CONSTELLA Hard capsule Ref.[7660] Active ingredients: Linaclotide

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Allergan Pharmaceuticals International Limited, Clonshaugh Business & Technology Park Dublin 17, D17 E400, Ireland

Product name and form

Constella 290 micrograms hard capsules.

Pharmaceutical Form

Hard capsule.

White to off-white-orange opaque capsule (18 mm x 6.35 mm) marked “290” with grey ink.

Qualitative and quantitative composition

Each capsule contains 290 micrograms of linaclotide.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Linaclotide

Linaclotide is a Guanylate Cyclase-C receptor agonist (GCCA) with visceral analgesic and secretory activities. Through its action at GC-C, linaclotide has been shown to reduce visceral pain and increase GI transit in animal models and increase colonic transit in humans.

List of Excipients

Capsule contents:

Microcrystalline cellulose
Hypromellose 4-6 mPa’s – substitution type 2910
Calcium chloride dihydrate
Leucine

Capsule shell:

Titanium dioxide (E171)
Gelatin
Red iron oxide (E172)
Yellow iron oxide (E172)

Capsule ink:

Shellac
Propylene glycol
Concentrated ammonia solution
Potassium hydroxide
Titanium dioxide (E171)
Black iron oxide (E172)

Pack sizes and marketing

White high density polyethylene (HDPE) bottle with a tamper evident seal and a child-resistant closure, together with one or more desiccant canisters containing silica gel.

Pack sizes: 10, 28 or 90 capsules and multipacks containing 112 (4 packs of 28) capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Allergan Pharmaceuticals International Limited, Clonshaugh Business & Technology Park Dublin 17, D17 E400, Ireland

Marketing authorization dates and numbers

EU/1/12/801/001
EU/1/12/801/002
EU/1/12/801/004
EU/1/12/801/005

Date of first authorisation: 26 November 2012

Date of latest renewal: 28 August 2017

Drugs

Drug Countries
CONSTELLA Austria, Canada, Estonia, Spain, Finland, Croatia, Ireland, Lithuania, Netherlands, New Zealand, Poland, United Kingdom

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