natgillin/translations-raw huggingface dataset:
Hotemin 10 mg capsule
Hotemin 10 mg Kapsula
Flamatrol 10mg Capsules
Flamatrol 10mg Kapsulas
United Kingdom Clonmel Healthcare Limited Waterford Road
Clonmel Healthcare Limited Waterford Road Clonmel, Co. Tipperary, Irska
The possible need for combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered.
Skrbno moramo presoditi o morebitni potrebi po kombiniranem zdravljenju z zdravili z zaščitnim delovanjem na želodec (na primer mizoprostolom ali zaviralci protonske črpalke) (glejte poglavje
Flamatrol 20mg Capsules
Flamatrol 20mg Kapsulas
Hotemin 20 mg capsule
Hotemin 20 mg Kapsula
20MG/ML Solution for injection Intramuscular use
20MG/ML Raztopina za injiciranje Intramuskularna uporaba
− the benefits of piroxicam outweigh the risks in the symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis;
− koristi piroksikama pri simptomatskem lajšanju osteoartritisa, revmatoidnega artritisa ali ankilozirajočega spondilitisa so večje od z njim povezanih tveganj;
Kent CT 13 9 NJ United Kingdom
Kent Ct13 9nj Velika Britanija
Aktuapharma N.V. Ambachtenlaan 13e B-3001 Leuven Belgium
Ambachtenlaan 13e B-3001 Leuven Belgija
Solution for injection Intramuscular use
Raztopina za injiciranje Intramuskularna uporaba
10 mg/cap Hard capsules
10 mg/cap Kapsula, trda
1x50 g/0,5 g Dermálny krém topical use
1x50 g/0,5 g Krema
Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs.
Podatki iz opazovalnih raziskav kažejo, da bi bil lahko piroksikam v primerjavi z drugimi nesteroidnimi antirevmatiki povezan z velikim tveganjem resnih toksičnih učinkov na prebavila.
Zerospam20 mg/cap Hard capsules
Zerospam20 mg/cap Kapsula, trda
Feldene 10 Mg Capsules
Feldene 10 Mg Kapsulas
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 atrisk patients.
Pri teh bolnikih s povečanim tveganjem moramo enako kot pri zdravljenju z drugimi nesteroidnimi antirevmatiki presoditi o uporabi piroksikama v kombinaciji z zdravili z zaščitnim delovanjem (na primer mizoprostolom ali zaviralci protonske črpalke).
20 mg/sachet Grannules for oral solution
20 mg/sachet Zrnca za peroralno raztopino
Felcam20 mg/sup Suppository
Felcam20 mg/sup Svečka
United Kingdom Neolab Limited 57 High Street
Cipla (Uk) Limited 53a High Street Esher
Feldene 20mg Capsules
Feldene 20mg Kapsulas
20 mg/cap Hard capsules
20 mg/cap Kapsula, trda
Estonia
Estinija
ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET Note: These sections of the Summary of Product Characteristics are the ones that were annexed to the Commission Decision on this Article 31 referral.
Opomba: Ta razdelek Povzetka glavnih značilnosti zdravila je bil priložen k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu s členom 31.
