← Drug database

Mycapssa (octreotide)

Region
🇪🇺 EU
Active substance
octreotide
Company
Amryt Pharmaceuticals DAC
Status
Withdrawn
Therapeutic area
Acromegaly
CHMP opinion
Thu 15 Sep 2022
EU approval
Fri 02 Dec 2022
Application
EMEA/H/C/005826
ATC
H01CB02
Official record
www.ema.europa.eu

Indication

Mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

Follow Mycapssa

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.