Tuberkulin PPD RT23 "SSI"

Primær information

  • Handelsnavn:
  • Tuberkulin PPD RT23 "SSI" 2 TE/dosis injektionsvæske, opløsning
  • Dosering:
  • 2 TE/dosis
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Tuberkulin PPD RT23 "SSI" 2 TE/dosis injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 14834
  • Sidste ændring:
  • 17-07-2018

Indlægsseddel

Tuberkulin PPD RT23

”SSI” 2 T.E./0,1 ml,

injektionsvæske,

opløsning

Tuberkulin PPD RT23

”SSI” 10 T.E./0,1 ml,

injektionsvæske,

opløsning

Tuberkulin PPD RT 23

Læs denne indlægsseddel grundigt,

inden du bliver hudtestet, da den

indeholder vigtige oplysninger.

Gem indlægssedlen. Du kan få

brug for at læse den igen.

Spørg lægen eller

apotekspersonalet, hvis der er

mere, du vil vide.

Lægen har ordineret Tuberkulin

PPD RT23 ”SSI” til dig

personligt. Lad derfor være med

at give det til andre. Det kan være

skadeligt for andre, selvom de har

de samme symptomer, som du har.

Kontakt lægen eller

apotekspersonalet, hvis en

bivirkning bliver værre, eller hvis

du får bivirkninger, som ikke er

nævnt her. Se punkt 4.

S T A T E N S

S E R U M

I

N S T I

T U T

Oversigt over indlægssedlen

1. Virkning og anvendelse

2. Det skal du vide, før du bliver hudtestet

3. Sådan bliver du hudtestet

4. Bivirkninger

5. Opbevaring

6. Pakningsstørrelser og yderligere oplysninger

1 VIRKNING OG ANVENDELSE

Tuberkulin PPD RT23 ”SSI” anvendes som hudtest for at

finde ud af, om du nogensinde har været smittet med en

bakterie, som giver tuberkulose.

Kun til diagnostisk brug.

2 DET SKAL DU VIDE, FØR DU BLIVER

HUDTESTET

Du må ikke lade dig hudteste

Hvis du er allergisk over for Tuberkulin PPD RT23

”SSI” eller et af de øvrige indholdsstoffer i Tuberkulin

PPD RT23 ”SSI”. Se punkt 6.

Hvis du har oplevet en kraftig lokal reaktion i forbindelse

med tuberkulinprodukter.

Brug af anden medicin sammen med Tuberkulin PPD

RT23 ”SSI”

Det er sikkert at indgive Tuberkulin PPD RT23 ”SSI”

sammen med alle vacciner. Men der kan være nedsat

reaktivitet efter vaccination mod mæslinger, fåresyge og

Artillerivej 5

2300 København S

Danmark

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

røde hunde (MFR-vaccine). Den nedsatte reaktivitet kan

give falsk negative reaktioner. Tidligere BCG vaccination

kan give en falsk positiv reaktion.

Fortæl det altid til lægen eller apotekspersonalet, hvis du

bruger anden medicin eller har gjort det for nylig. Dette

gælder også medicin, som ikke er købt på recept.

Graviditet, amning og fertilitet

Fortæl det til lægen, hvis du er gravid eller ammer.

Hudtesten kan udføres, mens du er gravid eller ammer.

Trafik- og arbejdssikkerhed

Tuberkulin PPD RT23 ”SSI” påvirker ikke din evne til at

køre bil eller betjene maskiner.

Tuberkulin PPD RT23 ”SSI”, indeholder kalium og

natrium

Dette lægemiddel indeholder mindre end 1 mmol kalium

(39 mg) og mindre end 1 mmol natrium (23 mg) pr. dosis,

dvs. det er stort set kalium- og natriumfrit.

3 SÅDAN BLIVER DU HUDTESTET

Lægen eller sygeplejersken indsprøjter Tuberkulin PPD

RT23 ”SSI” i det øverste hudlag i underarmen.

Dosis er 0,1 ml for børn og voksne.

Efter indsprøjtningen dannes der en lille papel på 8-10 mm

i diameter, som er synlig i omkring 10 minutter. Der kan

være rødme og hævelse på indsprøjtningsstedet. Efter 48-72

timer undersøges resultatet af hudtesten af lægen eller

sygeplejersken. Hvis der er kommet en hævelse, bør den

aftage herefter. Spørg lægen eller på apoteket, hvis der er

noget, du er i tvivl om.

