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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.euDA: 15 PA: 15 MOZ Rank: 16
Community update on access to Spinraza in Europe
In response to our request, Biogen has provided us with an update on access to SPINRAZA™ (nusinersen). There are now 29 European countries that have access to nusinersen via regular reimbursement. Since the last report, an updated situation can be found for Switzerland. As you can see from the table, there is a range of reimbursed access: in ...
Sma-europe.euDA: 17 PA: 50 MOZ Rank: 73
Spinraza, INN - nusinersen - Europa
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).
Ema.europa.euDA: 17 PA: 50 MOZ Rank: 96
EU label for Spinraza updated in Spinal Muscular Atrophy
Biogen announced an update to the European label for Spinraza (nusinersen), incorporating longer-term data from four studies (NURTURE, EMBRACE, SHINE and CS3A) which includes longer-term data across a broad range of ages and types of Spinal Muscular Atrophy. These studies, which looked at pre-symptomatic, infantile-onset and later-onset …
Medthority.comDA: 18 PA: 50 MOZ Rank: 92
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.ukDA: 18 PA: 18 MOZ Rank: 23
Spinraza - SMOP
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.euDA: 17 PA: 50 MOZ Rank: 94
SMA Europe
/essentials/treatments-for-sma/spinraza
Sma-europe.euDA: 17 PA: 40 MOZ Rank: 63
Assessment report for paediatric studies submitted according to …
Assessment report for paediatric studies submitted according to Article 46 of the Regulation (EC) No 1901/2006 Spinraza Page 4/17 showed that the majority of subjects had clinically significant improvements in motor function and
Ema.europa.euDA: 17 PA: 50 MOZ Rank: 43
Spinraza 12 mg solution for injection - Summary of Product ...
This information is intended for use by health professionals. 1. Name of the medicinal product. Spinraza 12 mg solution for injection. 2. Qualitative and quantitative composition. Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen. Each ml contains 2.4 mg of nusinersen.
Medicines.org.ukDA: 20 PA: 22 MOZ Rank: 50
Prescribing information: SPINRAZA (nusinersen)
Prescribing information: Spinraza ... EU/1/17/1188/001; Great Britain: 407/0018. Marketing PLGB 22 Authorisation Holder: Biogen Nethlands B.V., Prins Mauritslaaer n 13, 1171 LP Badhoevedorp, The Netherlands. Date of last revision of Prescribing Information: March 2022 . Adverse events should be reported. For Ireland, reporting forms and information can be found at . …
Spinraza.co.ukDA: 18 PA: 50 MOZ Rank: 41
SMA Europe | Biogen
Marketed as Spinraza™, it was the first potentially disease-modifying treatment available in Europe for 5q SMA. It is an antisense oligonucleotide (ASO) designed to modify the product of the SMN2 “backup” gene to produce more functional SMN protein. About Spinraza™ Method of Action. ASOs are small snippets of synthetic genetic material that bind ribonucleic acid (RNA). …
Sma-europe.euDA: 17 PA: 7 MOZ Rank: 34
Spinal muscular atrophy: Spinraza approval delights family - BBC
SMA is a genetic condition which affects the nerves in the spinal cord, weakening muscles and causing problems with movement, breathing and swallowing. It can significantly reduce life expectancy ...
Bbc.co.ukDA: 13 PA: 36 MOZ Rank: 60
Biogen's Spinraza OK'd in EU (NASDAQ:BIIB) | Seeking Alpha
As expected, the European Commission approves Biogen's (NASDAQ:BIIB) marketing application for SPINRAZA (nusinersen) for the treatment of 5q spinal muscular atrophy, the most common form of...
Seekingalpha.comDA: 16 PA: 40 MOZ Rank: 68
SMA Europe
Redirecting to https://www.sma-europe.eu/news/biogen-provides-community-update-on-spinraza-european-pricing
Sma-europe.euDA: 17 PA: 50 MOZ Rank: 97
MONOGRAPHIE DE PRODUIT INCLUANT LES RENSEIGNEMENTS …
Les effets de SPINRAZA sur le travail et l’accouchement ne sont pas connus. Populations particulières : Femmes enceintes : Il n’y a pas de données provenant d’études cliniques sur l’utilisation de SPINRAZA pendant la grossesse chez l’humain, et on ignore les effets de SPINRAZA sur le travail et l’accouchement.
Biogen.caDA: 13 PA: 50 MOZ Rank: 36
La recommandation provisoire de l'ACMTS pour SPINRAZA(MC) …
L'ACMTS n'admet pas comme preuve des nouvelles données probantes démontrant l'efficacité et l'innocuité de SPINRAZA pour le traitement de …
Lelezard.comDA: 16 PA: 25 MOZ Rank: 56
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