PENTASA

Medicinal product

(Invented) name

PENTASA

Active substance (s)

Mesalazinas

Strength

4 g

Pharmaceutical form

pailginto atpalaidavimo granulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A07EC02, Mesalazine

Marketing authorisation holder

Ferring GmbH, Vokietija

Date of authorisation

2023-12-14

Date of renewal

Documents

1965, 5295 PENTASA granules PCS PL 2025 01 21.docx

PENTASA_4g_mesalazinas_viešas_AR.pdf

1965, 5295 Pakuotės lapelis granules 2025 01 21.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Paketėlyje yra:	1 vnt.
Mesalazinas	4 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
112283	98398	1098398	paketėlis	N30		Receptinis	LT/1/23/5295/001	Netiekiama	2026-05-12	2026-07-01	Yes	2026-05-14	2026-06-30

Stadijos

Data	Stadija
2023-12-14	Registruotas