Vitamin B12 Amino

Hauptinformation

  • Handelsname:
  • Vitamin B12 Amino Injektionslösung
  • Darreichungsform:
  • Injektionslösung
  • Zusammensetzung:
  • cyanocobalaminum 1 mg, natrii phosphates oder, dinatrii phosphas, Wasser ad iniectabilia q.s. zu einer Lösung anstelle von 1 ml.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

  • für die Allgemeinheit:
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Lokalisierung

  • Erhältlich in:
  • Vitamin B12 Amino Injektionslösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Perniziöse Anämie; nachgewiesener Mangel an Vitamin B12

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 30219
  • Berechtigungsdatum:
  • 06-04-1966
  • Letzte Änderung:
  • 24-10-2018

Zusammenfassung der Merkmale des Arzneimittels: dosierung, wechselwirkungen, nebenwirkungen

Fachinformation

Vitamin B12 Amino

AMINO

Zusammensetzung

Wirkstoff: Cyanocobalaminum.

Hilfsstoffe: Natrii phosphates, Aqua ad iniectabilia q.s. ad solutionem.

Galenische Form und Wirkstoffmenge pro Einheit

Injektionslösung.

1 Ampulle zu 1 ml enthält 1 mg Cyanocobalamin.

Indikationen/Anwendungsmöglichkeiten

Perniziöse Anämie mit oder ohne neurologische Begleiterscheinungen, funikuläre Myelose, Vitamin

B12 Mangelzustände verschiedener Ätiologie wie nach Magenresektionen, nach ausgedehnter

Dünndarmresektion, bei einer Atrophie der Magenschleimhaut und ungenügender Bildung des

Intrinsicfaktors, bei Magenkarzinomen, bei tropischer und einheimischer Sprue (idiopathische

Steatorrhöe, gluteninduzierte Enteropathie), bei Befall mit Fischbandwürmern, beim blind loop

syndrome, nach langjähriger streng vegetarischer Ernährung.

Bei nutritivem Vitamin B12-Mangel muss das Vorhandensein eines Folsäuremangels, bei

Magenresektion dasjenige eines Folsäure- und Eisenmangels abgeklärt und allenfalls behandelt

werden. Vor Therapiebeginn muss die Diagnose gesichert sein.

Dosierung/Anwendung

Vitamin B12 Amino wird in der Regel intramuskulär verabreicht. Es kann aber auch langsam

intravenös oder subkutan gegeben werden.

Vitamin B12-Mangel ohne neurologische Begleiterscheinungen

Initialdosis: 250–1000 µg alle 2 Tage, während 1–2 Wochen.

Vitamin B12-Mangel mit neurologischen Begleiterscheinungen

Initialdosis: 1000 µg alle 2 Tage, bis Besserungseintritt.

Für die Dauerbehandlung zur Therapie der Perniziosa genügen 100–200 µg monatlich.

Das Ansprechen auf die Therapie hängt vom Schweregrad und Art des Vitamin B12-Mangels ab. Die

Dosierung ist individuell anzupassen. Bei ungenügendem Ansprechen kann ein latenter Folsäure-

und Eisenmangel vorliegen.

Bei perniziöser Anämie muss die Therapie unbeschränkt, bei anderen Vitamin B12-Mangelzuständen

bis zur Behebung der Ursache und zur Auffüllung der Depots weitergeführt werden.

Die Anwendung und Sicherheit von Vitamin B12 Amino, Injektionslösung bei Kindern und

Jugendlichen ist bisher nicht geprüft worden.

Kontraindikationen

Überempfindlichkeit gegenüber Vitamin B12 oder Kobalt, Leber’sche Optikusatrophie.

Warnhinweise und Vorsichtsmassnahmen

Vorsicht ist geboten bei Patienten mit Herzkreislaufstörungen, da Vitamin B12 eine Vermehrung des

Blutvolumens bewirkt. Bei Patienten mit Disposition zu Thrombose besteht auf Grund der

vorübergehend überschiessenden Thrombozytenproduktion das Risiko thromboembolischer

Komplikationen. Aufgrund der gesteigerten Erythropoese nimmt auch der Kaliumbedarf der

Erythrozyten erheblich zu, deshalb ist eine regelmässige Kontrolle des Serum-Kaliums unerlässlich.

Vitamin B12 kann die Symptome einer subakuten Rückenmarkdegeneration maskieren, deshalb

Vitamin B12 nicht verschreiben, bevor eine eindeutige Diagnose feststeht.

Maligne Tumoren: Da Vitamin B12 auf das Wachstum von Geweben mit hoher Multiplikationsrate

wirkt, muss eine beschleunigte Entwicklung berücksichtigt werden.

Das therapeutische Ansprechen auf Cyanocobalamin kann bei gleichzeitigem Vorliegen von

Infektionen oder Urämien verringert sein.

Bei Kindern und Jugendlichen wurde bisher die Wirksamkeit und Sicherheit von Vitamin B12

Amino nicht nachgewiesen, daher wird die Anwendung bei dieser Altersgruppe nicht empfohlen.

