FrancophonIA/ELRC3.0 huggingface dataset:
English: The active side of TachoSil should be applied so that it extends 1-2 cm beyond the margins of the wound.
Maltese: Il-parti attiva ta' TachoSil għandha tiġi applikata sabiex toħroġ 1-2 ċm 'il barra mit-truf tal-ferita.
English: When the active side comes into contact with fluids (such as blood, lymph or saline solution) the fibrinogen and the thrombin are activated and form a fibrin network.
Maltese: Metan-naħa attiva tiġi f'kuntatt ma' fluwidi (bħal demm, limfa jew soluzzjoni bil-melħ) il-fibrinoġen u t-trombin jiġu attivati u jiffurmaw xibka ta' fibrin.
English: No evidence of local intolerability has been observed in animal studies.
Maltese: Ma ġiet osservata l-ebda evidenza ta' intollerabilità lokali fi studji fuq l-annimali.
English: TachoSil must not be applied intravascularly.
Maltese: Tużahiex b'mod intravaskulari.
English: Open the inner sterile package and remove the matrix.
Maltese: Iftaħ il-pakkett sterili ta' ġewwa u oħroġ l-matriċi.
English: - The active substances are human fibrinogen (5.5 mg per cm 2) and human thrombin (2.0 IU per cm - The other ingredients are equine collagen, human albumin, riboflavin (E101), sodium chloride, sodium citrate (E331) and L-arginine-hydrochloride.
Maltese: Is-sustanzi l-oħra huma equine collagen, human albumin, riboflavin (E101), sodium chloride, sodium citrate (E331) u L-arginine-hydrochloride.
English: Tissue sealing in lung surgery was investigated in two controlled trials in patients undergoing lung surgery.
Maltese: Jistgħu jseħħu wkoll ostruzzjoni tal-imsaren u uġigħ wara kirurġiji addominali.
English: Scar tissues may develop in some patients after surgery and use of TachoSil.
Maltese: L-applikazzjoni ta' TachoSil għandha tkun individwalizzata mill-kirurgu li jkun qiegħed japplika ttrattament.
English: There were no adverse events attributable to the development of human fibrinogen or equine collagen antibodies.
Maltese: Ma kienx hemm każijiet avversi attribwiti għall-iżvilupp ta' antikorpi ta' fibrinoġen uman jew kollaġen ekwin.
English: Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Maltese: Is-sinjali ta' reazzjonijiet ta' sensittività eċċessiva jinkludu ħorriqija, urtikarja ġeneralizzata, tagħfis fis-sider, tħarħir, pressjoni baxxa u anafilassi.
English: Life threatening thromboembolic complications may occur if the preparation is applied intravascularly.
Maltese: Ladarba l-pakkett jinfetaħ, ma tkunx possibbli sterilizzazzjoni wara.
English: International non-proprietary name (INN): dexamethasone
Maltese: Isem mhux proprjetarju internazzjonali (INN): dexamethasone
English: The Committee appointed Dr C. Ibrahim as rapporteur and Dr D. Murphy as co-rapporteur.
Maltese: Ibrahim bħala rapporteur u lil Dr D.
English: Written explanations were provided by the marketing authorisation holders on 10 December 2012and 21 May 2013.
Maltese: Spjegazzjonijiet bil-miktub ġew ipprovduti mid-detenturi talawtorizzazzjoni għat-tqegħid fis-suq fl-10 ta' Diċembru 2012 u fil-21 ta' Mejju 2013.
English: Dexamethasone is a long acting synthetic glucocorticoid used as anti-inflammatory, antiallergic and gluconeogenetic agent for administration to agricultural and domestic animals.
Maltese: Dexamethasone huwa glukokortikojde sintetiku li jaġixxi fit-tul li jintuża bħala sustanza anti-infjammatorja, kontra l-allerġiji u glukoneoġenetiku li jingħata lill-annimali agrikoli u domestiċi.
English: On 22 August 2012, Germany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Dexadreson 2 mg/ml and associated names, and generic products thereof.
Maltese: Fit-22 ta' Awwissu 2012, il-Ġermanja ppreżentat lill-Aġenzija notifika ta' riferiment skont l-Artikolu 35 tad-Direttiva 2011/82/KE, dwar Dexadreson 2 mg/ml u ismijiet assoċjati, u l-prodotti ġeneriċi tiegħu.
English: The veterinary medicinal products Dexadreson 2 mg/ml and its associated names and generic products thereof are solutions for injection which contain 2 mg dexamethasone per ml.
Maltese: Il-prodotti mediċinali veterinarji Dexadreson 2 mg/ml u l-ismijiet assoċjati u l-prodotti ġeneriċi tiegħu huma soluzzjonijiet għal injezzjoni li fihom 2 mg ta' dexamethasone f'kull ml.
English: Opinion following an Article 350F referral for Dexadreson 2 mg/ml and associated names, and generic products thereof
Maltese: Opinjoni wara riferiment skont l-Artikolu 350F għal Dexadreson 2 mg/ml u ismijiet assoċjati, u l-prodotti ġeneriċi tiegħu
English: The referral started on 12 September 2012.
Maltese: Il-riferiment inbeda fit-12 ta' Settembru 2012.
English: The final opinion was converted into a Decision by the European Commission on 18 October 2013.
Maltese: L-opinjoni finali ġiet ikkonvertita f'Deċiżjoni mill-Kummissjoni Ewropea fit-18 ta' Ottubru 2013.
English: Based on the evaluation of the currently available data, the CVMP considered that overall benefit-risk profile for these products remains positive subject to changes of the product information related to harmonisation of the withdrawal periods.
Maltese: Abbażi tal-valutazzjoni tad-dejta attwalment disponibbli, is-CVMP ikkunsidra li l-profil ġenerali talbenefiċċju-riskju għal dawn il-prodotti jibqa' pożittiv soġġett għat-tibdil tal-informazzjoni dwar ilprodott relatata mal-armonizzazzjoni tal-perjodi ta' tiżmim.
English: Therefore, the Committee adopted a positive opinion on 18 July 2013, recommending variations to the terms of the marketing authorisations for Dexadreson 2 mg/ml and its associated names and generic products thereof.
Maltese: Għalhekk, fit-18 ta' Lulju 2013 il-Kumitat adotta opinjoni pożittiva, li tirrakkomanda l-varjazzjonijiet għat-termini tal-awtorizzazzjonijiet għattqegħid fis-suq għal Dexadreson 2 mg/ml u l-ismijiet assoċjati u l-prodotti ġeneriċi tiegħu.
English: The CVMP was requested to evaluate the adequacy and consumer safety of the withdrawal periods for meat in cattle and horses and the withdrawal periods for milk in cattle for the concerned products.
Maltese: Is-CVMP intalab jivvaluta l-adegwatezza u s-sigurtà għall-konsumatur tal-perjodi ta' tiżmim għal-laħam fil-baqar u ż-żwiemel u l-perjodi ta' tiżmim għall-ħalib fil-baqar għall-prodotti kkonċernati.
English: Efficacy of Combination Vaccines Against Bovine Respiratory Pathogens in Calves.
Maltese: (2008) Field Efficacy of Combination Vaccines Against Bovine Respiratory Pathogens in Calves.
English: Spain - 17.1% (Godinho et al, 20055).
Maltese: 2%, Spanja - 17.1% (Godinho et al, 20055).
English: = Conversion factor [1000 μg.mg-1]
Maltese: = Fattur ta' konverżjoni [1000 μg.mg-1]
English: 6 Makoschey B., Munoz Bielsa J., Oliviero L., Roy O., Pillet F., Dufe D., Valla G. and Cavirani S. (2008) Field
Maltese: 6 Makoschey B., Munoz Bielsa J., Oliviero L., Roy O., Pillet F., Dufe D., Valla G. and Cavirani S.
