Petidin "SAD"

Primær information

  • Handelsnavn:
  • Petidin "SAD" 50 mg/ml injektionsvæske
  • Dosering:
  • 50 mg/ml
  • Lægemiddelform:
  • injektionsvæske
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
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Lokation

  • Fås i:
  • Petidin "SAD" 50 mg/ml injektionsvæske
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 16443
  • Sidste ændring:
  • 22-02-2018

Produktresumé: dosering, interaktioner, bivirkninger

28. juli 2016

PRODUKTRESUMÉ

for

Petidin ”SAD”, injektionsvæske, opløsning

0.

D.SP.NR.

5239

1.

LÆGEMIDLETS NAVN

Petidin "SAD"

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 ml indeholder hhv. 10 og 50 mg pethidinhydrochlorid.

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Injektionsvæske, opløsning.

Udseende:

Klar, farveløs til næsten farveløs væske, fri for synlige partikler.

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Stærke smerter. Præmedikation.

4.2

Dosering og indgivelsesmåde

Petidin SAD, injektionsvæske kan indgives intramuskulært, subkutant eller som langsom

intravenøs injektion. Intramuskulær injektion foretrækkes frem for subkutan injektion, da

subkutan injektion kan give lokal irritation. Bør kun anvendes kortvarigt, da gentagen indgift

kan forårsage kumulation af norpethidin udløsende excitationssymptomer samt medførende

risiko for udvikling af tolerans og fysisk afhængighed.

Stærke smerter:

Voksne: 25-150 mg i.m. ellers.c. hver 3. - 4. time op til 6 gange i døgnet.

Børn over 1 år: 0,5-2 mg/kg i.m. eller s.c. hver 3.- 4. time op til 6 gange i døgnet. Enkeltdosis

bør ikke være større end 100 mg pethidin.

Akut behandling: 10 mg/ml: 25-50 mg som langsom (1-2 min.) i.v. injektion hver 4. time.

Bemærk: Pethidin bør kun administreres intravenøst, når en opioidantagonist (fx naloxon) og

udstyr til assisteret eller kontrolleret vejrtrækning er direkte tilgængelige. Patienten bør ligge

16443_spc.doc

Side 1 af 6

ned under administrationen. Obstetriske smerter: Initialt 50-100 mg i.m. eller s.c., når veerne

er regelmæssige. Dosis kan gentages hver 1.-3. time. Maksimalt 400 mg pr. døgn.

Præmedikation:

Voksne: 25-100 mg i.m. 30-90 min. før anæstesi.

Børn: 0,5-2,0 mg/kg i.m. 30-90 min. før anæstesi. Maksimalt 100 mg/dosis. Bør ikke

anvendes til børn under 1 år.

Patienter med nedsat leverfunktion

Dosisreduktion ved leverinsufficiens. På grund af akkumulering af metabolitten norpethidin

bør gentagne doser undgås til patienter med nedsat nyre- og/eller leverfunktion.

Patienter med nedsat nyrefunktion

Dosisreduktion ved let nedsat nyrefunktion er ikke nødvendig (GFR > 50 ml/min.). Dosis bør

reduceres til 75 % af normaldosis ved moderat nedsat nyrefunktion (GRF 10-50 ml/min.) og

til 50 % ved svært nedsat nyrefunktion (GFR < 10 ml/min.). På grund af akkumulering af

metabolitten norpethidin bør gentagne doser undgås til patienter med nedsat nyre- og/eller

leverfunktion.

Ældre

Ældre kan være mere følsomme overfor bivirkningerne af pethidin, initialdosis bør derfor

være nedsat.

4.3

Kontraindikationer

Overfølsomhed over for pethidinhydrochlorid. Samtidig behandling med – eller inden 14

dage efter seponering af MAO-hæmmere. (se punkt 4.5)

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Bør fortrinsvist benyttes i kortere perioder. Langtidsbehandlig øger risikoen for kramper,

formentlig på grund af akkumulering af metabolitten norpethidin. Endvidere kan

langtidsbehandling være afhængighedsskabende og udvikling af tolerans kan forekomme.

Gives med forsigtighed og evt. i reduceret dosis til ældre eller svækkede patienter samt til

patienter med kroniske nyre- og/eller leversygdomme, hovedskader, forhøjet interkranielt

tryk, supraventikulært takykardi, akut alkoholisme, hypothyreodisme, fæokromocytom,

galdevejslidelser,

binyrebarkinsufficiens,

hypotension,

shock,

forstørret

prostata,

inflammatoriske tarmsygdomme, myasthenia gravis samt patienter, der tidligere har haft

krampeanfald.

Patienter med åndedrætslidelser må observeres for respirationsdepression.

