FEB-12

Main information

  • Trade name:
  • FEB-12 SYR
  • Dosage:
  • WITH IRON
  • Pharmaceutical form:
  • SYR
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FEB-12 SYR
    India
  • Language:
  • English

Other information

Status

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

8-8-2018

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

19-7-2018

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

FDA - U.S. Food and Drug Administration

18-7-2018

Orphan designation:  Gevokizumab,  for the: Treatment of chronic non-infectious uveitis

Orphan designation: Gevokizumab, for the: Treatment of chronic non-infectious uveitis

On 12 March 2013, orphan designation (EU/3/13/1111) was granted by the European Commission to Les Laboratoires Servier, France, for gevokizumab for the treatment of chronic non-infectious uveitis.

Europe - EMA - European Medicines Agency

17-7-2018

The PictSweet Company Recalls 12 Ounce Steam’ables Baby Brussel Sprouts for Undeclared Milk and Soy Allergens

The PictSweet Company Recalls 12 Ounce Steam’ables Baby Brussel Sprouts for Undeclared Milk and Soy Allergens

Bells, TN – The Pictsweet Company has recalled 960 cases of Pictsweet Farms 12-ounce Steam’ables Baby Brussels Sprouts because they may contain undeclared milk and soy allergens. People who have an allergy or severe sensitivity to milk or soy may run the risk of serious allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

11-7-2018

Hoofdlijnenakkoord geestelijke gezondheidszorg ondertekend

Hoofdlijnenakkoord geestelijke gezondheidszorg ondertekend

Het hoofdlijnenakkoord over de toekomst van de geestelijke gezondheidszorg is getekend door staatssecretaris Paul Blokhuis (VWS) en 12 partijen uit de geestelijke gezondheidszorg en het sociaal domein. Ze hebben afspraken gemaakt om de kwaliteit en de toegankelijkheid van de geestelijke gezondheidszorg verder te verbeteren. Het ideaalbeeld voor de toekomst van de GGZ waar partijen aan werken is dat er goed naar mensen wordt geluisterd, deze de hulp krijgen die nodig is, afgestemd op hun behoefte en dat d...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

10-7-2018

Preventieve HIV-remmers (PrEP) worden verstrekt voor een periode van vijf jaar

Preventieve HIV-remmers (PrEP) worden verstrekt voor een periode van vijf jaar

PrEP wordt binnen een onderzoekssetting voor een periode van vijf jaar verstrekt aan de hoogrisicogroep van mannen die seks hebben met mannen (MSM). Dat heeft minister Bruno Bruins (Medische Zorg) vandaag bekend gemaakt. Op basis van schattingen van het RIVM zullen ongeveer 6500 mannen hiervan gebruik gaan maken en kunnen hiermee  250 hiv-infecties per jaar worden voorkomen. Voor gebruikers gaat een eigen bijdrage gelden van maximaal 25%, dat komt overeen met ongeveer 12 euro per maand. Ook wordt hen gev...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

16-6-2018

Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk

Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk

Del Monte Fresh Produce N.A., Inc. ("Del Monte Fresh") announced today, the voluntary recall of a limited quantity of 6 oz., 12 oz. and 28 oz. vegetable trays containing fresh broccoli, cauliflower, celery sticks, carrots, and dill dip sold to select retailers in Illinois, Indiana, Iowa, Michigan, Minnesota and Wisconsin. Del Monte was notified by state agencies of the outbreak and its potential involvement.

FDA - U.S. Food and Drug Administration

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

8-6-2018

Orphan designation:  Mepolizumab,  for the: Treatment of Churg-Strauss syndrome

Orphan designation: Mepolizumab, for the: Treatment of Churg-Strauss syndrome

On 12 March 2013, orphan designation (EU/3/13/1116) was granted by the European Commission to Glaxo Group Ltd, United Kingdom, for mepolizumab for the treatment of Churg-Strauss syndrome.

