Rupafin

Medicinal product

(Invented) name

Rupafin

Active substance (s)

Rupatadinas

Strength

1 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)

R06AX28, Rupatadine

Marketing authorisation holder

Noucor Health, S.A., Ispanija

Date of authorisation

2012-04-02

Date of renewal

2016-12-08

Documents

1006 Pakuotės lapelis 2024 05 17.docx

1006 Rupafin ger tirp II PL 2024 05 17.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

ES/H/0105/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Rupatadinas	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
44293	58086	1058086	buteliukas	120 ml ir geriamasis švirkštas N1		Receptinis	LT/1/08/1006/009	Tiekiama	2025-05-14	-	No	-	-	Download

Stadijos

Data	Stadija
2016-12-08	Perregistruotas
2012-04-02	Registruotas