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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/13/875|
|Orphan status based on designation EU/3/07/524 added on 30/04/2014 10 years of market exclusivity|
|ATC:||Anatomical main group: J - General antiinfectives for systemic use|
Therapeutic subgroup: J04 - Antimycobacterials
Pharmacological subgroup: J04A - Drugs for treatment of tuberculosis
Chemical subgroup: J04AK - Other drugs for treatment of tuberculosis
Chemical substance: J04AK06 - Delamanid
(See WHO ATC Index)
|Indication:||Treatment with delamanid should be initiated and monitored by a physician experienced in the management of multidrug-resistant Mycobacterium tuberculosis.|
Delamanid must always be administered as part of an appropriate combination regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB) . Treatment with an appropriate combination regimen should continue after completion of the 24-week delamanid treatment period according to WHO guidelines.
It is recommended that delamanid is administered by directly observed therapy (DOT).
|Marketing Authorisation Holder:||Otsuka Novel Products GmbH
Erika-Mann-Straße 21, D-80636 München, Deutschland
|EPAR and active 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.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|30/04/2014||Centralised - Authorisation||EMEA/H/C/2552||(2014)2916 of 28/04/2014|
|12/06/2014||Centralised - Variation||EMEA/H/C/2552/IAin/1/G|
|06/08/2014||Centralised - Variation||EMEA/H/C/2552/IB/2/G|