Tegsedi

Medicinal product

(Invented) name

Tegsedi

Active substance (s)

Inotersenas

Strength

284 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)

N07XX15, inotersen

Marketing authorisation holder

Akcea Therapeutics Ireland Ltd., Airija

Date of authorisation

2018-07-06

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	1.5 ml
Inotersenas	284 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
99853	85961	1085961	užpildytas švirkštas	N1		Receptinis	EU/1/18/1296/001	Netiekiama	-	-	No	-	-
99854	85962	1085962	užpildytas švirkštas	N4		Receptinis	EU/1/18/1296/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-06	Registruotas