natgillin/translations-raw huggingface dataset:
Arcoxia 30 mg, comprimé pelliculé ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg film- coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg Auxib 30 mg, 60 mg, 90 mg, 120 mg
ARCOXIA ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30, 60, 90, 120 mg Arcoxia Arcoxia Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen Turox 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen
Irland Island Italien
France Germany Greece Hungary Iceland Ireland Italy
Arcoxia 30, 60, 90 or 120 mg film- coated tablets Arcoxia Arcoxia 30, 60, 90, 120 mg compresse rivestite con film Algix 30, 60, 90, 120 mg compresse rivestite con film Recoxib 30, 60, 90, 120 mg compresse rivestite con film Tauxib 30, 60, 90, 120 mg compresse rivestite con film
Arcoxia 30 mg, comprimé pelliculé ARCOXIA 30/ 60/ 90/ 120 mg Filmtabletten ARCOXIA 30mg, 60mg, 90mg,120mg film-coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg filmtabletta Arcoxia Arcoxia 30, 60, 90 or 120 mg film-coated tablets Arcoxia 30, 60, 90, 120 mg compresse rivestite con film Algix 30, 60, 90, 120 mg compresse rivestite con film Recoxib 30, 60, 90, 120 mg compresse rivestite con film Tauxib 30, 60, 90, 120 mg compresse rivestite con film
Letland Litauen
Latvia Lithuania Luxembourg
Arcoxia 30 mg, 60 mg, 90 mg un 120 mg apvalkotās tablets Arcoxia 30, 60, 90, 120 mg plėvele dengtos tabletės
Arcoxia 30 mg, 60 mg, 90 mg un 120 mg apvalkotā s tablets Arcoxia 30, 60, 90, 120 mg plė vele dengtos tabletė s Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés Ranacox 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés
43 Luxemburg
Malta Netherlands
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés Ranacox 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés
ARCOXIA 30, 60, 90 or 120 mg film-coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg
Malta Norge Polen Portugal
Auxib 30 mg, 60 mg, 90 mg, 120 mg Norway Poland Portugal
ARCOXIA 30, 60, 90 or 120 mg film- coated tablets Arcoxia ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg tabletki powlekane ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película TUROX 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película EXXIV 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película
Arcoxia ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg tabletki powlekane ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película TUROX 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película EXXIV 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película
Rumænien Slovakiet Slovenien Spanien
Romania Slovakia Slovenia Spain
ARCOXIA 60 mg, 90 mg, 120 mg comprimate filmate ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30/ 60/ 90/ 120 mg filmsko obložene tablete Arcoxia 30, 60, 90 y 120 mg comprimidos recubiertos con película Exxiv 60, 90 y 120 mg comprimidos recubiertos con película
ARCOXIA 60 mg, 90 mg, 120 mg, comprimate filmate ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30/ 60/ 90/ 120 mg filmsko oblož ene tablete Arcoxia 30, 60, 90 y 120 mg comprimidos recubiertos con película Exxiv 60, 90 y 120 mg comprimidos recubiertos con película
Storbritannien Sverige
Sweden
ARCOXIA 30, 60, 90 or 120 mg film- coated tablets Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter Turox 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter
Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter Turox 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter
Tjekkiet Tyskland Ungarn Østrig
United Kingdom
ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg ARCOXIA 30/ 60/ 90/ 120 mg Filmtabletten Arcoxia 30 mg, 60 mg, 90 mg, 120 mg filmtabletta Arcoxia 30 mg, 60 mg, 90 mg, 120 mg- Filmtabletten Auxib 30 mg, 60 mg, 90 mg, 120 mg- Filmtabletten
ARCOXIA 30, 60, 90 or 120 mg film-coated tablets
Denne indlægsseddel blev senest godkendt MM/ ÅÅÅÅ
This leaflet was last approved in (MM/ YYYY).
44 BILAG IV
44 CONDITIONS OF THE MARKETING AUTHORISATION
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
who prescribe etoricoxib according to national practice.
