natgillin/translations-raw huggingface dataset:
Very Rare (occurring in less than 1 out of 10,000 people) Allergic reactions (which may be serious enough to require immediate medical attention) including hives, swelling of the face, lips, tongue, and/ or throat which may cause difficulty in breathing or swallowing, bronchospasm (wheezing or shortness of breath), severe skin reactions, inflammation of the stomach lining or stomach ulcers that can become serious and may lead to bleeding, liver problems, serious kidney problems, severe increase in blood pressure, confusion, seeing, feeling or hearing things that are not there (hallucinations).
Hyvin harvinaiset (esiintyy alle yhdellä 10 000 potilaasta) Allergiset reaktiot (jotka voivat olla niin vakavia, että on syytä välittömästi ottaa yhteys lääkäriin) mukaan lukien nokkosihottuma, kasvojen, huulien, kielen ja/ tai nielun turvotus, joka voi aiheuttaa hengitys - tai nielemisvaikeuksia, bronkospasmi (hengityksen vinkuminen tai hengenahdistus), vaikeat ihoreaktiot, mahan limakalvon tulehdus tai mahahaava, joka voi muuttua vakavaksi ja aiheuttaa verenvuotoa, maksan toimintahäiriöt, vakavat munuaissairaudet, voimakas verenpaineen kohoaminen, sekavuus, aistiharhat (hallusinaatiot).
HOW TO STORE< ARCOXIA >
5. < ARCOXIA > N SÄILYTTÄMINEN
Do not use< ARCOXIA > after the expiry date which is stated on the pack.
Älä käytä < ARCOXIA > a pakkauksessa mainitun viimeisen käyttöpäivämäärän jälkeen.
What< ARCOXIA > contains
Mitä < ARCOXIA > sisältää
• The active substance is etoricoxib.
- Vaikuttava aine on etorikoksibi.
Each film coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Yksi kalvopäällysteinen tabletti sisältää 30 mg, 60 mg, 90 mg
Tablet coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin.
Tabletin ydin: kalsiumvetyfosfaatti (vedetön), kroskarmelloosinatrium, magnesiumstearaatti, mikrokiteinen selluloosa Tabletin päällyste: karnaubavaha, laktoosimonohydraatti, hypromelloosi, titaanidioksidi (E 171), triasetiini.
The 30-, 60- and 120-mg tablets also contain yellow ferric oxide (E172, colouring agent) and indigo carmine lake (E132, colouring agent).
30 mg: n, 60 mg: n ja 120 mg: n tabletit sisältävät myös indigokarmiinilakkaa (väriaine E 132) ja keltaista rautaoksidia (väriaine E 172).
< ARCOXIA > Tablets are available in four strengths:
< ARCOXIA > n kuvaus ja pakkauskoot < ARCOXIA > - tableteista on saatavilla neljä vahvuutta:
30 mg blue-green, apple-shaped, biconvex film coated tablets marked ‘ ACX 30’ on one side and ‘ 101’ on the other.
30 mg: n kalvopäällysteiset tabletit ovat sinivihreitä, omenanmuotoisia, kaksoiskuperia, toisella puolella on merkintä 'ACX 30' ja toisella puolella '101'.
38 60 mg dark green, apple-shaped, biconvex film coated tablets marked ‘ ARCOXIA 60’ on one side and ‘ 200’ on the other.
41 60 mg: n tabletit ovat tummanvihreitä, omenanmuotoisia, kaksoiskuperia, toisella puolella on merkintä 'ARCOXIA 60' ja toisella puolella '200'.
90 mg white, apple-shaped, biconvex film coated tablets marked ‘ ARCOXIA 90’ on one side and ‘ 202’ on the other.
90 mg: n tabletit ovat valkoisia, omenanmuotoisia, kaksoiskuperia, toisella puolella on merkintä 'ARCOXIA 90' ja toisella puolella '202' '.
120 mg pale-green, apple-shaped, biconvex film coated tablets marked ‘ ARCOXIA 120’ on one side and ‘ 204’ on the other.
120 mg: n tabletit ovat vaaleanvihreitä, omenanmuotoisia, kaksoiskuperia, toisella puolella on merkintä 'ARCOXIA 120' ja toisella puolella '204'.
Pack sizes of 7 and 28 tablets in blisters.
30 mg 7 tai 28 tabletin läpipainopakkaus.
Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets in blisters; or 30 and 90 tablets in bottles.
60, 90 ja 120 mg 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 tai 100 tabletin läpipainopakkaukset; tai 30 ja 90 tabletin purkit.
Marketing Authorisation Holder and Manufacturer [See Annex 1-To be filled in nationally] {Name and address} {tel} {fax} {e-mail}
Myyntiluvan haltija ja valmistaja [Ks liite I - täytetään kansallisesti] {Nimi ja osoite} < {tel} > < {fax} > < {e- mail} >
Austria Belgium Bulgaria Czech Rep.
Alankomaat Belgia Bulgaria Eesti Espanja Irlanti Islanti Iso- Britannia Italia Itävalta Kreikka Kypros Latvia Liettua Luxemburg Malta Norja Portugali
Cyprus Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Slovakia Slovenia Spain
Puola Ranska Romania Ruotsi Saksa Slovakia Slovenia Suomi Tanska
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg-Filmtabletten Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés 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 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 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 ARCOXIA 30, 60, 90 or 120 mg film-coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg 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 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
ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg tabletki powlekane Arcoxia 30 mg, comprimé pelliculé ARCOXIA 60 mg, 90 mg, 120 mg, comprimate filmate Arcoxia 30 mg, 60 mg, 90 mg, 120 mg filmdragerade tabletter ARCOXIA 30/ 60/ 90/ 120 mg Filmtabletten ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30/ 60/ 09/ 120 mg filmsko obložene tablete Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen Arcoxia
39
42
Sweden United Kingdom
Tsekin tasavalta Unkari
Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter ARCOXIA 30, 60, 90 or 120 mg film-coated tablets
ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30 mg, 60 mg, 90 mg, 120 mg filmtabletta
This leaflet was last approved in (MM/ YYYY).
Tämä seloste on hyväksytty viimeksi {pvm}
40 ANNEX IV
43 LIITE IV
41 CONDITIONS OF THE MARKETING AUTHORISATION
44 MYYNTILUPAAN LIITTYVÄT EHDOT
- A direct healthcare professional communication (DHPC) must be sent to all healthcare professionals
- Kaikille etorikoksibia määrääville terveydenhuollon ammattilaisille on lähetettävä
who prescribe etoricoxib according to national practice.
terveydenhuollon ammattilaisille tarkoitettu tietopaketti kansallisen käytännön mukaisesti.
This information should inform healthcare professionals on the cardiorenal risks associated with Arcoxia and should be in line with the DHPC endorsed by the CHMP.
Tietopaketin on oltava lääkevalmistekomitean hyväksymän terveydenhuollon ammattilaisille tarkoittaman tietopaketin mukainen.
London, 23 October 2008 EMEA/ 438258/ 2008
Lontoo 23. lokakuuta 2008 EMEA/ CHMP/ 619556/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL
LÄÄKEVALMISTEKOMITEAN (CHMP) 6 ARTIKLAN 12 KOHDAN MUKAISEEN MENETTELYYN LIITTYVÄ LAUSUNTO
International non-proprietary name (INN): etoricoxib
Kansainvälinen yleisnimi (INN): etorikoksibi
BACKGROUND INFORMATION *
TAUSTATIETOA *
Etoricoxib is a selective inhibitor of COX-2 (cyclooxygenase 2) indicated in the symptomatic relief of osteoarthritis (OA, 30-60mg once daily (od)), rheumatoid arthritis (RA, 90mg od) and the pain and signs of inflammation associated with acute gouty arthritis (120mg od).
