qanastek/EMEA-V3 huggingface dataset:
Under these conditions the applicant is exempted from submitting further preclinical or clinical data on efficacy of the 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Ma ġiet identifikata l- ebda differenza 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. proposed product and can claim the same indications for use as for the reference product.
Reproduction is authorised provided the source is acknowledged. bejn iż- żewġ prodotti li tista ’ tiġġustifika konklużjonijiet differenti dwar is- sigurtà u l- effikaċja.
Therefore, the absence of efficacy documentation does not present a potential serious risk to animal health.
Għalhekk, in- nuqqas ta ’ dokumentazzjoni dwar l- effikaċja ma tippreżentax riskju serju potenzjali għas- saħħa tal- annimali.
The objections from France and Sweden should not prevent the granting of a marketing authorisation.
L- oġġezzjonijiet minn Franza u l- Iżvezja ma għandhomx jipprevjenu l- għoti tal- awtorizzazzjoni għat - tqegħid fis- suq.
The CVMP Opinion was adopted on 13 February 2008 and the subsequent Commission Decision on 2 April 2008.
L- Opinjoni tas- CVMP ġiet adottata fit- 13 ta ’ Frar 2008 u d- Deċiżjoni sussegwenti tal- Kummissjoni fit- 2 ta ’ April 2008.
EMEA/ 459391/ 2008-EN
EMEA/ 459391/ 2008- MT
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
L- ISEM, L- GĦAMLA FARMAĊEWTIKA, IL- QAWWA, L- ISPEĊI TA ’ ANNIMAL, MNEJN JINGĦATA U D- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
1/ 7 Applicant or Marketing Authorisation Holder
1/ 7 L- Applikant jew id - Detentur ta ’ l - Awtorizzazzjoni għat - Tqegħid fis- Suq
Product invented name
Isem inventat tal - prodott
Frequency and route of administration
Speċi ta ’ Frekwenza u Doża rakkomandata annimal mnejn jingħata
173 55216 Ingelheim Germany
173 55216 Ingelheim Il- Ġermanja
Compagel gel for horses
Compagel gel għaż - żwiemel
gel
ġell
100g gel contains: heparin sodium 50 000 IU levomenthol 0.5 g hydroxyethyl salicylate 5.0 g
100g ġell fih: heparin sodium 50 000 IU levomenthol 0. 5 g hydroxyethyl salicylate 5. 0 g
horse
żwiemel
topical
topiku
Up to a total daily quantity of 50 g gel per day is applied using finger tip pressure onto the affected area according to the veterinary surgeon’ s instructions until signs and symptoms resolve.
Sa massimu totali ta ’ 50 g ġell kuljum jiġi applikat fuq il- parti affettwata bil - ponta tas- saba ’ skond l- istruzzjonijiet tal- kirurgu veterinarju sakemm is - sinjali u s- sintomi jitranġaw.
After nerve block anaesthesia the gel should be applied to the skin in a layer the thickness of the back of a knife and covered with a bandage.
Wara l- anestesija bl- imblukkar tan - nervituri il- ġell għandu jiġi applikat mal- ġilda f’ saff oħxon daqs wara ta ’ sikkina u mgħotti b’ faxxa.
2/ 7 ANNEX II
2/ 7 ANNESS II
3/ 7 SCIENTIFIC CONCLUSIONS
3/ 7 KONKLUŻJONIJIET XJENTIFIĊI
Introduction and background
Daħla u Sfond
Germany, reference member state in the decentralised procedure, notified the EMEA on 21 December 2008 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement for Compagel gel for horses.
Il- Ġermanja, Stat Membru ta ’ referenza fil- proċedura ta ’ deċentralizzazzjoni, fil- 21 ta ’ Diċembru 2007, għarraf lill- EMEA li l- Grupp ta ’ Koordinazzjoni għall- Għarfien Reċiproku u l- Proċeduri Deċentralizzati - Veterinarji (is- CMD( v)) naqas milli jilħaq ftehim fuq Compagel gel għaż- żwiemel.
Pursuant to Article 33(4) of Council Directive 2001/ 82/ EC, as amended, the matter was referred to the CVMP.
Skond l- Artikolu 33( 4) tad- Direttiva tal- Kunsill 2001/ 82/ KE, kif emendata, il- materja ġiet referita lis - CVMP.
France and Sweden consider that due to the absence of efficacy documentation it cannot be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health.
Franza u l- Iżvezja jqisu li, minħabba n- nuqqas ta ’ dokumentazzjoni dwar l- effikaċja wieħed ma jistax jassumi li l- prodott huwa effikaċi u li dan jippreżenta riskju serju potenzjali għas- saħħa ta ’ l- annimali.
CVMP noted that Compagel gel for horses is a generic of Tensolvet 50000 (authorised in Germany) and that the concerns raised by France and Sweden can only be addressed in the framework of this procedure, in case any differences between the two products would justify different conclusions on the safety or efficacy.
Is- CVMP innota li Compagel gel għaż- żwiemel hu ġeneriku ta ’ Tensolvet 50000 (awtorizzat fil - Ġermanja) u li t- tħassib imqajjem minn Frranza u l- Iżvezja jista ’ jiġi indirizzat biss fil- qafas ta ’ din il - proċedura, fil- każ li jkun hemm xi differenzi bejn iż- żewġ prodotti li tkun tista ’ tiġġustifika l - konklużjonjiet differenti dwar is- sigurtà u l- effikaċja.
CVMP started the procedure on 16 January 2008.
Is- CVMP beda l- proċedura fis- 16 ta ’ Jannar 2008.
A list of questions was adopted the same day and sent to the applicant, by which the procedure clock was stopped.
Fl- istess jum ġiet adottata lista ta ’ mistoqsijiet u din intbagħtet lill- applikant u ż- żmien tal- proċedura twaqqaf.
On 22 January 2008 responses to the questions were received from applicant and the clock restarted.
Fit- 22 ta ’ Jannar 2008 waslu t- tweġibiet għall- mistoqsijiet mingħand l- applikant u ż- żmien reġa ’ nbeda.
The aim of the assessment is to establish whether marketing authorisations of veterinary medicinal products included in the referral procedure should be maintained, suspended, varied or revoked with view to the grounds for referral.
