This is the abbreviated version of the Summary of Product Caracteristics in Italy. For complete information, use the menu above to see the Summary of Product Caracteristics of your own country.

Trade Name of the Medicinal Product: 10 mg/ml concentrate for solution for infusion 1 vial of 1 ml - 10 mg/ml concentrate for solution for infusion 1 vial of 5 ml - NAVELBINE^® 20 mg soft capsule - NAVELBINE^® 30 mg soft capsule. Qualitative and Quantitative Composition.

Therapeutic Indications:

Treatment of non-small cell lung cancer. Treatment of metastatic breast cancer. Treatment of Prostate Cancer(1). Posology and Method of Administration* Contra-indications: pregnancy, lactation. Hypersensitivity to vinorelbine or other vinca alkaloids and other ingredients. Neutrophil count < 1500/mm3 or severe infection, patients with current or recent (within 2 weeks) history of infection. Patients requiring long-term oxygen therapy. For the Oral form: disease significantly affecting absorption - previous significant surgical resection of stomach or small bowel - severe hepatic insufficiency not related to the tumoral process. Special Warnings and Precautions for Use* Interactions with other Medicaments* Undesirable Effects* Pharmacological Properties* Preclinical safety Data* Pharmaceutical Particulars* Overdosage* Special Precautions for Storage* Instruction for Use/Handling*.

Administrative Data:

Marketing Authorisation Holder PIERRE FABRE PHARMA, Via G.G. Winckelmann,1 - 20 146 MILAN. Marketing Authorisation Number: 1 vial of 1 ml 027865082 September 1993 - 1 vial of 5 ml 027865094 September 1993 - M.A. No 027865106: 1 soft capsule NAVELBINE^® 20 mg. M.A. No 027865118: 1 soft capsule NAVELBINE^® 30 mg. Date of First Authorisation/Renewal of Autorisation: 14 August 2001/14 August 2006. Licence PIERRE FABRE MEDICAMENT-CNRS. NAVELBINE^®: a registered trademark of PIERRE FABRE MEDICAMENT. Laboratoires PIERRE FABRE ONCOLOGIE - 45, place Abel-Gance, 92100 Boulogne FRANCE. Tel: +33 (0)1 49 10 80 00 - Fax: +33 (0)1 49 10 96 93. Pharmacovigilance: Tel: +33 (0)1 49 10 96 18.

(1) Approval in Mexico and South Korea for the I.V. form