Elements for a Public Summary. Overview of disease epidemiology
|
|
|
- Clifton Carter
- 6 years ago
- Views:
Transcription
1 VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Acute myeloid leukemia (AML) Acute myeloid leukemia (AML) is a type of cancer characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. The symptoms of AML include fatigue, shortness of breath, easy bruising and bleeding, and increased risk of infection. As an acute leukemia, AML progresses rapidly and is typically fatal within weeks or months if left untreated. AML is the most common acute leukemia affecting adults, and its incidence increases with age. 1 PhV Page 60/100
2 Acute Myeloid Leukemia (AML) is a rare malignancy with 13,000 new cases diagnosed in the US each year. The majority patients die from their disease with an estimated 9,000 deaths annually. 1 VI.2.2 Summary of treatment benefits Acute myeloid leukaemia (AML) A study was conducted with high-dose cytarabine (HiDAC) monotherapy compared to intermediate- or high-dose cytarabine combinations in the treatment of acute myeloid leukaemia (AML) A median follow-up of 5 years showed that no significant differences were noted between the intermediate-dose group and the high-dose group with respect to complete remission rates (80% and 82%, respectively), probability of relapse, event-free survival at 5 years (34% and 35%), or overall survival (40% and 42%). High-dose cytarabine provided no clear advantage in any prognostic subgroup. 1 Acute lymphoblastic leukemia (ALL) has demonstrated efficacy in combination with other chemotherapeutic agents as consolidation therapy of acute lymphoblastic leukemia (ALL). In a Southwest Oncology Group study (n=168), the consolidation phase consisted of 3 cycles of cytarabine (continuous infusion of 200 mg/m2 for 5 days) and methotrexate alternating with 3 cycles of cytarabine (150 mg/m2 IV every 12 hours for 6 days) and thioguanine. 1 VI.2.3 Unknowns relating to treatment benefits Based on the currently available data, no gaps in knowledge about efficacy in the target population were identified, that would warrant post-authorisation efficacy studies. Furthermore, there is no evidence to suggest that treatment results would be different in any subgroup of the target population, taking into account factors such as age, sex, race or organ impairment. VI.2.4 Summary of safety concerns Important identified risks Risk What is known Preventability A significant reduction of blood cells production in the bone marrow (myelosuppression) strongly reduces blood cell production in the bone marrow. This can make patients more prone to infections or bleeding. The blood cell numbers can continue to fall for up to a week after stopping treatment. Yes, the doctor will perform blood tests regularly and examine the bone marrow if required. Increased possibility of developing infections (Increased susceptibility to infections) Breaking of the tumour (Tumour lysis syndrome) reduces the effectiveness of the immune system and infections may appear. These infections may be mild, but can be severe and at times fatal. The breaking of the tumour may lead to high levels of uric acid (showing that the cancer cells are destroyed) in the blood (hyperuricaemia) Yes, the doctor will perform blood test regularly. Yes, the doctor will decide the need to take any medicine to control this. PhV Page 61/100
3 Risk What is known Preventability during treatment. Damage to the central nervous system with high dose cytarabine (Central nerve system toxicity with high dose cytarabine) Lung toxicity with high dose cytarabine (Pulmonary toxicity (Pulmonary oedema, adult respiratory distress syndrome) ) Abdomen and intestine toxicity (Gastrointestinal toxicity) Liver toxicity (Hepatic toxicity) Serious and sometimes lifethreatening side effects can occur in the central nervous system: burning pain of palms and soles, neural toxicity, neuritis.. In higher dose therapy, patients may develop personality changes, changed alertness, difficulty in speaking, problems of coordination, tremor, nystagmus, confusion, sleepiness... These symptoms are usually reversible. Serious and sometimes lifethreatening side effects can occur in the lungs. The following side effects may occur: clinical signs of pulmonary oedema / Acute Respiratory Distress Syndrome (ARDS): Sudden, distressing breathing difficulties and water in the lungs. These are more likely to develop with high dose therapy. may cause severe pain in the abdomen, stomach ache or inflammation of the inner lining of the stomach. Especially during treatment with high doses of cytarabine, more severe reactions may appear in addition to common symptoms. During cytarabine treatment liver function should be monitored by using blood tests. Also, if the liver is not working well before treatment, cytarabine should be given only with utmost care. Some of the side effects that can occur when using cytarabine are: increased enzyme levels, impaired liver function, liver abscess. These symp- PhV Page 62/100
4 Risk What is known Preventability toms are usually reversible. Tingling, weakness or pain in hands or feet (Peripheral motor and sensory neuropathies) Headache, paralysis, coma and stroke like episodes (neurologic reactions) - cytarabine in combination with methotrexate Inflammation of the pancreas (pancreatitis) When using high dose cytarabine, damage to the nerves of the hand and feet may appear. This is usually reversible. should not be used in case of increasing difficulties in body coordination after radiation treatment with another anticancer drug such as methotrexate. Paralysis of the legs and lower body can occur when cytarabine is given into the space surrounding the spinal cord, therefore this method of administration is not recommended. A side effect of cytarabine is inflammation of the pancreas. This may appear after therapy with high doses. Yes, by avoiding using cytarabine in combination with methotrexate or other anticancer drugs and also by avoiding the administration of cytarabine into the space surrounding the spinal cord. Missing information Risk Use during breastfeeding (Use in lactating women) What is known The safety of cytarabine for use during breast-feeding is not established. VI.2.5 Summary of risk minimisation measures by safety concern All medicines have a Summary of Product Characteristics (SmPC) which provides physicians, pharmacists and other health care professionals with details on how to use the medicine, the risks and recommendations for minimising them. An abbreviated version of this in lay language is provided in the form of the package leaflet (PL). The measures in these documents are known as routine risk minimisation measures. This medicine has no additional risk minimisation measures. VI.2.6 Planned post authorisation development plan No post-authorisation safety or efficacy studies are ongoing or are planned to be conducted for cytarabine. PhV Page 63/100
5 VI.2.7 Summary of changes to the Risk Management Plan over time Version Date Safety Concerns Comment Important identified risks: NA first version Myelosuppression Hyperuricaemia Neurotoxicity Pulmonary toxicity (Ara-C) syndrome Use in pregnancy Important potential risks Reproductive toxicity Missing information Use in infants Important identified risks: The RMP was updated Myelosuppression in relation to Increased susceptibility to infections report and in order Day 70 Assesment Tumour lysis syndrome to harmonise the safety concerns with the Originator s list Central nerve system of safety concerns. toxicity with high dose cytarabine* Pulmonary toxicity (Pulmonary oedema, adult respiratory distress syndrome) with high dose cytarabine Gastrointestinal toxicity Hepatic toxicity with high dose cytarabine Peripheral motor and sensory neuropathies Neurologic reactions (headache, paralysis, coma and stroke like episodes) cytarabine in combination with methotrexate Pancreatitis Important potential risks Not applicable Missing information Use in lactating wom- PhV Page 64/100
6 Version Date Safety Concerns Comment en PhV Page 65/100
Elements for a Public Summary
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Chronic lymphocytic leukaemia 1 Chronic lymphocytic leukemia (CLL) is a condition characterized by a progressive accumulation
Summary of the risk management plan (RMP) for Oncaspar (pegaspargase)
EMA/829065/2015 Summary of the risk management plan (RMP) for Oncaspar (pegaspargase) This is a summary of the risk management plan (RMP) for Oncaspar, which details the measures to be taken in order to
Summary of the risk management plan (RMP) for Spectrila (asparaginase)
EMA/829066/2015 Summary of the risk management plan (RMP) for Spectrila (asparaginase) This is a summary of the risk management plan (RMP) for Spectrila, which details the measures to be taken in order
SUMMARY OF THE RISK MANAGEMENT PLAN FOR. BESPONSA 1mg (INOTUZUMAB OZOGAMICIN) Powder for concentrate for solution for infusion.
