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Home | SPINRAZA® (nusinersen) HCP

The SPINRAZA ® clinical trial ... This site is intended for EU healthcare professionals only. Biogen-53476. Date of preparation: April2020. Biogen International GmbH Neuhofstrasse 30, 6340 Baar, Switzerland. ...

Spinraza.eu

Administration | SPINRAZA® (nusinersen) HCP

SPINRAZA ® is given by ... This site is intended for EU healthcare professionals only. Biogen-53476. Date of preparation: April2020. Biogen International …

Spinraza.eu

Contact Us - spinraza.com

1-844-4SPINRAZA ( 1-844-477-4672) 8:30 AM to 8:00 PM ET, Monday through Friday.

Spinraza.com

Official Patient Site | SPINRAZA® (nusinersen)

Your healthcare provider should perform urine testing before you start treatment with SPINRAZA and before each dose to monitor for signs of this risk. The most common side effects of SPINRAZA include lower respiratory infection, fever, constipation, headache, vomiting, back pain, and post-lumbar puncture syndrome.

Spinraza.com

Request access to Spinraza.eu Real World Evidence page ...

Email * Information on how ... About SMA Mechanism of disease Natural History SPINRAZA ® essentials Mechanism of action Safety Posology Storage and handling Administration Technology behind SPINRAZA ® SPINRAZA ® study programme. Overview Infantile-onset (Type I) SMA Later-onset (Type II/III) SMA Pre-symptomatic SMA Mixed SMA populations Ongoing studies …

Spinraza.eu

Spinraza, INN - nusinersen - ema.europa.eu

Spinraza was designated as an orphan medicinal product EU/3/12/976 on 02 April 2012 in the following condition: Treatment of 5q spinal muscular atrophy . The applicant applied for the following indication : Spinraza is indicated for the treatment of Spinal Muscular Atrophy (SMA). Following the CHMP positive opinion on this marketing authorisation, the Committee for …

Ema.europa.eu

Important Safety Information - SPINRAZA® (nusinersen)

IMPORTANT SAFETY INFORMATION. Coagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been observed after administration of some antisense oligonucleotides.Patients may be at increased risk of bleeding complications. In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 24 of 146 …

Spinraza-hcp.com

QUESTIONS - SPINRAZA

SPINRAZA is the first approved therapy shown in clinical trials to change the expected course of SMA for some individuals, increasing survival, motor milestone achievement, and motor function. The effectiveness of SPINRAZA was evaluated in a well-controlled clinical study of 121 individuals with infantile-onset (Type 1) SMA aged 30 to 262 days and supported by clinical …

Spinraza.com

SPINRAZA Prescribing Information

SPINRAZA may cause a reduction in growth as measured by height when administered to infants, as suggested by observations from the controlled study. It is unknown whether any effect of SPINRAZA on growth would be reversible with cessation of treatment. Clinical Trial in Later-Onset SMA (Study 2) In Study 2, baseline disease characteristics were largely similar in the …

Spinraza.eu

Resources – Contact us - spinraza.co.uk

Contact us page enabling healthcare professionals to submit email queries to Biogen about Spinraza ® (nusinersen) Prescribing Information; Toggle navigation. This site is intended for UK and RoI Healthcare Professionals only. If you are a member of the public, please click here. A A A Size . Contrast . Go. Safety Safety. Overview Overview; Clinical Study Programme Clinical …

Spinraza.co.uk

Spinraza - Cure SMA

Spinraza (nusinersen), marketed by Biogen, was the first FDA-approved therapy to treat SMA. It is an SMN-enhancing therapy that works by targeting the SMN2 gene, causing it to make more complete protein. More About Spinraza . Spinraza is FDA-approved for all ages and types of SMA. Spinraza is given via an intrathecal (IT) injection, which is an injection into directly into …

Curesma.org

Important Safety Information - SPINRAZA

The most common side effects of SPINRAZA include lower respiratory infection, fever, constipation, headache, vomiting, back pain, and post-lumbar puncture syndrome. These are not all of the possible side effects of SPINRAZA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Spinraza.com

SPINRAZA ACCESS OVERVIEW

SPINRAZA is administered intrathecally by, or under the direction of, healthcare professionals experienced in performing lumbar punctures. Recommended Dosage The recommended dosage is 12 mg (5 mL) per administration. Initiate SPINRAZA treatment with 4 loading doses. The first three loading doses should be administered at 14-day intervals. The 4th loading dose should …

Spinraza-hcp.com

Official HCP Homepage | SPINRAZA® (nusinersen) | HCP

SPINRAZA has been studied in the longest clinical trial program in SMA to date. 3. The most common side effects of SPINRAZA include lower respiratory infection, pyrexia, constipation, headache, vomiting, back pain, and post-lumbar puncture syndrome. These are not all of the possible side effects of SPINRAZA. Discover the data.

Spinraza-hcp.com

Spinraza UK – Home

Online resource for healthcare professionals on Spinraza ® (nusinersen) Adverse events should be reported. For Ireland, reporting forms and information can be found at www.hpra.ie.For the UK, reporting forms and information can be found at yellowcard.mhra.gov.uk or via the Yellow Card app available from the Apple App Store or Google Play Store. . Adverse events should also be …

Spinraza.co.uk

Spinraza Most Effective in Younger SMA Type 1 Children ...

2022-04-15 · In a real-world study involving more than 40 Swiss patients with spinal muscular atrophy (SMA), Spinraza (nusinersen) was found to effectively improve motor function — particularly among younger children with SMA type 1. Older treated patients gained or stabilized their motor function, but infections prompted the need for ventilation and feeding support in …

Smanewstoday.com

Russia-Ukraine war live updates: E.U. proposes Russian oil ban

12 hours ago · By NBC News. The European Union is proposing a complete ban on Russian oil by the end of the year, a dramatic step for a continent that has had to weigh its growing support for Ukraine's defense ...

Nbcnews.com

Spinraza - SMOP - ema.europa.eu

Spinraza will be available as a 2.4 mg/ml solution for injection. The active substance of Spinraza is nusinersen, ... made available in all official European Union languages after the marketing authorisation has been granted by the European Commission. 1 Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 …

Ema.europa.eu

SPUS17CDNY1099 SPINRAZA StartForm iPDF r5 SetUp

[email protected] (this email address is an unattended inbox and is for Start Forms only). For questions, please contact Biogen at 1-844-477-4672 2 Meet your SPINRAZA team After the Start Form has been submitted to Biogen, the person receiving treatment will be enrolled in SMA360° support services. •360º support provides certain services that address nonmedical …

Spinraza-hcp.com

Individual results may vary based on several ... - SPINRAZA

SPINRAZA and before each dose to monitor for signs of these risks. Seek medical attention if unexpected bleeding occurs. Please see additional Important Safety Information on page 44 and accompanying full Prescribing Information. NAVIGATING A HEALTH PLAN’S APPROVAL PROCESS FOR SPINRAZA THE HEALTH PLAN APPROVAL PROCESS FOR SPINRAZA …

Spinraza.com

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