Pinex comp

Primær information

  • Handelsnavn:
  • Pinex comp 1000+60 mg filmovertrukne tabletter
  • Dosering:
  • 1000+60 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Pinex comp 1000+60 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 53786
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Pinex comp, 1000mg/60 mg filmovertrukne tabletter

Paracetamol og codeinphosphat

Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, 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 dette lægemiddel til dig personligt. Lad derfor være med at give medicinen

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 du får bivirkninger,

som ikke er nævnt her. Se punkt 4.

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal du vide, før du begynder at tage Pinex comp

Sådan skal du tage Pinex comp

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

VIRKNING OG ANVENDELSE

Navnet på din medicin er Pinex comp.

Pinex comp indeholder to forskellige smertestillende stoffer (analgetika), som hedder paracetamol og

codein (som codeinphosphathemihydrat). Codein tilhører en gruppe medicin, der kaldes opioide

analgetika, som virker smertestillende.

Pinex comp kan bruges til børn over 16 år til kortvarig lindring af moderate eller svære smerter, som

ikke lindres med andre smertestillende midler som paracetamol eller ibuprofen alene.

2.

DET SKAL DU VIDE, FØR

DU BEGYNDER AT TAGE PINEX COMP

Tag ikke Pinex comp:

hvis du er allergisk over for codein, paracetamol eller et af de øvrige indholdsstoffer i Pinex

comp (angivet i punkt 6). Tegn på en allergisk reaktion er bla. et udslæt og

vejrtrækningsbesvær. Der kan også forekomme hævelse af ben, arme, hals eller tunge.

hvis du er allergisk over for soja eller jordnødder

hvis du har alvorlige astmaanfald eller vejrtrækningsproblemer

hvis du for nylig er kommet til skade med hovedet

hvis du har alvorlige leverproblemer

hvis din læge har fortalt dig at du har forøget tryk i kraniet. Tegn på dette omfatter:

hovedpiner, opkastning og sløret syn

hvis du for nylig har gennemgået en operation i din lever, galdeblære eller galdegang

hvis du tager medicin til behandling af depression der kaldes MAO-hæmmere

(monoaminooxidase-hæmmere) eller har taget dem i løbet af de sidste 2 uger. MAO-hæmmere

er medicin som f.eks. moclobemid, phenelzin eller tranylcypramin (se ’brug af anden medicin

sammen med Pinex comp’).

hvis du på nuværende tidspunkt er alkoholmisbruger

hvis du er kvinde og ammer

hvis du ved, at du omdanner codein til morphin meget hurtigt.

Tag ikke Pinex comp i længere tid end din læge har fortalt dig.

20170609-Var009

Brug ikke dette lægemiddel til smertelindring hos børn og unge (i alderen 0-18 år) efter fjernelse af

mandler eller polypper på grund af anstrengt vejrtrækning under søvn (obstruktiv søvn-apnø)

Advarsler og forsigtighedsregler

Kontakt lægen eller apotekspersonalet, før du tager Pinex comp:

hvis du har alvorlige nyreproblemer

hvis du har leverproblemer

hvis du har problemer med at lade vandet eller problemer med prostata

hvis du har en nedsat funktion af skjoldbruskkirtlen

hvis du er afhængig af opioider

hvis du har problemer med binyrerne

hvis du har problemer med tarmen som f.eks. tyktarmsbetændelse (colitis) eller Chron’s

sygdom, eller du har en blokering i din tarm

hvis du er ældre

hvis du har blodmangel (nedsat antal røde blodlegemer)

hvis du er underernæret eller dehydreret

hvis personen som skal tage tabletterne er under 18 år og har vejrtrækningsproblemer

Hvis codein tages regelmæssigt i længere tid, kan det føre til afhængighed, som kan medføre, at du

føler dig rastløs og irritabel, når du stopper med at tage tabletterne.

Hvis du tager smertestillende medicin mod hovedpiner for ofte eller i for lang tid, kan det forværre

dem.

Tag aldrig mere af Pinex comp end anbefalet. En højere dosis øger ikke smertelindringen, i stedet kan

det føre til alvorlig leverskade. Symptomerne på leverskade ses først efter nogle dage. Det er derfor

meget vigtigt, at du kontakter din læge så hurtig som muligt, hvis du har taget mere Pinex comp end

anbefalet i denne indlægsseddel.

Et enzym omdanner codein til morphin i leveren. Morphin er det stof, der lindrer smerter. Nogle

mennesker har en variant af dette enzym, og dette kan påvirke mennesker på forskellige måder. Hos

nogle mennesker dannes der ikke morphin, eller det dannes i meget små mængder, og det vil ikke give

tilstrækkelig smertelindring. Andre mennesker har en øget risiko for at få alvorlige bivirkninger, fordi

der dannes en meget stor mængde morphin. Hvis du oplever nogen af følgende bivirkninger, skal du

ophøre med at tage denne medicin og straks søge lægehjælp: langsomt eller overfladisk åndedræt,

forvirring, søvnighed, små pupiller, kvalme, opkastning, forstoppelse, appetitløshed.

Børn og unge

Pinex comp bør ikke tages af børn under 16 år.

Brug hos børn og unge efter operation

Codein må

ikke anvendes til smertelindring hos børn og unge efter fjernelse af mandler eller polypper

på grund af anstrengt vejrtrækning under søvn (obstruktiv søvn-apnø).

Brug hos børn med vejrtrækningsproblemer

Det frarådes at give codein til børn med vejrtrækningsproblemer, da symptomerne på

morphinforgiftning kan blive værre hos disse børn.

Brug af anden medicin sammen med Pinex comp

Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for

nylig.

Dette er særlig vigtigt i tilfælde af:

Medicin til behandling af depression

Medicin der gør dig sløv eller søvnig (medicin der hæmmer centralnervesystemet) som f.eks.

sovepiller, medicin til behandling af angst eller bedøvelsesmidler

20170609-Var009

Medicin der bruges til at fortynde blodet som f.eks. warfarin

Medicin mod uregelmæssig hjerterytme som f.eks. quinidin

Antibiotika der bruges til behandling af infektioner (f.eks. chloramphenicol, rifampicin)

Metoclopramid eller domperidon - der bruges mod kvalme eller opkastning

Cholestyramin – der bruges til at nedsætte mængden af kolesterol i blodet

Probenecid – bruges til behandling af gigt

Naturlægemidlet perikon

Cimetidin – bruges til behandling af halsbrand og mavesår

Anden smertestillende medicin

Barbiturater (f.eks. phenobarbital)

Medicin til behandling af epilepsi (f.eks., phenytoin, carbamazepin)

P-piller

Mens du tager Pinex comp må du ikke tage nogle andre lægemidler der indeholder paracetamol

Dette omfatter visse typer smertestillende medicin og hoste- og forkølelsesmedicin. Det omfatter også

en lang række andre lægemidler, som lægen ordinerer og også mere udbredt som håndkøbsmedicin.

Brug af Pinex comp sammen med mad, drikke og alkohol

Du bør ikke drikke alkohol, mens du tager disse tabletter. Dette er fordi, alkohol øger risikoen for

alvorlige bivirkninger.

Graviditet og amning

Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal

du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.

Pinex comp bør ikke bruges under graviditet, med mindre din læge har rådet dig til det. Regelmæssig

brug under graviditet kan medføre abstinenssymptomer hos den nyfødte. Ved brug bør du tage den

lavest mulige dosis, som mindsker din smerte og/eller din feber, og tage det i kortest mulig tid.

Du må ikke tage Pinex comp, når du ammer, da det optages i modermælken.

Trafik- og arbejdssikkerhed

Pakningen er forsynet med en rød advarselstrekant. Det betyder, at Pinex Comp kan give bivirkninger,

for eksempel svimmelhed og søvnighed, som kan påvirke arbejdssikkerheden og evnen til at færdes

sikkert i trafikken.

Pinex comp indeholder sojalecithin

Hvis du er allergisk over for jordnødder eller soja, må du ikke tage denne medicin.

3.

SÅDAN SKAL DU TAGE PINEX COMP

Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning. Er du i tvivl, så spørg

lægen eller på apoteket.

Tag ikke mere end den anbefalede dosis

Denne medicin bør ikke tages i mere end 3 dage. Hvis smerten ikke aftager efter 3 dage,

skal du rådføre dig med lægen.

Tag denne medicin gennem munden.

Synk tabletterne hele med vand. Om nødvendigt kan tabletterne deles i halve, så det er lettere at sluge

dem.

Voksne

Den anbefalede dosis af Pinex comp er 1 tablet

Vent mindst 4 timer før der tages en yderligere dosis

Tag ikke mere end 4 tabletter i løbet af 24 timer

20170609-Var009

Ældre personer får eventuelt ordineret en lavere dosis

Patienter med nyreproblemer kan have behov for længere intervaller mellem doser.

Unge på 16 år og derover med kropsvægt på over 50 kg:

Den anbefalede dosis af Pinex comp er 1 tablet

Vent mindst 6 timer før der tages en yderligere dosis

Tag ikke mere end 4 tabletter i løbet af 24 timer

Børn under 16 år

Pinex comp 60mg/1000mg bør ikke gives til børn under 16 år.

