Valdoxan Les Laboratoires Servier · Authorised · authorised 19 Feb 2009 · ATC N06AX22
Therapeutic indication (EMA)
Treatment of major depressive episodes in adults.
Active substance
Agomelatine
- SFDA 1
- EMA 4
- NHS prices 1
- Safety 9
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| VALDOXAN 25MG FILM COATED TABLET | 25 mg | Film-coated tablet · Oral use | 28 Blister | SAR 104.95 | NCE · Prescription | SERVIER | Valid |
Indications — CHI Daman Drug Formulary
ANXIETY DISORDERS; DEPRESSION; INSOMNIA; JET LAG - INSOMNIA
EMA European Union — centrally authorised medicines
Valdoxan Les Laboratoires Servier · Refused
Thymanax Les Laboratoires Servier · Refused
Thymanax Servier (Ireland) Industries Ltd · Withdrawn · authorised 19 Feb 2009 · ATC N06AX22
Therapeutic indication (EMA)
Treatment of major depressive episodes in adults.
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| NHS Drug Tariff | Agomelatine 25mg tablets | £26.60 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- EMA PRAC 2 Sep 2016 PRAC signal: Leukopenia
Action for MAH: update of the product information: No - EMA PRAC 2 Sep 2016 PRAC signal: Urinary retention
Action for MAH: update of the product information: Yes - EMA PRAC 14 Apr 2016 PRAC signal: Leukopenia
Action for MAH: update of the product information: No - EMA PRAC 14 Apr 2016 PRAC signal: Urinary retention
Action for MAH: update of the product information: No - MHRA 11 Dec 2014 Agomelatine (Valdoxan): risk of liver toxicity
Reminder to test liver function before and during treatment. - MHRA 11 Dec 2014 Agomelatine (Valdoxan/ Thymanax): risk of dose-related hepatotoxicity and liver failure
Liver function tests should be carried out at treatment initiation, during treatment, and also when the dose is increased. - EMA PRAC 10 Oct 2013 PRAC signal: Electrocardiogram QT prolonged
Action for MAH: update of the product information: No - EMA PRAC 16 May 2013 PRAC signal: Electrocardiogram QT prolonged
Action for MAH: update of the product information: No - EMA PRAC 29 Nov 2012 PRAC signal: Angioedema
Action for MAH: update of the product information: Yes
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.