L- għan ta ’ din il- valutazzjoni kien li jiġi stabbilit jekk l- awtorizzazzjonijiet għat- tqegħid fis- suq tal - prodotti mediċinali inklużi fil- proċedura ta ’ riferiment għandhomx jinżammu, jiġu sospiżi, jinbidlu jew jiġu revokati minħabba r- raġunijiet għar- riferiment.
The applicant was requested to provide the following information:
L- applikant intalab jipprovdi dan it- tagħrif:
A copy of the information and documents referred to in the first subparagraph of Article 32(1) of the Directive and any additional information provided to the Reference Member State during the 60 day CMD(v) procedure (rapporteurs and EMEA only).
Kopja tat- tagħrif u d- dokumenti li hemm referenza għalihom fl- ewwel subparagrafu ta ’ l- Artikolu 32( 1) tad- Direttiva u kwalunkwe tagħrif ipprovdut lill- Istat Membru ta ’ Referenza matul il - proċedura tas- CMD( v) ta ’ 60 jum (rapporteurs u l- EMEA biss).
In view of the concerns raised by France and Sweden, to indicate and to substantiate where necessary, any differences between Compagel gel for horses and reference product Tensolvet 50000 (authorised in Germany) that could justify different conclusions on the efficacy for the two products.
Minħabba t- tħassib imqajjem minn Franza u l- Iżvezja, li jiġu indikati u sostanzjati fejn meħtieġ, id - differenzi kollha bejn Compagel gel għaż- żwiemel u l- prodott ta ’ referenza Tensolvet 50000 (awtorizzat fil- Ġermanja) li jistgħu jiġġustifikaw il- konklużjonijiet differenti fuq l- effikaċja taż - żewġ prodotti.
In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a mutual recognition procedure, and any supplementary data submitted during the mutual recognition procedure and the referral procedure in CMD(v) thereafter.
Bi tweġiba għall- mistoqsija numru 1, l- applikant ipprovda kopja tad- dossier oriġinali kif ippreżentat b’ appoġġ għall- applikazzjoni tal- proċedura ta ’ għarfien reċiproku, u kull dejta supplimentari sottomessa waqt il- proċedura ta ’ għarfien reċiproku u l- proċedura ta ’ riferiment fis- CMD( v) wara dan.
13 of Directive 2001/ 82/ EC as amended, in which it is stated that “ By way of derogation from point (j) of the first subparagraph of Article 12 (3), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of the safety and residue tests or of the preclinical and clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorized under Article 5 for not less than eight years in a Member State or the Community .”
L- applikazzjoni ta ’ Compagel gel għaż- żwiemel kienet ibbażata fuq l- Artikolu 13 tad- Direttiva 2001/ 82/ KE kif emendata, li fiha jintqal li “ B’ deroga minn punt (j) ta ’ l- ewwel subparagrafu ta ’ l - Artikolu 12 (3), u mingħajr preġudizzju għal- liġi dwar il- protezzjoni tal- proprjetà industrijali u kummerċjali, l- applikant ma għandux ikun meħtieġ jipprovdi r- riżultati tas- sigurtà u tat- testijiet tar - residwi jew ta ’ provi prekliniċi u kliniċi jekk jista ’ juri li l- prodott mediċinali huwa ġeneriku ta ’ prodott mediċinali ta ’ referenza li huwa jew li kien awtorizzat skond l- Artikolu 5 għal mhux inqas minn tmien snin fi Stat Membru jew fil- Komunità. ”
Reference is made to the reference product Tensolvet 50000 which has been registered and used over a period of more than eight years in Germany.
Qegħda ssir referenza għall- prodott ta ’ referenza Tensolvet 50000 li ġie rreġistrat u użat għal perjodu ta ’ iktar minn tmien snin fil- Ġermanja.
All concerned member states in the mutual recognition procedure agreed that Compagel gel for horses is essentially similar to Tensolvet 50000.
L- Istati Membri kollha konċernati fil- proċedura għall- għarfien reċiproku qablu li Compagel gel għaż- żwiemel huwa essenzjalment simili għal Tensolvet 50000.
In response to question 2, the applicant responded that there are no differences at all that would justify different conclusions on the safety and efficacy for the two products.
Bi tweġiba għall- mistoqsija numru 2, l- applikant wieġeb li ma kien hemm l- ebda differenza li tista ’ tiġġustifika konklużjonijiet differenti dwar l- effikaċja u s- sigurtà taż- żewġ prodotti.
4/ 7 Under these conditions the applicant is exempted from submitting further preclinical or clinical data on efficacy of the proposed product, and can claim the same indications for use as for the reference product Tensolvet 50000.
4/ 7 Taħt dawn il- kondizzjonijiet, l- applikant huwa eżentat milli jissottometti iktar dejta preklinika jew klinika fuq l- effikaċja tal- prodott propost, u jista ’ jiddikjara l- istess indikazzjonijiet għall- użu bħall - prodott ta ’ referenza Tensolvet 50000.
Conclusions and Recommendations
Konklużjonijiet u Rakkomandazzjonjiet
Compagel gel for horses proved to be essentially similar to the reference product, Tensolvet 50000.
Ġie ppruvat li l- Compagel gel għaż- żwiemel kien essenzjalment simili għall- prodott ta ’ referenza, Tensolvet 50000.
Consequently, the same conclusions on efficacy and safety apply to both products.
Konsegwentament, japplikaw l- istess konklużjonijiet għall- effikaċja u s- sigurtà għaż- żewġ prodotti.
The objections raised by France and Sweden should not prevent the granting of a marketing authorisation for Compagel gel for horses.
L- objezzjonijiet imqajma minn Franza u l- Iżvezja m’ għandhomx jipprevjenu l - għoti ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għal Compagel gel għaż- żwiemel.
5/ 7 ANNEX III
5/ 7 ANNESS III
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE INSERT
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF
6/ 7 The valid Summary of Product Characteristics, labelling and package leaflet are the versions agreed by the Reference Member State and Concerned Member States (except France and Sweden) at day 90 of the mutual recognition procedure.
6/ 7 Is- Sommarju tal- Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta ’ tagħrif huma l- verżjonijiet li qablu fuqhom l- Istati Membri ta ’ Referenza u l- Istati Membri Konċernati (ħlief Franza u l- Iżvezja) fid- 90 jum tal- proċedura ta ’ għarfien reċiproku.
