FLAGO-15

Main information

  • Trade name:
  • FLAGO-15 10 TAB
  • Dosage:
  • 100,15;MG
  • Pharmaceutical form:
  • TAB
  • Composition:
  • 10
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLAGO-15 10 TAB
    India
  • Language:
  • English

Other information

Status

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

16-2-2019

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Published on: Fri, 15 Feb 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the efficacy of a preparation of algae interspaced bentonite when used as aflatoxin B1 (AfB1) binder for all animal species; the additive is composed of bentonite feed grade and algae belonging to Ulva spp. The European Commission request follows an opinion of the FEEDAP Panel published in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-2-2019

Outcome of the consultation with Member States and EFSA on the basic substance application for L‐cysteine for use in plant protection as insecticide

Outcome of the consultation with Member States and EFSA on the basic substance application for L‐cysteine for use in plant protection as insecticide

Published on: Fri, 15 Feb 2019 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for L‐cysteine are presented. The context of the evaluation was that required by ...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

1-2-2019

Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK® 15 Monitor/Defibrillator

Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK® 15 Monitor/Defibrillator

The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death.

FDA - U.S. Food and Drug Administration

25-1-2019

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 9: suitability of taxonomic units notified to EFSA until September 2018

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 9: suitability of taxonomic units notified to EFSA until September 2018

Published on: Thu, 24 Jan 2019 The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre‐evaluation to support safety risk assessments of biological agents performed by EFSA's Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected by ‘qualifications’ which should be assessed at the strain lev...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-1-2019

Ruling by the French administrative court of Lyon: ANSES contests any error of assessment

Ruling by the French administrative court of Lyon: ANSES contests any error of assessment

ANSES has examined the ruling of 15 January 2019 by the French administrative court of Lyon overriding the marketing authorisation decision for Roundup Pro 360. It should be noted that, in order to protect human and environmental health, ANSES is responsible for implementing European regulations on the national level with regard to the marketing authorisation of regulated products (plant protection products, biocides and veterinary medicinal products). It also contributes to improving these regulations b...

France - Agence Nationale du Médicament Vétérinaire

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Enforcement Report for the Week of January 16, 2019

Enforcement Report for the Week of January 16, 2019

Recently Updated Records for the Week of January 16, 2019 Last Modified Date: Tuesday, January 15, 2019

FDA - U.S. Food and Drug Administration

16-1-2019

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 15 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance dazomet. To assess the occurrence of dazomet residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (including the supporting re...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Voorstelling van Zaken “GOED SCHEIDEN” in Internationaal Theater Amsterdam

Voorstelling van Zaken “GOED SCHEIDEN” in Internationaal Theater Amsterdam

De komende Voorstelling van Zaken GOED SCHEIDEN vindt plaats op dinsdag 26 februari 2019 van 14.00-17.15 uur in Internationaal Theater Amsterdam (voorheen Stadsschouwburg Amsterdam). De voorstelling is bedoeld voor professionals betrokken bij scheidingen. Phaedra Werkhoven, journalist en ervaringsdeskundige, leidt de gesprekken op het toneel. Acteurs Gijs Scholten van Aschat, Jacob Derwig en Hannah van Lunteren spelen scènes die de scheidingsproblematiek op unieke wijze zullen laten zien. Scheiden is pij...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

14-1-2019

Meer orgaan- en weefseltransplantaties in 2018

Meer orgaan- en weefseltransplantaties in 2018

In 2018 zijn in Nederland 815 orgaantransplantaties geweest en ruim 4000 patiënten geholpen met gedoneerd weefsel. Dit is een stijging van respectievelijk 15 en 18% in vergelijking met het jaar ervoor. Deze positieve jaarcijfers zijn gepubliceerd door de Nederlandse Transplantatie Stichting (NTS).

