to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing); to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia; to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections; to treat persistent neutropenia in patients with advanced human-immunodeficiency-virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate. The studies looked at the effects of single and repeated administration of various doses of the medicines, either injected under the skin or infused into a vein. This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease; patients suffering from acute coronary syndrome. This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health. Methylphenidate Hexal is a generic medicine based on a 'reference medicine', Concerta, which is authorised in all the EU Member States. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. EMA is in the process of making appropriate changes to this website. Tramadol Retard Hexal is a medicine available in a number of countries worldwide. The Committee also noted that the studies were performed by the applicant before the publication of recent updated guidance* for products of this type. Filgrastim Hexal is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately. Available for Android and iOS devices. Includes cetirizine side effects, interactions and indications. Filgrastim Hexal is used to stimulate the production of white blood cells in the following situations: Filgrastim Hexal can also be used in people who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow. Overview The marketing authorisation for Clopidogrel Hexal has been withdrawn at the … This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 33,61 USD zero rated for VAT ACC 100 TABS 50 pc. Hexal-Mpa Tablet is used for absence of menstrual periods, long acting contraceptive, irregular menstrual periods and other conditions. Filgrastim Hexal is a solution for injection or infusion (drip into a vein) in a prefilled syringe. Data sources include IBM Watson Micromedex (updated 1 Oct 2020), Cerner Multum™ (updated 1 Oct 2020), Wolters Kluwer™ (updated 30 Sep 2020) and others. Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. On 25 July 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Methylphenidate Hexal. It should not be construed to indicate that the use of any medication in any country is safe, appropriate or effective for you. More detail is available in the summary of product characteristics. Methylphenidate Hexal is a generic medicine based on a 'reference medicine', Concerta, which is authorised in all the EU Member States. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicine… For the full list of all side effects reported with Filgrastim Hexal, see the package leaflet. In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of of ≤ 0.5 x 10, Treatment of persistent neutropenia (ANC ≤ 0.5 x 10. in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate. European Medicines AgencyDomenico Scarlattilaan 61083 HS AmsterdamThe Netherlands. The marketing authorisation for Clopidogrel Hexal has been withdrawn at the request of the marketing-authorisation holder. EMA is in the process of making appropriate changes to this website. Following are the closest matches we could find. It contains the active substance filgrastim (30 or 48 million units). Size: 500 x 500 pixels. The grounds for the referral were objections raised by Germany and the Netherlands who considered that the bioequivalence study carried out under fed conditions did not show that Methylphenidate Hexal was bioequivalent for the immediate-release phase to its reference product. The reference medicine for Filgrastim Hexal is Neupogen. This medicine must be used together with a reduced-calorie diet and increased physical activity. Cetirizine treats cold or allergy symptoms such as sneezing, itching, watery eyes, or runny nose. This is a summary of the European public assessment report (EPAR). Other side effects may be seen in more than 1 patient in 10, depending on the condition that Filgrastim Hexal is being used for. The active substance in Filgrastim Hexal, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Methylphenidate Hexal outweigh its risks, and the marketing authorisation granted in Denmark can be recognised in other Member States of the EU. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Available for Android and iOS devices. It is available as a modified-release tablet, which releases some of the active substance immediately (the 'immediate-release phase') and the rest over several hours. All fields are optional. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The main measure in these studies was the neutrophil count over the first 10 days of treatment. Filgrastim Hexal is given by injection under the skin or infusion into a vein. It has been available since the 1950s as both immediate-release tablets and capsules, which release methylphenidate straight away, and as modified-release tablets that release some or all of the active substance more slowly over several hours. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine. This means that Filgrastim Hexal is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine’). If you have questions about your drug, for example... - What caused the drug in the body? This was considered sufficient to demonstrate that the benefits of Filgrastim Hexal are comparable to those of the reference medicine. If you use other drugs or over the counter products at the same time, the effects of Hexal-Mpa Tablet may change. Orlistat is used to aid in weight loss, or to help reduce the risk of regaining weight already lost. A list of US medications equivalent to MTX Hexal is available on the Drugs.com website. Methotrexate is reported as an ingredient of MTX Hexal in the following countries: Methotrexate sodium (a derivative of Methotrexate) is reported as an ingredient of MTX Hexal in the following countries: Important Notice: The Drugs.com international database is in BETA release. 7. This medicine is authorised for use in the European Union. Hexal A/S submitted Methylphenidate Hexal for mutual recognition on the basis of the initial authorisation granted by Denmark on 29 March 2012 and also valid through a decentralised procedure in Ireland. Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more. You are therefore advised to be selective about which sections or pages you wish to print. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Cetirizin HEXAL may be available in the countries listed below. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. European Medicines AgencyDomenico Scarlattilaan 61083 HS AmsterdamThe Netherlands. Page 1 of 4 - item 1 to 16 of 52 GINGIUM 40MG 120 pc. For further information please refer to section 5.1. Orlistat is for use only in adults that are overweight or obese. If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. *Committee for Human Medicinal Products. Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more. The company wanted the authorisation to be recognised in Germany (the 'concerned Member State'). Changes since initial authorisation of medicine, Initial marketing-authorisation documents, Committee for Medicinal Products for Human Use, International non-proprietary name (INN) or common name, Anatomical therapeutic chemical (ATC) code, Date of issue of marketing authorisation valid throughout the European Union. For more information, see Generic and hybrid medicines. Available for Android and iOS devices. Please note that the size of the above document can exceed 50 pages. How to store Mycophenolate Hexal 250 mg Capsules Keep this medicine out of the sight and reach of children. Filgrastim Hexal is a ‘biosimilar medicine'. Filgrastim is produced by a method known as ‘recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim. Methylphenidate is a medicine that is used to treat children aged between six and 18 years of age who have attention-deficit / hyperactivity disorder (ADHD), a condition in which children show a persistent inability to concentrate, hyperactivity and impulsive behaviour. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. L484, You may also search by drug name or NDC code. Data sources include IBM Watson Micromedex (updated 1 Oct 2020), Cerner Multum™ (updated 1 Oct 2020), Wolters Kluwer™ (updated 30 Sep 2020) and others. Select one or more newsletters to continue. The European Commission issued a decision on this opinion on 09 October 2013. Please note that the size of the above document can exceed 50 pages. It is not intended as a substitute for the expertise and judgement of your physician, pharmacist or other healthcare professional.

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