Dabigatran etexilate STADA

Medicinal product

(Invented) name

Dabigatran etexilate STADA

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)

No

ATC code (s)

B01AE07, Dabigatran etexilate

Marketing authorisation holder

STADA Arzneimittel AG, Vokietija

Date of authorisation

2024-02-14

Date of renewal

Documents

5353-5355_Dabigatran etexilate STADA.docx

Dabigatran etexilate STADA mokomoji medziaga sveikatos prieziuros specialistams 1.pdf

Dabigatran etexilate STADA mokomoji medziaga sveikatos prieziuros specialistams 2.pdf

5353_pakuotes lapelis_2024-02-14.docx

Dabigatran etexilate STADA mokomoji medziaga sveikatos prieziuros specialistams vaik. ind..pdf

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

MT/H/0671/001/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	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
112891	99009	1099009	dalomoji lizdinė plokštelė	N10×1		Receptinis	LT/1/24/5353/001	Netiekiama	-	-	No	-	-
112892	99010	1099010	dalomoji lizdinė plokštelė	N30×1		Receptinis	LT/1/24/5353/002	Netiekiama	-	-	No	-	-
112893	99011	1099011	dalomoji lizdinė plokštelė	N60×1		Receptinis	LT/1/24/5353/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-14	Registruotas