Atosiban Accord

Medicinal product

(Invented) name

Atosiban Accord

Active substance (s)

Atozibanas

Strength

6,75 mg/0,9 ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G02CX01, Atosiban

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2018-09-10

Date of renewal

2023-07-18

Documents

4250_pakuotes lapelis_2023-07-18.docx

4250_Atosiban Accord_perr2023-07-18.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/4551/002

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename užpildytame švirkšte (0,9 ml) yra:	0.9 ml
Atozibanas	6,75 mg

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
100045	86153	1086153	užpildytas švirkštas	0,9 ml N1		Receptinis	LT/1/18/4250/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-11-28	Išregistruotas
2023-07-18	Perregistruotas
2018-09-10	Registruotas