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Onasemnogene abeparvovec EMA

Onasemnogene abeparvovec is a gene therapy medicinal product that expresses the human survival motor neuron (SMN) protein. It is a non-replicating recombinant adeno-associated virus serotype 9 (AAV9) based vector containing the cDNA of the human SMN gene under the control of the cytomegalovirus enhancer/chicken-β-actin-hybrid promoter Onasemnogene abeparvovec (Zolgensma®) received an accelerated drug designation from the FDA in the US as breakthrough designation, the EMA in the EU as PRIME designation, and from the PMDA in Japan as SAKIGAKE designation 01/04/2020 6:58 pm Comments Off on zolgensma-ema. Essentials Informations. More information about SMA Europe. Publications. Find out more about the work we do. Contact. Registered Address: SMA Europe e. V., Im Moos 4, 79112 Freiburg, Germany Secretariat Address: 3 Glebe Fold, Chipping Campden, Glos GL55 6JP, UK ZOLGENSMA ® (onasemnogene abeparvovec-xioi) is a prescription gene therapy used to treat children less than 2 years old with spinal muscular atrophy (SMA). It targets the genetic root cause of SMA with a one-time-only dose and replaces the function of the missing or nonworking survival motor neuron 1 ( SMN1 ) gene with a new, working copy of a human SMN gene Mar 19 · A new market research report identifies onasemnogene abeparvovec as one of seven new drugs it believes will hit sales of $1 billion or more, the so-called blockbuster mark, by 2023 [11]. Dec 18 · FDA grants priority review for onasemnogene abeparvovec, which means it could be approved in May 2019 [9]

Objective: To review the efficacy and safety of onasemnogene abeparvovec-xioi (Zolgensma) in the treatment of spinal muscular atrophy (SMA). Data sources: An English-language literature search of PubMed, MEDLINE, and Ovid (1946 to December 2019) was completed using the terms onasemnogene, AVXS-101, and spinal muscular atrophy.. De minister voor Medische Zorg heeft het geneesmiddel onasemnogene abeparvovec (Zolgensma®) in de 'sluis voor dure geneesmiddelen' geplaatst. Dit middel wordt gebruikt bij de behandeling van de zeldzame spierziekte spinale musculaire atrofie (SMA). In mei 2020 heeft de European Medicine Agency (EMA) het middel onder voorwaarde toegelaten tot de Europese markt voor de behandeling van jonge.

Onasemnogene abeparvovec for treating type 1 spinal muscular atrophy has now been rescheduled into the work programme and is due to be discussed at the HST committee on 8 October 2020. Timelines and the expected publication date will be updated in due course Zolgensma (Onasemnogene abeparvovec) Dit betekent dat in Amerika kinderen tot de leeftijd van twee jaar in aanmerking komen voor behandeling met deze vorm van gentherapie. Op dit moment wordt in Europa door de European Medicines Agency (EMA) beoordeeld of dit medicijn ook in de Europese Unie beschikbaar komt

AAV based SMA gene therapy (Onasemnogene abeparvovec) is already approved in US for children below 2 years [54] and it is expected to be approved by the EMA in 2020 Onasemnogen abeparvovek, naprodaj pod trgovskim imenom Zolgensma, je gensko zdravilo, ki se v kombinaciji s kortikosteroidi uporablja za zdravljenje spinalne mišične atrofije (SMA) pri otrocih, mlajših od dveh let. Leta 2019 je bilo odobreno v Združenih državah za uporabo v obliki enkratne injekcije v veno, v Evroi uniji pa je zdravilo odobreno od maja 2020

DESCRIPTION. Onasemnogene abeparvovec-xioi (Zolgensma ®) is a recombinant adeno-associated virus-based (AAV9-based) gene therapy. It is designed to deliver a copy of the gene encoding the human SMN1 protein, or survival motor neuron1 protein into pediatric individuals less than 2 years of age with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene who have a diagnosis of Spinal. Onasemnogene abeparvovec is a unique gene therapy agent used to correct the abnormal gene responsible for spinal muscular atrophy type 1, a rare progressive neuromuscular disorder that typically leads to disability and death within the first two years of life. Onasemnogene abeparvovec is given as a onasemnogene abeparvovec (Zolgensma) SMC ID: SMC2311 Pharmaceutical company Novartis Gene Therapies BNF chapter Central nervous system Submission type Full Publication due date: Q1 2021 SMC meeting date: Q1 2021 Patient group submission deadline: 30 November 202 Onasemnogene abeparvovec is an adeno-associated virus vector-based gene therapy that has been approved by the FDA in May 2019 for the treatment of infant patients (less than 2 years of age) with spinal muscular atrophy (SMA) and a specific mutation in the survival motor neuron 1 (SMN1) gene. 5 SMA is a rare genetic disease that affects the survival and function of motor neurons, leading to.

