EU-B12

Main information

  • Trade name:
  • EU-B12 10 CAP
  • Pharmaceutical form:
  • CAP
  • Composition:
  • 10
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EU-B12 10 CAP
    India
  • Language:
  • English

Other information

Status

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

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

16-3-2018

Tobacco and related products

Tobacco and related products

The Tobacco Products Directive (2014/40/EU) lays down rules relating to the manufacture, presentation and sale of tobacco and related products (other smoking products, vaping products). While it does not establish a marketing authorisation system, the Directive requires manufacturers and importers to declare these products to the competent authorities of the Member States before they can be marketed. Their composition, emissions, toxicological data on the ingredients, in-depth studies for certain additiv...

France - Agence Nationale du Médicament Vétérinaire

13-3-2018

Orphan designation:  Itacitinib,  for the: EU/3/17/1964

Orphan designation: Itacitinib, for the: EU/3/17/1964

Europe - EMA - European Medicines Agency

8-3-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on effort to help bolster U.S. shellfish market by taking mutually beneficial steps to resume shellfish trade with the EU

Statement from FDA Commissioner Scott Gottlieb, M.D., on effort to help bolster U.S. shellfish market by taking mutually beneficial steps to resume shellfish trade with the EU

FDA announces proposed shellfish equivalence determination with the EU that will create new market access for U.S. exporters as well as make a wider selection of healthy and safe shellfish options available to consumers. It will also assure American consumers that imported molluscan shellfish from Europe is as safe as what we produce in the U.S.

FDA - U.S. Food and Drug Administration

6-3-2018

Orphan designation:  Carbetocin,  for the: Treatment of Prader-Willi syndrome

Orphan designation: Carbetocin, for the: Treatment of Prader-Willi syndrome

On 21 March 2012, orphan designation (EU/3/12/975) was granted by the European Commission to Ferring Pharmaceuticals A/S, Denmark, for carbetocin for the treatment of Prader-Willi syndrome.

Europe - EMA - European Medicines Agency

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2013 (Roche Registration Limited)

EU/3/18/2013 (Roche Registration Limited)

EU/3/18/2013 (Active substance: Polatuzumab vedotin) - Orphan designation - Commission Decision (2018)2409 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/231/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (Active substance: Genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII) - Orphan designation - Commission Decision (2018)2408 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2011 (Ultragenyx Germany GmbH)

EU/3/18/2011 (Ultragenyx Germany GmbH)

EU/3/18/2011 (Active substance: Burosumab) - Orphan designation - Commission Decision (2018)2407 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/026/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2010 (Novartis Europharm Limited)

EU/3/18/2010 (Novartis Europharm Limited)

EU/3/18/2010 (Active substance: Branaplam) - Orphan designation - Commission Decision (2018)2406 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/249/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (Active substance: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo) - Orphan designation - Commission Decision (2018)2405 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/246/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety

18-4-2018

VITAMIN B12 3000 (Cyanocobalamin) Injection [Vedco, Inc.]

VITAMIN B12 3000 (Cyanocobalamin) Injection [Vedco, Inc.]

Updated Date: Apr 18, 2018 EST

US - DailyMed

18-4-2018

VITAMIN B12 (Cyanocobalamin) Injection, Solution [Vedco, Inc.]

VITAMIN B12 (Cyanocobalamin) Injection, Solution [Vedco, Inc.]

Updated Date: Apr 18, 2018 EST

US - DailyMed

17-4-2018

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Active substance: Ornithine phenylacetate) - Transfer of orphan designation - Commission Decision (2018)2355 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/105/11/T/03

Europe -DG Health and Food Safety

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

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

29-3-2018

B12 INJECT KIT (Cyanocobalamin) Kit [Oaklock, LLC]

B12 INJECT KIT (Cyanocobalamin) Kit [Oaklock, LLC]

Updated Date: Mar 29, 2018 EST

US - DailyMed

28-3-2018

EU/3/04/241 (Roche Registration GmbH)

EU/3/04/241 (Roche Registration GmbH)

EU/3/04/241 (Active substance: Pirfenidone) - Transfer of orphan designation - Commission Decision (2018)2006 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/052/04/T/03

Europe -DG Health and Food Safety

28-3-2018

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Active substance: Chimeric monoclonal antibody against claudin-18 splice variant 2) - Transfer of orphan designation - Commission Decision (2018)2007 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/083/10/T/01

Europe -DG Health and Food Safety

28-3-2018

EU/3/13/1177 (Astellas Pharma Europe B.V.)

