Tecnemab K1

Application under evaluation
CHMP opinion
European Commission decision

Overview

The marketing authorisation for Tecnemab K1 has been withdrawn at the request of the marketing authorisation holder.

Product information

31/12/2009

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

Product details

Name of medicine: Tecnemab K1
Active substance: anti-melanoma mab fragments
International non-proprietary name (INN) or common name: anti-melanoma mab fragments
Therapeutic area (MeSH): Radioimmunodetection
Anatomical therapeutic chemical (ATC) code: V09IA02

Pharmacotherapeutic group

Diagnostic radiopharmaceuticals

Therapeutic indication

As an adjunct to other diagnostic procedures for visualization by radioimmunoscintigraphy (RIS) of regional lymph node and distant metastases in the staging and follow-up of patients with stage I-III melanoma. Aid in differential diagnosis of suspected ocular melanoma.

Authorisation details

EMA product number: EMEA/H/C/000068
Marketing authorisation holder: Amersham Sorin.S.r.l.
,
Via dei Giardini 7
20121 Milan Italy
Marketing authorisation issued: 05/09/1996

This page was last updated on 31/12/2009

Withdrawn