natgillin/translations-raw huggingface dataset:
Novartis (Hellas) AEBE - 12o Km National Road No1, 14451 Metamorfosis Attikis, Grækenland Att.:
Novartis (Hellas) AEBE 12o Km National Road No1, 14451 Metamorfosis Attikis, Greece Attn:
Hatzidakis
Hatzidakis
Mega- Calcium® Sandoz
Mega-Calcium® Sandoz
Consumer Health 1027 Budapest Horvát u.
Consumer Health 1027 Budapest Horvát u.
14- 24.
14-24.
Emelet Postacím:
Emelet Postacím:
1525 Budapest, Pf.
1525 Budapest, Pf.
118 Ungarn Att.:
118 Hungary Attn:
Miko
Miko
Calcium- Sandoz pezsgõtabletta
Calcium-Sandoz pezsgõtabletta
Novartis Healthcare A/ S, Lyngbyvej 172, 2100 København,
Grevsen
Calcium- Sandoz, freyðitöflur
Calcium-Sandoz, freyðitöflur
Grevsen
Ireland
Novartis Consumer Health UK Ltd, Wimblehurst Road, Horsham, West Sussex RH12 5AB Det Forenede Kongerige Att.:
Novartis Consumer Health UK Ltd, Wimblehurst Road, Horsham, West Sussex RH12 5AB
Sandocal 1000
Sandocal 1000
Novartis Consumer Health S. p. A, Largo U.
Novartis Consumer Health S. p. A, Largo U.
Boccioni, 1 21040 Origgio (VA), Italien Att.:
Boccioni, 1 21040 Origgio (VA), Italy Attn:
Maria Carla Baggio & Carlo Candiani
Ms Maria Carla Baggio & Mr Carlo Candiani
CALCIUM- SANDOZ 1000mg compresse effervescenti
CALCIUM-SANDOZ 1000mg compresse effervescenti
CALCIUM- SANDOZ 500mg compresse effervescenti
CALCIUM-SANDOZ 500mg compresse effervescenti
Novartis Consumer Health SA/ NV Medialaan, 30 Bus 5 - 1800 VILVOORDE
Novartis Consumer Health SA/ NV Medialaan, 30 Bus 5 - 1800 VILVOORDE Belgium Attn:
Pieter De Pourcq
The Netherlands
Novartis Consumer Health B. V, Claudius Prinsenlaan 140 4818 CP Breda, Nederlandene Att.:
Novartis Consumer Health B. V, Claudius Prinsenlaan 140 4818 CP Breda, Netherlands Attn:
W.
W.
VanBerckel
VanBerckel
Sandoz Calcium fortissimum, bruistabletten
Sandoz Calcium fortissimum, bruistabletten
Sandoz Calcium forte, bruistabletten
Sandoz Calcium forte, bruistabletten
Lam
Novartis Norge A/ S Consumer Health, Brynsalléen 4
Calcium- Sandoz® 500mg effervescent
Calcium-Sandoz® 500mg effervescent
Martin Bischof & Dr.
Mr Martin Bischof & Dr.
Unkauf
Markus Unkauf
CALCIUM- SANDOZ Forte
CALCIUM-SANDOZ Forte
NCH Produtos Farmaceuticos e Nutriçao Lda, Av.
NCH Produtos Farmaceuticos e Nutriçao Lda, Av.
CALCIUM - SANDOZ® FORTE 500mg
CALCIUM-SANDOZ® FORTE 500mg
U Nákladového nádraží 10 130 00 Prag3 Den Tjekkiske Republik Att.:
U Nákladového nádraž í 10 130 00 Praha3 Czech Republic Attn:
CALCIUM - SANDOZ® Forte
CALCIUM-SANDOZ® Forte
CALCIUM - SANDOZ® FF 1000mg
CALCIUM-SANDOZ® FF 1000mg
Slovenien
6 Slovenia
Medis, d. o. o.