EMA-approved application for ZOLGENSMA® (onasemnogene

  1. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting conditional marketing authorization for onasemnogene abeparvovec.
  2. istration of Zolgensma have not been evaluate
  3. Treatments are making a difference in SMA. With the approval of disease-modifying treatments, such as ZOLGENSMA ® (onasemnogene abeparvovec-xioi), for spinal muscular atrophy (SMA), the past few years have rapidly changed the outcomes for people with SMA. Historically, SMA Type 1 was likely fatal for a child within the first 2 years of life without treatment

Onasemnogene abeparvovec - Wikipedi

Onasemnogene abeparvovec is a single-dose, intravenous gene therapy designed to address the monogenic root cause of SMA by utilizing a non-replicating, non-integrating, recombinant adeno-associated virus serotype 9 (AAV9) capsid to deliver a stable, fully functional human SMN transgene to increase SMN protein expression and prevent motor neuron cell death, leading to improved neuronal and. Background: Spinal muscular atrophy type 1 (SMA1) is the leading genetic cause of infant mortality for which therapies, including AVXS-101 (onasemnogene abeparvovec, Zolgensma®) gene replacement therapy, are emerging. Objective: This study evaluated the effectiveness of AVXS-101 in infants with spinal muscular atrophy type 1 (SMA1) compared with a prospective natural history cohort and a. Onasemnogene abeparvovec dosage (more detail) What are some side effects that I need to call my doctor about right away? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug Onasemnogene abeparvovec (onasemnogene abeparvovec-xioi; formerly AVXS-101; ZOLGENSMA ®) is an adeno-associated viral vector-based gene therapy designed to deliver a functional copy of the human survival motor neuron (SMN) gene to the motor neuron cells of patients with spinal muscular atrophy (SMA).It has been developed by AveXis, a Novartis company, and was approved in May 2019 in the USA.

Concomitant therapy: Beginning the day prior to onasemnogene abeparvovec infusion, oral prednisolone (1 mg/kg/day or equivalent) should be administered and continued for ≥30 days to help prevent hepatic toxicity. At the end of 30 days, clinically assess liver and test hepatic function (ALT, AST, total bilirubin, and prothrombin time [PT]); if unremarkable findings (normal clinical exam. Onasemnogene abeparvovec (Zolgensma), an adeno-associated viral vector-based gene therapy, was approved by the U.S. Food and Drug Administration (FDA) on May 24, 2019 for the treatment of SMA in pediatric patients less than 2 years of age. It is a recombinant AAV9-base ZOLGENSMA (onasemnogene abeparvovec-xioi) is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular.

Onasemnogene abeparvovec GRT for patients with SMA1 appears to be promising, and because motor neurons are long-lived, a single administration of AAV9 GRT may be sufficient for continual transgene expression in SMA. Early signs of durable clinical effect of AAV GRT in this and other gene therapy programs are accumulating (Table 3).The recommendations provided here are intended to aid treating. Onasemnogene abeparvovec (onasemnogene abeparvovec-xioi; formerly AVXS-101; ZOLGENSMA®) is an adeno-associated viral vector-based gene therapy designed to deliver a functional copy of the human survival motor neuron (SMN) gene to the motor neuron cells of patients with spinal muscular atrophy (SMA). It has been developed by AveXis, a Novartis company, and was approved in May 2019 in the USA. Onasemnogene abeparvovec, sold under the brand name Zolgensma, is a gene therapy medication used to treat spinal muscular atrophy (SMA). It was approved for children less than two years old in 2019. It is used as a one-time injection into a vein with at least two months of corticosteroids.. Common side effects include vomiting and increased liver enzymes Generic Name: onasemnogene abeparvovec Brand Name: Zolgensma Manufacturer: Novartis Pharmaceuticals Canada Inc. Therapeutic Area: Spinal muscular atrophy (SMA), pediatrics Indications: Zolgensma is an adeno-associated virus (AVV) vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in. M09AX09 Onasemnogene abeparvovec D11559 Onasemnogene abeparvovec (USAN/INN) <US> Target-based classification of drugs [BR:br08310] Not elsewhere classified Signaling molecules Spliceosome SMN1 D11559 Onasemnogene abeparvovec (USAN/INN) <US> New drug approvals in the USA [br08319.html] Cellular and gene therapy products D1155