45 BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
45
London, den 23. oktober 2008 EMEA/ CHMP/ 620046/ 2008
London, 23 October 2008 EMEA/ 542169/ 2008
Lægemidler indeholdende Etoricoxib
Etoricoxib containing medicinal products
Denne procedure for indbragte sager vedrører en anmodning om voldgift vedrørende risk/ benefit - forholdet ved en dosis på 90 mg etoricoxib i behandlingen af reumatoid artritis og ankyloserende spondylitis (AS).
This referral procedure relates to a request for arbitration concerning the benefit/ risk of the 90mg dose of etoricoxib in the treatment of RA and ankylosing spondylitis (AS).
Ved afslutningen af den gensidige anerkendelsesprocdure for ændringen med den udvidede indikation til at omfatte ankyloserende spondylitis havde EU- medlemsstaterne forskellige opfattelser af sikkerheden i forbindelse med etoricoxib ved en dosis på 90 mg.
At the end of the mutual recognition procedure for the variation to extend the indication to include AS, there was a discrepancy between different European Union (EU) Member States regarding the safety of etoricoxib at the 90mg dose.
Da disse betænkeligheder ikke blev tilbagevist under proceduren, og da dosis på 90 mg etoricoxib blev anvendt til såvel reumatoid artritis og ankyloserende spondylitis, indgav Frankrig den 19. september 2007 en meddelelse om officiel indbringelse til voldgift, jf. artikel 31, stk.
As these concerns were not resolved during the course of the procedure, and since the 90mg dose of etoricoxib was used in both RA and AS, a notification of an official referral for arbitration under Article 31(2) of Directive 2001/ 83, as amended to the CHMP was made by France on 19 September 2007.
De betænkeligheder, som Frankrig havde identificeret og ikke fået afklaring på, var primært den langsigtede sikkerhed i forbindelse med en daglig dosis på 90 mg etoricoxib i lyset af den eventuelle øgede kardiovaskulære risiko i tilknytning til anvendelsen af en daglig dosis på 90 mg etoricoxib ved ankyloserende spondylitis og reumatoid artritis.
The main unresolved areas of concern identified by France were concerns regarding long term safety of a daily dose of 90mg etoricoxib in the view of possible increased cardiovascular (CV) risk related to the use of the 90mg dose in the RA and AS indications.
Frankrig mente, at en gennemgang af risk/ benefit - profilen for lægemidler indeholdende etoricoxib var af fællesskabsinteresse.
France considered that a review of the benefit/ risk profile of etoricoxib containing medicinal products was of Community interest.
CHMP drøftede voldgiftsproceduren på sit plenarmøde i september 2007, og dr.
The arbitration procedure was discussed by the CHMP at its plenary meeting in September 2007 and a Rapporteur (Dr.
Karl Broich og dr.
Karl Broich) and Co-Rapporteur (Dr.
Matthew Thatcher blev udpeget til henholdsvis rapportør og medrapportør.
Matthew Thatcher) were appointed.
Proceduren for indbragte sager blev indledt den 20. september 2007 med vedtagelse af CHMP' s liste med spørgsmål, som indehaverne af markedsføringstilladelserne skulle besvare.
The referral procedure was initiated on 20 September 2007 with the adoption of a CHMP list of questions that were to be addressed by the marketing authorisation holders (MAHs).
På mødet i februar 2008 blev dr.
During the February 2008 plenary meeting Dr.
Rafe Survana udpeget til medrapportør i stedet for dr.
Rafe Survana was appointed Co-Rapporteur, replacing Dr.
Indehaverne af markedsføringstilladelsen fremsendte skriftlige redegørelser den 14. december 2007, 5. maj 2008, 12. juni 2008 og 20. juni 2008.
Written explanations were provided by the MAHs on 14 December 2008, 5 May 2008, 12 June 2008 and 20 June 2008.
CHMP konkluderede, at de forelagte data bekræftede den kendte renovaskulære sikkerhedsprofil i forbindelse med etoricoxib (hypertension, ødemer og kongestiv hjerteinsufficiens).
The CHMP concluded that the data confirmed the known renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure).
Dataene bekræftede endvidere samme thrombotiske kardiovaskulære risiko som for diclofenac og nogen fordel i forbindelse med øvre gastrointestinale hændelser i forhold til naproxen og diclofenac (men ingen særlig sikkerhedsfordel i forbindelse med nedre gastrointestinale hændelser).
