Gadovist

Medicinal product

(Invented) name

Gadovist

Active substance (s)

Gadobutrolis

Strength

1 mmol/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V08CA09, Gadobutrol

Marketing authorisation holder

UAB Adeofarma, Lietuva

Date of authorisation

2015-05-20

Date of renewal

Documents

0267-01-2 Gadovist_DE_PZ-PL.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Gadobutrolis	1 mmol

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
62241	76614	1076614	užpildytas švirkštas	7,5 ml N5		Receptinis	LT/L/15/0267/001	Netiekiama	-	-	No	-	-
62242	76615	1076615	buteliukas	65 ml N10		Receptinis	LT/L/15/0267/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2015-05-20	Registruotas