PSILO-BALSAM

Medicinal product

(Invented) name

PSILO-BALSAM

Active substance (s)

Difenhidraminas

Strength

10 mg/g

Pharmaceutical form

gelis

Route (s) of administration

vartoti ant odos

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D04AA32, Diphenhydramine

Marketing authorisation holder

STADA Arzneimittel AG, Vokietija

Date of authorisation

1994-12-20

Date of renewal

2007-06-20

Documents

0765_1 PSILO_BALSAM gelis PZ PL 181015.docx

0765_1 Pakuotės lapelis 181015.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g gelio yra	1 g
Difenhidraminas	10 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
774	6675	1006675	tūbelė	20 g, N1		Nereceptinis	LT/1/94/0765/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-06-20	Perregistruotas
1994-12-20	Registruotas