SUMMARY OF THE RISK MANAGEMENT PLAN FOR BESPONSA 1mg (INOTUZUMAB OZOGAMICIN) Powder for concentrate for solution for infusion. This RMP Summary is based on Part VI of the EU RMP for BESPONSA (Inotuzumab
Elements for a Public Summary. Overview of disease epidemiology
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Gout i Gout has a worldwide distribution. In the United Kingdom from 2000 to 2007, the estimated occurrence of gout is 5.9% in
Pregabalin Aristo Version: RMP-Pregabalin0
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Epilepsy Epilepsy is a long-term condition affecting the brain and is characterised by recurring seizures (or fits). It is one
Summary of the risk management plan (RMP) for Kyprolis (carfilzomib)
EMA/639793/2015 Summary of the risk management plan (RMP) for Kyprolis (carfilzomib) This is a summary of the risk management plan (RMP) for Kyprolis, which details the measures to be taken in order to
Swiss Summary of the Risk Management Plan (RMP) for BLINCYTO (Blinatumomab)
Swiss Summary of the Risk Management Plan (RMP) for BLINCYTO (Blinatumomab) RMP Summary: Version 1, April 2017 EU RMP: Version 3.2, November 2016 Page 1 of 13 The Risk Management Plan (RMP) is a comprehensive
Elements for a public summary. VI.2.1 Overview of disease epidemiology
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Epilepsy: It is the commonest neurological condition, characterized by recurrent seizures, affecting people of all ages, race
Elements for a public summary
VI.2 Elements for a public summary Part VI.2 Elements for a public summary is applicable for all products that are covered by this RMP, except from the important potential risk of Medication error with
, version 1.1 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN
Docetaxel Orion 20 mg/1 ml concentrate for solution for infusion Docetaxel Orion 80 mg/4 ml concentrate for solution for infusion Docetaxel Orion 160 mg/8 ml concentrate for solution for infusion 11.8.2014,
Olumiant. (baricitinib) 2 mg and 4 mg, film-coated tablets. Summary of Risk Management Plan (RMP) Version 2.0, Page 1
Olumiant (baricitinib) 2 mg and 4 mg, film-coated tablets Summary of Risk Management Plan (RMP) Version 2.0, 16-04-2018 Page 1 Summary of the risk management plan (RMP) for Olumiant (baricitinib) The Risk
Elements for a Public Summary
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Parkinson s disease Parkinson s disease (PD) is in the category of movement disorders. It has four main symptoms: tremor and stiffness
VI.2 Elements for a public summary
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Leukaemia is a cancer that starts in the blood-forming cells of the bone marrow. Chronic lymphocytic leukaemia (CLL) is a type
Elements for a Public Summary Overview of disease epidemiology
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Acute pain usually responds to medication and should settle in less than three months. Inadequate pain relief may lead to other
Summary of the risk management plan (RMP) for Bortezomib Accord (bortezomib)
EMA/449387/2015 Summary of the risk management plan (RMP) for Bortezomib Accord (bortezomib) This is a summary of the risk management plan (RMP) for Bortezomib Accord, which details the measures to be
Zerlinda (MRP DK/H/2265/001)
Zerlinda (MRP DK/H/2265/001) VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Prevention of bone complications, e.g. fractures, in adult patients with bone metastases (spread
Summary of the risk management plan (RMP) for Pregabalin Pfizer (pregabalin)
EMA/247834/2014 Summary of the risk management plan (RMP) for Pregabalin Pfizer (pregabalin) Overview of disease epidemiology Epilepsy Epilepsy is a long-term condition affecting the brain and is characterised
Elements for a public summary. VI.2.1 Overview of disease epidemiology
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Coronary artery disease and as anticoagulant (inhibiting the clotting of the blood) in patients undergoing surgery to treat blockages
PUBLIC SUMMARY OF RISK MANAGEMENT PLAN MIRTAZAPIN ORION 15MG, 30MG AND 45MG TABLETS ORION CORPORATION DATE: , VERSION 2
PUBLIC SUMMARY OF RISK MANAGEMENT PLAN MIRTAZAPIN ORION 15MG, 30MG AND 45MG TABLETS ORION CORPORATION DATE: 16-12-2014, VERSION 2 VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology
Summary of the risk management plan (RMP) for Gazyvaro (obinutuzumab)
EMA/319729/2014 Summary of the risk management plan (RMP) for Gazyvaro (obinutuzumab) This is a summary of the risk management plan (RMP) for Gazyvaro, which details the measures to be taken in order to
Elements for a public summary
VI.2 VI.2.1 Elements for a public summary Overview of disease epidemiology Chronic myeloid leukaemia (CML) CML is the most common of the blood cancers. It accounts for 15-20% of all cases of leukemia.
PLENADREN EU-RMP VERSION 3.2. Elements for a Public Summary. Overview of Disease Epidemiology
PLENADREN EU-RMP VERSION 3.2 VI.2 VI.2.1 Elements for a Public Summary Overview of Disease Epidemiology PLENADREN contains hydrocortisone and is used to treat adrenal insufficiency (AI) in adults. AI occurs
srmp Atorvastatin Medical Valley
srmp Atorvastatin Medical Valley VI.2 VI.2.1 Elements for a public summary Overview of disease epidemiology This product is indicated for the lowering of cholesterol blood levels and the prevention of
Vildagliptin belongs to a group of medicines called oral antidiabetics.
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Vildagliptin belongs to a group of medicines called oral antidiabetics. Vildagliptin is used in a certain form of diabetes (type
Summary of the Risk Management Plan (RMP) V. 1.6, July 2017 for BAVENCIO. Avelumab 200 mg/10 ml. Concentrate for Solution for Infusion
Summary of the Risk Management Plan (RMP) V. 1.6, July 2017 for BAVENCIO Avelumab 200 mg/10 ml Concentrate for Solution for Infusion Marketing Authorisation Number 66380 Marketing Authorisation Holder:
srmp DK/H/2377/ /DC Gliclazid Sigillata
srmp DK/H/2377/001-002/DC Gliclazid Sigillata VI.2 VI.2.1 Elements for a public summary Overview of disease epidemiology Diabetes is a disease which causes patients blood sugar levels to be high. Gliclazide
Summary of the risk management plan (RMP) for Ristempa (pegfilgrastim)
EMA/183255/2015 Summary of the risk management plan (RMP) for Ristempa (pegfilgrastim) This is a summary of the risk management plan (RMP) for Ristempa, which details the measures to be taken in order
RMP version 3.0 Aripiprazole
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Schizophrenia The prevalence (proportion of the population found to have a disease) of schizophrenia (a disease characterised
VI.2 Elements for a Public Summary. VI.2.1 Overview of disease epidemiology
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Febuxostat is a medicine used in adults with gout to reduce high levels of uric acid in the blood. Gout results from a build up
Package leaflet: Information for the user. Cytarabine STADA 100 mg/ml, concentrate for solution for infusion Cytarabine
Package leaflet: Information for the user Cytarabine STADA 100 mg/ml, concentrate for solution for infusion Cytarabine Read all of this leaflet carefully before you start using this medicine. Keep this
Elements for a Public Summary
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Actavis is a cancer medicine used to treat two types of lung cancer, malignant pleural mesothelioma and advanced non-small-cell
Risk Management Plan Etoricoxib film-coated tablets
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Osteoarthritis (OA): OA is a condition in which the cartilage of the joints is broken down. This causes stiffness, pain and leads
Summary of the risk management plan (RMP) for Lenvima (lenvatinib)
EMA/227224/2015 Summary of the risk management plan (RMP) for Lenvima (lenvatinib) This is a summary of the risk management plan (RMP) for Lenvima, which details the measures to be taken in order to ensure
PUBLIC SUMMARY OF RISK MANAGEMENT PLAN (RMP) MODAFINIL ORION 100 MG, 200 MG Tablets ORION CORPORATION DATE: , VERSION 1.
PUBLIC SUMMARY OF RISK MANAGEMENT PLAN (RMP) MODAFINIL ORION 100 MG, 200 MG Tablets ORION CORPORATION DATE: 22-04-2015, VERSION 1.1 VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology
Piazza G, Creager M. Thromboangiitis Obliterans. Circulation Apr 27; 121(16):
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Thromboangiitis Obliterans (TAO) 12 TAO, also called Buerger disease, is an inflammatory disease that most commonly affects the
Prophylaxis of acute transplant rejection in patients receiving allogeneic renal transplants:
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Prophylaxis of acute transplant rejection in patients receiving allogeneic renal transplants: Over 1 million people worldwide
Elements for a Public Summary Overview of disease epidemiology
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Indication: Treatment of blood clots Blood clots in the large veins of the legs, known as deep vein thrombosis (DVT), are a common
VPRIV EU-RMP Version 9.2. Elements for a Public Summary. Overview of Disease Epidemiology
VI.2 VI.2.1 Elements for a Public Summary Overview of Disease Epidemiology Gaucher disease is a rare genetic illness due to the absence of a specific enzyme in the body. About 30,000 persons worldwide
RISK MANAGEMENT PLAN (RMP) PUBLIC SUMMARY ETORICOXIB ORION (ETORICOXIB) 30 MG, 60 MG, 90 MG & 120 MG FILM-COATED TABLET DATE: , VERSION 1.
RISK MANAGEMENT PLAN (RMP) PUBLIC SUMMARY ETORICOXIB ORION (ETORICOXIB) 30 MG, 60 MG, 90 MG & 120 MG FILM-COATED TABLET DATE: 07-10-2016, VERSION 1.2 VI.2 Elements for a Public Summary Etoricoxib Orion
Metformin appears to be a useful therapeutic option for physicians wishing to use drug therapy to control blood glucose levels. 3
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Type 2 diabetes mellitus Rates of diabetes are increasing worldwide. The International Diabetes Federation predicts that the number
Rydapt. Summary of the Risk Management Plan (RMP) for Rydapt (midostaurin)
Regulatory Affairs Rydapt 25 mg soft capsules Summary of the Risk Management Plan (RMP) for Rydapt (midostaurin) Document version: 01 Document status: Document Date: Final 02-June-2017 1 of 6 Summary of
Elements for a public summary. VI.2.1 Overview of disease epidemiology
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Nosocomial pneumonia (NP): NP (hospital acquired pneumonia) is most common in elderly patients; however, patients of any age may
VI.2 Elements for a Public Summary DULOXETINE Pharmalex 30 mg hard gastro-resistant capsules DULOXETINE Pharmalex 60 mg hard gastro-resistant capsules
VI.2 Elements for a Public Summary DULOXETINE Pharmalex 30 mg hard gastro-resistant capsules DULOXETINE Pharmalex 60 mg hard gastro-resistant capsules VI.2.1 Overview of disease epidemiology Depression
PART III: CONSUMER INFORMATION
PART III: CONSUMER INFORMATION Pr Cytarabine Injection 100 mg/ml This leaflet is part III of a three-part "Product Monograph" published when Cytarabine Injection was approved for sale in Canada and is
PUBLIC SUMMARY OF RISK MANAGEMENT PLAN (RMP) CIPROFLOXACIN ORION 750 MG FILM-COATED TABLETS ORION OYJ DATE: , VERSION 1.
PUBLIC SUMMARY OF RISK MANAGEMENT PLAN (RMP) CIPROFLOXACIN ORION 250 MG FILM-COATED TABLETS CIPROFLOXACIN ORION 500 MG FILM-COATED TABLETS CIPROFLOXACIN ORION 750 MG FILM-COATED TABLETS ORION OYJ DATE:
Risk What is known Preventability Increased symptoms of congestion when the effects of
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Nasal congestion Nasal congestion and rhinorrhoea (runny nose) are symptoms that commonly occur together. The most common causes
Reference: NHS England 1602
Clinical Commissioning Policy Proposition: Clofarabine for refractory or relapsed acute myeloid leukaemia (AML) as a bridge to stem cell transplantation Reference: NHS England 1602 First published: TBC
Methotrexate. About This Drug. Possible Side Effects. Warnings and Precautions
Methotrexate About This Drug Methotrexate is used to treat cancer. This drug is given in the vein (IV). Possible Side Effects Soreness of the mouth and throat. You may have red areas, white patches, or
Elements for a public summary
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Cardiovascular disease (CVD) is responsible for one-third of global deaths and is a leading and increasing contributor to the
Summary of the risk management plan (RMP) for Opdivo (nivolumab)
EMA/285771/2015 Summary of the risk management plan (RMP) for Opdivo (nivolumab) This is a summary of the risk management plan (RMP) for Opdivo, which details the measures to be taken in order to ensure
Overview of disease epidemiology
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Acne vulgaris (or simply acne) is a common human skin disease, characterized by areas of skin with seborrhea (scaly red skin),
Patient leaflet: Information for the user. Cytarabine 20mg/ml and 100mg/ml Solution for infusion or injection (Cytarabine)
Patient leaflet: Information for the user Cytarabine 20mg/ml and 100mg/ml Solution for infusion or injection (Cytarabine) Read all of this leaflet carefully before you start taking this medicine because
Etoricoxib STADA 30 mg, 60 mg, 90 mg and 120 mg film-coated tablets , Version V1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN
Etoricoxib STADA 30 mg, 60 mg, 90 mg and 120 mg film-coated tablets 23.5.2016, Version V1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN VI.2 Elements for a Public Summary Etoricoxib STADA 30 mg film-coated
Summary of the risk management plan (RMP) for Clopidogrel/Acetylsalicylic acid Teva (clopidogrel / acetylsalicylic acid)
EMA/411850/2014 London, 28 July 2014 Summary of the risk management plan (RMP) for (clopidogrel / acetylsalicylic acid) This is a summary of the risk management plan (RMP) for, which details the measures
Elements for a Public Summary
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Lung cancer is one of the most common types of cancer in European men and women. There are two main types of lung cancer: small
Elements for a public summary
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology HIV is a virus that attacks the immune system (the body s natural defences) and weakens it by destroying certain white blood cells
IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION ATRIANCE, for use in adults and children who have a certain type of leukemia (T-cell acute lymphoblastic leukemia) or lymphoma (T-cell lymphoblastic lymphoma), has been approved
Summary of the risk management plan (RMP) for Portrazza (necitumumab)
EMA/33513/2016 Summary of the risk management plan (RMP) for Portrazza (necitumumab) This is a summary of the risk management plan (RMP) for Portrazza, which details the measures to be taken in order to
Elements for a Public Summary
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology High blood pressure in lung vessels which carry blood away from the heart Several studies showed that spontaneous high blood pressure
Summary of Activities in the Risk Management Plan (RMP) for DARZALEX (daratumumab)
DARZALEX - Risk Management Plan Summary of Activities in the Risk Management Plan (RMP) for DARZALEX (daratumumab) Document Version: 3.2 Document Date: 14 August 2018 Page 1 / 8 The Risk Management Plan
ino_rmp version 4.1_2016 Module Risk-management system NO-RMP-V 2.1
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Persistent pulmonary hypertension of the newborn (PPHN) Persistent pulmonary hypertension of the newborn is a life threatening
Vancomycin Orion , Version 2 Public Summary of the Risk Management Plan
Vancomycin Orion 18.1.2016, Version 2 Public Summary of the Risk Management Plan VI.2 Elements for a Public Summary Vancomycin Orion is intravenously administered glycopeptide antibiotic. It is indicated
Elements for a public summary
VI.2 VI.2.1 Elements for a public summary Overview of disease epidemiology Malaria is caused by mosquito bites whereby the malaria parasites can enter the body and then live in body tissues such as red
Victoza (liraglutide) solution for injection 6 mg/ml
Page: 1 of 11 Victoza (liraglutide) solution for injection 6 mg/ml Summary of the risk management plan (RMP) for Victoza Author: Novo Nordisk Pharma AG Page: 2 of 11 Table of Contents Page Table of Contents...
Desmopressin Version 2.0. Public summary of the Risk Management Plan
Desmopressin 16.12.2015 Version 2.0 Public summary of the Risk Management Plan VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Bedwetting Bedwetting (also called primary nocturnal
Risk Management Plan Summary
Risk Management Plan Summary TREMFYA (guselkumab) 100 mg/ml pre-filled syringe Document Version: 1.0 (11.07.2018) Based on EU RMP version 1.2 Marketing authorization holder: Janssen-Cilag AG, Gubelstr.
