Deltyba

Medicinal product

(Invented) name

Deltyba

Active substance (s)

Delamanidas

Strength

50 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J04AK06, Delamanid

Marketing authorisation holder

Otsuka Novel Products GmbH, Vokietija

Date of authorisation

2014-04-28

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Delamanidas	50 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
60871	75162	1075162	lizdinė plokštelė	N48		Receptinis	EU/1/13/875/004	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-04-28	Registruotas