Medis, d. o. o.
2646, Brn i eva 1 čč 1000 Ljubljana, Slovenien Tone Strnad
2646, Brn i eva 1 čč 1000 Ljubljana, Slovenia Mr Tone Strnad
Calcium- Sandoz Forte
Calcium-Sandoz Forte
7 Spanien
Spain
Novartis Consumer Health SA, Gran Via Corts Catalanes 764, 08013 Barcelona Spanien Att.:
Novartis Consumer Health SA, Gran Via Corts Catalanes 764, 08013 Barcelona Spain Attn:
Catasus
Catasus
Calcium Sandoz Forte comprimidos efervescentes
Calcium Sandoz Forte comprimidos efervescentes
Novartis Sverige AB Consumer Health, Kemistvägen 1B, PO Box 1150 183 11 Täby, Sverige Att.:
Novartis Sverige AB Consumer Health, Kemistvägen 1B, PO Box 1150 183 11 Täby, Sweden Attn:
Sigerud
Sigerud
Calcium- Sandoz 1 g brustablett
Calcium-Sandoz 1 g brustablett
Calcium- Sandoz 500mg brustablett
Calcium-Sandoz 500mg brustablett
Novartis Consumer Health UK Ltd, Wimblehurst Road, Horsham, West Sussex RH12 5AB Det Forenede Kongerige Att.:
Novartis Consumer Health UK Ltd, Wimblehurst Road, Horsham, West Sussex RH12 5AB United Kingdom Attn:
Dr Jacinta Keogh - Bennett
Dr Jacinta Keogh-Bennett
SANDOCAL 1000
SANDOCAL 1000
8 BILAG II
8 SCIENTIFIC CONCLUSIONS
SAMLET RESUME AF DEN FAGLIGE VURDERING AF CALCIUM SANDOZ BRUSETABLETTER (OG TILKNYTTEDE NAVNE – SE BILAG 1)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CALCIUM SANDOZ EFFERVESCENT TABLETS (AND ASSOCIATED NAMES – SEE ANNEEX 1)
Novartis Consumer Health SA har på vegne af alle indehavere af markedsføringstilladelse (se bilag I) begæret harmonisering i henhold til artikel 30 i direktiv 2001/ 83/ EF, med senere ændringer, for produkterne Calcium Sandoz, brusetabletter, 500 mg (calciumlactogluconat + calciumcarbonat 1132 + 875 mg) og Calcium Sandoz, brusetabletter, 1000 mg (calciumlactogluconat + calciumcarbonat 2263 + 1750 mg).
Novartis Consumer Health SA acting on behalf of all Marketing Authorisation holders (see Annex I) has applied for harmonisation according to Article 30 of 2001/ 83/ EC, as amended, of their products Calcium Sandoz 500 mg effervescent tablets (Calcium lactate gluconate + Calcium carbonate 1132 + 875 mg) and Calcium Sandoz 1000 mg effervescent tablets (Calcium lactate gluconate + Calcium carbonate 2263 + 1750 mg).
De fysisk- kemiske og biologiske forhold, som er af betydning for ensartede kliniske egenskaber af produktet, er undersøgt og reguleret på tilfredsstillende måde.
Physicochemical and biological aspects relevant to the uniform clinical performance of the product have been investigated and are controlled in a satisfactory way.
Calcium er et livsvigtigt mineral, der er nødvendigt for knogledannelse og - vedligeholdelse, for kroppens elektrolytbalance og for den korrekte funktion af en lang række reguleringsmekanismer.
Calcium is an essential mineral, necessary for bone formation and maintenance, for electrolyte equilibrium in the body and for the proper functioning of numerous regulatory mechanisms.
Det blev vedtaget, at punktet indkationer skal dække følgende tre tilstande: den generelle indikation forebyggelse og behandling af calciummangel, som dækker de situationer, hvor øget calciumbehov forventes eller er muligt, osteoporose, hvor betydningen af calciumtilskud er veldokumenteret, og behandling af engelsk syge og osteomalaci, hvor tilstrækkelig tilførsel og virkning af vitamin D og tilstrækkelig calciumtilførsel er en forudsætning for normal mineralisering af knoglerne.
Successful treatment of rickets and osteomalacia will require adequate supply and action of vitamin D and sufficient supply of calcium to allow normal bone mineralisation.
Calcium Sandoz er derfor kontraindiceret hos patienter med overfølsomhed over de aktive indholdsstoffer eller hjælpestofferne i brusetabletterne, sygdomme og/ eller tilstande, der medfører hypercalcæmi og/ eller hypercalcuri; nephrocalcinosis og nephrolithiasis.
Calcium Sandoz is therefore contraindicated in patients with hypersensitivity to the active substances or to any of the excipients of the effervescent tablet; diseases and/ or conditions resulting in hypercalcaemia and/ or hypercalciuria; nephrocalcinosis and nephrolithiasis.
Klassifikation og terminologi er ændret i overensstemmelse med organklasse efter MedDRA- systemet.
Classification and terminology were amended according to the MedDRA system organ class.
Betragtninger vedrørende benefit/ risk- forholdet
Benefit/ Risk considerations
På grundlag af den dokumentation, der er forelagt af indehaverne af markedsføringstilladelserne, og de faglige drøftelser i udvalget anser CHMP benefit/ risk- forholdet for Calcium Sandoz brusetabletter, 500 mg og 1000 mg, for gunstigt til de godkendte og harmoniserede indikationer.
9 Based on the documentation submitted by the Marketing Authorisation Holders and the scientific discussion within the Committee, the CHMP considered that the benefit/ risk ratio of Calcium Sandoz 500 mg and 1000 mg effervescent tablets is positive for the agreed and harmonised indications.
10 BEGRUNDELSE FOR ÆNDRINGEN AF PRODUKTRESUMÉET
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
-
- the scope of the referral was the harmonisation of the Summary of Product Characteristics,
Indbringelsen vedrører harmoniseringen af produktresuméet og harmoniseringen af den farmaceutiske dokumentation – modul 3 (kvalitet).
and harmonisation of the pharmaceutical documentation – module 3 (quality)
-
- the Summary of Products Characteristic proposed by the Marketing Authorisation Holders has
Det produktresumé, der er foreslået af indehaverne af markedsføringtilladelsen, er blevet vurderet på grundlag af den forelagte dokumentation og de faglige drøftelser i udvalget -
been assessed based on the documentation submitted and the scientific discussion within the Committee,
anbefaler CPMP, at markedsføringstilladelserne ændres.
the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics is set out in Annex III of this opinion.
Produktresuméet fremgår af bilag III til denne udtalelse.
SUMMARY OF PRODUCT CHARACTERISTICS
11 BILAG III
11 1.
Calcium Sandoz og andre navne (Se Annex I.) 500 mg, brusetabletter Calcium Sandoz og andre navne (Se Annex I.) 1000 mg, brusetabletter
Calcium Sandoz and associated names (see Annex 1) 500 mg, effervescent tablets Calcium Sandoz and associated names (see Annex 1) 1000 mg, effervescent tablets
1132 mg calcium lactogluconat og 875 mg calciumcarbonat (svarende til 500 mg eller 12. 5 mmol calcium).
1132 mg of calcium lactate gluconate and 875 mg of calcium carbonate (equivalent to 500 mg or 12.5 mmol of calcium).
Hver brusetablet á 1000 mg indeholder:
Each effervescent tablet of 1000 mg contains:
2263 mg calcium lactogluconat og 1750 mg calciumcarbonat (svarende til 1000 mg eller 25 mmol calcium).
2263 mg of calcium lactate gluconate and 1750 mg of calcium carbonate (equivalent to 1000 mg or 25 mmol of calcium).
Brusetablet Hvide, cirkulære, flade, med skrå kant forsynede brusetabletter med appelsinduft.
Effervescent tablet White, circular, flat faced, bevelled edge effervescent tablets with an orange odour
- Forebyggelse og behandling af calciummangel
- Prevention and treatment of calcium deficiency
- Calcium supplement som tilskud til adjuverende specifik terapi i forebyggelse og behandling af
- Calcium supplement as an adjunct to specific therapy in the prevention and treatment of osteoporosis
- Som tilskud til vitamin D3 behandling af rakitis og osteomalaci,
- Rickets and osteomalacia, in addition to vitamin D3 therapy
500 – 1000 mg daglig Brusetabletterne bør opløses i et glas vand (ca.
500 – 1000 mg per day The effervescent tablets should be dissolved in a glass of water (approx.
200 ml) og drikker umiddelbart.
200 ml) and drunk immediately.
- Sygdomme og/ eller tilstande som resulterer i hypercalcæmi og/ eller hypercalciuri.
- Diseases and/ or conditions resulting in hypercalcaemia and/ or hypercalciuria
- Nephrocalcinosis, nephrolithiasis.
- Nephrocalcinosis, nephrolithiasis
Hos patienter med mild hypercalciuri (som overstiger 300 mg/ 24 timer eller 7. 5 mmol/ 24 timer), eller med en anamnese om nyresten, er monitorering af calciumudskillelsen i urinen påkrævet.
For patients with mild hypercalciuria (exceeding 300 mg/ 24 hours or 7.5 mmol/ 24 hours), or with a history of urinary calculi, monitoring of calcium excretion in the urine is required.
13 Hos patienter med nedsat nyrefunktion bør calciumsalte kun indtages under medicinsk supervision med monitorering af calcium og phosphat serumniveauer.
In patients with impaired renal function, calcium salts should be taken under medical supervision with monitoring of calcium and phosphate serum levels.
Publikationer har antydet en mulig øget absorption af aluminium med citratsalte.
12 There have been literature reports alluding to possible increased absorption of aluminium with citrate salts.
Hver Calcium Sandoz brusetablet indeholder aspartam, en fenylalaninkilde, svarende til 15 mg/ dosis og kan være skadelig for patienter med fenylketonuri.
Each Calcium Sandoz effervescent tablet contains aspartame, a source of phenylalanine equivalent to 15 mg/ dose, and may be harmful for people with phenylketonuria.
Bør ikke anvendes til patienter med hereditær fructoseintolerans eller med glucose- galactose malabsorption.
Patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this medicine.
Calcium Sandoz 500 mg indeholder 2. 976 mmol (svarende til 68, 45 mg) natrium pr tablet.
Calcium Sandoz 500 mg contains 2.976 mmol (corresponding to 68.45 mg) of sodium per tablet.
Calcium Sandoz 1000 mg indeholder 5. 95 mmol (svarende til 136, 90 mg) natrium pr tablet.
Calcium Sandoz 1000 mg contains 5.95 mmol (corresponding to 136.90 mg) of sodium per tablet.
Information til diabetikere:
Information for diabetics:
En brusetablet indeholder 0, 002 kulhydratenheder og er derfor velegnet til diabetikere.
One effervescent tablet contains 0.002 Carbohydrate Units and is therefore suitable for diabetics.
Thiaziddiuretika reducerer den renale ekskretion af calcium.
Thiazide diuretics reduce the urinary excretion of calcium.
Patienter bør ikke indtage calciumholdige midler før end to timer efter at have spist føre med oxal - eller fytinsyre.
The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.
Det dækkende daglige indtag (inklusive føde og kosttilskud) for normalt gravide and ammende kvinder er 1000- 1300 mg calcium.
The adequate daily intake (including food and supplementation) for normal pregnant and lactating women is 1000-1300 mg calcium.
Calcium Sandoz brusetabletter kan anvendes under graviditet og amning hos kvinder med kalkmangel.
Calcium Sandoz effervescent tablets can be used during pregnancy and lactation in case of a calcium deficiency
Nedennævnte bivirkninger er opremset efter organklasse og frekvens.
Adverse reactions are listed below, by system organ class and frequency.
Ikke - almindelig (> 1/ 1, 000, < 1/ 100), sjælden (> 1/ 10, 000, < 1/ 1, 000) eller meget sjælden (< 1/ 10, 000), inklusive enkeltstående rapporter.
Frequencies are defined as: uncommon (> 1/ 1,000 ,< 1/100), rare (> 1/ 10,000, < 1/ 1,000) or very rare (< 1/ 10,000), including isolated reports.
14 Lidelser i immunsystemet:
Immune system disorders:
Hypersensitivitet, som udslæt, pruritus, urticaria.
Hypersensitivity, such as rash, pruritus, urticaria.
Metaboliske og ernæringsmæssige lidelser:
Isolated cases of systemic allergic reactions (anaphylactic reaction, face oedema, angioneurotic oedema) have been reported Metabolism and nutrition disorders:
Ikke- almindelig:
Uncommon:
Hypercalcæmi, hypercalciuri.
Hypercalcaemia, hypercalciuria
Gastrointestinale lidelser:
13 Gastrointestinal disorders:
Flatulens, obstipation, diarré, kvalme, opkastning, abdominale smerter.
Rare: flatulence, constipation, diarrhoea, nausea, vomiting, abdominal pain
Overdosering medfører hypercalciuri og hypercalcæmi.
Overdose leads to hypercalciuria and hypercalcaemia.
Symptomer på hypercalcæmi kan omfatte: kvalme, opkastning, tørst, polydipsi, polyuri, dehydrering og obstipation.
Symptoms of hypercalcaemia may include: nausea, vomiting, thirst, polydipsia, polyuria, dehydration and constipation.
Kronisk overdosering med resulterende hypercalcæmi kan forårsage vasculær - og organkalcifikation.
Chronic overdose with resulting hypercalcaemia can cause vascular and organ calcification.
Et loopdiuretikum (f. eks., furosemid) kan gives til at øge calciumekskretionen og forebygge volumeoverbelastning, mens thiaziddiuretika bør undgås.
A loop diuretic (e. g., furosemide) may then be used to further increase calcium excretion and to prevent volume overload, but thiazide diuretics should be avoided.
A og D hypervitaminose, primær hyperparathyroidisme, maligniteter, nyresvigt eller immobilisering.
In the case of persistent hypercalcaemia, contributing factors should be excluded, e. g., vitamin A or D hypervitaminosis, primary hyperparathyroidism, malignancies, renal failure, or immobilisation.
Pharmacoterapeutisk klassifikation:
Pharmacotherapeutic group:
Mineralpræparater ATC koder:
ATC codes:
Calciumcarbonat (A 12 AA 04), Calcium lactogluconate (A 12 AA 06) Calcium er et essentielt mineral, nødvendig for dannelsen og vedligeholdelsen af knoglemassen, for elektrolytbalancen i kroppen og for den normale funktion af en række regulationsmekanismer.
Calcium carbonate (A 12 AA 04), Calcium lactate gluconate (A 12 AA 06) Calcium is an essential mineral, necessary for bone formation and maintenance, for electrolyte equilibrium in the body and for the proper functioning of numerous regulatory mechanisms.
25- 50% af den indtagne dosis calcium bliver absorberet, overvejende i den proximale del af tyndtarmen, og videregivet til de udskiftelige calciumreserver.
Some 25-50% of the ingested dose of calcium is absorbed, predominantly in the proximal part of the small intestine, and delivered to the exchangeable calcium pool.
Distribution and metabolisme Knoglernes og tændernes mineraler indeholder 99% af kroppens calcium.
The mineral component of bones and teeth contains 99% of the body’ s calcium.
Den resterende 1% findes i intra - and ekstracellulærvæskerne.
The remaining 1% is present in the intra- and extracellular fluids.
5% kompleksbundet til citrat, fosfat eller andre anioner.
About 50% of the total blood-calcium content is in the physiologically active ionised form, with approximately 5% being complexed to citrate, phosphate or other anions.
De resterende 45% af serumcalcium er proteinbundet, primært til albumin.
The remaining 45% of serum calcium is bound to proteins, principally albumin.
15 Der er ingen yderligere relevant information vedrørende vurderingen af sikkerhed ud over hvad der er anført i andre dele af produktresumeet.
There is no information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC.
Citronsyre vandfri (fine granulate) Orange aroma (indeholdende: orangeolie, maltodextrin, gummi arabicum, sorbitol (E 420), dextrose) Aspartam (E951) Macrogol 6000 Natriumhydrogencarbonat
14 Citric acid anhydrous (fine granulate) Orange flavour powder (contains: orange essential oils, maltodextrin, arabic gum, sorbitol (E 420), dextrose) Aspartame (E951) Macrogol 6000 Sodium hydrogen carbonate
Brusetabletterne er pakket i polypropylen- rør med børnesikret polyethylen låg og tørremiddel hver indeholdende 10 eller 20 tablets.
The effervescent tablets are packed in polypropylene tubes and tamperproof polyethylene stoppers with desiccant, each containing 10 or 20 tablets.
Rørene er pakket i æsker indeholdende 10, 20, 30, 40, 60, 80, 100 og 600 (kun for 500 mg) tabletter.
The tubes are packed in boxes containing 10, 20, 30, 40, 60, 80, 100 and 600 (for 500 mg only) tablets.
6. 6 Eventuelle instruktioner vedrørende anvendelse og håndtering
6.6 instructions for use and handling
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
9. august 2005 EMEA/ CHMP/ 289490/ 2005
9 August 2005 EMEA/ CHMP/ 289490/ 2005
SAMMENFATTENDE OPLYSNINGER OM UDTALELSE EFTER HENVISNING TIL VOLDGIFT I HENHOLD TIL ARTIKEL 30 I RÅDETS DIREKTIV 2001/ 83/ EF OM Calcium Sandoz og tilknyttede navne Internationalt fællesnavn (INN):
SUMMARY INFORMATION ON REFERRAL OPINION FOLLOWING ARBITRATION PURSUANT TO ARTICLE 30 OF COUNCIL DIRECTIVE 2001/ 83/ EC FOR Calcium Sandoz and associated names International Non-Proprietary Name (INN):
Calciumlactogluconat, calciumcarbonat
Calcium lactate gluconate, Calcium carbonate
Lægemidler indeholdende calciumlactogluconat og calciumcarbonat er blevet godkendt på nationalt plan i EU- medlemsstaterne, hvilket resulterer i forskellige produktresuméer på grundlag af de enkelte nationale afgørelser.
Medicinal products containing calcium lactate gluconate and calcium carbonate have been nationally authorised in EU Member States, resulting in different Summaries of Product Characteristics based on individual national decisions.
Novartis Consumer Health SA indbragte en sag for EMEA i henhold til artikel 30 i direktiv 2001/ 83/ EF med henblik på at harmonisere de nationale produktresuméer for lægemidlet Calcium Sandoz brusetabletter, 500/ 1000 mg og tilknyttede navne og endvidere også for at harmonisere den farmaceutiske dokumentation.
Novartis Consumer Health SA presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, in order to harmonise the national SPCs of the medicinal product Calcium Sandoz Effervescent tablets, 500/ 1000 mg and associated names and additionally to harmonise the pharmaceutical documentation.
Proceduren for indbragte sager indledtes den 21. oktober 2004.
A dossier in CTD format and a proposal for a harmonised SPC were submitted by the MAH on 22 September 2004.
Efter at CHMP havde behandlet vurderingsrapporterne fra rapportøren/ medrapportøren og taget hensyn til den faglige drøftelse i udvalget, var CHMP af den opfattelse, at Calcium Sandoz brusetabletter, 500/ 1000 mg og tilknyttede navne udviste et gunstigt benefit/ risk- forhold.
The referral procedure started on 21 October 2004 The CHMP having considered the Rapporteur and the Co-Rapporteur assessment reports, and scientific discussion within the Committee was of the opinion that the benefit/ risk ratio of Calcium Sandoz Effervescent tablets, 500/ 1000 mg and associated names is considered to be favourable.
Den 21. april 2005 vedtog CHMP en positiv udtalelse, som anbefalede en harmonisering af produktresuméet for Calcium Sandoz brusetabletter, 500/ 1000 mg og tilknyttede navne til følgende godkendte terapeutiske indikationer:
The CHMP issued a positive opinion, on 21 April 2005, recommending the harmonisation of the SPC for Calcium Sandoz Effervescent tablets, 500/ 1000 mg and associated names for the following agreed therapeutic indications: -Prevention and treatment of calcium deficiency -Calcium supplement as an adjunct to specific therapy in the prevention and treatment of osteoporosis -Rickets and osteomalacia, in addition to vitamin D3 therapy
Det harmoniserede produktresumé findes i bilag III.
An overall summary of the scientific evaluation is provided in Annex II together with the harmonised summary of product characteristics in Annex III.
Europa- Kommissionen traf en afgørelse den 9. august 2005.
A Decision was issued by the European Commission on 9 August 2005.
FORTEGNELSE OVER LÆGEMIDLETS/ LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM( ER), STYRKE( R), INDGIVELSESVEJ( E), ANSØGER( E), INDEHAVER( E) AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S)/ MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Dette produktresumé og denne etikettering og indlægsseddel er de samme som dem, der var vedlagt Kommissionens afgørelse af denne artikel 29- indbringelse vedrørende lægemidler indeholdende Doxazosin mesilat.
This SPC, labelling and package leaflet is the version that was annexed to the Commission Decision on this Article 29 referral for doxazosin mesilate containing medicinal products.
1/ 24 Medlemsstat
1/ 24
Indehaver af markedsføringstilladel Ansøger se
Pharmaceutical
Styrke
Member State
Lægemiddelform
Authorisation Holder
Ratiopharm GmBH Graf- Arco- Strasse 3 89079 Ulm, Tyskland Tlf.:
Ratiopharm GmBH Graf-Arco-Strasse 3 89079 Ulm, Germany Tel:
Pharmcom Oy Keijumaki 6B 30 02130 Espoo Finland Tlf.:
Pharmcom Oy Keijumaki 6B 30 02130 Espoo Finland Tel:
Uzoki utca 36/ a 1145 Budapest, Ungarn Tlf.:
Uzoki utca 36/ a 1145 Budapest, Hungary Tel:
Særnavn
Slovakia
Det Forenede
Marketing
Ratiopharm GmBH
Invented name
DoxaCard XL
Pharmaceutical
4 mg 4 mg
Route of
Depottabletter
Member State
Oral anvendelse
Authorisation Holder
Kongerige
Applicant
Graf- Arco- Strasse 3 89079 Ulm, Tyskland Tlf.:
Ratiopharm GmBH Graf-Arco-Strasse 3 89079 Ulm, Germany Tel:
prolonged release tablets
DoxaCard XL 4 mg prolonged release tablets
3/ 24 BILAG II
3/ 24 ANNEX II
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ( ER), ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
4/ 24 FAGLIGE KONKLUSIONER
4/ 24 SCIENTIFIC CONCLUSIONS
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF Cardoreg 4 mg depottabletter og de tilknyttede navne (se bilag I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF Cardoreg 4 mg prolonged release tablets and associated names (see Annex I)