Spinraza 12mg/5ml

Hauptinformation

  • Handelsname:
  • Spinraza 12mg/5ml Lösung zur intrathekalen Injektion
  • Darreichungsform:
  • Lösung zur intrathekalen Injektion
  • Zusammensetzung:
  • Freigabe: nusinersenum 12 mg bis nusinersenum natricum, natrii dihydrogenophosphas dihydricus, dinatrii phosphas, natrii chloridum, kalii chloridum, calcium chloridum dihydricum, magnesium, chloridum hexahydricum, natrii hydroxidum, Säure hydrochloridum, Wasser ad iniectabilia q.s. zu einer Lösung anstelle von 5 ml.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Spinraza 12mg/5ml Lösung zur intrathekalen Injektion
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Behandlung der 5q-assoziierten spinalen Muskelatrophie (SMA)

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 66495
  • Berechtigungsdatum:
  • 20-09-2017
  • Letzte Änderung:
  • 25-10-2018

Packungsbeilage

Patienteninformation

Spinraza®

Biogen Switzerland AG

Was ist Spinraza und wann wird es angewendet?

Spinraza wird auf Verschreibung des Arztes oder der Ärztin zur Behandlung einer genetisch

bedingten Erkrankung namens spinale Muskelatrophie (SMA) angewendet. Spinraza enthält den

Wirkstoff Nusinersen, der zu einer Gruppe von Arzneimitteln gehört, die als Antisense-

Oligonukleotide bezeichnet werden.

Was ist Spinale Muskelatrophie?

Spinale Muskelatrophie wird durch einen Mangel an einem Eiweiss (Protein) im Körper

hervorgerufen, das als Survival Motor Neuron oder kurz SMN bezeichnet wird. Dies führt zum

Verlust von Nervenzellen in der Wirbelsäule mit daraus resultierender Muskelschwäche in Schultern,

Hüfte, Oberschenkeln und im Bereich des oberen Rückens. Es können auch die Muskeln geschwächt

sein, die für die Atmung und das Schlucken erforderlich sind.

Wie wirkt Spinraza?

Spinraza wirkt, indem es den Körper dabei unterstützt, mehr von dem SMN-Protein zu bilden.

Dadurch wird der Verlust von Nervenzellen reduziert und die Muskelstärke kann so verbessert

werden.

Wie wurde Nusinersen untersucht?

In klinischen Studien half Nusinersen Kindern, sich in den motorischen Funktionen zu verbessern

und die Meilensteine der motorischen Funktionen zu erreichen (zum Beispiel Kopfkontrolle, freies

Sitzen oder Stehen; siehe nächste Abbildung).

Die Behandlung mit Nusinersen nützte Patienten unterschiedlichen Alters und mit unterschiedlichen

SMA-Typen wie der infantilen Form der SMA (Typ I), späterem SMA-Krankheitsbeginn (Typ II/III)

und präsymptomatischer, genetisch diagnostizierter SMA.

Hat die Erkrankung ein bestimmtes Stadium überschritten (z.B. Notwendigkeit einer permanenten

Beatmung), ist die Wirksamkeit von Spinraza im Vergleich zu einem Therapiebeginn in den

Frühstadien der Krankheit deutlich vermindert.

Was sollte dazu beachtet werden?

Spinraza enthält weniger als 1 mmol (23 mg) Natrium pro Dosis. Es ist nahezu «natriumfrei» und

kann von Patientinnen und Patienten, die eine kochsalzarme Diät einhalten müssen, angewendet

werden.

Wann darf Spinraza nicht angewendet werden?

Spinraza darf nicht angewendet werden,

·wenn Sie oder Ihr Kind allergisch gegen Nusinersen oder einen der Hilfsstoffe sind.

Wenn Sie sich nicht sicher sind, sprechen Sie mit Ihrem Arzt bzw. Ihrer Ärztin, bevor Sie oder Ihr

Kind mit Spinraza behandelt werden.

Wann ist bei der Anwendung von Spinraza Vorsicht geboten?

Es besteht ein Risiko, dass nach der Gabe von Spinraza mittels Lumbalpunktion Nebenwirkungen

auftreten können, die mit der Lumbalpunktion im Zusammenhang stehen. Diese können

Kopfschmerzen, Erbrechen und Rückenschmerzen einschliessen. Bei sehr jungen Patientinnen und

Patienten und bei Patientinnen und Patienten mit Skoliose (Wirbelsäulenverkrümmung) können

Schwierigkeiten bei der Anwendung eines Arzneimittels mittels Lumbalpunktion auftreten.

Andere Arzneimittel, die derselben Arzneimittelklasse angehören wie Spinraza, haben nachweislich

eine Wirkung auf die Zellen im Blut, die für die Blutgerinnung zuständig sind. Bevor Sie oder Ihr

Kind Spinraza erhalten, wird Ihr Arzt oder Ihre Ärztin eine Blutuntersuchung durchführen, um die

Gerinnungsfähigkeit Ihres Blutes oder des Blutes Ihres Kindes zu überprüfen. Ihr Arzt oder Ihre

Ärztin wird dies regelmässig während der Behandlung mit Spinraza wiederholen.

Andere Arzneimittel, die derselben Arzneimittelklasse angehören wie Spinraza, haben nachweislich

einen Einfluss auf die Nieren. Bevor Sie oder Ihr Kind Spinraza erhalten, wird Ihr Arzt oder Ihre

Ärztin eine Urinuntersuchung durchführen, um Ihre Nierenfunktion oder die Ihres Kindes zu

überprüfen. Dies wird regelmässig während der Behandlung mit Spinraza wiederholt.

Bevor Sie oder Ihr Kind Spinraza erhalten, macht Ihr Arzt oder Ihre Ärztin ein EKG, um

festzustellen, ob Sie oder Ihr Kind unter Herzrhythmusstörungen leiden. Dies wird regelmässig

während der Behandlung mit Spinraza wiederholt.

Es liegen Berichte vor, wonach Patienten nach der Behandlung mit Spinraza einen Hydrozephalus

(eine Ansammlung von zu viel Nervenwasser im Gehirn) entwickelten. Einigen dieser Patienten

musste zur Behandlung des Hydrozephalus ein so genannter ventrikulo-peritonealer Shunt

implantiert werden. Wenn Sie Symptome wie eine Zunahme des Kopfumfangs,

Bewusstseinsstörungen, anhaltende Übelkeit, anhaltendes Erbrechen oder anhaltende Kopfschmerzen

oder andere Symptome bei Ihrem Kind oder sich selber feststellen, die Ihnen Sorge bereiten,

informieren Sie bitte Ihren Arzt oder den Arzt Ihres Kindes, um die erforderliche Behandlung

einzuleiten. Über den Nutzen und die Risiken einer Weiterbehandlung mit Spinraza nach der

Implantation eines ventrikulo-peritonealen Shunts ist derzeit noch nichts bekannt.

Informieren Sie Ihren Arzt oder Ihre Ärztin, wenn Sie oder Ihr Kind

·an anderen Krankheiten leiden

·Allergien haben

·Andere Arzneimittel (auch selbst gekaufte!) einnehmen oder äusserlich anwenden

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Bisher liegen keine Hinweise vor, dass die Verkehrstüchtigkeit und das Bedienen von Maschinen

durch Spinraza beeinträchtigt werden.

Ihr Arzt oder Ihre Ärztin wird Ihnen erklären, ob Sie trotz Ihrer Erkrankung sicher am Verkehr

teilnehmen und Maschinen bedienen können.

Darf Spinraza während einer Schwangerschaft oder in der Stillzeit angewendet werden?

Wenn Sie schwanger sind oder stillen, oder wenn Sie vermuten, schwanger zu sein oder

beabsichtigen, schwanger zu werden, fragen Sie vor der Anwendung dieses Arzneimittels Ihren Arzt

oder Ihre Ärztin um Rat. Es ist vorzuziehen, die Anwendung von Spinraza während der

Schwangerschaft und Stillzeit zu vermeiden.

Wie verwenden Sie Spinraza?

Die übliche Dosis Spinraza beträgt 12 mg.

Spinraza wird Ihnen oder Ihrem Kind wie folgt injiziert:

·am ersten Tag der Behandlung, Tag 0

·dann am Tag 14, Tag 28 und Tag 63

·danach einmal alle 4 Monate.

Spinraza wird Ihnen bzw. Ihrem Kind als Injektion in den unteren Rücken gegeben. Diese Injektion

wird als Lumbalpunktion bezeichnet; dazu wird eine Nadel in den Raum um das Rückenmark

eingeführt. Die Behandlung wird von einem Arzt oder einer Ärztin vorgenommen, die Erfahrung mit

der Durchführung von Lumbalpunktionen hat. Sie oder Ihr Kind erhalten eventuell auch ein

Arzneimittel, das Sie während der Behandlung entspannt oder einschlafen lässt.

Wie lange wird Spinraza angewendet?

Ihr Arzt wird Ihnen sagen, wie lange Sie oder Ihr Kind mit Spinraza behandelt werden müssen.

Brechen Sie die Behandlung mit Spinraza nicht ab, sofern Ihr Arzt es Ihnen nicht ausdrücklich sagt.

Zu Spinraza sind limitierte Informationen zu einer Behandlungsdauer von über 3 Jahren nach

Therapiebeginn verfügbar. Es liegen auch nur begrenzt Daten bei Patienten über 18 Jahren vor.

Wenn Sie oder Ihr Kind eine Injektion versäumen

Wenn Sie oder Ihr Kind eine Dosis von Spinraza versäumen, sprechen Sie mit Ihrem Arzt oder Ihrer

Ärztin, damit die Behandlung mit Spinraza so bald wie möglich durchgeführt werden kann.