Interaktionen

Alkohol, Colchicin, p-Aminosalicylsäure, orale Antidiabetika (Biguanide) und Neomycin können die

enterale Absorption von Vitamin B12 vermindern. Durch gleichzeitige Gabe von Chloramphenicol

kann der therapeutische Effekt vermindert werden (Hemmung der Erythrozytenreifung).

Gleichzeitige Gabe von Methotrexat, Pyrimethamin und den meisten antiinfektösen Mitteln, können

die Resultate der mikrobiologischen Bestimmung des Plasmaspiegels von Vitamin B12 verfälschen.

Schwangerschaft/Stillzeit

Für parenteral verabreichtes Cyanocobalamin sind kontrollierte Studien mit Dosen, wie sie mit

Vitamin B12 Amino verabreicht werden, weder bei Tieren noch bei schwangeren Frauen verfügbar.

Obschon bis heute keine nachteiligen Folgen bekannt sind, soll das Arzneimittel in der

Schwangerschaft und während der Stillzeit nicht verabreicht werden, es sei denn, dies ist eindeutig

erforderlich.

Vitamin B12 tritt in die Muttermilch über.

Wirkung auf die Fahrtüchtigkeit und auf das Bedienen von Maschinen

Der Einfluss des Präparates auf die Fahrtüchtigkeit und auf das Bedienen von Maschinen wurde

nicht speziell untersucht. Ein diesbezüglicher negativer Einfluss ist jedoch eher unwahrscheinlich.

Unerwünschte Wirkungen

Häufigkeiten: häufig (>1/100, <1/10), gelegentlich (>1/1000, <1/100), selten (>1/10’000, <1/1000),

sehr selten (<1/10’000).

Blut- und Lymphsystem

Selten: Durch rasch gesteigerte Erythropoese kann es vorübergehend zu einem Mangel an Eisen,

Folsäure sowie zu einer Hypokaliämie kommen.

Immunsystem

Selten: Allergische Reaktionen (Urtikaria, anaphylaktischer Schock).

Haut und subkutanes Gewebe

Bei Patienten mit Psoriasis kann es zu einer Verschlimmerung der Symptome kommen.

Selten: Vorübergehend akneartige Hautveränderungen, Urtikaria.

Überdosierung

Eine Hypervitaminose B12 ist nicht bekannt. Es wurden keine Fälle von Überdosierung berichtet.

Eigenschaften/Wirkungen

ATC-Code: B03BA01

Vitamin B12 ist in allen Geweben an lebenswichtigen, enzymatischen Reaktionen beteiligt.

Der menschliche Körper benötigt Vitamin B12 für die Myelin- und Nukleinproteinsynthese, für die

Zellproduktion, das normale Wachstum, den Unterhalt der normalen Erythropoese und für den

Kohlenhydrat-, Fett- und Eiweiss-Stoffwechsel. Der Tagesbedarf des Menschen beträgt etwa 2–3 µg.

Beim Gesunden beträgt der Gesamtbestand im Körper 1–10 (durchschnittlich 5) mg, wovon 50–90%

in der Leber gespeichert sind. Der Serumspiegel beträgt 200–900 pg/ml. Ein Vitamin B12-Mangel

kann bei Ausfallen des Intrinsicfaktors oder nach schweren intestinalen Resorptionsstörungen

(hereditär oder neu erworben) eintreten. Aufgrund der Körperreserven und des geringen täglichen

Bedarfs können bei völliger Karenz 2–5 Jahre bis zum Auftreten klinischer Mangelerscheinungen

vergehen.

Der Mangel an Vitamin B12 (Blutspiegel von <200 pg/ml) führt zu megaloblastischer Anämie,

Schleimhautläsionen im Gastrointestinaltrakt und zu neurologischen Schäden, die sich in Form einer

funikulären Myelose äussern. Die Symptome, wie GI-Läsionen und megaloblastäre Anämie, sind mit

Hilfe von parenteraler Applikation von Vitamin B12 reversibel, neurologische Schäden hingegen

sind nur bedingt rückbildungsfähig.

Pharmakokinetik

Absorption

Nach i.m.-Injektion wird Cyanocobalamin vollständig resorbiert, maximale Plasmakonzentrationen

werden nach 1 Stunde erreicht.

Distribution

Im Blutkreislauf bindet sich das Cyanocobalamin hauptsächlich an das Plasmaprotein

Transcobalamin II, das für den Transport in die Leber und andere Gewebe verantwortlich ist.

Vitamin B12 ist placentagängig, und der Plasmaspiegel der Neugeborenen ist etwa 3–5× so hoch wie

der der Mutter.

Metabolismus

Cyanocobalamin wird zu Methyl- und Desoxyadenosylcobalamin umgewandelt und in dieser Form

im Körper gespeichert.

Elimination

Die Ausscheidung beträgt etwa 3–8 µg/Tag und erfolgt vor allem über die Galle. Der grösste Anteil

an Cyanocobalamin durchläuft den enterohepathischen Kreislauf. Mit dem Urin werden täglich

maximal 0,25 µg ausgeschieden, da nur die geringe, nicht proteingebundene Menge im Plasma

nierengängig ist. Bei parenteraler Verabreichung wird der die Serumskapazität von etwa 1,8 ng/ml

übersteigenden Teil einer Dosis renal eliminiert, der grösste Teil davon innerhalb von 8 Stunden

nach der Verabreichung. Dabei steigt der Wirkstoffverlust durch renale Elimination mit

zunehmender Dosis rasch an: von 5% bei einer Dosis von 25 µg auf 47% bei einer Dosis von 100 µg

und auf 85% bei einer solchen von 1000 µg.

Präklinische Daten

Es liegen keine präparatespezifischen präklinischen Daten vor. Aus der vorliegenden Literatur

ergeben sich keine Erkenntnisse über mutagene, kanzerogene oder reproduktionstoxische

Eigenschaften von Vitamin B12.

Sonstige Hinweise

Inkompatibilitäten

Cyanocobalamin wird in vitro durch zahlreiche Substanzen inaktiviert (insbesondere Oxidations- und

Reduktionsmittel, saure und alkalische Substanzen, Metallionen, Thiamin, Riboflavin,

Nicotinsäureamid). Das Präparat darf deshalb nicht mit anderen Injektionslösungen gemischt

werden.

Haltbarkeit

Das Arzneimittel darf nur bis zu dem auf der Packung mit «EXP» bezeichneten Datum verwendet

werden.

Nach Öffnen der Ampulle Lösung sofort verwenden. Nicht verwendete Lösung verwerfen.

Besondere Lagerungshinweise

Das Arzneimittel soll in der Originalpackung nicht über 30 °C und unter Lichtausschluss aufbewahrt

werden. Das Arzneimittel ist für Kinder unzugänglich aufzubewahren.

Zulassungsnummer

30219 (Swissmedic).

Packungen

Vitamin B12 Amino Lös 1000 µg Amp 10 × 1 ml. (B)

Vitamin B12 Amino Lös 1000 µg Amp 100 × 1 ml. (B)

Zulassungsinhaberin

Amino AG, Gebenstorf.

Stand der Information

Oktober 2008.

  • 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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Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

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)

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)

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

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

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

27-8-2018

Several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks

Several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks

Health Canada is advising Canadians that several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks. The 11products include vitamins, dietary supplements, workout supplements and decongestants. Seized products were labelled to contain various ingredients, including prescription drugs and controlled substances.

Health Canada

14-7-2018

Dringende Sicherheitsinformation zu Vitamin D total II, Elecsys Vitamin D total II von Roche Diagnostics GmbH

Dringende Sicherheitsinformation zu Vitamin D total II, Elecsys Vitamin D total II von Roche Diagnostics GmbH

Weitere Informationen sowie Details zum Produkt entnehmen Sie bitte der anliegenden Kundeninformation des Herstellers.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

20-6-2018

June 18, 2018: Vitamin Shop Owner Guilty of Selling Misbranded Drugs and Controlled Substance

June 18, 2018: Vitamin Shop Owner Guilty of Selling Misbranded Drugs and Controlled Substance

June 18, 2018: Vitamin Shop Owner Guilty of Selling Misbranded Drugs and Controlled Substance

FDA - U.S. Food and Drug Administration

11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: (S)-(−)-3-(4-aminophenyl)-2-methoxypropanoic acid, Treatment of idiopathic pulmonary fibrosis, 24/08/2018, Positive

Orphan designation: (S)-(−)-3-(4-aminophenyl)-2-methoxypropanoic acid, Treatment of idiopathic pulmonary fibrosis, 24/08/2018, Positive

Orphan designation: (S)-(−)-3-(4-aminophenyl)-2-methoxypropanoic acid, Treatment of idiopathic pulmonary fibrosis, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

22-11-2018


Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lym

Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lym

Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lymphocytic leukaemia, 06/12/2012, Withdrawn

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate) - Orphan designation - Commission Decision (2018)7795 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/106/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

2-10-2018

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Active substance: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone) - Transfer of orphan designation - Commission Decision (2018)6436 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/163/13/T/01

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

15-8-2018

Watched Vitamania? Here’s how the TGA regulates vitamins in Australia

Watched Vitamania? Here’s how the TGA regulates vitamins in Australia

Find out how the TGA regulates vitamins in Australia

Therapeutic Goods Administration - Australia

7-8-2018

B12 Ankermann® Tablette

Rote - Liste

27-7-2018

EU/3/04/192 (Celgene Europe B.V.)

EU/3/04/192 (Celgene Europe B.V.)

EU/3/04/192 (Active substance: 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione) - Transfer of orphan designation - Commission Decision (2018)5040 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/083/03/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

3-7-2018

Granupas (Eurocept International B.V.)

Granupas (Eurocept International B.V.)

Granupas (Active substance: Para-aminosalicylic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4256 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2709/T/25

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

20-6-2018

vitamin B12-Loges® Injektionslösung

Rote - Liste