London, June 2008 EMEA/ 532160/ 2007 – Rev.1
Londra, Ġunju 2008 EMEA/ 532160/ 2007 – Rev. 1
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
KUMITAT GĦAL PRODOTTI MEDIĊINALI GĦALL- UŻU VETERINARJU (CVMP)
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR DOLOVET
OPINJONI WARA REFERENZA SKOND L- ARTIKOLU 33 (4) GĦAL DOLOVET
Dolovet vet 2.4g oral powder is a powder presented in sachets of 15g, each containing 2.4g ketoprofen and is authorised for the treatment of fever and inflammation in cattle.
Dolovet vet 2. 4g trab orali huwa trab ippreżentat fi qratas ta ’ 15g, kull wieħed fih 2. 4g ketoprofen u huwa awtorizzat għat- trattament tad- deni u l- infjammazzjoni fl- ifrat.
A Mutual Recognition Procedure (MRP) started on 22 September 2005 with Finland acting as Reference Member State and twelve Concerned Member States.
Fit- 22 ta ’ Settembru 2005 bdiet proċedura ta ’ Rikonoxximent Reċiproku (MRP) mal- Finlandja bħala Stat Membru ta ’ Referenza u tnax- il Stat Membru Konċernat.
Belgium and Norway could not agree with granting a marketing authorisation.
Il- Belġju u n- Norveġja ma setgħux jaqblu ma ’ l- għoti ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
They considered the product to present a potential serious risk for animal health.
Huma ħassew li l- prodott jippreżenta riskju potenzjali serju għas- saħħa ta ’ l- annimali.
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v), and subsequently to the Committee for Medicinal Products for Veterinary Use (CVMP).
Il- kwistjoni ġiet riferuta lill- Grupp ta ’ Koordinament għall- Proċeduri ta ’ Rikonoxximent Reċiproku u Deċentralizzati, CMD( v), u suċċessivament lill- Kumitat għal Prodotti Mediċinali għall- Użu Veterinarju (CVMP).
Belgium and Norway considered that this medicinal product could present a potential serious risk to animal health on the grounds that the efficacy had not been sufficiently substantiated in the dossier.
Il- Belġju u n- Norveġja ħassew li dan il- prodott mediċinali jista ’ jippreżenta riskju potenzjali serju għas- saħħa ta ’ l- annimali minħabba li l- effikaċja tiegħu ma kinetx ġiet issostanzjata b’ mod suffiċjenti fir- rapport.
The CVMP during its meeting of 14-16 March 2006 started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC, as amended.
Waqt il- laqgħa tiegħu ta ’ l- 14- 16 ta ’ Marzu 2006, il- CVMP beda proċedura ta ’ referenza skond l - Artikolu 33( 4) tad- Direttiva 2001/ 82/ KE, kif emendat.
The Marketing Authorisation Holder (MAH) was requested to substantiate the efficacy of the product.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ġie mitlub jissostanzja l- effikaċja tal- prodott.
A dose confirmation study was submitted with the response.
Mat- tweġiba ġie ppreżentat studju ta ’ konferma tad- doża.
The experimental design of the study mimicked acute toxic mastitis.
Id- disinn sperimentali ta ’ l- istudju imita mastite tossika akuta.
The statistical report indicated that the number of animals used did not allow equivalence to be established (nor non-inferiority) between Dolovet containing ketoprofen administered orally at the dose of 4 mg/ kg bodyweight and Ketofen containing ketoprofen administered intramuscularly at the dose of 3 mg/ kg.
Ir- rapport statistiku indika li n- numru ta ’ annimali li ntużaw ma ppermettiex li tiġi stabbilita l- ekwivalenza (u lanqas in- non- inferjorità) bejn Dolovet li fih ketoprofen mogħti b’ mod orali fid- doża ta ’ 4 mg/ kg ta ’ piż tal- ġisem u Ketofen li fih ketoprofen mogħti ġol- muskoli fid- doża ta ’ 3 mg/ kg.
However, given that the pharmacokinetic data allowed the optimisation of the dose (keeping overall exposure comparable between the two products), it was concluded that a bridge existed allowing well established use to apply to Dolovet.
Madankollu, minħabba li d- dejta farmakokinetika ppermettiet l- ottimizzazzjoni tad- doża (li żżomm l - esponiment globali komparabbli bejn iż- żewġ prodotti), ġie konkluż li kien jeżisti pont li jippermetti li użu stabbilit sewwa jiġi applikat għal Dolovet.
Even though equivalence has not been formally shown, the two products perform similarly when compared to placebo in regards to a number of critical parameters, both clinical and otherwise (thromboxane B2 levels in plasma).
Minkejja li l- ekwivalenza ma ntwerietx b’ mod formali, iż- żewġ prodotti jaħdmu b’ mod simili meta mqabbla mal- plaċebo fir- rigward ta ’ numru ta ’ parametri kritiċi, it- tnejn kliniċi jew mod ieħor (livelli ta ’ thromboxane B2 fil- plażma).
If one accepts that a bridge exists, then the clinical indications that exist for Ketofen, as evidenced in the literature, should apply in large part to Dolovet.
Jekk wieħed jaċċetta li jeżisti pont, f’ dak il- każ l- indikazzjonijiet kliniċi li jeżistu għal Ketofen, kif murija fil- letteratura, għandhom japplikaw f’ parti sewwa għal Dolovet.
For example, in generic applications, a preclinical bridge is made that allows extrapolation to the field situation.
Per eżempju, f’ applikazzjonijiet ġeneriċi, ġie prodott pont ta ’ qabel l- użu kliniku li jippermetti l- estrapolazzjoni għas- sitwazzjoni fil- kamp.
For generic applications bioequivalence must be demonstrated.
Għall - applikazzjonijiet ġeneriċi, trid tiġi murija l- bijoekwivalenza.
For well- established use dossiers the bridge can be constructed more tentatively.
Fil- każ ta ’ faxxikli dwar użu stabbilit sewwa, il- pont jista ’ jinbena b’ mod iżjed tentattiv.
To restrict the indications of Dolovet to only those that were tested (endotoxemic mastitis control) would be inappropriate.
Li wieħed jillimita l- indikazzjonijiet ta ’ Dolovet għal dawk biss li ġew ittestjati (kontroll ta ’ l - endotoxemic mastitis) ma jkunx f’ waqtu.
Reducing of pyrexia or fever and alleviation of inflammation are considered important clinical claims that should be retained as they have been sufficiently well demonstrated.
