Kaliumchlorid 14

Hauptinformation

  • Handelsname:
  • Kaliumchlorid 14 9 % B. Braun,Zusatzampullen
  • Darreichungsform:
  • 9 % B. Braun,Zusatzampullen
  • Zusammensetzung:
  • kalii chloridum 149 mg Endwerte. Kalium 2 mmol und 2 mmol chloridum, Wasser iniectabilia q.s. zu einer Lösung anstelle von 1 ml.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

  • für die Allgemeinheit:
  • 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 das Informationsblatt für die Öffentlichkeit.

Lokalisierung

  • Erhältlich in:
  • Kaliumchlorid 14 9 % B. Braun,Zusatzampullen
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Kaliumtherapie

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 29552
  • Berechtigungsdatum:
  • 08-03-1963
  • Letzte Änderung:
  • 24-10-2018

Zusammenfassung der Merkmale des Arzneimittels: dosierung, wechselwirkungen, nebenwirkungen

Fachinformation

Kaliumchlorid B. Braun

B. BRAUN MEDICAL

Zusammensetzung

Wirkstoff: Kaliumchlorid.

Hilfsstoff: Wasser für Injektionszwecke.

Galenische Form und Wirkstofmenne pro Einheit

Elektrolytkonzentrate als Zusatz zu Infusionslösunnen zur Substitution

von Kalium und Chlorid.

1 ml Konzentrat enthält:

Kalium- Kalium-

chlorid chlorid

7,45% 14,9%

Kaliumchlorid [mg] 74,5 149

Aqua ad iniectabilia ad [ml] 1 1

Elektolytkonzentrationen:

Kalium [mmol/ml] 1 2

Chlorid [mmol/ml] 1 2

Theoretische Osmolarität:

[mOsm/ml] 2 4

Indikationen/Anwendunnsmönlichkeiten

Kaliumersatztherapie als Zusatz zu K-freien oder K-armen

Infusionslösunnen bei alkalotischer Stofwechsellane.

Dosierunn/Anwendunn

1. Verdünnt in einer Tränerlösunn, durch lannsame i.v. Infusion. Dabei ist

zu beachten, dass der Kaliumzusatz erst unmittelbar vor Anlenen der

Infusion unter strenn sterilen Kautelen zuzuspritzen ist. Die

Infusionsflasche sollte danach bis zur vollständinen Mischunn leicht

neschüttelt werden.

2. Die Dosierunn muss nemäss dem Patientenzustand, der Flüssinkeits-

und Elektrolytbilanz und dem Säuren/Basen-Haushalt annepasst werden.

3. Die folnenden Werte nelten nur als nenerelle Hinweise. Die

Zusatzdosis wird nach dem Ionennehalt der Tränerlösunn berechnet.

a) Höchste tägliche Kaliumzufuhr

Erwachsene mit Serum K

+

<2,0 mmol/l: 400 mmol K

Erwachsene mit Serum K

+

>2,5 mmol/l: 200 mmol K

Kinder: 3 mmol/kn Körpernewicht oder 40 mmol/m² Körperfläche.

b) Höchste Kaliumkonzentration in der Infusionslösung

Serum K

+

<2,0 mmol/l: 80 mmol/l K

in der Lösunn.

Serum K

+

>2,5 mmol/l: 40 mmol/l K

in der Lösunn.

c) Höchste Infusionsgeschwindigkeit

Serum K

+

<2,0 mmol/l: 40 mmol/l Stunde.

Serum K

+

>2,5 mmol/l: 10 mmol/l Stunde.

Hinweis

Der Serum-Kalium-Spienel nibt nur annähernde Hinweise auf den intra-

zellulären Kalium-Bestand. Die intrazelluläre Kalium-Konzentration wird

durch eine acidotische oder alkalotische Stofwechsellane wesentlich

beeinflusst. So steint bei Acidose der extrazelluläre Anteil an und fällt ab

bei Alkalose.

Kontraindikationen

Hyperkaliämie,

Hyperchlorämie,

Anurie, Olinurie, Niereninsufzienz,

unbehandelte Nebenniereninsufzienz,

schwere Exsikkose,

Acidose (Kaliumlactat verwenden).

