EPILEX

Main information

  • Trade name:
  • EPILEX 100 ML SYR
  • Dosage:
  • 200MG/5ML
  • Pharmaceutical form:
  • SYR
  • Composition:
  • 100 ML
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EPILEX 100 ML SYR
    India
  • Language:
  • English

Other information

Status

  • Source:
  • Central Drugs Standard Control Organization
  • Last update:
  • 09-08-2016

17-10-2014

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) recommends strengthening the restrictions on the use of the antiepileptic valproate due to the risk of malformations and developmental problems in children exposed to valproate in the womb.

Danish Medicines Agency

23-3-2018

News and press releases:  New measures to avoid valproate exposure in pregnancy endorsed

News and press releases: New measures to avoid valproate exposure in pregnancy endorsed

Member State representatives agree new restrictions and pregnancy prevention programme

Europe - EMA - European Medicines Agency

9-2-2018

News and press releases:  Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2018

News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2018

PRAC gives recommendations for valproate, flupirtine, retinoids and interim advice for Esmya

Europe - EMA - European Medicines Agency

9-2-2018

News and press releases:  PRAC recommends new measures to avoid valproate exposure in pregnancy

News and press releases: PRAC recommends new measures to avoid valproate exposure in pregnancy

New restrictions on use; pregnancy prevention programme to be put in place

Europe - EMA - European Medicines Agency

24-1-2018

VALPROATE SODIUM Injection [West-Ward Pharmaceuticals Corp]

VALPROATE SODIUM Injection [West-Ward Pharmaceuticals Corp]

Updated Date: Jan 24, 2018 EST

US - DailyMed

13-11-2017

DIVALPROEX SODIUM (Valproate Semisodium) Capsule [AbbVie Inc.]

DIVALPROEX SODIUM (Valproate Semisodium) Capsule [AbbVie Inc.]

Updated Date: Nov 13, 2017 EST

US - DailyMed

8-11-2017

Divalproex Sodium

Divalproex Sodium

Divalproex sodium is a stable coordination compound comprised of sodium valproate and valproic acid used to treat manic episodes associated with bipolar disorder, epilepsy, and migraine headaches.

US - RxList

26-9-2017

News and press releases:  EMA’s first public hearing: giving EU citizens a voice to help reduce the risk of valproate

News and press releases: EMA’s first public hearing: giving EU citizens a voice to help reduce the risk of valproate

Live broadcast on 26 September from 12:45 to 18:00 UK time

Europe - EMA - European Medicines Agency

22-9-2017

Agenda:  Agenda - Public hearing: Valproate

Agenda: Agenda - Public hearing: Valproate

Europe - EMA - European Medicines Agency

1-9-2017

News and press releases:  Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August-1 September 2017

News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August-1 September 2017

PRAC concludes two referrals; PRAC approves the list of participants and the agenda for the public hearing on valproate

Europe - EMA - European Medicines Agency

11-7-2017

News and press releases:  EMA seeks views of public during its safety review of valproate

News and press releases: EMA seeks views of public during its safety review of valproate

Registration opens for first public hearing

Europe - EMA - European Medicines Agency

7-7-2017

News and press releases:  Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 July 2017

News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 July 2017

PRAC concluded two referrals and issued provisional measures for treatment of multiple sclerosis; PRAC aware of contraindication for valproate in France

Europe - EMA - European Medicines Agency