It- tnaqqis tad- deni u t- taffija ta ’ l- infjammazzjoni huma kkunsidrati bħala affermazzjonijiet kliniċi importanti li għandhom jinżammu billi dawn ġew murija b’ mod suffiċjentement tajjeb.
Considering the data provided and the well-established use of ketoprofen, the CVMP was of the opinion that the claim “ Alleviation of inflammation and reduction of fever in individual animals” had been substantiated.
Wara li kkunsidra d- dejta pprovduta u l- użu stabbilit sewwa ta ’ ketoprofen, is- CVMP kien ta ’ l - opinjoni li l- affermazzjoni “ It- taffija ta ’ l- infjammazzjoni u t- tnaqqis tad- deni f’ annimali individwali ” kienet ġiet issostanzjata.
The CVMP Opinion was adopted on 9 November 2006 and the subsequent Commission Decision on 17 April 2007.
L- Opinjoni tas- CVMP ġiet adottata fid- 9 ta ’ Novembru 2006 u d- Deċiżjoni suċċessiva tal - Kummissjoni ġiet adottata fis- 17 ta ’ April 2007.
EMEA/ 532160/ 2007-Rev.1
EMEA/ 532160/ 2007- Rev. 1- MT
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER Member State
1/ 21 Stat Membru
Applicant or Marketing Authorisation Holder
Applikant jew detentur ta ’ l- Awtorizzazzjoni tal - Kummerċ
Product invented name
Isem tal- prodott inventat
Animal species
Speċje ta ’ l- annimal
Frequency and route of administration
Frekwenza u rotta ta ’ amministrazzjoni
Recommended dose
Doża rakkomandata
Belgium, Czech Republic, Germany, Greece, Spain, France, Italy, The Netherlands, Poland, Portugal and Slovakia
Il- Belġju, ir- Repubblika Ċeka, il -
Pigs (after weaning)
Majjali
In feed use
Fl- użu ta ’ l- għalf
10 mg/ kg. bw
10 mg/ kg. bw
2/ 21 ANNEX II
2/ 21 ANNESS II
3/ 21 SCIENTIFIC CONCLUSIONS
3/ 21 KONKLUŻJONIJIET XJENTIFIĊI
Doxyprex 100 mg premix presented in 5 kg, 20 kg and 25 kg thermosealed bags containing 100 mg/ g doxycycline base as hyclate.
Doxyprex 100 mg premix ippreżentat f’ boroż magħluqin bis- sħana ta ’ 5 kg, 20 kg u 35 kg li fihom 100 mg/ g ta ’ bażi ta ’ doxycyline bħala hyclate.
In Spain the product has been authorised for the indication the treatment of swine respiratory disease caused by Pasteurella multocida, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.
Fi Spanja l- prodott ġie awtorizzat għall- indikazzjoni tat- trattament tal- marda respiratorja fil- majjali kkawżata minn Pasteurella multocida, Bordetella bronchiseptica u Mycoplasma hyopneumoniae.
This is also the indication applied for at the start of the mutual recognition procedure (MRP).
Din hija l- indikazzjoni applikata fil- bidu tal- proċedura ta ’ għarfien reċiproku (MRP).
Following discussions in the CMD(v), the proposed indication was changed during the course of the MRP to: “ For treatment of swine respiratory disease caused by susceptible Pasteurella multocida, Bordetella bronchiseptica and Mycoplasma hyopneumoniae to doxycycline. ” Germany notified the EMEA on 30 May 2006 that the CMD(v) failed to reach an agreement regarding the product.
Wara diskussjonijiet fis- CMD( v), l- indikazzjoni proposta ġiet mibdula matul il- kors tal- MRP għal: “ Għal trattament tal- marda respiratorja fil- majjali kkawżata minn Pasteurella multocida, Bordetella bronchiseptica u Mycoplasma hyopneumoniae suxxettibbli għal doxycycline. ” Il- Ġermanja nnotifikat lill- EMEA fit- 30 ta ’ Mejju 2006 li s- CMD( v) ma rnexxilux jilħaq ftehim fir - rigward tal- prodott.
Pursuant to Article 33(4) of Directive 2001/ 82/ EC, as amended, the matter was referred to the CVMP.
Skond l- Artikolu 33( 4) tad- Direttiva 2001/ 82/ KE, kif emendat, il- kwistjoni ġiet riferuta lis- CVMP.
The reason for this was that the national competent authority of Germany considered that this veterinary medicinal product could present a potential serious risk to animal health on the grounds that the efficacy has not been sufficiently substantiated in the dossier.
Ir- raġuni għal dan kienet li l- awtorità kompetenti nazzjonali tal- Ġermanja kkunsidrat li dan il- prodott medinċinali veterinarju jista ’ jippreżenta riskju potenzjali serju għas- saħħa ta ’ l- annimali abbażi tal - fatt li l- effikaċja ma ġietx issostanzjata biżżejjed fid- dosjer.
The CVMP during its meeting of 21-22 June 2006 started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC, as amended, for Doxyprex 100 mg premix.
Is- CVMP waqt il- laqgħa tiegħu tal- 21- 22 ta ’ Ġunju 2006 beda proċedura ta ’ referenza taħt l- Artikolu 33( 4) tad- Direttiva 2001/ 82/ KE, kif emendat, għal Doxyprex 100 mg premix.
The Marketing Authorisation Holder (MAH) was requested to substantiate the indication and posology as discussed during the recent MRP.
Id- Detentur ta ’ l - Awtorizzazzjoni ta ’ Kummerċjalizzazzjoni (MAH) ġie mitlub jissostanzja l- indikazzjoni u l - pożoloġija kif diskussa matul l- MRP riċenti.
The responses were submitted to the EMEA on 19 December 2006.
It- tweġibiet ġew ippreżentati lill- EMEA fid- 19 ta ’ Diċembru 2006.
In the introduction to the responses the applicant has given a justification for submission of this application on a “ well-established use” basis.
Fl- introduzzjoni għat- tweġibiet l- applikant ta ġustifikazzjoni għall- preżentazzjoni ta ’ din l - applikazzjoni fuq bażi “ b’ użu stabbilit tajjeb ”.
Within the EU doxycycline-based premix products for pigs at recommended dose rates of 10mg/ kg once daily for 5 days are stated as having been authorised since 1985.
