<p>On 29 November 2000 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product NeoSpect, depreotide, which had been approved for diagnostic use only, for scintigraphic imaging of suspected malignant tumours in the lung after initial detection, in combination with CT scan or chest X-ray, in patients with solitary pulmonary nodules. </p><p>The marketing authorisation holder (MAH) responsible for NeoSpect was CIS bio international. The European Commission was notified by a letter dated 30 September 2010 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for NeoSpect for commercial reasons. NeoSpect had been marketed in all European countries. </p><p>On 28 October 2010 the European Commission issued a decision to withdraw the marketing authorisation for NeoSpect. </p><p>Pursuant to this decision the European Public Assessment Report for NeoSpect is updated to reflect that the marketing authorisation is no longer valid.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>This medicinal product is for diagnostic use only.<br>For scintigraphic imaging of suspected malignant tumours in the lung after initial detection, in<br>combination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.</p></div>
Therapeutic Area (MeSH)
ATC Code
V09IA05
ATC Item
N/A
Pharmacotherapeutic Group
Diagnostic radiopharmaceuticals
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| depreotide trifluoroacetate | N/A | depreotide trifluoroacetate |
EMA Name
NeoSpect
Medicine Name
NeoSpect
Aliases
N/ANo risk management plan link.