Etorikoksibi on COX- 2: n (syklo- oksygenaasi 2) selektiivinen inhibiittori, jonka käyttöaiheena on osteoartriitin (30 - 60 mg kerran päivässä) ja reumaattisen artriitin (90 mg kerran päivässä) oireiden lievittäminen sekä akuuttiin kihtiartriittiin (120 mg kerran päivässä) liittyvien kipujen ja tulehdusoireiden lievittäminen.
This referral procedure relates to a request for arbitration concerning a type II variation for a new indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
Tämä menettely liittyy pyyntöön järjestää välimiesmenettely tyypin II mukaisen muutoksen tekemiseksi, jotta uuteen käyttöaiheeseen voitaisiin lisätä selkärankareuman hoito 90 mg: n suositeltavalla päivittäisannoksella.
At the end of the mutual recognition procedure, there was a discrepancy between different European Union (EU) Member States regarding the safety of etoricoxib at the 90mg dose in the new proposed indication.
Vastavuoroisen tunnustamismenettelyn lopussa Euroopan unionin jäsenmaiden välillä ilmeni erimielisyyttä etorikoksibin turvallisuudesta 90 mg: n annoksena uudessa ehdotetussa käyttöaiheessa.
As these concerns were not resolved during the course of the procedure, a notification of an official referral for arbitration under Article 6(12) of Commission Regulation EC No 1084/ 2003 to the CHMP was made by France on 19 September 2007.
Koska näistä huolenaiheista ei päästy yksimielisyyteen menettelyn aikana, Ranska esitti 19. syyskuuta 2007 lääkevalmistekomitealle välimiesmenettelyä koskevan virallisen pyynnön komission asetuksen EY N: o 1084/ 2003 6 artiklan 12 kohdan mukaisesti.
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 ankylosing spondylitis (AS) indication.
Ranskan esiintuomat tärkeimmät ratkaisemattomat huolenaiheet koskivat etorikoksibin 90 mg: n päivittäisannoksen pitkäaikaista turvallisuutta mahdollisesti lisääntyvän kardiovaskulaarisen riskin osalta silloin, kun 90 mg: n annostuksen käyttöaiheena on selkärankareuma.
France considered that a review of the benefit/ risk profile of Arcoxia was needed.
Ranska katsoi, että Arcoxian hyötyriskisuhde on otettava uudelleen tarkasteltavaksi.
Matthew Thatcher) were appointed.
Lääkevalmistekomitea käsitteli syyskuun 2007 täysistunnossaan välimiesmenettelyä, jossa asiaa varten nimitettiin esittelijä (tri Karl Broich) sekä rinnakkaisesittelijä (tri Matthew Thatcher).
Matthew Thatcher.
Helmikuun 2008 täysistunnossa tri Rafe Survana nimitettiin rinnakkaisesittelijäksi tri Matthew Thatcherin tilalle.
There was little direct comparative safety data for individual non-steroidal anti-inflammatory drugs (NSAIDs) other than diclofenac and naproxen.
Tietojen perusteella voitiin lisäksi vahvistaa samankaltainen kardiovaskulaarinen tukosriski kuten diklofenaakilla sekä jonkinasteinen mahalaukun ja suolen ylempien alueiden turvallisuusetu naprokseeniin ja diklofenaakkin nähden (ei kuitenkaan merkittävää mahalaukun ja suolen alempien alueiden turvallisuusetua).
Drug utilisation data showed that some patients with high blood pressure are being initiated on etoricoxib.
Yksittäisistä steroideihin kuulumattomista tulehduskipulääkkeistä (NSAID) ei ollut diklofenaakin ja naprokseenin ohella käytettävissä paljon suoraan verrattavissa olevaa turvallisuustietoa.
The CHMP therefore recommended the strengthening of the contraindication in hypertensive patients and alerts prescribers that blood pressure needs to be monitored, especially
Sen vuoksi oli vaikeaa määrittää etorikoksibin riskejä verrattuna ibuprofeeniin, ketoprofeeniin tai muihin harvemmin käytettyihin NSAID- valmisteisiin.
Reproduction is authorised provided the source is acknowledged. within 2 weeks of treatment initiation.
Lääkkeiden käyttötietojen perusteella joillekin korkeaa verenpainetta sairastaville potilaille annetaan etorikoksibia.
Healthcare professionals were to be reminded of these measures through a communication letter (Dear Healthcare Professional Letter).
Terveydenhuollon ammattilaisia muistutetaan näistä toimista tiedotekirjeellä (” Hyvä terveydenhuollon ammattilainen, … ”).
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.
Tämän vuoksi lääkevalmistekomitea suositteli, että olisi tutkittava annostuksia koskevia tutkimustuloksia, jotta voitaisiin päätellä, voisiko myös 60 mg: n päivittäisannos olla riittävä joillekin potilaille.
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.
Luettelo valmistenimistä on liitteessä I, tieteelliset päätelmät liitteessä II, muutetut valmistetiedot liitteessä III sekä myyntiluvan ehdot liitteessä IV.
∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 26 June 2008.
Tässä asiakirjassa ja sen liitteissä esitetyt tiedot heijastavat yksinomaan CPMP: n 26. kesäkuuta 2008 päivättyä lausuntoa.
The Member States’ competent authorities will continue to keep the product under regular review.
Jäsenvaltioiden toimivaltaiset viranomaiset suorittavat edelleenkin tuotteen säännöllistä seurantaa.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LUETTELO LÄÄKEVALMISTEEN NIMISTÄ, LÄÄKEMUODOSTA, VAHVUUKSISTA, ANTOREITISTÄ JA MYYNTILUVAN HALTIJOISTA JÄSENVALTIOISSA
1 Member State Austria Austria Austria Austria Belgium Belgium Belgium Belgium Denmark Denmark Denmark Denmark Finland Finland Finland Finland Germany Germany Germany Germany Greece Greece
1 Jäsenvaltio
Pfizer S. A.
Myyntiluvan haltija
Invented name Sortis Sortis Sortis Sortis Lipitor Lipitor Lipitor Lipitor Zarator Zarator Zarator Zarator Lipitor Lipitor Lipitor Lipitor Sortis Sortis Sortis Sortis Lipitor Lipitor
Kauppanimi Nimi
Strength 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg
Vahvuus
Pharmaceutical form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Lääkemuoto
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Antoreitti
2 Member State Greece Greece Italy Italy Italy Italy Luxembourg Luxembourg Luxembourg Luxembourg Netherlands Netherlands Netherlands Netherlands Portugal Portugal Portugal Portugal Spain Spain Spain Spain
Itävalta
Pfizer S. A.
Pfizer Corporation Austria Ges. m. b. H.
Pfizer S. A.
Sortis
Invented name Lipitor Lipitor Xarator Xarator Xarator Xarator Lipitor Lipitor Lipitor Lipitor Lipitor Lipitor Lipitor Lipitor Zarator Zarator Zarator Zarator Zarator Zarator Zarator Zarator
10 mg
Strength 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg 10mg 20mg 40mg 80mg
Kalvopäällysteinen tabletti
Pharmaceutical form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Suun kautta
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Itävalta
3 Member State Sweden Sweden Sweden Sweden
Pfizer Corporation Austria Ges. m. b. H.
Marketing Authorisation Holder Pfizer AB Pfizer AB Pfizer AB Pfizer AB
20 mg
Invented name Lipitor Lipitor Lipitor Lipitor
Kalvopäällysteinen tabletti
Strength 10mg 20mg 40mg 80mg
Suun kautta
Pharmaceutical form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Itävalta
Route of administration Oral use Oral use Oral use Oral use
Pfizer Corporation Austria Ges. m. b. H.
4 ANNEX II
Sortis
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
40 mg
5 SCIENTIFIC CONCLUSIONS
Kalvopäällysteinen tabletti
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ATORVASTATIN (Sortis and associated names - see Annex I)
Suun kautta
Sortis and associated names contain atorvastatin, a well-known HMG-CoA reductase inhibitor (statin), registered in the EU since 1996 through Mutual Recognition Procedure and national procedures.
Itävalta
- as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein
Pfizer Corporation Austria Ges. m. b. H.
B, and tryglicerides in patients with primary hypercholesterolemia including familial hypercholesterolemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Sortis
- to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia an
80 mg
adjunct to other lipid-lowering treatments (e. g.
Kalvopäällysteinen tabletti
LDL apheresis) or if such treatments are unavailable.
Suun kautta
Background information on the type II variation through the MRP In the initial type II variation dossier submitted by MRP, the Applicant claimed the following indication: “ Prevention of cardiovascular events in patients with multiple risk factors (e. g. type 2 diabetics with one risk factor and hypertensive patients with 3 risk factors) with normal or elevated cholesterol levels but without clinically evident coronary heart disease (CHD )”.
Belgia
This wording was based on the results of 2 randomised controlled trials performed with atorvastatin 10 mg for the primary prevention of cardiovascular disease (CVD).
Pfizer S. A.
In the Final Assessment report (1 November 2005) the Reference Member State proposed, and the MAH agreed to, the following indication: “ Prevention of cardiovascular events in patients with type 2 diabetes and one additional risk factor with normal to mildly elevated cholesterol level without clinically evident coronary heart disease”.
Lipitor
thus restricting the indication to the population included in the CARDs trial and relegating the results of the ASCOT-LLA trial to a description in section 5.1. of the SPC, based on the lack of demonstrated efficacy in the female subgroup.
10 mg
At the December plenary meeting, the CHMP adopted a LoQ centred on the following points:
Kalvopäällysteinen tabletti
1.
Suun kautta
2.
Belgia
3.
Pfizer S. A.
4.
Lipitor
5.
20 mg
Evaluation of Clinical Efficacy
Kalvopäällysteinen tabletti
The main issue discussed by the CHMP has been the results of the ASCOT-LLA trial, most importantly the lack of established benefit and adverse mortality trends in the female subgroup and, secondly, the impact of the observed interaction between the antihypertensive amlodipine and atorvastatin on the main trial outcomes for certain subgroups.
Suun kautta
The Applicant has presented arguments for the view that the results for women in ASCOT-LLA based on subgroup analyses are most likely chance findings and are not considered scientifically robust enough to form the basis for regulatory actions.
Belgia
The main concern relates to the “ risk of CVD”.
Pfizer S. A.
Regarding the interaction observed between atorvastatin and amlodipine, the body of data assessed indicates that this interaction is of questionable clinical relevance, if it exists at all, and does not warrant regulatory action dictating the prescription of the product.
Lipitor
A point of minor discussion was the applicability of the trial results to other strengths of atorvastatin.
40 mg
7 recommendations is section 4.2 of the SPC, not section 4.1, and adequate dosing recommendations have been added.
Kalvopäällysteinen tabletti
Finally, there has been much discussion regarding the wording of the indication that best reflects the results of the of the assessed trials.
Suun kautta
In the light of the above the CHMP concludes that the indication for atorvastatin “ Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors .” adequately reflects the available data.
Belgia
Overall conclusion on benefit/ risk
Pfizer S. A.
At its meeting of 20-23 March 2006, the CHMP considered the data on efficacy presented by the MAHs and concluded that it had been shown that atorvastatin, as an adjunct to correction of other risk factors, was effective in the prevention of CV events in patients estimated to have a high risk for a first CV event.
Lipitor
The CHMP recommended the granting of the type II variation to extend the indication.
80 mg
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Kalvopäällysteinen tabletti
Whereas, • the CHMP considered the referral made under article 6.12 of Commission Regulation (EC) No 1084/ 2003, for atorvastatin (Sortis and associated names - see Annex I), • The MAH has implemented the text proposed by the CHMP in the SPC:
Suun kautta
- It is proposed to add the following indication in section 4.1:
Tanska
Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
Pfizer ApS
-
Zarator
In the primary prevention trials the dose was 10 mg/ day.
10 mg
Higher dosages may be necessary in order to attain (LDL-)cholesterol levels according to current guidelines.
Kalvopäällysteinen tabletti
-
Tanska
Section 5.1 has been updated to include the results of the ASCOT-LLA and CARDS trials as follows:
Zarator
8 Patients were treated with anti-hypertensive therapy (either amlodipine or atenolol-based regimen) and either atorvastatin 10 mg daily (n=5168) or placebo (n=5137).
20 mg
The absolute and relative risk reduction effect of atorvastatin was as follows:
Kalvopäällysteinen tabletti
Relative
Suun kautta
No. of
Tanska
Absolute
Pfizer ApS
Risk
Zarator
Events
40 mg
Risk
Suun kautta
Reduction
Tanska
(Sortis vs
Pfizer ApS
Reduction1
Zarator
Event
80 mg
(%)
Suomi
Placebo)
Pfizer Oy
(%)
Lipitor
p-value
10 mg
Fatal CHD plus non-fatal MI Total cardiovascular events
Kalvopäällysteinen tabletti
36%
Suun kautta
100 vs.
Suomi
154
Pfizer Oy
1.1%
Lipitor
0.0005
20 mg
and revascularization procedures Total coronary events 1
Kalvopäällysteinen tabletti
20% 29%
Suun kautta
389 vs.
Suomi
483 178 vs 247
Pfizer Oy
1.9% 1.4%
Lipitor
0.0008 0.0006
40 mg
CHD = coronary heart disease; MI = myocardial infarction.
Kalvopäällysteinen tabletti
212 events, p=0.17 and 74 vs.
Suun kautta
82 events, p=0.51).
Pfizer Oy
30 and 17 vs.
Lipitor
The effect of atorvastatin on fatal and non-fatal cardiovascular disease was also assessed in a randomised, double-blind, multicentre, placebo-controlled trial, the Collaborative Atorvastatin Diabetes Study (CARDS) in patients with type 2 diabetes, 40-75 years of age, without prior history of cardiovascular disease, and with LDL-C ≤ 4.14 mmol/ l (160 mg/ dl) and TG≤ 6.78 mmol/ l (600 mg/ dl).
80 mg
The absolute and relative risk reduction effect of atorvastatin were as follows:
Kalvopäällysteinen tabletti
No. of
Saksa
Absolute
Sortis
Risk
10 mg
Events
Suun kautta
Risk
Saksa
Reduction
PARKE- DAVIS GmbH
(Sortis vs
Sortis
Reduction1
20 mg
Event Major cardiovascular events (fatal and non-fatal AMI, silent MI, acute CHD death, unstable angina, CABG, PTCA,
Kalvopäällysteinen tabletti
(%)
Saksa
Placebo)
PARKE- DAVIS GmbH
(%)
Sortis
p-value
40 mg
revascularisation, stroke) MI (fatal and non-fatal AMI, silent MI) Strokes (Fatal and non-fatal) 1
Kalvopäällysteinen tabletti
37% 42% 48%
Suun kautta
83 vs.
Saksa
39
PARKE- DAVIS GmbH
3.2% 1.9% 1.3%
Sortis
0.0010 0.0070 0.0163
80 mg
Based on difference in crude events rates occurring over a median follow-up of 3.9 years.
Kalvopäällysteinen tabletti