Fi ħdan l- UE, il- prodotti premix ibbażati fuq doxycycline għall- majjali b’ rati ta ’ doża rakkomandati ta ’ 10mg/ kg darba kuljum għal 5 tijiem huma ddikjarati bħala awtorizzati mill- 1985.
Similar products with 8 or 10 days treatment durations are also available within the EU.
Prodotti simili bi trattament li jdum 8 jew 10 ijiem huma disponibbli wkoll fi ħdan l- UE.
Annex I of Directive 2001/ 82/ EC as amended by directive 2004/ 28/ EC notes that post-marketing experience with other products containing the same constituents is of particular importance and applicants should put a special emphasis on this issue.
L- Anness I tad- Direttiva 2001/ 82/ KE kif emendat bid- direttiva 2004/ 28/ KE jinnota li l- esperjenza ta ’ wara l- kummerċjalizzazzjoni ma ’ prodotti oħrajn li tinkludi l- istess kostitwenti hija ta ’ importanza partikolari u l- applikanti għandhom jagħmlu enfażi speċjali fuq din il- kwistjoni.
Therefore, the CVMP considered that the reports mentioned above give favourable evidence for the safety and efficacy of doxycycline in general, but also for the specific final formulation as marketed in Spain.
Għalhekk, CVMP jikkunsidra li r- rapporti msemmijin hawn fuq jagħtu provi favorevoli għas- sigurtà u l- effikaċja ta ’ doxycycline in ġenerali, iżda wkoll għall- formulazzjoni finali speċifika kif ikkummerċjalizzata fi Spanja.
Pivotal clinical trial with Doxycyline 10% premix
Prova klinika ewlenija bi Doxycyline 10% premix
The choice of positive control products and the dosing regiment applied were discussed:
L- għażla ta ’ prodotti ta ’ kontroll pożittivi u r- reġimen tad- doża applikata ġew diskussi:
The applicant explained that their choice of positive controls in the pivotal field trial was not intended to compare their product with a product, which had been used for the same proposed posology within the Community for at least 10 years.
L- applikant spjega li l- għażla tagħhom ta ’ kontrolli pożittivi fil- prova klinika ewlenija ma kinitx intiża biex tqabbel il- prodott tagħhom ma ’ prodott ieħor, li ntuża għall- istess pożoloġija proposta fi ħdan il - Komunità għal mill- inqas 10 snin.
In fact the two positive controls were selected because at that time there were no doxycycline based premix reference products available in Spain.
Fil- fatt iż- żewġ kontrolli pożittvi ntgħażlu peress li f’ dak iż- żmien ma kienx hemm prodotti ta ’ referenza ta ’ premix ibbażati fuq doxycycline fi Spanja.
The positive control products were chosen on the basis that they were also medicated premixes, indicated for use in pigs, which contained a single active substance, which had a spectrum of activity inclusive of those organisms causing the proposed indications.
Il- prodotti ta ’ kontroll pożittiv ġew magħżulin fuq il- bażi li huma kienu wkoll premixes medikati, indikati għall- użu fil- majjali, li kien fihom sustanza attiva unika, li kellha spettru ta ’ attività li tinkludi dawk l- organiżmi li jikkawżaw l- indikazzjonijiet proposti.
The applicant has explained the choice of dose.
L- applikant spjega l- għażla tad- doża.
4/ 21 Although the choice of positive controls would not be acceptable when assessed under current standards, the CVMP concluded that the applicant has justified that at the time there were no doxycycline based authorised premix for the proposed indications.
4/ 21 Għalkemm l- għażla tal- kontrolli pożittivi ma tkunx aċċettabbli meta vvalutata taħt l- istandards attwali, CVMP ikkonkluda li l- applikant iġġustifika li f’ dak iż- żmien ma kienx hemm premix awtorizzat ibbażat fuq doxycycline għal indikazzjonijiet proposti.
The applicant has a justifiable rational behind the choice of products used as positive controls.
L- applikant għandu argument ġustifikabbli wara l- għażla ta ’ prodotti użati bħala kontrolli pożittivi.
In addition, a negative control was used.
Barra minn hekk, intuża kontroll negattiv.
Given that the statistical analysis is appropriate, this study design can conclude that the actual final formulation has shown field efficacy when compared to a negative control group and has produced as least as good results as a comparator product TM550 (oxytetracycline).
Minħabba li l- analiżi statistika hija waħda xierqa, dan id- disinn ta ’ studju jista ’ jikkonkludi li l - formulazzjoni finali proprja uriet effikaċja fil- qasam meta mqabbla mal- grupp ta ’ kontroll negattiv u għallinqas ipproduċiet riżultati tajbin daqs prodott komparattiv TM550 (oxytetracycline).
No dose confirmation studies appear to have been presented the above mentioned study, therefore it is important that the references provided should present robust evidence for the field efficacy of the product.
Ma jidher li ġew ippreżentati ebda studji ta ’ konferma li r- referenzi pprovduti għandhom jippreżentaw prova robusta għall- effikaċja fil- qasam tal- prodott.
In the answer to the CVMP question the applicant has not discussed or justified the two doses (200ppm and 300ppm) of Doxyprex applied in the clinical trial.
Bi tweġiba għall- mistoqsija ta ’ CVMP l- applikant ma ddiskutiex jew ma ġġustifikax iż- żewġ dożi (200ppm u 300ppm) ta ’ Doxyprex applikati fil- prova klinika.
During the MRP the applicant did however explain that the incorporation rates of doxycycline in the feed used in the clinical trial were decided to take into account the variability that would be found in the field in regard to pig body weight and feed consumption.
Matul l- MRP l- applikant madankollu spjega li r- rati ta ’ inkorporazzjoni ta ’ doxycycline fl- għalf użat fil- prova klinika ġew deċiżi li jieħdu f’ kont il- varjabbli li ser jinstab fil- qasam f’ rigward tal- piż tal- ġisem tal- majjal u l- konsum ta ’ l- ikel.
The main object was to try to ensure intake of the proposed dose of 10 mg/ kg b. w.
Il - mira prinċipali kienet li jsir tentattiv sabiex jiġi żgurat it- teħid tad- doża proposta ta ’ 10 mg/ kg b. w.
It is observed that during the first days of treatment the 300 ppm food incorporation came closest to the recommended dose, but as food consumption picked up this was achieved with 200ppm.
