Synagis

Medicinal product

(Invented) name

Synagis

Active substance (s)

Palivizumabas

Strength

50 mg/0,5 ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J06BD01, Palivizumab

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

1999-08-13

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

Solution for injection	0.5 ml
Palivizumabas	50 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
102916	89017	1089017	flakonas	0,5 ml N1		Receptinis	EU/1/99/117/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1999-08-13	Registruotas