English: Shotaflor contains florfenicol, which is a broad-spectrum primarily bacteriostatic, antibiotic with a range of activity, including many Gram-negative and Gram-positive organisms.
Maltese: Shotaflor fih florfenicol, li huwa antibijotiku ta' spettru wiesa' b'azzjoni prinċipalment batterjostatika b'medda ta' attività li jinkludi bosta organiżmi Gram-negattivi u Gram-pożittivi.
English: The dossier as submitted in the referral procedure is considered to fulfil the necessary requirements with regards to the environmental risk assessment (as established in Article 12(3)(j) of Directive 2001/82/EC, as amended by Directive 2004/28/EC), provided that the product is used only for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Maltese: Id-dossier kif ippreżentat filproċedura ta' referenza huwa meqjus li jissodisfa r-rekwiżiti meħtieġa fir-rigward tal-valutazzjoni tarriskju ambjentali (kif stabbilita fl-Artikolu 12(3)(j) tad-Direttiva 2001/82/KE, kif emendata midDirettiva 2004/28/KE) sakemm il-prodott jintuża biss għall-kura terapewtika tal-infezzjonijiet talapparat respiratorju fil-frat ikkawżati minn Mannheimia haemolytica, Pasteurella multocida u Histophilus somni.
English: = EU nitrogen spreading limit [kg N.ha-1]
Maltese: Tabella 3 tal-linja gwida.) = limitu tal-UE tal-firxa tan-nitroġenu [kg N.ha-1]
English: 5 Godinho K., Wolf R., Sherington J., Rowan T., Sunderland S. and Evans N. (2005) Efficacy of tulathromycin in the treatment and prevention of natural outbreaks of bovine respiratory disease in European cattle.
Maltese: 5 Godinho K., Wolf R., Sherington J., Rowan T., Sunderland S. and Evans N.
English: During the mutual recognition procedure concerns were raised that Shotaflor 300 mg/ml solution for injection for cattle may present a potential serious risk to the environment.
Maltese: Waqt il-proċedura ta' rikonoxximent reċiproku tqajjem tħassib dwar il-fatt li Shotaflor 300 mg/ml soluzzjoni għall-injezzjoni għall-frat jista' jippreżenta riskju gravi potenzjali għall-ambjent.
English: = Fraction of herd treated [value between 0 and 1] (see Table 2 of the guideline.)
Maltese: = Frazzjoni tal-merħla kkurata [valur bejn 0 u 1] (ara t-Tabella 2 tal-linja gwida.)
English: = Animal turnover rate per place per year [place-1.y-1] (see Table 3 of the guideline.)
Maltese: = Nitroġenu prodott f'sena f'kull post [kg.N. post-1.s-1] (ara t-Tabella 3 tal-linja gwida.)
English: The Marketing Authorisation Holder provided data with the aim of demonstrating that the percentage of herd animals that will be treated for Bovine Respiratory Disease (BRD) is less than the default value of 50% given in the CVMP guideline mentioned above (EMEA/CVMP/ERA/418282/2005Rev.1)).
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda data bl-għan li juri li l-perċentwal ta' annimali tal-merħla li sejrin jiġu kkurati għall-Mard Respiratorju Bovin (BRD) huwa inqas mill-valur prestabbilit ta' 50% mogħti fil-linja gwida tas-CVMP msemmi hawn fuq (EMEA/CVMP/ERA/418282/2005-Rev.1).
English: = Bulk density of dry soil [kg.m-3]
Maltese: = Densità tal-volum tal-ħamrija niexfa [kg.m-3] = Erja ta' ettaru [m2 .ha-1]
English: • Commercial farms (several breeds and age): France - 15.7%, Germany - 20.3%, Italy - 15.2%,
Maltese: 7%, il-Ġermanja - 20.3%, l-Italja15.
English: When such specific information is not available then the default values given in Table 2 of the CVMP guideline in support of VICH guidelines (Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - EMEA/CVMP/ERA/418282/2005Rev.1 - also known as the Technical Guidance Document - TGD) should be used.
