VERIFI®, is a non-invasive prenatal test (NIPT), offering early genetic screening for chromosomal abnormalities using just one tube of blood—as early as 10 weeks into a patient’s pregnancy. Verifi analyzes cell free fetal and maternal DNA from a blood sample to screen for common chromosome conditions including trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), and trisomy 13 (Patau syndrome). Verifi poses minimal risk to the mother or baby with high detection rates and low false positives.
PYLERA® (bismuth subcitrate potassium, metronidazole, tetracycline HCl) in combination with omeprazole, is a 3-in-1 capsule for the eradication treatment of Helicobacter pylori. The eradication of Helicobacter pylori has been shown to reduce the risk of duodenal ulcer recurrence as well as reduce the risk of gastric cancer.
GLICONORM™, Glibenclamide + Metformin hydrochloride, is a second line therapy to treat non-insulin dependent diabetes mellitus. This fixed dose in one tablet provides convenience for patients and helps increase patient compliance.
DIBASE, Cholecalciferol (vitamin D3), is used in the treatment of hypoparathyroidism, vitamin D resistant rickets, and low vitamin D levels.
AFIRMA® Thyroid FNA Analysis is a comprehensive solution that combines the advantages of specialized cytopathology with the power of genomics. Afirma GEC analyzes the expression level of 142 different genes. Together, these genes demonstrate a recognizable pattern of expression in benign thyroid nodules. Afirma can help doctors identify benign nodules when cytopathology is indeterminate, thereby reducing the number of unnecessary thyroid surgeries. And, if the patient needs surgery, Afirma can also provide valuable additive information that may help guide decisions on the appropriate surgery – all from one FNA.
*for full prescribing information please refer to your locally approved label*
Name Verifi™ - prenatal test Description A non-invasive prenatal test that detects multiple fetal chromosomal aneuploidies using a single 7-10 ml of maternal blood draw with near-diagnostic accuracy. The test can be done as early as 10 weeks of pregnancy. Performance Verifi™ prenatal test is a non-invasive test that detects multiple fetal chromosomal aneuploidies. The test detects three primary chromosomal aneuploidies for trisomies 21, 18 and 13 and sex chromosome as monosomy X, XXX, XXY or XYY, trisomy 9, trisomy 16 and the microdeletion panel which screens for subchromosomal conditions such as DiGeorge or Prader-Willi syndromes.
For pregnant at 10+ weeks gestation with singleton pregnancies who meet any of the following criteria: Advanced maternal age, positive results of prenatal aneuploidy screening, presence of ultrasound abnormalities and previous affected pregnancy for fetal aneuploidy.
Intended to use The Verifi™ prenatal test leverages the power of Massively Parallel Sequencing (MPS) with a highly optimized algorithm to provide clear, informative results. The Verifi™ prenatal test is safe, accurate, easy and comprehensive. Regulatory Status CLIA cleared Partner Illumina Inc.
PYLERA® capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration.
Name PYLERA® Description PYLERA® (bismuth subcitrate potassium, metronidazole, tetracycline HCl) is an effective 3-in-1 capsule for the first line option in the eradication treatment of H. pylori, a bacteria that is now believed to cause up to 90% of duodenal ulcers. Active substance Bismuth subcitrate potassium 140 mg, metronidazole 125 mg, tetracycline hydrochloride 125 mg given as 3 capsules q.i.d. plus omeprazole for 10 days. Indication PYLERA® capsules, in combination with omeprazole (20 mg b.i.d), are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Regulatory Status Approved by US FDA in September 2006, (NDA) 050786.
MEA region approved countries: Bahrain, Kuwait, Lebanon, Morocco, Qatar Under registration in Tunisia
Business Partner Allergan plc
Gliconorm™ is a film-coated, divisible tablet which contains a fixed dose of glibenclamide (5 mg) and metformin (500 mg).
Name Gliconorm Description Gliconorm™ is a second line therapy to treat non-insulin dependent diabetes mellitus (NIDDM). This fixed dose in one tablet provides convenience for patients and helps increase patient compliance. Active substance Glibenclamide, Metformin. Indication Gliconorm™ is a second line therapy to treat non-insulin dependent diabetes mellitus (NIDDM) that cannot be satisfactorily controlled with diet alone, diet plus a sulfonylurea, or diet plus metformin. Strengths Glibenclamide 5mg + Metformin 500mg. Regulatory Status Approved in Italy, last revised: Nov 2007
Approved in Bahrain - 14 Dec 2011
Under registration – Iraq and Kuwait
Business Partner ABIOGEN
Name Dibase® Cholecalciferol (Vitamin D3) Description Vitamin D and analogues, cholecalciferol Active substance Cholecalciferol Indication Prevention and treatment of vitamin D deficiency Strengths DIBASE 10.000 I.U./ml oral drops solution
DIBASE 25.000 I.U. /2,5 ml oral solution
DIBASE 50.000 I.U. /2,5 ml oral solution
DIBASE 100.000 I.U./1ml solution for injection
DIBASE 300.000 I.U./1ml solution for injection
Regulatory Status Under registration in KSA, Kuwait, UAE and Lebanon Business Partner ABIOGEN PHARMA S.p.A.
Name Afirma® Thyroid FNA Analysis Description The novel Afirma Gene Expression Classifier (GEC), the centerpiece of the Afirma Thyroid FNA Analysis, helps physicians reduce the number of avoidable surgeries by preoperatively identifying benign nodules among those that were originally classified by cytopathology as indeterminate. The GEC measures the expression of 142 genes to determine if the FNA sample is benign or suspicious for cancer -- enabling patients with benign results to potentially avoid unnecessary surgery. Performance
Veracyte introduced its Afirma Malignancy Classifiers to further establish the Afirma Thyroid FNA Analysis as a comprehensive tool for reducing unnecessary surgeries and healthcare costs.
- Medullary thyroid cancer (MTC) is an aggressive type of thyroid cancer that is not definitively identified by cytopathology alone about half of the time.20
- About 40% of patients with MTC do not undergo a total thyroidectomy with central neck dissection – the recommended treatment in current guidelines.2,21,22
- As a result, many patients with MTC may subsequently undergo a “follow-up” surgery, once the presence of MTC becomes known.
- The presence of the BRAF V600E gene mutation may also prompt surgeons to perform more extensive thyroid surgeries.
Intended to use The Afirma Malignancy Classifiers comprise tests for MTC and to assess BRAF V600E gene mutation status, and are intended to provide physicians with preoperative information that can enable them to perform a more appropriate procedure the first time, potentially reducing the need for additional surgeries – and the risks and costs that accompany them. Regulatory Status CLIA cleared Partner Veracyte