ISOPRINOSINE

Medicinal product

(Invented) name

ISOPRINOSINE

Active substance (s)

Inozino acedobeno dimepranolis

Strength

50 mg/ml

Pharmaceutical form

sirupas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AX05, Inosine pranobex

Marketing authorisation holder

Ewopharma International, s.r.o., Slovakija

Date of authorisation

2014-11-03

Date of renewal

2019-06-20

Documents

Isoprinosine_AR.pdf

0673 Pakuotės lapelis sirup 2021 10 15, VRA_7230.docx

0673 ISOPRINOSINE sirup PL 2021 10 15, VRA_7230.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml sirupo yra	1 ml
Inozino acedobeno dimepranolis	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
57353	71468	1071468	buteliukas	150 ml ir matavimo šaukštas N1		Receptinis	LT/1/98/0673/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-06-20	Perregistruotas
2014-11-03	Registruotas