Praluent

Medicinal product

(Invented) name

Praluent

Active substance (s)

Alirokumabas

Strength

75 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C10AX14, Alirocumab

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2015-09-23

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 in pre-filled syringe	1 ml
Alirokumabas	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
63969	78414	1078414	užpildytas švirkštas	N1		Receptinis	EU/1/15/1031/004	Netiekiama	-	-	No	-	-
63970	78415	1078415	užpildytas švirkštas	N2		Receptinis	EU/1/15/1031/005	Netiekiama	-	-	No	-	-
63971	78416	1078416	užpildytas švirkštas	N6		Receptinis	EU/1/15/1031/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-09-23	Registruotas