Der er nærmere oplysninger om indgivelse og evaluering af

hudtesten under ”Følgende oplysninger er tiltænkt læger og

sundhedspersonale”.

4 BIVIRKNINGER

Tuberkulin PPD RT23 ”SSI” kan som al anden medicin

give bivirkninger, men ikke alle får bivirkninger.

Alvorlige allergiske reaktioner (anafylaksi) som hævelse i

læber, ansigt og svælg, vejrtrækningsbesvær og nældefeber

kan forekomme i meget sjældne tilfælde (hos færre end 1 ud

af 10.000 patienter). Kontakt straks lægen, hvis du

observerer nogen af disse reaktioner.

Andre bivirkninger:

Almindelige bivirkninger

(kan forekomme hos færre end 1

ud af 10 patienter):

Smerter, kløe og irritation på indsprøjtningsstedet.

Ikke almindelige bivirkninger

(kan forekomme hos færre

end 1 ud af 100 patienter):

Feber og forstørrelse af lymfeknuderne.

Sjældne bivirkninger

(kan forekomme hos færre end 1 ud

af 1.000 patienter):

Hudnekrose, som normalt forsvinder i løbet af få dage, samt

blæredannelse.

Hyppighed ikke kendt

(kan ikke estimeres ud fra

forhåndenværende data):

Hovedpine og nældefeber (urticaria).

Følgende oplysninger er tiltænkt læger og

sundhedspersonale

Indgivelsesmåde

Nedenfor gives en detaljeret beskrivelse af indgivelse af

Tuberkulin PPD RT23 ”SSI”:

0,1 ml indgives med en 1 ml underinddelt

injektionssprøjte med en kort kanyle med skrå kant

(25G eller 26G).

Injektionen skal gives intradermalt i den midterste

tredjedel af underarmen. Injektion nær håndleddet eller

albueleddet kan svække reaktionen.

Huden strækkes let, og kanylen holdes næsten parallelt

med hudoverfladen med den skrå kant opad. Spidsen af

nålen indføres i det øverste lag af huden.

Kanylen skal ved indføringen være synlig under

epidermis. De 0,1 ml injiceres langsomt, og der

fremkommer en lille bleg papel på 8-10 mm i diameter.

Denne papel forsvinder igen i løbet af ca. 10 minutter.

Hvis der ikke fremkommer nogen papel, er injektionen

givet for dybt, og hudtesten skal gentages på den anden

arm eller på samme arm mindst 4 cm fra det første

injektionssted.

Nationale anbefalinger vedrørende udførelse af Mantoux

tuberkulinhudtesten bør tages i betragtning.

Evaluering af reaktionen

En hudtestreaktion ses som en flad, ujævn, let forhøjet indu-

ration omgivet af et område med rødme.

0,1 ml

Epidermis

Dermis

Subcutis

13-462-01

06-2015

Tal med lægen eller apoteket, hvis en bivirkning er

generende eller bliver værre, eller hvis du får bivirkninger,

som ikke er nævnt her.

Indberetning af bivirkninger til Sundhedsstyrelsen

Hvis du oplever bivirkninger, bør du tale med din læge,

sygeplejerske eller apoteket. Dette gælder også mulige

bivirkninger, som ikke er medtaget i denne indlægsseddel.

Du eller dine pårørende kan også indberette bivirkninger

direkte til Sundhedsstyrelsen på www.meldenbivirkning.dk,

ved at kontakte Sundhedsstyrelsen via mail på

sst@sst.dk eller med almindeligt brev til Sundhedsstyrelsen,

Axel Heides Gade 1, 2300 København S. Ved at

indrapportere bivirkninger kan du hjælpe med at fremskaffe

mere information om sikkerheden af dette lægemiddel.

5 OPBEVARING

Opbevar Tuberkulin PPD RT23 ”SSI” utilgængeligt for

børn.

Brug ikke Tuberkulin PPD RT23 ”SSI” efter den

udløbsdato, der står på pakningen efter EXP.

Udløbsdatoen (EXP) er den sidste dag i den nævnte

måned.

Opbevares i køleskab (2ºC-8ºC).

Opbevares i den originale emballage for at beskytte mod

lys.

Tuberkulin PPD RT23 ”SSI” bør anvendes straks efter

åbning. Hvis det ikke anvendes med det samme, er

holdbarhedstiden og opbevaringsbetingelserne efter

anbrud og før brug brugerens ansvar og vil normalt ikke

være længere end 24 timer ved 2°C-8°C.

Spørg på apoteket, hvordan du skal bortskaffe

medicinrester. Af hensyn til miljøet må du ikke smide

medicinrester i afløbet, toilettet eller skraldespanden.

Tuberkulin PPD RT23 ”SSI” indeholder ikke levende

materiale.

6 PAKNINGSSTØRELSER OG YDERLIGERE

OPLYSNINGER

Tuberkulin PPD RT23 ”SSI” indeholder:

Aktivt stof: Tuberkulin PPD RT 23

1 dosis (0,1 ml) Tuberkulin PPD RT23 ”SSI” 2 T.E.

indeholder 0,04 mikrogram Tuberkulin PPD RT 23.

1 dosis (0,1 ml) Tuberkulin PPD RT23 ”SSI” 10 T.E.

indeholder 0,2 mikrogram Tuberkulin PPD RT 23.

Øvrige indholdsstoffer: dinatriumphosphatdihydrat,

kaliumdihydrogenphosphat, natriumchlorid,

kaliumhydroxyquinolinsulfat, polysorbat 80 og vand til

injektionsvæsker.

Udseende og pakningsstørrelser

Tuberkulin PPD RT23 ”SSI” er en injektionsvæske,

opløsning (injektionsvæske).

Det er en klar, farveløs til svagt gul opløsning.

Tuberkulin PPD RT23 ”SSI” markedsføres i to styrker.

2 T.E. og 10 T.E.

Pakningsstørrelser:

Tuberkulin PPD RT23 ”SSI” 2 T.E. hætteglas med 1,5 ml i

pakningsstørrelser på 1 eller 10.

Tuberkulin PPD RT23 ”SSI” 10 T.E. hætteglas med 1,5 ml i

pakningsstørrelser på 1 eller 10.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

Statens Serum Institut

Artillerivej 5

2300 København S

Danmark

Tlf.: +45 3268 3268

Fax: +45 3268 3973

E-mail: serum@ssi.dk

Dette lægemiddel er godkendt i EEAs medlemslande

under følgende navne:

DK: Tuberkulin PPD RT23 ”SSI”

DE: Tuberkulin PPD RT23 SSI

Denne indlægsseddel blev senest revideret juni 2015.

Den nyeste indlægsseddel kan findes på

www.indlaegsseddel.dk

Indurationen bør vurderes 48-72 timer efter injektionen og

bør derefter aftage. Kun indurationen vurderes.

Indurationens diameter måles i millimeter med en

gennemsigtig, fleksibel plastlineal på tværs af underarmens

længdeakse.

Anbefalinger vedrørende tolkning af Mantoux

tuberkulintesten er vist i Tabel 1.

Indurationens diameter i millimeter

Negativ

Positiv

Stærkt positiv

0-5 mm

6-14 mm

+15 mm

Tabel 1: Normal tolkning af hudtestresultatet.

Alternative tolkninger kan anvendes afhængigt af nationale

anbefalinger samt individuelle og epidemiologiske faktorer.

Tolkning

En positiv reaktion indikerer en immunrespons af en eller

flere af følgende årsager:

Infektion med

Mycobacterium tuberculosis

kompleks,

inklusive

M. tuberculosis, M. bovis, M. africanum,

M. microtii,

eller

M. tuberculosis

subsp

. caprae.

Infektion med non-tuberkuløse mykobakterier.

Tidligere BCG vaccination (BCG-vaccinerede personer

bliver normalt tuberkulin-positive efter 4-8 uger).

Det er usandsynligt, at reaktioner over 15 mm skyldes

tidligere BCG vaccination eller eksponering af

mykobakterier fra omgivelserne.

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28-5-2018

Incresync (Takeda Pharma A/S)

Incresync (Takeda Pharma A/S)

Incresync (Active substance: alogliptin / pioglitazone) - Centralised - Renewal - Commission Decision (2018)3347 of Mon, 28 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2178/R/23

Europe -DG Health and Food Safety

25-5-2018

Section 23 instruments

Section 23 instruments

Section 23 instruments for assessed listed medicines, registered complementary medicines and medicines listed applications.

Therapeutic Goods Administration - Australia

23-5-2018

Zessly (Sandoz GmbH)

Zessly (Sandoz GmbH)

Zessly (Active substance: infliximab) - Centralised - Authorisation - Commission Decision (2018)3215 of Wed, 23 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4647

Europe -DG Health and Food Safety

22-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/mNsFqKTfFk

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/WAPabvM811

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/YRV0lVSRkh

FDA - U.S. Food and Drug Administration

21-5-2018

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/GzY50eEVp9

FDA - U.S. Food and Drug Administration

18-5-2018

Ovaleap (Teva B.V.)

Ovaleap (Teva B.V.)

Ovaleap (Active substance: Follitropin alfa) - Centralised - Renewal - Commission Decision (2018)3154 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2608/R/23

Europe -DG Health and Food Safety

18-5-2018

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (Active substance: A highly purified formulation of Staphylococcus aureus protein A) - Transfer of orphan designation - Commission Decision (2018)3144 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/111/15/T/01

Europe -DG Health and Food Safety

15-5-2018

Riluzole Zentiva (Zentiva k.s.)

Riluzole Zentiva (Zentiva k.s.)

Riluzole Zentiva (Active substance: Riluzole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3055 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2622/T/23

Europe -DG Health and Food Safety

23-4-2018

EnCyzix (Renable Pharma Limited)

EnCyzix (Renable Pharma Limited)

EnCyzix (Active substance: enclomifene) - Refusal of authorisation - Commission Decision (2018)2187 of Mon, 23 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4198

Europe -DG Health and Food Safety

23-4-2018

Mylotarg (Pfizer Limited)

Mylotarg (Pfizer Limited)

Mylotarg (Active substance: gemtuzumab ozogamicin) - New authorisation - Commission Decision (2018)2504 of Mon, 23 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4204

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1992 (argenx BVBA)

EU/3/18/1992 (argenx BVBA)

EU/3/18/1992 (Active substance: Efgartigimod alfa) - Orphan designation - Commission Decision (2018)1881 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/245/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1991 (TurnKey PharmaConsulting Ireland Limited)

EU/3/18/1991 (TurnKey PharmaConsulting Ireland Limited)

EU/3/18/1991 (Active substance: Docosahexaenoic acid ethyl ester) - Orphan designation - Commission Decision (2018)1880 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/235/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1989 (FGK Representative Service GmbH)

EU/3/18/1989 (FGK Representative Service GmbH)

EU/3/18/1989 (Active substance: (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidine-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridine-2-yl)-4-fluoropyrrolidine-2-carboxamide) - Orphan designation - Commission Decision (2018)1878 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/208/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1893 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/222/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1892 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/217/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Active substance: Recombinant modified ricin toxin A-chain subunit) - Orphan designation - Commission Decision (2018)1889 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/242/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1894 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/234/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1995 (Loxo Oncology Limited)

EU/3/18/1995 (Loxo Oncology Limited)

EU/3/18/1995 (Active substance: Larotrectinib) - Orphan designation - Commission Decision (2018)1884 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/213/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1994 (QRC Consultants Ltd)

EU/3/18/1994 (QRC Consultants Ltd)

EU/3/18/1994 (Active substance: Ivosidenib) - Orphan designation - Commission Decision (2018)1883 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1993 (IQVIA RDS Ireland Limited)

EU/3/18/1993 (IQVIA RDS Ireland Limited)

EU/3/18/1993 (Active substance: Gemfibrozil) - Orphan designation - Commission Decision (2018)1882 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/218/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Active substance: Recombinant human acid alpha-glucosidase) - Orphan designation - Commission Decision (2018)1877 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/230/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1999 (uniQure Biopharma B.V.)

EU/3/18/1999 (uniQure Biopharma B.V.)

EU/3/18/1999 (Active substance: Recombinant adeno-associated viral vector containing a codon-optimized Padua derivative of human coagulation factor IX cDNA) - Orphan designation - Commission Decision (2018)1888 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/232/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1998 (Blue-Reg Europe)

EU/3/18/1998 (Blue-Reg Europe)

EU/3/18/1998 (Active substance: Patidegib) - Orphan designation - Commission Decision (2018)1887 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/206/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1997 (QRC Consultants Ltd)

EU/3/18/1997 (QRC Consultants Ltd)

EU/3/18/1997 (Active substance: Miransertib) - Orphan designation - Commission Decision (2018)1886 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/226/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1996 (Therapicon Srl)

EU/3/18/1996 (Therapicon Srl)

EU/3/18/1996 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)1885 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/227/17

Europe -DG Health and Food Safety