Phenylephrine hydrochloride Sintetica

Medicinal product

(Invented) name

Phenylephrine hydrochloride Sintetica

Active substance (s)

Fenilefrino hidrochloridas

Strength

0,1 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01CA06, Phenylephrine

Marketing authorisation holder

Sintetica GmbH, Vokietija

Date of authorisation

2020-07-30

Date of renewal

2022-01-17

Documents

4600_Phenylephrine_HCl_perr2022-01-17.docx

4600_pakuotes lapelis_perr2022-01-17.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/4407/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Fenilefrino hidrochloridas	0,1 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
104768	90869	1090869	ampulė	5 ml N10		Receptinis	LT/1/20/4600/001	Netiekiama	-	-	No	-	-
107036	93139	1093139	flakonas	50 ml N1		Receptinis	LT/1/20/4600/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-03-28	Išregistruotas
2022-01-17	Perregistruotas
2020-07-30	Registruotas