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 10ml,15ml,20ml 2024 11 07.docx

3990 Dotagraf 10ml,15ml,20ml PCS PL 2024 11 07.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/3944/001/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
65215	79716	1079716	flakonas	10 ml N1		Receptinis	LT/1/16/3990/001	Netiekiama	-	-	No	-	-
66949	81489	1081489	flakonas	10 ml N10		Receptinis	LT/1/16/3990/002	Tiekiama	-	-	No	-	-
66950	81490	1081490	flakonas	15 ml N1		Receptinis	LT/1/16/3990/003	Netiekiama	-	-	No	-	-
66951	81491	1081491	flakonas	15 ml N10		Receptinis	LT/1/16/3990/004	Netiekiama	-	-	No	-	-
66952	81492	1081492	flakonas	20 ml N1		Receptinis	LT/1/16/3990/005	Netiekiama	-	-	No	-	-
66953	81493	1081493	flakonas	20 ml N10		Receptinis	LT/1/16/3990/006	Netiekiama	-	-	No	-	-	Download

Stadijos

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