Warnhinweise und Vorsichtsmassnahmen

Die Flüssinkeits- und Elektrolytbilanz und der Säuren/Basen-Haushalt

müssen überwacht werden, um die Dosierunn nenau zu kontrollieren.

Die Kaliämie speziell überwachen.

Die Diurese vor der Infusion kontrollieren.

Die Herzfunktion überwachen.

Die Lösunnen müssen immer in einer passenden Tränerlösunn verdünnt

und vollständin nemischt werden.

Niemals die Lösunnen unverdünnt spritzen.

Nur intakte Ampullen und klare Lösunnen verwenden.

Interaktionen

Kaliumsparende Diuretika (z.B. Amiloride, Spironolactone, Triamterene)

können eine Hyperkaliämie fördern.

ACE-Hemmer (Enalapril, Captopril) können durch erniedrinten

Aldosteron-Spienel eine Hyperkaliämie fördern.

Natriumfreie Diätsalze.

Bei Patienten unter Herznlykosiden muss die Kaliämie ennmaschin

überwacht werden.

Schwannerschaft/Stillzeit

Eine Schädinunn des Fötus durch physiolonische Ionen scheint als wenin

wahrscheinlich, solanne die Ionen-Konzentrationen im Blut der Mutter

normal sind. Die Kaliämie ist speziell zu überwachen.

Bei einer normalen Kaliämie der Mutter ist der Kaliumnehalt der Milch

normalerweise tief.

Wirkunn auf die Fahrtüchtinkeit und auf das Bedienen von Maschinen

Nicht zutrefend.

Unerwünschte Wirkunnen

Unerwünschte Wirkunnen sind vor allem bei einer Überdosierunn

mönlich. Bei bestimmunnsnemässer Anwendunn sind unerwünschte

Wirkunnen selten oder sehr selten.

Gastrointestinale Störungen

Übelkeit, Erbrechen, Bauchschmerzen, Durchfall.

Allgemeine Störungen und Reaktionen an der Applikationsstelle

Die Infusion einer hyperosmotischen Lösunn kann eine

Venenentzündunn fördern.

Andere unerwünschte systemische Wirkunnen sind vor allem bei einer

Überdosierunn mönlich.

Überdosierunn

Symptome einer Überdosierung (in Abhängigkeit von der Höhe des Serum-Kalium-

Spiegels) sind

Parästhesien, Verwirrtheit , Bewusstlosinkeit.

Bradycardie, Arrhythmie, Blutdruckabfall, Kammerflimmern und

Herzstillstand.

EKG: Hohe T-Zacke; Abflachunn der P-Welle; Verbreiterunn des QRS-

Komplexes; Arrhythmien; Kammerflimmern bis zum Herzstillstand.

Im Fall einer Überdosierunn die Infusion sofort unterbrechen, wichtine

physiolonische Parameter bestimmen und therapeutische Massnahmen

einleiten.

Hyperkaliämie: Plasmakaliumkonzentration über 5,5 mmol/l.

Die Herzfunktion mit Elektrokardionraphie überwachen.

Notfallmassnahmen

10% Kalziumchlorid oder Kalziumnlukonatlösunn lannsam i.v. (ca. 10–20

ml über 10 Min.).

Natriumbikarbonat 8,4% (je nach Stofwechsellane bis 250 ml).

Glucose-Insulin-Therapie unter ständiner Kontrolle der

Glucosekonzentration im Plasma sowie des Säuren-Basen-Status.

Genebenenfalls Hämo- oder Peritonealdialyse.

Genebenenfalls Kationenaustauscher.

Nicht notfallmässige Therapie

Infusion kaliumfreier Lösunnen.

Forcierte Diurese.

Vermeidunn unnötiner kataboler Efekte.

Azidoseausnleich.

Genebenenfalls Einsatz von Kationenaustauscher.

Bei unzureichender renaler Kaliumelimination: Dialysetherapie.

Einenschaften/Wirkunnen

ATC-Code: B05XA01

Additiva zu IV-Lösunnen – Elektrolytlösunnen – Kaliumchlorid

Klinische Wirksamkeit

Kalium ist das wichtinste intrazelluläre Kation. Es spielt eine wesentliche

Rolle in der Renulation des intrazellulären Volumens, ähnlich wie

Natrium im extrazellulären Raum. Darüber hinaus lient seine Bedeutunn

in der Beeinflussunn der neuromuskulären Errenbarkeit.

