Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Otsuka Novel Products GmbH, Erika-Mann-Straße 21, 80636 München, Germany
Deltyba 25 mg dispersible tablets.
| Pharmaceutical Form |
|---|
|
Dispersible tablet. Round, white to off-white dispersible tablet, 11 mm in diameter, debossed with “DLM” and “25” on one side. |
Each dispersible tablet contains 25 mg delamanid.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Delamanid |
The pharmacological mode of action of delamanid involves inhibition of the synthesis of the mycobacterial cell wall components, methoxy-mycolic and keto-mycolic acid. The identified metabolites of delamanid do not show anti-mycobacterial activity. |
| List of Excipients |
|---|
|
Hypromellose phthalate |
Aluminium/Aluminium blister: 48 tablets.
Otsuka Novel Products GmbH, Erika-Mann-Straße 21, 80636 München, Germany
EU/1/13/875/005
Date of first authorisation: 28 April 2014
Date of latest renewal: 22 March 2022
| Drug | Countries | |
|---|---|---|
| DELTYBA | Austria, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Japan, Lithuania, Poland, Romania, Turkey, United Kingdom, South Africa |
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