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-12-2018

Avian influenza overview August – November 2018

Avian influenza overview August – November 2018

Published on: Thu, 20 Dec 2018 Between 16 August and 15 November 2018, 14 highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments in Bulgaria and seven HPAI A(H5N6) outbreaks, one in captive birds in Germany and six in wild birds in Denmark and the Netherlands were reported in the European Union (EU). No human infection due to HPAI A(H5N8) and A(H5N6) viruses have been reported in Europe so far. Seroconversion of people exposed during outbreaks in Russia has been reported in...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018


eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

Europe - EMA - European Medicines Agency

15-12-2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Published on: Fri, 14 Dec 2018 The EFSA Scientific Network on bovine spongiform encephalopathies and other transmissible spongiform encephalopathies (BSE‐TSE) held its 13th meeting on 15‐16 October 2018 in Parma. The meeting served as an opportunity to exchange scientific information on BSE‐TSE related issues among EU Member States, countries from the European Free Trade Association (EFTA), EFSA, the European Commission and ad hocparticipants. In this occasion, ad hoc representation included the World A...

Europe - EFSA - European Food Safety Authority Publications

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Prague, Czech Republic, from 15/05/2019 to 17/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Prague, Czech Republic, from 15/05/2019 to 17/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Prague, Czech Republic, from 15/05/2019 to 17/05/2019

Europe - EMA - European Medicines Agency

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Vienna, Austria, from 13/03/2019 to 15/03/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Vienna, Austria, from 13/03/2019 to 15/03/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Vienna, Austria, from 13/03/2019 to 15/03/2019

Europe - EMA - European Medicines Agency

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018


Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Europe - EMA - European Medicines Agency

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

20-11-2018

Mariam, Floris en Mookie beëdigd tot kinderbewindspersonen van VWS

Mariam, Floris en Mookie beëdigd tot kinderbewindspersonen van VWS

Nederland is vandaag op de Internationale Dag van de Rechten van het Kind drie bewindspersonen rijker. Mariam Yousfi (13 jaar) en Floris Vooren (13 jaar) zijn door ministers Hugo de Jonge en Bruno Bruins benoemd tot kinderminister en Mookie Saluna (15 jaar) is door staatssecretaris Paul Blokhuis benoemd tot kinderstaatssecretaris. De kinderbewindspersonen zullen een jaar lang het ministerie van Volksgezondheid, Welzijn en Sport (VWS) met slimme tips en praktische adviezen helpen het beleid beter en kindv...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

FDA - U.S. Food and Drug Administration

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

4-2-2019

EU/3/15/1498 (Clinical Network Services (NL) B.V.)

EU/3/15/1498 (Clinical Network Services (NL) B.V.)

EU/3/15/1498 (Active substance: 2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl)acetamide) - Transfer of orphan designation - Commission Decision (2019)815 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003040

Europe -DG Health and Food Safety

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Gadolinium, [α3,α6,α9-tris[3-[(2,3-dihydroxypropyl)amino]-3-oxopropyl]-3,6,9,15-tetraazabicyclo[9.3.1]pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-κN3,κN6,κN9,κN15,κO3,κO6,κO9]-(P03277), dec

Opinion/decision on a Paediatric investigation plan (PIP): Gadolinium, [α3,α6,α9-tris[3-[(2,3-dihydroxypropyl)amino]-3-oxopropyl]-3,6,9,15-tetraazabicyclo[9.3.1]pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-κN3,κN6,κN9,κN15,κO3,κO6,κO9]-(P03277), dec

Opinion/decision on a Paediatric investigation plan (PIP): Gadolinium, [α3,α6,α9-tris[3-[(2,3-dihydroxypropyl)amino]-3-oxopropyl]-3,6,9,15-tetraazabicyclo[9.3.1]pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-κN3,κN6,κN9,κN15,κO3,κO6,κO9]-(P03277), decision type: , therapeutic area: , PIP number: P/0323/2018

Europe - EMA - European Medicines Agency

28-1-2019

Consultation: Options for the regulation of Faecal Microbiota Transplantation materials

Consultation: Options for the regulation of Faecal Microbiota Transplantation materials

The TGA is seeking comments from interested parties on Options for the Regulation of Faecal Microbiota Transplantation materials. Closing date: 15 March 2019

Therapeutic Goods Administration - Australia

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 4 - diphtheria CRM197

Opinion/decision on a Paediatric investigation plan (PIP): pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 4 - diphtheria CRM197

Opinion/decision on a Paediatric investigation plan (PIP): pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 4 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 5 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 6A- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 6B - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotyp...

