Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Allergan Pharmaceuticals International Limited, Clonshaugh Business & Technology Park Dublin 17, D17 E400, Ireland
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. |
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 Capsule shell: Titanium dioxide (E171) Capsule ink: Shellac |
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.
Allergan Pharmaceuticals International Limited, Clonshaugh Business & Technology Park Dublin 17, D17 E400, Ireland
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
| Drug | Countries | |
|---|---|---|
| CONSTELLA | Austria, Canada, Estonia, Spain, Finland, Croatia, Ireland, Lithuania, Netherlands, New Zealand, Poland, United Kingdom |
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