PENTASA

Medicinal product

(Invented) name

PENTASA

Active substance (s)

Mesalazinas

Strength

1 g

Pharmaceutical form

žvakutės

Route (s) of administration

vartoti į tiesiąją žarną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A07EC02, Mesalazine

Marketing authorisation holder

Ferring GmbH, Vokietija

Date of authorisation

1996-07-11

Date of renewal

2010-05-12

Documents

1965 Pakuotės lapelis zvakutes 2025 01 21.docx

1965 PENTASA zvakutes PCS PL 2025 01 21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Vienoje žvakutėje yra	1 vnt.
Mesalazinas	1 g

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
2713	1535	1001535	lizdinė plokštelė	N28		Receptinis	LT/1/96/1965/007	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-05-12	Perregistruotas
1996-07-11	Registruotas