Balmedil

Medicinal product

(Invented) name

Balmedil

Active substance (s)

Paracetamolis/Feniramino maleatas/Askorbo rūgštis

Strength

500 mg/25 mg/200 mg

Pharmaceutical form

granulės geriamajam tirpalui

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02BE51, Paracetamol, combinations excl. psycholeptics

Marketing authorisation holder

PharmaSwiss Česká republika s.r.o., Čekija

Date of authorisation

2017-07-10

Date of renewal

Documents

4094_1 Balmedil_DC.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0219/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Paketėlyje yra	9.5 g
Paracetamolis	500 mg
Feniramino maleatas	25 mg
Askorbo rūgštis	200 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
68732	83315	1083315	paketėlis	9,5 g N8		Nereceptinis	LT/1/17/4094/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-02-07	Išregistruotas
2017-07-10	Registruotas