Helixor P 0

Hauptinformation

  • Handelsname:
  • Helixor P 0 01 mg Injektionslösung, anthrop. Arzneimittel
  • Darreichungsform:
  • 01 mg Injektionslösung, anthrop. Arzneimittel
  • Zusammensetzung:
  • Auszug aquosum Flüssigkeit 0.2 mg ex viscum album (pini) ist ein neu 0.01 mg, natrii chloridum, aqua q.s. zu einer Lösung anstelle von 1 ml.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Helixor P 0 01 mg Injektionslösung, anthrop. Arzneimittel
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Anthroposophische Arzneimittel
  • Therapiebereich:
  • Zusatzbehandlung bei malignen Erkrankungen

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 56208
  • Berechtigungsdatum:
  • 08-09-2006
  • Letzte Änderung:
  • 25-10-2018

Packungsbeilage

Patienteninformation

Helixor®

Anthroposophisches Arzneimittel

Information für Patientinnen und Patienten

Lesen Sie diese Packungsbeilage sorgfältig, bevor Sie das Arzneimittel anwenden. Bewahren Sie die

Packungsbeilage auf, Sie wollen sie vielleicht später nochmals lesen. Dieses Arzneimittel ist Ihnen

persönlich verschrieben worden und Sie sollten es nicht an andere Personen weitergeben. Auch wenn

diese die gleichen Krankheitssymptome haben wie Sie, könnte das Arzneimittel dort Schaden

anrichten.

Helixor® A Helixor® M Helixor® P

Anthroposophisches Arzneimittel

Wann wird Helixor® angewendet?

Gemäss der anthroposophischen Menschen- und Naturerkenntnis kann Helixor® auf Verschreibung

Ihres Arztes oder Ihrer Ärztin als Zusatzbehandlung bei malignen Erkrankungen angewendet

werden.

Was sollte dazu beachtet werden?

Wenn Ihnen Ihr Arzt oder Ihre Ärztin andere Medikamente verschrieben hat, fragen Sie Ihren Arzt

oder Apotheker bzw. Ihre Ärztin oder Apothekerin, ob Helixor® gleichzeitig angewendet werden

darf.

Wann darf Helixor® nicht oder nur mit Vorsicht angewendet werden?

Helixor® darf nicht angewendet werden bei Überempfindlichkeit (Allergie) gegenüber

Mistelzubereitungen sowie bei akut entzündlichen oder hochfieberhaften Erkrankungen.

·Bei zeitnaher Anwendung anderer immunwirksamer Arzneistoffe (z. B. Thymusextrakte), bei

Allergieneigung, Schilddrüsenüberfunktion, chronisch granulomatösen Entzündungen oder

Autoimmunkrankheiten sowie bei Anwendung während einer Bestrahlung oder Chemotherapie ist

eine sorgfältige Verlaufskontrolle durch Ihren Arzt oder Ihre Ärztin, evt. verbunden mit einer

Anpassung der Dosierung, erforderlich.

Informieren Sie Ihren Arzt, Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie

·an anderen Krankheiten leiden,

·Allergien haben oder

·andere Arzneimittel (auch selbstgekaufte) einnehmen!

Darf Helixor® während einer Schwangerschaft oder in der Stillzeit angewendet werden?

Über die Anwendung von Helixor® während der Schwangerschaft entscheidet Ihr Arzt oder Ihre

Ärztin. Während der Stillzeit darf Helixor® nicht angewendet werden.

Wie verwenden Sie Helixor®?

Dosierung/Anwendung:

Die Dosierung und die Häufigkeit der Anwendung werden von Ihrem Arzt oder Ihrer Ärztin

individuell festgelegt. Ändern Sie nicht von sich aus die verschriebene Dosierung. Wenn Sie

glauben, das Arzneimittel wirke zu schwach oder zu stark, so sprechen Sie mit Ihrem Arzt oder

Apotheker bzw. mit Ihrer Ärztin oder Apothekerin.

Helixor® wird als subkutane Injektion (Spritze unter die Haut) an wechselnden Stellen der intakten

Haut (z. B. Bauchhaut, Vorder- und Aussenseite der Oberschenkel) angewendet. Ihr Arzt bzw. Ihre

Ärztin wird Sie bezüglich Vorbereiten der Spritzen und Injektionstechnik genau informieren. Halten

Sie sich genau an diese Anweisungen.

Spritzen Sie nicht in entzündete Hautbezirke (z. B. entzündliche Reaktionen an früheren

Einspritzstellen, Venenentzündungen), meiden Sie Bestrahlungsfelder.

Vorsichtshalber sollte Helixor® nicht zusammen mit anderen Arzneimitteln in einer Spritze

aufgezogen werden.