Terapia genică Zolgensma primește recomandarea de aprobare

Zolgensma 2 x 10Exp13 vector genomes/mL solution for

Onasemnogen abeparvovek (INN, angl. onasemnogene abeparvovec, obchodní název Zolgensma) je genová terapie používaná k léčbě spinální svalové atrofie (SMA).Funguje na bázi vytvoření nové kopie genu, který kóduje SMN protein.V roce 2019 byl schválen pro léčbu dětí mladších dvou let s touto nemocí Evaluation of onasemnogene abeparvovec by NICE to determine NHS reimbursement is already underway, and we will continue to work closely with relevant organisations across the UK to help them complete their assessments, the firms added, also noted that it had already engaged with key UK stakeholders including patient advocacy groups and clinicians Biogen Announces First Patient Treated in RESPOND Study Evaluating Benefit of SPINRAZA® (nusinersen) in Patients Treated With Zolgensma® (onasemnogene abeparvovec) January 8, 2021 at 7:30 AM EST The global Phase 4 RESPOND study will evaluate the efficacy and safety of SPINRAZA in patients with a suboptimal clinical response to Zolgensm Zolgensma ® (onasemnogene abeparvovec-xioi) is a gene replacement therapy indicated for the treatment of spinal muscular atrophy (SMA) in paediatric patients.. Originally developed by Avexis, the drug became a part of Novartis' portfolio after it acquired Avexis in May 2018. Novartis submitted a biologics license application (BLA) for the drug to the US Food and Drug Administration (FDA) in.

Zolgensma (onasemnogene abeparvovec-xioi) is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA). SMA is a rare, genetic neuromuscular disease caused by a defective or missing survival motor neuron 1 (SMN1) gene Basel, August 6, 2019 - Today the FDA released a statement addressing data integrity issues with the Biologics License Application (BLA) for Zolgensma® (onasemnogene abeparvovec-xioi).First and foremost, we are fully confident in the safety, quality and efficacy of Zolgensma. The FDA supports the continued marketing and use of Zolgensma for patients with spinal muscular atrophy (SMA) less. The EMA also conditionally authorised Zolgensma (onasemnogene abeparvovec) from AveXis, a gene therapy to treat children with another rare condition, spinal muscular atrophy. Source: In Europe, the EMA recommended suspending sales of all ranitidine products because of the impurity in April,. Biogen Announces First Patient Treated in RESPOND Study Evaluating Benefit of SPINRAZA® (nusinersen) in Patients Treated With Zolgensma® (onasemnogene abeparvovec) Details Category: DNA RNA and Cells Published on Saturday, 09 January 2021 17:08 Hits: 125

Onasemnogene Abeparvovec - an overview ScienceDirect Topic

ZOLGENSMA (onasemnogene abeparvovec-xioi) is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spina Novartis is on the final straight to approval of its spinal muscular atrophy (SMA) gene therapy Zolgensma in the EU, after getting a recommendation for approval from the CHMP Onasemnogene Abeparvovec - Last updated on January 12, 2021 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. Educational Resources. Log in to print or send this list to your patient and save lists of resources you use frequently Injection, Onasemnogene abeparvovec-xioi, per treatment, up to 5x1015 vector genomes J3490 Unclassified drugs J3590 Unclassified biologics ICD-10 Procedure Codes ICD-10-PCS codes: Code Description XW033F3 Introduction of Other New Technology Therapeutic Substance into Peripheral Vein, Percutaneous Approach, New Technology Group Onasemnogene abeparvovec, vândut sub numele de marcă Zolgensma, este o medicație de terapie genică utilizată pentru a trata atrofia musculară spinală (AMS). Este folosită alături de corticosteroizi ca o singură injecție intravenoasă.Medicația a fost aprobată în Statele Unite în 2019 pentru copiii mai mici de doi ani și în Japonia în 2020

zolgensma-ema SMA Europ

CAMBRIDGE, Mass., Jan. 08, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) today announced that the first patient has been treated in the global clinical study, RESPOND.The Phase 4 study will. Prescribers should contact the manufacturer for all Zolgensma® (onasemnogene abeparvovec-xioi) referrals. Getting started on ZOLGENSMA® (onasemnogene abeparvovec-xioi) Call 855-441-GENE (4363) , 8am-8pm ET, Monday-Friday Medscape - Spinal muscular atrophy type 1 disease dosing for Zolgensma (onasemnogene abeparvovec), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information First patient treated in Biogen's global RESPOND study of nusinersen, following treatment with onasemnogene abeparvovec (Zolgensma™) In response to our request, Biogen shared an update on the RESPOND trial with us

ZOLGENSMA® (onasemnogene abeparvovec-xioi

Onasemnogene abeparvovec is used to treat spinal muscular atrophy in children younger than 2 years old who have a specific gene mutation that affects nerve signals to the muscles. This medicine may not be effective in a child who is completely paralyzed or is dependent on a ventilator for breathing. Onasemnogene..

