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Abstral
Abstral
Company: Orexo
Product introduction: Abstral® is a drug that provides fast and effective treatment of breakthrough pain in cancer patients. It is based on Orexo’s sublingual tablet technology and the analgesic fentanyl.
Launched year: 2008
Aeroneb® Pro
Aeroneb® Pro
Company: Aerogen
Product information: The Aeroneb® Pro is Aerogen’s flagship nebulizer for aerosol therapy. Aeroneb® Pro is a proven nebulizer for effectively treating mechanically ventilated patients . The Aeroneb® Pro is a reusable, multi-patient use nebulizer which is suitable for hospital environments where the appropriate sanitization facilities are available.
This autoclavable nebulizer provides effective dose delivery of physician- prescribed inhalation solutions for infants through adults in both on and off ventilator applications. Therapy can be delivered using an aerosol mask or a mouthpiece in an off ventilator application, see the Instructions for Use manual for more information.
Utilizing Aerogen’s OnQ™ Aerosol Generator, the Aeroneb® Pro produces a fine particle, low velocity aerosol without environmentally unfriendly propellants, inefficient compressors or costly ultrasonic elements. The Aeroneb® Pro nebulizer is a vibrating mesh nebulizer in a class of its own.
Launched year: 2002
Arestin
Arestin
Company: Orapharma Inc
Product introduction: Arestin® (minocycline HCl) is a subgingival sustained-release product containing the antibiotic minocycline hydrochloride incorporated into a bioresorbable polymer for professional subgingival administration into periodontal pockets.
Launched year: 2002
Beleodaq
Beleodaq
Company: Onxeo
Product introduction: Beleodaq® (belinostat) is a histone deacetylase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response.
Launched year: 2014
Ceplene
Ceplene
Company: Maxim Pharmaceuticals
Product introduction: Ceplene® (histamine dihydrochloride) is an immune-enhancing product which is intended to use in combination with interleukin-2 (IL-2) as a remission maintenance treatment of acute myeloid leukemia.
Launched year: 2010
CERAMENT™|BONE VOID FILLER
CERAMENT™|BONE VOID FILLER
Company: Bonesupport AB
Product description: The CERAMENT™|BONE VOID FILLER is ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. It provides bone void filler that resorbs and is replaced by bone during the healing process. The product is intended to be injected into bony voids or gaps in the skeletal system, i.e. extremities, spine, and pelvis.
Indication: Bone cysts; bone defects caused by various reasons
CE mark received: 2009
FDA clearance received: 2005
CERAMENT™|GENTAMICIN and supporting systems
CERAMENT™|GENTAMICIN and supporting systems
Company: Bonesupport AB
Product description: The CERAMENT™|GENTAMICIN is an injectable formulation of synthetic bioceramic bone substitute and the antibiotic drug gentamicin. The biomaterial consists of calcium sulphate and hydroxyapatite combined with liquid Iohexol creates a highly injectable, osteoconductive and bioactive material. It is designed to mimic human cancellous bone by providing short term resorbable support for the fracture or bone void, and longer term osteoconductive support which enhances new bone growth.
Indication: Osteomyelitis
CE mark received: 2013
FDA clearance: 2022
CERAMENT™|SPINE SUPPORT
CERAMENT™|SPINE SUPPORT
Company: Bonesupport AB
Product description: The CERAMENT™|SPINE SUPPORT is an injectable ceramic bone substitute intended to use in the stabilization of vertebral compression fractures in the vertebral body. It is the only fully injectable biological material with C.E. MARK for the treatment of Vertebral Compression Fractures offering clinically demonstrated bone remodelling / healing.
Indication: Spinal compression fracture
CE mark received: 2008
Chartis Pulmonary Assessment System
Chartis Pulmonary Assessment System
Company: Pulmonx
Indicator: Emphysema
Product description: The Chartis System is a unique assessment tool that provides precise flow and pressure readings at the lobar or segmental level. This information enables the physician to make assessments regarding the level of collateral ventilation, or inter-lobar airflow in the lungs. Collateral ventilation (CV) can limit the effectiveness of endobronchial lung-volume reduction therapy, and is therefore an important predictor of EBV treatment success.
By directly detecting the presence of CV in the targeted lobes of the lungs, this innovative technology platform empowers physicians to plan data-driven treatment with Zephyr valve therapy.
FDA clearance received: 2009
Chronic Pain
Chronic Pain
Company: HelloBetter
Product Introduction: The ratiopharm Chronic Pain course was developed by experts from science, psychotherapy and psychology, incorporating input from people who suffer from chronic pain. Patients will acquire effective strategies for dealing with chronic pain: learn how to change the way that pain affects you through acceptance, discover what’s truly important to you in life and how you can apply this knowledge to reshape your everyday life. The effectiveness of the course has been examined and confirmed in a randomised controlled trial where the participants reported significantly less pain interference.
Launched year: 2021
Crysvita
Crysvita
Company: Ultragenyx
Product introduction: Crysvita (burosumab) is an anti-FGF23 fully human monoclonal antibody for the treatment of X-linked hypophosphatemia (XLH) in children. XLH is a rare, chronic progressive musculoskeletal disorder that affects children and adults.
Launched year: 2018
Diabetes and Depression
Diabetes and Depression
Company: HelloBetter
Product Introduction: Diabetes and Depression is the first online therapy course for the treatment of depressive symptoms in people with type 1 and 2 diabetes. The course is based on cognitive behavioral therapy and patients learn about their disorder, strengthen their problem-solving skills, and learn new behaviors as well as long-term strategies to prevent relapses. The RCT demonstrated that 62 percent of participants showed a substantial improvement in depressive symptoms.
Launched year: 2021
DOJOLVI
DOJOLVI
Company: Ultragenyx
Product introduction: Dojolvi™ (UX007/triheptanoin) is the first FDA-approved therapy for the treatment of long-chain fatty acid oxidation disorders, a group of rare, lifelong and life-threatening genetic disorders in which the body is unable to convert long-chain fatty acids into energy.
Launched year: 2020
Edluar
Edluar
Company: Orexo
Product introduction: Edluar® (zolpidem tartrate) is based on Orexo’s sublingual tablet technology and the active substance zolpidem and offers treatment for short-term insomnia. The Edluar tablet is placed under the tongue where it rapidly dissolves and the active substance is absorbed through the mucous membrane.
Launched year: 2009
Femifect
Femifect
Company: Lumavita
Product introduction: FemiFect® (pentamycin), a broad-spectrum macrolide antibiotic, is approved for the treatment of vaginitis.
Launched year: 2010
Firazyr
Firazyr
Company: Jerini (Shire)
Product introduction: Firazyr® (icatibant) Injection for the treatment of acute attacks of a rare condition hereditary angioedema (HAE) in people ages 18 years and older.
Launched year: 2009
Innohep
Innohep
Company: Pharmion
Product introduction: Innohep® (tinzaparin sodium) is a low molecular weight heparin (LMWH) with antithombotic properties indicated for the treatment and prophylaxis of deep vein thrombosis and pulmonary embolism.
Launched year: 2008
MEPSEVII
MEPSEVII
Company: Ultragenyx
Product introduction: MEPSEVII™ (vestronidase alfa) is an enzyme replacement therapy indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome).
Launched year: 2017
Mips Brain Protection System BPS
Mips Brain Protection System BPS
Company: Mips
Product description: In a helmet with MIPS Brain Protection System the shell and the liner are separated by a low friction layer. When a helmet with MIPS Brain Protection System is subjected to an angled impact, the low friction layer allows the helmet to slide relative to the head. The brain is surrounded by a low-friction cushion of cerebrospinal fluid that protects it by allowing it to slide slightly on impact. MIPS imitates the brain’s way of protecting itself by giving the helmet its own low-friction layer between the outer shell and the liner, which
also slides to absorb much of the energy created by an angled blow to the head.
Navigated Brain Stimulation (NBS) System 4
Navigated Brain Stimulation (NBS) System 4
Company: Nexstim
Product description: The product is a new navigated brain stimulation device for non-invasive direct cortical mapping in clinical neurosurgery and clinical research into applications of navigated repetitive transcranial magnetic stimulation (rTMS). It combines MRI-guided TMS with EMG measurement and incorporates DICOM export to surgical planning systems, surgical navigators and microscopes. The device is fully self-contained and mobile, does not require a dedicated room or fixed installation, and has a floor footprint of less than 0.6 m2.
Clinical applications: Pre-operational direct brain functional mapping
CE mark and FDA clearance received
NBT® System
NBT® System
Company: Nexstim
Product description: NBT® works by using navigated rTMS at a slow frequency in order to help restore the brain´s natural inhibitory balance between its two hemispheres: allowing the injured side of the brain to benefit from subsequent physiotherapy. It is a non-invasive, personalized adjunct therapy to standard physiotherapy.
Clinical applications: Stimulation therapy for stroke rehabilitation
CE mark received: 2012
Opsumit
Opsumit
Company: Actelion
Product introduction: Opsumit® (macitentan) is an orally available endothelin receptor antagonist (ERA) that resulted from a tailored drug discovery process with the target of developing an ERA to address efficacy and safety.
Launched year: 2013
PEPAXTO®
PEPAXTO®
Company: Oncopeptides
Product introduction: Pepaxto® (melphalan flufenamide) is an anticancer peptide-drug conjugate indicated in patients with relapsed or refractory multiple myeloma.
Launched year: 2021
Ponvory
Ponvory
Company: Actelion/ Janssen
Product introduction: Ponvory is an oral sphingosine-1-phosphate receptor modulator indicated for treatment of patients with relapsing multiple sclerosis.
