DELTYBA Film-coated tablet Ref.[7597] Active ingredients: Delamanid

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Otsuka Novel Products GmbH, Erika-Mann-Straße 21, 80636, München, Germany

Product name and form

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.

Qualitative and quantitative composition

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
Povidone
all-rac-α-Tocopherol
Cellulose, microcrystalline
Sodium starch glycolate (type A)
Carmellose calcium
Silica, colloidal hydrated
Magnesium stearate
Lactose monohydrate

Film coating:

Hypromellose
Macrogol 8000
Titanium dioxide
Talc
Iron oxide yellow (E172)

Pack sizes and marketing

Aluminium/Aluminium blister: 48 tablets.

Marketing authorization holder

Otsuka Novel Products GmbH, Erika-Mann-Straße 21, 80636, München, Germany

Marketing authorization dates and numbers

EU/1/13/875/004

Date of first authorisation: 28 April 2014
Date of latest renewal: 22 March 2022

Drugs

Drug Countries
DELTYBA Austria, Estonia, Spain, France, Hong Kong, Ireland, Japan, Lithuania, Poland, Romania, Turkey, United Kingdom, South Africa

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