DOTAREM

Medicinal product

(Invented) name

DOTAREM

Active substance (s)

Gadotero rūgštis

Strength

0,5 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)

V08CA02, Gadoteric acid

Marketing authorisation holder

Guerbet, Prancūzija

Date of authorisation

2014-02-11

Date of renewal

2017-02-13

Documents

3509 DOTAREM multidose PCS PL 2024 05 08.docx

3509 Pakuotės lapelis multidose 2024 05 08.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

NL/H/0381/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml injekcinio tirpalo yra	1 ml
Gadotero rūgštis	0,5 mmol/ml

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
56345	70443	1070443	flakonas	60 ml N1		Receptinis	LT/1/14/3509/006	Netiekiama	-	-	No	-	-
58535	72701	1072701	flakonas	100 ml N1		Receptinis	LT/1/14/3509/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-02-13	Perregistruotas
2014-02-11	Registruotas