EU/3/13/1177 (Astellas Pharma Europe B.V.)

EU/3/13/1177 (Active substance: Chimeric monoclonal antibody against claudin-18 splice variant 2) - Transfer of orphan designation - Commission Decision (2018)2010 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/071/13/T/01

Europe -DG Health and Food Safety

28-3-2018

EU/3/12/1092 (Astellas Pharma Europe B.V.)

EU/3/12/1092 (Astellas Pharma Europe B.V.)

EU/3/12/1092 (Active substance: Chimeric monoclonal antibody against claudin 6) - Transfer of orphan designation - Commission Decision (2018)2009 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/147/12/T/01

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

26-3-2018

EU/3/18/1990 (PharmaBio Consulting)

EU/3/18/1990 (PharmaBio Consulting)

EU/3/18/1990 (Active substance: Dimethyl fumarate) - Orphan designation - Commission Decision (2018)1879 of Mon, 26 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/219/17

Europe -DG Health and Food Safety

26-3-2018

News and press releases:  EU recommendations for 2018/2019 seasonal flu vaccine composition

News and press releases: EU recommendations for 2018/2019 seasonal flu vaccine composition

EU advice based on WHO recommendations

Europe - EMA - European Medicines Agency

23-3-2018

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Active substance: Recombinant human acid alpha-glucosidase) - Orphan designation - Commission Decision (2018)1877 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/230/17

Europe -DG Health and Food Safety

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

EU/3/18/1998 (Blue-Reg Europe)

EU/3/18/1998 (Blue-Reg Europe)

EU/3/18/1998 (Active substance: Patidegib) - Orphan designation - Commission Decision (2018)1887 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/206/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1997 (QRC Consultants Ltd)

EU/3/18/1997 (QRC Consultants Ltd)

EU/3/18/1997 (Active substance: Miransertib) - Orphan designation - Commission Decision (2018)1886 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/226/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1996 (Therapicon Srl)

EU/3/18/1996 (Therapicon Srl)

EU/3/18/1996 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)1885 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/227/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1995 (Loxo Oncology Limited)

EU/3/18/1995 (Loxo Oncology Limited)

EU/3/18/1995 (Active substance: Larotrectinib) - Orphan designation - Commission Decision (2018)1884 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/213/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1991 (TurnKey PharmaConsulting Ireland Limited)

EU/3/18/1991 (TurnKey PharmaConsulting Ireland Limited)

EU/3/18/1991 (Active substance: Docosahexaenoic acid ethyl ester) - Orphan designation - Commission Decision (2018)1880 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/235/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1989 (FGK Representative Service GmbH)

EU/3/18/1989 (FGK Representative Service GmbH)

EU/3/18/1989 (Active substance: (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidine-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridine-2-yl)-4-fluoropyrrolidine-2-carboxamide) - Orphan designation - Commission Decision (2018)1878 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/208/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2006 (Quintiles Ireland Limited)

EU/3/18/2006 (Quintiles Ireland Limited)

EU/3/18/2006 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1894 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/234/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2005 (Quintiles Ireland Limited)

EU/3/18/2005 (Quintiles Ireland Limited)

EU/3/18/2005 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1893 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/222/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2004 (Quintiles Ireland Limited)

EU/3/18/2004 (Quintiles Ireland Limited)

EU/3/18/2004 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1892 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/217/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Active substance: Recombinant modified ricin toxin A-chain subunit) - Orphan designation - Commission Decision (2018)1889 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/242/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1993 (Quintiles Ireland Limited)

EU/3/18/1993 (Quintiles Ireland Limited)

EU/3/18/1993 (Active substance: Gemfibrozil) - Orphan designation - Commission Decision (2018)1882 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/218/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1992 (argenx BVBA)

EU/3/18/1992 (argenx BVBA)

EU/3/18/1992 (Active substance: Efgartigimod alfa) - Orphan designation - Commission Decision (2018)1881 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/245/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1994 (QRC Consultants Ltd)

EU/3/18/1994 (QRC Consultants Ltd)

EU/3/18/1994 (Active substance: Ivosidenib) - Orphan designation - Commission Decision (2018)1883 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17

