The marketing authorisation for Indimacis 125 has been withdrawn at the request of the marketing authorisation holder.
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
CIS bio international
|Date of issue of marketing authorisation valid throughout the European Union||
31/12/2009 Indimacis 125 - EMEA/H/C/000065 -
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Positive diagnosis of relapsing ovarian adenocarcinoma when serum CA 125 is increased without positive results of ultrasound or computerised tomography scan.