Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lemtrada ( Alemtuzumab ) 12 ...
The European Commission has granted marketing authorisation for Tafinlar ( Dabrafenib ) as an oral targeted treatment indicated in monotherapy for unresectable melanoma or metastatic melanoma in adult ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Provenge.The indication rec ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Inflectra, 100 mg powder fo ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Remsima, 100 mg powder for ...
The European Medicines Agency’s Committee for Medicinal Products for Human Use ( CHMP ) has recommended granting of marketing authorisations for the first two monoclonal-antibody biosimilars.Remsima a ...
Dendreon has announced that the European Commission ( EC ) has granted marketing authorization for Provenge ( autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or Sipuleucel-T ) ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Somatropin Biopartners, 2 m ...
The European Medicines Agency’s Committee for Medicinal Products for Human Use ( CHMP ) has recommended marketing authorisation for Pomalidomide Celgene ( Imnovid ) to treat patients with multiple mye ...
The European Medicines Agency’s Committee for Medicinal Products for Human Use ( CHMP ) has recommended marketing authorisation for Tafinlar ( Dabrafenib ) for the treatment of adult patients with adv ...
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee ( PRAC ) has concluded that the benefits of Diane 35 ( Cyproterone acetate 2 mg / Ethinylestradiol 35 micrograms ) and its g ...
On 21 March 2013, Santhera Pharmaceuticals ( Deutschland ) GmbH officially notified the Committee for Medicinal Products for Human Use ( CHMP ) that it wishes to withdraw its application for a marketi ...
Retigabine ( Trobalt ) should now only be used as an adjunctive treatment for drug-resistant partial onset seizures with or without secondary generalisation in patients age 18 years or older with epil ...
Ondansetron ( brand leader Zofran ) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of pos ...
A Europe-wide review of intravenous Iron products for iron deficiency and anaemia has recommended strengthened measures are taken to manage and minimise the risk of hypersensitivity reactions, which m ...
Use of Nitrofurantoin for urinary tract infections is contraindicated in patients with less than 60 mL/min creatinine clearance. Healthcare professionals should be aware of a patient’s current renal f ...
Physicians should no longer prescribe oral Ketoconazole for fungal infections, and should review patients’ treatment options because of a risk of liver injury. The European Medicines Agency’s Committe ...
The European Medicines Agency’s Committee on Medicinal Products for Human Use has reviewed the benefits and risks of the antiemetic Metoclopramide. The review was done at the request of the French med ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Xeljanz, intended for the ...
The European Medicines Agency’s Committee for Medicinal Products for Human Use ( CHMP ) has recommended granting a marketing authorisation for a new advanced-therapy medicinal product ( ATMP ). Proven ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Erivedge 150 mg ...
The Committee for Medicinal Products for Human Use ( CHMP ) has recommended the granting of a marketing authorisation for Nuedexta, a medicine for the treatment of pseudobulbar affect in adults.Pseudo ...
The EMA ( European Medicines Agency ) has recommended updating the prescribing information for Victrelis ( Boceprevir ) with information about drug interactions between this hepatitis C medicine and t ...
The FDA ( Food and Drug Administration ) has assigned Priority Review to the regulatory submission for Ramucirumab as a single-agent treatment for advanced gastric cancer following disease progression ...
The health care professionals have been informed of the risk of severe cutaneous reactions associated with the use of Capecitabine ( Xeloda ).Xeloda is authorized for the following indications:a) Colo ...
The Food and Drug Administration ( FDA ) has approved Cimzia ( Certolizumab pegol ) for the treatment of adult patients with active psoriatic arthritis ( PsA ).Psoriatic arthritis is a chronic, inflam ...
MHRA ( Medicines and Healthcare Products Regulatory Agency ) previously advised that the contraindications for Dabigatran ( Pradaxa ) had been clarified to include a range of clinical conditions where ...
In the treatment of metastatic colorectal cancer, evidence of wildtype RAS status ( at exons 2, 3, and 4 of KRAS and NRAS ) is required before initiating treatment with Panitumumab ( Vectibix ) alone ...