Launch year: 2021
Recorlev
Recorlev
Company: Xeris Biopharma (Strongbrigde)
Product introduction: Recorlev is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Endogenous Cushing’s syndrome is a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure.
Launched year: 2021
Refludan
Refludan
Company: Pharmion
Product introduction: Refludan® (Lepirudin) is a recombinant hirudin derived from yeast cells and acts as a highly specific direct inhibitor of thrombin. The product is indicated to treat anticoagulation in patients with heparin-induced thrombocytopenia and associated thromboembolic disease.
Launched year: 2008
Restylane
Restylane
Company: Q-Med
Product description: Restylane is the trade name for a range of injectable fillers with a specific formulation of non-animal sourced hyaluronic acid (HA). Restylane was the first stabilized hyaluronic acid filler on the market and reportedly has been used in over 11 million treatments worldwide. In the United States, Restylane was the first hyaluronic acid filler to be approved by the FDA for cosmetic injection into sub dermal facial tissues.
FDA Approval: 2003
ReValvingTM system
ReValvingTM system
Company: CoreValve (Medtronic)
Product description: Corevalve has developed the ReValvingTM system for replacing an aortic heart valve by a peripheral, intravascular, percutaneous approach. The device is based on a catheter delivery system containing a self-expanding frame hosting a tissue valve. The product has revolutionized the medical practice moving from open surgery to a percutanous process where the valve together with its frame will be placed in the heart via a peripheral vessel.
Indication: severe aortic stenosis patients who are too ill or frail to have open-heart surgery for aortic valves replacement
CE mark received: 2007
RhinoChill IntraNasal Cooling System
RhinoChill IntraNasal Cooling System
Company: BeneChill
Product description: RhinoChill® IntraNasal Cooling System is a hypothermal device that simultaneously implement conductive cooling, evaporative cooling and convective cooling system to facilitate heat transfer. The product uses a transnasal evaporative catheter to deliver a mist of liquid perfluorocarbon into the nasal cavity. The perfluorocarbon evaporates on contact with the internal nares and base of skull, facilitating rapid and significant heat transfer. It is the first product with mild therapeutic hypothermia to effectively preserve the brain during cerebral ischemia events.
Indications: Cardiac arrest; stroke
CE mark received: 2011
Savene
Savene
Company: Onxeo
Product introduction: Savene® (dexrazoxane), developed by TopoTarget (Onxeo), is used for the treatment of anthracycline extravasation, a rare complication to chemotherapy. The product works by inhibiting DNA topoisomerase II, which is the target of anthracycline chemotherapy.
Launched year: 2006
Spacevision, C3, Ulis, Lumis, P.l.u.s, Flex2, UniThread
Spacevision, C3, Ulis, Lumis, P.l.u.s, Flex2, UniThread
Company: SpineVision
Product description:
A series of innovative products which offer key advantages to surgeons and benefits to patients. SpineVision’s current products offer solutions for approximately 90% of spinal pathologies i.e. lumbar degenerative disc diseases, deformities, cervical disorders, trauma and tumors. With its new generation products Flex+2 and LUMIS SpineVision® is the only manufacturer offering a dynamic stabilization system which can be used in a percutaneous approach.
Stress and Burnout
Stress and Burnout
Company: HelloBetter
Product Introduction: The Stress and Burnout course is based on cognitive behavioral therapy and patients learn how to reduce the effects of stress through – among others – psychoeducation, behavioural activation and mindfulness techniques.Eight clinical studies have proven its effectiveness in reducing stress, depressive symptoms, insomnia and symptoms of exhaustion.
Launched year: 2021
Tavneos
Tavneos
Company: ChemoCentryx
Product introduction: Tavneos (avacopan) is a complement C5 receptor inhibitor indicated for the treatment of patients with Anti-Neutrophil Cytoplasmic Autoantibody (ANCA) vasculitis, a systemic autoimmune disease characterized by destruction of small blood vessels leading to organ damage and failure (typically kidneys), which often is fatal if not treated.
Launched year: 2021
Thalomid
Thalomid
Company: Pharmion
Product introduction: Thalomid® (thalidomide) is an immunomodulator used to treat and prevent moderate to severe skin lesions caused by leprosy. The product is also used to treat multiple myeloma in combination with dexamethasone.
Launched year: 1998
Tracleer
Tracleer
Company: Actelion
Product introduction: Being the lead product of Actelion, Tracleer® (bosentan) – an endothelin receptor antagonist – was the first oral treatment approved for PAH.
Launched year: 2001
Translarna
Translarna
Company: PTC Therapeutics
Product introduction: Translarma (ataluren) is a protein restoration therapy that treats Duchenne muscular dystrophy (DMD). The product was launched in Germany after conditional approval for marketing in the EU states was granted by the European Commission in August 2014. It is the first treatment approved for DMD.
Launched year: 2014
Uptravi
Uptravi
Company: Actelion
Product introduction: Uptravi is used to treat Pulmonary Arterial Hypertension (PAH).
Launched year: 2016
Vaginismus Plus
Vaginismus Plus
Company: HelloBetter
Product Introduction: The Vaginismus Plus course was developed by experts from science, psychotherapy and psychology, incorporating input from people who suffer from vaginal pain. Patients will learn what could be causing the pain, gain valuable insights into the female body, pleasure and arousal, and learn how to effectively perform vaginal training using dilators with the aim of making vaginal penetration possible by the end of the course. The effectiveness of the course has been examined and confirmed in a clinical trial where 34% of participants were able to have sexual intercourse after completing the course.
Launched year: 2022
Veletri
Veletri
Company: Actelion
Product introduction: Veletri® (Epoprostenol for Injection) is intravenous prostacyclin. Unlike other epoprostenol formulations approved for PAH, Veletri is stable at room temperature for up to 48 hours when administered immediately upon reconstitution and dilution, making the use of frozen gel packs unnecessary.
Launched year: 2010
Ventavis
Ventavis
Company: Actelion
Prodcut introduction: Ventavis® (inhaled iloprost) is an inhaled formulation of iloprost, a synthetic compound that is structurally similar to prostacyclin (PGI2) – a naturally occurring molecule that causes blood vessels to dilate, limits cellular hypertrophy, and inhibits platelet aggregation.
Launched year: 2007
VICTUS™ Femtosecond Laser
VICTUS™ Femtosecond Laser
Company: Technolas Perfect Vision
Product Description: The VICTUS™ Femtosecond Laser is a versatile platform with cataract, LASIK flap, and therapeutic indications.
Vidaza
Vidaza
Company: Pharmion
Product introduction: Vidaza® (azacitidine) is a pyrimidinenucleoside analog of cytidine which induces antineoplastic activity. The product is approved by the FDA and is indicated for the treatment of high-risk myelodysplastic syndrome.
Launched year: 2008
Vyzulta
Vyzulta
Company: Nicox/Bausch & Lomb
Product description: VYZULTA™ (latanoprostene bunod) is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Launched year: 2017
Wartec
Wartec
Company: Conpharm
Product introduction: Wartec cream® (podofilox) is an over the counter topical solution formulated to treat genital warts that are found in the external genital region (penis or vulva) or around the anus, caused by human papillomavirus (HPV).
Launched year: 1999
Xofigo
Xofigo
Company: Algeta (Bayer)
Product introduction: Xofigo® (radium Ra 223 dichlorideis) is the first and only approved alpha particle-emitting radiopharmaceutical product for the treatment of castration-resistant prostate cancer with symptomatic bone metastases.
Launched year: 2013
Zavesca
Zavesca
Company: Actelion
Product introduction: Miglustat, the active ingredient of Zavesca®, is an orally available molecule with a large volume of distribution, which was developed for the treatment of type 1 Gaucher disease (GD1).
Launched year: 2003
Zephyr Endobronchial Valve
Zephyr Endobronchial Valve
Company: Pulmonx
Indicator: Emphysema
MoA: Endobronchial valve (EBV) therapy based on Chartis treatment planning is an effective, minimally invasive method developed by Pulmonx to manage hyperinflation.1 It is intended to predict and achieve reduction of volume in the diseased portion of the lung, without the risks and complications of surgery. EBV therapy involves an assessment of the patient’s hyperinflated lobes for the presence of collateral ventilation, or airflow within or between lobes of the lung, and then treating the patient by placing small, one-way valves in the targeted airways to direct the flow of air out of diseased portions of the lung. A typical procedure involves a Chartis assessment which typically takes about 5 minutes per lobe, and then placing three to four valves in the target lobe, which takes approximately 10 to 30 minutes to complete.
CE mark received: Zephyr® Endobronchial Valve 2003
Zephyr® Valve Delivery System
Zephyr® Valve Delivery System
Company: Pulmonx
Indicator: Emphysema
Product Description: The Zephyr® Endobronchial Valve is delivered to the target airway using a flexible delivery catheter which is inserted through standard bronchoscopes with a 2.8 mm or larger working channel, and 550 mm or 600 mm working length, depending on the manufacturer. Once positioned in the target bronchus, an actuator button on the catheter retracts the sheath, allowing the Zephyr® valve to expand against the bronchial wall. A typical procedure involves placing approximately three to four valves to isolate the target lobe, and takes approximately 10 to 30 minutes to complete.
Zubsolv
Zubsolv
Company: Orexo
Product introduction: Zubsolv® (buprenorphine and naloxone) sublingual tablet is indicated for treatment of adult opioid dependence. The product should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support.
Launched year: 2013