Europe -DG Health and Food Safety

21-3-2018

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Active substance: Clonidine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)1817 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/11/T/02

Europe -DG Health and Food Safety

21-3-2018

EU/3/17/1861 (Roivant Sciences Ireland Limited)

EU/3/17/1861 (Roivant Sciences Ireland Limited)

EU/3/17/1861 (Active substance: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester) - Transfer of orphan designation - Commission Decision (2018)1826 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/299/16/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1763 (Quintiles Ireland Limited)

EU/3/16/1763 (Quintiles Ireland Limited)

EU/3/16/1763 (Active substance: Tadekinig alfa) - Transfer of orphan designation - Commission Decision (2018)1825 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/150/16/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd.)

EU/3/16/1711 (Akcea Therapeutics UK Ltd.)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1639 (Quintiles Ireland Limited)

EU/3/16/1639 (Quintiles Ireland Limited)

EU/3/16/1639 (Active substance: (1E,6E)-1,7-bis(3,4-dimethoxyphenyl)-4-cyclobutylmethyl-1,6-heptadiene-3,5-dione) - Transfer of orphan designation - Commission Decision (2018)1820 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/252/15/T/01

Europe -DG Health and Food Safety

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

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

21-3-2018

EU/3/16/1714 (Quintiles Ireland Limited)

EU/3/16/1714 (Quintiles Ireland Limited)

EU/3/16/1714 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-a-L-talofuranosyl)-paromamine sulfate) - Transfer of orphan designation - Commission Decision (2018)1823 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/16/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1671 (Quintiles Ireland Limited)

EU/3/16/1671 (Quintiles Ireland Limited)

EU/3/16/1671 (Active substance: 2'-O-(2-methoxyethyl)phosphorothioate antisense oligonucleotide targeting the growth hormone receptor) - Transfer of orphan designation - Commission Decision (2018)1821 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/023/16/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1727 (Quintiles Ireland Limited)

EU/3/16/1727 (Quintiles Ireland Limited)

EU/3/16/1727 (Active substance: Recombinant human interleukin-12) - Transfer of orphan designation - Commission Decision (2018)1824 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/116/16/T/01

Europe -DG Health and Food Safety

15-3-2018

EU/3/14/1362 (Inventiva)

EU/3/14/1362 (Inventiva)

EU/3/14/1362 (Active substance: 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid) - Corrigendum - Commission Decision (2018)1645 of Thu, 15 Mar 2018

Europe -DG Health and Food Safety

15-3-2018

EU/3/14/1361 (Inventiva)

EU/3/14/1361 (Inventiva)

EU/3/14/1361 (Active substance: 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid) - Corrigendum - Commission Decision (2014)1644 of Thu, 15 Mar 2018

Europe -DG Health and Food Safety

14-3-2018

VITAMIN B12 (Cyanocobalamin) Injection [Butler Animal Health Supply LLC]

VITAMIN B12 (Cyanocobalamin) Injection [Butler Animal Health Supply LLC]

Updated Date: Mar 14, 2018 EST

US - DailyMed

7-3-2018

VITAMIN B12 (Cyanocobalamin) Injection [Vet Tek]

VITAMIN B12 (Cyanocobalamin) Injection [Vet Tek]

Updated Date: Mar 7, 2018 EST

US - DailyMed

5-3-2018

EU/3/16/1789 (La Jolla Pharmaceutical II BV)

EU/3/16/1789 (La Jolla Pharmaceutical II BV)

EU/3/16/1789 (Active substance: Synthetic human hepcidin) - Transfer of orphan designation - Commission Decision (2018)1427 of Mon, 05 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/144/16/T/02

Europe -DG Health and Food Safety

5-3-2018

EU/3/15/1555 (La Jolla Pharmaceutical II BV)

EU/3/15/1555 (La Jolla Pharmaceutical II BV)

EU/3/15/1555 (Active substance: Synthetic hepcidin) - Transfer of orphan designation - Commission Decision (2018)1426 of Mon, 05 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/15/T/02

Europe -DG Health and Food Safety

5-3-2018

EU/3/12/975 (Voisin Consulting S.A.R.L.)

EU/3/12/975 (Voisin Consulting S.A.R.L.)

EU/3/12/975 (Active substance: Carbetocin) - Transfer of orphan designation - Commission Decision (2018)1425 of Mon, 05 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/11/T/01

Europe -DG Health and Food Safety