Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Tecnemab-K-1
Auth. number : EU/1/96/019
INN : Anti-melanoma Mab fragments
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V09 - Diagnostic radiopharmaceuticals
Pharmacological subgroup: V09I - Tumour detection
Chemical subgroup: V09IA - Technetium (99mTc) compounds
Chemical substance: V09IA02 - Technetium (99mTc) antimelanoma antibody
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Sorin Radiofarmaci S.r.l.
14 via Borgonuovo, 20121 Milano, Italy

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/09/1996 Centralised - Authorisation EMEA/H/C/68 (96)2475 of 05/09/1996
24/04/1997 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/68/T/2 (97)1172 of 22/04/1997
09/06/1997 Centralised - Variation EMEA/H/C/68/I/1 (97)1652 of 06/06/1997
10/06/1999 Centralised - Variation EMEA/H/C/68/I/3 (1999)1444 of 02/06/1999
09/02/2000 Centralised - Withdrawal (2000)151 of 31/01/2000