DRO SPAZ

Medicinal product

(Invented) name

DRO SPAZ

Active substance (s)

Drotaverino hidrochloridas

Strength

20 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A03AD02, Drotaverine

Marketing authorisation holder

UAB Niromed, Lietuva

Date of authorisation

2024-03-06

Date of renewal

Documents

2102_DRO SPAZ 20mg-ml_inj_tirp_PZPL_2024-03-06.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Ampulėje (2 ml tirpalo) yra	1 ml
Drotaverino hidrochloridas	20 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
113043	99161	1099161	ampulė	2 ml N10		Receptinis	LT/L/24/2102/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-03-06	Registruotas