NEOCORT-ANTI INFLAMMATORY ANTIBIOTIC CREAM

Main information

  • Trade name:
  • NEOCORT-ANTI INFLAMMATORY ANTIBIOTIC CREAM
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NEOCORT-ANTI INFLAMMATORY ANTIBIOTIC CREAM
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • UNKNOW - WAITING TO CATEG

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Archived
  • Authorization number:
  • 35733
  • Last update:
  • 09-08-2016

16-1-2019

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Published on: Mon, 14 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of B‐Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B‐Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qua...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Antimicrobial resistance

Antimicrobial resistance

Antimicrobial resistance is a major international human and animal health issue, because the emergence and spread of drug-resistant strains of bacteria call into question the efficacy of these treatments in humans and animals alike. Preserving the effectiveness of antibiotics is therefore a genuine public health challenge requiring an integrated approach across all types of medicine, according to the "One Health" concept covering both humans and animals. ANSES has mobilised significant resources to addr...

France - Agence Nationale du Médicament Vétérinaire

21-12-2018

FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients

FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients

FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients

FDA - U.S. Food and Drug Administration

20-12-2018

Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

FDA - U.S. Food and Drug Administration

18-12-2018

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects

[07-26-2016] The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection).

FDA - U.S. Food and Drug Administration

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Questions on antimicrobial resistance

Questions on antimicrobial resistance

Antimicrobial resistance is a major public health issue in France: resistance to antibiotics calls into question the efficacy of treatments for infections occurring in humans and animals alike. At its annual symposium on this issue, ANSES will be presenting the result of its two reports on national trends in resistance in animals (Resapath report) and sales of veterinary antimicrobials.

France - Agence Nationale du Médicament Vétérinaire

12-11-2018

European Antibiotic Awareness Day 2018

European Antibiotic Awareness Day 2018

European Antibiotic Awareness Day 2018

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

8-11-2018

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Published on: Wed, 07 Nov 2018 00:00:00 +0100 In 2017, EFSA published a ‘simplified’ food safety management system (FSMS) for certain small retail establishments (butcher, grocer, baker, fish and ice cream shop) based on the application of prerequisite programme (PRP) criteria. The aim of this opinion was to develop similar FSMSs for other small retail enterprises including retail distribution centres, supermarkets, restaurants (including pubs and other catering activities) and food donation. The latter...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

22-10-2018

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

FDA - U.S. Food and Drug Administration

19-10-2018

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nause...

FDA - U.S. Food and Drug Administration

18-10-2018

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Health Canada seized “Surfaz-SN Triple Action Cream”—an unauthorized skin cream promoted for antifungal, antibacterial and anti-inflammatory use—because it is labelled to contain prescription drugs (betamethasone dipropionate and neomycin sulphate). The product was seized from Kaf African Caribbean Market (2642 Liruma Road, Unit 2A) in Mississauga, Ontario.

Health Canada

10-10-2018

Voluntary Recall Issued for Sweet Me Creamery Brookie Dough Ice Cream that may Contain an Undeclared Peanut Allergen

Voluntary Recall Issued for Sweet Me Creamery Brookie Dough Ice Cream that may Contain an Undeclared Peanut Allergen

Kemps of St. Paul, Minn., is voluntarily recalling Sweet Me Creamery Brookie Dough ice cream, individual pints and pint four-packs, because it may contain an undeclared peanut allergen. Individuals who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

5-10-2018

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade Ice Cream, Inc. of St. Petersburg, FL is conducting a voluntary recall of No Sugar Added Vanilla and No Sugar Added Chocolate ice cream manufactured in three-gallon tubs during the month of May 2018. The recall is being conducted due to a potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only...

FDA - U.S. Food and Drug Administration

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

1-10-2018

Minister Bruno Bruins naar ministeriële G20-bijeenkomst over gezondheid

Minister Bruno Bruins naar ministeriële G20-bijeenkomst over gezondheid

Op woensdag 3 en donderdag 4 oktober is minister Bruno Bruins (Medische Zorg) namens Nederland aanwezig bij de G20-bijeenkomst over gezondheid. Tijdens deze bijeenkomst in Argentinië komen alle gezondheidsministers van de grootste economieën van de wereld samen. Op de agenda staat onder andere de gezamenlijke strijd tegen antibioticaresistentie. Onderdeel hiervan is een crisissimulatie over een internationale infectieziekte-uitbraak met een multiresistente bacterie. Ook wordt er gesproken over het verste...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

FDA - U.S. Food and Drug Administration

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

15-8-2018

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Ice Cream is voluntarily recalling a limited number of its Chocolate Gooey Brownie pints because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life threatening allergic reaction if they consume this product. The product is safe to consume unless you have a peanut allergy or sensitivity. No illnesses have been reported to date in connection with this problem.

FDA - U.S. Food and Drug Administration

3-8-2018

Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant

Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant

The antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients.

FDA - U.S. Food and Drug Administration

3-8-2018

Apricot kernels pose a risk of cyanide poisoning

Apricot kernels pose a risk of cyanide poisoning

A familiar ingredient for jam-makers, apricot kernels are increasingly being consumed as a natural remedy for their claimed "anti-cancer" properties. While one kernel added to perfume several jars of jam is not a problem, ingesting them in large quantities exposes consumers to the risk of cyanide poisoning. ANSES has identified several cases of apricot kernel poisoning in France through its toxicovigilance scheme, and encourages consumers to exercise caution.

France - Agence Nationale du Médicament Vétérinaire

2-8-2018

"Jian Pai Natural Skin Care Cream" contains antifungal drugs not listed on the label, which may pose serious health risks

"Jian Pai Natural Skin Care Cream" contains antifungal drugs not listed on the label, which may pose serious health risks

Health Canada testing of “Jian Pai Natural Skin Care Cream,” also called ‘’Yikangshuang,” found that it contains two antifungal drugs (fluconazole and miconazole) that are not listed on the product label, and may pose serious health risks.

Health Canada

1-8-2018

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Health Canada seized eight unauthorized skin lotions and creams from Ayotai Canada because they are labelled to contain a prescription drug (clobetasol propionate or betamethasone dipropionate). The unauthorized lotions and creams were distributed by Ayotai and sold by various retailers in Quebec.

Health Canada

30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

19-7-2018

H-E-B Voluntarily Issues Recall Two Variety Packs of Creamy Creations Ice Creams and Sherbets in 3-Ounce Cups Recalled due to Broken Metal in Processing Equipment

H-E-B Voluntarily Issues Recall Two Variety Packs of Creamy Creations Ice Creams and Sherbets in 3-Ounce Cups Recalled due to Broken Metal in Processing Equipment

H-E-B is voluntarily issuing a recall for two variety packs of Creamy Creations ice cream and sherbets in 3-ounce cups due to broken metal found in processing equipment during routine maintenance. The potentially affected products were distributed only to H-E-B stores in Texas. Please note, the product was not distributed to the Houston area or Mexico.

FDA - U.S. Food and Drug Administration

18-7-2018

Orphan designation:  Recombinant humanised anti-human interleukin-1 beta monoclonal antibody,  for the: Treatment of Behçet’s disease

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

18-7-2018

"Anti-pollution" masks: not enough data to demonstrate a health benefit and justify recommending their use

"Anti-pollution" masks: not enough data to demonstrate a health benefit and justify recommending their use

In a context where prevention of ambient air pollution is a real public health issue, questions are regularly asked about the value of recommending that the population wear personal protective equipment. This led ANSES to assess the potential health benefits of wearing "anti-pollution" masks. Its expert appraisal revealed a lack of data demonstrating a health benefit. To reduce the health impacts associated with ambient air pollution, the Agency reiterates the importance of prioritising action at the sou...

France - Agence Nationale du Médicament Vétérinaire

10-7-2018

FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions

FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions

FDA is requiring safety labeling changes for fluoroquinolones to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances.

FDA - U.S. Food and Drug Administration

10-7-2018

Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects

Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects

FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.

FDA - U.S. Food and Drug Administration

12-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections

The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. FDA is taking steps to combat antibiotic-resistant bacteria.

FDA - U.S. Food and Drug Administration

31-5-2018

H-E-B Voluntarily Issues Recall Specific flavors and container sizes of EconoMax and Hill Country Fare ice creams and Creamy Creations sherbets recalled for broken metal in processing equipment

H-E-B Voluntarily Issues Recall Specific flavors and container sizes of EconoMax and Hill Country Fare ice creams and Creamy Creations sherbets recalled for broken metal in processing equipment

Committed to the quality of its products, H-E-B is voluntarily issuing an all-store recall for certain flavors and container sizes of EconoMax and Hill Country Fare ice creams and Creamy Creations sherbets for broken metal in processing equipment found during routine maintenance. The affected products were distributed to stores in Texas and Mexico.

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

18-5-2018

Unauthorized prescription antibiotic drugs seized from Gigi's Market in Ottawa, ON, may pose serious health risks

Unauthorized prescription antibiotic drugs seized from Gigi's Market in Ottawa, ON, may pose serious health risks

Health Canada has seized four unauthorized drugs from Gigi’s Market, 23 Montreal Road, Ottawa, ON. The products (Ampicillin, Kamox, Medampi and Medomox) are labelled to contain antibiotic drugs (ampicillin or amoxicillin) that can only be dispensed by a healthcare professional to a patient with a valid prescription. The products listed below have not been evaluated by Health Canada for safety, effectiveness or quality and may pose serious health risks.

Health Canada

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

27-4-2018

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

Today, the Agency is publishing an inventory of alternatives to antibiotics aimed at reducing their use in animal husbandry and based on an original method for evaluating the diverse scientific publications in the field. In its report, ANSES identifies numerous products and substances including compounds, plants, plant extracts and micro-organisms, which are used as alternatives to antibiotics. However, it emphasises the diversity of the data available to assess their safety and efficacy, and their abili...

France - Agence Nationale du Médicament Vétérinaire

3-3-2017

New transatlantic agreement on mutual recognition of inspections

New transatlantic agreement on mutual recognition of inspections

The EU and the USA have agreed to recognise inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic.

Danish Medicines Agency

14-1-2019


Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobials

Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobials

Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobials

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA (B-cell maturation antigen) chimeric antigen receptor (CAR) T-cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA (B-cell maturation antigen) chimeric antigen receptor (CAR) T-cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA (B-cell maturation antigen) chimeric antigen receptor (CAR) T-cells

Europe - EMA - European Medicines Agency

6-12-2018


Human anti-d immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001614/201803

Human anti-d immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001614/201803

Human anti-d immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001614/201803

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2094 (Y-mAbs Therapeutics A/S)

EU/3/18/2094 (Y-mAbs Therapeutics A/S)

EU/3/18/2094 (Active substance: Anti-GD2 monoclonal antibody 3F8 humanised) - Orphan designation - Commission Decision (2018)7804 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/126/18

Europe -DG Health and Food Safety

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Active substance: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA) - Orphan designation - Commission Decision (2018)5283 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Active substance: 2'-O-(2-methoxyethyl) antisense oligonucleotide targeting microtubule-associated protein tau pre-mRNA) - Orphan designation - Commission Decision (2018)5273 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/050/18

Europe -DG Health and Food Safety

27-7-2018

Scientific guideline:  Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimic...

Europe - EMA - European Medicines Agency

18-5-2018

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3148 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/041/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3147 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (Active substance: Humanised recombinant IgG4 anti-human tau antibody) - Transfer of orphan designation - Commission Decision (2018)3024 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/239/15/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1671 (IQVIA RDS Ireland Limited)

EU/3/16/1671 (IQVIA RDS 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