Neurotoksisitet er set hos patienter med nyresvigt, cancer eller seglcelleanæmi og ved

samtidig brug af anticholinerge lægemidler eller længerevarende behandling med pethidin i

høje doser.

Forsigtighed bør udvises ved samtidig administration af andre opioider og kombinerede

agonist/antagonist opioider. (se punkt 4.5)

4.5

Interaktion med andre lægemidler og andre former for interaktion

MAO-hæmmere: Meget alvorlige reaktioner inkl. koma, svær respirationsdepression, cyanosis

og hypotension er observeret hos patienter, der blev behandlet med MAO-hæmmere (inkl.

16443_spc.doc

Side 2 af 6

moclobemid og selegilin) samtidig med pethidin. Der er også set hyperexcitabilitet, kramper,

takykardi, hyperpyrexia samt hyper- eller hypotension. Pethidin bør derfor ikke gives sammen

med - eller inden 14 dage efter seponering af monoaminooxydasehæmmere.

Barbiturater, benzodiazepiner, phenothiaziner og opioider: Pethidins respirationshæmmende

effekt forstærkes af barbiturater, benzodiazepiner, phenothiaziner og opioider. Kombinationen

bør derfor undgås.

Phenytoin:

Phenytoin

sænker

muligvis

pethidins

plasmakoncentration

øget

metabolisering. Patienten bør observeres for nedsat analgetisk effekt og øget toksisitet af

metabolitten norpethidin.

Centralt virkende lægemidler mod fedme (sibutramin)

Mekanisme: Serotonerg hyperstimulation

Effekt: Serotonergt syndrom (rastløshed, myoklonier, ændret bevidsthedsniveau,

hyperrefleksi, skælven, tremor og svedudbrud).

Naltrexon og kombinerede agonist/antagonist opioider:

Samtidig administration kan

forårsage pludselige og voldsomme opioid abstinenssymptomer.

Cimetidin og disulfiram: Cimetidin og disulfiram kan hæmme metaboliseringen af pethidin.

Isoniazid: Pethidin kan forværre bivirkningerne af isoniazid.

Alkohol: Alkohol kan forstærke den sederende og hypotensive effekt af pethidin.

4.6

Graviditet og amning

Graviditet:

Pethidin kan anvendes til gravide. Der er ingen meddelelser om teratogen effekt. Pethidin

passerer let placenta og medfører ved længerevarende brug risiko for udvikling af

afhængighed også hos fosteret. Ved anvendelse lige før og under fødslen er der risiko for

påvirkning af det nyfødte barn i form af respirationsdepression. Efter langvarig behandling er

der risiko for abstinenser hos den nyfødte. Særlig obstetrisk kontrol anbefales ved

længerevarende behandling under graviditeten eller anvendelse tæt ved fødslen på grund af

risikoen for neonatale effekter.

Amning:

Erfaring savnes. Kan give respirationspåvirkning og bradykardi hos det ammede barn.

Pethidin udskilles i modermælken, men risikoen for påvirkning af det ammede barn synes

usandsynlig ved terapeutiske doser. Erfaring vedrørende effekten af mulig akkumulering af

metabolitten norpethidin savnes.

4.7

Virkninger på evnen til at føre motorkøretøj eller betjene maskiner

Mærkning.

Petidin SAD kan på grund af bivirkningerne påvirke evnen til at føre motorkøretøj eller

betjene maskiner i væsentlig grad.

4.8

Bivirkninger

Ca. 20 % af patienterne oplever bivirkninger. De fleste bivirkninger er dosisafhængige.

Metabolitten norpethidin kan ved høj dosering påvirke CNS ekscitatorisk og evt. medføre

kramper og hallucinationer.

16443_spc.doc

Side 3 af 6

Frekvens

Meget

almindelige

>1/10

Almindelige

>1/100 og

<1/10

Ikke

almindelige

>1/1.000 og

<1/100

Ukendt

frekvens

Organsystem

Immunsystemet

Overfølsomhedsre

aktioner

Psykiske forstyrrelser

Humørsvingninge

Nervesystemet

Rastløshed

Konfusion

Svimmelhed

Respirationshæm

ning

Sedation

Besvimelse

Eufori

Ansigtsrødmen

Hallucinationer

Øjne

Miosis

Hjerte

Takykardi

Bradykardi

Vaskulære sygdomme

Ortostatisk

hypotension

Luftveje, thorax og

mediastinum

Hurtig

i.v.

injektion kan give

bronkospasmer

Mave-tarmkanalen

Kvalme

Opkastning

Obstipation

Mundtørhed

Lever og galdeveje

Galdevejsspasmer

Hud og subkutane væv

Urticaria

Kløe

Knogler, led, muskler og

bindevæv

Kramper kan

forekomme ved

langvarig

behandling eller

overdosering

Muskelsvaghed

Nyrer og urinveje

Urinretention

Almene symptomer og

reaktioner på

administrationsstedet

S.c. injektion kan

give

lokal

irritation

Hypotermi

Indberetning af formodede bivirkninger

Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig. Det

muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet. Læger og

sundhedspersonale anmodes om at indberette alle formodede bivirkninger via:

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

4.9

Overdosering

Symptomer

Symptomer på toksicitet er bl.a. miosis, kvalme, takykardi, hypotension, kramper,

respirationsdepression og koma.

