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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/13/890|
|Orphan status based on designation EU/3/08/610 added on 26/03/2014|
|Indication:||Cometriq is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.|
For patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision
|Marketing Authorisation Holder:||TMC Pharma Services Ltd.
Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom
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.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|26/03/2014||Centralised - Authorisation||EMEA/H/C/2640||(2014)2043 of 21/03/2014|
|28/04/2014||Centralised - Variation||EMEA/H/C/2640/IA/1|
|28/05/2014||Centralised - Variation||EMEA/H/C/2640/IB/2|
|17/06/2014||Centralised - Variation||EMEA/H/C/2640/IB/3|