Lemtrada

Medicinal product

(Invented) name

Lemtrada

Active substance (s)

Alemtuzumabas

Strength

12 mg

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)

L04AG06, Alemtuzumab

Marketing authorisation holder

Sanofi Belgium, Belgija

Date of authorisation

2013-09-12

Date of renewal

Documents

Lemtrada kontrolinis sarasas sveikatos prieziuros specialistams.pdf

Lemtrada mokomoji medziaga sveikatos prieziuros specialistams.pdf

Lemtrada paciento kortele.pdf

Lemtrada mokomoji medziaga pacientams.pdf

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	1.2 ml
Alemtuzumabas	12 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
57103	71216	1071216	flakonas	1,2 ml N1		Receptinis	EU/1/13/869/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-09-12	Registruotas