Sedastop Vet.

Primær information

  • Handelsnavn:
  • Sedastop Vet. 5 mg/ml injektionsvæske, opløsning
  • Dosering:
  • 5 mg/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
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Lokation

  • Fås i:
  • Sedastop Vet. 5 mg/ml injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 45054
  • Sidste ændring:
  • 22-02-2018

Produktresumé: dosering, interaktioner, bivirkninger

25. juni 2015

PRODUKTRESUMÉ

for

Sedastop Vet., injektionsvæske, opløsning

0.

D.SP.NR

26644

1.

VETERINÆRLÆGEMIDLETS NAVN

Sedastop Vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 ml injektionsvæske, opløsning indeholder:

Aktivt stof:

Atipamezolhydrochlorid

5,0 mg

(svarende til 4,27 mg atipamezol)

Hjælpestof:

Methylparahydroxybenzoat

1,0 mg

Alle hjælpestoffer er anført under pkt. 6.1

3.

LÆGEMIDDELFORM

Injektionsvæske, opløsning.

Klar, farveløs, steril og vandholdig væske.

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Hund og kat.

4.2

Terapeutiske indikationer

Atipamezolhydrochlorid er indiceret til ophævelse af den sederende virkning og

kardiovaskulære virkning efter brug af α2-agonist såsom medetomidin og dexmetomedin hos

hund og kat.

45054_spc.doc

Side 1 af 6

4.3

Kontraindikationer

Bør ikke anvendes til

avlsdyr

dyr som lider af lever-, nyre-, eller hjertesygdomme.

Se også pkt. 4.7.

4.4

Særlige advarsler

Det er vigtigt, at det sikres, at dyret har genvundet normale synkereflekser førend det tilbydes

føde eller væske.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Efter administration af lægemidlet skal dyret hvile et roligt sted.

Under opvågningen skal dyret være under opsyn.

På grund af de forskellige dosisanbefalinger bør der udvises forsigtighed, hvis lægemidlet

anvendes off-label til andre dyr end de dyrearter, lægemidlet er beregnet til.

Hvis der anvendes andre sedativa end medetomidin, kan effekten af disse sedativa vedvare

efter effekten af (dex)medetomidin er ophævet.

Atipamezol ophæver ikke virkningen af ketamin, som kan forårsage krampeanfald hos

hunde og udløse kramper hos katte, når det anvendes alene. Atipamezol må tidligst

anvendes 30-40 minutter efter samtidig administration af ketamin.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

På grund af atipamezols potente farmakologiske virkning skal hud-, øjen- og

slimhindekontakt med lægemidlet undgås. I tilfælde af utilsigtet hud-, øjen- eller

slimhindekontakt skal det berørte område straks vaskes med rigeligt vand, og forurenet tøj

direkte i kontakt med huden skal fjernes.

Undgå utilsigtet indtagelse eller selvinjektion. I tilfælde af utilsigtet indtagelse eller

selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten vises til

lægen.

Andre forsigtighedsregler

Ingen.

4.6

Bivirkninger

Der er observeret forbigående, hypotensiv effekt i løbet af de første 10 minutter efter

injektion af atipamezolhydrochlorid. I sjældne tilfælde kan der forekomme hyperaktivitet,

takykardi, øget spytproduktion, atypiske vokale lyde, muskeltremor, opkastning, hurtigere

vejrtrækning, ukontrolleret urinering og defækation. I meget sjældne tilfælde kan den

sedative virkning vende tilbage eller opvågningstiden ikke blive forkortet efter

administration af atipamezol.

Ved anvendelse af lave doser til delvis ophævelse af virkningerne af medetomidin eller

dexmedetomidin hos katte, skal der træffes foranstaltninger mod hypotermi, som kan

forekomme (selv når katten er vækket af den sederede tilstand).

