Tractocile

Medicinal product

(Invented) name

Tractocile

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

Ferring Pharmaceuticals A/S, Danija

Date of authorisation

2000-01-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

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
28797	31315	1031315	flakonas	N1		Receptinis	EU/1/99/124/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2000-01-20	Registruotas