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20 September 2012 EMA/CHMPCommittee for Medicinal Products for Human Use (CHMP) CHMP assessment report Constella
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Document Date: 2013-07-21 06:37:37

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City

Rome / London / /

Company

AAA ACE ADO ADR AE / IR IS ISS ITT IV IVRS K2EDTA LC / RW SA SAE / Almirall S.A. / Procedure Acetate Ironwood Pharmaceuticals / /

Country

United States / United Kingdom / /

Currency

pence / /

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Event

Product Recall / Product Issues / FDA Phase / /

Facility

A stable / Canary Wharf / /

IndustryTerm

above medicinal product / food allergies / herbal products / treatment of moderate to severe irritable bowel syndrome / authorised orphan medicinal product / bowel gas / pharmaceuticals / authorised orphan medicinal products / symptom-based diagnostic systems / /

MedicalCondition

chronic stable disorder / Constipation Irritable Bowel Syndrome / altered motor dysfunction / Irritable Bowel Syndrome Irritable Bowel Syndrome / chronic renal failure / bloating / common disorder / interstitial cystitis / syncope / sensory dysfunction / food allergies / viral enteric infections / cystic fibrosis transmembrane conductance regulator / constipation / MS / Summary Irritable bowel syndrome / once organic diseases / chronic pelvic pain / abdominal pain / subclinical inflammation / disease / e.g. fibromyalgia / functional gastrointestinal disorder / pain / GERD / chronic functional gastrointestinal disorder / diabetes mellitus / severe irritable bowel syndrome / diseases / dizziness / Irritable Bowel Syndrome / depression / dehydration / /

MedicalTreatment

antibiotics / Psychological therapies / cognitive behavioural therapy / /

NaturalFeature

Clinically Important Difference Chloride Channel / /

Organization

Case Report Form Complete Spontaneous Bowel Movement / Food and Drug Administration / Committee for Medicinal Products for Human Use / U.S. Securities and Exchange Commission / European Medicines Agency’s Committee for Medicinal Products for Human Use / E-mail info@ema.europa.eu Website www.ema.europa.eu An / European Medicines Agency / FDA / Bowel Movement / European Union / /

Person

Harald Enzmann / ELISA EMA EQ / SPE TEAE ULN ULOQ / LS LSMD LTS MCP / /

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Position

contents Executive / /

Product

EMA/709077/2012 Relative Standard Deviation Randomized / data / MM-420026 / Change Pharmacokinetics oral / 15N13C9 / /

Technology

population pharmacokinetics Per Protocol / X-ray / sorption / tomography / Interactive Voice Response System / Pharmacokinetics / /

URL

www.ema.europa.eu / /

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