Product Information

Registration Status: Active

FLUVOXAMINE MALEATE TABLET 50MG is approved to be sold in Singapore with effective from 2002-02-26. It is marketed by PHARMLINE MARKETING PTE LTD, with the registration number of SIN11823P.

This product contains Fluvoxamine 50mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.

This product is manufactured by ROTTENDORF PHARMA GMBH in GERMANY.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.



Fluvoxamine is an antidepressant which functions pharmacologically as a selective serotonin reuptake inhibitor. Though it is in the same class as other SSRI drugs, it is most often used to treat obsessive-compulsive disorder. Fluvoxamine has been in use in clinical practice since 1983 and has a clinical trial database comprised of approximately 35,000 patients. It was launched in the US in December 1994 and in Japan in June 1999. As of the end of 1995, more than 10 million patients worldwide have been treated with fluvoxamine.


Indicated predominantly for the management of depression and for Obsessive Compulsive Disorder (OCD) [FDA Label]. Has also been used in the management of bulimia nervosa [A250].

Mechanism of Action

The exact mechanism of action of fluvoxamine has not been fully determined, but appears to be linked to its inhibition of CNS neuronal uptake of serotonin [FDA Label, A249, A250]. Fluvoxamine blocks the reuptake of serotonin at the serotonin reuptake pump of the neuronal membrane, enhancing the actions of serotonin on 5HT1A autoreceptors [FDA Label, A249, A250]. Studies have also demonstrated that fluvoxamine has virtually no affinity for α1- or α2-adrenergic, β-adrenergic, muscarinic, dopamine D2, histamine H1, GABA-benzodiazepine, opiate, 5-HT1, or 5-HT2 receptors, despite having an affinity for binding to σ1 receptors [A250].


Well absorbed, bioavailability of fluvoxamine maleate is 53% [FDA Label].
* 25 L/kg [FDA Label].
Fluvoxamine is metabolized extensively by the liver [FDA Label].


Fluvoxamine is a member of antidepressants that possess an increased risk compared to placebo of suicidal thinking and behaviour (suicidality) in children, adolescents, and young adults (ages including and and below 24) in short-term studies of major depressive disorder and other psychiatric disorders [FDA Label]. Fluvoxamine maleate tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) [FDA Label]. Side effects include anorexia, constipation, dry mouth, headache, nausea, nervousness, skin rash, sleep problems, somnolence, liver toxicity, mania, increase urination, seizures, sweating increase, tremors, or Tourette's syndrome [FDA Label].

Active Ingredient/Synonyms

Fluvoxamina | Fluvoxamine | Fluvoxaminum | Fluvoxamine |

Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.


  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank