Tuberkulin PPD RT 23 SSI

Hauptinformation

  • Handelsname:
  • Tuberkulin PPD RT 23 SSI 2TE/0.1 ml, Injektionslösung
  • Darreichungsform:
  • 2TE/0.1 ml, Injektionslösung
  • Zusammensetzung:
  • tuberculinum (PPD RT 23) 0.4 µg, dinatrii phosphas dihydricus, kalii dihydrogenophosphas, natrii chloridum, polysorbatum 80, conserv.: kalii 8-hydroxychinolini sulfas hydricus (2:2:2:1) 0.1 mg, aqua ad iniectabilia q.s. ad solutionem pro 1 ml.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

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.


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Lokalisierung

  • Erhältlich in:
  • Tuberkulin PPD RT 23 SSI 2TE/0.1 ml, Injektionslösung
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Impfstoffe
  • Therapiebereich:
  • Diagnose von M.tuberculosis Infektion

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 641
  • Berechtigungsdatum:
  • 03-07-2000
  • Letzte Änderung:
  • 12-09-2017

Zusammenfassung der Merkmale des Arzneimittels

Fachinformation

Zusammensetzung, Galenische Form und Wirkstoffmenge pro Einheit, Dosierung/Anwendung,

Packungen, Stand der Information

Tuberkulin PPD RT 23 SSI

Mantoux-Test

Zusammensetzung

Tuberkulin PPD RT 23 SSI enthält pro 1 ml Lösung:

Wirkstoffe

Tuberkulin PPD-Lösung zu 2 TE (Tuberkulin-Einheiten)* pro 0,1 ml:

Tuberkulin PPD RT 23 von Mycobacterium tuberculosis 0,4 µg

* 1 Tuberkulin-Einheit (TE) entspricht 0,02 µg Tuberkulin PPD RT 23

Hilfsstoffe

Dinatriumhydrogenphosphat Dihydrat 7,6 mg

Kaliumdihydrogenphosphat 1,5 mg

Natriumchlorid 4,8 mg

Hydroxychinolinkaliumsulfat 100 mg

Polysorbat 80 50 mg

Wasser für Injektionszwecke q.s.p. 1 ml

Galenische Form und Wirkstoffmenge pro Einheit

Tuberkulin PPD (Purified Protein Derivative) RT 23 SSI ist eine klare gebrauchsfertige Lösung von

PPD ausgewählter Stämme von Mycobacterium tuberculosis. Tuberkulin PPD RT 23 SSI wird in

Mehrdosenbehältern (ca. 10 Dosen pro Behälter) in der Konzentration 2 Tuberkulineinheiten (TE)

hergestellt. 1 ml Tuberkulin-Lösung enthält 50 mg Polysorbat 80 (Tween 80) als Stabilisator, 100 mg

Konservierungsmittel (Hydroxychinolinkaliumsulfat (Chinosol)), Kochsalz und Phosphatpuffer.

Indikationen/Anwendungsmöglichkeiten

Zu Diagnosezwecken: Der Mantoux-Test mit Tuberkulin PPD RT 23 SSI ist ein anerkanntes

Hilfsmittel zur Bestimmung, ob eine Person jemals mit Mycobacterium tuberculosis infiziert wurde.

Dosierung/Anwendung

0,1ml intradermal

Der Hauttest hat anhand der Mantoux-Methode zu erfolgen. Wird der Test zu medizinisch-

diagnostischen Zwecken eingesetzt, empfiehlt sich die Verwendung von 0,1 ml Tuberkulin PPD RT

23 SSI zu 2 TE. Die Dosis beträgt 0,1 ml der Lösung PPD RT 23. Die intradermale Injektion ist am

mittleren Drittel des Unterarms vorzunehmen, da die Reaktion in Richtung Handgelenk und Ellbogen

abnimmt. Für jede Injektion ist eine neue Spritze zu verwenden.

Zur Verabreichung des Produkts empfiehlt sich die Verwendung einer Spritze mit 1 ml-Skala (0,5 x

10 mm) und einer leicht abgeschrägten Nadel (25-26 Gauge). Es ist etwas mehr als 0,1 ml der

Tuberkulin-Lösung aufzuziehen. Die überschüssige Menge sowie Luftblasen sind auszustossen, so

dass die Spritze exakt 0,1 ml der Lösung enthält. Die Injektion wird folgendermassen vorgenommen:

Haut leicht spreizen und Nadelspitze (abgeschrägte Fläche nach oben) in die obere Hautschicht

einstechen. Anschliessend die gesamte Dosis von 0,1 ml langsam injizieren. Die Injektion muss

unbedingt in die oberste Hautschicht erfolgen: Bei einer zu tiefen Injektion der Tuberkulin-PPD-

Lösung ist die Reaktion schwierig zu beurteilen. Wird die Injektion korrekt vorgenommen, bildet

sich unmittelbar danach eine kleine Erhöhung oder eine Quaddel von 8-10 mm Durchmesser, die

während rund 10 Minuten sichtbar bleibt. Bildet sich keine Erhebung, ist die Lösung möglicherweise

zu tief gespritzt worden, und der Hauttest sollte im Abstand von 4 oder mehr Zentimetern von der

ersten Injektionsstelle wiederholt werden.

Auswertung und Interpretation des Mantoux-Tests

Bei einer positiven Reaktion tritt 48-72 Stunden nach der Injektion eine Induration auf, die von einer

Rötung umgeben sein kann. Zu messen ist nur die Induration und dies etwa 3 Tage nach der

Verabreichung von Tuberkulin PPD RT 23 SSI. Die Hautreaktion kann als flache, unregelmässige

und leicht erhabene Induration ertastet werden, die mit Hilfe eines transparenten, biegsamen

Massstabs zu messen ist.

Eine positive Tuberkulin PPD RT 23 SSI Reaktion ist definiert als Induration mit einem

Durchmesser von über 6 mm.

ABLESEN DES MANTOUX-

TESTS

Durchmesser der Induration in

negativ positiv

stark positiv

0-5 mm 6-14 mm ≥15 mm

In Ländern, in denen die BCG-Impfung praktiziert wird, kann der Grenzwert für eine positive

Reaktion höher angesetzt werden.

Bei Patienten mit einem Immundefizit kann die Reaktion in bestimmten Fällen auch bei einer

Induration von unter 6 mm Durchmesser als positiv eingestuft werden.

Kontraindikationen

Überempfindlichkeitsreaktionen nach einem früheren Hauttest mit den Produkten Sensitin PPD oder

Tuberkulin PPD schliessen eine weitere Verwendung dieser Produkte aus.

Warnhinweise und Vorsichtsmassnahmen

Bei Personen, bei denen bei einem früheren Test mit den Produkten Tuberkulin PPD oder Sensitin

PPD schwere Hautreaktion aufgetreten sind, ist äusserste Vorsicht geboten.

Für jede Injektion eine neue Spritze verwenden. Angebrochene Behälter am gleichen Tag

aufbrauchen; bis zur Verwendung verschlossen bei +2° - +8°C aufbewahren und allfällige Reste

verwerfen.

Interaktionen

Impfungen mit Lebendimpfstoffen (zum Beispiel MMR-Impfung gegen Masern, Mumps und Röteln)

oder Virusinfektionen, wie Masern, HIV oder Grippe, können die Tuberkulinreaktion vorübergehend

abschwächen. Andere Erkrankungen, einschliesslich Krebs und Sarkoidose, können die Sensitivität

gegenüber Tuberkulin herabsetzen. Bei unterernährten oder immundefizienten Patienten kann die

Reaktion auf Tuberkulin PPD RT 23 SSI schwächer ausfallen als erwartet.

Personen mit aktiver Tuberkulose, deren Immunsystem durch die Turberkuloseinfektion schwer

geschwächt ist, können eine Reaktion von unter 6 mm zeigen.

Bei manchen Personen kann der Mantoux-Test positiv ausfallen, obwohl sie keine

Tuberkuloseinfektion haben oder hatten. Dies kann auf eine frühere BCG-Impfung oder Infektion

mit einem Nicht-Tuberkel-Mycobacterium, das offensichtlich keine Erkrankung ausgelöst hat,

zurückzuführen sein.

Schwangerschaft, Stillzeit

Der Tuberkulin-Test PPD RT 23 SSI kann während Schwangerschaft und Stillzeit durchgeführt

werden.

Wirkung auf die Fahrtüchtigkeit und auf das Bedienen von Maschinen

Nicht zutreffend.

Unerwünschte Wirkungen

Unmittelbar nach der Injektion können selten Schmerzen, Reizungen oder Unbehagen an der

Einstichstelle auftreten, die jedoch nach kurzer Zeit abklingen. Bei Personen, die auf Tuberkulin

extrem empfindlich reagieren, können an der Einstichstelle Bläschen oder Nekrosen auftreten. Es ist

auch über leicht erhöhte Temperatur oder Lymphknotenschwellungen berichtet worden.

Überdosierung

Nicht zutreffend.

Eigenschaften / Wirkungen

ATC-Code: V04CF01

Pharmakotherapeutische Gruppe: Tuberkulose-Diagnostika

Pharmakokinetik

Absorptions-, Distributions- oder Eliminationsstudien sind für dieses Produkt nicht sinnvoll und

wurden nicht durchgeführt.

Präklinische Daten

Tierexperimentelle Studien an Meerschweinchen und Kaninchen belegen, dass das im Präparat

enthaltene Detergens Polysorbat 80 (Tween 80) nicht zu einer Sensibilisierung führt. Die Ergebnisse

der Tierstudien wurden am Menschen bestätigt.

Sonstige Hinweise

Haltbarkeit

Das Präparat darf nach Ablauf des auf dem Behältnis und auf der äusseren Umhüllung angegebenen

Verfalldatums nicht mehr verwendet werden.

Besondere Lagerungshinweise

Die Lösungen Tuberkulin PPD RT 23 SSI sind gekühlt bei Temperaturen zwischen +2° und +8° C

und vor Licht geschützt aufzubewahren. Nach Entnahme der ersten Dosis ist die Ampulle wieder zu

verschliessen und bei einer Temperatur zwischen +2° und +8° C aufzubewahren. Die restliche

Lösung muss noch am selben Tag aufgebraucht werden; allfällige Reste sind zu verwerfen.

Zulassungsnummer

00641 (Swissmedic)

Packungen

1 Stechampulle mit 1,5ml Tuberkulin PPD RT 23 SSI Lösung 2 TE / 0,1ml

10 Stechampullen mit 1,5ml Tuberkulin PPD RT 23 SSI Lösung 2 TE / 0,1ml

Abgabekategorie B

Zulassungsinhaberin

Pro Farma AG, 6340 Baar

Herstellerin

Statens Serum Institut

Artillerivej 5

DK-2300 Kopenhagen S

Stand der Information

Februar 2016

  • 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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EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1964 (Incyte Biosciences Distribution B.V.)

EU/3/17/1964 (Incyte Biosciences Distribution B.V.)

EU/3/17/1964 (Active substance: Itacitinib) - Transfer of orphan designation - Commission Decision (2018)7573 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/169/17/T/01

Europe -DG Health and Food Safety

12-11-2018

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

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

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

Europe -DG Health and Food Safety

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

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

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

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

Europe -DG Health and Food Safety

6-11-2018

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Authorisation - Commission Decision (2018)7415 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4682

Europe -DG Health and Food Safety

6-11-2018

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7416 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4363/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7417 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4781/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Neulasta (Amgen Europe B.V.)

Neulasta (Amgen Europe B.V.)

Neulasta (Active substance: Pegfilgrastim) - Centralised - Yearly update - Commission Decision (2018)7420 of Tue, 06 Nov 2018

Europe -DG Health and Food Safety

6-11-2018

Samsca (Otsuka Pharmaceutical Netherlands B.V.)

Samsca (Otsuka Pharmaceutical Netherlands B.V.)

Samsca (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7419 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/980/T/36

Europe -DG Health and Food Safety

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

5-11-2018

Improvac (Zoetis Belgium S.A.)

Improvac (Zoetis Belgium S.A.)

Improvac (Active substance: Not available) - Centralised - Yearly update - Commission Decision (2018)7381 of Mon, 05 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here:  https://go.usa.gov/xPyHT  #MedicalDevice

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT  #MedicalDevice

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT  #MedicalDevice

FDA - U.S. Food and Drug Administration

1-11-2018

Zolvix (Elanco GmbH)

Zolvix (Elanco GmbH)

Zolvix (Active substance: monepantel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7383 of Thu, 01 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/000154/T/0024

Europe -DG Health and Food Safety

1-11-2018

Protopic (Leo Pharma A/S)

Protopic (Leo Pharma A/S)

Protopic (Active substance: Tacrolimus) - Centralised - Yearly update - Commission Decision (2018)7343 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Taxespira (Hospira UK Limited)

Taxespira (Hospira UK Limited)

Taxespira (Active substance: docetaxel) - Centralised - Withdrawal - Commission Decision (2018)7368 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Passiflora Kinderzäpfchen

Rote - Liste

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

Europe -DG Health and Food Safety

31-10-2018

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (Active substance: Ambrisentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7339 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/839/T/56

Europe -DG Health and Food Safety

31-10-2018

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Active substance: adalimumab) - Centralised - Yearly update - Commission Decision (2018)7341 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

31-10-2018

Eporatio (ratiopharm GmbH)

Eporatio (ratiopharm GmbH)

Eporatio (Active substance: epoetin theta) - Centralised - Yearly update - Commission Decision (2018)7336 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

31-10-2018

Viramune (Boehringer Ingelheim International GmbH)

Viramune (Boehringer Ingelheim International GmbH)

Viramune (Active substance: nevirapine) - Centralised - Yearly update - Commission Decision (2018)7337 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety