FANDHI

Main information

  • Trade name:
  • FANDHI 1/1/1 VIAL
  • Dosage:
  • 250IU.
  • Pharmaceutical form:
  • VIAL
  • Composition:
  • 1/1/1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FANDHI 1/1/1 VIAL
    India
  • Language:
  • English

Other information

Status

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

29-3-2018

FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse

FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse

FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse

FDA - U.S. Food and Drug Administration

28-3-2018

Orphan designation:  Recombinant fusion protein linking coagulation factor VIIa with albumin,  for the: Treatment of congenital factor VII deficiency

Orphan designation: Recombinant fusion protein linking coagulation factor VIIa with albumin, for the: Treatment of congenital factor VII deficiency

On 7 October 2013, orphan designation (EU/3/13/1188) was granted by the European Commission to CSL Behring GmbH, Germany, for recombinant fusion protein linking coagulation factor VIIa with albumin for the treatment of congenital factor VII deficiency.

Europe - EMA - European Medicines Agency

28-3-2018

Orphan designation:  Recombinant fusion protein linking human coagulation factor VIIa with human albumin,  for the: Treatment of haemophilia B

Orphan designation: Recombinant fusion protein linking human coagulation factor VIIa with human albumin, for the: Treatment of haemophilia B

On 13 May 2011, orphan designation (EU/3/11/863) was granted by the European Commission to CSL Behring GmbH, Germany, for recombinant fusion protein linking human coagulation factor VIIa with human albumin for the treatment of haemophilia B.

Europe - EMA - European Medicines Agency

13-2-2018

Comunicado de la FDA sobre la seguridad de los medicamentos: Nuevo factor de riesgo para la leucoencefalopatía multifocal progresiva (PML por sus siglas en inglés) relacionado con Tysabri (natalizumab)

Comunicado de la FDA sobre la seguridad de los medicamentos: Nuevo factor de riesgo para la leucoencefalopatía multifocal progresiva (PML por sus siglas en inglés) relacionado con Tysabri (natalizumab)

El 20 de enero del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) informó al público que ha identificado como factor de riesgo para la leucoencefalopatía multifocal progresiva (PML por sus siglas en inglés) la detección en pruebas de anticuerpos contra el virus JC. PML es una infección poco común pero grave del cerebro relacionada con el uso de Tysabri (natalizumab) para el tratamiento de esclerosis múltiple o enfermedad de Crohn.

FDA - U.S. Food and Drug Administration

13-2-2018

FDA Drug Safety Communication: UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy

FDA Drug Safety Communication: UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy

[11-03-2011] The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of Tumor Necrosis Factor (TNF) blockers and malignancy (cancer) in children, adolescents, and young adults (30 years of age or younger).

FDA - U.S. Food and Drug Administration

11-12-2017

FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)

FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)

[01-20-2012] The U.S. Food and Drug Administration (FDA) is informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML).

FDA - U.S. Food and Drug Administration

16-11-2017

FDA approves new treatment to prevent bleeding in certain patients with hemophilia A

FDA approves new treatment to prevent bleeding in certain patients with hemophilia A

FDA approves new treatment to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have Factor VIII inhibitors.

FDA - U.S. Food and Drug Administration

6-4-2018

EU/3/12/1072 (Le4D Limited)

EU/3/12/1072 (Le4D Limited)

EU/3/12/1072 (Active substance: Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotrophic factor) - Transfer of orphan designation - Commission Decision (2018)2008 of Fri, 06 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/11/T/01

Europe -DG Health and Food Safety

24-3-2018

Depression Could Be a Risk Factor for A-Fib: Study

Depression Could Be a Risk Factor for A-Fib: Study

Title: Depression Could Be a Risk Factor for A-Fib: StudyCategory: Health NewsCreated: 3/22/2018 12:00:00 AMLast Editorial Review: 3/23/2018 12:00:00 AM

US - MedicineNet

23-3-2018

EU/3/18/1999 (uniQure Biopharma B.V.)

