natgillin/translations-raw huggingface dataset:
4. 3 Kontraindikationer • Fortilfælde af gastrointestinal ulceration, blødning eller perforation. • Patienter med fortilfælde af gastrointestinale lidelser, der prædisponerer til blødningstilstande såsom colitis ulcerosa, Chrohns sygdom, gastrointestinal cancer eller diverculitis. • Patienter med aktivt peptisk ulcus, inflammatoriske gastrointestinale lidelser eller gastrointestinal blødning. • Samtidig anvendelse af andre NSAID- præparater, herunder COX- 2 selektive NSAID og acetetylsalicylsyre ved smertestillende doser. • Samtidig anvendelse af antikoagulantia. • Patienter, der tidligere har haft alvorlige allergiske lægemiddelreaktioner af enhver type, især kutanreaktioner såsom erythema multiforme, Stevens- Johnsons syndrom, toksisk epidermal nekrolyse. • Overfølsomhed over for det aktive stof, tidligere hudreaktioner (uanset alvorlighed) i forbindelse med brugen af piroxicam, andre NSAID og anden medicin.
Radiculalgia 4.3 Contraindications … []… • “ History of gastro-intestinal ulceration, bleeding or perforation. • Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn’ s disease, gastrointestinal cancers or diverticulitis. • Patients with active peptic ulcer, inflammatory gastrointestinal disorder or gastrointestinal bleeding. • Concomitant use with other NSAIDs, including COX-2 selective NSAIDs and acetyl-salicylic acid at analgesic doses. • Concomitant use with anticoagulants. • History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. • Hypersensitivity to the active substance, previous skin reaction (regardless of severity) to piroxicam, other NSAIDs and other medications .” … []…
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special Warnings and Special Precautions for Use
Bivirkningerne kan minimeres ved at bekæmpe symptomerne i så kort tid og med så lav dosis som muligt.
… []… “ Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms.
Ved den første forekomst af kutanreaktion eller relevant gastrointestinal hændelse skal behandlingen straks seponeres.
The clinical benefit and tolerability should be re-evaluated periodically and treatment should be immediately discontinued at the first appearance of cutaneous reactions or relevant gastrointestinal events .” … []…
Gastrointestinale virkninger, risiko for gastrointestinal ulceration, blødning og perforation.
… []… “ Gastrointestinal (GI) Effects, Risk of GI Ulceration, Bleeding, and Perforation.
NSAID- præparater, herunder piroxicam, kan forårsage alvorlige gastrointestinale hændelser, herunder blødning, ulceration eller perforation i maven, tyndtarmen eller tyktarmen, og disse kan være fatale.
NSAIDs, including piroxicam, can cause serious gastrointestinal events including bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal.
Disse alvorlige bivirkninger kan opstå på ethvert tidspunkt under behandlingen med NSAID- præparater, med eller uden advarende symptomer.
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.
Både korttids- og langtidsbehandling med NSAID kan give en øget risiko for alvorlige gastrointestinale bivirkninger.
NSAID exposures of both short and long duration have an increased risk of serious GI event.
Epidemiologiske studier tyder på, at brugen af piroxicam kan være forbundet med stor risiko for alvorlig gastrointestinal toksicitet i forhold til andre NSAID- præparater.
Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs.
4. 3 og nedenfor).
Patients with significant risk factors for serious GI events should be treated with piroxicam only after careful consideration (See sections 4.3 and below).
Behovet for kombinationsbehandling med slimhindebeskyttende midler (f. eks. misoprostol eller protonpumpehæmmere) bør omhyggeligt overvejes (se pkt.
The possible need for combination therapy with gastro-protective agents (e. g. misoprostol or proton pump inhibitors) should be carefully considered.
Alvorlige gastrointestinale komplikationer Identifikation af risiko- personer Risikoen for udvikling af alvorlige gastrointestinale komplikationer stiger med alderen.
Serious GI Complications Identification of at-risk subjects The risk for developing serious GI complications increases with age.
