FILGRASTIM MCG

Main information

  • Trade name:
  • FILGRASTIM MCG VIAL INJ
  • Dosage:
  • 300MCG(RECOMBINANT HUMAN GRANULOCYTE COLONY SIMULATING FACTOR (G-CSF) INJ,FILGRASTIM 300MCG INJ)
  • Pharmaceutical form:
  • INJ
  • Composition:
  • VIAL
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FILGRASTIM MCG VIAL INJ
    India
  • Language:
  • English

Other information

Status

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

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Udenyca, pegfilgrastim, Opinion date: 26-Jul-2018

Pending EC decision: Udenyca, pegfilgrastim, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Pelgraz, pegfilgrastim, Opinion date: 26-Jul-2018

Pending EC decision: Pelgraz, pegfilgrastim, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

5-7-2018

Blokhuis: jaarlijks 4 miljoen euro naar onderzoek Lifelines tot 2024

Blokhuis: jaarlijks 4 miljoen euro naar onderzoek Lifelines tot 2024

Derde onderzoeksronde Lifelines in 2019 van start Lifelines, de data- en biobank waarin informatie over de gezondheid van drie generaties inwoners in de noordelijke provincies gedurende dertig jaar wordt verzameld, start in 2019 met de derde onderzoeksronde onder alle Lifelines-deelnemers. Dit wordt mogelijk gemaakt door het Ministerie van VWS, de RUG en het UMCG en de provincies Groningen, Friesland en Drenthe. Deze gezamenlijke inzet weerspiegelt het belang van Lifelines voor zowel volksgezondheid, wet...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

4-6-2018

FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment

FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment

FDA approves Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer.

FDA - U.S. Food and Drug Administration

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

29-5-2018

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal...

FDA - U.S. Food and Drug Administration

27-4-2018

EpiPen 300 mcg adrenaline auto-injector

EpiPen 300 mcg adrenaline auto-injector

Medicine shortages

Therapeutic Goods Administration - Australia

21-11-2013

Danish Pharmacovigilance Update, 26 September 2013

Danish Pharmacovigilance Update, 26 September 2013

In this issue of Danish Pharmacovigilance Update: Filgrastim (Neupogen) and pegfilgrastim (Neulasta) are associated with risk of capillary leak syndrome.

Danish Medicines Agency

25-9-2018

Udenyca (ERA Consulting GmbH)

Udenyca (ERA Consulting GmbH)

Udenyca (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6290 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004413/0000

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

29-8-2018

Filgrastim Hexal (Hexal AG)

Filgrastim Hexal (Hexal AG)

Filgrastim Hexal (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5766 of Wed, 29 Aug 2018

Europe -DG Health and Food Safety

29-8-2018

Zarzio (Sandoz GmbH)

Zarzio (Sandoz GmbH)

Zarzio (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5764 of Wed, 29 Aug 2018

Europe -DG Health and Food Safety

27-8-2018

Nivestim (Pfizer Europe MA EEIG)

Nivestim (Pfizer Europe MA EEIG)

Nivestim (Active substance: Filgrastim) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5683 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1142/T/51

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Grastofil (Apotex Europe B.V.)

Grastofil (Apotex Europe B.V.)

Grastofil (Active substance: filgrastim) - Centralised - Yearly update - Commission Decision (2018)5228 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

29-5-2018

Withdrawn application:  Fulphila, pegfilgrastim, Initial authorisation

Withdrawn application: Fulphila, pegfilgrastim, Initial authorisation

Europe - EMA - European Medicines Agency

15-5-2018

Lonquex (UAB Sicor Biotech)

Lonquex (UAB Sicor Biotech)

Lonquex (Active substance: lipegfilgrastim) - Centralised - Renewal - Commission Decision (2018)3009 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2556/R/39

Europe -DG Health and Food Safety