Kun for børnesikrede blisterpakninger:

Brugsvejledning for børnesikrede blistre:

1. Forsøg ikke at trykke tabletten direkte ud af lommen. Tabletten kan ikke trykkes ud gennem folien.

I stedet skal folien trækkes tilbage.

2. Adskil først en blisterlomme fra resten af blisterkortet ved perforeringen

3. Træk så forsigtigt bagsiden af for at åbne lommen

4. Derefter kan du tage tabletten ud af lommen.

Kun for børnesikrede beholdere

Brugsvejledning for børnesikrede beholdere:

Tryk låget ned og drej for at åbne

20170609-Var009

Hvis du har taget mange Pinex comp

Kontakt omgående din læge eller skadestuen på det nærmeste hospital, også selv om du føler, du

har det godt. Det er fordi for meget paracetamol kan medføre forsinket, alvorlig leverskade.

Husk at tage alle de resterende tabletter og pakningen med dig. Det er fordi lægen da kan se, hvad

du har taget.

Hvis du har glemt at tage Pinex comp

Hvis du har glemt at tage en dosis på det fastsatte tidspunt, kan du tage den, så snart du kommer i

tanke om det.

Hvis det næsten er tid til din næste dosis, skal du dog springe den glemte dosis over. Du må ikke tage

en dobbeltdosis som erstatning for den glemte dosis. Husk at der skal gå mindst 4 timer mellem doser

hos voksne og 6 timer mellem doser hos unge.

Hvis du holder op med at tage Pinex comp

Ændrer eller stopper behandling

Langtidsbrug af Pinex comp kan føre til tolerans og afhængighed. Hvis du har taget regelmæssige

daglige doser af Pinex comp i lang tid, kan du eventuelt få abstinenssymptomer hvis du pludselig

stopper behandling. Rådfør dig med din læge om hvordan du gradvist stopper med at tage tabletterne,

så du undgår abstinenssymptomer.

Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.

4.

BIVIRKNINGER

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Vigtige bivirkninger du bør kende til

Ved for ofte og for langvarig brug af smertestillende medicin mod hovedpiner kan

hovedpinerne forværres.

Regelmæssig brug af codein i for lang tid kan medføre afhængighed, som kan føre til, at du

føler dig rastløs og irritabel, når du stopper med at tage tabletterne.

Stop med at tage Pinex comp og kontakt omgående lægen eller tag til hospitalet hvis:

Du har besvær med at trække vejret, og du føler dig svimmel

Du får hævelser på hænder, fødder, ankler, ansigt, læber eller hals, der kan medføre

vejrtræknings- eller synkebesvær. Du oplever måske også et kløende, ujævnt udslæt eller

nældefeber. Dette kan betyde at du har en

allergisk reaktion

over for Pinex comp.

Du får en alvorlig hudreaktion. Der er rapporteret meget sjældne tilfælde.

20170609-Var009

Kontakt omgående lægen hvis du opdager den følgende alvorlige bivirkning:

Svære mavesmerter, som kan stråle ud i ryggen. Dette kan være et tegn på en betændelseslignende

tilstand i bugspytkirtlen (pancreatitis). Dette er en meget sjælden bivirkning.

Andre bivirkninger:

Almindelige: kan påvirke op til 1 ud af 10 personer:

Døsighed, hovedpine, unormal svedtendens, kvalme, opkastning, forstoppelse, træthed.

Ikke almindelige: kan påvirke op til 1 ud af 100 personer:

Svimmelhed, synsproblemer, mundtørhed.

Sjældne: kan påvirke op til 1 ud af 1000 personer:

Du får nemmere infektioner og blå mærker, end du plejer. Dette kan være på grund af problemer med

blodet (f.eks. agranulocytose, neutropeni, pancytopeni, anæmi eller trombocytopeni). Søvnbesvær,

åndenød, gulfarvning af huden og det hvide i øjnene (symptomer på leverskade), hududslæt.

Meget sjælden: kan påvirke op til 1 ud af 10.000 personer:

Der er meget sjældent set nyreskade hos patienter, der fik langtidsbehandling med Pinex comp.

Indberetning af bivirkninger

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 Lægemiddelstyrelsen på www.meldenbivirkning.dk eller via

Lægemiddelstyrelsen, Axel Heides Gade 1, DK-2300 København S, e-mail: dkma@dkma.dk. Ved at

indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette

lægemiddel.

5.

Opbevaring

Opbevar lægemidlet utilgængeligt for børn.

Brug ikke lægemidlet efter den udløbsdato, der står på kartonen eller etiketten efter Exp.