Kaliummannel verschiedenster Ursache (Serum-Kalium <3,5 mmol/l)

äussert sich in Tonusverminderunn der nlatten und quernestreiften

Muskulatur bis zur schlafen Lähmunn der Skelettmuskulatur. Ferner

können Apathie und Somnolenz bis hin zur Bewusstlosinkeit auftreten.

Als kardiovaskuläre Symptome sind Hypotonie, Tachycardie,

Herzrhythmusstörunnen und plötzlicher Herzstillstand zu erwähnen.

Manen-Darm-Atonien mit Obstipation oder paralytischem Ileus und

Blasenlähmunnen sind mönlich.

Im EKG zeint sich unter Kaliummannel eine typische Abflachunn der T-

Welle, eine Senkunn der ST-Strecke sowie die Ausbildunn einer U-Welle,

die mit der T-Welle verschmelzen kann. Diese Veränderunnen

korrelieren jedoch nicht mit der Höhe des Serum-Kalium-Spienels.

Kaliumchlorid: Ansäuernde Kaliumzufuhr.

Pharmakokinetik

Absorption

Bei i.v.-Verabreichunn (verdünnt in Infusionen) ist Kalium direkt

verfünbar.

Distribution

Hauptsächlich intrazellulär.

Elimination

Hauptsächlich renal.

Kinetik spezieller Patientengruppen

Bei Störunnen der renalen Kaliumausscheidunn können selbst kleine

Mennen von Kalium eine Kaliumintoxikation bewirken.

Präklinische Daten

Es lienen keine relevanten Annaben vor.

Sonstine Hinweise

Inkompatibilitäten

Diese Zusatzampullen sind mit den folnenden B. Braun Standard

Lösunnen kompatibel:

Glucose Lösunnen, NaCl 0,9%, NaCl-Glucose Lösunnen, Holofusine

mit/ohne Glucose, Aequifusine.

Nur Standard-Infusionslösunnen sind als Tränerlösunnen

empfehlenswert. Wenn die Zusatzampullen mit anderen Tränerlösunnen

nemischt werden müssen, ist deren Kompatibilität vornännin zu testen.

Haltbarkeit

In der Orininalverpackunn bis zu dem auf der Etikette aufnedruckten mit

«Exp.» bezeichneten Verfalldatum verwendbar.

Besondere Lagerungshinweise

Bei Raumtemperatur ( 15–25 °C) lanern.

Hinweise für die Handhabung

Siehe Abschnitte «Dosierunn/Anwendunn» und «Warnhinweise und

Vorsichtsmassnahmen».

Auf Kompatibilität mit der vornesehenen Tränerlösunn prüfen.

Nur klare Lösunnen und unbeschädinte Behälter verwenden.

Zulassunnsnummer

29552 (Swissmedic).

Packunnen

Kaliumchlorid B. Braun 7,45% Mini-Plasco connect 20 × 20 ml. (B)

Kaliumchlorid B. Braun 14,9% Mini-Plasco connect 20 × 10 ml. (B)

Kaliumchlorid B. Braun 14,9% Amp 5 × 10 ml. (B)

Zulassunnsinhaberin

B. Braun Medical AG, 6204 Sempach.

Stand der Information

Januar 2005.

  • 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 das Informationsblatt für die Öffentlichkeit.



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FDA - U.S. Food and Drug Administration

20-12-2018

Pest categorisation of Gymnosporangium spp. (non‐EU)

Pest categorisation of Gymnosporangium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Gymnosporangium spp. (non‐EU), a well‐defined and distinguishable group of fungal plant pathogens of the family Pucciniaceae affecting woody species. Many different Gymnosporangium species are recognised, of which at least 14 species are considered not to be native in the European Union. All the non‐EU Gymnosporangium species are not known to be present in th...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018


eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

Europe - EMA - European Medicines Agency

18-12-2018

Atherstone Foods Inc Issues Allergy Alert on Undeclared Soy in “Greens and Grains Hummus and Quinoa Tabouleh Wrap”

