Drotaverine Actiofarma [DRO SPAZ]

Medicinal product

(Invented) name

Drotaverine Actiofarma [DRO SPAZ]

Active substance (s)

Drotaverino hidrochloridas

Strength

40 mg

Pharmaceutical form

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

UAB Actiofarma, Lietuva

Date of authorisation

2017-08-08

Date of renewal

Documents

0526-002,004_Drotaverine Actiofarma [Dro Spaz] N100_2020-09-30.docx

0526-001,003_Drotaverine Actiofarma [Dro Spaz] N20_2020-09-30.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Drotaverino hidrochloridas	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
97470	83564	1083564	lizdinė plokštelė	N20		Nereceptinis	LT/L/17/0526/001	Netiekiama	-	-	No	-	-	Download
103404	89506	1089506	lizdinė plokštelė	N100		Receptinis	LT/L/17/0526/003	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
	Išregistruotas
2017-08-08	Registruotas