Toxer 90
Hauptinformation
- Handelsname:
- Toxer 90
- Wirkstoff:
- Glyphosat
- Verfügbar ab:
- Omya (Schweiz) AG
- INN (Internationale Bezeichnung):
- Glyphosate
- Darreichungsform:
- SL Wasserlösliches Konzentrat
- Verwenden für:
- Pflanzen
- Art der Medizin:
- Agrochemisch
Dokumenten
- für die Allgemeinheit:
- Packungsbeilage
-
- Information für medizinisches Fachpersonal:
- Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.
Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.
Lokalisierung
- Erhältlich in:
-
Schweiz
- Sprache:
- Deutsch
Therapeutische Informationen
- Therapiegruppe:
- Herbizid
Weitere Informationen
Status
- Quelle:
- UFAG - Ufficio federale dell'agricoltura. OFAG - Office fédéral de l'agriculture. BLW - Bundesamt für Landwirtschaft.
- Zulassungsnummer:
- W-6312
- Letzte Änderung:
- 15-11-2018
Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit
Handelsbezeichnung: Toxer 90
Pflanzenschutzmittelverzeichnis (Stand: 06.11.2018)
Produktkategorie:
Bewilligungsinhaber:
Eidg. Zulassungsnummer:
Herbizid
Omya (Schweiz) AG
W-6312
Stoff(e):
Gehalt:
Formulierungscode:
Wirkstoff: Glyphosat
8.6 % 90 g/l
[als 11.6% Glyphosat-Isopropylammoniumsalz
(121.5 g / l)]
SL Wasserlösliches
Konzentrat
Anwendungen
A
Kultur
Schaderreger/Wirkung
Dosierungshinweise
Auflagen
B Brombeere
Einjährige
Dicotyledonen
(Unkräuter)
Einjährige
Monocotyledonen
(Ungräser)
Gemeine Quecke
Aufwandmenge: 8 - 12 l/ha
1, 2
B Brombeere
Mehrjährige
Dicotyledonen
(Unkräuter)
Mehrjährige
Monocotyledonen
(Ungräser)
Aufwandmenge: 16 - 40 l/ha
1, 2
Kernobst
Steinobst
Einjährige
Dicotyledonen
(Unkräuter)
Einjährige
Monocotyledonen
(Ungräser)
Gemeine Quecke
Aufwandmenge: 8 - 12 l/ha
1, 2
Kernobst
Steinobst
Mehrjährige
Dicotyledonen
(Unkräuter)
Mehrjährige
Monocotyledonen
(Ungräser)
Aufwandmenge: 16 - 40 l/ha
1, 2
W Ertragsreben
Einjährige
Dicotyledonen
Aufwandmenge: 8 - 12 l/ha
1, 2
A
Kultur
Schaderreger/Wirkung
Dosierungshinweise
Auflagen
(Unkräuter)
Einjährige
Monocotyledonen
(Ungräser)
Gemeine Quecke
W Ertragsreben
Mehrjährige
Dicotyledonen
(Unkräuter)
Mehrjährige
Monocotyledonen
(Ungräser)
Aufwandmenge: 16 - 40 l/ha
1, 2
G Brache
Einjährige
Dicotyledonen
(Unkräuter)
Einjährige
Monocotyledonen
(Ungräser)
Gemeine Quecke
Aufwandmenge: 8 - 12 l/ha
1, 3
G Brache
Mehrjährige
Dicotyledonen
(Unkräuter)
Mehrjährige
Monocotyledonen
(Ungräser)
Aufwandmenge: 16 - 40 l/ha
1, 3
Brache
Einjährige
Dicotyledonen
(Unkräuter)
Einjährige
Monocotyledonen
(Ungräser)
Gemeine Quecke
Aufwandmenge: 8 - 12 l/ha
1, 3
Brache
Mehrjährige
Dicotyledonen
(Unkräuter)
Mehrjährige
Monocotyledonen
(Ungräser)
Aufwandmenge: 16 - 40 l/ha
1, 3
Mais
Einjährige
Dicotyledonen
(Unkräuter)
Einjährige
Monocotyledonen
(Ungräser)
Gemeine Quecke
Aufwandmenge: 8 - 12 l/ha
Anwendung: Bei der Saat.
1, 4, 5
Mais
Mehrjährige
Aufwandmenge: 16 - 40 l/ha
1, 4, 5
A
Kultur
Schaderreger/Wirkung
Dosierungshinweise
Auflagen
Dicotyledonen
(Unkräuter)
Mehrjährige
Monocotyledonen
(Ungräser)
Anwendung: Bei der Saat.
Wiesen und Weiden
Dicotyledonen
(Unkräuter)
Monocotyledonen
(Ungräser)
Konzentration: 2 - 6 %
Anwendung: Mit
Rückenspritze.
1, 6, 7
Wiesen und Weiden
Dicotyledonen
(Unkräuter)
Monocotyledonen
(Ungräser)
Konzentration: 20 - 40 %
Anwendung: Mit
Handspritzgeräten.
1, 6, 7
Wiesen und Weiden
Dicotyledonen
(Unkräuter)
Monocotyledonen
(Ungräser)
Aufwandmenge: 16 - 40 l/ha
Anwendung:
Flächenbehandlung; vor
Neuansaat.
1, 3
Bäume und Sträucher (ausserhalb
Forst)
Rosen
Einjährige
Dicotyledonen
(Unkräuter)
Einjährige
Monocotyledonen
(Ungräser)
Gemeine Quecke
Aufwandmenge: 8 - 12 l/ha
1, 2
Bäume und Sträucher (ausserhalb
Forst)
Rosen
Mehrjährige
Dicotyledonen
(Unkräuter)
Mehrjährige
Monocotyledonen
(Ungräser)
Aufwandmenge: 16 - 40 l/ha
1, 2
Brache
Einjährige
Dicotyledonen
(Unkräuter)
Einjährige
Monocotyledonen
(Ungräser)
Gemeine Quecke
Aufwandmenge: 8 - 12 l/ha
1, 3
Brache
Mehrjährige
Dicotyledonen
(Unkräuter)
Mehrjährige
Monocotyledonen
(Ungräser)
Aufwandmenge: 16 - 40 l/ha
1, 3
Forstliche Pflanzgärten
Einjährige
Aufwandmenge: 8 - 12 l/ha
1, 2
A
Kultur
Schaderreger/Wirkung
Dosierungshinweise
Auflagen
Dicotyledonen
(Unkräuter)
Einjährige
Monocotyledonen
(Ungräser)
Gemeine Quecke
Forstliche Pflanzgärten
Mehrjährige
Dicotyledonen
(Unkräuter)
Mehrjährige
Monocotyledonen
(Ungräser)
Aufwandmenge: 16 - 40 l/ha
1, 2
Auf und an National- und
Kantonsstrassen
Einjährige
Dicotyledonen
(Unkräuter)
Einjährige
Monocotyledonen
(Ungräser)
Gemeine Quecke
Aufwandmenge: 8 - 12 l/ha
1, 4, 8
Auf und an National- und
Kantonsstrassen
Mehrjährige
Dicotyledonen
(Unkräuter)
Mehrjährige
Monocotyledonen
(Ungräser)
Aufwandmenge: 16 - 40 l/ha
1, 4, 8
Böschungen und Grünstreifen
entlang von Verkehrswegen
(gem. ChemRRV)
Einjährige
Dicotyledonen
(Unkräuter)
Einjährige
Monocotyledonen
(Ungräser)
Gemeine Quecke
Aufwandmenge: 8 - 12 l/ha
1, 4, 8
Böschungen und Grünstreifen
entlang von Verkehrswegen
(gem. ChemRRV)
Mehrjährige
Dicotyledonen
(Unkräuter)
Mehrjährige
Monocotyledonen
(Ungräser)
Aufwandmenge: 16 - 40 l/ha
1, 4, 8
Auflagen und Bemerkungen:
Keine Niederschläge während mindestens 6 Stunden nach der Behandlung.
Behandlung spätestens bis Ende August. Es dürfen keine grünen Teile der Kulturpflanzen mit dem
Herbizid in Kontakt kommen.
Behandlung bis spätestens 2 Wochen vor der Saat oder Pflanzung.
Die Aufwandmenge bezieht sich auf die effektiv zu behandelnde Fläche.
Behandlung der unbearbeiteten Zwischenreihen bei der Streifenfrässaat.
Beweidung oder Schnitt (Grünfutter oder Konservierung) frühestens 3 Wochen nach der
Behandlung. Ausnahme: Für nicht laktierende Tiere beträgt die Wartefrist 2 Wochen.
Einzelpflanzenbehandlung.
Gemäss Chemikalien-Risikoreduktions-Verordnung (ChemRRV): Nur Einzelpflanzenbehandlung
anderweitig nicht bekämpfbarer Problempflanzen.
Gefahrenkennzeichnungen:
Bewilligt für die nichtberufliche Verwendung.
Darf nicht in die Hände von Kindern gelangen.
EUH 401 Zur Vermeidung von Risiken für Mensch und Umwelt die Gebrauchsanleitung
einhalten.
H412 Schädlich für Wasserorganismen, mit langfristiger Wirkung.
SP 1 Mittel und/oder dessen Behälter nicht in Gewässer gelangen lassen.
Im Zweifelsfall gelten einzig die Originaldokumente der Zulassung. Die Erwähnung eines Produktes,
Wirkstoffes oder einer Firma stellt keine Empfehlung dar und bedeutet nicht, dass sich das Produkt im
Verkauf befindet.
- Der Zugriff auf dieses Dokument steht nur registrierten Benutzern zur Verfügung.
Registrieren Sie sich jetzt für den Vollzugriff
26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials
Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...
Europe - EFSA - European Food Safety Authority EFSA Journal
23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)
Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...
Europe - EFSA - European Food Safety Authority EFSA Journal
17-1-2019