Capillary leak syndrome ( CLS ) has been reported in recipients of Filgrastim, including patients undergoing chemotherapy and a healthy donor undergoing peripheral blood progenitor-cell mobilisation; ...
Although the risk of neuropsychiatric side effects with Mefloquine is well-established, a recent review of the prescribing information has led to strengthened warnings and new measures to help minimis ...
The use of short-acting beta2 agonists ( SABAs ) for tocolysis in premature labour has been restricted to 48 hours’ maximum parenteral use under specialist supervision, after a European safety review. ...
There is new evidence on neurodevelopmental delay in children following maternal use of Sodium Valproate. A European review is underway to evaluate all currently available evidence on the association ...
Different antiepileptic drugs ( AEDs ) vary considerably in their characteristics, which influences the risk of whether switching between different manufacturers’products of a particular drug may caus ...
Cases of intraoperative floppy iris syndrome ( IFIS ) during cataract surgery have been reported in patients taking the atypical antipsychotics Risperidone ( Risperdal ) or Paliperidone ( Invega ). IF ...
The use of Codeine for analgesia in children and adolescents under 18 has been restricted after a European safety review. The review was triggered by case reports of children who received Codeine for ...
The risk of foetal malformation with oral retinoids is extremely high, even when used at a low dose or for a short time during pregnancy. All oral retinoids have an associated Pregnancy Prevention Pro ...
Following a Europe-wide review of Cyproterone acetate with Ethinylestradiol ( Co-cyprindiol ), the balance of benefits and risks of Dianette ( brand leader ) and its generics remains positive. To furt ...
Available data indicate that the cardiovascular risk with Diclofenac is similar to that of the selective COX-2 inhibitors. Consistent with COX-2 inhibitors, Diclofenac is now contraindicated in those ...
Patients treated with Thalidomide ( Thalidomide Celgene ) have an increased risk of haematological second primary malignancies ( acute myeloid leukaemia and myelodysplastic syndromes ).Healthcare prof ...
Drug-induced liver injury has been observed in clinical trials investigating potential use in patients with autosomal dominant polycystic kidney disease ( ADPKD, an unlicensed indication ) at higher d ...
A review of available safety data for Strontium ranelate ( Protelos ) has raised concern about its cardiovascular safety beyond the already recognised risk of venous thromboembolism. An analysis of ra ...
Cilostazol ( Pletal ) is restricted to second-line use in patients for whom life-style modifications and other appropriate interventions have failed to sufficiently improve their symptoms.Furthermore, ...
Botulinum toxin type B ( Neurobloc ) is indicated only for the treatment of cervical dystonia ( torticollis ) in adults. MHRA ( Medicines and Healthcare Products Regulatory Agency ) recommends that pr ...
Dabigatran etexilate ( Pradaxa ) is contraindicated in patients with prosthetic heart valves requiring anti-coagulant treatment related to their valve surgery, regardless of the length of time elapsed ...
Atypical femoral fractures have been reported rarely in patients with postmenopausal osteoporosis receiving long-term ( greater than or equal to 2.5 years ) treatment with Denosumab 60 mg ( Prolia ) i ...
Roflumilast ( Daxas ) is a phosphodiesterase-type-4 ( PDE4 ) inhibitor used for maintenance treatment of severe chronic obstructive pulmonary disease ( COPD ) associated with chronic bronchitis. It is ...
Tredaptive is a fixed-dose combination product containing extended-release Nicotinic acid ( 1000 mg ) and Laropiprant ( 20 mg ), which has been indicated for the treatment of dyslipidemia, particularl ...
Elevations of liver enzymes occur in 1-10 patients out of every 100 treated with Lenalidomide ( Revlimid ) for multiple myeloma in clinical trials; the majority of these are non-serious. Serious ( pot ...
Starting Fingolimod ( Gilenya ) treatment, or re-starting Fingolimod after treatment interruption, results in transient decreases in heart rate. In some patients it can also cause transient bradycardi ...
The FDA ( Food and Drug Administration ) has approved Olysio ( Simeprevir ), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen ...
