Available EU DMF/CEP
EU DMF
CEP
API Status
Commercial
Pipeline
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
Opthalmological preparations
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Available US DMF
US DMF
Available Japanese/Chinese DMF
Japanese DMF
Chinese DMF
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R-Baclofen

CAS No.

69308-37-8

Innovator/marketer

N/A

Polymorphic form

Form B

Therapeutic Area

Musculo-skeletal system

Status

Commercial

EU DMF readiness

US DMF readiness

031824

Drug description:

Baclofen is a muscle relaxer and an antispastic agent.
Baclofen is indicated for the relief of spasticity of voluntary muscle resulting from disorders such as multiple sclerosis and other spinal lesions, including tumours of the spinal cord, motor neurone disease, syringomyelia, transverse myelitis and traumatic partial section of the spinal cord. Baclofen is indicated for adults and children in the relief of spasticity of voluntary muscle arising from conditions such as cerebral palsy, cerebrovascular accidents, traumatic head injury and meningitis.

Mechanism of action:

Arbaclofen acts as selective GABAB receptors agonist. GABA (gamma-aminobutyric acid) is the major inhibitory neurotransmitter in the brain. Its production, release, re-uptake and metabolism occur in the nervous system.

DISCLAIMER
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).

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