Synagis

Medicinal product

(Invented) name

Synagis

Active substance (s)

Palivizumabas

Strength

50 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

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

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for solution for injection	1 vnt.
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
28282	30812	1030812	flakonas	N1+N1 (tirpiklio ampulė)		Receptinis	EU/1/99/117/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
1999-08-13	Registruotas