Ephedrine hydrochloride Sintetica

Medicinal product

(Invented) name

Ephedrine hydrochloride Sintetica

Active substance (s)

Efedrino hidrochloridas

Strength

50 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01CA26, Ephedrine

Marketing authorisation holder

Sintetica GmbH, Vokietija

Date of authorisation

2021-08-03

Date of renewal

Documents

4797 Ephedrine_HCl_Sintetica 50mg.doc

4797 pakuotes lapelis_2021-08-03.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

AT/H/1003/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Efedrino hidrochloridas	50 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
107065	93168	1093168	ampulė	1 ml N10		Receptinis	LT/1/21/4797/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-31	Išregistruotas
2021-08-03	Registruotas