Maltese: Gwida tas-CVMP dwar il-Valutazzjoni tal-Impatt Ambjentali għal Prodotti Mediċinali Veterinarji b'Appoġġ għal-Linji gwida VICH GL6 u GL38 - EMEA/CVMP/ERA/418282/2005Rev.1).
English: The CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) indicates that the proportion of animals in the herd which is treated may be available from information in the dossier such as field trial data or from the scientific literature.
Maltese: Il-Linja Gwida tas-CVMP dwar il-Valutazzjoni tal-Impatt Ambjentali għal Prodotti Mediċinali Veterinarji b'Appoġġ għal-Linji Gwida VICH GL6 u GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) tindika li l-proporzjon ta' annimali fil-merħla li tkun qiegħda tiġi ttrattata jista' jkun disponibbli minn informazzjoni fid-dossier, bħalma hija d-data ta' prova fil-post ta' applikazzjoni jew mill-materjal letterarju xjentifiku.
English: The CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL8 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) provides default values for the proportion of animals in a herd which is treated, for use in the calculation of PECsoil.
Maltese: Gwida dwar il-Valutazzjoni tal-Impatt Ambjentali għal Prodotti Mediċinali Veterinarji b'Appoġġ għal-Linji gwida VICH GL6 u GL38 - EMEA/CVMP/ERA/418282/2005-Rev.1 - magħrufin ukoll bħala d-Dokument ta' Gwida Teknika - TGD).
English: United Kingdom Virbac S.A. 1ere avenue 2065 m L.I.D.
Maltese: Mediċinali Veterinarji tas-CVMP b'Appoġġ għal-linji gwida VICH GL6 u GL38
English: It is available as white, round tablets (0.088, 0.18, 0.35 and 0.7 mg).
Maltese: Huwa disponibbli f'pilloli tondi u bojod (0.088, 0.18, 0.35 u 0.7 mg).
English: Pramipexole Teva is a ‘generic medicine'.
Maltese: Pramipexole Teva huwa ‘mediċina ġenerika'.
English: Pramipexole Teva is a medicine containing the active substance pramipexole base.
Maltese: Pramipexole Teva huwa mediċina li fiha s-sustanza attiva pramipexole base.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PRAMIPEXOLE TEVA EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) PRAMIPEXOLE TEVA Sommarju tal-EPAR għall-pubbliku
English: The starting dose is 0.088 mg three times per day.
Maltese: Id-doża inizjali hija ta' 0.088 mg tliet darbiet kuljum.
English: This summary was last updated in 11-2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 11-2008.
English: This means that Pramipexole Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Sifrol.
Maltese: Dan ifisser li Pramipexole Teva huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Sifrol.
English: The maximum daily dose is 1.1 mg three times per day.
Maltese: Id-doża massima kuljum hija ta' 1.1 mg tliet darbiet kuljum.
English: What is Pramipexole Teva?
Maltese: X'inhu Pramipexole Teva?
English: Because Pramipexole Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (i.e. that the two medicines produce the same levels of the active substance in the body).
Maltese: Minħabba li Pramipexole Teva huwa mediċina ġenerika, l-istudji ġew limitati għal testijiet biex jiġi determinat li huwa bijoekwivalenti għall-mediċina ta' referenza (jiġifieri li ż-żewġ mediċini jipproduċu l-istess livelli ta' sustanza attiva fil-ġisem).
English: Pramipexole Teva is used to treat the symptoms of Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Maltese: Pramipexole Teva jintuża għat-trattament tas-sintomi tal-marda ta' Parkinson li hija disturb mentali progressiv li jikkawża rogħda, dewmien fil-movimenti u ebusija muskolari.
English: Why has Pramipexole Teva been approved?
Maltese: Għaliex ġie approvat Pramipexole Teva?
English: The dose should be increased every five to seven days until symptoms are controlled without causing side effects that cannot be tolerated.
Maltese: Id-doża għandha tiġi miżjuda kull ħames sa sebat ijiem sakemm is-sintomi jiġu kontrollati mingħajr ma jiġu kkawwżati effetti sekondarji li ma jistgħux jiġu tollerati.
English: What are the benefit and risk of Pramipexole Teva?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Pramipexole Teva?
English: The European Commission granted a marketing authorisation valid throughout the EU for Pramipexole Teva to Teva Pharma B.V. on 18 December 2008.
Maltese: BV fi 18 ta' Diċembru 2008.
English: Because Pramipexole Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Minħabba li Pramipexole Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċini ta' referenza, il-benefiċċju u r-riskju tiegħu huma meqjusa li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pramipexole Teva has been shown to have comparable quality and to be bioequivalent to Sifrol.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li, b'mod konformi mal-ħtiġijiet tal-UE, Pramipexole Teva wera li għandu kwalità komparabbli ma' u huwa bijoekwivlenti għal Sifrol.
English: Therefore, the CHMP's view was that, as for Sifrol, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal Sifrol, il-benefiċċji jegħlbu r-riskji identifikati.
English: The active substance in Pramipexole Teva, pramipexole, is a dopamine agonist, which imitates the action of dopamine.
Maltese: Din il-mediċina tista' tinkiseb biss b'riċetta tat-tabib.
English: Dopamine is a messenger substance in the parts of the brain that control movement and co-ordination.
Maltese: Id-dopamina hija sustanza li taħdem bħala messaġġiera fil-partijiet tal-moħħ li jikkontrollaw il-moviment u l-koordinazzjoni.
English: Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as shaking, stiffness and slowness of movement.
Maltese: Pramipexole jistimola l-moħħ hekk kif tagħmel id-dopamina, biex b'hekk il-pazjenti jkunu jistgħu jikkontrollaw ilmovimenti tagħhom u jkollhom inqas sinjali u sintomi tal-marda ta' Parkinson, bħar-rogħda, l-ebusija u d-dewmien fil-movimenti.
English: How is Pramipexole Teva used?
Maltese: Kif jintuża Pramipexole Teva?
English: EU Number
Maltese: IRU
English: 6 spare Insulin Release Units (IRUs)
Maltese: Units ta' Rilaxx ta' l-Insulina (IRU) fuq ir-riħ addizjonali.
English: *Inhalation Kit:
Maltese: *Kit ta' l-inalazzjoni: inalatur ta' l-insulina ċejmber fuq ir-riħ addizjonali.
English: Strength Pharmaceutical Form Route of Administration Packaging
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: The full EPAR for Efficib can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Efficib sitagliptin / metformin hydrochloride
Maltese: Efficib sitagliptina / metformina idrokloridrat
English: This is a summary of the European public assessment report (EPAR) for Efficib.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Efficib.
English: What is Efficib?
Maltese: X'inhu Efficib?
English: What is the risk associated with Efficib?
Maltese: X'inhu r-riskju assoċjat ma' Efficib?
English: The European Commission granted a marketing authorisation valid throughout the EU for Efficib on 16 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Efficib fis-16 ta' Lulju 2008.
English: Efficib is a medicine that contains two active substances, sitagliptin and metformin hydrochloride.
Maltese: Efficib huwa mediċina li fiha żewġ sustanzi attivi, sitagliptina u metformina idrokloridrat.
English: The most common side effect with Efficib (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Maltese: L-effett sekondarju l-aktar komuni b'Efficib (li deher f'bejn pazjent 1 u 10 minn 100) huwa nawżja (dardir).
English: Efficib should be taken with food to avoid any stomach problems caused by metformin.
Maltese: Efficib għandu jittieħed mal-ikel sabiex jiġu evitati problemi tal-istonku kkawżati minn metformina.
English: If Efficib is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Maltese: sulfonilurea jew l-insulina, id-doża ta' sulfonilurea jew l-insulina jista' jkun meħtieġ li tiġi mnaqqsa sabiex tiġi evitata ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: What benefit has Efficib shown during the studies?
Maltese: X'benefiċċji wera Efficib matul l-istudji?
English: The active substances in Efficib, sitagliptin and metformin hydrochloride, each have a different mode of action.
Maltese: Is-sustanzi attivi f'Efficib, is-sitagliptina u l-metformina idrokloridrat, kull waħda għandha azzjoni differenti.
English: It must not be used in patients who have diabetic ketoacidosis or pre coma (dangerous conditions that can occur in diabetes), problems with the kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Maltese: Ma għandux jintuża f'pazjenti li jbatu minn ketoaċidożi dijabetika jew prekoma (kondizzjonijiet perikolużi li jistgħu jseħħu fid-dijabete), problemi bil-fwied jew bil-kliewi, kundizzjonijiet li jistgħu jaffettwaw il-kliewi, jew marda li tikkawża provvista mnaqqsa ta' ossiġnu lit-tessuti bħal insuffiċjenza kardijaka jew tal-pulmun jew attakk tal-qalb reċenti.
English: The CHMP decided that Efficib's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Efficib huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Efficib with that of metformin or sitagliptin alone.
Maltese: Fl-ewwel wieħed ħadu sehem 1,091 pazjent li ma kinux kontrollati b'mod sodisfaċenti bid-dieta u bl-eżerċizzju biss u dan qabbel leffett ta' Efficib ma' dak tal-metformina jew tas-sitagliptina biss.
English: Efficib is taken twice a day.
Maltese: Efficib jittieħed darbtejn kuljum.
English: 190 09 Pikermi- Attica- Athens Greece
Maltese: 190 09 Pikermi- Attica- Athens Greċja
English: Via M. Civitali, 1 20148 Milano Italy
Maltese: Civitali, 1 20148 Milano Italja
English: À Av. da Siderurgia Nacional P.O.
Maltese: À Av. da Siderurgia Nacional P.O. Box 56
English: LU- Luxembourg Therabel Pharma 110 Rue Egide Van Ochem B 1180 Bruxelles
Maltese: LU- Lussemburgu Therabel Pharma 110 Rue Egide Van Ochem B 1180 Bruxelles
English: Octegra was initially approved in June 1999.
Maltese: Octegra kien approvat inizjalment f'Ġunju ta' l-1999.
English: This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Octegra film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, EL, ES, FR, IT, LU, NL and PT on 5 December 2006.
Maltese: Din il-proċedura hija riferiment wara Proċedura ta' Għarfien Reċiproku dwar l-applikazzjoni talvarjazzjoni msemmija fuq li ġiet sottomessa għall-pilloli miksijin b'rita ta' Octegra lill-Ġermanja bħala Stat Membru ta' Referenza (RMS) u lill-Istati Membri Konċernati (CMS) AT, BE, EL, ES, FR, IT, LU, NL u PT fil-5 ta' Diċembru ta' l-2006.
English: BE - Belgium THERABEL PHARMA S.A. Rue Egide Van Ophem 108
Maltese: THERABEL PHARMA S.A. Rue Egide Van Ophem 108 1180 BRUXELLES Belgju
English: The MRP variation application DE/H/156/01/II/34 concerned an extension of the indication to include the treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis.
Maltese: L-applikazzjoni tal-varjazzjoni ta' l-MRP DE/H/156/01/II/34 kienet dwar estensjoni ta' l-indikazzjoni biex ikun inkluż it-trattament tal-marda infjammatorja tal-pelvis (PID) moderata jew severa, jiġifieri infezzjonijiet tal-parti ta' fuq tal-passaġġ ġenitali, inklużi s-salpinġite u l-endometrite.
English: - The Committee considered the Referral made under Article 6(12) of Commission Regulation (EC) No 1084/2003, for Octegra and associated names (See Annex 1).
Maltese: - Il-Kumitat ikkunsidra r-Riferiment magħmul skond l-Artikolu 6(12) tar-Regolament talKummissjoni (KE) Nru 1084/2003, għal Octegra u ismijiet assoċjati (ara l-Anness 1).