Dospax

Medicinal product

(Invented) name

Dospax

Active substance (s)

Drotaverino hidrochloridas

Strength

80 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A03AD02, Drotaverine

Marketing authorisation holder

PharmaSwiss Česká republika s.r.o., Čekija

Date of authorisation

2018-01-24

Date of renewal

Documents

4183-5-6 Dospax 80_DC.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PL/H/0441/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Drotaverino hidrochloridas	80 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
98776	84880	1084880	lizdinė plokštelė	N10		Nereceptinis	LT/1/18/4183/005	Netiekiama	-	-	No	-	-
98777	84881	1084881	lizdinė plokštelė	N20		Nereceptinis	LT/1/18/4183/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-07-02	Išregistruotas
2018-01-24	Registruotas