Europe - EMA - European Medicines Agency

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

27-7-2018

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5043 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/158/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2018)5032 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/146/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/13/1127 (Pfizer Europe MA EEIG)

EU/3/13/1127 (Pfizer Europe MA EEIG)

EU/3/13/1127 (Active substance: Inotuzumab ozogamicin) - Transfer of orphan designation - Commission Decision (2018)5046 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/194/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/998 (Orchard Therapeutics Ltd)

EU/3/12/998 (Orchard Therapeutics Ltd)

EU/3/12/998 (Active substance: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene) - Transfer of orphan designation - Commission Decision (2018)5062 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/014/12/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Active substance: tafamidis) - Transfer of orphan designation - Commission Decision (2018)5066 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/115/12/T/01

Europe -DG Health and Food Safety

22-7-2018

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device and earlier agency actions

FDA - U.S. Food and Drug Administration

19-7-2018

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Active substance: Humanised single chain monoclonal antibody against CD37) - Transfer of orphan designation - Commission Decision (2018)4839 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/128/12/T/02

Europe -DG Health and Food Safety

13-7-2018

News and press releases:  Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 July 2018

News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 July 2018

PRAC recommends restricting use of prostate cancer medicine Xofigo

Europe - EMA - European Medicines Agency

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

TGA presentations: The new Code - where are we at? 12 & 13 June 2018

TGA presentations: The new Code - where are we at? 12 & 13 June 2018

These presentations provided an update on the implementation of the new Therapeutic Goods Advertising Code and complaints system

Therapeutic Goods Administration - Australia

9-7-2018

Agenda:  Agenda - PRAC draft agenda of meeting 9-12 July 2018

Agenda: Agenda - PRAC draft agenda of meeting 9-12 July 2018

Europe - EMA - European Medicines Agency

27-6-2018

EU/3/12/999 (Merck Sharp and Dohme B.V.)

EU/3/12/999 (Merck Sharp and Dohme B.V.)

EU/3/12/999 (Active substance: Letermovir) - Transfer of orphan designation - Commission Decision (2018)4104 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/008/12/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/13/1121 (Eisai GmbH)

EU/3/13/1121 (Eisai GmbH)

EU/3/13/1121 (Active substance: Lenvatinib) - Transfer of orphan designation - Commission Decision (2018)4079 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/173/12/T/01

Europe -DG Health and Food Safety

12-6-2018

Cholib (Mylan Products Limited)

Cholib (Mylan Products Limited)

Cholib (Active substance: fenofibrate / simvastatin) - Centralised - Renewal - Commission Decision (2018)3153 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2559/R/17

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt) - Transfer of orphan designation - Commission Decision (2018)3797 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/16/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1922 (Gilead Sciences Ireland UC)

EU/3/17/1922 (Gilead Sciences Ireland UC)

EU/3/17/1922 (Active substance: Entospletinib) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/17/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1956 (Sangamo Therapeutics UK LTD)

EU/3/17/1956 (Sangamo Therapeutics UK LTD)

EU/3/17/1956 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene) - Transfer of orphan designation - Commission Decision (2018)3811 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/168/17/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1955 (Sangamo Therapeutics UK LTD)

EU/3/17/1955 (Sangamo Therapeutics UK LTD)

EU/3/17/1955 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene) - Transfer of orphan designation - Commission Decision (2018)3810 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/167/17/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/16/1615 (Gilead Sciences Ireland UC)

EU/3/16/1615 (Gilead Sciences Ireland UC)

EU/3/16/1615 (Active substance: 2-ethylbutyl (2S)-2-{[(S)-{[(2R,3S,4R,5R)-5-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate) - Transfer of orphan designation - Commission Decision (2018)3804 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/197/15/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/16/1802 (Quality Regulatory Clinical Ireland Limited)

EU/3/16/1802 (Quality Regulatory Clinical Ireland Limited)

EU/3/16/1802 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)3805 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/197/16/T/01

Europe -DG Health and Food Safety

11-6-2018

 Minutes of the PRAC meeting 9-12 Apil 2018

Minutes of the PRAC meeting 9-12 Apil 2018

Europe - EMA - European Medicines Agency

11-6-2018

 Minutes of the PRAC meeting 9-12 April 2018

Minutes of the PRAC meeting 9-12 April 2018

Europe - EMA - European Medicines Agency