Find all the evidence you need on Onasemnogene abeparvovec via the Trip Database. Helping you find trustworthy answers on Onasemnogene abeparvovec | Latest evidence made eas Dit type goedkeuring is mogelijk bij aandoeningen waar nog geen goede behandelopties voor zijn. Aanvullende resultaten uit de lopende onderzoeken naar Zolgensma zullen voortdurend door het EMA worden beoordeeld. Aantal kopieën. Zolgensma is de merknaam voor de gentherapie waarvan het werkzame bestanddeel de naam onasemnogene abeparvovec heeft Onasemnogene abeparvovec is the first gene therapy to be approved for SMA in the USA. The recommended dose is 1.1 × 10 14 vector genomes per kg of bodyweight, administered as a single intravenous infusion over 60 min. Regulatory assessments for this formulation of onasemnogene abeparvovec are underway in the EU and Japan; an intrathecal formulation is currently undergoing clinical development.

2019年に日米欧で承認された新薬まとめ | Insights4 Pharma

Onasemnogene abeparvovec - Medicines - SPS - Specialist

  1. Biogen Announces First Patient Treated in RESPOND Study Evaluating Benefit of SPINRAZA® (nusinersen) in Patients Treated With Zolgensma® (onasemnogene abeparvovec
  2. Onasemnogene abeparvovec-xioi (AVXS-101) терапија развиена од американската компанија AveXis за лекување на Спинална Мускулна Атрофија. Припаѓа на класата на лекови наречени генски терапии или терапии кои содржат синтетичка ДНК која.
  3. Zolgensma (onasemnogene abeparvovec-xioi) Injection) Last review: June 11, 2020 Page 4 of 5 • Patient will receive prophylactic prednisolone (or glucocorticoid equivalent) prior to and following receipt of Zolgensma within accordance of the United States Food and Drug.
  4. Along with its needed effects, onasemnogene abeparvovec may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor or nurse immediately if any of the following side effects occur while taking onasemnogene abeparvovec: More common. Clay-colored stool
  5. Onasemnogene abeparvovec has no known side effects, however there have been a number of adverse events observed during the three small clinical trials. They are mentioned on the leaflet, in line with regulatory requirements, but I don't think it makes much sense to list them in the lede unless we know they occur frequently

August 13, 2019 - Onasemnogene abeparvovec-xioi (Zolgensma) is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 gene.It has been approved by the American Food and Drug Administration (FDA) in May of this year Onasemnogene abeparvovec-xioi is a non-replicating recombinant adeno-associated virus serotype 9 containing the human survival motor neuron gene under the control of the cytomegalovirus enhancer/chicken β-actin-hybrid promoter. Onasemnogene abeparvovec-xioi administered as a one-time intravenous. This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continu Onasemnogene abeparvovec (Zolgensma, AveXis) is a single-use gene replacement therapy made of a viral vector that has been modified to contain the primary gene for the human survival motor neuron (SMN) protein, which is lacking or mutated in people with SMA EMA adviseert goedkeuring Spinraza voor behandeling SMA Geplaatst op 21/04/2017 10/04/2019 door SMA Onderzoek De European Medicines Agency (EMA) heeft vandaag een positief advies gegeven over Spinraza (Nusinersen) voor de behandeling van kinderen en volwassenen met SMA

Onasemnogene Abeparvovec-xioi: Gene Therapy for Spinal

Pakketadvies sluisgeneesmiddel onasemnogene abeparvovec

ZOLGENSMA ® (onasemnogene abeparvovec-xioi) is a gene therapy for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) 1. SEE EFFICACY DATA. Getting started with ZOLGENSMA. Complete the ZOLGENSMA Prescription and Patient Consent Forms for eligible patients to help with insurance and prescription-related processes Risdiplam and to some extent onasemnogene abeparvovec‐xioi have peripheral effects, with the latter dependent on peripheral cell replication. Neurologists should consider drug cell targets, efficacy, and durability of SMN protein augmentation, potential iatrogenic phenotypes, and financial/ethical issues when providing patients with informed consent for innovative therapies D11559 Onasemnogene abeparvovec (USAN/INN) <US> New drug approvals in the USA [br08319.html] Cellular and gene therapy products D11559 New drug approvals in Europe [br08329.html] European public assessment reports (EPAR) authorised medicine D11559 New drug approvals in Japan [br08318.html] Cellular and gene therapy products D1155 ZOLGENSMA® (onasemnogene abeparvovec-xioi) is the first one-time-only gene therapy for pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) Your resource for understanding reimbursement for ZOLGENSMA * The global Phase 4 RESPOND study will evaluate the efficacy and safety of SPINRAZA in patients with a suboptimal clinical response to Zolgensma * Clinical and real-world experience have reported.

Project information Onasemnogene abeparvovec for

Study of Intrathecal Administration of Onasemnogene Abeparvovec-xioi for Spinal Muscular Atrophy (STRONG) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government August 13, 2019 - Onasemnogene abeparvovec-xioi (Zolgensma) is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 gene Zolgensma® (onasemnogene abeparvovec) Recommended for European Commission (EC) Conditional Approval . 27 March 2020. Today, the Committee for Human Medicinal Products (CHMP) of the EMA adopted a positive opinion for Zolgensma for patients who have SMA and a clinical diagnosis of SMA Type 1 or SMA patients with up to three copies of the SMN2 gene

ZOLGENSMA® (onasemnogene abeparvovec-xioi) Suspension for intravenous infusion ZOLGENSMA is a suspension of an adeno-associated viral vector-based gene therapy for intravenous infusion. It is a recombinant self-complementary AAV9 containing a transgene encoding the human survival motor neuron (SMN) protein, under the control of a cytomegalovirus enhancer/chicken-β-actin hybrid promoter Market Research Report Summary. Zolgensma (onasemnogene abeparvovec-xioi) - Drug Insight and Market Forecast report is published on February 19, 2020 and has 50 pages in it. This market research report provides information about Drug Pipeline, Research & Development (Pharma & Healthcare), Drug Discovery, Pharma & Healthcare industry

Onasemnogene Abeparvovec. Book from National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda (MD), 27 Nov 2020 National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda (MD), 27 Nov 202 Background: Spinal muscular atrophy type 1 (SMA1) is the leading genetic cause of infant mortality for which therapies, including AVXS-101 (onasemnogene abeparvovec, Zolgensma® ) gene replacement therapy, are emerging. Objective: This study evaluate Gene therapy (also called human gene transfer) is a medical field which focuses on the utilization of the therapeutic delivery of nucleic acids into a patient's cells as a drug to treat disease. The first attempt at modifying human DNA was performed in 1980 by Martin Cline, but the first successful nuclear gene transfer in humans, approved by the National Institutes of Health, was performed in. thasso, the new generation glocalized patient network in theragenomic and personalized medicine and individualized drug safety provides access to and sharing of personal and professional information in health and disease to individual patients, to patient subgroups, and to large patient populations worldwid

Zolgensma (Onasemnogene abeparvovec

Onasemnogene abeparvovec is used to treat spinal muscular atrophy in children younger than 2 years old who have a specific gene mutation that affects nerve signals to the muscles Onasemnogene abeparvovec-xioi (formerly AVXS-101), a one-time, AAV9-based, intravenous gene therapy, addresses the genetic root cause of SMA and is designed for sustained SMN protein expression in neurons

Onasemnogene Abeparvovec: First Global Approva

  1. Thuốc Zolgensma (Onasemnogene Abeparvovec) được chỉ định trong liệu pháp điều trị gen cho bệnh nhi bị teo cơ tủy sống - SMA (trẻ dưới 2 tuổi). Thuốc Zolgensma - Onasemnogene Abeparvovec là một vectơ AAV tái tổ hợp không sao chép sử dụng capsid AAV9 để cung cấp một gen chuyển SMN người có đầy đủ chức năng ổn định
  2. Onasemnogen abeparvovek - Wikipedija, prosta enciklopedij
  3. Onasemnogene Abeparvovec-xio
  4. Onasemnogene Abeparvovec - PubMe
  5. onasemnogene abeparvovec (Zolgensma

Onasemnogene abeparvovec DrugBank Onlin

  1. EMA Panel Backs Zolgensma Gene Therapy for SM
  2. onasemnogene abeparvovec (Zolgensma) BCBSN
  3. SMA Progression ZOLGENSMA® (onasemnogene abeparvovec-xioi
  4. Hepatotoxicity following administration of onasemnogene
  5. AVXS-101 (Onasemnogene Abeparvovec) for SMA1: Comparative
EGFR T790M Mutation | thassoCHMP oordeelt positief over influenza vaccin — PW
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