Hyppigheden af bivirkninger er defineret som:

- Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling)

- Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr)

45054_spc.doc

Side 2 af 6

- Ikke almindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr)

- Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr)

- Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter

4.7

Drægtighed, diegivning eller æglægning

Lægemidlets sikkerhed under drægtighed, diegivning er ikke fastlagt. Produktet bør ikke

administreres til drægtige eller diegivende dyr.

4.8

Interaktion med andre lægemidler og andre former for interaktion

Samtidig anvendelse af atipamezol og andre CNS-stimulerende lægemidler såsom

diazepam, acepromazin eller opiater frarådes.

4.9

Dosering og indgivelsesmåde

Engangsinjektion. Til intramuskulær anvendelse.

Atipamezolhydrochlorid skal indgives 15-60 min efter administration af

medetomidinhydrochlorid eller dexmedetomidinhydrochlorid.

Hunde: Den intramuskulære dosis af atipamezolhydrochlorid (i µg) er 5 gange større end

den forudgående dosis af medetomidinhydrochlorid eller 10 gange større end den

forudgående dosis af dexmedetomidinhydrochlorid. Som følge af den 5 gange større

koncentration af det aktive stof (atipamezolhydrochlorid) i dette lægemiddel sammenlignet

med koncentrationen i præparater, der indeholder 1 mg medetomidinhydrochlorid pr. ml,

og den 10 gange større koncentration sammenlignet med koncentrationen i præparater, der

indeholder 0,5 mg dexmedetomidinhydrochlorid, skal der anvendes den samme mængde af

de to lægemidler.

Doseringseksempel for hunde:

Medetomidin, 1 mg/ml, injektionsvæske,

opløsning

Sedastop vet, 5 mg/ml, injektionsvæske,

opløsning, til hunde

0,04 ml/kg legemsvægt,

dvs. 40 μg/kg legemsvægt

0,04 ml/kg legemsvægt,

dvs. 200 μg/kg legemsvægt

Dexmedetomidin, 0,5 mg/ml,

injektionsvæske, opløsning

Sedastop vet, 5 mg/ml, injektionsvæske,

opløsning, til hunde

0,04 ml/kg legemsvægt,

dvs. 20 μg/kg legemsvægt

0,04 ml/kg legemsvægt,

dvs. 200 μg/kg legemsvægt

Katte: Den intramuskulære dosis af atipamezolhydrochlorid (i µg) er 2,5 gange større end

den forudgående dosis af medetomidinhydrochlorid eller 5 gange større end den

forudgående dosis af dexmedetomidinhydrochlorid. Som følge af den 5 gange større

koncentration af det aktive stof (atipamezolhydrochlorid) i dette lægemiddel sammenlignet

med koncentrationen i præparater, der indeholder 1 mg medetomidinhydrochlorid pr. ml,

og den 10 gange større koncentration sammenlignet med koncentrationen i præparater, der

indeholder 0,5 mg dexmedetomidinhydrochlorid, skal der anvendes det halve af den

tidligere administrerede mængde medetomidin eller dexmedetomidin.

45054_spc.doc

Side 3 af 6

Doseringseksempel for katte:

Medetomidin, 1 mg/ml, injektionsvæske,

opløsning

Sedastop vet, 5 mg/ml, injektionsvæske,

opløsning, til katte

0,08 ml/kg legemsvægt,

dvs. 80 μg/kg legemsvægt

0,04 ml/kg legemsvægt,

dvs. 200 μg/kg legemsvægt

Dexmedetomidin, 0,5 mg/ml,

injektionsvæske, opløsning

Sedastop vet, 5 mg/ml, injektionsvæske,

opløsning, til katte

0,08 ml/kg legemsvægt,

dvs. 40 μg/kg legemsvægt

0,04 ml/kg legemsvægt,

dvs. 200 μg/kg legemsvægt

Opvågningstiden reduceres til ca. 5 minutter. Dyret er mobilt ca. 10 minutter efter

administration af lægemidlet.

