natgillin/translations-raw huggingface dataset:
In conclusion, the heart failure data remain a concern and are inconclusive, but do not significantly alter the benefit/ risk balance in locally advanced prostate cancer patients.
Podatki o odpovedi srca ostajajo s tem sporni in ne omogočajo jasnega zaključka, vendar ne pomenijo znatne spremembe razmerja med koristmi in tveganji pri bolnikih z lokalno napredovalim rakom prostate.
However, these data do support the Committee’ s position that the indication should be restricted to selected patients with locally advanced prostate cancer at high risk of disease progression.
Vendar pa ti podatki podpirajo stališče Odbora, da bi morala biti indikacija omejena na izbrane bolnike z lokalno napredovalim rakom prostate in z visokim tveganjem za napredovanje bolezni.
A more specific target population is hard to define from the EPC data, and the general term “ high risk” better accommodates wide differences in local practice and inevitable changes in the standard of care, and takes into account the many variables in the individual patient which may contribute to risk of progression.
Iz podatkov o EPC je težko opredeliti še bolj specifično ciljno populacijo, tako da splošni izraz „ visoko tveganje “ bolj odgovarja velikim razlikam v lokalni praksi in neizbežnim spremembam v standardu oskrbe, pri tem pa upošteva mnoge spremenljivke pri posameznem bolniku, ki lahko prispevajo k tveganju za napredovanje bolezni.
Therefore, clinicians may
Povzetek glavnih značilnosti zdravila je bil ustrezno dopolnjen, tako da poglavje 5. 1 vsebuje opombo, da je bilo pri bolnikih z lokalno napredovalo boleznijo „ znižanje tveganja objektivnega napredovanja bolezni... najbolj očitno pri tistih, katerih tveganje za napredovanje bolezni je bilo največje.
13 decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing .” Section 5.1 of the SPC also includes a summary of the efficacy results from the EPC study.
Zato se klinični zdravniki lahko odločijo, da je odložitev hormonskega zdravljenja do pojava znakov, ki nakazujejo na napredovanje bolezni, najboljša strategija zdravljenja za bolnike z majhnim tveganjem za napredovanje bolezni, še posebej če se načrtuje uporaba kot adjuvans po radikalni prostatektomiji “.
-
- Odbor je upošteval napotitev v skladu s členom 31 Direktive 2001/ 83/ ES z vsemi
The Committee considered the referral made under article 31 of Directive 2001/ 83/ EC, as amended, for medicinal products containing bicalutamide 150 mg.
dopolnili za zdravila, ki vsebujejo bikalutamid 150 mg.
The Committee considered that bicalutamide 150 mg is effective in the treatment of locally advanced prostate cancer; however the CHMP considered that the therapeutic indication should be restricted to treatment of patients at high risk of disease progression.
- Odbor je upošteval, da je bikalutamid 150 mg učinkovit pri zdravljenju lokalno
-
- Glede na razpoložljive podatke je CHMP zaključil, da morebitne povezave med
In view of the available data, the CHMP concluded that a potential association between the use of bicalutamide 150 mg and heart failure cannot be ruled out and therefore considered that the need to further study cardiovascular morbidity and mortality remains.
uporabo bikalutamida 150 mg in srčno odpovedjo ni mogoče izključiti in je zato mnenja, da potreba po nadaljnjem raziskovanju kardiovaskularne obolevnosti in smrtnosti ostaja.
The CHMP concluded that the benefit/ risk balance of bicalutamide 150 mg containing medicinal products in the agreed restricted indication is favourable.
- CHMP je zaključil, da je pri zdravilih, ki vsebujejo biklautamid 150 mg, in ob
As a consequence, the CHMP has recommended to maintain the Marketing Authorisations for all medicinal products and to grant Marketing Authorisations for all applications referred to in Annex I of the Opinion in accordance with the amendments to the relevant sections of the Summary of Product Characteristics, set out in Annex III of the Opinion.
dogovorjeni omejeni indikaciji razmerje med koristmi in tveganji ugodno.
14 ANNEX III
14 Kot posledica tega je CHMP predlagal, da družba zadrži dovoljenja za promet za vsa zdravila in da se ji odobri dovoljenja za vse aplikacije, ki so bile omenjene v Dodatku I mnenja, v skladu z dopolnili predmetnih poglavij Povzetka glavnih značilnosti zdravila, kot so bile zastavljene v Dodatku III mnenja.
This Annex III (Amendments to the Summary of Product Characteristics) is the one that was Annexed to the Commission Decision on this Article 31 referral for bicalutamide 150 mg containing medicinal products.
Ta Dodatek III (Spremembe Povzetka glavnih značilnosti zdravila) je identičen tistemu, ki je bil priložen odločbi Komisije v zvezi z napotitvenim postopkom, sproženim v skladu s členom 31, za zdravila, ki vsebujejo bikalutamid 150 mg.
15 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR BICALUTAMIDE 150MG CONTAINING MEDICINAL PRODUCTS
16 SPREMEMBE, KI BODO VKLJUČENE V USTREZEN ODSTAVEK POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVIL, KI VSEBUJEJO BIKALUTAMID 150 MG
[Invented name] 150mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1).
[Izmišljeno ime zdravila] 150 mg je indiciran bodisi kot monoterapija ali kot adjuvantna terapija poleg radikalne prostatektomije ali radioterapije pri bolnikih z lokalno napredovalim rakom prostate z visokim tveganjem za napredovanje bolezni (glejte poglavje 5. 1).
CASODEX (Bicalutamide) 150 mg was studied as a treatment for patients with localised (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, any N, M0; T1-T2, N+, M0) non-metastatic prostate cancer in a combined analysis of 3 placebo controlled double-blind studies in 8113 patients, where CASODEX was given as immediate hormonal therapy or as adjuvant to radical prostatectomy or radiotherapy, (primarily external beam radiation).
CASODEX je bil uporabljen kot takojšnja hormonska terapija ali kot adjuvantna terapija poleg radikalne prostatektomije ali radioterapije (v prvi vrsti z zunanjim obsevanjem).
At 7.4 years median follow up, 27.4% and 30.7% of all CASODEX and placebo-treated patients, respectively, had experienced objective disease progression.
Po mediano 7, 4 leta spremljanja se je objektivno napredovanje bolezni pojavilo pri 27, 4% vseh bolnikov, ki so dobivali CASODEX, in pri 30, 7% vseh bolnikov, ki so dobivali placebo.
No overall survival difference was seen at 7.4 years median follow up with 22.9% mortality (HR=0.99; 95% CI 0.91 to1.09).
0, 91– 1, 09).
Events (%) in Events (%) in placebo Hazard ratio CASODEX patients patients (95% CI)
Razmerje ogroženosti (95% IZ)
Watchful waiting Radiotherapy
Nadzorovano opazovanje
Radical prostatectomy
0, 60 (0, 49 – 0, 73)
179/ 870 (20.6)
66/ 161 (41, 0) 179/ 870 (20, 6)
0.75 (0.61 to 0.91)
0, 56 (0, 40 – 0, 78) 0, 75 (0, 61 – 0, 91)
Table 2
17 Tabela 2
Overall survival in locally advanced disease by therapy sub-group
Celotno preživetje pri lokalno napredovali bolezni po terapevtskih podskupinah
Deaths (%) in Deaths (%) in placebo Hazard ratio CASODEX patients patients (95% CI)
Razmerje ogroženosti (95% IZ)
Radical prostatectomy
0, 81 (0, 66 – 1, 01)
1.09 (0.85 to 1.39)
0, 65 (0, 44 – 0, 95) 1, 09 (0, 85 – 1, 39)
16 placebo patients (HR=1.16; 95% CI 0.99 to 1.37).
Pri teh bolnikih je obstajal trend h krajšemu preživetju v primerjavi z bolniki, ki so dobivali placebo (RO = 1, 16; 95% IZ:
17 ANNEX IV
18 DODATEK IV
18 National Competent Authorities (NCA), coordinated by the Reference Member State (RMS), shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
19 Nacionalni pristojni organi, katerih delo usklajuje referenčna država članica (RMS), bodo zagotovili, da imetnik dovoljenja za promet z zdravilom izpolnjuje naslednje pogoje:
- A new pharmacoepidemiological study(ies) should be undertaken to get a better understanding of
- Imetnik mora opraviti novo farmakoepidemiološko študijo (ali študije), ki bodo pripomogle k
cardiovascular risk.
boljšemu razumevanju kardiovaskularnega tveganja.
- The outcome of the 4th analysis of the EPC data should be provided to the RMS and the NCAs where
- Izide četrte analize podatkov o EPC bi moral predložiti RMS in nacionalnim pristojnim
bicalutamide 150 mg is authorised.
organom, kjer je bikalutamid 150 mg odobren.
- For all MAHs, in addition to routine pharmacovigilance activities, identified and potential risks
- Vsi imetniki dovoljenj za promet z zdravilom bi morali poleg rutinskih aktivnosti
highlighted for increased monitoring and follow-up should include:
farmakovigilance za poostreno opazovanje izpostaviti tudi prepoznana in morebitna tveganja, ki vključujejo:
Heart failure Hepatic failure Interstitial lung disease Breast cancer Reports concerning pregnancy in partners of patients taking bicalutamide
odpoved srca odpoved jeter intersticijsko bolezen pljuč raka na prsih poročila o nosečnosti partneric bolnikov, ki jemljejo bikalutamid
ANNEX I
ANEKS I
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, NAČINOV APLIKACIJE, klPREDLAGATELJEV IN DRŽAV ČLANIC
1 Member State EU/ EEA
1 Država članica EU/ EEA
Box 552 2003 RN Haarlem, The Netherlands
Box 552 2003 RN Haarlem, Nizozemska
15 U (USP)/ vial
15 U (USP) / vialo
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/ Intratumoral injections
Intramuskularna injekcija Subkutana injekcija Intravenska aplikacija Intraarterijska aplikacija Intraplevralna injekcija Intraperitonealna aplikacija Lokalna/ intratumorska injekcija
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/ Intratumoral injections
Intramuskularna injekcija Subkutana injekcija Intravenska aplikacija Intraarterijska aplikacija Intraplevralna injekcija Intraperitonealna aplikacija
2
2 Država članica EU/ EEA
Pharmaceutical Route of administration Form
Način aplikacije Lokalna/ intratumorska injekcija
Bleo-TEVA 15 mg Pulver zur Herstellung einer Injektionslösung
Bleo- TEVA 15 mg Pulver 15 U (USP) / vialo zur Herstellung einer
powder for solution for injection
Prašek za raztopino za
Italy
P. O.
Bleomicina TEVA, 15 U 15 U (USP)/ vial polvere per soluzione iniettabile
Bleomicina TEVA, 15 U 15 U (USP) / vialo polvere per soluzione iniettabile
Member State EU/ EEA
Država članica EU/ EEA
(Invented) Name
Predlagatelj (Lastniško) ime
Route of administration Local/ Intratumoral injections
Način aplikacije Lokalna/ intratumorska injekcija
BLEOMYCINE TEVA 15 U (USP)/ vial 15U poudre pour solution injectable
BLEOMYCINE TEVA 15 U (USP) / vialo 15U poudre pour solution injectable
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Local/ Intratumoral injections
Intramuskularna injekcija Subkutana injekcija Intravenska aplikacija Intraarterijska aplikacija Intraplevralna injekcija Lokalna/ intratumorska injekcija
Bleomycine 15 U (USP), 15 U (USP)/ vial poeder voor oplossing voor injectie
Bleomycine 15 U (USP), 15 U (USP) / vialo poeder voor oplossing voor injectie
Bleomycin Teva, Pulver 15 U (USP)/ vial og væske til injeksjonsvæske, oppløsning
15 U (USP) / vialo
Bleomycin Teva 15 U (USP)/ vial
15 U (USP) / vialo
Route of administration Intraperitoneal administration Local/ Intratumoral injections
Način aplikacije Intraperitonealna aplikacija Lokalna/ intratumorska injekcija
The administration of bleomycin almost always takes place in combination with other cytostatic drugs and/ or radiation therapy.
Bleomicin se skoraj vedno daje v kombinaciji z drugimi citostatičnimi zdravili in/ ali zdravljenjem z obsevanjem.
- Squamous cell carcinoma of external genitalia: penile carcinoma, cervix carcinoma.
– ploščatocelični karcinom glave in vratu (SCCHN), – ploščatocelični karcinom zunanjih spolovil: karcinom penisa, karcinom materničnega vratu, – (ne -) Hodgkinov limfom in drugi maligni limfomi, – karcinom testisov, – intraplevralno zdravljenje malignega plevralnega izliva.
Because the benefit/ risk assessment for these indications was negative for the originator product and because the indications were consequently deleted from the authorised indications for all bleomycin-containing products in Germany, the indications were regarded as new indications, and the objecting member state considered that the submitted data was insufficient for granting a marketing authorisation for the proposed new indications.
Ker je bilo ocena koristi in tveganj teh indikacij za originatorsko zdravilo negativno in ker so v Nemčiji te indikacije posledično izbrisali iz odobrenih indikacij vseh zdravil, ki vsebujejo bleomicin, so indikacije upoštevali kot nove indikacije, ugovarjajoča država članica pa je menila, da predloženi podatki ne zadostujejo za odobritev dovoljenja za promet z zdravilom za predlagane nove indikacije.
Because consensus could not be reached, the CMD(h) referred the procedure to the CHMP.
Ker ni bilo mogoče doseči soglasja, je (CMD( h)) postopek predal odboru CHMP.
Most of the presented data describe bleomycin as component of multi- drug chemotherapy including cisplatin and therefore the individual contribution of bleomycin cannot be unequivocally determined, however a number of studies and publications clearly indicate that bleomycin demonstrates efficacy.
Večina predloženih podatkov opisuje bleomicin kot sestavni del kemoterapije z več zdravili, med katerimi je vključen tudi cisplatin, zato posameznega prispevka bleomicina ni mogoče jasno določiti, vendar pa večje število študij in publikacij jasno kaže na učinkovitost bleomicina.
In addition to the documentation already provided during the decentralised procedure, supporting a modest but certain role for bleomycin in the treatment of SCCHN, a number of recent reports support the role of bleomycin in conjunction with other chemotherapeutic moieties, identifying both a recovery ratio (RR) of 34% in second line treatment and the improvement of loco-regional control and survival in patients with advanced HNC through concomitant postoperative radio- and chemotherapeutical treatment with mitomycin C and bleomycin.
Poleg dokumentacije, ki je bila že predložena med decentraliziranim postopkom v podporo skromni, a gotovi vlogi bleomicina pri zdravljenju ploščatoceličnega karcinoma glave in vratu, številna novejša poročila podpirajo vlogo bleomicina v povezavi z drugimi sestavnimi deli kemoterapije, v katerih sta bila ugotovljena 34- odstotna stopnja ozdravljenja, kadar so zdravilo uporabljali pri zdravljenju druge izbire, in izboljšanje lokoregionalnega nadzora ter preživetja bolnikov z napredovalim rakom glave in vratu pri sočasnem pooperacitivnem zdravljenju z obsevanjem in kemoterapijo z mitomicinom C in bleomicinom.
Regarding the indication in Epidermoid carcinoma of external genitalia, the CHMP noted that bleomycin is currently still in use in cervical cancer, and it was agreed that although the clinical efficacy is modest in
Kombinacija bleomicina, vindezina, mitomicina C in cisplatina
The combination of bleomycin, vindesine, mitomycin C and cisplatin in patients with recurrent and/ or metastatic squamous cell carcinoma of the cervix was recently shown to be of benefit with regards to survival and a phase II study showed bleomycin to be part of a clinically relevant alternative treatment regimen for cisplatin, in patients with recurrent cervical cancer.
7 pri bolnicah s ponovljenim in/ ali metastatskim ploščatoceličnim karcinomom materničnega vratu se je v zadnjem času izkazala kot koristna glede na preživetje, v študiji II. faze pa so dokazali, da je bleomicin del klinično pomembnega alternativnega zdravljenja za cisplatin pri bolnicah s ponovljenim rakom materničnega vratu.
The CHMP also noted that bleomycin is still in use and also mentioned in current treatment guidelines in Europe and North America, such as the SCCHN:
Odbor CHMP je prav tako ugotovil, da je bleomicin še vedno v uporabi in je tudi omenjen v trenutno veljavnih smernicah za zdravljenje ploščatoceličnega karcinoma glave in vratu v Evropi in Severni Ameriki:
Practice Guidelines in Oncology-v.2.2008 (HCCN, USA), the CCO (Cancer Care Ontario) Formulary, revised 2006/ 2007, and the Guidelines on penile cancer (March 2004) of the European Association of Urology.
Practice Guidelines in Oncology- v. 2. 2008 (Smernice za prakso v onkologiji) (HCCN, ZDA), CCO (Cancer Care Ontario) Formulary, revidirano 2006/ 2007, in Guidelines on penile cancer (Smernice za raka penisa) (marec 2004) Evropskega urološkega združenja.
In conclusion, the CHMP considered that this efficacy outweighs the toxicity of the product, and that the benefit/ risk balance is positive.
Odbor CHMP je na koncu menil, da ta učinkovitost odtehta toksičnost zdravila in da je razmerje med koristmi in tveganji pozitivno.
- Squamous cell carcinoma (SCC) of the head and neck, external genitalia and cervix.
Bleomicin je namenjen za: – zdravljenje ploščatoceličnega karcinoma (SCC) glave in vratu, zunanjih spolovil in materničnega vratu, – zdravljenje Hodgkinovega limfoma, – zdravljenje ne- Hodgkinovega limfoma srednje in visoke stopnje malignosti pri odraslih, – zdravljenje karcinoma testisov (seminomski in neseminomski), – intraplevralno zdravljenje malignega plevralnega izliva.
8 GROUNDS FOR OPINION
8 PODLAGA ZA MNENJE
- the observed toxicity risks are outweighed by the established efficacy of bleomycin,
– ugotovljena učinkovitost bleomicina odtehta tveganja glede ugotovljene toksičnosti,
- the efficacy of bleomycin can be considered as established through published literature and current
– se učinkovitost bleomicina lahko šteje za ugotovljeno prek izdane literature in trenutno veljavnih smernic za zdravljenje v Evropi in Severni Ameriki,
- and taking into account the current therapeutic use of bleomycin,
– ter ob upoštevanju trenutne terapevtske uporabe bleomicina,
the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination Group procedure as mentioned in Annex III for Bleomycin Pharmachemie and associated names (see Annex I).
je odbor CHMP priporočil odobritev dovoljenja za promet z zdravilom, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki kot končne različice, dogovorjene med postopkom Usklajevalne skupine, kakor je omenjeno v Dodatku III za zdravilo Bleomycin Pharmachemie in z njim povezana imena (glejte Dodatek I).
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OVOJNINA IN NAVODILO ZA UPORABO
10 The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
10 Veljavni povzetek glavnih značilnosti zdravila, ovojnine in navodila za uporabo so končne verzije, potrjene v postopku pred Koordinacijsko skupino.
Ref.
London, 17. marca 2009 Sklic dok.:
EMEA/ CHMP/ 191900/ 2009 EMEA/ H/ A-29/ 1096
EMEA/ 189590/ 2009 EMEA/ H/ A- 29/ 1096
Questions and answers on the referral for Bleomycin, powder for solution for injection, 15 U/ Vial, from Pharmachemie BV
Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Bleomycin, prašek za raztopino za injiciranje, 15 e/ vialo, družbe Pharmachemie BV
The Agency’ s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Bleomycin injection, from Pharmachemie BV, outweigh its risks, and the marketing authorisation can be granted in the Member States of the European Union and the European Economic Area.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMEA je zaključil, da koristi zdravila Bleomycin, injekcija, družbe Pharmachemie BV odtehtajo njegova tveganja in da se dovoljenje za promet z zdravilom lahko odobri v državah članicah Evropske unije in Evropskega gospodarskega prostora.
The review was carried out under an ‘ Article 29’ referral1 procedure.
Pregled se je opravil v okviru napotitvenega postopka v skladu s členom 291.
Bleomycin is a cytostatic substance; this means that it stops the growth of cells.
To pomeni, da zaustavlja rast celic.
Pharmachemie BV submitted a Marketing Authorisation Application for Bleomycin powder for solution for injection 15 U/ vial in the decentralised procedure on 10 July 2007, the Netherlands acting as the reference member state.
Družba Pharmachemie BV je vlogo za pridobitev dovoljenja za promet z zdravilom Bleomycin, prašek za raztopino za injiciranje, 15 e/ vialo, predložila po decentraliziranem postopku dne 10. julija 2007, pri tem pa je Nizozemska prevzela vlogo referenčne države članice.
The indications ‘ head and neck carcinoma’ and ‘ epidermoid carcinoma of external genitalia such as penile carcinoma, or cervix’ had been deleted from the authorised indications for all bleomycin-containing products in Germany because the balance of benefit/ risk for bleomycin in these indications was considered negative.
Indikaciji „ karcinom glave in vratu “ ter „ epidermoidni karcinom zunanjih spolovil, kot je karcinom penisa ali cerviksa “, sta bili v Nemčiji izbrisani iz odobrenih indikacij za vsa zdravila, ki vsebujejo bleomicin, ker se je menilo, da je razmerje med koristmi in tveganji za bleomicin pri teh indikacijah negativno.
The RMS and the other positive CMSs were in favour of retaining these indications.
Postopek je bil napoten na odbor CHMP, ker ni bilo mogoče doseči soglasja.
Because consensus could not be reached, the procedure was
Odbor CHMP je ovrednotil razpoložljive podatke, da bi ugotovil, ali je mogoče zadevni indikaciji podpreti.
Referral start date:
Datum začetka postopka napotitve:
Opinion date:
20. november 2008 Datum izdaje mnenja:
Barbara van Zwieten-Boot (NL) Harald Enzmann (DE) 20 November 2008 18 December 2008
18. december 2008
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINOV UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH LANICAH Č
Pharmaceutical Form
Način uporabe zdravila
Route of administration
Država lanica č
Novartis Consumer Health-Gebro GmbH, Bahnhofbichl 13 6391 Fieberbrunn/ Tirol, Austria Attn:
Novartis Consumer Health- Gebro GmbH, Bahnhofbichl 13 6391 Fieberbrunn/ Tirol, Avstrija Vročiti:
Werner Attn:
Werner Vročiti:
Effervescent tablets
Šumeče tablete
Novartis Consumer Health SA/ NV Medialaan, 30 Bus 5 - 1800 VILVOORDE Belgium Attn:
Novartis Consumer Health SA/ NV Medialaan, 30 Bus 5 - 1800 VILVOORDE Belgija Vročiti: g.
Mr Pieter De Pourcq
Pieter De Pourcq
1060 Nicosia Cyprus.
1060 Nicosia Ciper.
Attn:
Vročiti:
Calcium-Sandoz® forte 500mg Ca 500mg
Calcium- Sandoz® forte 500mg Ca 500mg
Czech Republic
CALCIUM- SANDOZ® FF Č
2 130 00 Praha3 Czech Republic Attn:
2 eška republika Č Vročiti:
U Nákladového nádraž í 10 130 00 Praha3 Czech Republic Attn:
U Nákladového nádraží 10 130 00 Praha3 eška republika Č Vročiti:
Novartis Healthcare A/ S, Lyngbyvej 172, 2100 Kobenhavn, Denmark Attn:
Novartis Healthcare A/ S, Lyngbyvej 172, 2100 Kobenhavn, Danska Vročiti:
Calcium-Sandoz, brusetabletter
Calcium- Sandoz, brusetabletter
Novartis Finland Oy, Metsänneidonkuja 10, 02130 Espoo, Finland Attn:
Novartis Finland Oy, Metsänneidonkuja 10, 02130 Espoo, Finska, Vročiti: g.
Mega-Calcium 1g Ca2+ poretabletti
poretabletti
Novartis Finland Oy, Metsänneidonkuja 10, 02130 Espoo, Finland Attn:
Novartis Finland Oy, Metsänneidonkuja 10, 02130 Espoo,
Calcium-Sandoz 500mg Ca2+ poretabletti
Calcium- Sandoz 500mg Ca2+
France
Ca 1000mg
Novartis Consumer Health GmbH, Zielstattstrasse 40, 81379 München, Germany Attn:
81379 München, Nemčija Vročiti:
Calcium-Sandoz® fortissimum 1000mg
Calcium- Sandoz® forte Nemčija