PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD CARTON

1. NAME OF THE MEDICINAL PRODUCT_

Somatuline Autogel <60mg><90mg><120mg>, solution for injection in a pre-fílled syringe Lanreotide

2. STATEMENT OF ACTIVE SUBSTANCE(S)_

One pre-filled syringe contains <60mg><90mg><120mg> of lanreotide (as lanreotide acetate).

3. LIST OF EXCIPIENTS_

Other ingredients : water for injections, acetic acid glacial (for pH adjustment).

4. PHARMACEUTICAL FORM AND CONTENTS_

Solution for injection, one pre-filled syringe with an automatic safety system.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Deep subcutaneous injection.

For single use only.

Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN_

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Use only as directed by your doctor.

8. EXPIRY DATE

EXP {MM/YYYY}

9. SPECIAL STORAGE CONDITIONS_

Store in a refrigerator (2°C to 8°C) in the original package.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Ipsen Pharma, Boulogne Billancourt, France

12. MARKETING AUTHORISATION NUMBER(S)

Registrační číslo: 56/002/03-C <60mg> 56/003/03-C <90mg> 56/004/03-C <120mg>

13. BATCH NUMBER

Lot :

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE_

Somatuline Autogel <60 mg> <90 mg> <120 mg>