Dotagraf

Medicinal product

(Invented) name

Dotagraf

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

Bayer AG, Vokietija

Date of authorisation

2016-10-31

Date of renewal

2020-05-13

Documents

3990 Pakuotės lapelis 60ml,100ml 2024 11 07.docx

3990 Dotagraf 60ml,100ml PCS PL 2024 11 07.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/3944/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml 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
65216	79717	1079717	flakonas	60 ml N1		Receptinis	LT/1/16/3990/007	Netiekiama	-	-	No	-	-
66954	81494	1081494	flakonas	60 ml N10		Receptinis	LT/1/16/3990/008	Netiekiama	-	-	No	-	-
66955	81495	1081495	flakonas	100 ml N1		Receptinis	LT/1/16/3990/009	Netiekiama	-	-	No	-	-
66956	81496	1081496	flakonas	100 ml N10		Receptinis	LT/1/16/3990/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-05-13	Perregistruotas
2016-10-31	Registruotas