Halagon (halofuginone lactate) – Conditions or restrictions regarding supply and use - QP51AX08

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Divasa-Farmavic, S.A.

Ctra. Sant Hipolit, Km. 71

08503 Gurb-Vic, Barcelona

Spain

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Veterinary medicinal product subject to prescription.

C.STATEMENT OF THE MRLs

The active substance in HALAGON is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:

Pharmacologically

Marker

Animal

MRLs

Target

Other

Therapeutic

active substance

residue

species

tissues

provisions

classification

 

Halofuginone

Halofugin

Bovine

10 μg/kg

Muscle

Not for use in

Antiparasitic

 

one

 

25 μg/kg

Fat

animals from

agents/Agents

 

 

 

30 μg/kg

Liver

which milk is

acting against

 

 

 

30 μg/kg

Kidney

produced for

protozoa

 

 

 

 

 

human

 

 

 

 

 

 

consumption

 

 

 

 

 

 

 

 

The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

HALAGON 0.5 mg/ml oral solution halofuginone

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Halofuginone (as lactate salt)

0.50 mg/ml

3.PHARMACEUTICAL FORM

Oral Solution

4.PACKAGE SIZE

290 ml

490 ml

980 ml

5.TARGET SPECIES

Cattle (newborn calves)

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

Meat and offal: 13 days.

9.SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10.EXPIRY DATE

EXP

Shelf-life after first opening the container: 6 months.

Once broached, use by …

11.SPECIAL STORAGE CONDITIONS

Keep the bottle in the outer carton in order to protect from light.

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Disposal: read package leaflet.

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE

For animal treatment only.

To be supplied only on veterinary prescription.

14.THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

EMDOKA bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/16/201/001 (290 ml)

EU/2/16/201/002 (490 ml)

EU/2/16/201/003(980 ml)

17.MANUFACTURER’S BATCH NUMBER

Batch {number}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 290ml, 490 ml or 980 ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

HALAGON 0.5 mg/ml oral solution halofuginone

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Halofuginone (as lactate salt)

0.50 mg/ml

3. PHARMACEUTICAL FORM

4. PACKAGE SIZE

290 ml

490 ml

980 ml

5. TARGET SPECIES

Cattle (newborn calves)

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

For oral use

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Meat and offal: 13 days.

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP

Shelf-life after first opening the container: 6 months.

Once broached, use by …

11. SPECIAL STORAGE CONDITIONS

Keep the bottle in the outer carton in order to protect from light.

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE AMTERIALS, IF ANY

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE

For animal treatment only.

To be supplied only on veterinary prescription.

14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

EMDOKA bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/16/201/001 (290 ml)

EU/2/16/201/002 (490 ml)

EU/2/16/201/003 (980 ml)

17. MANUFACTURER’S BATCH NUMBER

Batch {number}

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