Atosiban Sun

Medicinal product

(Invented) name

Atosiban Sun

Active substance (s)

Atozibanas

Strength

6,75 mg/0,9 ml

Pharmaceutical form

injekcinis tirpalas

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

Solution for injection	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
56969	71076	1071076	flakonas	N1		Receptinis	EU/1/13/852/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-07-31	Registruotas