Basildon, Essex SS14 3FR United Kingdom
Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR Velika Britanija
20 mg/sup Suppository
20 mg/sup Svečka
20 mg/ml, 1ml Solution for injection Intramuscular use
20 mg/ml, 1ml Raztopina za injiciranje Intramuskularna uporaba
Piroxicam 10mg Capsules Bp
Piroxicam 10mg Kapsulas Bp
Piroxicam 20mg Capsules Bp
Piroxicam 20mg Kapsulas Bp
Piroxicam Innotech International 10 Mg, Gélule
Piroxicam Innotech International 10 Mg,
20 mg/3 mg Granules for oral solution
20 mg/3 mg Zrnca za peroralno raztopino
Piroxicam Capsules Bp 20mg
Piroxicam Kapsulas Bp 20mg
Highfield, Cheadle SK8 3GY
Cheadle Royal Business Park Highfield, Cheadle Sk8 3gy Veliak Britanija
Piroxicam Capsules Bp 10mg
Piroxicam Kapsulas Bp 10mg
Piroxicam Capsules 10mg
Piroxicam Kapsulas 10mg
Torrex Chiesi Pharma Gmbh Gonzagagasse 16/16
Torrex Chiesi Pharma Gmbh
Tablets
Tablets uporaba
Via Palermo 26 A 43100, Parma Italy
Via Palermo 26 A 43100, Parma Italija
Mobilat P Cream 5 mg/g
Mobilat P Krema
Piroxicam Capsules 20mg
Piroxicam Kapsulas 20mg
Esplanade Heysel B 22 B-1020 Bruxelles Belgium
Eurogenerics S.A. Esplanade Heysel B 22 B-1020 Bruxelles Belgija
Esplanade Heysel, B 22 B-1020 Bruxelles Belgium
Eurogenerics S.A. Esplanade Heysel, B 22 B-1020 Bruxelles Belgija
United Kingdom Actavis Uk Limited Whiddon Vally
Actavis Uk Limited Whiddon Vally Barnstaple Devon Ex32 8ns United Kingdom
Combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should also be carefully considered for all patients and in particular for the elderly.
Pri vseh bolnikih, še zlasti pa pri starejših, je treba temeljito pretehtati tudi kombinirano zdravljenje z učinkovinami za zaščito prebavnega trakta (npr. z mizoprostolom ali zaviralci protonske črpalke).
Piroxicam 10mg Capsules
Piroxicam 10mg Kapsulas
Piroxicam 20mg Capsules
Piroxicam 20mg Kapsulas
United Kingdom Trinity-Chiesi Pharmaceuticals Limited Cheadlw Royal Business Park
Trinity-Chiesi Pharmaceuticals Limited Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY Velika Britanija
Tablet for oral solution Oral use
Peroralna suspenzija Peroralna uporaba
20124 Milano Italy
20158 Milano Italija uporaba
Rectal
Rektalna
Effervescent tablets
Gastrorezistentna tableta
Eye drops, solution Ocular use
Kapljice za oko, raztopina
Via Palermo, 26/A 43100 Parma Italy
Via Palermo, 26/A 43100 Parma Italija
Surrey KT20 7NS
Surrey Kt10 9qr Velika Britanija
Injection 20mg/Ml
Intramuscular Intramuskularna uporaba 20mg/Ml
Hotemin Injection 20 mg/ml -1ml Solution for injection Intramuscular use
20 mg/ml -1ml Raztopina za injiciranje Intramuskularna uporaba
7-9, Avenue François-Vincent Raspail Bp 32, 94111 Arcueil Cedex France
Bp 32, 94111 Arcueil Cedex Francija
55216, Ingelheim Am Rhein Germany
55216, Ingelheim Am Rhein Nemčija
Ratiopharm 20 Mg Comprimidos
Ratiopharm 10 Mg Comprimidos uporaba
Feldene Dispersible Tablets-20 Mg
Feldene Tableta za peroralno suspenzijos-20 Mg
Gerakas 15344 Greece
Marathonos 106 Gerakas 15344 Grčija uporaba
D-55216 Ingelheim am Rhein Germany
D-55216 Ingelheim Am Rhein Nemčija
D-55216 Ingelheim Am Rhein Germany
D-55216 Ingelheim am Rhein Nemčija
Docpharma S.A. Ambachtenlaan 13h B-3001 Heverlee Belgium
Docpharma S.A. Ambachtenlaan 13h
Dispersible tablet
Šumeča tableta
55216 Ingelheim Am Rhein Germany
55216 Ingelheim Am Rhein Madžarska
Egis Pharmaceuticals Plc Kereszturi Ut 30-38 H-1106 Budapest Hungary
Egis Pharmaceuticals Plc Kereszturi Ut 30-38
Cutaneous use
Okularna uporaba
Dental treatment and in the course of infections Relief of fever and pain associated with acute upper respiratory tract inflammation.
akutna faza protina primarna dismenoreja pooperativna bolečina stomatološki posegi in med okužbami zmanjšanje vročine in bolečine pri akutnem vnetju zgornjih dihalnih poti akutna mišično-skeletna obolenja (na primer burzitis, tendinitis) akutne motnje po poškodbah radikulalgija
Via Di Scandicci, 37
Via Di Scandicci, 37 50143 Firenze
Anfarm Hellas Ae K. Palaiologou & Perikleous 27
Anfarm Hellas Ae
50143 Firenze Italy
00144 Rome Italija
Viale Bodio, 37/B 20158 Milano
Viale G. Rictrda, 7 20143 Milano
Chiesi España, S.A. Av. Berlin, 38-48 7ª Planta
Av. Berlin, 38-48 7ª Planta 08029 Barcelona Španija uporaba
Dispersible Tablet
Žvečljiva Tableta
Feldene Intramuscular
Hotemin Intramuskularna uporaba
Piroxicam Dispersible Tablets 10mg
Piroxicam Tableta za peroralno suspenzijos 10mg
Strength Pharmaceutical Form Route of Administration Immediate Packaging
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
MA (EU) Number Name
Številka EU
The average improvement was about 1.4 points.
V povprečju je prišlo do izboljšanja za približno 1,4 točke.
The patients had an average of 0.08 serious infections per year.
Bolniki so imeli v povprečju 0,08 resne okužbe na leto.
Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Privigen.
Nadaljnje informacije za zdravilo Privigen so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Privigen.
What measures are being taken to ensure the safe and effective use of Privigen?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Privigen?
The European Medicines Agency concluded that Privigen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Privigen večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
Other information about Privigen
Druge informacije o zdravilu Privigen
Privigen received a marketing authorisation valid throughout the EU on 25 April 2008.
Zdravilo Privigen je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 25. aprila 2008.
What is Privigen and what is it used for?
Kaj je zdravilo Privigen in za kaj se uporablja?
An overview of Privigen and why it is authorised in the EU
Pregled zdravila Privigen in zakaj je odobreno v EU
Privigen was not compared to other treatments in the studies.
Zdravila Privigen v študijah niso primerjali z drugimi zdravili.
Privigen is a medicine used to support the immune system (the body's natural defences) in two main groups of patients:
Zdravilo Privigen se uporablja kot podpora imunskemu sistemu (naravnemu obrambnemu mehanizmu telesa) pri dveh glavnih skupinah bolnikov:
What are the risks associated with Privigen?
Kakšna tveganja so povezana z zdravilom Privigen?
Since this is below the predefined threshold of one serious infection per year, this indicates that the medicine is effective as replacement therapy.
Ker je ta vrednost nižja od mejne vrednosti, ki je enaka eni resni okužbi na leto, to kaže, da je zdravilo kot nadomestno zdravljenje učinkovito.
The dose may need to be adjusted for patients depending on their response.
Bolnikom bo glede na njihov odziv odmerek morda treba prilagoditi.
As for all medicines, data on the use of Privigen are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Privigen stalno spremljajo.
In this third study, 17 (61%) of the 28 patients responded to treatment with an improvement of at least one point on the disability scale.
V tej tretji študiji se je 17 (61 %) od 28 bolnikov odzvalo na zdravljenje z izboljšanjem za vsaj eno točko na lestvici prizadetosti.
Why is Privigen authorised in the EU?
Zakaj je zdravilo Privigen odobreno v EU?
This confirmed that Privigen is effective in immunomodulation.
To potrjuje, da je zdravilo Privigen učinkovito pri imunomodulaciji.
The dose and frequency of infusions (how often it is given) depend on the disease being treated.
Odmerek in pogostost infuzije sta odvisna od zdravljene bolezni.
Privigen was given on two consecutive days.
Zdravilo Privigen se je dajalo dva dni zapored.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Privigen have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Privigen upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Side effects reported with Privigen are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Privigen, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
As human normal immunoglobulin has been used to treat these diseases for a long time, and in accordance with current guidelines, only three small studies were needed to establish the effectiveness and safety of Privigen in patients.
Ker se humani polispecifični imunoglobulin že dlje časa uporablja za zdravljenje teh bolezni, so za potrditev učinkovitosti in varnosti zdravila Privigen pri bolnikih v skladu z veljavnimi smernicami zadostovale tri manjše študije.
The company that markets Privigen has made some changes in the way it is produced to reduce this risk and is performing a study to monitor the effect of the changes.
Da bi zmanjšala to tveganje, je družba, ki trži zdravilo Privigen, naredila nekaj sprememb pri načinu proizvodnje zdravila, in izvaja študijo spremljanja učinka sprememb.
The most common side effects with Privigen (seen in more than 1 patient in 10) are headache, nausea, pain (including in the back, neck, limbs, joints and face), fever, chills and a flu-like illness.
Najpogostejši neželeni učinki zdravila Privigen (ki se pojavijo pri več kot 1 bolniku od 10) so glavobol, navzeja, bolečina (tudi v hrbtu, vratu, udih, sklepih in obrazu), povišana telesna temperatura, mrzlica in gripi podobna bolezen.
Privigen can only be obtained with a prescription and treatment for patients with a lack of antibodies should be started and monitored by a doctor experienced in treating such conditions.
Predpisovanje in izdaja zdravila Privigen je le na recept, zdravljenje bolnikov s pomanjkanjem protiteles pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem tovrstnih stanj.
For more information about using Privigen, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Privigen glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
• Patients who are at risk of infection because they do not have enough antibodies (also called immunoglobulins, proteins in the blood that help the body to fight disease).
• pri bolnikih, pri katerih obstaja nevarnost okužbe zaradi nezadostnega števila protiteles (imenovanih tudi imunoglobulini, tj. beljakovine v krvi, ki pomagajo telesu pri premagovanju bolezni).
What benefits of Privigen have been shown in studies?
Kakšne koristi je zdravilo Privigen izkazalo v študijah?
Privigen works by restoring abnormally low IgG levels to their normal range in the blood.
Zdravilo Privigen deluje tako, da nenormalno nizko koncentracijo IgG vrne v območje njene normalne vrednosti v krvi.
The medicine is available as a solution for infusion (drip) into a vein.
Zdravilo je na voljo kot raztopina za infundiranje (kapalno infuzijo) v veno.
These comprise patients with primary immune thrombocytopenia (ITP), who do not have enough platelets (components in the blood that help it to clot) and who are at high risk of bleeding; patients with Guillain-Barré syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), inflammatory disorders of the nerves that result in muscle weakness and numbness; patients with Kawasaki disease, a disease mainly seen in children which causes inflammation of blood vessels; and patients with multifocal motor neuropathy (MMN), nerve damage which causes weakness of the arms and legs.
Ta skupina vključuje bolnike s primarno imunsko trombocitopenijo (ITP), ki nimajo dovolj trombocitov (sestavin v krvi, ki prispevajo k strjevanju krvi) in pri katerih obstaja veliko tveganje za krvavitve, bolnike z Guillain-Barréjevim sindromom ali kronično vnetno demielinizacijsko polinevropatijo (CIDP), tj. vnetnim obolenjem živcev, ki povzroča slabitev in otrplost mišic, bolnike s Kawasakijevim sindromom, tj. boleznijo, ki je prisotna predvsem pri otrocih in povzroča vnetje krvnih žil, in bolnike z multifokalno motorično nevropatijo (MN), tj. poškodbo živcev, ki povzroča oslabelost rok in nog.
The main measure of effectiveness was the highest blood platelet level that was achieved in the week after Privigen was given.
Glavno merilo učinkovitosti je bila najvišja koncentracija trombocitov v krvi, dosežena v tednu po uporabi zdravila Privigen.
Privigen must not be used in patients with hyperprolinaemia type I or II (a genetic disorder causing high levels of the amino acid proline in the blood).
Zdravilo Privigen se ne sme uporabljati pri bolnikih s hiperprolinemijo tipa I ali II (dedno motnjo, ki povzroča visoke ravni aminokisline prolin v krvi).
In this study, 46 (81%) of the 57 patients had a platelet count above 50 million platelets per millilitre at least once during the study.
V tej študiji je bila pri 46 (81 %) od 57 bolnikov koncentracija trombocitov vsaj enkrat v času trajanja študije nad 50 milijonov trombocitov na mililiter.
Some side effects are more likely with a high rate of infusion, in patients with low immunoglobulin levels, or in patients who have not received human normal immunoglobulin before or for a long time.
Nekateri neželeni učinki so verjetnejši pri uporabi visoke hitrosti infundiranja, pri bolnikih z nizko ravnjo imunoglobulina ali bolnikih, ki v preteklosti niso prejemali humanega polispecifičnega imunoglobulina ali ga niso prejemali dolgo.
The active substance in Privigen, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood).
Zdravilna učinkovina zdravila Privigen, humani polispecifični imunoglobulin, je visoko prečiščena beljakovina, pridobljena iz človeške plazme (dela krvi).
Privigen must not be used in people who are hypersensitive (allergic) to normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Zdravila Privigen ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) humani polispecifični imunoglobulin ali katero koli drugo sestavino zdravila, ter bolniki, ki so alergični na druge vrste imunoglobulinov, še posebno, če imajo pomanjkanje (zelo nizko raven) imunoglobulina A (IgA) ter imajo protitelesa proti IgA.
The main measure of effectiveness was the number of patients who showed improvement of their disability, measured by a decrease on a 10point scale of disability in their arms and legs.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je prišlo do izboljšanja prizadetosti rok in nog, merjene z zmanjšanjem na 10-stopenjski lestvici prizadetosti.
In the first study, Privigen was used in 80 patients with PID, with the medicine being infused every three or four weeks.
V prvi študiji je bilo zdravilo Privigen uporabljeno pri 80 bolnikih s sindromom primarne imunske pomanjkljivosti, pri čemer se je zdravilo infundiralo vsake tri ali štiri tedne.
These also include people who have developed a lack of antibodies after birth (secondary immunodeficiency syndrome, SID), who have low levels of certain antibodies (called IgG) and who suffer from infections that are severe, keep coming back, and are not cured by medicines used to treat infections.
To lahko vključuje tudi osebe, pri katerih je pomanjkanje protiteles nastopilo po rojstvu (sindrom sekundarne imunske pomanjkljivosti, SID), ki imajo nizke ravni določenih protiteles (imenovanih IgG) in ki trpijo zaradi hudih, ponavljajočih se okužb ter jih ne moremo zdraviti z drugimi zdravili za zdravljenje okužb.
The second study looked at using Privigen in 57 patients with ITP.
V drugi študiji so proučevali uporabo zdravila Privigen pri 57 bolnikih s primarno imunsko trombocitopenijo.
A third study examined the use of Privigen for immunomodulation in 28 patients with CIDP who were given Privigen every three weeks over a period of 24 weeks.
V tretji študiji so proučevali uporabo zdravila Privigen za imunomodulacijo pri 28 bolnikih s kronično vnetno demielinizacijsko polinevropatijo, ki so zdravilo v obdobju 24 tednov prejemali vsake tri tedne.
How is Privigen used?
Kako se zdravilo Privigen uporablja?
For the full list of all side effects with Privigen, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Privigen, glejte navodilo za uporabo.
Haemolysis (breakdown of red blood cells) is an uncommon side effect in patients given human normal immunoglobulin (occurring with less than 1 dose in 100).
Redek neželeni učinek pri bolnikih, ki prejemajo humani polispecifični imunoglobulin (ki se pojavi pri manj kot 1 odmerku od 100), je hemoliza (razkroj rdečih krvnih celic).
Severe haemolysis has previously been reported to be slightly more frequent with Privigen than with some other products containing the same active substance.
