EXITING

Main information

  • Trade name:
  • EXITING 170ML GEL
  • Pharmaceutical form:
  • GEL
  • Composition:
  • 170ML
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EXITING 170ML GEL
    India
  • Language:
  • English

Other information

Status

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

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Nieuwsbericht Slotervaart

Nieuwsbericht Slotervaart

Minister Bruno Bruins voor Medische Zorg en Sport heeft de Tweede Kamer geïnformeerd dat de curatoren van het Slotervaart ziekenhuis hebben aangegeven geen mogelijkheden voor een doorstart te zien.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

12-11-2018

AMvB in consultatie voor inrichting wietteeltexperiment

AMvB in consultatie voor inrichting wietteeltexperiment

Minister Bruins voor Medische Zorg en minister Grapperhaus van Justitie en Veiligheid  hebben vandaag de concept algemene maatregel van bestuur (AMvB) voor de inrichting van het ‘Experiment gesloten coffeeshopketen’ in consultatie gedaan. De concept-AMvB betreft een nadere invulling van de regels, die zijn opgenomen in het wetsvoorstel experiment gesloten coffeeshopketen dat in juli 2018 aan de Tweede Kamer is aangeboden. Gedurende zes weken kan iedereen op dit concept reageren. Daarnaast schrijven minis...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

18-10-2018

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Certain ProBuilt Aluminum Posts have an issue with the screws that affix the base plate to the post which may cause the post to separate from the base plate when forces over 334 pounds are applied horizontally to the top side of the post. As a result, the posts do not fully comply with local building code requirements and may pose a fall hazard.

Health Canada

17-10-2018

New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice

New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice

New Nan Fong Hong Trading Inc. is recalling its 16 oz (454g) packages of Source Day Natural Treasures Dried Liquorice Slice because they contain undeclared sulfites. Consumers who are allergic to sulfite allergens run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

1-10-2018

Kabinet zet in op betere gehandicaptenzorg

Kabinet zet in op betere gehandicaptenzorg

Minister De Jonge (Volksgezondheid, Welzijn en Sport) komt op de eerste dag van de week van de toegankelijkheid met een reeks maatregelen om de zorg voor mensen met een beperking te verbeteren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

25-9-2018

Eerste Kamer stemt voor: Eigen risico blijft komende jaren gelijk

Eerste Kamer stemt voor: Eigen risico blijft komende jaren gelijk

Het eigen risico wordt de komende jaren bevroren op 385 euro. De Eerste Kamer heeft vandaag ingestemd met het wetsvoorstel van minister Bruno Bruins (Medische Zorg) dat dit regelt.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

14-9-2018

Minister van Sport Bruno Bruins aanwezig bij MXGP Assen

Minister van Sport Bruno Bruins aanwezig bij MXGP Assen

Dit weekend staat de Motorcross Grand Prix (MXGP) op het TT circuit van Assen op de agenda. Dit jaar kan een bijzondere editie worden, omdat Jeffrey Herlings de mogelijkheid heeft om de eerste Nederlandse wereldkampioen in de MXGP-categorie te worden.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

13-9-2018

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level. King Bio Inc., a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that potentially could have affected this product. King Bio has issued a recall of these active ingredients in BioLyte’s lot specific product. To date, there have been no reports of illness or...

FDA - U.S. Food and Drug Administration

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

24-8-2018

Imagine recalls Buckyballs magnet sets

Imagine recalls Buckyballs magnet sets

Health Canada has determined that these magnet sets are a danger to human health and safety because they contain small powerful magnets which can be easily swallowed or inhaled by children. Unlike other small objects that would be more likely to pass normally through the digestive system if swallowed, when more than one small powerful magnet is swallowed, the magnets can attract one another while travelling through the digestive system. The magnets can then pinch together and create a blockage and slowly...

Health Canada

17-8-2018

FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder

FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder

FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder

FDA - U.S. Food and Drug Administration

14-8-2018

Neo-Image Candlelight Ltd recalls Thermoglow Stem Wick Chafing fuel & Thermoglow Methanol Gel Chafing Fuel

Neo-Image Candlelight Ltd recalls Thermoglow Stem Wick Chafing fuel & Thermoglow Methanol Gel Chafing Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

7-8-2018

Seaweed consumption: remain vigilant to the risk of excess iodine intake

Seaweed consumption: remain vigilant to the risk of excess iodine intake

Over the last few years, seaweed has become increasingly common on our plates. Fresh, dried or as a food supplement, its iodine content varies and can sometimes be high. ANSES assessed the risk of excess iodine intake from the consumption of seaweed-based products. In view of the non-negligible risk of exceeding the upper limit of safe intake for iodine, the Agency advises against the consumption of seaweed and seaweed-based food supplements by certain at-risk populations, and recommends that regular con...

France - Agence Nationale du Médicament Vétérinaire

27-7-2018

Pending EC decision:  Imfinzi, durvalumab, Opinion date: 26-Jul-2018

Pending EC decision: Imfinzi, durvalumab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

26-7-2018

Subsidie voor duurzame zorg

Subsidie voor duurzame zorg

Zorginstellingen kunnen dit jaar subsidie krijgen voor energiebesparende maatregelen en het opwekken van duurzame energie. In totaal is hiervoor 4,7 miljoen euro beschikbaar. Deze subsidieregeling geeft (deels) uitvoering aan het regeerakkoord om ook in de zorgsector energiebesparingen en gebruik van duurzame energie verder te stimuleren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

24-7-2018

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

FDA - U.S. Food and Drug Administration

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

10-7-2018

FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product

FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product

FDA granted an EUA to DOD to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma (referred to as French FDP).

FDA - U.S. Food and Drug Administration

10-7-2018

Eerste Kamer stemt in met beroepsverbod via tuchtrecht

Eerste Kamer stemt in met beroepsverbod via tuchtrecht

De Eerste Kamer heeft vandaag ingestemd met een wetsvoorstel van minister Bruno Bruins voor Medische Zorg dat een beroepsverbod binnen het tuchtrecht regelt. Als er sprake is van ernstig gevaar voor patiënten kan de tuchtrechter de BIG-geregistreerde zorgverlener een beroepsverbod opleggen. Het gaat om ernstig gedrag, waarbij de tuchtrechter vindt dat iemand niet geschikt is het eigen beroep uit te oefenen, maar ook niet geschikt is een ander beroep in de zorg uit te oefenen waarbij hij (een categorie va...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

6-7-2018

LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots

LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling all lots of Prescript-Assist (still within expiration date), a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, milk, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

6-7-2018

Blokhuis: maatregelen nodig tegen probleemgebruik energiedrankjes

Blokhuis: maatregelen nodig tegen probleemgebruik energiedrankjes

Een relatief kleine groep jongeren tussen de 13 en 18 jaar drinkt te veel energiedrank en loopt daarmee risico op gezondheidsklachten. Dat blijkt uit onderzoek dat het RIVM uitvoerde in opdracht van staatssecretaris Paul Blokhuis (VWS) naar aanleiding van signalen van kinderartsen eerder dit jaar. Over het algemeen is de consumptie van energiedrankjes onder jongeren de afgelopen jaren afgenomen. Vier op de vijf jongeren drinkt het nooit of minder dan wekelijks.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

29-6-2018

UPDATE: FDA Animal Drug Safety Communication: FDA continues to warn about risk of accidental overdosing of dogs with the noise aversion drug Sileo

UPDATE: FDA Animal Drug Safety Communication: FDA continues to warn about risk of accidental overdosing of dogs with the noise aversion drug Sileo

FDA is alerting dog owners and veterinarians about the risk of accidental overdose to dogs treated with the drug Sileo, a prescription gel that is given to dogs by mouth to treat noise aversion.

FDA - U.S. Food and Drug Administration

29-6-2018

LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement

LL’s Magnetic Clay Inc Issues Allergy Alert on Undeclared Allergens in Prescript-Assist Dietary Supplement

LL’s Magnetic Clay, Inc. of Austin, Texas is recalling certain lots of Prescript-Assist, a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, dairy, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

28-6-2018

Minister Bruno Bruins verbetert transparantie zorgverzekeringen

Minister Bruno Bruins verbetert transparantie zorgverzekeringen

Er zijn in Nederland 55 verschillende standaard basisverzekeringen. In de praktijk worden verzekeringen onder allerlei namen en in verschillende verpakkingen aangeboden. Een van de verpakkingsvormen zijn de ongeveer 51.000 verschillende collectieve zorgverzekeringen. Hierdoor is de zorgverzekeringsmarkt ondoorzichtig geworden en is goed vergelijken een haast onmogelijke opgave. Minister Bruno Bruins (Medische Zorg) wil daarom dat zorgverzekeraars zorgen voor meer transparantie, onder andere door precies ...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

22-6-2018

Aruba, Curaçao, Nederland en Sint Maarten samen aan de slag voor betere gezondheidszorg Caribische deel Koninkrijk

Aruba, Curaçao, Nederland en Sint Maarten samen aan de slag voor betere gezondheidszorg Caribische deel Koninkrijk

Vier landen willen samen beter voorbereid zijn op toekomstige crisissituaties als orkaan Irma. Geneeskundige hulp moet optimaal zijn als het Caribisch deel van het Koninkrijk in de toekomst wordt getroffen door een crisis of ramp zoals orkaan Irma. Zodat slachtoffers zo snel en optimaal mogelijk opvang en kwalitatief goede medische zorg krijgen, de zorg voor bestaande patiënten en kwetsbare groepen niet in gevaar komt, medicijnen op voorraad zijn en medische hulpverleners goed zijn getraind en regelmatig...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

19-6-2018

Golden Star Wholesale  Issues Allergy Alert on Undeclared Sulfites in Dried Apricots Sour

Golden Star Wholesale Issues Allergy Alert on Undeclared Sulfites in Dried Apricots Sour

Golden Star Wholesale of Troy, MI 48084 is recalling, AL Reef Dried Apricots Sour, because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Durvalumab, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Durvalumab, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

18-6-2018

340 miljoen voor thuiswonende ouderen: zelfstandig oud worden in vertrouwde omgeving

340 miljoen voor thuiswonende ouderen: zelfstandig oud worden in vertrouwde omgeving

Ouderen willen het liefst in hun eigen vertrouwde omgeving zelfstandig oud worden en een fijn en zinvol leven leiden. Om dat beter mogelijk te maken presenteert minister De Jonge (VWS) vandaag het programma Langer Thuis. Het Kabinet investeert daar de komende jaren ruim 340 miljoen euro in. Het programma is vandaag door minister De Jonge en minister Ollongren (BZK) naar de Tweede Kamer gestuurd.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-6-2018

Minister Bruins presenteert maatregelen om uitgavengroei geneesmiddelen te beheersen

Minister Bruins presenteert maatregelen om uitgavengroei geneesmiddelen te beheersen

Lagere maximumprijzen, scherper inkopen en beter kijken welke geneesmiddelen tegen welke prijs vergoed worden.  Dat zijn drie belangrijke onderwerpen in een nieuw pakket aan maatregelen van minister Bruno Bruins voor Medische Zorg. Doel is de uitgavengroei aan geneesmiddelen te beheersen.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

7-6-2018

Minister Bruno Bruins (Sport) opent Special Olympics 2018

Minister Bruno Bruins (Sport) opent Special Olympics 2018

Dit weekend worden in de Achterhoek de Special Olympics Nationale Spelen gehouden. Meer dan 2000 sporters met een verstandelijke beperking gaan de strijd aan in 20 takken van sport. Sportminister Bruno Bruins zal de Spelen vrijdagavond officieel openen tijdens een feestelijke ceremonie in Stadion de Vijverberg in Doetinchem. Bruno Bruins: ‘Sporten is gezond en vooral leuk. Ik vind het belangrijk dat iedereen kan sporten en er lol aan beleeft. Dat is ook een belangrijk onderdeel van het sportakkoord dat i...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

30-5-2018

Climate change and health

Climate change and health

Climate change is a reality on which there is broad consensus in the scientific community. Because of the inertia of the climate system, changes to the climate related to human activities will continue for many years, regardless of any measures taken today. Combating climate change, which is part of a more global environmental change, is therefore essential to limit its magnitude.

France - Agence Nationale du Médicament Vétérinaire

26-5-2018

Global Commodities Inc. Issues Allergy Alert on Undeclared Sulfites In Apricot with Pitt Watan Brand

Global Commodities Inc. Issues Allergy Alert on Undeclared Sulfites In Apricot with Pitt Watan Brand

Global Commodities, Inc. of Hicksville, NY is recalling 1lb and 0.5lb packages of WATAN DRY FRUITS Brand Natural Dried Apricot with Pitt, because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

26-5-2018

Shadow Holdings, LLC Issues Voluntary Nationwide Recall of X-Jow and Acne Shave products due to Possible Bacterial Contamination

Shadow Holdings, LLC Issues Voluntary Nationwide Recall of X-Jow and Acne Shave products due to Possible Bacterial Contamination

Shadow Holdings is voluntarily recalling all lots, within expiry, of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit to the retail level. The products may be contaminated with bacteria.

FDA - U.S. Food and Drug Administration

23-5-2018

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

FDA - U.S. Food and Drug Administration

23-5-2018

Do Teething Babies Need Medicine on Their Gums? No

Do Teething Babies Need Medicine on Their Gums? No

Teething is a normal part of childhood that doesn’t need a 'cure' with prescription or over-the-counter (OTC) medications. FDA warns parents that benzocaine products are not safe for treating teething in children. There are safer, non-toxic alternatives.

FDA - U.S. Food and Drug Administration

23-5-2018

Oral Over-the-Counter Benzocaine Products: Drug Safety Communication  - Risk of Serious and Potentially Fatal Blood Disorder

Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder

Oral over-the-counter benzocaine products should not be used to treat infants and children younger than 2 years and should only be used in adults and children 2 years and older if they contain certain warnings on the drug label.

FDA - U.S. Food and Drug Administration

22-5-2018

Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics

Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics

FDA is taking safety actions regarding over-the-counter benzocaine oral drug products and prescription local anesthetics.

FDA - U.S. Food and Drug Administration

17-5-2018

Alumilite recalls Amazing Clear Cast

Alumilite recalls Amazing Clear Cast

The recalled products do not have proper consumer chemical hazard packaging and labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

16-5-2018

FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings

FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings

FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and we have concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.

FDA - U.S. Food and Drug Administration

25-4-2018

Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry

Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry

FDA is currently evaluating data which suggests that potentially inaccurate MR thermometry information can be displayed during treatment. Posted 04/25/2018

FDA - U.S. Food and Drug Administration

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

25-9-2018

Imfinzi (AstraZeneca AB)

Imfinzi (AstraZeneca AB)

Imfinzi (Active substance: durvalumab) - Centralised - Authorisation - Commission Decision (2018)6289 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004771/0000

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (Active substance: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate) - Orphan designation - Commission Decision (2018)5727 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/060/18

Europe -DG Health and Food Safety

6-8-2018

Kyntheum (Leo Pharma A/S)

Kyntheum (Leo Pharma A/S)

Kyntheum (Active substance: brodalumab) - Centralised - Yearly update - Commission Decision (2018)5383 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

6-8-2018

Siklos (Addmedica)

Siklos (Addmedica)

Siklos (Active substance: hydroxycarbamide) - Centralised - Yearly update - Commission Decision (2018)5382 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Cyanokit (SERB S.A.)

Cyanokit (SERB S.A.)

Cyanokit (Active substance: hydroxocobalamin) - Centralised - Yearly update - Commission Decision (2018)5229 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

19-7-2018

HES (hydroxyethyl starch)

HES (hydroxyethyl starch)

HES (hydroxyethyl starch) (Active substance: hydroxyethyl starch (HES), solutions for infusion) - Community Referrals - Art 107i - Commission Decision (2018)4832 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-107i/1457

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2030 (Biophytis)

EU/3/18/2030 (Biophytis)

EU/3/18/2030 (Active substance: 20-hydroxyecdysone) - Orphan designation - Commission Decision (2018)4175 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/18

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

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

18-5-2018

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (Active substance: Poly[2-[(4-{[1-carboxy-2-(hexadecylcarbamoyl)ethyl]sulfanyl}-2,3-bis({2-[((2S)-2-(2-{[(2R)-2-carbamoyl-(2-{[(2S)-1-ethoxy-3-(3-hydroxy-4oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}ethyl]sulfanyl}-3-{[(2S)-1-ethoxy-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}propanamido)-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)propanoyl Ethyl ester) )-methoxy]acetyl}oxy)butyl)sulfanyl]-3-(hexadecylcarbamoyl)propanoic acid]-poly(ethylene glycol)-este...

Europe -DG Health and Food Safety