Pradaxa

Medicinal product

(Invented) name

Pradaxa

Active substance (s)

Dabigatranas eteksilatas

Strength

6,25 mg/ml

Pharmaceutical form

milteliai ir tirpiklis geriamajam tirpalui

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

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Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for oral solution. Each mL of reconstituted oral solution contains	1 ml
Dabigatranas eteksilatas	6,25 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
105663	91763	1091763	paketėlis	N30 (ir 30 paruošimo pakuočių (tirpiklio buteliukas (28 ml) + sukralozės miltelių paketėlis + 2 dozavimo pipetės (12 ml) + buteliuko adapteris)		Receptinis	EU/1/08/442/031	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2008-03-18	Registruotas