

Poland

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan, 25 mg/ml, zawiesina do wstrzykiwań dla bydła i świń

Cefquinomum

25 mg/ml

Suspention for injection

Cattle, pigs

Poland

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 4,5 % proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań dla koni i bydła

Cefquinomum

45 mg/ml

Powder and solution for solution for injection

Cattle, horses

Poland

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 % zawiesina do wstrzykiwań dla bydła

Cefquinomum

75 mg/ml

Suspention for injection

Cattle

Portugal

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml pó e solvente para solução injectável para bovinos e suínos

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Portugal

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef Pó para solução injectável para bovinos e suínos

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder for solution for injection.

Cattle, pigs

Portugal

| Intervet Portugal – Saúde Animal, Lda |
| --- |
| Rua Agualva dos Açores n.o 16 |
| 2735-557 Agualva-Cacém |
| PORTUGAL |

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores n.o 16

2735-557 Agualva-Cacém

PORTUGAL

COBACTAN 2,5 % p/v suspensão injectável para bovinos e suínos

Cefquinome (as sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs

Portugal

| Laboratórios Pfizer, Lda |
| --- |
| Lagoas Park – Edifício 10 |
| 2740-244 Porto Salvo |
| PORTUGAL |

Laboratórios Pfizer, Lda

Lagoas Park – Edifício 10

2740-244 Porto Salvo

PORTUGAL

EXCENEL RTU

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection.

Cattle, pigs

Portugal

| CALIER PORTUGAL, S.A. |
| --- |
| Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro |
| Estrada de Albarraque |
| 2710 - 335 Sintra |
| PORTUGAL |

CALIER PORTUGAL, S.A.

Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro

Estrada de Albarraque

2710 - 335 Sintra

PORTUGAL

CEFTIOMAX 50 mg/ml suspensão injectável para bovinos e suínos

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Portugal

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 mg/ml suspensão injectável para suínos e bovinos

Ceftiofur (as Ceftiofur Hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Portugal

| Intervet Portugal – Saúde Animal, Lda |
| --- |
| Rua Agualva dos Açores n.o 16 |
| 2735-557 Agualva-Cacém |
| PORTUGAL |

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores n.o 16

2735-557 Agualva-Cacém

PORTUGAL

COBACTAN LA 7,5 %, suspensão injectável para bovinos

Cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

Portugal

| Intervet Portugal – Saúde Animal, Lda |
| --- |
| Rua Agualva dos Açores n.o 16 |
| 2735-557 Agualva-Cacém |
| PORTUGAL |

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores n.o 16

2735-557 Agualva-Cacém

PORTUGAL

Cobactan 4,5 % pó e solvente para solução injectável para equinos e bovinos

cefquinome (as sulphate)

45 mg/ml

Powder and solvent for solution for injection

Horses (adult and foal), cattle (adult and calf)

Portugal

| Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda. |
| --- |
| Rua Doutor António Loureiro Borges, no 9/9A, 9oA |
| Miraflores- 1495-131 Algés |
| PORTUGAL |

Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda.

Rua Doutor António Loureiro Borges, no 9/9A, 9oA

Miraflores- 1495-131 Algés

PORTUGAL

CEVAXEL 50 mg/ml pó e solvente para solução injectável para bovinos e suínos

Ceftiofur (as sodium)

50 mg/ml

Powder and solvent for solution for injection.

Cattle, pigs

Portugal

| VÉTOQUINOL, Lda |
| --- |
| Rua Consiglieri Pedroso, no 123, Edifício H |
| Queluz de Baixo |
| 2730-056 BARCARENA |
| PORTUGAL |

VÉTOQUINOL, Lda

Rua Consiglieri Pedroso, no 123, Edifício H

Queluz de Baixo

2730-056 BARCARENA

PORTUGAL

Ceftiocyl 50 mg/ml, suspensão injectável para Bovinos e Suínos

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Portugal

| Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda. |
| --- |
| Rua Doutor António Loureiro Borges, no 9/9A, 9oA |
| Miraflores- 1495-131 Algés |
| PORTUGAL |

Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda.

Rua Doutor António Loureiro Borges, no 9/9A, 9oA

Miraflores- 1495-131 Algés

PORTUGAL

CEVAXEL -RTU 50 mg/ml, suspensão injectável para bovinos e suínos

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Portugal

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

Actionis 50 mg/ml, suspensão injectável para suínos e bovinos

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Portugal

| Laboratorios Maymó, S.A. |
| --- |
| Vía Augusta, 302 |
| 08017. Barcelona |
| SPAIN |

Laboratorios Maymó, S.A.

Vía Augusta, 302

08017. Barcelona

SPAIN

CEMAY 50 mg/ml, suspension for injection for pigs

Ceftiofur (as hydrochloride)

50 mg/ml

Supension for injection

Pigs

Portugal

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Pigs weighing up to 125 kg. Cattle.

Romania

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 2,5 %

Cefquinome

25 mg/ml

Injectable suspension

Cattle, dairy cows, calves, pigs, piglets

Romania

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 7,5 % L.A.

Cefquinome

75 mg/ml

Injectable suspension

Cattle

Romania

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

EXCENEL RTU

Ceftiofur

50 mg/ml

Injectable suspension

Cattle, pigs

Romania

| Pfizer Animal Health |
| --- |
| Boulevard de la Paine 17 |
| B-1050 Brussels |
| BELGIUM |

Pfizer Animal Health

Boulevard de la Paine 17

B-1050 Brussels

BELGIUM

EXCENEL

Ceftiofur

50 mg/ml.

Sterile powder

Cattle, pigs

Romania

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50mg/ml

Ceftiofur

50 mg/ml

Oily suspension

Cattle, pigs

Romania

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL 50 m

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Romania

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL 50mg/ml

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, horses, pigs

Romania

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

CEFTIOMAX 50mg/ml

Ceftiofur

50 mg/ml

Injectable suspension

Cattle, pigs

Slovakia

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6J |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6J

UNITED KINGDOM

Cefenil 50 mg/ml prášok a riedidlo na prípravu injekčného roztoku pre hovädzí dobytok a ošípané

ceftiofurum

50 mg/ml

powder+ diluent

Cattle, pigs

Slovakia

| Vetoquinol s.r.o. |
| --- |
| Zámečnícka 411 |
| CZ-288 02 Nymburk |
| CZECH REPUBLIC |

Vetoquinol s.r.o.

Zámečnícka 411

CZ-288 02 Nymburk

CZECH REPUBLIC

Ceftiocyl 50 mg/ml injekčná suspenzia

Ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Slovakia

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

Cevaxel 50 mg/ml prášok a riedidlo na prípravu injekčného roztoku pre hovädzí dobytok a ošípané

ceftiofurum

50 mg/ml

powder+ diluent

Cattle, pigs

Slovakia

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Efficur 50 mg/ml injekčná suspenzia pre ošípané a hovädzí dobytok

ceftiofurum

50 mg/ml

Suspension for injection

Cattle, pigs

Slovakia

| Pfizer Manufacturing Belgium N,V./S.A. |
| --- |
| Rijksweg 12 |
| B-2870 Puurs |
| BELGIUM |

Pfizer Manufacturing Belgium N,V./S.A.

Rijksweg 12

B-2870 Puurs

BELGIUM

Excenel 50 mg/ml lyofilizát na prípravu injekčného roztoku

ceftiofurum

50 mg/ml

lyophilisate

Cattle, pigs, one day old chicken, horses.

Slovakia

| Pfizer Manufacturing Belgium N,V./S.A. |
| --- |
| Rijksweg 12 |
| B-2870 Puurs |
| BELGIUM |

Pfizer Manufacturing Belgium N,V./S.A.

Rijksweg 12

B-2870 Puurs

BELGIUM

Excenel RTU 50 mg/ml injekčná suspenzia

ceftiofurum

50 mg/ml

Suspension for injection

Cattle, pigs

Slovakia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 25 mg/ ml injekčná suspenzia

cefquinomum

25 mg/ml

Suspension for injection

Cattle, pigs

Slovakia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 % inj.susp. pre hovädzí dobytok

cefquinomum

75 mg/ml

Suspension for injection

Cattle

Slovakia

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef prášok na prípravu injekčného roztoku pre hovädzí dobytok a ošípané

Ceftiofurum (ut natricum)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Slovakia

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

Cevaxel RTU 50 mg/ml injekčná suspnzia pre hovädzí dobytok a ošípané

ceftiofurum

50 mg/ml

Suspension for injection

Cattle, pigs

Slovenia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 2,5 %

cefquinome (as sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs

Slovenia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA 7,5 % suspenzija za injiciranje za govedo

cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

Slovenia

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 mg/ml suspenzija za injiciranje za prašiče in govedo

ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| 51 Avenue J.F.Kennedy |
| L-1855 Luxembourg |
| LUXEMBOURG |

Pfizer Luxembourg SARL

51 Avenue J.F.Kennedy

L-1855 Luxembourg

LUXEMBOURG

EXCENEL 50 mg/ml prašek za raztopino za injiciranje za govedo in prašiče

ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, pigs

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| 51 Avenue J.F.Kennedy |
| L-1855 Luxembourg |
| LUXEMBOURG |

Pfizer Luxembourg SARL

51 Avenue J.F.Kennedy

L-1855 Luxembourg

LUXEMBOURG

EXCENEL RTU suspenzija za injiciranje za prašiče in govedo

ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial

28108 La Moraleja

SPAIN

EXCENEL

Ceftiofur

50 mg/ml

Sterile powder to dissolve into sterile bacteriostatic water

Cattle, pigs

Spain

| CEVA SALUD ANIMAL, S.A. |
| --- |
| Carabela La Niña no 12 |
| 5a planta |
| 08017 Barcelona |
| SPAIN |

CEVA SALUD ANIMAL, S.A.

Carabela La Niña no 12

5a planta

08017 Barcelona

SPAIN

CEVAXEL 50 mg/ml

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Spain

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL 50 mg/ml POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE PARA BOVINO Y PORCINO

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial

28108 La Moraleja

SPAIN

EXCENEL RTU

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

CEFTIOMAX 50 mg/ml SUSPENSION INYECTABLE PARA PORCINO

ceftiofur

50 mg/ml

Suspension for injection

Pigs

Spain

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR

ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

CEFTIOMAX 50 mg/ml SUSPENSION INYECTABLE PARA PORCINO Y VACUNO

ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Vetoquinol Especialidades Veterinarias, S.A. |
| --- |
| Autovia Fuencarral-Alcobendas km 15 |
| 700-Edificio Europa I, Portal 3, 2o5 |
| 28108 Alcobendas. |
| SPAIN |

Vetoquinol Especialidades Veterinarias, S.A.

Autovia Fuencarral-Alcobendas km 15

700-Edificio Europa I, Portal 3, 2o5

28108 Alcobendas.

SPAIN

CEFTIOCYL 50 mg/ml SUSPENSION INYECTABLE PARA PORCINO Y BOVINO

ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| CEVA SALUD ANIMAL, S.A. |
| --- |
| Carabela La Niña no 12 |
| 5a planta |
| 08017 Barcelona |
| SPAIN |

CEVA SALUD ANIMAL, S.A.

Carabela La Niña no 12

5a planta

08017 Barcelona

SPAIN

CEVAXEL RTU 50 MG/ML SUSPENSIÓN INYECTABLE PARA BOVINO Y PORCINO

ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil HCL Injection for Cattle and Swine (Name proposed in ES: Cefenil RTU)

Procedure curretly ongoing

ceftiofur

50 mg/ml

Solution for injection

Cattle, pigs

Spain

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle

ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

ACTIONIS 50 mg/ml SUSPENSIÓN INYECTABLE PARA PORCINO Y BOVINO

ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Laboratorios Maymó, S.A. |
| --- |
| Vía Augusta, 302 |
| 08017. Barcelona |
| SPAIN |

Laboratorios Maymó, S.A.

Vía Augusta, 302

08017. Barcelona

SPAIN

CEMAY 50 mg/ml SUSPENSIÓN INYECTABLE PARA PORCINO

ceftiofur

50 mg/ml

Suspension for injection

Pigs

Spain

| Laboratorios E Industrias Iven, S.A. |
| --- |
| Luis I, 56. |
| Polígono Industrial Vallecas |
| 28031 Madrid |
| SPAIN |

Laboratorios E Industrias Iven, S.A.

