Myrelez

Medicinal product

(Invented) name

Myrelez

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

Amdipharm Limited, Airija

Date of authorisation

2021-05-24

Date of renewal

Documents

4747_4749 Pakuotės lapelis 2025 08 08.docx

4747_4749 Myrelez PL 2025 08 08.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3027/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Užpildytame 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
106551	92652	1092652	užpildytas švirkštas	0,5 ml ir saugioji adata N1		Receptinis	LT/1/21/4747/001	Netiekiama	-	-	No	-	-
106552	92653	1092653	užpildytas švirkštas	0,5 ml ir saugioji adata N3		Receptinis	LT/1/21/4747/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-05-24	Registruotas