V primerjavi z nekaterimi drugimi zdravili, ki vsebujejo enako učinkovino, so pri jemanju zdravila Privigen nekoliko pogosteje poročali o pojavu hujše oblike hemolize.
How does Privigen work?
Kako zdravilo Privigen deluje?
O MA (EU) number (Invented) name
(Izmišljeno) ime
Co. Down BT35 6JP Northern Ireland
Co. Down BT35 6JP Severna Irska
Combimox was authorised in the United Kingdom on 9 May 2003 under Article 13(1) of Directive 2001/82/EC.
Zdravilo Combimox je bilo odobreno v Združenem kraljestvu dne 9. maja 2003 v skladu s členom 13(1) Direktive 2001/82/ES.
The application was submitted to the Concerned Member State, Ireland, under the mutual recognition procedure.
Vloga je bila predložena zadevni državi članici, Irski, po postopku z medsebojnim priznavanjem.
Consequently the matter was referred to the CVMP
Zato je bila zadeva napotena na CVMP.
• the efficacy of Combimox was not confirmed;
• Učinkovitost zdravila Combimox ni bila potrjena.
Ireland considered that the authorisation of Combimox may present a potential serious risk to human and animal health since the safety and efficacy of the product had not been sufficiently demonstrated.
Irska je menila, da bi odobritev zdravila Combimox lahko predstavljala možno resno tveganje za zdravje ljudi in živali, saj varnost in učinkovitost zdravila nista bili ustrezno dokazani.
Therefore the CVMP concluded that the particulars submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC and recommended the refusal of granting the Marketing Authorisation in the Concerned Member State and the suspension of the existing Marketing Authorisation in the Reference Member State.
CVMP je zato sklenil, da predloženi podatki v podporo vlogi niso v skladu s členom 13 Direktive 2001/82/ES, ter priporočil zavrnitev odobritve dovoljenja za promet z zdravilom v zadevnih državah članicah in začasni umik obstoječega dovoljenja za promet z zdravilom v referenčni državi članici.
The applicant presented comparative viscosity data between the ‘old' and ‘new' formulations of Combimox.
Predlagatelj je predstavil primerjalne podatke o viskoznosti med „staro“ in „novo“ formulacijo zdravila Combimox.
The CVMP was asked to give its opinion on the concerns raised by Ireland and to conclude on the benefit/risk balance for Combimox.
CVMP je bil naprošen, da poda mnenje v zvezi z zadržki, ki jih je izrazila Irska, in sprejme sklep glede razmerja med tveganji in koristmi za zdravilo Combimox.
During the procedure, there was disagreement between the Reference Member State and Concerned Member State on the applicability of demonstrating systemic bioequivalence for a locally-applied, locally-acting product, as well as an additional concern on the adequacy of the proposed withdrawal period.
Med postopkom je prišlo do nesoglasja med referenčno državo članico in zadevnimi državami članicami glede uporabnosti dokazovanja sistemske biološke enakovrednosti za lokalno uporabljeno in lokalno delujoče zdravilo, pojavili pa so se tudi dodatni zadržki glede ustreznosti predlagane karence.
Not established
Ni ugotovljeno
Scientific conclusions and grounds for refusal of the granting of the marketing authorisation(s)
Znanstveni zaključki in podlaga za zavrnitev podelitve dovoljenj(a) za promet z zdravilom
Appropriate clinical data should be provided to confirm the efficacy of Combimox Lactating Cow Intramammary Suspension.
Predložiti je treba ustrezne klinične podatke za potrditev učinkovitosti zdravila Combimox Lactating Cow Intramammary Suspension.
An additional issue reviewed by the CVMP was a change in the formulation of Combimox during development to increase the stability of the product, which was identified as potentially affecting the release of the active substances from the product into the tissue.
Dodatno vprašanje, ki ga je CVMP preučil, je bila sprememba formulacije zdravila Combimox med razvojem, s čimer so želeli povečati stabilnost zdravila in za kar je bilo ugotovljeno, da bi lahko vplivalo na sproščanje zdravilne učinkovine iz zdravila v tkivo.