Die Anwendung muss unterbrochen werden, sobald eine Entzündungsreaktion grösser als 5 cm

Durchmesser an der Einspritzstelle (Rötung, Schwellung, Verhärtung im Unterhautgewebe), Fieber

oder grippeähnliche Symptome (Krankheitsgefühl, Frösteln, Kopf- oder Gliederschmerzen) im

Anschluss an die Anwendung von Helixor® auftreten. In diesem Fall kontaktieren Sie Ihren Arzt

oder Ihre Ärztin.

Die Anwendungsdauer ist prinzipiell nicht begrenzt. Sie wird vom Arzt oder der Ärztin festgelegt.

Die Dosierung sollte in Abständen von 3 - 6 Monaten von Ihrem Arzt oder von Ihrer Ärztin überprüft

werden.

Wenn Sie versehentlich eine zu hohe Dosis angewendet haben

Zeichen einer Überdosierung können übermässige entzündliche Reaktionen an der Einspritzstelle,

oder andere unter „Welche Nebenwirkungen kann Helixor® haben?“ beschriebene Symptome sein.

Wenn Sie die Anwendung von Helixor® versäumt haben...

holen Sie die Anwendung von Helixor® zum nächstmöglichen Zeitpunkt in gleicher Dosis nach.

Nach längeren Behandlungspausen von über 4 Wochen sollten Sie Ihren Arzt oder Ihre Ärztin

fragen, wie resp. in welcher Dosierung Sie Helixor® weiterverwenden sollen.

Welche Nebenwirkungen kann Helixor® haben?

Folgende Nebenwirkungen können bei der Anwendung von Helixor® auftreten:

Sehr häufig: grössere örtliche Entzündungsreaktionen (Rötung, Schwellung, Verhärtung) an der

Einspritzstelle. Entzündungsreaktionen an der Einspritzstelle unter 5 cm Durchmesser und leichte

Steigerung der Körpertemperatur sind meist unbedenklich. Wenden Sie sich an Ihren Arzt oder Ihre

Ärztin und fragen Sie, wie Sie die Behandlung fortsetzen sollen.

Gelegentlich: Juckreiz am ganzen Körper, örtliche oder ausgebreitete Nesselsucht, Hautausschlag,

Fieber, Abgeschlagenheit, Frösteln, allgemeines Krankheitsgefühl, Kopfschmerzen,

Gelenkschmerzen, Lymphknotenschwellung, Aktivierung von Entzündungen.

Selten: knotige Verhärtungen im Unterhautgewebe am Injektionsort, Blasenbildung, Haut- und

Schleimhautschwellung im Gesichtsbereich (Quincke-Ödem), Augenbrennen und -tränen,

heuschnupfenartige Beschwerden, Atemnot, Bronchialverkrampfung (Bronchospasmus),

Schüttelfrost, Schwindel.

Sehr selten (Einzelfälle): schwerwiegende allergische Hautreaktionen (Erythema exsudativum

multiforme), Schock (Kreislaufversagen im Rahmen einer allergischen Reaktion).

Bei allergischen Reaktionen (Juckreiz am ganzen Körper, Nesselsucht, Hautausschlag,

Gesichtsschwellung, Atemnot, Schock) muss Helixor® abgesetzt und sofort Kontakt mit einem Arzt

oder einer Ärztin aufgenommen werden.

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder

Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.

Was ist ferner zu beachten?

Lagern Sie Helixor®-Ampullen unter Lichtschutz in der geschlossenen Ampullenschachtel bei einer

Temperatur nicht über 25 °C.

Das Präparat darf nur bis zu dem auf dem Behälter mit „EXP“ bezeichneten Datum verwendet

werden.

Vor Kindern geschützt aufbewahren.

Angebrochene Ampullen dürfen Sie für eine spätere Injektion nicht aufbewahren.

Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese

Personen verfügen über die ausführliche Fachinformation.

Was ist in Helixor® enthalten?

Die verschiedenen Dosierungsstärken werden mit Gehalt an Frischpflanzenmaterial in mg pro

Ampulle bezeichnet.

Ampullen zu 1 ml Injektionslösung. 1 Ampulle enthält den wässrigen Auszug aus 0,01 – 50 mg

frischem Mistelkraut (Viscum album) des jeweiligen Wirtsbaums. Auszugsmittel: Wasser.

Ampullen zu 2 ml Injektionslösung. 1 Ampulle enthält den wässrigen Auszug aus 100 mg frischem

Mistelkraut (Viscum album) des jeweiligen Wirtsbaums. Auszugsmittel: Wasser.

Diese Präparate enthalten zusätzlich Hilfsstoffe:

Kochsalz, Wasser für Injektionszwecke.

Zulassungsnummer

56206 Helixor® A, Injektionslösung

56207 Helixor® M, Injektionslösung

56208 Helixor® P, Injektionslösung

Wo erhalten Sie Helixor®? Welche Packungen sind erhältlich?

In Apotheken gegen ärztliche Verschreibung, die nur zum einmaligen Bezug berechtigt.

Es stehen 3 Sorten von Helixor® zur Verfügung, die von Misteln unterschiedlicher Wirtsbäume

gewonnen wurden:

Helixor® A: Tannenmistel (Viscum album abietis)

Helixor® M: Apfelbaummistel (Viscum album mali)

Helixor® P: Kiefernmistel (Viscum album pini).

Serienpackungen (SE)

mit je 7 Ampullen in

steigender

Konzentration

Originalpackungen (OP)

mit je 8 Ampullen der

gleichen Konzentration

SE I

SE II

SE III

SE IV OP

1 mg

10 mg

1 mg

20 mg

OP 0,01 mg

1 mg

10 mg

5 mg

20 mg

OP 0,1 mg

OP 1 mg

1 mg

20 mg

5 mg

30 mg

OP 5 mg

OP 10 mg

5 mg

20 mg

10 mg

30 mg

OP 20 mg

OP 30 mg

5 mg

30 mg

10 mg

50 mg

OP 50 mg

OP 100 mg

5 mg

30 mg

10 mg

50 mg

10 mg 30 mg

20 mg

50 mg

Zulassungsinhaberin

Target BioScience AG, 8803 Rüschlikon.

Herstellerin

Helixor Heilmittel GmbH, Fischermühle 1, 72348 Rosenfeld, Deutschland

Diese Packungsbeilage wurde im Oktober 2013 letztmals durch die Arzneimittelbehörde

(Swissmedic) geprüft.

8-11-2018

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Published on: Wed, 07 Nov 2018 00:00:00 +0100 In 2017, EFSA published a ‘simplified’ food safety management system (FSMS) for certain small retail establishments (butcher, grocer, baker, fish and ice cream shop) based on the application of prerequisite programme (PRP) criteria. The aim of this opinion was to develop similar FSMSs for other small retail enterprises including retail distribution centres, supermarkets, restaurants (including pubs and other catering activities) and food donation. The latter...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision:  Inflacam, meloxicam, Opinion date: 13-Sep-2018

Pending EC decision: Inflacam, meloxicam, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision:  Rheumocam, meloxicam, Opinion date: 13-Sep-2018

Pending EC decision: Rheumocam, meloxicam, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision:  NexGard, afoxolaner, Opinion date: 13-Sep-2018

Pending EC decision: NexGard, afoxolaner, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

27-7-2018

Pending EC decision:  Opdivo, nivolumab, Opinion date: 26-Jul-2018

Pending EC decision: Opdivo, nivolumab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Ilumetri, tildrakizumab, Opinion date: 26-Jul-2018

Pending EC decision: Ilumetri, tildrakizumab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Gefitinib Mylan, gefitinib, Opinion date: 26-Jul-2018

Pending EC decision: Gefitinib Mylan, gefitinib, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Kigabeq, vigabatrin, Opinion date: 26-Jul-2018

Pending EC decision: Kigabeq, vigabatrin, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

21-9-2018

Regulatory and procedural guideline:  Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

Regulatory and procedural guideline: Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

This report provides a final agreed draft Context of Use for public consultation describing where Stride Velocity measured at the ankle 95th Centile is deemed by CHMP as an appropriate endpoint in studies to support regulatory decision making on medicines for the treatment of Duchenne Muscular Dystrophy (DMD), together with CHMP’s scientific consideration of the submission leading to the draft opinion. The document also includes the questions posed by the applicant and also raised by CHMP to the Applic...

Europe - EMA - European Medicines Agency

12-9-2018

 Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2018, European Medicines Agency, London, UK, From: 11-Sep-2018, To: 13-Sep-2018

Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2018, European Medicines Agency, London, UK, From: 11-Sep-2018, To: 13-Sep-2018

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.

Europe - EMA - European Medicines Agency

12-9-2018

Humanalbumin 200 g/l Kedrion

Rote - Liste

5-9-2018

 Opinion of the CVMP on the establishment of maximum residue limits: Porcine prolactin, adopted

Opinion of the CVMP on the establishment of maximum residue limits: Porcine prolactin, adopted

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits

Europe - EMA - European Medicines Agency

5-9-2018

 Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin, adopted

Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin, adopted

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits

Europe - EMA - European Medicines Agency

2-8-2018

Pinimenthol® Erkältungssalbe

Rote - Liste