Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, Ireland
Revestive 5 mg powder and solvent for solution for injection.
| Pharmaceutical Form |
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Powder and solvent for solution for injection. The powder is white and the solvent is clear and colourless. |
One vial of powder contains 5 mg of teduglutide*.
After reconstitution, each vial contains 5 mg teduglutide in 0.5 ml of solution, corresponding to a concentration of 10 mg/ml.
* A glucagon-like peptide-2 (GLP-2) analogue produced in Escherichia coli cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Teduglutide |
Teduglutide is an analogue of GLP-2. The naturally occurring human glucagon-like peptide-2 (GLP-2) is a peptide secreted by L cells of the intestine which is known to increase intestinal and portal blood flow, inhibit gastric acid secretion, and decrease intestinal motility. In several nonclinical studies, teduglutide has been shown to preserve mucosal integrity by promoting repair and normal growth of the intestine through an increase of villus height and crypt depth. |
| List of Excipients |
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Powder: L-histidine Solvent: Water for injections |
Powder: 3 ml vial (glass) with rubber stopper (bromobutyl) containing 5 mg teduglutide.
Solvent: Pre-filled syringe (glass) with plungers (bromobutyl) containing 0.5 ml of solvent.
Pack sizes of 1 vial of powder with 1 pre-filled syringe or 28 vials of powder with 28 pre-filled syringes.
Not all pack sizes may be marketed.
Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, Ireland
EU/1/12/787/001
EU/1/12/787/002
Date of first authorisation: 30 August 2012
Date of latest renewal: 23 June 2017
| Drug | Countries | |
|---|---|---|
| REVESTIVE | Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, New Zealand, Poland, Romania, United Kingdom |
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