Huwa osservat li matul l- ewwel ġranet ta ’ trattament, l- inkorporazzjoni ta ’ l- ikel 300 ppm kien l- eqreb tad- doża rakkomandata, iżda meta żdied il- konsum ta ’ l- ikel dan inkiseb b’ 200ppm.
The justification was considered acceptable, but the dosing section of the SPC should be amended to better reflect the use as proposed and documented by the applicant.
Il- ġustifikazzjoni kienet ikkunsidrata aċċettabbli, iżda s- sezzjoni dwar id- doża ta ’ l- SPC għandha tiġi emendata biex tirrifletti aħjar l- użu kif propost u dokumentat mill- applikant.
Less emphasis should be put on the standard incorporation of 250 ppm. related to “ normal” food consumption.
Fir- rigward ta ’ konsum ta ’ ikel “ normali ”.
It should also be included that the incorporation rate should be based on average food consumption at time of initiating treatment.
Għandu jiġi inkluż ukoll li r- rata ta ’ inkorporazzjoni għandha tkun ibbażata fuq il- konsum medju ta ’ ikel fiż- żmien meta jinbeda t- trattament.
The CVMP/ 627/ 01 and GCP guideline stated that the response to therapy must be based on clinical and microbiological criteria wherever possible.
Il- linja gwida CVM/ 627/ 01 u l- GCP iddikjaraw li t- tweġiba għat- terapija għandha tkun ibbażata fuq kriterji kliniċi u mikrobioloġiċi kull fejn possibbli.
The lack of evidence of bacteriological cure should be justified and may affect the wording of the indication.
In- nuqqas ta ’ provi ta ’ kura bijoloġika għandhom jiġu ġġustifikati u dan jista ’ taffettwa l- formulazzjoni ta ’ l- indikazzjoni.
The applicant has submitted a scientific report on Porcine Respiratory Disease Complex (PRDC) and also pointed out that the above mentioned Guideline were not in effect at time of the study or the initial submission to the Spanish Authority.
L- applikant ippreżenta rapport xjentifiku dwar il- Kumpless tal- Marda Respiratorja tal- Majjali (PRDC) u indika wkoll li l- Linja Gwida msemmija hawn fuq ma kinitx fis- seħħ fiż- żmien ta ’ l- istudju jew meta saret il- preżentazzjoni inizjali lill- Awtorità Spanjola.
In the pivotal clinical trial, the presence of P. multocida and B. bronchiseptica was clearly demonstrated in sick pigs, however no post treatment sampling was done to show bacteriological cure.
Fil- prova klinika ewlenija, il- preżenza ta ’ P. multocida u B. bronchiseptica kienet murija biċ- ċar f’ majjali morda, madankollu ma ttieħed ebda kampjun ta ’ wara t- trattament biex juri kura batterjoloġika.
The applicant justifies that the presence of M. hyopneumoniae was not determined by bacteriological methods because it was difficult to isolate at that time.
L- applikant jiġġustifika li l- preżenza ta ’ M. hyopneumoniae ma kinitx stabbilita b’ metodi batterjoloġiċi peress li huwa diffiċli li tiġi iżolata f’ dak iż- żmien.
The presence was assumed.
Il- preżenza kienet assunta.
The applicant provided evidence of efficacy of the active substance, doxycycline, against M. hyopneumoniae in pigs from published literature and from MIC studies.
L- applikant ipprovda prova ta ’ l- effikaċja tas- sustanza attiva, doxycycline, kontra M. hyopneumoniae fil- majjali minn letteratura ppubblikata u minn studji tal- MIC.
These are all references provided with the original submission.
Dawn huma r- referenzi kollha pprovduti mal- preżentazzjoni oriġinali.
Farms were selected if at least 20% of pigs were showing clinical signs of respiratory disease.
L- irziezet intagħżlu jekk mill- inqas 20% tal- majjali kienu qed juru sinjali kliniċi ta ’ mard respiratorju.
The actual groups of pigs studied were all showing clinical signs.
Il- gruppi propja ta ’ majjali studjati kienu kollha qed juru sinjali kliniċi.
The clinical end points were ” Time to clinical cure” and ” overall clinical cure”.
Il- punti ta ’ tmiem kliniċi kienu “ Żmien għal kura klinka ” u “ kura klinika globali ”.
Relapses were assessed.
Ir- reċidivi kienu vvalutati.
In the practical situation, the premix is usually fed to pigs showing clinical signs and incontact pigs, therefore this active substance is for controlling the clinical signs of disease.
Fis- sitwazzjoni prattika, il- premix huma normalment mitmugħ lill- majjali li qed juru sinjali kliniċi u majjali li huma f’ kuntatt, għalhekk din is- sustanza attiva tintuża biex jiġu kkontrollati s- sinjali kliniċi tal- mard.
Efficacy against M. hyopneumoniae has furthermore not been established in the field study, since its presence was not demonstrated.
Barra minn hekk, l- effikaċja kontra M. hyopneumoniae għadha ma ġietx stabbilita fl- istudju tal- qasam, peress li l - preżenza tagħha ma ġietx murija.
The CVMP considers that the fact that no post treatment bacteriological samples were taken mean that bacteriological cure cannot be assumed or claimed.
CVMP iddiskuta li l- fatt li ma ttieħdu ebda kampjuni batterjoloġiċi ta ’ wara t- trattament tfisser li l - kura batterjoloġika ma tistax tiġi assunta jew iddikjarata.
For these reasons, the appropriate proposed indication is suggested as follows:
Għal dawn ir- raġunijiet, l- indikazzjoni proposta xierqa hija ssuġġerita kif ġej:
“ For the treatment and prevention of porcine respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd. “
“ Għat- trattament u l- prevenzjoni tal- marda respiratorja fil- majjali ikkawżata minn Pasteurella multocida u Bordetella bronchiseptica, suxxettibbli għal doxycycline, meta l- marda ġiet djanjostikata fil- merħla. ”
The Committee agreed that all prudent use recommendations should be put under 4.5.
5/ 21 Il- Kumitat qabel li r- rakkomandazzjonijiet kollha għal użu prudenti għandhom jitqiegħdu taħt 4. 5.
Due to variability in susceptibility of bacteria for doxycycline, use of the product should be based on bacteriological sampling and susceptibility testing or recent experience on the farm.