Europe - EMA - European Medicines Agency

23-1-2019

EU/3/15/1490 (S-cubed Pharmaceutical Services ApS)

EU/3/15/1490 (S-cubed Pharmaceutical Services ApS)

EU/3/15/1490 (Active substance: Triamcinolone acetonide) - Transfer of orphan designation - Commission Decision (2019)579 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003126

Europe -DG Health and Food Safety

22-1-2019


EMA/2018/15/CO – Ex-ante publicity of a negotiated procedure - On demand supply of books

EMA/2018/15/CO – Ex-ante publicity of a negotiated procedure - On demand supply of books

EMA/2018/15/CO – Ex-ante publicity of a negotiated procedure - On demand supply of books

Europe - EMA - European Medicines Agency

15-1-2019

Macimorelin Aeterna Zentaris (Aterna Zentaris GmbH)

Macimorelin Aeterna Zentaris (Aterna Zentaris GmbH)

Macimorelin Aeterna Zentaris (Active substance: macimorelin) - New authorisation - Commission Decision (2019)203 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4660

Europe -DG Health and Food Safety

15-1-2019

Topotecan Actavis (Actavis Group PTC ehf.)

Topotecan Actavis (Actavis Group PTC ehf.)

Topotecan Actavis (Active substance: topotecan) - Withdrawal - Commission Decision (2019)207 of Tue, 15 Jan 2019

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2133 (TLC Biopharmaceuticals B.V.)

EU/3/18/2133 (TLC Biopharmaceuticals B.V.)

EU/3/18/2133 (Active substance: Vinorelbine tartrate) - Orphan designation - Commission Decision (2019)227 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001988

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2131 (UCB Biopharma SPRL)

EU/3/18/2131 (UCB Biopharma SPRL)

EU/3/18/2131 (Active substance: Rozanolixizumab) - Orphan designation - Commission Decision (2019)240 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002029

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2130 (Arena Pharmaceuticals Limited)

EU/3/18/2130 (Arena Pharmaceuticals Limited)

EU/3/18/2130 (Active substance: Ralinepag) - Orphan designation - Commission Decision (2019)239 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002037

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2128 (Thiogenesis Therapeutics S.A.R.L)

EU/3/18/2128 (Thiogenesis Therapeutics S.A.R.L)

EU/3/18/2128 (Active substance: Mercaptamine-pantetheine disulfide) - Orphan designation - Commission Decision (2019)224 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002209

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2127 (Therapicon Srl)

EU/3/18/2127 (Therapicon Srl)

EU/3/18/2127 (Active substance: Melatonin) - Orphan designation - Commission Decision (2019)223 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001921

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2126 (Hanmi Europe Limited)

EU/3/18/2126 (Hanmi Europe Limited)

EU/3/18/2126 (Active substance: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment) - Orphan designation - Commission Decision (2019)222 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001592

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2124 (IntraBio Ltd)

EU/3/18/2124 (IntraBio Ltd)

EU/3/18/2124 (Active substance: Acetylleucine) - Orphan designation - Commission Decision (2019)220 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001741

Europe -DG Health and Food Safety

15-1-2019

Vizamyl (GE Healthcare AS)

Vizamyl (GE Healthcare AS)

Vizamyl (Active substance: flutemetamol (18F)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)201 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2557/T/18

Europe -DG Health and Food Safety

15-1-2019

EU/3/17/1852 (Voisin Consulting S.A.R.L.)

EU/3/17/1852 (Voisin Consulting S.A.R.L.)

EU/3/17/1852 (Active substance: Allogeneic ex-vivo-expanded umbilical cord blood-derived hematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived hematopoietic mature myeloid and lymphoid cells) - Transfer of orphan designation - Commission Decision (2019)233 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002948

Europe -DG Health and Food Safety

15-1-2019

Symkevi (Vertex Pharmaceuticals (Ireland) Limited)

Symkevi (Vertex Pharmaceuticals (Ireland) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)188 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004682/T/0003

Europe -DG Health and Food Safety

15-1-2019

Imatinib Actavis (Actavis Group PTC ehf.)

