Desloratadine Sopharma

Medicinal product

(Invented) name

Desloratadine Sopharma

Active substance (s)

Desloratadinas

Strength

0,5 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R06AX27, Desloratadine

Marketing authorisation holder

SOPHARMA AD, Bulgarija

Date of authorisation

2015-06-16

Date of renewal

2020-01-24

Documents

3736 Desloratadine Sopharma PCS PL 2023 08 11.docx

3736 Pakuotės lapelis 2023 08 11.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0123/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml geriamojo tirpalo yra	1 ml
Desloratadinas	0,5 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
59480	73709	1073709	buteliukas	120 ml, taurelė ir geriamasis švirkštas N1		Receptinis	LT/1/15/3736/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2020-01-24	Perregistruotas
2015-06-16	Registruotas