FLUBIP

Main information

  • Trade name:
  • FLUBIP 5 ML E/E DPS
  • Dosage:
  • 0.03,0.25,0.002;% W/V
  • Pharmaceutical form:
  • E/E DPS
  • Composition:
  • 5 ML
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLUBIP 5 ML E/E DPS
    India
  • Language:
  • English

Other information

Status

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

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/14/1363 (Quintiles Ireland Limited)

EU/3/14/1363 (Quintiles Ireland Limited)

EU/3/14/1363 (Active substance: 4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid) - Transfer of orphan designation - Commission Decision (2018)1818 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/14/T/01

Europe -DG Health and Food Safety

26-2-2018

EU/3/18/1988 (Chiesi Farmaceutici S.p.A.)

EU/3/18/1988 (Chiesi Farmaceutici S.p.A.)

EU/3/18/1988 (Active substance: (R)-2-(5-cyano-2-(6-(methoxycarbonyl)-7-methyl-3-oxo-8-(3-(trifluoromethyl)phenyl)-2,3,5,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrimidine-5-yl)phenyl)-N,N,N-trimethylethanaminium methanesulfonate dehydrate) - Orphan designation - Commission Decision (2018)1255 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/203/17

Europe -DG Health and Food Safety

13-2-2018

EU/3/10/802 (Genkyotex S.A.)

EU/3/10/802 (Genkyotex S.A.)

EU/3/10/802 (Active substance: 2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione) - Transfer of orphan designation - Commission Decision (2018)939 of Tue, 13 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/10/T/02

Europe -DG Health and Food Safety

13-2-2018

EU/3/15/1559 (Genkyotex S.A.)

EU/3/15/1559 (Genkyotex S.A.)

EU/3/15/1559 (Active substance: 2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione) - Transfer of orphan designation - Commission Decision (2018)944 of Tue, 13 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/105/15/T/01

Europe -DG Health and Food Safety

6-2-2018

EU/3/07/478 (ICON Clinical Research Limited)

EU/3/07/478 (ICON Clinical Research Limited)

EU/3/07/478 (Active substance: N- (2-Amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide) - Transfer of orphan designation - Commission Decision (2018)697 of Tue, 06 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/07/T/03

Europe -DG Health and Food Safety

5-2-2018

EU/3/07/526 (ICON Clinical Research Limited)

EU/3/07/526 (ICON Clinical Research Limited)

EU/3/07/526 (Active substance: N- (2-Amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide) - Transfer of orphan designation - Commission Decision (2018)698 of Mon, 05 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/07/T/03

Europe -DG Health and Food Safety

19-1-2018

EU/3/17/1967 (Millendo Therapeutics Ltd)

EU/3/17/1967 (Millendo Therapeutics Ltd)

EU/3/17/1967 (Active substance: N-[2,6-bis(1-methylethyl)phenyl]-N'-[[1-[4-(dimethylamino)phenyl]cyclopentyl]methyl]urea, hydrochloride salt) - Orphan designation - Commission Decision (2018)389 of Fri, 19 Jan 2018 European Medicines Agency (EMA) procedure number: EMA/OD/179/17

Europe -DG Health and Food Safety

25-8-2017

EU/3/17/1902 (Eisai Europe Limited)

EU/3/17/1902 (Eisai Europe Limited)

EU/3/17/1902 (Active substance: N-{2-[(6-{[(2,6-dichloro-3,5-dimethoxyphenyl)carbamoyl](methyl)amino}pyrimidin-4-yl)amino]-5-(4-ethylpiperazin-1-yl)phenyl}prop-2-enamide) - Orphan designation - Commission Decision (2017)5911 of Fri, 25 Aug 2017 European Medicines Agency (EMA) procedure number: EMA/OD/052/17

Europe -DG Health and Food Safety