EU/3/18/1999 (uniQure Biopharma B.V.)

EU/3/18/1999 (Active substance: Recombinant adeno-associated viral vector containing a codon-optimized Padua derivative of human coagulation factor IX cDNA) - Orphan designation - Commission Decision (2018)1888 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/232/17

Europe -DG Health and Food Safety

23-3-2018

COAGADEX (Coagulation Factor X Human) Kit [Bio Products Laboratory Limited]

COAGADEX (Coagulation Factor X Human) Kit [Bio Products Laboratory Limited]

Updated Date: Mar 23, 2018 EST

US - DailyMed

22-3-2018

FDA has a new update to the ongoing lead test investigation. A chemical interference from tube stoppers is a contributing factor  https://go.usa.gov/xQx6e 

FDA has a new update to the ongoing lead test investigation. A chemical interference from tube stoppers is a contributing factor https://go.usa.gov/xQx6e 

FDA has a new update to the ongoing lead test investigation. A chemical interference from tube stoppers is a contributing factor https://go.usa.gov/xQx6e 

FDA - U.S. Food and Drug Administration

21-3-2018

EU/3/15/1595 (Quintiles Ireland Limited)

EU/3/15/1595 (Quintiles Ireland Limited)

EU/3/15/1595 (Active substance: Live attenuated Listeria monocytogenes bioengineered with a chimeric human epidermal growth factor receptor 2 fused to a truncated form of the Lm protein listeriolysin O) - Transfer of orphan designation - Commission Decision (2018)1819 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/162/15/5T/01

Europe -DG Health and Food Safety

1-3-2018

One Key Factor Raises Gay and Lesbian Teens' Suicide Risk

One Key Factor Raises Gay and Lesbian Teens' Suicide Risk

Title: One Key Factor Raises Gay and Lesbian Teens' Suicide RiskCategory: Health NewsCreated: 2/27/2018 12:00:00 AMLast Editorial Review: 2/28/2018 12:00:00 AM

US - MedicineNet

26-2-2018

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Active substance: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor) - Orphan designation - Commission Decision (2018)1246 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/189/17

Europe -DG Health and Food Safety

7-2-2018

Noise May be Risk Factor for Heart Disease: Study

Noise May be Risk Factor for Heart Disease: Study

Title: Noise May be Risk Factor for Heart Disease: StudyCategory: Health NewsCreated: 2/6/2018 12:00:00 AMLast Editorial Review: 2/6/2018 12:00:00 AM

US - MedicineNet

24-1-2018

ADVATE (Antihemophilic Factor (Recombinant)) Kit [Baxalta US Inc.]

ADVATE (Antihemophilic Factor (Recombinant)) Kit [Baxalta US Inc.]

Updated Date: Jan 24, 2018 EST

US - DailyMed

24-1-2018

ADVATE (Antihemophilic Factor, Human Recombinant) Kit [Baxalta US Inc.]

ADVATE (Antihemophilic Factor, Human Recombinant) Kit [Baxalta US Inc.]

Updated Date: Jan 24, 2018 EST

US - DailyMed

19-1-2018

BDNF (Brain-Derived Neurotrophic Factor Human) Spray [VIATREXX BIO INCORPORATED]

BDNF (Brain-Derived Neurotrophic Factor Human) Spray [VIATREXX BIO INCORPORATED]

Updated Date: Jan 19, 2018 EST

US - DailyMed

10-1-2018

OBIZUR (Antihemophilic Factor (Recombinant), Porcine Sequence) Kit [Baxalta US Inc.]

OBIZUR (Antihemophilic Factor (Recombinant), Porcine Sequence) Kit [Baxalta US Inc.]

Updated Date: Jan 10, 2018 EST

US - DailyMed

3-1-2018

VONVENDI (Von Willebrand Factor (Recombinant)) Kit [Baxalta US Inc.]

