Rebetol

Medicinal product

(Invented) name

Rebetol

Active substance (s)

Ribavirinas

Strength

40 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AP01, ribavirin

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2005-01-25

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

oral solution	1 ml
Ribavirinas	40 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
28108	30644	1030644	buteliukas	100 ml N10		Receptinis	EU/1/99/107/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-10-18	Išregistruotas
2005-01-25	Registruotas