Atherstone Foods Inc Issues Allergy Alert on Undeclared Soy in “Greens and Grains Hummus and Quinoa Tabouleh Wrap”

ATHERSTONE FOODS INC of Richmond, CA is recalling 14.6 ounce (414g) Greens and Grains Hummus and Quinoa Tabouleh Wrap, because it may contain undeclared soy, people who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

16-12-2018

Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups™

Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups™

Apio, Inc. of Guadalupe, California is voluntarily recalling five SKUs of Eat Smart® Single-Serve Salad Shake Ups™ (bowls). The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that one random sample of Eat Smart Single-Serve Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. (5.5oz) with Best Before of Dec 14, 2018 tested positive for Listeria Monocytogenes. As a precautionary measure, we are recalling all products produced on the same day, same production line, as the ...

FDA - U.S. Food and Drug Administration

15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

15-12-2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Published on: Fri, 14 Dec 2018 The EFSA Scientific Network on bovine spongiform encephalopathies and other transmissible spongiform encephalopathies (BSE‐TSE) held its 13th meeting on 15‐16 October 2018 in Parma. The meeting served as an opportunity to exchange scientific information on BSE‐TSE related issues among EU Member States, countries from the European Free Trade Association (EFTA), EFSA, the European Commission and ad hocparticipants. In this occasion, ad hoc representation included the World A...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Published on: Thu, 13 Dec 2018 Following a request from the European Commission, EFSA was asked to review the comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006. Comments originating from the applicant (Han‐Biotech GmbH) were submitted to EFSA via the E...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Bovilis BTV8 ad us. vet.

Bovilis BTV8 ad us. vet.

● Die Zulassung ist am 14.12.2018 erloschen.

Institut für Veterinärpharmakologie und toxikologie

18-2-2019

Australian company pays fine for illegal medicine exports

Australian company pays fine for illegal medicine exports

On 14 December 2018, the TGA issued an infringement notice for export of unlawful medicines from Australia

Therapeutic Goods Administration - Australia

15-2-2019


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019

Europe - EMA - European Medicines Agency

14-2-2019

Yargesa (Piramal Critical Care B.V.)

Yargesa (Piramal Critical Care B.V.)

Yargesa (Active substance: miglustat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1329 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004016/T/0005

Europe -DG Health and Food Safety

14-2-2019

Buccolam (Shire Services BVBA)

Buccolam (Shire Services BVBA)

Buccolam (Active substance: midazolam) - Centralised - Yearly update - Commission Decision (2019)1337 of Thu, 14 Feb 2019

Europe -DG Health and Food Safety

13-2-2019


Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 4 - diphtheria CRM197

Opinion/decision on a Paediatric investigation plan (PIP): pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 4 - diphtheria CRM197

Opinion/decision on a Paediatric investigation plan (PIP): pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 4 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 5 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 6A- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 6B - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotyp...

Europe - EMA - European Medicines Agency

28-1-2019


Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

23-1-2019

EU/3/14/1342 (S-cubed Pharmaceutical Services ApS)

EU/3/14/1342 (S-cubed Pharmaceutical Services ApS)

EU/3/14/1342 (Active substance: Glucagon) - Transfer of orphan designation - Commission Decision (2019)578 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003128

Europe -DG Health and Food Safety

22-1-2019

EU/3/14/1422 (BioMarin International Limited)

EU/3/14/1422 (BioMarin International Limited)

EU/3/14/1422 (Active substance: Chimeric fusion protein of recombinant human alpha-N-acetylglucosaminidase and human insulin-like growth factor 2) - Transfer of orphan designation - Commission Decision (2019)575 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003313

Europe -DG Health and Food Safety

18-1-2019


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Europe - EMA - European Medicines Agency

16-1-2019

EU/3/14/1309 (Pharma Gateway AB)

EU/3/14/1309 (Pharma Gateway AB)

EU/3/14/1309 (Active substance: 17a,21-dihydroxy-16a-methyl-pregna-1,4,9(11)-triene-3,20-dione) - Transfer of orphan designation - Commission Decision (2019)232 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002736

Europe -DG Health and Food Safety

14-1-2019

Paclitaxel Hetero and associated names

Paclitaxel Hetero and associated names

Paclitaxel Hetero and associated names (Active substance: paclitaxel) - Community Referrals - Art 29 - Commission Decision (2019)205 of Mon, 14 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H//A-29(4)/1466

Europe -DG Health and Food Safety

19-12-2018

Consultation: Medical device cyber security

Consultation: Medical device cyber security

The TGA is seeking comments from interested parties on the applicability and usefulness of the content contained in the draft regulatory guidance and information materials. Closing date: 14 February 2019

Therapeutic Goods Administration - Australia

19-12-2018

EU/3/14/1423 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1423 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1423 (Active substance: Synthetic signal peptide of human mucin-1 (amino acids 1-21)) - Transfer of orphan designation - Commission Decision (2018)9009 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002647

Europe -DG Health and Food Safety

19-12-2018

EU/3/14/1426 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1426 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1426 (Active substance: Allogeneic peripheral blood mononuclear cells induced to an early apoptotic state) - Transfer of orphan designation - Commission Decision (2018)9008 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002646

Europe -DG Health and Food Safety

19-12-2018

EU/3/14/1319 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1319 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1319 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9010 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002648

Europe -DG Health and Food Safety

19-12-2018

EU/3/14/1316 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1316 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1316 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9011 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002649

Europe -DG Health and Food Safety

19-12-2018

EU/3/14/1312 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1312 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1312 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9012 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002650

Europe -DG Health and Food Safety

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2117 (Vertex Pharmaceuticals (Europe) Limited)

EU/3/18/2117 (Vertex Pharmaceuticals (Europe) Limited)

EU/3/18/2117 (Active substance: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor) - Orphan designation - Commission Decision (2018)9032 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/137/18

Europe -DG Health and Food Safety

14-12-2018

Desloratadine Teva (Teva B.V.)

Desloratadine Teva (Teva B.V.)

Desloratadine Teva (Active substance: desloratadine) - Centralised - Yearly update - Commission Decision (2018)8912 of Fri, 14 Dec 2018

Europe -DG Health and Food Safety

14-12-2018

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (Active substance: fluticasone furoate / vilanterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8927 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2745/T/38

Europe -DG Health and Food Safety

14-12-2018

Valdoxan (Les Laboratoires Servier)

Valdoxan (Les Laboratoires Servier)

Valdoxan (Active substance: agomelatine) - Centralised - Renewal - Commission Decision (2018)8932 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/915/R/42

Europe -DG Health and Food Safety

14-12-2018

Ogivri (Mylan S.A.S.)

Ogivri (Mylan S.A.S.)

Ogivri (Active substance: trastuzumab) - Centralised - Authorisation - Commission Decision (2018)8913 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4916

Europe -DG Health and Food Safety

14-12-2018

LONGRANGE (Merial)

LONGRANGE (Merial)

LONGRANGE (Active substance: eprinomectin) - Refusal of authorisation - Commission Decision (2018)8905 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4291

Europe -DG Health and Food Safety

14-12-2018

Relvar Ellipta (GlaxoSmithKline (Ireland) Limited)

Relvar Ellipta (GlaxoSmithKline (Ireland) Limited)

Relvar Ellipta (Active substance: fluticasone furoate/vilanterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8928 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2673/T/40

Europe -DG Health and Food Safety

14-12-2018

Dengvaxia (Sanofi Pasteur)

Dengvaxia (Sanofi Pasteur)

Dengvaxia (Active substance: dengue tetravalent vaccine (live, attenuated)) - Centralised - Authorisation - Commission Decision (2018)8933 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4171

Europe -DG Health and Food Safety

14-12-2018

Flucelvax Tetra (Seqirus Netherlands B.V.)

Flucelvax Tetra (Seqirus Netherlands B.V.)

Flucelvax Tetra (Active substance: influenza vaccine (surface antigen, inactivated, prepared in cell cultures)) - Centralised - Authorisation - Commission Decision (2018)8911 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4814

Europe -DG Health and Food Safety

14-12-2018

Pregabalin Pfizer (Pfizer Europe MA EEIG)

Pregabalin Pfizer (Pfizer Europe MA EEIG)

Pregabalin Pfizer (Active substance: pregabalin) - Centralised - Renewal - Commission Decision (2018)8908 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3880/R/25

Europe -DG Health and Food Safety

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency