Dawnzera

Medicinal product

(Invented) name

Dawnzera

Active substance (s)

Donidalorsenas

Strength

80 mg

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)

B06AC09, donidalorsen

Marketing authorisation holder

Otsuka Pharmaceutical Netherlands B.V., Nyderlandai

Date of authorisation

2026-01-19

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

Užpildytame švirkštiklyje (0,8 ml tirpalo) yra	0.8 mg
Donidalorsenas	80 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
119895	106001	1106001	užpildytas švirkštiklis	N1		Receptinis	EU/1/25/2001/001	Netiekiama	-	-	No	-	-
119896	106002	1106002	užpildytas švirkštiklis	N3		Receptinis	EU/1/25/2001/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-01-19	Registruotas