Alofisel

Medicinal product

(Invented) name

Alofisel

Active substance (s)

Darvadstrocelis

Strength

5 mln. ląst./ml

Pharmaceutical form

injekcinė suspensija

Route (s) of administration

vartoti į pažeistą vietą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AX08, darvadstrocel

Marketing authorisation holder

Takeda Pharma A/S, Danija

Date of authorisation

2018-03-23

Date of renewal

Documents

2024-12-16_Alofisel_DHCP_letter_signed.pdf

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

Suspension for injection	1 ml
Darvadstrocelis	5 mln. ląst.

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
99217	85323	1085323	flakonas	6 ml N4		Receptinis	EU/1/17/1261/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-12-14	Išregistruotas
2018-03-23	Registruotas