VONVENDI (Von Willebrand Factor (Recombinant)) Kit [Baxalta US Inc.]

Updated Date: Jan 3, 2018 EST

US - DailyMed

2-1-2018

PROFILNINE (Factor Ix Complex) Kit [GRIFOLS USA, LLC]

PROFILNINE (Factor Ix Complex) Kit [GRIFOLS USA, LLC]

Updated Date: Jan 2, 2018 EST

US - DailyMed

29-12-2017

ALPHANINE SD (Coagulation Factor Ix (Human)) Kit [GRIFOLS USA, LLC]

ALPHANINE SD (Coagulation Factor Ix (Human)) Kit [GRIFOLS USA, LLC]

Updated Date: Dec 29, 2017 EST

US - DailyMed

15-12-2017

Rheumatoid Factor (RF)

Rheumatoid Factor (RF)

Title: Rheumatoid Factor (RF)Category: Procedures and TestsCreated: 1/28/2002 12:00:00 AMLast Editorial Review: 12/15/2017 12:00:00 AM

US - MedicineNet

1-12-2017

REBINYN ((Coagulation Factor Ix (Recombinant), Glycopegylated)) Kit [Novo Nordisk]

REBINYN ((Coagulation Factor Ix (Recombinant), Glycopegylated)) Kit [Novo Nordisk]

Updated Date: Dec 1, 2017 EST

US - DailyMed

29-11-2017

RIXUBIS (Coagulation Factor Ix (Recombinant)) Kit [BAXALTA US INC.]

RIXUBIS (Coagulation Factor Ix (Recombinant)) Kit [BAXALTA US INC.]

Updated Date: Nov 29, 2017 EST

US - DailyMed

20-11-2017

KOGENATE Bayer (Bayer AG)

KOGENATE Bayer (Bayer AG)

KOGENATE Bayer (Active substance: Recombinant coagulation factor VIII (octocog alfa)) - Referral - Commission Decision (2017)7811 of Mon, 20 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/275/A31/185

Europe -DG Health and Food Safety

20-11-2017

Helixate NexGen (Bayer AG)

Helixate NexGen (Bayer AG)

Helixate NexGen (Active substance: Recombinant coagulation factor VIII (octocog alfa)) - Referral - Commission Decision (2017)7812 of Mon, 20 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/276/A31/178

Europe -DG Health and Food Safety

16-11-2017

BEBULIN (Coagulation Factor Ix Human) Kit [Baxalta Incorporated]

BEBULIN (Coagulation Factor Ix Human) Kit [Baxalta Incorporated]

Updated Date: Nov 16, 2017 EST

US - DailyMed

13-11-2017

Human coagulation factor VIII

Human coagulation factor VIII

Human coagulation factor VIII (Active substance: Human coagulation factor VIII) - Community Referrals - Art 31 - Commission Decision (2017)7630 of Mon, 13 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1448

Europe -DG Health and Food Safety

31-10-2017

KOVALTRY (Antihemophilic Factor (Recombinant)) Kit [Bayer HealthCare LLC]

KOVALTRY (Antihemophilic Factor (Recombinant)) Kit [Bayer HealthCare LLC]

Updated Date: Oct 31, 2017 EST

US - DailyMed

30-10-2017

Scientific guideline:  Draft guideline on clinical investigation of recombinant and 4 human plasma-derived factor VIII products, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of recombinant and 4 human plasma-derived factor VIII products, draft: consultation open

This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor VIII products is made for use in treatment and prevention of bleeding in patients with haemophilia A. The guidance covers clinical investigations to be conducted pre- and post-marketing authorisation. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.

Europe - EMA - European Medicines Agency

30-10-2017

Scientific guideline:  Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products, draft: consultation open

Scientific guideline: Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products, draft: consultation open

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor VIII products, which are indicated for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). In case of an indication claim in von Willebrand’s disease, see also core SmPC for von Willebrand factor products (CPMP/BPWG/278/02).

Europe - EMA - European Medicines Agency