Luis I, 56.

Polígono Industrial Vallecas

28031 Madrid

SPAIN

CEFTIONIL 50 mg/ml SUSPENSIÓN INYECTABLE PARA PORCINO

ceftiofur

50 mg/ml

Suspension for injection

Pigs

Spain

| Laboratorios Intervet, S.A. |
| --- |
| Polígono Industrial El Montalvo I |
| C/ Zeppelín no 6, parcela 39 |
| 37188- Carbajosa de la Sagrada (Salamanca) |
| SPAIN |

Laboratorios Intervet, S.A.

Polígono Industrial El Montalvo I

C/ Zeppelín no 6, parcela 39

37188- Carbajosa de la Sagrada (Salamanca)

SPAIN

COBACTAN 2,5 % P/V SUSPENSIÓN INYECTABLE PARA BOVINO Y PORCINO

cefquinoma

25 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA 7,5 %

cefquinoma

75 mg/ml

Suspension for injection

Cattle

Spain

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 4,5 % INYECTABLE PARA EQUINO Y BOVINO

Cefquinoma

45 mg/ml

Powder and solvent for solution for injection

Cattle, horses

Sweden

| Pfizer Oy, Animal Health |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health

Tietokuja 4

FI-00330 Helsinki

FINLAND

Excenel vet.®

ceftiofur sodium

1g and 4g

Powder for injection

Cattle

Sweden

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Ceftiofur N-vet

ceftiofur sodium

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Sweden

| Vetoquinol scandinavia AB |
| --- |
| Box 9 |
| SE-26521 Åstorp |
| SWEDEN |

Vetoquinol scandinavia AB

Box 9

SE-26521 Åstorp

SWEDEN

Ceftiocyl

ceftiofur hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Ceva Santé Animale B.V. |
| --- |
| Tiendweg 8c |
| 2671 SB Naaldwijk |
| THE NETHERLANDS |

Ceva Santé Animale B.V.

Tiendweg 8c

2671 SB Naaldwijk

THE NETHERLANDS

CEVAXEL 50 mg/ml poeder en oplosmiddel voor oplossing voor injectie voor runderen en varkens

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

The Netherlands

Vétoquinol BV

Postbus 3191

NL-5203 DD

’s-Hertogenbosch

THE NETHERLANDS

CEFTIOCYL 50 mg/ml, suspensie voor injectie voor runderen en varkens

Ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

READYCEF 50 mg/ml suspensie voor injectie voor varkens en runderen

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Ceva Santé Animale B.V. |
| --- |
| Tiendweg 8c |
| 2671 SB Naaldwijk |
| THE NETHERLANDS |

Ceva Santé Animale B.V.

Tiendweg 8c

2671 SB Naaldwijk

THE NETHERLANDS

CEVAXEL-RTU 50 mg/ml, suspensie voor injectie voor runderen en varkens

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan, 50 mg/ml, suspensie voor injectie voor runderen en varkens

Ceftiofur

50 mg/ml

Suspension for injection

Pigs weighing up to 125 kg.

Cattle

The Netherlands

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 mg/ml suspensie voor injectie voor runderen en varkens

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Pfizer Animal Health B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 Ld Capelle a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 Ld Capelle a/d Ijssel

THE NETHERLANDS

EXCENEL RTU

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| D-Vett. B.V. |
| --- |
| Gebroek 37 |
| 6043 GP Roermond |
| THE NETHERLANDS |

D-Vett. B.V.

Gebroek 37

6043 GP Roermond

THE NETHERLANDS

EXCENEL RTU

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Intervet Nederland B.V. |
| --- |
| Postbus 50 |
| 5830 AB Boxmeer |
| THE NETHERLANDS |

Intervet Nederland B.V.

Postbus 50

5830 AB Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 %

Cefquinome

75 mg/ml

Suspension for injection

Cattle

The Netherlands

| Intervet Nederland B.V. |
| --- |
| Postbus 50 |
| 5830 AB Boxmeer |
| THE NETHERLANDS |

Intervet Nederland B.V.

Postbus 50

5830 AB Boxmeer

THE NETHERLANDS

Cobactan 4,5 %, poeder en oplosmiddel voor oplssing voor injectie.

Cefquinome

45 mg/ml

Powder and solvent for solution for injection.

Horses (adult and foal) and cattle (adult and calf)

The Netherlands

| Intervet Nederland B.V. |
| --- |
| Postbus 50 |
| 5830 AB Boxmeer |
| THE NETHERLANDS |

Intervet Nederland B.V.

Postbus 50

5830 AB Boxmeer

THE NETHERLANDS

Cobactan IV 4,5 %

Cefquinome

45 mg/ml

Powder and solvent for solution for injection.

Horses (adult and foal)

The Netherlands

| Intervet Nederland B.V. |
| --- |
| Postbus 50 |
| 5830 AB Boxmeer |
| THE NETHERLANDS |

Intervet Nederland B.V.

Postbus 50

5830 AB Boxmeer

THE NETHERLANDS

Cobactan 2,5 % suspensie voor injectie voor rund en varken

Cefquinome

25 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| D-Vett. B.V. |
| --- |
| Gebroek 37 |
| 6043 GP Roermond |
| THE NETHERLANDS |

D-Vett. B.V.

Gebroek 37

6043 GP Roermond

THE NETHERLANDS

Cobactan 2,5 % suspensie voor injectie voor rund en varken

Cefquinome

26 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Pfizer Animal Health B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

THE NETHERLANDS

Excenel

Ceftiofur

50 mg/ml

Powder for solution for injection.

Cattle, pigs

The Netherlands

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml, poeder en oplosmiddel voor oplossing voor injectie voor runderen en varkens

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection.

Cattle, pigs

United Kingdom

| Intervet UK |
| --- |
| Walton Manor, Walton |
| Milton Keynes |
| Buckinghamshire |
| MK7 7AJ |
| UNITED KINGDOM |

Intervet UK

Walton Manor, Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

UNITED KINGDOM

Cobactan 2,5 % w/v suspension for injection for cattle and pigs

Cefquinome (as sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Intervet UK |
| --- |
| Walton Manor, Walton |
| Milton Keynes |
| Buckinghamshire |
| MK7 7AJ |
| UNITED KINGDOM |

Intervet UK

Walton Manor, Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

UNITED KINGDOM

Cobactan 25 mg/ml Suspension for Injection

Cefquinome (as sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 4,5 % Powder and Solvent for Solution for Injection for Horse and Cattle

Cefquinome (as sulfate)

45 mg/ml

Powder and solvent for solution for injection

Cattle, horses

United Kingdom

| Intervet UK |
| --- |
| Walton Manor, Walton |
| Milton Keynes |
| Buckinghamshire |
| MK7 7AJ |
| UNITED KINGDOM |

Intervet UK

Walton Manor, Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

UNITED KINGDOM

Cobactan LA 7,5 % Suspension for Injection for Cattle

Cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

United Kingdom

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

Actionis 50 mg/ml Suspension for Injection for Cattle and Pigs

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for Cattle and Pigs

Ceftiofur Sodium

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

United Kingdom

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for Cattle, Pigs and Horses

Ceftiofur Sodium

50 mg/ml

Powder and solvent for solution for injection

Cattle, horses, pigs

United Kingdom

| Vetoquinol UK Limited |
| --- |
| Vetoquinol House |
| Great Slade |
| Buckingham Industrial Park |
| Buckingham |
| MK18 1PA |
| UNITED KINGDOM |

Vetoquinol UK Limited

Vetoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

UNITED KINGDOM

Ceftiocyl 50 mg/ml Suspension for Injection for Cattle and Pigs

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| The Netherlands |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

The Netherlands

Ceftiosan 50 mg/ml Injectable Suspension for Cattle and Pigs

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Ceva Animal Health Ltd |
| --- |
| 90 The Broadway |
| Chesham |
| Buckinghamshire |
| HP5 1EG |
| UNITED KINGDOM |

Ceva Animal Health Ltd

90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

UNITED KINGDOM

Cevaxel 50 mg/ml Powder and Solvent for Solution for Injection for Cattle and Pigs

Ceftiofur Sodium

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

United Kingdom

| Ceva Animal Health Ltd |
| --- |
| 90 The Broadway |
| Chesham |
| Buckinghamshire |
| HP5 1EG |
| UNITED KINGDOM |

Ceva Animal Health Ltd

90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

UNITED KINGDOM

Cevaxel - RTU

Ceftiofur Hydrochloride

No information provided

Suspension for injection

Cattle, pigs

United Kingdom

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur 50 mg/ml Suspension for Injection for Pigs and Cattle

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

Excenel 1 g Sterile Powder for Solution for Injection

Ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, horses, pigs

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

Excenel 4 g Sterile Powder for Solution for Injection

Ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, horses, pigs

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

Excenel RTU 50 mg/ml Suspension for Injection for Pigs and Cattle

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Readycef 50 mg/ml Suspension for Injection for Swine and Cattle

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Continental Farmaceutica, S.L. |
| --- |
| Parque Empresarial La Moraleja |
| Avenida de Europa 20-B |
| E-28108 Madrid, Alcobendas |
| SPAIN |

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPAIN

Truleva RTU 50 mg/ml Suspension for Injection for Pigs and Cattle

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef Powder for Solution for Injection for Cattle and Pigs

Ceftiofur as Ceftiofur Sodium

50 mg/ml

Powder for solution for injection

Cattle, pigs

United Kingdom

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef Sterile Powder for Cattle, Pigs and Horses

Ceftiofur as Ceftiofur Sodium

50 mg/ml

Powder for solution for injection

Cattle, horses, pigs

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | CSC Pharmaceuticals Handels GmbH |
| Gewerbestraße 18-20 |
| A-2102 Bisamberg |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

AT - Austria

CSC Pharmaceuticals Handels GmbH

Gewerbestraße 18-20

A-2102 Bisamberg

Austria

Aulin 100 mg - Granulat

100 mg

Granules for oral suspension

Oral use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Gewerbestraße 18-20 |
| A-2102 Bisamberg |
| Austria |

CSC Pharmaceuticals Handels GmbH

Gewerbestraße 18-20

A-2102 Bisamberg

Austria

Aulin 100 mg - Suppositorien

100 mg

Suppository

Rectal use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Gewerbestraße 18-20 |
| A-2102 Bisamberg |
| Austria |

CSC Pharmaceuticals Handels GmbH

Gewerbestraße 18-20

A-2102 Bisamberg

Austria

Aulin 200 mg - Suppositorien

200 mg

Suppository

Rectal use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Gewerbestraße 18-20 |
| A-2102 Bisamberg |
| Austria |

CSC Pharmaceuticals Handels GmbH

Gewerbestraße 18-20

A-2102 Bisamberg

Austria

Aulin 100 mg - Tabletten

100 mg

Tablet

Oral use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Heiligenstädter Straße 395 b |
| A-1190 Wien |
| Austria |

CSC Pharmaceuticals Handels GmbH

Heiligenstädter Straße 395 b

A-1190 Wien

Austria

Mesulid 100 mg - Granulat

100 mg

Granules for oral suspension

Oral use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Gewerbestraße 18-20 |
| A-2102 Bisamberg |
| Austria |

CSC Pharmaceuticals Handels GmbH

Gewerbestraße 18-20

A-2102 Bisamberg

Austria

Mesulid 100 mg - Suppositorien

100 mg

Suppository

Rectal use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Heiligenstädter Straße 395 b |
| A-1190 Wien |
| Austria |

CSC Pharmaceuticals Handels GmbH

Heiligenstädter Straße 395 b

A-1190 Wien

Austria

Mesulid 200 mg - Suppositorien

200 mg

Suppository

Rectal use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Heiligenstädter Straße 395 b |
| A-1190 Wien |
| Austria |

CSC Pharmaceuticals Handels GmbH

Heiligenstädter Straße 395 b

A-1190 Wien

Austria

Mesulid 100 mg - Tabletten

100 mg

Tablet

Oral use

BG - Bulgaria

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 |
| 56010 PISA La Vettola |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897

56010 PISA La Vettola

Italy

Nimesil

100 mg

Granules for oral suspension

Oral use

BG - Bulgaria

| Zentiva k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Coxtral

100 mg

Tablet

Oral use

BG - Bulgaria

| Actavis EAD |
| --- |
| 29 Atanas Dukov str. |
| 1407 Sofia |
| Bulgaria |

Actavis EAD

29 Atanas Dukov str.

1407 Sofia

Bulgaria

Enetra

100 mg

Tablet

Oral use

BG - Bulgaria

| Inbiotech Ltd |
| --- |
| 5A Triaditza str. |
| 1000 Sofia |
| Bulgaria |

Inbiotech Ltd

5A Triaditza str.