There was little direct comparative safety data for individual non-steroidal anti-inflammatory drugs (NSAIDs) other than diclofenac and naproxen.
Der findes kun få direkte 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
The CHMP therefore recommended the strengthening of the contraindication in 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
CHMP anbefalede derfor, at kontraindikationen for patienter med for højt blodtryk skærpes, og at ordinerende læger advares om, at blodtrykket skal kontrolleres, navnlig i de 2 første uger efter behandlingens start.
Reproduction is authorised provided the source is acknowledged. hypertensive patients and alerts prescribers that blood pressure needs to be monitored, especially within 2 weeks of treatment initiation.
Sundhedspersonale skal underrettes om disse foranstaltninger i en meddelelse (Kære sundhedspersonale- brev).
Healthcare professionals were to be reminded of these measures through a communication letter (Dear Healthcare Professional Letter).
Oplysninger fra kliniske undersøgelser viste en klinisk betydningsfuld behandlingseffekt ved en daglig dosis på 90 mg etoricoxib ved både reumatoid artritis og ankyloserende spondylitis; der foreligger imidlertid nogle oplysninger, der tyder på, at lavere doser også kan have en effekt.
Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for both RA and AS indications; however, some data are available to indicate that lower doses might also show effect.
CHMP anbefalede derfor, at der skulle gennemføres dosisfindingsundersøgelser for at fastslå, om behandling med 60 mg en gang dagligt også ville være passende hos nogle patienter.
The CHMP therefore recommended that dose finding studies should be explored to conclude if treatment with 60mg once daily would also be adequate for some patients.
På baggrund af vurderingen af de oplysninger, der er blevet fremlagt, var CHMP af den opfattelse, at fordelene ved etoricoxib er større end risiciene i behandlingen af reumatoid artritis og ankyloserende spondylitis.
Based on the review of the available data, the CHMP considered that the benefits of etoricoxib outweigh the risks in the treatment of rheumatoid arthritis and ankylosing spondylitis.
På baggrund af de data, som indehaverne af markedsføringstilladelsen havde fremsendt, anbefalede CHMP den 26. juni 2008 at godkende ændringen af markedsføringstilladelserne.
On 26 June 2008, the CHMP, having considered the data provided by the MAHs, recommended the granting of the variation to the marketing authorisations.
De faglige konklusioner findes i bilag II, den ændrede produktinformation i bilag III og betingelserne for markedsføringstilladelsen i bilag IV.
The scientific conclusions are provided in Annex II, the amended product information in Annex III and the conditions of the marketing authorisation in Annex IV.
Den endelige udtalelse blev omdannet til en afgørelse truffet af Europa- Kommissionen den 9. september 2008.
The final opinion was converted into a decision by the European Commission on 9 September 2008.
Oplysningerne i dette dokument og bilagene hertil afspejler kun CHMP' s udtalelse af 26. juni 2008.
∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 26 June 2008.
Medlemsstaternes kompetente myndigheder fører fortsat regelmæssigt tilsyn med produktet.
The Member States’ competent authorities will continue to keep the product under regular review.
28. november 2005 EMEA/ CHMP/ 383082/ 2005
28 November 2005 EMEA/ CHMP/ 324317/ 2005
UDTALELSE FRA UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 31 FOR SAMTLIGE LÆGEMIDLER INDEHOLDENDE CELECOXIB, ETORICOXIB, LUMIRACOXIB, PARECOXIB OG VALDECOXIB
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL
ETORICOXIB
ETORICOXIB
2309/ 93, formålet med proceduren til ud over de kardiovaskulære sikkerhedsaspekter også at omfatte vurderingen af oplysninger om alvorlige hudreaktioner.
Therefore, on 20 April 2005 further to a request from the EC, the CHMP broadened the scope of the procedure under Article 31 of Directive 2001/ 83/ EC, as amended and the review procedure under Article 18 of Council Regulation (EEC) No 2309/ 93, to include the assessment of serious skin reactions in the ongoing class review in addition to the cardiovascular safety aspects.
