Jext

Medicinal product

(Invented) name

Jext

Active substance (s)

Adrenalinas

Strength

300 µg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01CA24, Epinephrine

Marketing authorisation holder

ALK-Abello A/S, Danija

Date of authorisation

2022-12-02

Date of renewal

2024-01-19

Documents

Jext mokomoji medziaga sveikatos prieziuros specialistams.pdf

Jext paciento kortele.pdf

5078-5079_pakuotes lapelis_2024-01-19.docx

5078_5079 Jext PCS 2024 10 16.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

SE/H/0908/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Užpildytame švirkštiklyje (0,3 ml) yra:	0.3 ml
Adrenalinas	300 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
109932	96039	1096039	užpildytas švirkštiklis	N1		Receptinis	LT/1/22/5079/001	Netiekiama	-	-	No	-	-
109933	96040	1096040	užpildytas švirkštiklis	N2×1		Receptinis	LT/1/22/5079/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-19	Perregistruotas
2022-12-02	Registruotas