Letal dosis for utilvænnede er ca. 1 g.

16443_spc.doc

Side 4 af 6

Behandling

Respirationsdepressionen kan ophæves med den opioide antagonist, naloxon. Naloxon kan

ikke erstatte respiratorbehandling ved alvorlig forgiftning. Øvrig behandling er symptomatisk.

4.10

Udlevering

A § 4.

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

ATC-kode: N 02 AB 02 – Opioid analgetikum

5.1

Farmakodynamiske egenskaber

Pethidins analgetiske effekt beror dels på en ændret smerteoplevelse samt en øgning af

smertetærskelen. Pethidin forårsager desuden en generel CNS-depression.

Pethidin er en ren opioidagonist. Pethidin har en høj affinitet til (my) receptorerne og lidt

lavere for (sigma)- og (kappa) receptorerne. CNS-effekterne afspejles af bindingen til recep-

torerne, der giver følgende effekter:

(my) receptor: supraspinal analgesi, respiratorisk hæmning, eufori samt psykisk afhængighed.

(sigma) receptor: spinalanalgesi, miosis samt sedation.

(kappa) receptor: dysfori samt hallucinationer.

Pethidin fremkalder desuden kvalme ved stimulering af dopaminreceptorer i "triggerzonen".

Pethidin øger frigørelsen af antidiuretisk hormon og histamin. Pethidin medfører tillige

obstipation.

Analgetisk effekt ses efter 10-15 min. ved i.m. og s.c. administration og efter ca. 2-5 min. ved

i.v. administration. Maksimal effekt ses 30-60 min. efter i.m. og s.c. administration.

Virkningsvarigheden er 2-4 timer.

5.2

Farmakokinetiske egenskaber

Fordeling

Proteinbindingsgraden er 65-80 %. Pethidin passerer blod-hjernebarrieren og placenta samt

udskilles i modermælk.

Metabolisme

Metaboliseres hovedsageligt i leveren ved hydrolyse eller demethylering, fulgt af konjugering

til glukuronsyre. Hovedmetabolitten, norpethidin, er farmakologisk aktiv. Akkumulering af

norpethidin kan give toksisitet. Pethidin er derfor ikke egnet til behandling af kroniske

smerter.

Elimination

Plasmahalveringstiden for pethidin er 3-6 timer, mens norpethidin har en plasmahalveringstid

på 8-20 timer ved normal nyre- og leverfunktion. Ved nedsat leverfunktion er

plasmahalveringstiden for pethidin forlænget til 7-11 timer, og ved nedsat nyrefunktion er

norpethidins plasmahalveringstid forlænget til mere end 30 timer. Af den indgivne dosis

udskilles ca. 5 % uomdannet gennem nyrerne. Udskillelsen er pH-afhængig og øges ved

faldende pH.

16443_spc.doc

Side 5 af 6

5.3

Prækliniske sikkerhedsdata

Ingen oplysninger

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Natriumchlorid (kun 10 mg/ml), vand til injektionsvæsker.

6.2

Uforligeligheder

Blandbar med isotonisk glucoseinfusionsvæske, glucoseinfusionsvæske 100 g/l, isotonisk

natriumchloridglucose infusionsvæske, isotonisk natriumchlorid infusionsvæske og Ringer-

chlorid infusionsvæske.

6.3

Opbevaringstid

3 år.

6.4

Særlige opbevaringsforhold

Opbevares i originalemballagen.

6.5

Emballagetyper og pakningsstørrelser

Ampul, 1, 2 og 5 ml, fremstillet af farveløst neutralglas. Ph.Eur.

6.6

Regler for destruktion og anden håndtering

Ingen særlige forholdsregler.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Amgros I/S

Dampfærgevej 22

Postbox 2593

2100 København Ø

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

10 mg/ml: 16441

50 mg/ml: 16443

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

1. oktober 1986

10.

DATO FOR ÆNDRING AF TEKSTEN

28. juli 2016

16443_spc.doc

Side 6 af 6

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    Anmode informationsbrochure for offentligheden.



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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

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

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