Elements for a Public Summary
Safety concern CSF antibodies Routine risk minimisation measures Additional risk minimisation measures VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Reduction in the duration
Elements for a Public Summary
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Generalised anxiety disorder Generalised anxiety disorder (GAD) is an umbrella term that covers a wide range of anxiety disorders
PUBLIC SUMMARY OFRISK MANAGEMENT PLAN
RASAGILINE ORION 1 MG TABLETS PUBLIC SUMMARY OFRISK MANAGEMENT PLAN DATE: 08-07-2015, VERSION 1.1 VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Parkinson s disease (PD) is
Package leaflet: Information for the user. Bupivacaine 0.25% w/v, 0.5% w/v solution for injection Bupivacaine Hydrochloride
Package leaflet: Information for the user Bupivacaine 0.25% w/v, 0.5% w/v solution for injection Bupivacaine Hydrochloride Read all of this leaflet carefully before you start using this medicine because
N Engl J Med Volume 373(12): September 17, 2015
Review Article Acute Myeloid Leukemia Hartmut Döhner, M.D., Daniel J. Weisdorf, M.D., and Clara D. Bloomfield, M.D. N Engl J Med Volume 373(12):1136-1152 September 17, 2015 Acute Myeloid Leukemia Most
Summary of the risk management plan (RMP) for Vimizim (elosulfase alfa)
EMA/127543/2014 Summary of the risk management plan (RMP) for Vimizim (elosulfase alfa) This is a summary of the risk management plan (RMP) for Vimizim, which details the measures to be taken in order
Elements for a Public Summary
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Nanogam is intended to be used for the treatment of diseases in patients who are suffering from a shortage of immunoglobulins
Nivolumab. Other Names: Opdivo. About this Drug. Possible Side Effects (More Common) Warnings and Precautions
Nivolumab Other Names: Opdivo About this Drug Nivolumab is used to treat cancer. It is given in the vein (IV). Possible Side Effects (More Common) Bone marrow depression. This is a decrease in the number
Summary of the risk management plan (RMP) for Cresemba (isavuconazole)
EMA/576866/2015 Summary of the risk management plan (RMP) for Cresemba (isavuconazole) This is a summary of the risk management plan (RMP) for Cresemba, which details the measures to be taken in order
PUBLIC SUMMARY OF RISK MANAGEMENT PLAN (RMP) CANDESARTAN/HYDROCHLOROTHIAZIDE ORION 8 MG/12.5 MG, 16 MG/12.5 MG, 32 MG/12.5 MG, 32 MG/25 MG ORION
PUBLIC SUMMARY OF RISK MANAGEMENT PLAN (RMP) CANDESARTAN/HYDROCHLOROTHIAZIDE ORION 8 MG/12.5 MG, 16 MG/12.5 MG, 32 MG/12.5 MG, 32 MG/25 MG ORION CORPORATION DATE: 17-04-2015, VERSION 2 VI.2 Elements for
Summary of the risk management plan (RMP) for Zykadia (ceritinib)
EMA/154751/2015 Summary of the risk management plan (RMP) for Zykadia (ceritinib) This is a summary of the risk management plan (RMP) for Zykadia, which details the measures to be taken in order to ensure
Summary of the risk management plan (RMP) for Rezolsta (darunavir / cobicistat)
EMA/608280/2014 Summary of the risk management plan (RMP) for Rezolsta (darunavir / cobicistat) This is a summary of the risk management plan (RMP) for Rezolsta, which details the measures to be taken
Package leaflet: Information for the user. Zavedos 5 mg and 10 mg Powder for Solution for Injection idarubicin hydrochloride
Package leaflet: Information for the user Zavedos 5 mg and 10 mg Powder for Solution for Injection idarubicin hydrochloride Read all of this leaflet carefully before you start taking this medicine because
Summary of the risk management plan (RMP) for Voriconazole Hospira (voriconazole)
EMA/246037/2015 Summary of the risk management plan (RMP) for Voriconazole Hospira (voriconazole) This is a summary of the risk management plan (RMP) for Voriconazole Hospira, which details the measures
Elements for a Public Summary
Page 3 of 7 VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Growth hormone deficiency occurs when the pituitary gland does not produce enough growth hormone.. Growth hormone
A study conducted in Norway found the combined estimate for panic and generalized anxiety disorder was 1.10 per 1,000 person-years.