1000 Sofia

Bulgaria

Biolin

100 mg

Tablet

Oral use

BG - Bulgaria

| Sopharma AD |
| --- |
| 16 Iliensko shosse str. |
| 1220 Sofia |
| Bulgaria |

Sopharma AD

16 Iliensko shosse str.

1220 Sofia

Bulgaria

Ameolin

100 mg

Tablet

Oral use

BG - Bulgaria

| CSC Pharmaceuticals Ltd-Bulgaria EOOD, |
| --- |
| 10 Assen Jordanov str., |
| 1592 Sofia, |
| Bulgaria |

CSC Pharmaceuticals Ltd-Bulgaria EOOD,

10 Assen Jordanov str.,

1592 Sofia,

Bulgaria

Aulin

100 mg

Tablet

Oral use

BG - Bulgaria

| CSC Pharmaceuticals Ltd-Bulgaria EOOD, |
| --- |
| 10 Assen Jordanov str., |
| 1592 Sofia, |
| Bulgaria |

CSC Pharmaceuticals Ltd-Bulgaria EOOD,

10 Assen Jordanov str.,

1592 Sofia,

Bulgaria

Aulin

100 mg

Granules for oral suspension

Oral use

BG - Bulgaria

| CSC Pharmaceuticals Ltd-Bulgaria EOOD, |
| --- |
| 10 Assen Jordanov str., |
| 1592 Sofia, |
| Bulgaria |

CSC Pharmaceuticals Ltd-Bulgaria EOOD,

10 Assen Jordanov str.,

1592 Sofia,

Bulgaria

Nimed

100 mg

Tablet

Oral use

BG - Bulgaria

| Chaikapharma – Highquality medicines AD, |
| --- |
| 1 G.M.Dimitrov Blvd |
| 1172 Sofia, |
| Bulgaria |

Chaikapharma – Highquality medicines AD,

1 G.M.Dimitrov Blvd

1172 Sofia,

Bulgaria

AllGone

100 mg

Effervescent tablet

Oral use

CY - Cyprus

| CDL PHARMACEUTICAL LTD |
| --- |
| 5 Diomedous str. |
| P.O.Box 40981 |
| 6308 Larnaca |
| Cyprus |

CDL PHARMACEUTICAL LTD

5 Diomedous str.

P.O.Box 40981

6308 Larnaca

Cyprus

ELINAP TABLETS 100 mg

100 mg

Tablet

Oral use

CY - Cyprus

| CHR. K. UNIMED LTD |
| --- |
| 21 Davlou |
| 2114 Aglantzia |
| Lefkosia |
| Cyprus |

CHR. K. UNIMED LTD

21 Davlou

2114 Aglantzia

Lefkosia

Cyprus

FLOGOSTOP TABLETS 100 mg

100 mg

Tablet

Oral use

CY - Cyprus

| CODAL SYNTO LTD |
| --- |
| 33 Thekla Lysioti str. |
| Dorothea Building, 6th floor |
| P.O.Box 51785 |
| 3508 Lemessos |
| Cyprus |

CODAL SYNTO LTD

33 Thekla Lysioti str.

Dorothea Building, 6th floor

P.O.Box 51785

3508 Lemessos

Cyprus

NIMM TABLETS 100 mg

100 mg

Tablet

Oral use

CY - Cyprus

| MEDOCHEMIE LTD |
| --- |
| 1-10 Constantinoupoleos str. |
| P.O.Box 51409 |
| 3505 Lemessos |
| Cyprus |

MEDOCHEMIE LTD

1-10 Constantinoupoleos str.

P.O.Box 51409

3505 Lemessos

Cyprus

APONIL TABLETS 100 mg

100 mg

Tablet

Oral use

CZ - Czech Republic

| Laboratori Guidotti S.p.A (Menarini Group). |
| --- |
| Via Livornese 897 |
| 560 10 San Piero a Grado Pisa |
| Italy |

Laboratori Guidotti S.p.A (Menarini Group).

Via Livornese 897

560 10 San Piero a Grado Pisa

Italy

Nimesil

100 mg

Granules for oral suspension

Oral use

CZ - Czech Republic

| Medicom International, s.r.o. |
| --- |
| Páteřní 1216/7 |
| 635 00 Brno |
| Czech Republic |

Medicom International, s.r.o.

Páteřní 1216/7

635 00 Brno

Czech Republic

Aulin

100 mg

Granules for oral solution

Oral use

CZ - Czech Republic

| Medicom International, s.r.o. |
| --- |
| Páteřní 1216/7 |
| 635 00 Brno |
| Czech Republic |

Medicom International, s.r.o.

Páteřní 1216/7

635 00 Brno

Czech Republic

Aulin

100 mg

Tablet

Oral use

CZ - Czech Republic

| Zentiva k.s. |
| --- |
| Evropská 846/176a |
| 160 00 Prague |
| Czech Republic |

Zentiva k.s.

Evropská 846/176a

160 00 Prague

Czech Republic

COXTRAL 100 MG TABLETY

100 mg

Tablet

Oral use

CZ - Czech Republic

| Medicom International, s.r.o. |
| --- |
| Páteřní 1216/7 |
| 635 00 Brno |
| Czech Republic |

Medicom International, s.r.o.

Páteřní 1216/7

635 00 Brno

Czech Republic

MESULID

100 mg

Granules for oral solution

Oral use

CZ - Czech Republic

| Medicom International, s.r.o. |
| --- |
| Páteřní 1216/7 |
| 635 00 Brno |
| Czech Republic |

Medicom International, s.r.o.

Páteřní 1216/7

635 00 Brno

Czech Republic

MESULID

100 mg

Tablet

Oral use

CZ - Czech Republic

| Medicom International, s.r.o. |
| --- |
| Páteřní 1216/7 |
| 635 00 Brno |
| Czech Republic |

Medicom International, s.r.o.

Páteřní 1216/7

635 00 Brno

Czech Republic

Nimed

100 mg

Tablet

Oral use

EL - Greece

| ALET PHARMACEUTICALS |
| --- |
| M. Alexander 121 |
| Agia Varvara 12351 |
| Greece |

ALET PHARMACEUTICALS

M. Alexander 121

Agia Varvara 12351

Greece

SPECILID

100 MG/TAB

Tablet

Oral use

EL - Greece

| ANFARM HELLAS S.A. |
| --- |
| Perikleous 53-57 |
| Gerakas Attikis 153 44 |
| Greece |

ANFARM HELLAS S.A.

Perikleous 53-57

Gerakas Attikis 153 44

Greece

LEMESILIN

100 MG/TAB

Tablet

Oral use

EL - Greece

| ANTONIOS POLYCHRONIS OF MARINOU |
| --- |
| Ethnikis Antistaseos 6A |
| Holargos 15562 |
| Greece |

ANTONIOS POLYCHRONIS OF MARINOU

Ethnikis Antistaseos 6A

Holargos 15562

Greece

OMNIBUS

100 MG/TAB

Tablet

Oral use

EL - Greece

| ANTOR EPE |
| --- |
| P. Mavromihali 1 |
| Vrilissia 15235 |
| Greece |

ANTOR EPE

P. Mavromihali 1

Vrilissia 15235

Greece

MELIMONT

100 MG/TAB

Tablet

Oral use

EL - Greece

| ARMEDICA A.E. |
| --- |
| Agias Markellis 17 |
| Athens 11855 |
| Greece |

ARMEDICA A.E.

Agias Markellis 17

Athens 11855

Greece

ALENCAST

100 MG/TAB

Tablet

Oral use

EL - Greece

| B.I. FARMA A.E. |
| --- |
| Aristotelous 73 |
| Athens 10434 |
| Greece |

B.I. FARMA A.E.

Aristotelous 73

Athens 10434

Greece

NIMESULIDE / B.I. FARMA

100 MG/TAB

Tablet

Oral use

EL - Greece

| BALU EPE |
| --- |
| 30 Km Athens-Lavrion |
| Markopoulo 19003 |
| Greece |

BALU EPE

30 Km Athens-Lavrion

Markopoulo 19003

Greece

NIBERAN

100 MG/TAB

Tablet

Oral use

EL - Greece

| BIOMEDICA-CHEMICA A.E. |
| --- |
| G. Lyra 25 |
| Kato Kifissia 14564 |
| Greece |

BIOMEDICA-CHEMICA A.E.

G. Lyra 25

Kato Kifissia 14564

Greece

NIMESULIDE / BIOMEDICA CHEMICA

100 MG/TAB

Tablet

Oral use

EL - Greece

| BIOSPRAY ABEE |
| --- |
| 18TH Km Marathonos Avenue |
| Pallini 15344 |
| Greece |

BIOSPRAY ABEE

18TH Km Marathonos Avenue

Pallini 15344

Greece

FLOGOSTOP

100 MG/TAB

Tablet

Oral use

EL - Greece

| BOEHRINGER INGELHEIM HELLAS S.A. |
| --- |
| Ellinikou 2 |
| 167 77 Elliniko |
| Greece |

BOEHRINGER INGELHEIM HELLAS S.A.

Ellinikou 2

167 77 Elliniko

Greece

MESULID

100 MG/TAB

Tablet

Oral use

EL - Greece

| BOEHRINGER INGELHEIM HELLAS S.A. |
| --- |
| Ellinikou 2 |
| 167 77 Elliniko |
| Greece |

BOEHRINGER INGELHEIM HELLAS S.A.

Ellinikou 2

167 77 Elliniko

Greece

MESULID

200 MG/SUPP

Suppository

Rectal use

EL - Greece

| BOEHRINGER INGELHEIM HELLAS S.A. |
| --- |
| Ellinikou 2 |
| 167 77 Elliniko |
| Greece |

BOEHRINGER INGELHEIM HELLAS S.A.

Ellinikou 2

167 77 Elliniko

Greece

MESULID

100 MG/SACHET

Granules for oral solution

Oral use

EL - Greece

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia 14564

Greece

DISCORID

100 MG/TAB

Tablet

Oral use

EL - Greece

| COUP ABEE |
| --- |
| Agias Varvaras 53-55 |
| Dafni, Athens 17235 |
| Greece |

COUP ABEE

Agias Varvaras 53-55

Dafni, Athens 17235

Greece

MELICAT

100 MG/TAB

Tablet

Oral use

EL - Greece

| DEMO ABEE |
| --- |
| 21ST Km National Highway Athens-Lamia 14565 |
| Greece |

DEMO ABEE

21ST Km National Highway Athens-Lamia 14565

Greece

RITAMINE

100 MG/TAB

Tablet

Oral use

EL - Greece

| ELPEN A.E. PHARMACEUTICAL INDUSTRY, |
| --- |
| Marathonos Avenue 95 |
| Pikermi 19009 |
| Greece |

ELPEN A.E. PHARMACEUTICAL INDUSTRY,

Marathonos Avenue 95

Pikermi 19009

Greece

ROLAKET

100 MG/TAB

Tablet

Oral use

EL - Greece

| ELPEN A.E. PHARMACEUTICAL INDUSTRY, |
| --- |
| Marathonos Avenue 95 |
| Pikermi 19009 |
| Greece |

ELPEN A.E. PHARMACEUTICAL INDUSTRY,

Marathonos Avenue 95

Pikermi 19009

Greece

ROLAKET

200 MG/SUPP

Suppository

Rectal use

EL - Greece

| EVAGGELOS KALOFOLIAS & SIA O.E. |
| --- |
| Menandrou 54 |
| Athens 10431 |
| Greece |

EVAGGELOS KALOFOLIAS & SIA O.E.

Menandrou 54

Athens 10431

Greece

ALGOVER

100 MG/TAB

Tablet

Oral use

EL - Greece

| FARMANIC CHEMIPHARMA S.A. |
| --- |
| Fylis 137 |
| Kamatero Attikis 13451 |
| Greece |

FARMANIC CHEMIPHARMA S.A.

