Atosiban Sun

Medicinal product

(Invented) name

Atosiban Sun

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)

ATC code (s)

G02CX01, Atosiban

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B. V., Nyderlandai

Date of authorisation

2013-07-31

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	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
56970	71077	1071077	flakonas	N1		Receptinis	EU/1/13/852/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-07-31	Registruotas