Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: PIERRE FABRE MEDICAMENT, Les Cauquillous, 81500 Lavaur, France
Obgemsa 75 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet (tablet). Light green oval film-coated tablet, debossed with V75 on one side and plain on the other side. Tablet dimension is approximately 9 mm (length) x 4 mm (width) × 3 mm (height). |
Each film-coated tablet contains 75 mg of vibegron.
Excipient with known effect: Each film-coated tablet contains 1.5 mg of lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Vibegron |
Vibegron is a selective and potent human beta-3 adrenergic receptor agonist over β1-AR and β2-AR. Activation of the beta-3 adrenergic receptor located in the bladder detrusor muscle increases bladder capacity by relaxing the detrusor smooth muscle during bladder filling. |
| List of Excipients |
|---|
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Core tablet: Mannitol Film coating: Indigo carmine aluminium lake (E132) |
HDPE white, square or round bottle respectively closed with a child resistant polypropylene (PP) cap and an inner seal containing a polyethylene (PE) layer in contact with the tablets. Each bottle contains 7, 30 or 90 film-coated tablets.
Not all pack sizes may be marketed.
PIERRE FABRE MEDICAMENT, Les Cauquillous, 81500 Lavaur, France
EU/1/24/1822/001 7 film-coated tablets in round bottle
EU/1/24/1822/002 30 film-coated tablets in round bottle
EU/1/24/1822/003 90 film-coated tablets in round bottle
EU/1/24/1822/004 7 film-coated tablets in square bottle
EU/1/24/1822/005 30 film-coated tablets in square bottle
EU/1/24/1822/006 90 film-coated tablets in square bottle
| Drug | Countries | |
|---|---|---|
| OBGEMSA | Lithuania |
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