Fylis 137

Kamatero Attikis 13451

Greece

CHEMISULIDE

100 MG/TAB

Tablet

Oral use

EL - Greece

| FARMEDIA A.E. |
| --- |
| Athinas 22 & Apollonos |
| Gerakas Attikis 15344 |
| Greece |

FARMEDIA A.E.

Athinas 22 & Apollonos

Gerakas Attikis 15344

Greece

MULTIFORMIL

100 MG/TAB

Tablet

Oral use

EL - Greece

| FARMILIA E.E. |
| --- |
| Favierou 48 |
| Athens 10438 |
| Greece |

FARMILIA E.E.

Favierou 48

Athens 10438

Greece

AUROMELID

100 MG/TAB

Tablet

Oral use

EL - Greece

| FINIXFARM EPE |
| --- |
| Dervenakion 38 & Sahini |
| Gerakas 15344 |
| Greece |

FINIXFARM EPE

Dervenakion 38 & Sahini

Gerakas 15344

Greece

KARTAL

100 MG/TAB

Tablet

Oral use

EL - Greece

| GENEPHARM A.E. |
| --- |
| 18th Km Marathonos Avenue |
| Pallini Attikis 15351 |
| Greece |

GENEPHARM A.E.

18th Km Marathonos Avenue

Pallini Attikis 15351

Greece

NIMELIDE

100 MG/TAB

Tablet

Oral use

EL - Greece

| HELP ABEE |
| --- |
| Valaoritou 10 |
| Metamorfosi Attikis 14452 |
| Greece |

HELP ABEE

Valaoritou 10

Metamorfosi Attikis 14452

Greece

MOSUOLIT

100 MG/TAB

Tablet

Oral use

EL - Greece

| INTERMED ABEE |
| --- |
| Kalyftaki 27 |
| Athens 14564 |
| Greece |

INTERMED ABEE

Kalyftaki 27

Athens 14564

Greece

DOLOSTOP

100 MG/TAB

Tablet

Oral use

EL - Greece

| INTERMED ABEE |
| --- |
| Kalyftaki 27 |
| Athens 14564 |
| Greece |

INTERMED ABEE

Kalyftaki 27

Athens 14564

Greece

DOLOSTOP

100 MG/TAB

Effervescent tablet

Oral use

EL - Greece

| INTERMED ABEE |
| --- |
| Kalyftaki 27 |
| Athens 14564 |
| Greece |

INTERMED ABEE

Kalyftaki 27

Athens 14564

Greece

DOLOSTOP

100 MG/SACHET

Granules for oral solution

Oral use

EL - Greece

| INTERMED ABEE |
| --- |
| Kalyftaki 27 |
| Athens 14564 |
| Greece |

INTERMED ABEE

Kalyftaki 27

Athens 14564

Greece

DOLOSTOP

200 MG/SUPP

Suppository

Rectal use

EL - Greece

| KLEVA EPE |
| --- |
| Parnithos Avenue 189 |
| Aharnai Attikis 13671 |
| Greece |

KLEVA EPE

Parnithos Avenue 189

Aharnai Attikis 13671

Greece

ELINAP

100 MG/TAB

Tablet

Oral use

EL - Greece

| LAVIPHARM HELLAS A.E. |
| --- |
| Agias Marinas |
| Paiania Attikis 19002 |
| Greece |

LAVIPHARM HELLAS A.E.

Agias Marinas

Paiania Attikis 19002

Greece

AULIN

100 MG/TAB

Tablet

Oral use

EL - Greece

| LEOVAN, M. LEWN & SIA EE |
| --- |
| Argonafton 22 |
| Argyroupoli 16452 |
| Greece |

LEOVAN, M. LEWN & SIA EE

Argonafton 22

Argyroupoli 16452

Greece

RISTOLZIT

100 MG/TAB

Tablet

Oral use

EL - Greece

| MEDARTE PHARMACEUTICLS ABEE |
| --- |
| Spyrou Vretou 10 |
| Metamorfosi 14452 |
| Greece |

MEDARTE PHARMACEUTICLS ABEE

Spyrou Vretou 10

Metamorfosi 14452

Greece

MESILEX

100 MG/TAB

Tablet

Oral use

EL - Greece

| MEDICHROM A.E. |
| --- |
| 6 Km Markopoulou-Koropi Avenue |
| Markopoulo Mesogeion 19003 |
| Greece |

MEDICHROM A.E.

6 Km Markopoulou-Koropi Avenue

Markopoulo Mesogeion 19003

Greece

NIMESUL

100 MG/TAB

Tablet

Oral use

EL - Greece

| MED-ONE S.A., HELLAS |
| --- |
| Parnithos Avenue 211 |
| Aharnai 13671 |
| Greece |

MED-ONE S.A., HELLAS

Parnithos Avenue 211

Aharnai 13671

Greece

ALGOSULID

100 MG/TAB

Tablet

Oral use

EL - Greece

| MINERVA PHARMAKEFTIKI A.E. |
| --- |
| Kifissou Avenue 132 |
| Peristeri 12131 |
| Greece |

MINERVA PHARMAKEFTIKI A.E.

Kifissou Avenue 132

Peristeri 12131

Greece

MIN-A-PON

100 MG/TAB

Tablet

Oral use

EL - Greece

| NORMA HELLAS A.E. |
| --- |
| Menandrou 54 |
| Athens 10431 |
| Greece |

NORMA HELLAS A.E.

Menandrou 54

Athens 10431

Greece

MYXINA

100 MG/TAB

Tablet

Oral use

EL - Greece

| PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS |
| --- |
| Dilou 9 |
| Peristeri Attikis 12134 |
| Greece |

PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS

Dilou 9

Peristeri Attikis 12134

Greece

FLADALGIN

100 MG/TAB

Tablet

Oral use

EL - Greece

| PHARMACYPRIA HELLAS A.E. |
| --- |
| Paster 6 |
| Ampelokipoi 11521 |
| Greece |

PHARMACYPRIA HELLAS A.E.

Paster 6

Ampelokipoi 11521

Greece

LALIDE

100 MG/TAB

Tablet

Oral use

EL - Greece

| PHARMACYPRIA HELLAS A.E. |
| --- |
| Paster 6 |
| Ampelokipoi 11521 |
| Greece |

PHARMACYPRIA HELLAS A.E.

Paster 6

Ampelokipoi 11521

Greece

LALIDE

50 MG/5ML

Oral suspension

Oral use

EL - Greece

| PHARMATHEN INTERNATIONAL S.A. GREECE, |
| --- |
| Dervenakion 4 |
| Pallini Attikis 15351 |
| Greece |

PHARMATHEN INTERNATIONAL S.A. GREECE,

Dervenakion 4

Pallini Attikis 15351

Greece

BIOXIDOL

100 MG/TAB

Tablet

Oral use

EL - Greece

| RAFARM AEBE |
| --- |
| Korintou 12 |
| N. Psychiko 15451 |
| Greece |

RAFARM AEBE

Korintou 12

N. Psychiko 15451

Greece

VENTOR

100 MG/TAB

Tablet

Oral use

EL - Greece

| RAFARM AEBE |
| --- |
| Korintou 12 |
| N. Psychiko 15451 |
| Greece |

RAFARM AEBE

Korintou 12

N. Psychiko 15451

Greece

VENTOR

100 MG/SACHET

Granules for oral solution

Oral use

EL - Greece

| REMEDINA ABEE |
| --- |
| Gounari 25 & Areos |
| Kamatero Attikis 13451 |
| Greece |

REMEDINA ABEE

Gounari 25 & Areos

Kamatero Attikis 13451

Greece

AMOCETIN

100 MG/TAB

Tablet

Oral use

EL - Greece

| REMEK PHARMACEUTICALS ABEE |
| --- |
| Pentelis 34 |
| Palaio Faliro Attikis 17564 |
| Greece |

REMEK PHARMACEUTICALS ABEE

Pentelis 34

Palaio Faliro Attikis 17564

Greece

MESUPON

100 MG/TAB

Tablet

Oral use

EL - Greece

| S.J.A. PHARM O.E. |
| --- |
| Arkoleon 11 |
| Kato Patissia 10445 |
| Greece |

S.J.A. PHARM O.E.

Arkoleon 11

Kato Patissia 10445

Greece

CLIOVYL

100 MG/TAB

Tablet

Oral use

EL - Greece

| VELKA HELLAS AEBE |
| --- |
| Kapodistriou & Korinthou 12 |
| Neo Psychiko 15451 |
| Greece |

VELKA HELLAS AEBE

Kapodistriou & Korinthou 12

Neo Psychiko 15451

Greece

NAOFID

100 MG/TAB

Tablet

Oral use

EL - Greece

| VIOFAR EPE |
| --- |
| Ethnikis Antistaseos & Trifyllias |
| Aharnai 13671 |
| Greece |

VIOFAR EPE

Ethnikis Antistaseos & Trifyllias

Aharnai 13671

Greece

VOLONTEN

100 MG/TAB

Tablet

Oral use

EL - Greece

| VOCATE PHARMAKEFTIKI A.E. |
| --- |
| Gounari 150 |
| Glyfada 16674 |
| Greece |

VOCATE PHARMAKEFTIKI A.E.

Gounari 150

Glyfada 16674

Greece

TRANZICALM

100 MG/TAB

Tablet

Oral use

ES - Spain

| HELSINN BIREX PHARMACEUTICALS LTD. |
| --- |
| Damastown Mulhuddart |
| County Dublin 15 |
| Ireland |

HELSINN BIREX PHARMACEUTICALS LTD.

Damastown Mulhuddart

County Dublin 15

Ireland

GUAXAN 100 mg comprimidos

100 mg

Tablet

Oral use

FR - France

| CLL PHARMA |
| --- |
| Nice Premier - Arenas |
| 455, promenade des Anglais |
| 06299 NICE Cedex 03 |
| France |

CLL PHARMA

Nice Premier - Arenas

455, promenade des Anglais

06299 NICE Cedex 03

France

NIMESULIDE CEHEL PHARMA

100 mg

Tablet

Oral use

FR - France

| EG LABO - Laboratoires EuroGenerics |
| --- |
| "Le Quintet" - Bâtiment A |
| 12, rue Danjou |
| 92517 BOULOGNE BILLANCOURT Cedex |
| France |

EG LABO - Laboratoires EuroGenerics

"Le Quintet" - Bâtiment A

12, rue Danjou

92517 BOULOGNE BILLANCOURT Cedex

France

NIMESULIDE EG

100 mg

Tablet

Oral use

FR - France

| HELSINN BIREX PHARMACEUTICALS Ltd |
| --- |
| Damastown Mulhuddart |
| Dublin 15 |
| Ireland |

HELSINN BIREX PHARMACEUTICALS Ltd

Damastown Mulhuddart

Dublin 15

Ireland

OXETIAN

100 mg

Tablet

Oral use

FR - France

| HELSINN BIREX PHARMACEUTICALS Ltd |
| --- |
| Damastown Mulhuddart |
| Dublin 15 |
| Ireland |

HELSINN BIREX PHARMACEUTICALS Ltd

Damastown Mulhuddart

Dublin 15

Ireland

OXETIAN

100 mg

Granules for oral solution in sachet

Oral use

FR - France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 PARIS LA DEFENSE Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 PARIS LA DEFENSE Cedex

France

NIMESULIDE TEVA

100 mg

Tablet

Oral use

FR - France

| THERABEL LUCIEN PHARMA |
| --- |
| 19 rue Alphonse de Neuville |
| 75017 PARIS |
| France |

THERABEL LUCIEN PHARMA

19 rue Alphonse de Neuville

75017 PARIS

France

NEXEN

100 mg

Tablet

Oral use

FR - France

| THERABEL LUCIEN PHARMA |
| --- |
| 19 rue Alphonse de Neuville |
| 75017 PARIS |
| France |

THERABEL LUCIEN PHARMA

19 rue Alphonse de Neuville

75017 PARIS

France

NEXEN

100 mg

Granules for oral solution in sachet

Oral use

HU - Hungary

| Eurodrug Lab. BV |
| --- |
| Laan Copes van Cattenbruch 74. |
| 2585 GD, The Hague, |
| The Netherlands |

Eurodrug Lab. BV

Laan Copes van Cattenbruch 74.

2585 GD, The Hague,

The Netherlands

Nidol

100mg

Tablet

Oral use

HU - Hungary

| Lab. Guidotti S.p.A. |
| --- |
| Via Livornese 897 |
| 56010 San Piero a Grado, PISA |
| Italy |

Lab. Guidotti S.p.A.

Via Livornese 897

56010 San Piero a Grado, PISA

Italy

Xilox

50 mg/g

Granules for oral suspension

Oral use

HU - Hungary

| PannonPharma Kft. |
| --- |
| Pannonpharma út 1. |
| 7720, Pécsvárad |
| Hungary |

PannonPharma Kft.

Pannonpharma út 1.

7720, Pécsvárad

Hungary

Nimelid

100 mg

Tablet

Oral use

HU - Hungary

| sanofi-aventis zrt. |
| --- |
| Tó u. 1-5. |
| 1045 Budapest |
| Hungary |

sanofi-aventis zrt.

Tó u. 1-5.

1045 Budapest

Hungary

Mesulid

100 mg

Tablet

Oral use

HU - Hungary

| sanofi-aventis zrt. |
| --- |
| Tó u. 1-5. |
| 1045 Budapest |
| Hungary |

sanofi-aventis zrt.

Tó u. 1-5.

1045 Budapest

Hungary

Mesulid

50 mg/g

Granules

Oral use

IT - Italy

| Actavis Group PTC EHF |
| --- |
| Reykjavikurvegi 76-78 |
| Hafnarf Joerdur |
| Iceland |

Actavis Group PTC EHF

Reykjavikurvegi 76-78

Hafnarf Joerdur

Iceland

NIMESULIDE ACTAVIS

100 mg

Granules

Oral use

IT - Italy

| Actavis Group PTC EHF |
| --- |
| Reykjavikurvegi 76-78 |
| Hafnarf Joerdur |
| Iceland |

Actavis Group PTC EHF

Reykjavikurvegi 76-78

Hafnarf Joerdur

Iceland

NIMESULIDE ACTAVIS

100 mg

Tablet

Oral use

IT - Italy

| Aesculapius Farmaceutici Srl |
| --- |
| Via Cozzaglio, 24 |
| 25125 Brescia |
| Italy |

Aesculapius Farmaceutici Srl

Via Cozzaglio, 24

25125 Brescia

Italy

EFRIDOL

100 mg

Tablet

Oral use

IT - Italy

| Aesculapius Farmaceutici Srl |
| --- |
| Via Cozzaglio, 24 |
| 25125 Brescia |
| Italy |

Aesculapius Farmaceutici Srl

Via Cozzaglio, 24

25125 Brescia

Italy

EFRIDOL

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Agips Farmaceutici Srl |
| --- |
| Via Amendola, 4 |
| 16035 Rapallo (GE) |
| Italy |

Agips Farmaceutici Srl

Via Amendola, 4

16035 Rapallo (GE)

Italy

DELFOS

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Agips Farmaceutici Srl |
| --- |
| Via Amendola, 4 |
| 16035 Rapallo (GE) |
| Italy |

Agips Farmaceutici Srl

Via Amendola, 4

16035 Rapallo (GE)

Italy

DELFOS

100 mg

Tablet

Oral use

IT - Italy

| Almus Srl |
| --- |
| Via Cesarea, 11/10 |
| 16121 Genova |
| Italy |

Almus Srl

Via Cesarea, 11/10

16121 Genova

Italy

NIMESULIDE ALMUS

100 mg

Tablet

Oral use

IT - Italy

| Almus Srl |
| --- |
| Via Cesarea, 11/10 |
| 16121 Genova |
| Italy |

Almus Srl

Via Cesarea, 11/10

16121 Genova

Italy

NIMESULIDE ALMUS

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Angenerico Spa |
| --- |
| Via Nocera Umbra, 75 |
| 00181 Roma |
| Italy |

Angenerico Spa

Via Nocera Umbra, 75

00181 Roma

Italy

NIMESULIDE ANGENERICO

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Angenerico Spa |
| --- |
| Via Nocera Umbra, 75 |
| 00181 Roma |
| Italy |

Angenerico Spa

Via Nocera Umbra, 75

00181 Roma

Italy

NIMESULIDE ANGENERICO

200 mg

Suppository

Rectal use

IT - Italy

| Aurobindo Pharma Italia Srl |
| --- |
| Vicolo San Giovanni sul Muro, 9 |
| 20121 Milano |
| Italy |

Aurobindo Pharma Italia Srl

Vicolo San Giovanni sul Muro, 9

20121 Milano

Italy

ORONIME

100 mg

Orodispersible tablet

Oral use

IT - Italy

| C.T.Laboratorio Farmaceutico Srl |
| --- |
| Villa Sayonara - Strada Solaro, 75/77 |
| 18038 Sanremo (IM) |
| Italy |

C.T.Laboratorio Farmaceutico Srl

Villa Sayonara - Strada Solaro, 75/77

18038 Sanremo (IM)

Italy

FLOLID

100 mg

Tablet

Oral use

IT - Italy

| C.T.Laboratorio Farmaceutico Srl |
| --- |
| Villa Sayonara - Strada Solaro, 75/77 |
| 18038 Sanremo (IM) |
| Italy |

C.T.Laboratorio Farmaceutico Srl

Villa Sayonara - Strada Solaro, 75/77

18038 Sanremo (IM)

Italy

FLOLID

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Doc Generici Srl |
| --- |
| Via Manuzio, 7 |
| 20124 Milano |
| Italy |

Doc Generici Srl

Via Manuzio, 7

20124 Milano

Italy

NIMESULIDE DOC GENERICI

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Doc Generici Srl |
| --- |
| Via Manuzio, 7 |
| 20124 Milano |
| Italy |

Doc Generici Srl

Via Manuzio, 7

20124 Milano

Italy

NIMESULIDE DOC GENERICI

100 mg

Tablet

Oral use

IT - Italy

| Dorom Srl |
| --- |
| Via Messina, 38 |
| 20154 Milano |
| Italy |

Dorom Srl

Via Messina, 38

20154 Milano

Italy

NIMESULIDE DOROM

100 mg

Powder for oral solution

Oral use

IT - Italy

| Dr Reddy's Srl |
| --- |
| Via Fernanda Wittengs, 3 |
| 20123 Milano |
| Italy |

Dr Reddy's Srl

Via Fernanda Wittengs, 3

20123 Milano

Italy

NIMESULIDE DR REDDY'S

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Ecobi Farmaceutici sas |
| --- |
| Via E. Bazzano, 26 |
| 16019 Ronco Scrivia (GE) |
| Italy |

Ecobi Farmaceutici sas

Via E. Bazzano, 26

16019 Ronco Scrivia (GE)

Italy

AREUMA

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Ecobi Farmaceutici sas |
| --- |
| Via E. Bazzano, 26 |
| 16019 Ronco Scrivia (GE) |
| Italy |

Ecobi Farmaceutici sas

Via E. Bazzano, 26

16019 Ronco Scrivia (GE)

Italy

AREUMA

100 mg

Tablet

Oral use

IT - Italy

| Ecobi Farmaceutici sas |
| --- |
| Via E. Bazzano, 26 |
| 16019 Ronco Scrivia (GE) |
| Italy |

Ecobi Farmaceutici sas

Via E. Bazzano, 26

16019 Ronco Scrivia (GE)

Italy

AREUMA

200 mg

Suppository

Rectal use

IT - Italy

| Eg S.p.A. |
| --- |
| Via Domenico Scarlatti, 31 |
| 20124 Milano |
| Italy |

Eg S.p.A.

Via Domenico Scarlatti, 31

20124 Milano

Italy

NIMESULIDE EG

100 mg

Tablet

Oral use

IT - Italy

| Eg S.p.A. |
| --- |
| Via Domenico Scarlatti, 31 |
| 20124 Milano |
| Italy |

Eg S.p.A.

Via Domenico Scarlatti, 31

20124 Milano

Italy

NIMESULIDE EG

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Farmac.Caber Spa |
| --- |
| Viale Città D'Europa, 681 |
| 00144 Roma |
| Italy |

Farmac.Caber Spa

Viale Città D'Europa, 681

00144 Roma

Italy

NIMS

100 mg

Granules

Oral use

IT - Italy

| Farmac.Damor Spa |
| --- |
| Via Emilio Scaglione, 27 |
| 80145 Napoli |
| Italy |

Farmac.Damor Spa

Via Emilio Scaglione, 27

80145 Napoli

Italy

SULIDAMOR

100 mg

Powder for oral suspension

Oral use

IT - Italy

| Farmac.Damor Spa |
| --- |
| Via Emilio Scaglione, 27 |
| 80145 Napoli |
| Italy |

Farmac.Damor Spa

Via Emilio Scaglione, 27

80145 Napoli

Italy

SULIDAMOR

100 mg

Tablet

Oral use

IT - Italy

| Benedetti & Co spa |
| --- |
| Via Bolognese, 250 |
| 51020 Pistoia |
| Italy |

Benedetti & Co spa

Via Bolognese, 250

51020 Pistoia

Italy

NIMESULIDE Benedetti & Co

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Francia Farmac.Ind.Far.Bio.Srl |
| --- |
| Via dei Pestagalli, 7 |
| 20138 Milano |
| Italy |

Francia Farmac.Ind.Far.Bio.Srl

Via dei Pestagalli, 7

20138 Milano

Italy

ALGIMESIL

100 mg

Tablet

Oral use

IT - Italy

| Francia Farmac.Ind.Far.Bio.Srl |
| --- |
| Via dei Pestagalli, 7 |
| 20138 Milano |
| Italy |

Francia Farmac.Ind.Far.Bio.Srl

Via dei Pestagalli, 7

20138 Milano

Italy

ALGIMESIL

100 mg

Granules

Oral use

IT - Italy

| Germed Pharma Spa |
| --- |
| Via Cesare Cantù, 11 |
| 20092 Cinisello Balsamo (Milano) |
| Italy |

Germed Pharma Spa

Via Cesare Cantù, 11

20092 Cinisello Balsamo (Milano)

Italy

NIMESULIDE GERMED

100 mg

Tablet

Oral use

IT - Italy

| Germed Pharma Spa |
| --- |
| Via Cesare Cantù, 11 |
| 20092 Cinisello Balsamo (Milano) |
| Italy |

Germed Pharma Spa

Via Cesare Cantù, 11

20092 Cinisello Balsamo (Milano)

Italy

NIMESULIDE GERMED

100 mg

Granules

Oral use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

AULIN

100 mg

Tablet

Oral use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

AULIN

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

AULIN

200 mg

Suppository

Rectal use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

MESULID FAST

400 mg

Granules

Oral use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

MESULID

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

MESULID

100 mg

Tablet

Oral use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

MESULID

200 mg

Suppository

Rectal use

IT - Italy

| Hexal Spa |
| --- |
| Largo Boccioni 1 |
| 21040 Origgio Varese |
| Italy |

Hexal Spa

Largo Boccioni 1

21040 Origgio Varese

Italy

NIMESULIDE HEXAL

100 mg

Tablet

Oral use

IT - Italy

| I.B.N. Savio Srl |
| --- |
| Via E. Bazzano, 14 |
| 16019 Ronco Scrivia (GE) |
| Italy |

I.B.N. Savio Srl

Via E. Bazzano, 14

16019 Ronco Scrivia (GE)

Italy

EUDOLENE

100 mg

Granules

Oral use

IT - Italy

| Italfarmaco S.p.A. |
| --- |
| Viale Fulvio Testi, 330 |
| 20126 Milano |
| Italy |

Italfarmaco S.p.A.

Viale Fulvio Testi, 330

20126 Milano

Italy

NIMEDEX

400 mg

Granules for oral suspension

Oral use

IT - Italy

| Italfarmaco S.p.A. |
| --- |
| Viale Fulvio Testi, 330 |
| 20126 Milano |
| Italy |

Italfarmaco S.p.A.

