Dotagita

Medicinal product

(Invented) name

Dotagita

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

Agfa HealthCare Imaging Agents GmbH, Vokietija

Date of authorisation

2014-09-04

Date of renewal

Documents

3608_1_10 Dotagita_PCS 180716.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/3604/001/DC

Marketing authorisation procedure

Decentralizuota 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
55824	69876	1069876	flakonas	5 ml N1		Receptinis	LT/1/14/3608/001	Netiekiama	-	-	No	-	-
59954	74225	1074225	flakonas	5 ml N10		Receptinis	LT/1/14/3608/002	Netiekiama	-	-	No	-	-
59955	74226	1074226	flakonas	10 ml N1		Receptinis	LT/1/14/3608/003	Netiekiama	-	-	No	-	-
59956	74227	1074227	flakonas	10 ml N10		Receptinis	LT/1/14/3608/004	Netiekiama	-	-	No	-	-
59957	74228	1074228	flakonas	15 ml N1		Receptinis	LT/1/14/3608/005	Netiekiama	-	-	No	-	-
59958	74229	1074229	flakonas	15 ml N10		Receptinis	LT/1/14/3608/006	Netiekiama	-	-	No	-	-
59959	74230	1074230	flakonas	20 ml N1		Receptinis	LT/1/14/3608/007	Netiekiama	-	-	No	-	-
59960	74231	1074231	flakonas	20 ml N10		Receptinis	LT/1/14/3608/008	Netiekiama	-	-	No	-	-
59961	74232	1074232	flakonas	60 ml N1		Receptinis	LT/1/14/3608/009	Netiekiama	-	-	No	-	-
59962	74233	1074233	flakonas	60 ml N10		Receptinis	LT/1/14/3608/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-05	Išregistruotas
2014-09-04	Registruotas