MYCAPSSA Gastro-resistant hard capsule Ref.[50619] Active ingredients: Octreotide

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Amryt Pharmaceuticals DAC, 45 Mespil Road, Dublin 4, Ireland

Product name and form

Mycapssa 20 mg gastro-resistant hard capsules.

Pharmaceutical Form

Gastro-resistant hard capsule (gastro-resistant capsule).

White, size 0 enteric-coated hard gelatine capsules.

Qualitative and quantitative composition

Each gastro-resistant hard capsule contains octreotide acetate equivalent to 20 mg octreotide.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Octreotide

Octreotide is a synthetic octapeptide derivative of naturally occurring somatostatin with similar pharmacological effects, but with a considerably prolonged duration of action. It inhibits pathologically increased secretion of growth hormone (GH) and of peptides and serotonin produced within the GEP endocrine system.
List of Excipients

Povidone
Sodium caprylate
Magnesium chloride
Polysorbate 80
Glyceryl monocaprylate
Glyceryl tricaprylate
Gelatine
Titanium dioxide (E171)
Methacrylic acid – ethyl acrylate copolymer (1:1)
Talc
Triethyl citrate
Silica, colloidal anhydrous
Sodium hydrogen carbonate
Sodium laurilsulfate

Pack sizes and marketing

Polychlorotrifluoroethylene [PCTFE]/polyethylene [PE]/polyvinylchloride [PVC]-aluminium blisters.

Pack size of 28 gastro-resistant hard capsules.

Marketing authorization holder

Amryt Pharmaceuticals DAC, 45 Mespil Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/22/1690/001

Drugs

Drug Countries
MYCAPSSA Austria, Estonia, Croatia, Ireland, Italy, Lithuania, Poland, United States
 
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