Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Otsuka Novel Products GmbH, Erika-Mann-Straße 21, 80636, München, Germany
Deltyba 50 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Round, yellow, film-coated tablet, 11.7 mm in diameter, debossed with “DLM” and “50” on one side. |
Each film-coated tablet contains 50 mg delamanid.
Excipient with known effect: each film-coated tablet contains 100 mg lactose (as monohydrate).
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 |
|---|
|
Tablet core: Hypromellose phthalate Film coating: Hypromellose |
Aluminium/Aluminium blister: 48 tablets.
Otsuka Novel Products GmbH, Erika-Mann-Straße 21, 80636, München, Germany
EU/1/13/875/004
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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