Udløbsdatoen er den sidste dag i den nævnte måned.

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

Kun for tabletbeholdere:

Holdbarhed efter første åbning: 100 dage.

Spørg på apoteket, hvordan du skal bortskaffe medicinrester. Af hensyn til miljøet må du ikke smide

medicinrester i afløbet, toilettet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

Pinex comp indeholder:

Aktivt stof: Paracetamol og codeinphosphathemihydrat. Hver

filmovertrukken tablet indeholder 1000 mg paracetamol og 60 mg codeinphosphat.

Øvrige indholdsstoffer: Povidon K29/32, magnesiumstearat, silica, kolloid vandfri, talcum,

natriumcroscarmellose, copovidon (25,2-30,8), cellulose mikrokrystallinsk, modificeret

stivelse, polyol, sojalecithin (E322) og titandioxid (E171)

Udseende og pakningsstørrelser

20170609-Var009

Pinex comp 60 mg/1000 mg filmovertrukne tabletter er hvide, ovale, 10,7 x 21,4 mm, bikonvekse

tabletter, mærket ’10 6’ på den ene side, med et delekærv og delekærv i siderne.

Pakningsstørrelser:

Hvide PVC/Aluminium blistre eller børnesikrede hvide PVC/Aluminium/PE/papir blistre: 8, 10, 16,

20, 24, 30, 40, 50 og 100 filmovertrukne tabletter

Hvide tabletbeholdere i plastik: 50 og 100 filmovertrukne tabletter

Ikke alle pakningsstørrelser er nødvendigvis markedsført

Indehaver af markedsføringstilladelsen og fremstiller

Indehaver af markedsføringstilladelsen

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78

220 Hafnarfjörður

Island

Repræsentant for Danmark

Actavis A/S, Ørnegårdsvej 16, 2820 Gentofte.

Fremstiller

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitsa 2600

Bulgarien

Dette lægemiddel er godkendt i EEA’s medlemslande under følgende navne:

Pinex Comp 1000 mg/60 mg

Co-Codamol

Parkódín Forte 1000 mg/60 mg

CoCodamol 1000 mg/60 mg

Co-Codamol 1000 mg/60 mg

Pinex Major

Co-Codamol Max

Paracetamol/Kodein Actavis 1000 mg/60 mg

Codamol 1000 mg/60 mg

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FDA - U.S. Food and Drug Administration

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

23-7-2018

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues making progress on bulk drug substances for compounding

FDA - U.S. Food and Drug Administration

28-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

FDA - U.S. Food and Drug Administration

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

6-6-2018

National Network for the Monitoring and Prevention of Occupational Diseases: new data published on cancers of occupational origin

National Network for the Monitoring and Prevention of Occupational Diseases: new data published on cancers of occupational origin

At the 35th French occupational medicine and health congress (CNMST) held in Marseille from 5 to 8 June 2018, ANSES presented for the very first time data on cancers of occupational origin collected by the National Network for Monitoring and Prevention of Occupational Diseases (RNV3P) coordinated by the Agency. These data are used to build up a comprehensive picture of the cancers associated with occupational exposure situations, in order toidentify the industry sectors and situations most at risk, with ...

France - Agence Nationale du Médicament Vétérinaire

5-6-2018

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.

FDA - U.S. Food and Drug Administration

22-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

The FDA is announcing three new efforts as part of a comprehensive set of actions to advance the FDA’s framework for sun protection products ahead of this coming summer

FDA - U.S. Food and Drug Administration

27-4-2018

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

Today, the Agency is publishing an inventory of alternatives to antibiotics aimed at reducing their use in animal husbandry and based on an original method for evaluating the diverse scientific publications in the field. In its report, ANSES identifies numerous products and substances including compounds, plants, plant extracts and micro-organisms, which are used as alternatives to antibiotics. However, it emphasises the diversity of the data available to assess their safety and efficacy, and their abili...

France - Agence Nationale du Médicament Vétérinaire

17-4-2018

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

FDA - U.S. Food and Drug Administration

16-1-2018

Yunnan Feng Shi Ling capsules – counterfeit

Yunnan Feng Shi Ling capsules – counterfeit

Yunnan Feng Shi Ling capsules contain the undeclared substance paracetamol.

Therapeutic Goods Administration - Australia

16-11-2017

Medicines Safety Update, Volume 8, Number 5, October-November 2017

Medicines Safety Update, Volume 8, Number 5, October-November 2017

Ibrutinib - ventricular tachyarrhythmia, hepatitis B reactivation and infection; Improving Product Information; Codeine-containing products - use in children and ultra-rapid metabolisers

Therapeutic Goods Administration - Australia

26-2-2016

New comprehensive list of euphoriant substances regulated in Denmark

New comprehensive list of euphoriant substances regulated in Denmark

You can now find a comprehensive list of euphoriant substances that are subject to control in Denmark via the executive order on euphoriant substances.