Wenn Sie Fragen zur Anwendung von Spinraza haben, wenden Sie sich an Ihren Arzt oder Ihre

Ärztin.

Welche Nebenwirkungen kann Spinraza haben?

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben, die aber nicht bei

jedem auftreten müssen.

Wenden Sie sich an Ihren Arzt oder Ihre Ärztin, wenn bei Ihnen oder Ihrem Kind Nebenwirkungen

auftreten, die Sie oder Ihr Kind belasten oder über längere Zeit bestehen.

Nebenwirkungen der Lumbalpunktion

Während der Gabe von Spinraza oder kurz danach, in der Regel innerhalb 72 Stunden nach der

Verabreichung, können Nebenwirkungen wie Kopfschmerzen, Rückenschmerzen oder Erbrechen in

Zusammenhang mit der Lumbalpunktion auftreten.

Die häufigsten Nebenwirkungen, die bei Spinraza behandelten Patienten auftraten, waren:

·Fieber

·Schnupfen,

·Husten

·Verstopfung

Sehr häufige Nebenwirkungen (können mehr als 1 von 10 Behandelten betreffen)

·Husten

·Schnupfen

·Rückenschmerzen

·Kopfschmerz

·Erbrechen

·Zahnen

Häufige Nebenwirkungen (können mehr als 1 von 100 Behandelten betreffen)

·Blasenentzündung

·Heuschnupfen

·Nasenbluten

·Sturz

·Ohrenentzündung

·Durchfall

·Blähungen

·Gewichtsabnahme

Zusätzliche Nebenwirkungen, die in klinischen Studien nicht beobachtet wurden:

Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar)

·Schwerwiegende Infektion in Zusammenhang mit der Lumbalpunktion (z.B. Meningitis)

·Hydrozephalus (Ansammlung von zu viel Nervenwasser im Gehirn)

Auswirkung auf das Wachstum

Spinraza könnte eine Reduktion des Wachstums verursachen, wie anhand der gemessenen

Körpergrösse in einer Placebo kontrollierten Studie beobachtet wurde. Es ist nicht bekannt, ob ein

Effekt von Spinraza auf das Wachstum bei einem Therapieabbruch reversibel ist.

Meldung von Nebenwirkungen

Wenn Sie oder Ihr Kind Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie

Ihren Arzt bzw. Ihre Ärztin informieren.

Was ist ferner zu beachten?

Was ist in Spinraza enthalten?

Wirkstoff: Jede 5 ml-Durchstechflasche enthält Nusinersen, entsprechend 12 mg Nusinersen. Ein

Milliliter enthält 2,4 mg Nusinersen.

Hilfsstoffe: Natriumdihydrogenphosphat-Dihydrat, Dinatriumhydrogenphosphat, Natriumchlorid,

Kaliumchlorid, Calciumchlorid-Dihydrat, Magnesiumchlorid-Hexahydrat, Natriumhydroxid,

Salzsäure, Wasser für Injektionszwecke.

Zulassungsnummer

66495 (Swissmedic).

Wo erhalten Sie Spinraza? Welche Packungen sind erhältlich?

Nur in Spital-basierten, spezialisierten neuromuskulären Zentren, gegen ärztliche Verschreibung.

Zulassungsinhaberin

Biogen Switzerland AG, 6300 Zug.

Diese Packungsbeilage wurde im Oktober 2018 letztmals durch die Arzneimittelbehörde

(Swissmedic) geprüft.

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27-9-2018

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Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 During the project seven standard operating procedures (SOP) were developed for the four data domains (zoonoses, chemical contaminant, pesticide residues and veterinary medical products residues). The SOPs describe 1) How the national governance of risk assessment data is organised, 2) how data are collected and validated before delivering to EFSA covering all four domains, 3) How data is transferred to EFSA, 4) how to respond to EFSA request for clarificati...

Europe - EFSA - European Food Safety Authority Publications

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

Ruconest (Active substance: Conestat alfa) - Centralised - Yearly update - Commission Decision (2018)7548 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

30-10-2018

SUTENT® 12,5/25/37,5/50 mg Hartkapseln

Rote - Liste

25-10-2018

Moventig® 12,5 mg/25 mg Filmtabletten

Rote - Liste

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

25-9-2018

Spinraza®

Rote - Liste

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5972 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2660/T/12

Europe -DG Health and Food Safety

14-9-2018

Agenda:  Agenda - CAT agenda of the 12-14 September 2018 meeting

Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting

Europe - EMA - European Medicines Agency

14-9-2018

Fentanyl AWD® Matrix 12 Mikrogramm/h

Rote - Liste

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

5-9-2018

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application:  https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.usa.gov/xPcpn  #MedicalDevice

FDA - U.S. Food and Drug Administration

4-9-2018

Spinraza (Biogen Idec Limited)

Spinraza (Biogen Idec Limited)

Spinraza (Active substance: nusinersen) - Centralised - 2-Monthly update - Commission Decision (2018)5862 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/II/4

Europe -DG Health and Food Safety