Mycapssa

Medicinal product

(Invented) name

Mycapssa

Active substance (s)

Oktreotidas

Strength

20 mg

Pharmaceutical form

skrandyje neirios kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H01CB02, Octreotide

Marketing authorisation holder

Amryt Pharmaceuticals DAC, Airija

Date of authorisation

2022-12-02

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Gastro-resistant hard capsules	1 vnt.
Oktreotidas	20 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
109938	96045	1096045	lizdinė plokštelė	N28		Receptinis	EU/1/22/1690/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-26	Išregistruotas
2022-12-02	Registruotas