Danish Medicines Agency

27-2-2014

Paracetamol use during pregnancy

Paracetamol use during pregnancy

A new Danish study suggests a possible connection between mothers' use of paracetamol painkillers during pregnancy and the risk of developing disorders like ADHD (attention deficit hyperactivity disorder) in children.

Danish Medicines Agency

3-8-2012

Danish Pharmacovigilance Update, 21 June 2012

Danish Pharmacovigilance Update, 21 June 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Decrease in the number of intoxications and suicide attempts using drugs containing acetylsalicylic acid or paracetamol.

Danish Medicines Agency

26-8-2011

Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine

Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine

On 15 August 2011, the Danish Medicines Agency announced that we would begin reassessing the reimbursement status of medicines in ATC group N02A, opioids. The Reimbursement Committee opened its preliminary discussions at its meeting on 23 August 2011 and recommended to include the opioids methadone (N07BC02) and codeine (R05DA04), also used in pain management, in the reassessment of reimbursement status of medicinal products in ATC group N02A.

Danish Medicines Agency

8-9-2009

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

On 3 september 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds).

Danish Medicines Agency

11-9-2018

Agenda:  Agenda - COMP agenda of the 11-13 September 2018 meeting

Agenda: Agenda - COMP agenda of the 11-13 September 2018 meeting

Europe - EMA - European Medicines Agency

30-8-2018

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'. Closing date 31 October 2018

Therapeutic Goods Administration - Australia

30-8-2018

Modified release paracetamol

Modified release paracetamol

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'

Therapeutic Goods Administration - Australia

17-8-2018

 Minutes of the COMP meeting of 22-24 May 2018

Minutes of the COMP meeting of 22-24 May 2018

Europe - EMA - European Medicines Agency

17-8-2018

 Minutes of the COMP meeting of 19-21 June 2018

Minutes of the COMP meeting of 19-21 June 2018

Europe - EMA - European Medicines Agency

19-7-2018

Regulatory and procedural guideline:  Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018

The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA).

Europe - EMA - European Medicines Agency

17-7-2018

Agenda:  Agenda - COMP agenda of the 17-19 July 2018 meeting

Agenda: Agenda - COMP agenda of the 17-19 July 2018 meeting

Draft agenda for the meeting on 17-19 July 2018

Europe - EMA - European Medicines Agency

16-7-2018

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments: https://go.usa.gov/xQ7Jb  pic.twitter.com/hQxiKdMZBK

FDA - U.S. Food and Drug Administration

28-6-2018

 Minutes of the COMP meeting of 17-19 April 2018

Minutes of the COMP meeting of 17-19 April 2018

Europe - EMA - European Medicines Agency

18-6-2018

Agenda:  Agenda - COMP agenda of the 19-21 June 2018 meeting

Agenda: Agenda - COMP agenda of the 19-21 June 2018 meeting

Committee for Orphan Medicinal Products (COMP) draft agenda for the meeting on 19-21 June 2018

Europe - EMA - European Medicines Agency

1-6-2018

hydrocodone (Vicodin®), codeine, morphine, and many others. #DYK #FDAInnovationChallenge (2 of 2 messages)  https://go.usa.gov/xQwmW pic.twitter.com/bGlnTFOzVE

hydrocodone (Vicodin®), codeine, morphine, and many others. #DYK #FDAInnovationChallenge (2 of 2 messages) https://go.usa.gov/xQwmW pic.twitter.com/bGlnTFOzVE

hydrocodone (Vicodin®), codeine, morphine, and many others. #DYK #FDAInnovationChallenge (2 of 2 messages) https://go.usa.gov/xQwmW  pic.twitter.com/bGlnTFOzVE

FDA - U.S. Food and Drug Administration

28-5-2018

 Minutes of the COMP meeting of 13-15 March 2018

Minutes of the COMP meeting of 13-15 March 2018

Europe - EMA - European Medicines Agency

22-5-2018

Agenda:  Agenda - COMP agenda of the 22-24 May 2018 meeting

Agenda: Agenda - COMP agenda of the 22-24 May 2018 meeting

Europe - EMA - European Medicines Agency

15-5-2018

 Minutes of the COMP meeting of 13-15 February 2018

Minutes of the COMP meeting of 13-15 February 2018

Europe - EMA - European Medicines Agency