4.10

Overdosering

Overdosering af atipamezolhydrochlorid kan medføre forbigående takykardi og overdreven

årvågenhed (hyperaktivitet, muskeltremor). Disse symptomer kan, om nødvendigt,

elimineres med en dosis af (dex)medetomidinhydrochlorid, som er lavere end sædvanlige

kliniske dosis.

Hvis atipamezolhydrochlorid uforvarende administreres til et dyr, der ikke forinden er

blevet behandlet med (dex)medetomidinhydrochlorid, kan der forekomme hyperaktivitet

og muskeltremor. Disse virkninger kan vare ved i ca. 15 minutter.

Overdreven årvågenhed hos katte håndteres bedst ved at minimere eksterne stimuli.

4.11

Tilbageholdelsestid

Ikke relevant.

5.

FARMAKOLOGISKE EGENSKABER

Farmakoterapeutisk gruppe:

α2-receptorantagonist (antidot)

ATCvet-kode:

QV03AB90

5.1

Farmakodynamiske egenskaber

Atipamezol er en potent og selektiv α2-receptorhæmmer (α2-antagonist), som stimulerer

frigivelse af neurotransmitterstoffet noradrenalin i det centrale såvel som det perifere

nervesystem. Den sympatiske aktivering medfører aktivering af CNS. Anden

farmakodynamisk effekt, som f.eks. påvirkning af det kardiovaskulære system, er kun

begrænset. Dog kan der i løbet af de første 10 minutter efter injektion af

atipamezolhydrochlorid forekomme forbigående blodtryksfald.

Atipamezol er en α2-antagonist og kan derfor eliminere (eller hæmme) virkningen af α2-

receptoragonisten, medetomidin eller dexmedetomidin. Derved ophæver atipamezol den

sedative virkning af (dex)medetomidinhydrochorid hos hunde og katte, hvilket i nogle

tilfælde kan medføre forbigående øget hjerterytme.

5.2

Farmakokinetiske egenskaber

Atipamezolhydrochlorid absorberes hurtigt efter intramuskulær injektion.

Maksimumkoncentrationen i CNS nås efter 10-15 minutter. Distributionsvolumen (V

) er

ca. 1-2,5 l/kg. Atipamezolhydrochlorids halveringstid (t

) er ca. 1 time.

Atipamezolhydrochlorid metaboliseres hurtigt og fuldstændigt. Dets metabolitter udskilles

hovedsageligt i urinen og i mindre omfang i fæces.

45054_spc.doc

Side 4 af 6

5.3

Miljømæssige forhold

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Methylparahydroxybenzoat (E218)

Natriumchlorid

Saltsyre (til pH-justering)

Natriumhydroxid (til pH-justering)

Vand til injektionsvæsker

6.2

Uforligeligheder

Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette

lægemiddel ikke blandes med andre veterinære lægemidler.

6.3

Opbevaringstid

I salgspakning: 3 år

Efter første åbning af den indre emballage: 28 dage

6.4

Særlige opbevaringsforhold

Opbevar hætteglasset i den ydre karton for at beskytte mod lys.

6.5

Emballage

Klart hætteglas (type I) med bromobutylgummiprop (type I) med 10 ml injektionsvæske.

Papæske med et 10 ml hætteglas

Papæske med fem 10 ml hætteglas

Papæske med ti 10 ml hætteglas

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

Ikke anvendte veterinære lægemidler, samt affald heraf bør destrueres i henhold til lokale

retningslinjer.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Le Vet B.V.

Wilgenweg 7

3421 TV Oudewater

Holland

Repræsentant

Dechra Veterinary Products A/S

Mekuvej 9

7171 Uldum

Danmark

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

45054

45054_spc.doc

Side 5 af 6

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

25. juni 2010

10.

DATO FOR ÆNDRING AF TEKSTEN

25. juni 2015

11.

UDLEVERINGSBESTEMMELSE

45054_spc.doc

Side 6 af 6

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



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Europe -DG Health and Food Safety

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

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

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

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

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

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

13-11-2018

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

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

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

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety