EN combined label-leaflet template_clean



PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE - COMBINED LABEL AND PACKAGE LEAFLET

{NATURE/TYPE}

1. Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release , if different

2. Name of the veterinary medicinal product

{(Invented) name of veterinary medicinal product pharmaceutical form }

{active substance(s)}

3. Statement of the active substance (s) and other ingredients

4. Pharmaceutical form

5. Package size

6. Indication(s)

7. Contraindications

8. Adverse reactions

If you notice any side effects, even those not already listed in this label or you think that the medicine has not worked, please inform your veterinary surgeon.

[For MRP/DCP only]

9. Target species

10. Dosage for each species, route(s) and method of administration

11. Advice on correct administration

12. Withdrawal period(s)

13. Special storage precautions

or

Do not use this veterinary medicinal product after the expiry date which is stated on the .

14. Special warning(s)

15. Special precautions for the disposal of unused product or waste materials, if any

16. Date on which the label was last approved

|België/Belgique/Belgien |Lietuva |

|{Nom/Naam/Name} |{pavadinimas} |

| |

|Tél/Tel: + {N° de téléphone/Telefoonnummer/ |Tel: +370{telefono numeris} |

|Telefonnummer} | |

| | |

|Република България |Luxembourg/Luxemburg |

|{Наименование} |{Nom} |

| |

|Teл: + 359 {Телефонен номер} |Tél/Tel: + {N° de téléphone/Telefonnummer} |

| | |

|Česká republika |Magyarország |

|(Název( |{Név} |

| |

|Tel: +(telefonní číslo( |Tel.: + {Telefonszám} |

| | |

|Danmark |Malta |

|{Navn} |{Isem} |

| |

|Tlf: + {Telefonnummer} |Tel: + {Numru tat-telefon} |

| | |

|Deutschland |Nederland |

|{Name} |{Naam} |

| |

|Tel: + {Telefonnummer} |Tel: + {Telefoonnummer} |

| | |

|Eesti |Norge |

|(Nimi) |{Navn} |

| |

|Tel: +(Telefoninumber) |Tlf: + {Telefonnummer} |

| | |

|Ελλάδα |Österreich |

|{Όνομα} |{Name} |

| |

|Τηλ: + {Αριθμός τηλεφώνου} |Tel: + {Telefonnummer} |

| | |

|España |Polska |

|{Nombre} |{Nazwa/ Nazwisko:} |

| |

|Tel: + {Teléfono} |Tel.: + {Numer telefonu:} |

| | |

|France |Portugal |

|{Nom} |{Nome} |

| |

|Tél: + {Numéro de téléphone} |Tel: + {Número de telefone} |

| | |

|Hrvatska |România |

|{Ime} |{Nume} |

| |

|Tel: + {Telefonski broj} |Tel: + {Număr de telefon} |

| | |

|Ireland |Slovenija |

|{Name} |{Ime} |

| |

|Tel: + {Telephone number} |Tel: + {telefonska številka} |

| | |

|Ísland |Slovenská republika |

|{Nafn} |{Meno} |

| |

|Sími: + {Símanúmer} |Tel: + {Telefónne číslo} |

| | |

|Italia |Suomi/Finland |

|{Nome} |{Nimi/Namn} |

| |

|Tel: + {Numero di telefono}> |Puh/Tel: + {Puhelinnumero/Telefonnummer} |

| | |

|Κύπρος |Sverige |

|{Όνομα} |{Namn} |

| |

|Τηλ: + {Αριθμός τηλεφώνου} |Tel: + {Telefonnummer} |

| | |

|Latvija |United Kingdom |

|{Nosaukums} |{Name} |

| |

|Tel: + {Telefona numurs} |Tel: + {Telephone number} |

| | |

18. The words “For animal treatment only” and conditions or restrictions regarding supply and use, if applicable

For animal treatment only.

19. The words “Keep out of the sight and reach of children”

Keep out of the sight and reach of children.

20. Expiry date

21. Marketing authorisation number(s)

EU/0/00/000/000

22. Manufacturer’s batch number

{number}

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