VI.2 Elements for a public summary For sake of completeness, with reference to article 11 of the Directive 2001/83, the applicant retains the option to carve out the patented indication in the national
Summary of the risk management plan (RMP) for Nivolumab BMS (nivolumab)
EMA/359171/2015 Summary of the risk management plan (RMP) for Nivolumab BMS (nivolumab) This is a summary of the risk management plan (RMP) for Nivolumab BMS, which details the measures to be taken in
PUBLIC SUMMARY OF RISK MANAGEMENT PLAN (RMP) METHOTREXATE ORION 2.5 MG & 10 MG TABLET (METHOTREXATE DISODIUM) DATE: , VERSION 1.
PUBLIC SUMMARY OF RISK MANAGEMENT PLAN (RMP) METHOTREXATE ORION 2.5 MG & 10 MG TABLET (METHOTREXATE DISODIUM) DATE: 23-6-2016, VERSION 1.2 VI.2 Elements for a Public Summary Methotrexate is indicated for:
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology VI.2.2 Summary of treatment benefits
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Nausea and vomiting are common ailments had by many individuals. Nausea is defined as the unpleasant, painless sensation that
Summary of the risk management plan (RMP) for Pemetrexed Actavis (pemetrexed)
EMA/58503/2016 Summary of the risk management plan (RMP) for Pemetrexed Actavis (pemetrexed) This is a summary of the risk management plan (RMP) for Pemetrexed Actavis, which details the measures to be
Elements for a Public Summary. Overview of disease epidemiology. Cardiovascular Events
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Cardiovascular Events Each year cardiovascular disease (CVD) causes 3.9 million deaths in Europe and over 1.8 million deaths in
Zinplava Swiss Risk Management Plan Summary V1.5. Swiss Summary of the Risk Management Plan (RMP) for. Zinplava. (Bezlotoxumab 1000mg)
Swiss Summary of the Risk Management Plan (RMP) for (Bezlotoxumab 1000mg) Concentrate for solution for infusion Version 1.5 (November 2016) The Risk Management Plan (RMP) is a comprehensive document submitted
Important new concerns or changes to the current ones will be included in updates of YESCARTA s RMP.
PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN Summary of risk management plan for YESCARTA (axicabtagene ciloleucel) This is a summary of the risk management plan (RMP) for YESCARTA. The RMP details important
Elements for a Public Summary. Overview of disease epidemiology
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology A bladder spasm occurs when the bladder muscle squeezes suddenly without warning, causing an urgent need to release urine. The
PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN
Cofact 250 IU and 500 IU powder and solvent for solution for injection PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Cofact contains
Summary of the risk management plan (RMP) for Ebymect (dapagliflozin / metformin)
EMA/672415/2015 Summary of the risk management plan (RMP) for Ebymect (dapagliflozin / metformin) This is a summary of the risk management plan (RMP) for Ebymect, which details the measures to be taken
Elements for a Public Summary. Overview of Disease Epidemiology
VI.2 VI.2.1 Elements for a Public Summary Overview of Disease Epidemiology Toxicity of Folic acid antagonists Despite having a low frequency of major toxicity, low dose Methotrexate (MTX, folic acid antagonist)
Nocturnal polyuria has been linked to abnormalities of the daily rhythm of (circadian rhythmic) release of naturally occurring antidiuretic hormone.
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Bedwetting Bedwetting (also called primary nocturnal enuresis) is probably the most common developmental problem in children,
Elements for a public summary
VI.2 VI.2.1 Elements for a public summary Overview of disease epidemiology Telmisartan/hydrochlorothiazide is a combination of an angiotensin II receptor antagonist and a thiazide diuretic used in the
Zopiclone Orion. Date: , Version 1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN
Zopiclone Orion Date: 16-11-2016, Version 1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Insomnia (i.e. sleeplessness) is a common
Summary of the risk management plan (RMP) for Pregabalin Mylan (pregabalin)
EMA/285074/2015 Summary of the risk management plan (RMP) for Pregabalin Mylan (pregabalin) This is a summary of the risk management plan (RMP) for Pregabalin Mylan, which details the measures to be taken
Discussing TECENTRIQ (atezolizumab) with your healthcare team
Discussing TECENTRIQ (atezolizumab) with your healthcare team What is TECENTRIQ? TECENTRIQ is a prescription medicine used to treat: a type of lung cancer called non-small cell lung cancer (NSCLC). TECENTRIQ