90 miljoen voor inzet technologie bij zorg thuis
Inzet van technologie kan voor veel ouderen met een chronische ziekte of beperking van betekenis zijn, om met een goede kwaliteit van leven zelfstandig te kunnen blijven wonen. Om de inzet van zulke e-health toepassingen toe te laten nemen, investeert het kabinet de komende jaren 90 miljoen euro via een stimuleringsregeling. Aanbieders van zorg en ondersteuning kunnen dit voorjaar samen met inkopers dit voorjaar daarvoor plannen indienen.
Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport
15-1-2019

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials
Published on: Mon, 14 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long‐term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 μm or less and the average size is 9 μm, has a layered structure w...
Europe - EFSA - European Food Safety Authority EFSA Journal
10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)
Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...
Europe - EFSA - European Food Safety Authority EFSA Journal
20-12-2018

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction
Published on: Wed, 19 Dec 2018 EFSA was requested to provide scientific assistance to the European Commission on a detoxification process for dioxins and PCBs from sunflower cake by hexane extraction in an emergency situation, as specified in Article 7 of Commission Regulation (EU) 2015/786. The process entails hexane extraction of sunflower oil from the cake to remove dioxins (PCDDs and PCDFs) as well as DL- and NDL-PCBs. The data provided by the applicant were assessed with respect to the efficacy of ...
Europe - EFSA - European Food Safety Authority EFSA Journal
1-12-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)
Published on: Fri, 30 Nov 2018 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP‐Nzd22) by DuPont. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The endo‐1,4‐β‐xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of dis...
Europe - EFSA - European Food Safety Authority Publications
29-11-2018

Glyphosate: ANSES launches a comparative assessment with the available alternatives
Following the five-year re-approval of this active substance at European level in December 2017, ANSES is reassessing marketing authorisations for products containing glyphosate. For products for which an application for authorisation or re-authorisation has been submitted, the Agency will carry out a comparative assessment with the available alternatives. For each glyphosate-based product, all uses for which there is an alternative that meets the substitution criteria will therefore be prohibited.
France - Agence Nationale du Médicament Vétérinaire
17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)
Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...
Europe - EFSA - European Food Safety Authority Publications
15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)
Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...
Europe - EFSA - European Food Safety Authority Publications
15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)
Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...
Europe - EFSA - European Food Safety Authority Publications
15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)
Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...
Europe - EFSA - European Food Safety Authority Publications
15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)
Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...
Europe - EFSA - European Food Safety Authority Publications
1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)
Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...
Europe - EFSA - European Food Safety Authority Publications
1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)
Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...
Europe - EFSA - European Food Safety Authority Publications
1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)
Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...
Europe - EFSA - European Food Safety Authority Publications
1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)
Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...
Europe - EFSA - European Food Safety Authority Publications
31-10-2018

Comfortis 90 mg ad us. vet., Kautabletten
● Die Zulassung ist am 31.10.2018 erloschen.
Institut für Veterinärpharmakologie und toxikologie
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)
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
17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities
Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...
Europe - EFSA - European Food Safety Authority Publications
7-9-2018

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
10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration
Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...
FDA - U.S. Food and Drug Administration
3-8-2018

Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted
Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance
Europe - EFSA - European Food Safety Authority EFSA Journal
16-7-2018

Human medicines European public assessment report (EPAR): Harvoni, ledispavir 90 mg / sofosbuvir 400 mg, Revision: 15, Authorised
Europe - EMA - European Medicines Agency
29-5-2018

Rote-Hand-Brief zu mycophenolatmofetil-(MMF)/mycophenolsäurehaltigen Arzneimitteln (MPA): Angepasste Empfehlungen zur Kontrazeption
Da Mycophenolatmofetil (MMF) und Mycophenolsäure (MPA) genotoxisch sind, wird bei männlichen Patienten empfohlen, dass der Patient oder dessen Partnerin während der Behandlung und für mindestens 90 Tage nach Beendigung der Behandlung eine zuverlässige Verhütungsmethode anwendet.
Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte
29-5-2018

Fälschung des Arzneimittels Harvoni® 90 mg / 400 mg Filmtabletten (Charge 16SFC021D) auf den deutschen Markt gelangt (mit Ergänzungen vom 22.06., 14.06. und 06.06.2017)
Pressemitteilung Nr. 9/17
Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte
18-1-2019

Opinion/decision on a Paediatric investigation plan (PIP): Omega-3-acid ethyl esters 90 / rosuvastatin (calcium), decision type: , therapeutic area: , PIP number: P/0309/2018
Opinion/decision on a Paediatric investigation plan (PIP): Omega-3-acid ethyl esters 90 / rosuvastatin (calcium), decision type: , therapeutic area: , PIP number: P/0309/2018
Europe - EMA - European Medicines Agency
15-11-2018

alitretinoin
alitretinoin (Active substance: alitretinoin) - Centralised - Art 28 - (PSUR - Commission Decision (2018)7675 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/90/201801
Europe -DG Health and Food Safety
1-10-2018
STELARA® 45 mg/-90 mg Injektionslösung/-Injektionslösung in einer Fertigspritze
Rote - Liste
25-9-2018

Zonegran (Eisai GmbH)
Zonegran (Active substance: zonisamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6285 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/577/T/90
Europe -DG Health and Food Safety
5-9-2018

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments: h
#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments: https://go.usa.gov/xPcpT pic.twitter.com/hAuLWaIYiK
FDA - U.S. Food and Drug Administration
3-7-2018

Efficib (Merck Sharp and Dohme B.V.)
Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90
Europe -DG Health and Food Safety
3-7-2018

Aerius (Merck Sharp and Dohme B.V.)
Aerius (Active substance: desloratadine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4255 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/313/T/90
Europe -DG Health and Food Safety
3-7-2018

Janumet (Merck Sharp and Dohme B.V.)
Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90
Europe -DG Health and Food Safety
22-6-2018

First continuous glucose monitoring system that includes a fully implantable glucose sensor that can be worn up to 90 days approved today. #cgm #diabetes #fda #medicaldevice https://go.usa.gov/xUqg5 pic.twitter.com/6zs99z2Dlz
First continuous glucose monitoring system that includes a fully implantable glucose sensor that can be worn up to 90 days approved today. #cgm #diabetes #fda #medicaldevice https://go.usa.gov/xUqg5 pic.twitter.com/6zs99z2Dlz
FDA - U.S. Food and Drug Administration