Viale Fulvio Testi, 330

20126 Milano

Italy

NIMEDEX

400 mg

Tablet

Oral use

IT - Italy

| Lab.Guidotti Spa |
| --- |
| Via Livornese, 897 |
| 56010 La Vettola - Pisa |
| Italy |

Lab.Guidotti Spa

Via Livornese, 897

56010 La Vettola - Pisa

Italy

NIMESULENE

200 mg

Suppository

Rectal use

IT - Italy

| Lab.Guidotti Spa |
| --- |
| Via Livornese, 897 |
| 56010 La Vettola - Pisa |
| Italy |

Lab.Guidotti Spa

Via Livornese, 897

56010 La Vettola - Pisa

Italy

NIMESULENE

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Lab.Guidotti Spa |
| --- |
| Via Livornese, 897 |
| 56010 La Vettola - Pisa |
| Italy |

Lab.Guidotti Spa

Via Livornese, 897

56010 La Vettola - Pisa

Italy

NIMESULENE

100 mg

Tablet

Oral use

IT - Italy

| Laboratori Alter Srl |
| --- |
| Via Egadi, 7 |
| 20144 Milano |
| Italy |

Laboratori Alter Srl

Via Egadi, 7

20144 Milano

Italy

NIMESULIDE ALTER

100 mg

Granules

Oral use

IT - Italy

| Crinos spa |
| --- |
| Via Pavia, 6 |
| 20136 Milano |
| Italy |

Crinos spa

Via Pavia, 6

20136 Milano

Italy

LEDOREN

100 mg

Tablet

Oral use

IT - Italy

| Crinos spa |
| --- |
| Via Pavia, 6 |
| 20136 Milano |
| Italy |

Crinos spa

Via Pavia, 6

20136 Milano

Italy

LEDOREN

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Levofarma Srl |
| --- |
| Via Conforti, 42 |
| 84083 Castel San Giorgio (Salerno) |
| Italy |

Levofarma Srl

Via Conforti, 42

84083 Castel San Giorgio (Salerno)

Italy

NOALGOS

100 mg

Granules

Oral use

IT - Italy

| Magis Farmaceutici Spa |
| --- |
| Via Cacciamali, 34-36-38/B |
| 25125 Brescia |
| Italy |

Magis Farmaceutici Spa

Via Cacciamali, 34-36-38/B

25125 Brescia

Italy

ISODOL

100 mg

Tablet

Oral use

IT - Italy

| Magis Farmaceutici Spa |
| --- |
| Via Cacciamali, 34-36-38/B |
| 25125 Brescia |
| Italy |

Magis Farmaceutici Spa

Via Cacciamali, 34-36-38/B

25125 Brescia

Italy

ISODOL

100 mg

Granules for oral suspension

Oral use

IT - Italy

| MDM Spa |
| --- |
| Viale Papiniano, 22/B |
| 20100 Milano |
| Italy |

MDM Spa

Viale Papiniano, 22/B

20100 Milano

Italy

SOLVING

100 mg

Granules for oral suspension

Oral use

IT - Italy

| MDM Spa |
| --- |
| Viale Papiniano, 22/B |
| 20100 Milano |
| Italy |

MDM Spa

Viale Papiniano, 22/B

20100 Milano

Italy

SOLVING

100 mg

Tablet

Oral use

IT - Italy

| Hexal AG |
| --- |
| Industriestrasse, 25 |
| D-83607 Holzkirchen – |
| Germany |

Hexal AG

Industriestrasse, 25

D-83607 Holzkirchen –

Germany

NIMESULIDE HEXAL AG

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Hexal AG |
| --- |
| Industriestrasse, 25 |
| D-83607 Holzkirchen – |
| Germany |

Hexal AG

Industriestrasse, 25

D-83607 Holzkirchen –

Germany

NIMESULIDE HEXAL AG

100 mg

Tablet

Oral use

IT - Italy

| Mylan Spa |
| --- |
| Via Vittor Pisani, 20 |
| 20124 Milano |
| Italy |

Mylan Spa

Via Vittor Pisani, 20

20124 Milano

Italy

NIMESULIDE MYLAN GENERICS

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Mylan Spa |
| --- |
| Via Vittor Pisani, 20 |
| 20124 Milano |
| Italy |

Mylan Spa

Via Vittor Pisani, 20

20124 Milano

Italy

NIMESULIDE MYLAN GENERICS

100 mg

Tablet

Oral use

IT - Italy

| New Research Srl |
| --- |
| Via della Tenuta di Torrenova, 142 |
| 00133 Roma |
| Italy |

New Research Srl

Via della Tenuta di Torrenova, 142

00133 Roma

Italy

NERELID

100 mg

Capsule

Oral use

IT - Italy

| New Research Srl |
| --- |
| Via della Tenuta di Torrenova, 142 |
| 00133 Roma |
| Italy |

New Research Srl

Via della Tenuta di Torrenova, 142

00133 Roma

Italy

NERELID

100 mg

Granules

Oral use

IT - Italy

| Pantafarm Srl |
| --- |
| Via Palestro, 14 |
| 00185 Roma |
| Italy |

Pantafarm Srl

Via Palestro, 14

00185 Roma

Italy

PANTAMES

100 mg

Orodispersible tablet

Oral use

IT - Italy

| Pensa Pharma Spa |
| --- |
| Via Rosellini Ippolito, 12 |
| 20124 Milano |
| Italy |

Pensa Pharma Spa

Via Rosellini Ippolito, 12

20124 Milano

Italy

NIMESULIDE PENSA

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Pensa Pharma Spa |
| --- |
| Via Rosellini Ippolito, 12 |
| 20124 Milano |
| Italy |

Pensa Pharma Spa

Via Rosellini Ippolito, 12

20124 Milano

Italy

NIMESULIDE PENSA

100 mg

Tablet

Oral use

IT - Italy

| Ranbaxy Italia Spa |
| --- |
| Piazza Filippo Meda, 3 |
| 20121 Milano |
| Italy |

Ranbaxy Italia Spa

Piazza Filippo Meda, 3

20121 Milano

Italy

NIMESULIDE RANBAXY

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Ratiopharm GmbH |
| --- |
| Graf-Arcostrasse, 2 |
| ULM D-89070 |
| Germany |

Ratiopharm GmbH

Graf-Arcostrasse, 2

ULM D-89070

Germany

NIMESULIDE RATIOPHARM

100 mg

Tablet

Oral use

IT - Italy

| Ratiopharm GmbH |
| --- |
| Graf-Arcostrasse, 2 |
| ULM D-89070 |
| Germany |

Ratiopharm GmbH

Graf-Arcostrasse, 2

ULM D-89070

Germany

NIMESULIDE RATIOPHARM

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Ratiopharm GmbH |
| --- |
| Graf-Arcostrasse, 2 |
| ULM D-89070 |
| Germany |

Ratiopharm GmbH

Graf-Arcostrasse, 2

ULM D-89070

Germany

NIMESULIDE RATIOPHARM

100 mg

Effervescent tablet

Oral use

IT - Italy

| Sandoz Spa |
| --- |
| Largo U. Boccioni, 1 |
| 21040 Origgio (VA) |
| Italy |

Sandoz Spa

Largo U. Boccioni, 1

21040 Origgio (VA)

Italy

NIMESULIDE SANDOZ

100 mg

Capsule

Oral use

IT - Italy

| Sandoz Spa |
| --- |
| Largo U. Boccioni, 1 |
| 21040 Origgio (VA) |
| Italy |

Sandoz Spa

Largo U. Boccioni, 1

21040 Origgio (VA)

Italy

NIMESULIDE SANDOZ

100 mg

Granules

Oral use

IT - Italy

| Sarda Pharmaceutica Srl |
| --- |
| Via Castiglione, 92/B |
| 09100 Cagliari |
| Italy |

Sarda Pharmaceutica Srl

Via Castiglione, 92/B

09100 Cagliari

Italy

DIMESUL

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Selvi Laboratorio Bioterapico Spa |
| --- |
| Via Procoio, 28 |
| 0065 Fiano Romano (Roma) |
| Italy |

Selvi Laboratorio Bioterapico Spa

Via Procoio, 28

0065 Fiano Romano (Roma)

Italy

ANTALGO

100 mg

Granules

Oral use

IT - Italy

| SIAR Pharma Srl |
| --- |
| Via Verdi, 33 |
| 20060 Bussero (MI) |
| Italy |

SIAR Pharma Srl

Via Verdi, 33

20060 Bussero (MI)

Italy

ALGOLIDER

100 mg

Granules for oral suspension

Oral use

IT - Italy

| So.Se.Pharm Srl |
| --- |
| Via dei Castelli Romani, 22 |
| 00040 Pomezia (Roma) |
| Italy |

So.Se.Pharm Srl

Via dei Castelli Romani, 22

00040 Pomezia (Roma)

Italy

DOMES

100 mg

Granules for oral suspension

Oral use

IT - Italy

| So.Se.Pharm Srl |
| --- |
| Via dei Castelli Romani, 22 |
| 00040 Pomezia (Roma) |
| Italy |

So.Se.Pharm Srl

Via dei Castelli Romani, 22

00040 Pomezia (Roma)

Italy

DOMES

100 mg

Orodispersible tablet

Oral use

IT - Italy

| Sofar Spa |
| --- |
| Via Isonzo, 8 |
| 20100 Milano |
| Italy |

Sofar Spa

Via Isonzo, 8

20100 Milano

Italy

FANSULIDE

100 mg

Tablet

Oral use

IT - Italy

| Sofar Spa |
| --- |
| Via Isonzo, 8 |
| 20100 Milano |
| Italy |

Sofar Spa

Via Isonzo, 8

20100 Milano

Italy

FANSULIDE

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Teva Italia Srl |
| --- |
| Via Messina, 38 |
| 20154 Milano |
| Italy |

Teva Italia Srl

Via Messina, 38

20154 Milano

Italy

NIMESULIDE TEVA

100 mg

Tablet

Oral use

IT - Italy

| Teva Italia Srl |
| --- |
| Via Messina, 38 |
| 20154 Milano |
| Italy |

Teva Italia Srl

Via Messina, 38

20154 Milano

Italy

NIMESULIDE TEVA

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Union Health Srl |
| --- |
| Via Roccamandolfi, 1 |
| 00156 Roma |
| Italy |

Union Health Srl

Via Roccamandolfi, 1

00156 Roma

Italy

NIMESULIDE UNION HEALTH

100 mg

Tablet

Oral use

IT - Italy

| Union Health Srl |
| --- |
| Via Roccamandolfi, 1 |
| 00156 Roma |
| Italy |

Union Health Srl

Via Roccamandolfi, 1

00156 Roma

Italy

NIMESULIDE UNION HEALTH

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Piam Farmaceutici Spa |
| --- |
| Via Padre G. Semeria, 5 |
| 16131 Genova |
| Italy |

Piam Farmaceutici Spa

Via Padre G. Semeria, 5

16131 Genova

Italy

REMOV

100 mg

Tablet

Oral use

IT - Italy

| Piam Farmaceutici Spa |
| --- |
| Via Padre G. Semeria, 5 |
| 16131 Genova |
| Italy |

Piam Farmaceutici Spa

Via Padre G. Semeria, 5

16131 Genova

Italy

REMOV

100 mg

Granules

Oral use

LT - Lithuania

| Helsinn Birex Pharmaceuticals Ltd. |
| --- |
| Damastown Mulhuddart |
| Dublin 15 |
| Ireland |

Helsinn Birex Pharmaceuticals Ltd.

Damastown Mulhuddart

Dublin 15

Ireland

Mesulid

100 mg

Tablet

Oral use

LT - Lithuania

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 |
| Pisa-La Vettola |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897

Pisa-La Vettola

Italy

Nimesil

100 mg

Granules for oral suspension

Oral use

LT - Lithuania

| Medochemie Ltd. |
| --- |
| P.O. Box 51409 |
| Limassol, CY-3505 |
| Cyprus |

Medochemie Ltd.

P.O. Box 51409

Limassol, CY-3505

Cyprus

Apronil

100 mg

Tablet

Oral use

LT - Lithuania

| Zentiva k.s. |
| --- |
| U Kabelovny 130, |
| 102 37, Prague 10, |
| Dolni Mecholupy |
| Czech Republic |

Zentiva k.s.

U Kabelovny 130,

102 37, Prague 10,

Dolni Mecholupy

Czech Republic

Coxtral

100 mg

Tablet

Oral use

LV - Latvia

| Helsinn Birex Pharmaceutical Ltd. |
| --- |
| Damastown, Mulhuddart |
| Dublin-15 |
| Ireland |

Helsinn Birex Pharmaceutical Ltd.

