Imlygic

Medicinal product

(Invented) name

Imlygic

Active substance (s)

Talimogenas laherparepvekas

Strength

10(x8) PFV/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

vartoti į pažeistą vietą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XL02, Talimogene laherparepvec

Marketing authorisation holder

Amgen Europe B.V., Nyderlandai

Date of authorisation

2015-12-16

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	1 ml
Talimogenas laherparepvekas	10(x8) PFV/ml

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
64761	79250	1079250	flakonas	N1		Receptinis	EU/1/15/1064/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-12-16	Registruotas