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 Tamro, Lietuva

Date of authorisation

2018-10-11

Date of renewal

Documents

0747_Gadovist_PZPL_2018-10-11.docx

Stage

Registruotas

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
100288	86397	1086397	buteliukas	65 ml N10	ASPĮ	Receptinis	LT/L/18/0747/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2018-10-11	Registruotas