Kiralda

Medicinal product

(Invented) name

Kiralda

Active substance (s)

Gadobutrolis

Strength

1 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)

V08CA09, Gadobutrol

Marketing authorisation holder

Bayer AG, Vokietija

Date of authorisation

2020-01-24

Date of renewal

Documents

4506 Kiralda inj flak_but PCS PL 2022 08 10.docx

4506 Pakuotės lapelis 2022 08 10.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10c

Procedure number

DE/H/5452/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml injekcinio tirpalo yra:	1 ml
Gadobutrolis	1 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
103132	89233	1089233	flakonas	7,5 ml N1		Receptinis	LT/1/20/4506/001	Netiekiama	-	-	No	-	-
103133	89234	1089234	flakonas	7,5 ml N10		Receptinis	LT/1/20/4506/002	Netiekiama	-	-	No	-	-
103134	89235	1089235	flakonas	15 ml N1		Receptinis	LT/1/20/4506/003	Netiekiama	-	-	No	-	-
103135	89236	1089236	flakonas	15 ml N10		Receptinis	LT/1/20/4506/004	Netiekiama	-	-	No	-	-
103136	89237	1089237	flakonas	30 ml N1		Receptinis	LT/1/20/4506/005	Netiekiama	-	-	No	-	-
103137	89238	1089238	flakonas	30 ml N10		Receptinis	LT/1/20/4506/006	Netiekiama	-	-	No	-	-
103138	89239	1089239	buteliukas	65 ml N1		Receptinis	LT/1/20/4506/007	Netiekiama	-	-	No	-	-
103139	89240	1089240	buteliukas	65 ml N10		Receptinis	LT/1/20/4506/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-01-31	Išregistruotas
2020-01-24	Registruotas