Somatuline Autogel

Medicinal product

(Invented) name

Somatuline Autogel

Active substance (s)

Lanreotidas

Strength

60 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H01CB03, Lanreotide

Marketing authorisation holder

IPSEN PHARMA, Prancūzija

Date of authorisation

2005-04-20

Date of renewal

2011-04-04

Documents

0197 Pakuotės lapelis 2025 04 01.docx

0197 Somatuline Autogel RPP 2025 04 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Švirkšte yra	0.5 ml
Lanreotidas	60 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
9266	13933	1013933	užpildytas švirkštas	0,5 ml su adata N1		Receptinis	LT/1/05/0197/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-04-04	Perregistruotas
2005-04-20	Registruotas