Central Nervous System

Authorized indications:

Treatment of motor fluctuations (on-off phenomenon) in patients with Parkinson's disease insufficiently controlled by oral antiparkinsonian treatment. French industry.

Authorized indications:

Treatment of motor fluctuations (on-off phenomenon) in patients with Parkinson's disease insufficiently controlled by oral antiparkinsonian treatment.

Authorized indications:

VALTOCO® is indicated for the acute treatment of stereotypic, intermittent episodes of frequent seizure activity (e.g., seizure clusters, acute repetitive seizures) that are different from the patient's usual seizure pattern, in patients with epilepsy aged 6 years and older.

Authorized indications:

Teglutik® is indicated to extend life or time to mechanical ventilation in patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that riluzole extends survival for patients with ALS. Survival was defined as patients who were alive, without intubation for mechanical ventilation, and tracheotomy-free. There is no evidence that riluzole exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. In late stages of ALS, riluzole has not been shown to be effective. The safety and efficacy of riluzole have only been studied in ALS. Therefore, riluzole should not be used in patients with other form of motor neuron diseases.

Spanish industry

Authorized indications:

Indicated to improve neurological symptoms and motor disorders secondary to an Ischemic Cerebrovascular Accident (ICA). Administration must occur within the first 24 hours after symptom onset and should not exceed 14 days. EDARANOVAG^® is indicated to inhibit the progression of functional impairment in patients with Amyotrophic Lateral Sclerosis (ALS).

Authorized indications:

LEVENOVA® is indicated as monotherapy in the treatment of partial onset seizures in patients 16 years of age and older with a new epilepsy diagnosis. LEVENOVA® is indicated for concomitant therapy in the treatment of

• Partial onset seizures in patients 1 month of age and older with epilepsy.
• Myoclonic seizures in patients 12 years of age and older with Juvenile Myoclonic Epilepsy.
• Primary generalized tonic-clonic seizures in patients 12 years of age and older with Idiopathic generalized epilepsy.

Authorized indications:

• Aripiprazole is indicated for the treatment of schizophrenia (DSM IV) in adults and adolescents aged 15 years and over.
• Aripiprazole is indicated for the treatment of moderate to severe manic episodes in patients with bipolar I disorder (DSM IV) and for the prevention of new manic episodes in adults who have had predominantly manic episodes and who have responded to treatment with aripiprazole.
• Aripiprazole is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder (DSM IV) for up to 12 weeks in adolescents aged 13 years and older.

Indicaciones autorizadas:

Adults

• Olanzapine is indicated for the treatment of schizophrenia.
• Olanzapine is effective in maintaining clinical improvement during continuation therapy in patients who show an initial therapeutic response.
• Olanzapine is indicated for the treatment of moderate to severe manic episode.
• Olanzapine is indicated for the prevention of relapse in patients with bipolar disorder who have responded to treatment with olanzapine during the manic episode.

Authorized indications:

QUETIANOVA film-coated tablets are indicated for:

The treatment of schizophrenia (DSM IV). The treatment of bipolar disorder (DSM IV):

• The treatment of moderate to severe manic episodes in bipolar disorder.
• The treatment of major depressive episodes in bipolar disorder.
• The prevention of recurrence of manic or depressive episodes in patients with bipolar disorder who have previously responded to treatment with quetiapine (DSM IV). **

Authorized indications:

Treatment of major depressive episodes (according to DSM IV). Treatment of panic disorder with or without agoraphobia (according to DSM IV). Treatment of social anxiety disorder (social phobia) (according to DSM IV). Treatment of generalized anxiety disorder (according to DSM IV). Treatment of obsessive-compulsive disorder (according to DSM IV).

Portuguese industry

Authorized indications:

SERTRANOVA® is indicated in the treatment of: • Major depressive episodes. Prevention of recurrence of major depressive episodes. • Panic disorder, with or without agoraphobia • Obsessive-compulsive disorder in adults and pediatric patients aged 6-17 years • Social anxiety disorder • Post-traumatic stress disorder

Industria española

Authorized indications:

DONENOVA® is indicated for the symptomatic treatment of mild to moderately severe Alzheimer's disease.

Portuguese industry

Authorized indications:

NOZINAN® 

In adults:

• Acute psychotic states.
• Chronic psychotic states (schizophrenias; chronic non-schizophrenic delusions: paranoid delusions, chronic hallucinatory psychosis).
• In association with an antidepressant: short-term treatment of certain severe forms of major depressive episode. This association can only be made during the initial treatment period (first 4 to 6 weeks).