Atosiban Accord

Medicinal product

(Invented) name

Atosiban Accord

Active substance (s)

Atozibanas

Strength

37,5 mg/5 ml

Pharmaceutical form

koncentratas infuziniam tirpalui

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

2015-09-30

Date of renewal

2022-02-22

Documents

3797 Pakuotės lapelis 2022 07 20.docx

3797 Atosiban Accord 37,5mg II PL 2022 07 20.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4551/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename 5 ml tirpalo flakone yra	5 ml
Atozibanas	37,5 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
59508	73738	1073738	flakonas	5 ml N1		Receptinis	LT/1/15/3797/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-11-28	Išregistruotas
2022-02-22	Perregistruotas
2015-09-30	Registruotas