Epipen

Medicinal product

(Invented) name

Epipen

Active substance (s)

Epinefrinas

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

Viatris Healthcare Limited, Airija

Date of authorisation

2013-10-31

Date of renewal

2021-04-19

Documents

Epipen kontroliniai klausimai recepto israsymui.pdf

Epipen mokomoji medziaga pacientams.pdf

3418 Pakuotės lapelis 300mcg 2025 07 16.docx

Epipen mokomojo prietaiso tekstas.pdf

3418 Epipen 300 PCS PL 2025 07 16.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

SE/H/1287/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Vienkartinėje 0,3 ml dozėje yra	0.3 ml
Epinefrinas	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
52951	66891	1066891	užpildytas švirkštiklis	N1 (automatinis injektorius)		Receptinis	LT/1/13/3418/003	Tiekiama	-	-	No	-	-	Download
57599	71716	1071716	užpildytas švirkštiklis	N2 (automatinis injektorius)		Receptinis	LT/1/13/3418/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-04-19	Perregistruotas
2013-10-31	Registruotas