Damastown, Mulhuddart

Dublin-15

Ireland

Mesulid 100 mg tabletes

100 mg

Tablet

Oral use

LV - Latvia

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese 897 – |
| 56010 Pisa – La Vettola |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese 897 –

56010 Pisa – La Vettola

Italy

Nimesil 100 mg granulas iekšķīgi lietojamās suspensijas pagatavošanai

100 mg

Granules for oral suspension

Oral use

LV - Latvia

| Medochemie Ltd. |
| --- |
| Constantinoupoleos Str. 1-10 |
| Limassol, CY–3011 |
| Cyprus |

Medochemie Ltd.

Constantinoupoleos Str. 1-10

Limassol, CY–3011

Cyprus

Aponil 100 mg tabletes

100 mg

Tablet

Oral use

LV - Latvia

| Zentiva k.s. |
| --- |
| U kabelovny 130 |
| Dolni Mecholupy |
| Praha 10, CZ-10237 |
| Czech Republic |

Zentiva k.s.

U kabelovny 130

Dolni Mecholupy

Praha 10, CZ-10237

Czech Republic

Coxtral 100 mg tabletes

100 mg

Tablet

Oral use

MT - Malta

| VECCHI & C. PIAM s.a.p.a. |
| --- |
| Via Padre G. Semeria, |
| 5 - 16131 Genova |
| Italy |

VECCHI & C. PIAM s.a.p.a.

Via Padre G. Semeria,

5 - 16131 Genova

Italy

Remov

100 mg

Tablet

Oral use

MT - Malta

| VECCHI & C. PIAM s.a.p.a. |
| --- |
| Via Padre G. Semeria, |
| 5 - 16131 Genova |
| Italy |

VECCHI & C. PIAM s.a.p.a.

Via Padre G. Semeria,

5 - 16131 Genova

Italy

Remov

100 mg/sachet

Granules for oral suspension

Oral use

PL - Poland

| Laboratori Guidotti S.p.A. (Menarini Group) |
| --- |
| Via Livornese 897 |
| I-56010, Piza |
| Italy |

Laboratori Guidotti S.p.A. (Menarini Group)

Via Livornese 897

I-56010, Piza

Italy

Nimesil

100 mg

Granules for oral suspension

Oral use

PL - Poland

| Medicom International s.r.o. |
| --- |
| Paterni 7 |
| 635 00, Brno |
| Czech Republic |

Medicom International s.r.o.

Paterni 7

635 00, Brno

Czech Republic

Aulin

100 mg

Granules for oral suspension

Oral use

PL - Poland

| Medicom International s.r.o. |
| --- |
| Paterni 7 |
| 635 00, Brno |
| Czech Republic |

Medicom International s.r.o.

Paterni 7

635 00, Brno

Czech Republic

Aulin

100 mg

Tablet

Oral use

PL - Poland

| Pabianickie Zakłady Farmaceutyczne Polfa S.A. |
| --- |
| Marszałka J. Piłsudskiego 5, |
| 95-200 Pabianice |
| Poland |

Pabianickie Zakłady Farmaceutyczne Polfa S.A.

Marszałka J. Piłsudskiego 5,

95-200 Pabianice

Poland

Minesulin

100 mg

Powder for oral suspension

Oral use

PL - Poland

| Pabianickie Zakłady Farmaceutyczne Polfa S.A. |
| --- |
| Marszałka J. Piłsudskiego 5, |
| 95-200 Pabianice |
| Poland |

Pabianickie Zakłady Farmaceutyczne Polfa S.A.

Marszałka J. Piłsudskiego 5,

95-200 Pabianice

Poland

Minesulin

100 mg

Tablet

Oral use

PL - Poland

| Zentiva a.s. |
| --- |
| U Kabelovny 130 |
| 102 37 Praha 10 |
| Czech Republic |

Zentiva a.s.

U Kabelovny 130

102 37 Praha 10

Czech Republic

Coxtral

100 mg

Tablet

Oral use

PT - Portugal

| Alter, S.A. |
| --- |
| Estrada Marco do Grilo - Zemouto |
| 2830-000 Coina |
| Portugal |

Alter, S.A.

Estrada Marco do Grilo - Zemouto

2830-000 Coina

Portugal

Nimesulida Alter

100 mg

Tablet

Oral use

PT - Portugal

| Angelini Farmacêutica, Lda. |
| --- |
| Rua João Chagas, 53 - 3o |
| 1499-040 Cruz Quebrada – Dafundo |
| Portugal |

Angelini Farmacêutica, Lda.

Rua João Chagas, 53 - 3o

1499-040 Cruz Quebrada – Dafundo

Portugal

Aulin

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Angelini Farmacêutica, Lda. |
| --- |
| Rua João Chagas, 53 - 3o |
| 1499-040 Cruz Quebrada – Dafundo |
| Portugal |

Angelini Farmacêutica, Lda.

Rua João Chagas, 53 - 3o

1499-040 Cruz Quebrada – Dafundo

Portugal

Aulin

100 mg

Tablet

Oral use

PT - Portugal

| Arrowblue Produtos Farmacêuticos S.A. |
| --- |
| Av. D. João II, |
| 10 Esqo - Torre Fernão de Magalhães |
| 1998-025 Lisboa |
| Portugal |

Arrowblue Produtos Farmacêuticos S.A.

Av. D. João II,

10 Esqo - Torre Fernão de Magalhães

1998-025 Lisboa

Portugal

Nimesulida Arrowblue

100 mg

Tablet

Oral use

PT - Portugal

| Baldacci - Portugal, S.A. |
| --- |
| Rua Cândido de Figueiredo, 84-B |
| 1549-005 Lisboa |
| Portugal |

Baldacci - Portugal, S.A.

Rua Cândido de Figueiredo, 84-B

1549-005 Lisboa

Portugal

Nimesulida Baldacci

100 mg

Tablet

Oral use

PT - Portugal

| Bluepharma Genéricos - Comércio de Medicamentos, S.A. |
| --- |
| São Martinho do Bispo |
| 3045-016 Coimbra |
| Portugal |

Bluepharma Genéricos - Comércio de Medicamentos, S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

Nimesulida Bluepharma

100 mg

Tablet

Oral use

PT - Portugal

| Ciclum Farma Unipessoal, Lda. Quinta da Fonte, |
| --- |
| Rua Vitor Câmara, 2 – |
| Edifício D. Amélia, Piso 1, Ala B |
| 2770-229 Paço de Arcos |
| Portugal |

Ciclum Farma Unipessoal, Lda. Quinta da Fonte,

Rua Vitor Câmara, 2 –

Edifício D. Amélia, Piso 1, Ala B

2770-229 Paço de Arcos

Portugal

Nimesulida Ciclum

100 mg

Tablet

Oral use

PT - Portugal

| Cinfa Portugal, Lda. |
| --- |
| Av. Tomás Ribeiro, 43 - Bloco 1, 4o B – |
| Edifício Neopark |
| 2790-221 Carnaxide |
| Portugal |

Cinfa Portugal, Lda.

Av. Tomás Ribeiro, 43 - Bloco 1, 4o B –

Edifício Neopark

2790-221 Carnaxide

Portugal

Nimesulida Cinfa

100 mg

Tablet

Oral use

PT - Portugal

| Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, |
| --- |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2,

Abrunheira

2710-089 Sintra

Portugal

Nimesulida Farmoz

100 mg

Coated tablet

Oral use

PT - Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Rua João de Deus, 19 |
| 2700-487 Amadora |
| PORTUGAL |

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

PORTUGAL

Nimesulida Generis

100 mg

Tablet

Oral use

PT - Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Rua João de Deus, 19 |
| 2700-487 Amadora |
| PORTUGAL |

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

PORTUGAL

Nimesulida Generis

100 mg

Granules for oral solution

Oral use

PT - Portugal

| Germed Farmacêutica, Lda. |
| --- |
| Rua Alto do Montijo, 13 – 1o Dto – |
| Edifício Monsanto |
| 2790-012 Portela de Carnaxide |
| Portugal |

Germed Farmacêutica, Lda.

Rua Alto do Montijo, 13 – 1o Dto –

Edifício Monsanto

2790-012 Portela de Carnaxide

Portugal

Nimesulida Germed

100 mg

Tablet

Oral use

PT - Portugal

| Germed Farmacêutica, Lda. |
| --- |
| Rua Alto do Montijo, 13 – 1o Dto – |
| Edifício Monsanto |
| 2790-012 Portela de Carnaxide |
| Portugal |

Germed Farmacêutica, Lda.

Rua Alto do Montijo, 13 – 1o Dto –

Edifício Monsanto

2790-012 Portela de Carnaxide

Portugal

Nimesulida Germed

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| GP - genéricos portugueses, Lda. |
| --- |
| Rua Henrique Paiva Couceiro, 29 – |
| Venda Nova |
| 2700-451 Amadora |
| Portugal |

GP - genéricos portugueses, Lda.

Rua Henrique Paiva Couceiro, 29 –

Venda Nova

2700-451 Amadora

Portugal

Nimesulida GP

100 mg

Tablet

Oral use

PT - Portugal

| Jaba Recordati, S. A. |
| --- |
| Lagoas Park, Edificio 5, Torre C, |
| Piso 32 |
| 2740-298 Porto Salvo |
| Portugal |

Jaba Recordati, S. A.

Lagoas Park, Edificio 5, Torre C,

Piso 32

2740-298 Porto Salvo

Portugal

Nimesulida Jabasulide

100 mg

Tablet

Oral use

PT - Portugal

| Jaba Recordati, S. A. |
| --- |
| Lagoas Park, Edificio 5, Torre C, |
| Piso 32 |
| 2740-298 Porto Salvo |
| Portugal |

Jaba Recordati, S. A.

Lagoas Park, Edificio 5, Torre C,

Piso 32

2740-298 Porto Salvo

Portugal

Nimesulida Jabasulide

100 mg

Granules for oral solution

Oral use

PT - Portugal

| Labesfal - Laboratórios Almiro, S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Nimesulida Labesfal

100 mg

Tablet

Oral use

PT - Portugal

| Labesfal - Laboratórios Almiro, S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Nimesulida Labesfal

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Laboratori Guidotti, S.p.A. |
| --- |
| Via Livornese, 897 |
| I-56010 La Vettola – Pisa |
| Italy |

Laboratori Guidotti, S.p.A.

Via Livornese, 897

I-56010 La Vettola – Pisa

Italy

Nimesulene

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Laboratórios Basi - Indústria Farmacêutica, S.A. |
| --- |
| Rua do Padrão, 98 |
| 3000-312 Coimbra |
| Portugal |

Laboratórios Basi - Indústria Farmacêutica, S.A.

Rua do Padrão, 98

3000-312 Coimbra

Portugal

Nimesulida Basi

100 mg

Tablet

Oral use

PT - Portugal

| Laboratórios Basi - Indústria Farmacêutica, S.A. |
| --- |
| Rua do Padrão, 98 |
| 3000-312 Coimbra |
| Portugal |

Laboratórios Basi - Indústria Farmacêutica, S.A.

Rua do Padrão, 98

3000-312 Coimbra

Portugal

Nimesulida Basi

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Laboratórios Inibsa, S.A. |
| --- |
| Zona Industrial da Abrunheira – |
| Edifício 1 - 2o I - Sintra Business Park |
| 2710-089 Sintra |
| Portugal |

Laboratórios Inibsa, S.A.

Zona Industrial da Abrunheira –

Edifício 1 - 2o I - Sintra Business Park

2710-089 Sintra

Portugal

Nimesulida Inibsa

100 mg

Tablet

Oral use

PT - Portugal

| Laboratórios Inibsa, S.A. |
| --- |
| Zona Industrial da Abrunheira – |
| Edifício 1 - 2o I - Sintra Business Park |
| 2710-089 Sintra |
| Portugal |

Laboratórios Inibsa, S.A.

Zona Industrial da Abrunheira –

Edifício 1 - 2o I - Sintra Business Park

2710-089 Sintra

Portugal

Nimesulida Inibsa

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Mer Medicamentos, Lda. |
| --- |
| Rua João deDeus,19 |
| Venda Nova |
| 2700-487 Amadora |
| Portugal |

Mer Medicamentos, Lda.