Indehaverne af markedsføringstilladelserne afgav mundtlige redegørelser den 18. januar 2005.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int  EMEA 2005 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Upon consideration of all available data, the CHMP adopted an opinion for etoricoxib on 23 June 2005 recommending the maintenance of the Marketing Authorisations for etoricoxib containing medicinal products in the indications stated in the Summary of Product Characteristics as set out in Annex III.
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE OG NORGE OG ISLAND
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
Lœgemiddel- form
Film-coated tablet
Indgivelses- vej
Oral use
Chaussée de Waterloo, 1135 B - 1180 Bruxelles Belgien
Chaussée de Waterloo 1135 B-1180 Brussels Belgium
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem Holand
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
60 mg
90 mg
Medlems - land
3 Member State
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem Holland
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
90 mg
60 mg
120 mg
90 mg
Waarderweg 39, Post Bus 581 2003 PC Haarleem Holland
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
60 mg
120 mg
Waaderweg 39, Post Bus 581 2003 PC Haarleem Holland
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
Estland
Strength
Merck Sharp & Dohme OÜ Peterburi tee 46 11415 Tallinn Estland
Route of administration
Merck Sharp & Dohme OÜ Peterburi tee 46 11415 Tallinn Estland
Merck Sharp & Dohme OÜ Peterburi tee 46 11415 Tallinn Estonia
Merck Sharp & Dohme OÜ Peterburi tee 46
Merck Sharp & Dohme OÜ Peterburi tee 46 11415 Tallinn Estonia
3 Medlems - land
Estonia
Indehaver af markedføringstilladelsen
Merck Sharp & Dohme OÜ Peterburi tee 46 11415 Tallinn Estonia
Sœrnavn
Arcoxia
Styrker
120 mg
11415 Tallinn Estland Finland
Finland
Haarlem Holland
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
60 mg
60mg
90 mg
90mg
120 mg
120mg
Vianex S. A.
Germany
18th Km Athens- Lamia
MSD Sharp & Dohme GmbH Lindenplatz 1 85540 Haar Germany
Arcoxia
Etoricoxib MSD
4 Medlems - land
6 Member State
National Road 14671Nea Erythrea, Athens Grækenland
MSD Sharp & Dohme GmbH Lindenplatz 1 85540 Haar Germany
Pharmaceuticals & Cosmetic Industry Licensee/ Distributor of Merck Sharp & Dohme Tatoiou Street.
MSD Sharp & Dohme GmbH Lindenplatz 1 85540 Haar Germany
Arcoxia
Auxib
90 mg
120 mg
120 mg
60 mg
Turox
Arcoxia
5 Medlems - land
7 Member State
14671Nea Erythrea, Athens Grækenland
Vianex S. A Tatoiou Street 18 Km Athens-Lamia National Road 14671 Nea Erythrea Athens Greece
Vianex S. A.
Greece
18th Km Athens- Lamia National Road 14671Nea Erythrea, Athens Grækenland
Vianex S. A Tatoiou Street 18 Km Athens-Lamia National Road 14671 Nea Erythrea Athens Greece
Box 581 2003 PC Haarlem Holland
Vianex S. A Tatoiou Street 18 Km Athens-Lamia National Road 14671 Nea Erythrea Athens Greece
Arcoxia 60
Turox
Merck Sharp & Dohme BV Waarderweg 39, Post Bus 581 2003 PC Haarlem Holland
Vianex S. A Tatoiou Street 18 Km Athens-Lamia National Road 14671 Nea Erythrea Athens Greece
Arcoxia 90
Turox
Holland
8 Member State
Merck Sharp & Dohme BV Waarderweg 39, Post Bus 581 2003 PC Haarlem Holland
Marketing Authorisation Holder
Arcoxia 120
Invented name
120 mg
Strength
Filmovertrukket tablet
Pharmaceutical Form
Auxib 60
Turox
60 mg
120mg
Merck Sharp & Dohme BV Waarderweg 39, Post Bus 581 2003 PC Haarlem Holland
Alkotás utca 48-50 H-1123 Budapest Hungary
Auxib 90
Arcoxia
6 Medlems - land
Hungary
Indehaver af markedføringstilladelsen
Alkotás utca 48-50 H-1123 Budapest Hungary
Styrker
90 mg
Auxib 120
Arcoxia
Island
9 Member State
Waaderweg 39, Post Bus 581 2003 P. C.
