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Pharmaceuticals - Community Register
Community list of not active medicinal products for human use
|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
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register.
|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|