Dabigatran etexilate Sandoz [Dabigatran etexilate Polpharma]

Medicinal product

(Invented) name

Active substance (s)

Dabigatranas eteksilatas

Strength

75 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

B01AE07, Dabigatran etexilate

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2024-09-25

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

MT/H/0669/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Dabigatranas eteksilatas	75 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
115174	101283	1101283	dalomoji lizdinė plokštelė	N10×1	Receptinis	LT/1/24/5591/001	Netiekiama	-	-	No	-	-
115175	101284	1101284	lizdinė plokštelė	N30×1	Receptinis	LT/1/24/5591/002	Netiekiama	-	-	No	-	-
115176	101285	1101285	dalomoji lizdinė plokštelė	N60×1	Receptinis	LT/1/24/5591/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-25	Registruotas