4. 5).
Patients taking concomitant oral corticosteroids, selective serotonin reuptake inhibitors (SSRIs) or anti-platelet agents such as low-dose acetylsalicylic acid are at increased risk of serious GI complications (see below and section 4.5).
Ligesom for andre NSAID- præparater bør brugen af piroxicam i kombination med slimhindebeskyttende midler (f. eks. misoprostol eller protonpumpehæmmere) overvejes til disse risiko- patienter.
As with other NSAIDs, the use of piroxicam in combination with protective agents (e. g. misoprostol or proton pump inhibitors) must be considered for these at- risk patients.
Patienter og læger bør være opmærksomme på tegn og symptomer på gastrointestinal ulceration og/ eller blødning under piroxicam- behandling.
Patients and physicians should remain alerted for signs and symptoms of GI ulceration and/ or bleeding during piroxicam treatment.
Hvis en gastrointestinal komplikation opstår hos patienter i behandling med piroxicam, skal behandlingen straks seponeres, og ny klinisk vurdering og behandling bør overvejes.
If a gastrointestinal complication is suspected during treatment, piroxicam should be discontinued immediately and additional clinical evaluation and treatment should be considered .” … []…
4. 8).
… []… “ Skin reactions Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8).
Epidemiologiske studier tyder på, at brugen af piroxicam kan være forbundet med en større risiko for alvorlige hudreaktioner i forhold til nogle andre NSAID - præparater.
Evidence from observational studies suggests that piroxicam may be associated with a higher risk of serious skin reactions than other non-oxicam NSAIDs.
Behandling med piroxicam bør straks seponeres ved symptomer som udslæt, slimhindelæsioner eller andre tegn på overfølsomhedsreaktion.
Piroxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity .” … []…
4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other Medicinal Products and other forms of Interaction
4. 4).
… []… “ As with other NSAIDs, the use of piroxicam together with acetyl-salicylic acid or concomitant use with other NSAIDs, including other piroxicam formulations, must be avoided, since data are inadequate to show that such combinations produce greater improvement than that achieved with piroxicam alone; moreover, the potential for adverse reactions is enhanced (see section 4.4).
4. 4).
Human studies have shown that concomitant use of piroxicam and acetyl-salicylic acid reduces the plasma piroxicam concentration to about 80% of the usual value Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Antikoagulantia:
Anti-coagulants:
NSAID- præparater, herunder piroxicam kan forstærke effekten af antikoagulantia, såsom warfarin.
NSAIDs, including piroxicam, may enhance the effects of anti-coagulants, such as warfarin.
4. 3).
Therefore, the use of piroxicam with concomitant anticoagulant such as warfarin should be avoided.
Øget risiko for gastrointestinal blødning (se pkt.
(see section 4.3).
ÆNDRINGER, DER SKAL INKLUDERES I RELEVANTE AFSNIT I INDLÆGSSEDLEN FOR SYSTEMISKE LÆGEMIDDELFORMULERINGER, DER INDEHOLDER PIROXICAM
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4) .” … []… AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLETFOR SYSTEMIC FORMULATIONS OF PIROXICAM CONTAINING MEDICINAL PRODUCTS
PIROXICAMS [Særnavn] VIRKNING, OG HVAD DE SKAL BRUGE DET TIL Lægen vil vurdere fordelene ved denne medicin over for risikoen for at udvikle bivirkninger, før lægen ordinerer piroxicam.
WHAT IS PIROXICAM [Invented name] AND WHAT IT IS USED FOR …. []… “ Before prescribing piroxicam, your doctor will assess the benefits this medicine may give you against your risk of developing side effects.
Deres læge vil kun udskrive piroxicam til Dem, hvis lindring af symptomerne ikke er tilfredsstillende efter brug af andre NSAID- præparater.
Your doctor will prescribe piroxicam to you only when you have had unsatisfactory relief of symptoms with other non-steroidal anti-inflammatory medicines (NSAIDs) .” …. []…
• hvis De tidligere har haft mavesår, sår på tarmen, mave- tarmblødning eller perforation • hvis De har mavesår, sår på tarmene, mave- tarmblødning eller perforation • hvis De har eller har haft fortilfælde af mave- tarm- lidelser (betændelse i maven eller tarmene), som kan føre til blødningstilstande, såsom blødende tyktarmbetændelse (colitis ulcerosa), kronisk betændelse i mave og tarm (Crohns sygdom), mave- tarmkræft eller diverticulitis (betændelse eller inficeret udposning i tyktarmen) • hvis De tager andre NSAID- præparater, herunder COX- 2 selektive NSAID- præparater og acetylsalicylsyre (et stof, der findes i megen medicin, som bruges til at lindre smerter og nedsætte feber. • hvis De tager blodfortyndende medicin såsom warfarin • hvis De tidligere har haft en alvorlig allergisk reaktion i forbindelse med brugen af piroxicam, andre NSAID og anden medicin, især alvorlige hudreaktioner (uanset sværhedsgrad), såsom eksfoliativ dermatitis (intens rødmen af huden med afskalning i skæl eller flager), dannelse af store og små blærer (Stevens- Johnsons syndrom, en tilstand med røde blærer, sårdannelse, blodig eller skorpet hud) og toksisk epidermal nekrolyse (en tilstand med blærer og afskalning af hudens øverste lag).
DO NOT TAKE PIROXICAM: …. []… • “ If you previously had a stomach or intestinal ulcer, bleeding or perforation. • If you currently have stomach or intestinal ulcer, bleeding or perforation. • If you have or have had a history of gastrointestinal disorders (inflammation of the stomach or intestines) that predispose to bleeding disorders such as ulcerative colitis, Crohn’ s disease, gastrointestinal cancers, diverticulitis (inflamed or infected pouches/ pockets in the colon). • If you are taking other NSAIDs, including COX-2 selective NSAIDs and acetyl-salicylic acid, a substance present in many medicines used to relieve pain and lower fever. • If you are taking anticoagulants, such as warfarin, to prevent blood clots. • If you previously had a serious allergic drug reaction to piroxicam, other NSAIDs and other medications, especially serious skin reactions (regardless of severity) such as exfoliative dermatitis (intense reddening of skin, with skin peeling off in scales or layers), vesiculo-bullous reactions (Stevens-Johnson syndrome, a condition with red blistered, eroded, bloody or crusted skin) and toxic epidermal necrolysis, (a disease with blistering and peeling of the top layer of skin) .” …. []… • “ If any of these applies to you, you should not be given piroxicam.
Kontakt straks lægen.
Tell your doctor immediately .” …. []…
Vær ekstra forsigtig med at tage [Særnavn]: og fortæl det altid til lægen, før De bruger [Særnavn] som for andre NSAID- præparater kan [Særnavn] give alvorlige reaktioner i maven og tarmene, såsom smerter, blødning, sår og perforation.
TAKE SPECIAL CARE WITH… …. []… “ Take special care with [Invented name] and always tell your doctor before using [Invented name]: like all non-steroidal-anti-inflammatory drugs, [Invented name] can cause serious reactions in the stomach and intestines, such as pain, bleeding, ulceration, and perforation.
Kontakt straks lægen.
You should immediately stop taking piroxicam and tell your doctor if you have stomach pain, or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements, or vomiting blood.
Kontakt straks lægen.
You should immediately stop taking piroxicam and tell your doctor if you have any allergic reaction such as a skin rash, swelling of the face, wheezing or difficulty breathing.
Dette gælder også for medicin, som ikke er på recept.
Make sure you have told your doctor about any other medicines that you are taking, including those that you have bought without a prescription .” …. []…
Fortæl det altid til lægen, hvis De tager anden medicin eller har taget det for nylig (i sidste uge).
TAKING OTHER MEDICINES …. []… “ Tell your doctor about any other medicines you are taking or took recently (in the last week) – even medicines you bought yourself without a prescription.
Dette gælder også for medicin, som ikke er på recept.
Medicines can sometimes interfere with each other.
De skal især være opmærksom:
It’ s especially important to mention:
- hvis De tager acetylsalicylsyre eller andre NSAID- præparater til lindring af smerter
- if you are taking aspirin or other non-steroidal anti-inflammatory drugs for pain relief
- hvis De tager binyrebarkhormoner, der er medicin til behandling af forskellige tilstande, såsom allergi
- if you are taking corticosteroids, which are drugs given to treat a variety of conditions such as
og ubalance i hormonerne
allergies and hormone imbalances
- hvis De tager blodfortyndende medicin for at hindre blodet i at størkne, såsom warfarin
- if you are taking anticoagulants such as warfarin to prevent blood clots
- hvis De tager visse typer medicin mod depression, de såkaldte selektive serotoningenoptagshæmmere
- if you are taking certain drugs for depression called selective serotonin re-uptake inhibitors (SSRI)
(SSRI)
…. []…
- hvis De tager medicin, der forhindrer blodpropper, såsom acetylsalicylsyre
- If any of these applies to you tell your doctor immediately .”
Kontakt straks lægen, hvis noget af dette gælder for Dem.
…. []…
SÅDAN SKAL DE TAGE PIROXICAM Tag altid piroxicam nøjagtigt efter lægens anvisning.
HOW TO TAKE PIROXICAM …. []… “ Always use piroxicam exactly as your doctor has told you.
De må ikke øge dosis Hvis De føler, at medicinen ikke er effektiv nok, skal De altid kontakte lægen.
Do not increase the dose If you feel that the medicine is not very effective, always talk to your doctor.
BILAG IV
If you have any further questions on the use of this product, ask your doctor .” …. []… ANNEX IV
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN De nationale kompetente myndigheder sikrer, at indehaverne af markedsføringstilladelserne opfylder følgende vilkår:
CONDITIONS OF THE MARKETING AUTHORISATION National Competent Authorities (NCA) shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
- Der udsendes en meddelelse (Direct Healthcare Professional Communication (DHPC)) til alle
- A Direct Healthcare Professional Communication (DHPC) must be sent to all Health Care
fagfolk i sundhedssektoren, der ordinerer piroxicam i henhold til national praksis.
Professionals who prescribe piroxicam according to national practice.
Denne meddelelse skal informere de ordinerende sundhedspersoner om de risici for gastrointestinale reaktioner og hudreaktioner, der er forbundet med piroxicam, i overensstemmelse med den af CHMP godkendte DHPC.
This communication should inform healthcare professionals of the risks of gastrointestinal and skin reactions associated with piroxicam and should be in line with the DHPC endorsed by the CHMP.
London, den 20. september 2007 EMEA/ 470112/ 2007
London, 20 September 2007 EMEA/ 380917/ 2007
2, FOR
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31(2) REFERRAL
For visse ikke- selektive NSAID, herunder piroxicam, blev der imidlertid fundet behov for en yderligere vurdering af risk/ benefit forholdet.
However a need to further evaluate the benefit/ risk balance of some non-selective NSAIDs including piroxicam was identified.
Ved gennemgangen fandtes de begrænsede epidemiologiske data og oplysninger fra spontane bivirkningsindberetninger at pege på, at der er større risiko for gastrointestinale reaktioner og hudreaktioner (herunder livstruende bulløse reaktioner) for piroxicam end for andre ikke- selektive NSAID.
The review found that limited epidemiological data and spontaneous adverse drug reaction data provided a signal of increased risk of gastrointestinal and skin reactions (including life-threatening bullous reactions) for piroxicam relative to other non-selective NSAIDs.
CHMP fandt, at vurderingen gav anledning til betænkelighed vedrørende risk/ benefit forholdet for piroxicam, og underrettede Europa- Kommissionen herom.
The CHMP considered that the assessment raised concerns on the benefit/ risk balance of piroxicam and informed the European Commission accordingly.
Den 2. august 2006 indbragte Europa- Kommissionen sagen for EMEA i henhold til artikel 31 i Rådets direktiv 2001/ 83/ EF, med senere ændringer, for lægemidler indeholdende piroxicam.
On 2 August 2006, the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/ 83/ EC, as amended, for piroxicam containing medicinal products.
Calvo- Rojas.
The Rapporteur and Co-Rapporteur appointed were Dr Rossi and Dr Calvo-Rojas respectively.
Indehaverne af markedsføringstilladelserne indsendte skriftlige redegørelser den 18. december 2006 og den 13. april 2007, og afgav mundtlige forklaringer til CHMP den 22. og 23. maj 2007.
The MAHs presented oral explanations to the CHMP on 22 and 23 May 2007.
På baggrund af de foreliggende oplysninger fandt CHMP, at risk/ benefit forholdet for systemiske formuleringer af piroxicam er positivt til symptomlindring ved osteoartritis, reumatoid artritis og ankyloserende spondylitis; CHMP fandt imidlertid, at risk/ benefit forholdet for piroxicam til behandling af akutte tilstande er negativt, og at disse indikationer bør slettes.
Based on the available data the CHMP considered that the benefit/ risk balance for systemic formulations of piroxicam is positive in the treatment of symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; however the CHMP considered that the benefit/ risk balance of piroxicam in the treatment of acute conditions is negative and that these indications should be revoked.
De faglige konklusioner fremgår af bilag II, det ændrede produktresumé af bilag III, og vilkårene for markedsføringstilladelsen af bilag IV.
The scientific conclusions are provided in Annex II, together with the amended product information in Annex III and the conditions of the Marketing Authorisation in Annex IV.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 13 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged ∗ Bemærkninger: oplysningerne i dette dokument og i bilagene afspejler alene CHMP' s udtalelse dateret 21 juni 2007.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged The final opinion was converted into a Decision by the European Commission on 7 September 2007.
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE, EMBALLAGE OG PAKNINGSSTØRRELSER I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, IN THE MEMBER STATES
CPMP/ 6214/ 03
CPMP/ 6214/ 03
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Indehaver af markedføringstilladelse Addresse
Marketing Authorisation Holder
Bristol- Myers Squibb GesmbH Columbusgasse 4 A- 1101 Wien
Bristol-Myers Squibb GesmbH Columbusgasse 4 A-1101 Wien
Pravachol
Pravachol
Selipran
Selipran
Bristol- Myers Squibb Belgium SPRL/ BVBA Chaussée de La Hulpe, 185 B- 1170 Bruxelles
Bristol-Myers Squibb Belgium sa/ nv Chaussée de La Hulpe,185 B-1170 Bruxelles
Pravasine
Pravasine
Danmark
Denmark CPMP/ 6214/ 03
Bristol- Myers Squibb AB Gustavslundsvägen 12 Box 15200 S- 167 15 Bromma
Bristol-Myers Squibb AB
Pravachol
Pravachol 2/ 28
Oral anvendelse
Oral use  EMEA 2004
Bristol- Myers Squibb AB Gustavslundsvägen 12 Box 15200 S- 167 15 Bromma
Bristol-Myers Squibb AB Gustavslundsvägen 145 Box 15200 S-167 15 Bromma
Bristol- Myers Squibb AB Gustavslundsvägen 12
Bristol-Myers Squibb AB Gustavslundsvägen 145 Box 15200 S-167 15 Bromma
Styrke
France
Bristol- Myers Squibb 1, parvis de La Défence F- 92800 Puteaux
Bristol-Myers Squibb 1, parvis de La Défence F-92800 Puteaux
Elisor
Elisor
Tyskland
Germany CPMP/ 6214/ 03
Bristol- Myers Squibb GmbH Sapporobogen 6- 8 D- 80809 München
Bristol-Myers Squibb GmbH
Pravasin
Pravasin 3/ 28
Bristol- Myers Squibb GmbH Sapporobogen 6- 8 D- 80809 München
Bristol-Myers Squibb GmbH Sapporobogen 6-8 D-80809 München
Pravasin
Pravasin
Pravasin Protect
Pravasin Protect
Selip
Selip
Liprevil
Liprevil
Bristol- Myers Squibb EPE 102 Tatoiou and Kolokotroni Sreet
Bristol-Myers Squibb AEBE 102 Tatoiou and Kolokotroni Sreet 14671 Nea Erythrea Attikis
Styrke
Greece
Bristol- Myers Squibb EPE 102 Tatoiou and Kolokotroni Sreet 14671 Nea Erythrea Attikis
Bristol-Myers Squibb AEBE 102 Tatoiou and Kolokotroni Sreet 14671 Nea Erythrea Attikis
Bristol- Myers Squibb Pharmaceuticals Ltd Watery Lane IRL- Swords, Co.
Bristol-Myers Squibb Pharmaceuticals Ltd Watery Lane IRL-Swords, Co.
Lipostat
Lipostat
Irland
Ireland CPMP/ 6214/ 03
Dublin
Bristol-Myers Squibb Pharmaceuticals Ltd
Lipostat
Lipostat 5/ 28
EMEA 2004
Oral use  EMEA 2004
Indehaver af markedføringstilladelse Addresse
Dublin
IRL- Swords, Co.
Ireland
Bristol- Myers Squibb, S. r. l.
Bristol-Myers Squibb, S. p. A.
Via Virgilio Maroso, 50 I- 00142
Via Virgilio Maroso, 50 I-00142
Selectin
Selectin
Bristol- Myers Squibb B. V.
Bristol-Myers Squibb B. V.
Vijzelmolenlaan 9 NL- 3447 GX Woerden
Vijzelmolenlaan 9 NL-3447 GX Woerden
Selektine
Selektine
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6/ 28
Vijzelmolenlaan 9 NL- 3447 GX Woerden
Marketing Authorisation Holder NL-3447 GX Woerden
Selektine
Invented name
Tabletter
Pharmaceutical Form
Bristol- Myers Squibb Farmacêutica Portuguesa, Lda Edifício Fernão de Magalhães - Quinta da Fonte - Porto Salvo P- 2780 730 Paço de Arcos
Bristol-Myers Squibb Farmacêutica Portuguesa, LDA Quinta da Fonte P-2780 730 Paço de Arcos
Pravacol
Pravacol
Portugal
Portugal CPMP/ 6214/ 03
Bristol- Myers Squibb Farmacêutica Portuguesa, Lda Edifício Fernão de Magalhães - Quinta da Fonte - Porto Salvo P- 2780 730 Paço de Arcos
Bristol-Myers Squibb
Pravasin
Pravasin 7/ 28
Bristol- Myers Squibb S. L. c / Almansa, 101 E- 28040 Madrid
Grupo Bristol-Myers Squibb c/ Almansa, 101 E-28040 Madrid
Bristacol
Bristacol
Lipemol
Lipemol
Bristol- Myers Squibb Pharmaceuticals Ltd 141- 149 Staines Road Hounslow TW3 3JA
Bristol-Myers Squibb Pharmaceuticals Ltd 141-149 Staines Road Hounslow TW3 3JA
11/ 32
9/ 28
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉERNE FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
CPMP/ 6214/ 03 FAGLIGE KONKLUSIONER
CPMP/ 6214/ 03 SCIENTIFIC CONCLUSIONS
12/ 32
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SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF PRAVACHOL OG TILKNYTTEDE NAVNE (se bilag I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PRAVACHOL AND ASSOCIATED NAMES (See Annex I)
Der blev ikke fundet væsentlige problemer af kvalitativ art.
No significant issues relating to Quality were identified.
De enkelte EU- medlemsstaters produktresuméer var bl. a. forskellige på følgende områder:
The divergences that previously existed across the SPCs of EU Member States included: