Pradaxa

Medicinal product

(Invented) name

Pradaxa

Active substance (s)

Dabigatranas eteksilatas

Strength

50 mg

Pharmaceutical form

dengtos granulės

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

Boehringer Ingelheim International GmbH, Vokietija

Date of authorisation

2008-03-18

Date of renewal

Documents

Pradaxa mokomoji medziaga sveikatos prieziuros specialistams, skirta vaiku indikacijai.pdf

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

Coated granules	1 vnt.
Dabigatranas eteksilatas	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
105660	91760	1091760	paketėlis	N60		Receptinis	EU/1/08/442/028	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-03-18	Registruotas