Rua João deDeus,19

Venda Nova

2700-487 Amadora

Portugal

Nimesulida Mer

100 mg

Tablet

Oral use

PT - Portugal

| Mylan, Lda. |
| --- |
| Rua Doutor António Loureiro Borges, |
| Edíficio Arquiparque 1, R/C Esqo |
| 1499-016 Algés |
| Portugal |

Mylan, Lda.

Rua Doutor António Loureiro Borges,

Edíficio Arquiparque 1, R/C Esqo

1499-016 Algés

Portugal

Nimesulida Mylan

100 mg

Tablet

Oral use

PT - Portugal

| Mylan, Lda. |
| --- |
| Rua Doutor António Loureiro Borges, |
| Edíficio Arquiparque 1, R/C Esqo |
| 1499-016 Algés |
| Portugal |

Mylan, Lda.

Rua Doutor António Loureiro Borges,

Edíficio Arquiparque 1, R/C Esqo

1499-016 Algés

Portugal

Nimesulida Mylan

100 mg

Granules for oral solution

Oral use

PT - Portugal

| Almus,Lda. |
| --- |
| Rua Engenheiro Ferreira Dias, |
| 728, 3o Piso Sul |
| 4149-014 Porto |
| Portugal |

Almus,Lda.

Rua Engenheiro Ferreira Dias,

728, 3o Piso Sul

4149-014 Porto

Portugal

Nimesulida Almus

100 mg

Film-coated tablet

Oral use

PT - Portugal

| Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. |
| --- |
| Edifício Atlas II, |
| Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31 |
| 1495-139 Miraflores – Algés |
| Portugal |

Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Edifício Atlas II,

Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31

1495-139 Miraflores – Algés

Portugal

Nimesulida Pharmakern

100 mg

Tablet

Oral use

PT - Portugal

| Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. |
| --- |
| Edifício Botânico |
| Rua do Campo Alegre |
| 1306-5o-sala 501 |
| 4150-174 Porto |
| Portugal |

Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda.

Edifício Botânico

Rua do Campo Alegre

1306-5o-sala 501

4150-174 Porto

Portugal

Nimesulida Ranbaxy

100 mg

Tablet

Oral use

PT - Portugal

| Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. |
| --- |
| Edifício Botânico |
| Rua do Campo Alegre |
| 1306-5o-sala 501 |
| 4150-174 Porto |
| Portugal |

Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda.

Edifício Botânico

Rua do Campo Alegre

1306-5o-sala 501

4150-174 Porto

Portugal

Nimesulida Ranbaxy

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. |
| --- |
| Rua Quinta do Pinheiro – |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.

Rua Quinta do Pinheiro –

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Nimesulida Ratiopharm

100 mg

Tablet

Oral use

PT - Portugal

| Rega Farma - Promoção de Produtos Farmacêuticos, |
| --- |
| S.A. Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada |
| Portugal |

Rega Farma - Promoção de Produtos Farmacêuticos,

S.A. Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada

Portugal

Donulide

100 mg

Tablet

Oral use

PT - Portugal

| Rega Farma - Promoção de Produtos Farmacêuticos, S.A. |
| --- |
| Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada |
| Portugal |

Rega Farma - Promoção de Produtos Farmacêuticos, S.A.

Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada

Portugal

Donulide

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Sandoz Farmacêutica, Lda. |
| --- |
| Alameda da Beloura, Edifício 1, 2o - |
| Escritório 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica, Lda.

Alameda da Beloura, Edifício 1, 2o -

Escritório 15

2710-693 Sintra

Portugal

Nimesulida Sandoz

100 mg

Tablet

Oral use

PT - Portugal

| Helsinn Birex Pharmaceuticals, Ltd |
| --- |
| Damastown-Mulhuddart |
| 15 Dublin |
| Republic of Ireland |

Helsinn Birex Pharmaceuticals, Ltd

Damastown-Mulhuddart

15 Dublin

Republic of Ireland

Nimed

100 mg

Film-coated tablet

Oral use

PT - Portugal

| Helsinn Birex Pharmaceuticals, Ltd |
| --- |
| Damastown-Mulhuddart |
| 15 Dublin |
| Republic of Ireland |

Helsinn Birex Pharmaceuticals, Ltd

Damastown-Mulhuddart

15 Dublin

Republic of Ireland

Nimed

100 mg

Granules for oral solution

Oral use

PT - Portugal

| APceuticals-Farmacêutica, Lda |
| --- |
| Av Aida, Edif. Garden-Bloco 9, Lj 910 |
| 2765-187 Estoril |
| Portugal |

APceuticals-Farmacêutica, Lda

Av Aida, Edif. Garden-Bloco 9, Lj 910

2765-187 Estoril

Portugal

Nimesulida APceuticals

100 mg

Film-coated tablet

Oral use

PT - Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 – Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2 – Abrunheira

2710-089 Sintra

Portugal

Nimesulida Neuride

100 mg

Film-coated tablet

Oral use

PT - Portugal

| Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16o Piso, |
| --- |
| Amoreiras |
| 1070-274 Lisboa |
| Portugal |

Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16o Piso,

Amoreiras

1070-274 Lisboa

Portugal

Nimesulida Wynn

100 mg

Tablet

Oral use

RO - Romania

| ANFARM HELLAS S.A. |
| --- |
| Perikleous 53-57 |
| 153 44 Gerakas Attikis |
| Greece |

ANFARM HELLAS S.A.

Perikleous 53-57

153 44 Gerakas Attikis

Greece

LEMESIL, comprimate, 100 mg

100 mg

Tablet

Oral use

RO - Romania

| CSC PHARMACEUTICALS HANDELS GmbH |
| --- |
| Gewerbestrasse 18-20 |
| Gewerbegebiet Klein-Engersdorf |
| A-2102 Bisamberg |
| Austria |

CSC PHARMACEUTICALS HANDELS GmbH

Gewerbestrasse 18-20

Gewerbegebiet Klein-Engersdorf

A-2102 Bisamberg

Austria

AULIN, granule pentru suspensie orală, 100 mg/plic

100 mg/sachet

Granules for oral suspension

oral use

RO - Romania

| CSC PHARMACEUTICALS HANDELS GmbH |
| --- |
| Gewerbestrasse 18-20 |
| Gewerbegebiet Klein-Engersdorf |
| A-2102 Bisamberg |
| Austria |

CSC PHARMACEUTICALS HANDELS GmbH

Gewerbestrasse 18-20

Gewerbegebiet Klein-Engersdorf

A-2102 Bisamberg

Austria

AULIN 100 mg,

100 mg

Tablet

Oral use

RO - Romania

| Dr. REDDY’S LABORATORIES ROMÂNIA S.R.L, |
| --- |
| Str. Nicolae Caramfil nr. 71-73, et. 5 spațiul 10, sector 1, |
| București |
| Romania |

Dr. REDDY’S LABORATORIES ROMÂNIA S.R.L,

Str. Nicolae Caramfil nr. 71-73, et. 5 spațiul 10, sector 1,

București

Romania

NISE 100 mg, comprimate

100 mg

Tablet

Oral use

RO - Romania

| LABORATORI GUIDOTTI SpA |
| --- |
| Via Livornese, 897 |
| 56010 Pisa-La Vettola |
| Italy |

LABORATORI GUIDOTTI SpA

Via Livornese, 897

56010 Pisa-La Vettola

Italy

NIMESIL, granule pentru suspensie orală, 100 mg

100 mg/sachet

Granules for oral suspension

oral use

RO - Romania

| MEDOCHEMIE LTD. - CYPRUS, |
| --- |
| P.O. Box 51409 |
| Limassol |
| Cyprus |

MEDOCHEMIE LTD. - CYPRUS,

P.O. Box 51409

Limassol

Cyprus

APONIL, comprimate, 100 mg

100 mg

Tablet

Oral use

RO - Romania

| S.C. ARENA GROUP S.A. |
| --- |
| Str. Ștefan Mihăileanu, Nr. 31, Sector 2, |
| București, |
| Romania |

S.C. ARENA GROUP S.A.

Str. Ștefan Mihăileanu, Nr. 31, Sector 2,

București,

Romania

NIMESULID ARENA 100 mg, comprimate

100 mg

Tablet

Oral use

RO - Romania

| S.C. FARMEX COMPANY SRL |
| --- |
| Str.Drumul Potcoavei nr. 30, Pipera |
| Voluntari, Jud. Ilfov, |
| Romania |

S.C. FARMEX COMPANY SRL

Str.Drumul Potcoavei nr. 30, Pipera

Voluntari, Jud. Ilfov,

Romania

NIMESULID FARMEX 100 mg, comprimate

100 mg

Tablet

Oral use

RO - Romania

| S.C. LABORMED PHARMA S.A. |
| --- |
| B-dul Theodor Pallady nr. 44B sector 3, |
| Bucuresti |
| Romania |

S.C. LABORMED PHARMA S.A.

B-dul Theodor Pallady nr. 44B sector 3,

Bucuresti

Romania

NIMESULID LPH 100 mg, comprimate

100 mg

Tablet

Oral use

RO - Romania

| S.C. MAGISTRA C&C S.R.L. |
| --- |
| B-dul Aurel Vlaicu nr. 82 A, |
| Constanța |
| Romania |

S.C. MAGISTRA C&C S.R.L.

B-dul Aurel Vlaicu nr. 82 A,

Constanța

Romania

NIMESULID 100 mg, comprimate

100 mg

Tablet

Oral use

RO - Romania

| S.C. SLAVIA PHARM SRL |
| --- |
| Str. Știrbei Vodă nr. 53-55 sector 1, |
| București |
| Romania |

S.C. SLAVIA PHARM SRL

Str. Știrbei Vodă nr. 53-55 sector 1,

București

Romania

NIMESULID SLAVIA, comprimate, 100 mg

100 mg

Tablet

Oral use

RO - Romania

| Zentiva k.s., |
| --- |
| U kabelovny 130, |
| Dolní Měcholupy |
| 102 37, Praha 10, |
| Czech Republic |

Zentiva k.s.,

U kabelovny 130,

Dolní Měcholupy

102 37, Praha 10,

Czech Republic

COXTRAL, comprimate, 100 mg

100 mg

Tablet

Oral use

SI - Slovenia

| CSC Pharma d.o.o. |
| --- |
| Jana Husa 1a |
| SI-1000 Ljubljana |
| Slovenia |

CSC Pharma d.o.o.

Jana Husa 1a

SI-1000 Ljubljana

Slovenia

Aulin 100 mg tablete

100 mg

Tablet

Oral use

SI - Slovenia

| CSC Pharma d.o.o. |
| --- |
| Jana Husa 1a |
| SI-1000 Ljubljana |
| Slovenia |

CSC Pharma d.o.o.

Jana Husa 1a

SI-1000 Ljubljana

Slovenia

Aulin 100 mg zrnca za peroralno suspenzijo

100 mg

Granules for oral suspension

oral use

SK - Slovakia

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese 897 |
| 56010 Pisa - La Vettola |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese 897

56010 Pisa - La Vettola

Italy

Nimesil

100 mg

Granules for oral suspension

Oral use

SK - Slovakia

| Medicom International s.r.o. |
| --- |
| Páteřní 7 |
| 635 00, Brno |
| Czech Republic |

Medicom International s.r.o.

Páteřní 7

635 00, Brno

Czech Republic

AULIN 100 mg granulát

100 mg

Granules for oral solution

Oral use

SK - Slovakia

| Medicom International s.r.o. |
| --- |
| Páteřní 7 |
| 635 00, Brno |
| Czech Republic |

Medicom International s.r.o.

Páteřní 7

635 00, Brno

Czech Republic

AULIN 100 mg tablety

100 mg

Tablet

Oral use

SK - Slovakia

| Medicom International s.r.o. |
| --- |
| Páteřní 7 |
| 635 00, Brno |
| Czech Republic |

Medicom International s.r.o.

Páteřní 7

635 00, Brno

Czech Republic

NIMED

100 mg

Tablet

Oral use

SK - Slovakia

| Zentiva k.s., |
| --- |
| Evropská 846/176a, |
| 160 00, Praha |
| Czech Republic |

Zentiva k.s.,

Evropská 846/176a,

160 00, Praha

Czech Republic

COXTRAL

100 mg

Tablet

Oral use

---