Marketing Authorisation Holder
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU Storbritannien
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
Tablet
Film-coated tablet
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU Storbritannien
Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom
7 Medlems - land
Ireland
Indehaver af markedføringstilladelsen
Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom
Lœgemiddel- form
Tablet
Via G.
Merck Sharp E Dohme Italia S. p. A Via G.
Fabbroni, 6 I- 00191 Roma Italien
Fabbroni, 6 I-00191 Roma Italy
Via Mazzini, 112 I- 56125 Pisa Italien
Via Benedetto Croce, 37 I-56125 Pisa Italy
Via Mazzini, 112 I- 56100 Pisa Italien
Via Benedetto Croce, 37 I-56125 Pisa Italy
Viale Shakespeare, 47 00100 Roma Italien
Via dei Santi Pietro e Paolo, 30 00144 Roma Italy
SIA ” Merck Sharp & Dohme Latvija ” Skanstes iela 13 LV- 1013 Riga Letland
SIA ” Merck Sharp & Dohme Latvija” Skanstes iela 13 LV-1013 Riga Latvia
9 Medlems - land
Lithuania
Indehaver af markedføringstilladelsen
Merck Sharp & Dohme UAB, Lithuania Gelezinio Vilko 18A 01112 Vilnius Lithuania
Styrker
60 mg
Litauen
12 Member State
Merck Sharp & Dohme UAB, Lithuania Gelezinio Vilko 18A 01112 Vilnius Litauen
Marketing Authorisation Holder
60 mg
Strength
Merck Sharp & Dohme UAB, Lithuania Gelezinio Vilko 18A 01112 Vilnius Litauen
Merck Sharp & Dohme UAB, Lithuania Gelezinio Vilko 18A 01112 Vilnius Lithuania
Merck Sharp & Dohme B. V.
Merck Sharp & Dohme s. a.
Chaussée de Waterloo 1135 B- 1180 Bruxelles BELGIEN
1180, Chaussée de Waterloo B-1135 Bruxelles Belgium
10 Medlems - land
13 Member State
Merck Sharp & Dohme Limited Hertfordshire Road Hoddesdon Hertfordshire EN11 9BU Storbritannien
Merck Sharp & Dohme Limited Hertfordshire Road Hoddesdon Hertfordshire EN11 9BU United Kingdom
Filmovertrukket tablet
Tablet
Norway
The Netherlands
Merck Sharp & Dohme BV Waarderweg 39, Post Bus 581 2003 PC Haarlem Holland
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
Oral anvendelse
The Netherlands
Merck Sharp & Dohme BV Waarderweg 39, Post Bus 581 NL- 2003 PC Haarlem Holland
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
11 Medlems - land
14 Member State
MSD Polska Sp. z o. o. ul.
Pharmaceutical Form
Polen
The Netherlands
Puławska 303 02- 785 Warszawa Polen
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
Portugal
The Netherlands
Quinta da Fonte, Edifício Vasco da Gama n. º 19, Porto Salvo 2780- 730 Paço d 'Arcos Portugal
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
Mamede do Coronado Portugal
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
Exxiv
Arcoxia
12 Medlems - land
15 Member State
Vasco da Gama, 19 - Porto Salvo 2780- 730 Paço D' Arcos Portugal
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
Portugal
Poland
Farmacox - Companhia Farmacêutica, Lda Quinta da Fonte, Ed.
MSD Polska Sp. z o. o. ul.
Vasco da Gama, 19 - Porto Salvo 2780- 730 Paço D' Arcos Portugal
Puł awska 303 02-785 Warszawa Poland
90mg
60 mg
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem Holland
Puł awska 303 02-785 Warszawa Poland
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem Holland
Merck Sharp & Dohme, Lda Quinta Da Fonte Edificio Vasco da Gama, nº19, Porto Salvo 2770-192 Paço d´Arcos Portugal
13 Medlems - land
16 Member State
Šmartinska cesta 140 SI- 1000 Ljubljana Slovenien
Merck Sharp & Dohme, Lda Quinta Da Fonte Edificio Vasco da Gama, nº19, Porto Salvo 2770-192 Paço d´Arcos Portugal
Merck sharp & Dohme Ltd.
Bial-Portela & Ca., S. A.
Šmartinska cesta 140 SI- 1000 Ljubljana Slovenien
Mamede do Coronado Portugal
120 mg
Av.
Filmovertrukket tablet
Da Siderurgia Nacional 4745-457 S.
Spanien
Mamede do Coronado Portugal
Merck Sharp & Dohme de Espana, S. A. c / Josefa Valcarcel 38 28027 Madrid Spanien
Bial-Portela & Ca., S. A.
90 mg
Av.
Laboratorios Abello c / Josefa Valcarcel 38 28027 Madrid Spanien
Turox Quinta Da Fonte Edificio Vasco da Gama, nº19, Porto Salvo 2770-192 Paço d´Arcos Portugal
14 Medlems - land
17 Member State
Laboratorios Abello c / Josefa Valcarcel 38 28027 Madrid Spanien
Farmacox-Companhia Farmacêutica, Lda.
Merck Sharp & Dohme BV Waarderweg 39, Post Bus 581 2003 PC Haarlem Holland
Turox Quinta Da Fonte Edificio Vasco da Gama, nº19, Porto Salvo 2770-192 Paço d´Arcos Portugal
Merck Sharp & Dohme BV Waarderweg 39, Post Bus 581 2003 PC Haarlem Holland
Merck Sharp & Dohme B. V Arcoxia Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
Merck Sharp & Dohme BV Waarderweg 39, Post Bus 581 2003 PC Haarlem Holland
Š martinska cesta 140 SI-1000 Ljubljana Slovenia
15 Medlems - land
18 Member State
Storbritannien
Slovenia
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU Storbritannien
Š martinska cesta 140 SI-1000 Ljubljana Slovenia
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU Storbritannien
Josefa Valcárcel 38 Madrid 28027 SPAIN
Auxib
Arcoxia
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU
Josefa Valcárcel 38 Madrid 28027 SPAIN
16 Medlems - land
Spain
Indehaver af markedføringstilladelsen
Josefa Valcárcel 38 Madrid 28027 SPAIN
Sœrnavn
Exxiv
Styrker
120mg
Storbritannien
19 Member State
Storbritannien
Marketing Authorisation Holder
Exxiv
Invented name
Tablet
Pharmaceutical Form
Storbritannien
Sweden
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU Storbritannien
Merck Sharp & Dohme B. V Waarderweg 39 Post Bus 581 2003 PC Haarlem The Netherlands
17 Medlems - land
20 Member State
MSD Sharp & Dohme GmbH Lindenplatz 1 85540 Haar Tyskland
Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom
Etoricoxib MSD
Arcoxia
Alkotás utca 50 H- 1123 Budapest Ungarn
Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom
Østrig
21 Member State
Donau- City Strasse 6 A- 1220 Wien Østrig
Marketing Authorisation Holder
Donau- City Strasse 6 A- 1220 Wien Østrig
Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom
Donau- City Strasse 6 A- 1220 Wien
Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom
18 Medlems - land
United Kingdom
Indehaver af markedføringstilladelsen
Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom
Auxib
Turox
19 BILAG II
22 Member State
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRINGEN AF PRODUKTRESUMEET FREMLAGT AF EMEA
Marketing Authorisation Holder
20 FAGLIGE
Invented name
KONKLUSIONER
Strength
VEDRØRENDE
Pharmaceutical Form
ÆNDRINGEN
23 ANNEX II
AF
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
MARKEDSFØRINGSTILLADELSEN
24 SCIENTIFIC CONCLUSIONS FOR THE AMENDMENT OF THE MARKETING AUTHORISATION
- de nye oplysninger om rofecoxib fra den kliniske undersøgelse APPROVe, der viste risiko
- the new data provided on rofecoxib by the APPROVe clinical study, which revealed a risk of
for thrombotiske kardiovaskulære hændelser,
thrombotic CV events,
- oplysningerne om celecoxib i APC- undersøgelsen, som tydede på en dosisrelateret øget
- the data on celecoxib presented in the APC study, which suggested a dose-related increased risk