FEBUSTAT
Main information
- Trade name:
- FEBUSTAT 10 TAB
- Active ingredient:
- FEBUXOSTAT
- Available from:
- Piramal Hc.
- Dosage:
- 120MG
- Pharmaceutical form:
- TAB
- Composition:
- 10
- Medicine domain:
- Humans
- Medicine type:
- Allopathic drug
Documents
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
India
- Language:
- English
Other information
Status
- Source:
- Central Drugs Standard Control Organization
- Last update:
- 09-08-2016
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- Access to this document is only available to registered users.
Register now for full access
27-3-2018
Human medicines European public assessment report (EPAR): Adenuric, febuxostat, Revision: 16, Authorised
Europe - EMA - European Medicines Agency
15-2-2018
Opinion/decision on a Paediatric investigation plan (PIP): Adenuric, Febuxostat, Therapeutic area: Oncology
Europe - EFSA - European Food Safety Authority EFSA Journal
15-11-2017
Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death
Preliminary safety trial results in over 6,000 patients with gout being evaluated.
FDA - U.S. Food and Drug Administration
15-11-2017
FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)
The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new inf...
FDA - U.S. Food and Drug Administration
19-10-2017
Human medicines European public assessment report (EPAR): Febuxostat Mylan, febuxostat, Revision: 0, Authorised
Europe - EMA - European Medicines Agency
24-4-2017
Human medicines European public assessment report (EPAR): Adenuric, febuxostat, Revision: 15, Authorised
Europe - EMA - European Medicines Agency
7-3-2018
Adenuric (Menarini International Operations Luxembourg S.A.)
Adenuric (Active substance: febuxostat) - PSUSA - Modification - Commission Decision (2018) 1483 of Wed, 07 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/777/PSUSA/1353/201704
Europe -DG Health and Food Safety
23-10-2017
ULORIC (Febuxostat) Tablet [Aphena Pharma Solutions - Tennessee, LLC]
Updated Date: Oct 23, 2017 EST
US - DailyMed
24-8-2017
ULORIC (Febuxostat) Tablet [Takeda Pharmaceuticals America, Inc.]
Updated Date: Aug 24, 2017 EST
US - DailyMed
19-6-2017
Febuxostat Mylan (Mylan S.A.S.)
Febuxostat Mylan (Active substance: febuxostat) - Centralised - Authorisation - Commission Decision (2017)4267 of Mon, 19 Jun 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/4374
Europe -DG Health and Food Safety