Clemastinum PPH [CLEMASTINUM WZF Polfa]

Medicinal product

(Invented) name

Clemastinum PPH [CLEMASTINUM WZF Polfa]

Active substance (s)

Klemastinas

Strength

0,1 mg/ml

Pharmaceutical form

sirupas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R06AA04, Clemastine

Marketing authorisation holder

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

1997-02-11

Date of renewal

2012-05-21

Documents

1012 Clemastinum PPH sirupas RPP 2024 03 01.docx

1012 Pakuotės lapelis sirupas 2024 03 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml sirupo yra	1 ml
Klemastinas	0,1 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
3874	482	1000482	buteliukas	100 ml ir taurelė (10 ml) N1		Receptinis	LT/1/97/1012/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2012-05-21	Perregistruotas
1997-02-11	Registruotas