Gadovist PFS

Medicinal product

(Invented) name

Gadovist PFS

Active substance (s)

Gadobutrolis

Strength

1 mmol/ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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 Lex ano, Lietuva

Date of authorisation

2015-07-21

Date of renewal

Documents

Gadovist PFS.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
62943	77357	1077357	užpildytas švirkštas	7,5 ml N1		Receptinis	LT/L/15/0287/001	Netiekiama	-	-	No	-	-
62944	77358	1077358	užpildytas švirkštas	15 ml N1		Receptinis	LT/L/15/0287/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Registruotas
	Išregistruotas
2015-07-21	Registruotas