Imatinib Actavis (Actavis Group PTC ehf.)

Imatinib Actavis (Active substance: Imatinib) - Centralised - 2-Monthly update - Commission Decision (2019)209 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002594/IB/0017/G

Europe -DG Health and Food Safety

15-1-2019

Corlentor (Les Laboratoires Servier)

Corlentor (Les Laboratoires Servier)

Corlentor (Active substance: Ivabradine) - PASS - Modification - Commission Decision (2019)191 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/598/N/PSR/S/19

Europe -DG Health and Food Safety

15-1-2019

Sirturo (Janssen-Cilag International NV)

Sirturo (Janssen-Cilag International NV)

Sirturo (Active substance: bedaquiline) - Centralised - Annual renewal - Commission Decision (2019)204 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2614/R/31

Europe -DG Health and Food Safety

15-1-2019

Hizentra (CSL Behring GmbH)

Hizentra (CSL Behring GmbH)

Hizentra (Active substance: human normal immunoglobulin) - Centralised - 2-Monthly update - Commission Decision (2019)195 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2127/II/97G

Europe -DG Health and Food Safety

15-1-2019

Meloxidyl (Ceva SantE Animale)

Meloxidyl (Ceva SantE Animale)

Meloxidyl (Active substance: Meloxicam) - Centralised - Yearly update - Commission Decision (2019)210 of Tue, 15 Jan 2019

Europe -DG Health and Food Safety

15-1-2019

EU/3/16/1680 (Chugai Pharma France)

EU/3/16/1680 (Chugai Pharma France)

EU/3/16/1680 (Active substance: Humanised anti-IL-6 receptor monoclonal antibody) - Transfer of orphan designation - Commission Decision (2019)229 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003065

Europe -DG Health and Food Safety

15-1-2019

Procoralan (Les Laboratoires Servier)

Procoralan (Les Laboratoires Servier)

Procoralan (Active substance: Ivabradine) - PASS - Modification - Commission Decision (2019)192 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/597/N/PSR/S/19

Europe -DG Health and Food Safety

4-1-2019


Orphan designation: Glibenclamide for the treatment of neonatal diabetes, Treatment of neonatal diabetes, 15/01/2016, Positive

Orphan designation: Glibenclamide for the treatment of neonatal diabetes, Treatment of neonatal diabetes, 15/01/2016, Positive

Orphan designation: Glibenclamide for the treatment of neonatal diabetes, Treatment of neonatal diabetes, 15/01/2016, Positive

Europe - EMA - European Medicines Agency

19-12-2018

EU/3/15/1545 (Seagen Ireland Limited)

EU/3/15/1545 (Seagen Ireland Limited)

EU/3/15/1545 (Active substance: CD33-directed antibody-drug conjugate consisting of an antibody conjugated to a DNA cross-linking pyrrolobenzodiazepine dimer drug) - Transfer of orphan designation - Commission Decision (2018)9039 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002611

Europe -DG Health and Food Safety

4-12-2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

A detailed walkthrough of the Code with examples to illustrate the application of the key sections.

Therapeutic Goods Administration - Australia

29-11-2018

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)8036 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2497/X/15

Europe -DG Health and Food Safety

23-11-2018

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more:  https://go.usa.gov/xPHxf   #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

15-11-2018

alitretinoin

alitretinoin

alitretinoin (Active substance: alitretinoin) - Centralised - Art 28 - (PSUR - Commission Decision (2018)7675 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/90/201801

Europe -DG Health and Food Safety

15-11-2018

Benepali (Samsung Bioepis NL B.V.)

Benepali (Samsung Bioepis NL B.V.)

Benepali (Active substance: etanercept) - Centralised - Yearly update - Commission Decision (2018) 7557 of Thu, 15 Nov 2018

Europe -DG Health and Food Safety

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety