Besremi

Medicinal product

(Invented) name

Besremi

Active substance (s)

Ropeginterferonas alfa-2b

Strength

250 µg/0,5 ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L03AB15, Ropeginterferon alfa-2b

Marketing authorisation holder

AOP Orphan Pharmaceuticals GmbH, Austrija

Date of authorisation

2019-02-15

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 pen	0.5 ml
Ropeginterferonas alfa-2b	250 µg

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
100950	87061	1087061	užpildytas švirkštiklis	0,5 ml ir 2 adatos N1		Receptinis	EU/1/18/1352/001	Tiekiama	2025-03-27	2027-03-26	No	-	-
106012	92113	1092113	užpildytas švirkštiklis	0,5 ml ir 2 adatos N3		Receptinis	EU/1/18/1352/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-02-15	Registruotas