Minħabba l- varjabbli fis- suxxebbiltà ta ’ batterji għal doxycycline, l- użu tal- prodott għandu jkun ibbażat fuq it- teħid ta ’ kampjuni batterjoloġiċi u l- ittestjar suxxettibbli jew l- esperjenza riċneti fir - razzett.
5/ 21 Amendments to the pharmacokinetic section of the SPC and the origin of the MIC values included in this section should be inserted, too.
L- emendi għat- taqsima farmakokinetika ta ’ l- SPC u l- oriġini tal- valuri tal- MIC inklużi f’ din it- taqsima għandhom jiġu inseriti, ukoll.
The Applicant has given a full discussion on statistical analyses conducted for the pivotal trial.
L- Applikant ta diskussjoni sħiħa dwar l- analiżi statistiċi mwettqin għal prova ewlenija.
During the Mutual Recognition Procedure this statistical evaluation was questioned and found to be inappropriate.
Matul il - Proċedura ta ’ Għarfien Reċiproku din l- evalwazzjoni statistika ġiet mistoqsija u nstabet li ma kinitx xierqa.
Therefore the applicant performed another statistical evaluation using the original database.
Għalhekk l- applikant wettaq evalwazzjoni statisitika oħra bl- użu tad- database oriġinali.
The applicant felt that this was more adapted towards the Guideline EMEA/ CVMP/ 816/ 00 and obtained greater clinical significance.
L - applikant ħass li din kienet adattata aktar għal- Linja gwida EMEA/ CVM/ 816/ 00 u kisbet sinifikanza klinika akbar.
A new primary end point was defined as Time to clinical cure, i. e. the time to absence of clinical signs.
Punt ta ’ tmiem primarju ġdid kien definit bħala Żmien għal kura klinika, jiġifieri, iż - żmien għall- assenza ta ’ sinjali kliniċi.
New secondary end points were defined as percentage clinically cured on day 7 relapse and mortality rates.
Punti ta ’ tmiem sekondarji ġodda kienu definiti bħala perċentwali ta ’ kurati klinikament fis- 7 jum rati ta ’ reċidiva u mortalità.
Global evaluations were justified because the statistical guideline incorporates them.
Evalwazzjonijiet globali kienu ġustifikati peress li l- linja gwida statistika tinkorporahom.
For Time to clinical cure, Doxyprex at 200ppm and at 300ppm groups were cured at 3.2 and 3.33 days respectively compared to the TM550 group at 8.2 days, the Stabox group at 11.75 days and the control group at 13.67 days.
Għal Żmien għal kura klinika, gruppi fuq Doxyprex 200ppm u 300ppm ġew ikkurati f’ 3. 2 u 3. 33 jiem rispettivament meta mqabbla mal- grupp TM550 ta ’ 8. 2 jiem, il- grupp Stabox ta ’ 11. 75 jiem u l - grupp ta ’ kontroll ta ’ 13. 67 jiem.
In two-by-two analysis, both Doxyprex groups were significantly quicker to cure than the negative control and the positive control groups.
F’ analiżi tnejn- bi- tnejn, iż- żewġ gruppi ta ’ Doxyprex ġew ikkurati ferm aktar malajr mill- kontroll negattiv u l- gruppi ta ’ kontroll pożittiv.
Time to clinical cure was considered the primary end point.
Iż- Żmien għal kura klinika kien ikkunsidrat bħala l- punt ta ’ tmiem primarju.
The CVMP concluded that according to “ current” GCP requirements this pivotal study design has many deficiencies.
CVMP ikkonkluda li skond il- ħtiġiet ta ’ GCP “ attwali ” dan id- disinn ta ’ studju ewlieni għandu ħafna nuqqasijiet.
This is in agreement with the German Competent National Authority (BVL) and expert opinion.
Dan huwa ftehim ma ’ l- Awtorità Nazzjonali Kompetenti Ġermaniża (BVL) u l- opinjoni esperta.
However, the study was conducted and assessed prior to these requirements and the applicant has attempted many additional analyses on the original data and has justified various deficiencies.
Madankollu, l- istudju kien immexxi u vvalutat qabel dawn il- ħtieġiet u l- applikant ipprova bosta analiżi addizzjonali dwar id- data oriġinali u ġġustifika diversi nuqqasijiet.
Although on the surface the individual numbers of pigs involved looks small, the applicant has justified that because of the large difference in results between the Doxyprex and control groups the small number of animals still allows a 80% power to be achieved.
Għalkemm fil- wiċċ, in- numri individwali ta ’ majjali involuti jidhru żgħar, l- appplikant iġġustifika li minħabba d- differenza kbira fir- riżultati bejn Doxyprex u l- gruppi ta ’ kontroll, in- numru iżgħar ta ’ annimali xorta jippermetti li tinkiseb saħħa ta ’ 80%.
This should therefore be acceptable.
Dan għalhekk għandu jkun aċettabbli.
All the results show a clear improvement of Doxyprex treated pigs, with no relapses and no deaths, compared to a negative control.
Ir- riżultati kollha juru titjib ċar ta ’ majjali ittrattati b’ Doxyprex, mingħajr reċidivi u mingħajr imwiet, meta mqabbel mal- kontroll negattiv.
To sum up the applicant has indeed performed a number of analyses based on the original data and they seem to have been performed appropriately.
Fil- qosor l- applikant tassew wettaq numru ta ’ analiżi bbażati fuq id- data oriġinali u dawn jidhru li twettqu b’ mod xieraq.
Deficiencies in the pivotal clinical trial demonstrating efficacy of the product for the treatment of P. multocida and B. bronchiseptica were compensated for by a discussion of the field data in the literature reference provided.
Id- defiċjenzi fil- prova klinika ewlenija li turi l- effikaċja tal- prodott għat- trattament ta ’ P. multocida u B. bronchiseptica ġew ikkompensati b’ diskussjoni tad- data fil- qasam fir- referenza tal- letteratura pprovduta.
The applicant demonstrated through these references that the product fulfils the criteria for a well-established use application.
L- applikant wera permezz ta ’ dawn ir- referenzi li l- prodott jissodisfa l- kriterji għal applikazzjoni ta ’ l- użu stabbilita tajjeb.
In conclusion the applicant has justified their application as well-established use of the active substance, doxycycline.
F’ konklużjoni l- applikant iġġustifika l- applikazzjoni tagħhom bħala użu stabbilit tajjeb tas- sustanza attiva, doxycycline.
The submitted references supported pharmacodynamics including MIC data (more than 5 years old) and pharmacokinetics of the active substance, doxycycline.
Ir- referenzi ppreżentati appoġġaw il- farmakodinamiċi inkluż id- data MIC (aktar minn 5 snin) u farmakokinetika tas- sustanza attiva, doxycycline.
In addition the pharmacokinetics study using their final formulation and more up-to-date (2001) MIC data for respiratory pathogens isolated from pigs in Spain are provided.
Barra minn hekk l- istudju farmakokinetiku uża l- formulazzjoni finali tagħhom u hemm ipprovdut data (2001) ta ’ MIC aktar aġġornata għal patoġeni respiratorji iżolati minn majjali fi Spanja.
The applicant submitted a target species tolerance study and post marketing pharmacovigilance data to support safety of the product.
L- applikant ippreżenta studju ta ’ tolleranza għal speċi fil- mira u tagħrif ta ’ farmakoviġilanza ta ’ wara l- kummerċjalizzazzjoni biex jappoġġa s- sigurtà tal- prodott.
Resistance was covered adequately in literature.
Ir- reżistenza kienet koperta b’ mod adegwat fil- letteratura.
The applicant conducted a pivotal controlled, randomized two-centred field trial using their final formulation to demonstrate efficacy for respiratory disease caused by P. multocida and B. bronchiseptica.
L- applikant mexxa prova tal- qasam b’ żewġ ċentri b’ ordni każwali u kkontrollata ewlenija bl- użu tal- formulazzjoni finali tagħhom biex juri l- effikaċja għal mard respiratorju kkawżat minn P. multocida u B. bronchiseptica.
The submitted post marketing experience consists of:
L- esperjenza ta ’ wara l- kummerċjalizzazzjoni ppreżentata tikkonsisti f ’:
(1) Pharmacovigilance – reporting a nil return for suspected adverse drugs reactions and lack of efficacy; and (2) Five expert opinions written by veterinarians who work closely with large pigs farms in Spain, all containing positive comments on their use of this product.
(1) Framkoviġilanza – rapportaġġ ta ’ ebda ritorn għal reazzjonijiet negattivi suspettati dwar droga u nuqqas ta ’ effikaċja; u (2) Ħames opinjonijiet esperti miktubin minn veterinarji li jaħdmu mill- qrib ma ’ rziezet kbar tal - majjali fi Spanja, ilkoll fihom kummenti pożittivi dwar l- użu tagħhom ta ’ dan il- prodott.
From all this information, a significant potential serious risk for safety or efficacy of Doxyprex, for the treatment or control of clinical signs of porcine respiratory disease caused by P. multocida and B. bronchiseptica cannot be identified.
6/ 21 trattament jew il- kontroll ta ’ sinjali kliniċi ta ’ mard respiratorju fil- majjali ikkaġunat minn P. multocida u B. bronchiseptica ma jistax jiġi identifikat.
For the second clinical study “ Efficacy of the doxycycline in feed for the control of pneumonia caused by P. multocida and Mycoplasma hyopneumoniae
Għat- tieni studju kliniku “ L- effikaċja ta ’ doxycyline fl- għalf għall- kontroll tal- pnewmonja kkaġunata minn P. multocida u Mycoplasma hyopneumoniae
6/ 21 No dose confirmation studies appear to have been presented in this study and therefore it was important that the references provided should present robust evidence for the field efficacy of the product.
Ebda studji ta ’ konferma ta ’ doża ma jidhru li ġew ippreżentati f’ dan l- istudju u għalhekk kien importanti li r- referenzi pprovduti għandhom jippreżentaw prova robusta għall- effikaċja fil- qasam tal - prodott.
Pulmodox is indicated for prevention of clinical respiratory disease and not for treatment,
Pulmodox huwa indikat għall- prevenzjoni tal- mard respiratorju kliniku u mhux għal trattament,
In order to establish that Doxyprex is similarly bioavailable to the product Pulmodox 5% Premix, the applicant referred to information from the SPC and the hevra. org website.
Sabiex jiġi stabbilit li Doxyprex huwa bijodisponibbli b’ mod simili għall- prodott Pulmodox 5% Premix, l- applikant irrefera l- informazzjoni mill- SPC u l- websajt hevra. org.
It was pointed out that even though there are small differences in dosage the mean and maximum steady state plasma concentration are similar.
Ġie nnotat li minkejja li hemm differenzi żgħar fid- doża l- istat kostanti intermedju u massimu ta ’ konċentrazzjoni ta ’ plażma huma simili.
There are however differences in both dose recommendation (12.5 mg/ kg/ day versus 10 mg/ kg/ day) and duration of treatment (8 versus 7 days).
Hemm madankollu differenzi kemm fid- doża rakkomandata (12. 5 mg/ kg/ ġurnata kontra 10 mg/ kg/ ġurnata) kif ukoll fit- tul ta ’ żmien tat- trattament (8 kontra 7 ijiem).
Based on this information the CVMP agreed that the provided references are not suitable as pivotal evidence of clinical efficacy of the product Doxyprex for the proposed indication and dose regimen for M. Hyopneumoniae
Abbażi ta ’ din l- informazzjoni CVMP qabel li r- referenzi pprovduti mhumiex xierqa bħala provi ewlenin ta ’ l- effikaċja klinika tal- prodott Doxyprex għall- indikazzjoni proposta u għar- reġimen tad - doża għal M. Hyopneumoniae
Conclusion and recommendation The CVMP recommendation is to grant the marketing authorisation to Doxyprex 100 mg/ g Premix for medicated feeding stuff for pigs the following suggested indication because a positive risk: benefit analysis has been demonstrated and no potential serious risk has been identified.
Konklużjoni u rakkomandazzjoni Ir- rakkomandazzjoni ta ’ CVMP hija li tagħti awtorizzazzjoni ta ’ kummerċjalizzazzjoni għal Doxyprex 100 mg/ g Premix għal oġġetti ta ’ l- għalf medikati għall- majjali bl- indikazzjoni ssuġġerita li ġejja peress li intweriet analiżi riskju: benefiċċju pożittiva u ma ġie identifikat ebda riskju serju potenzjali.
“ For the treatment and prevention of porcine respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd. ” A risk: benefit analysis could not be conducted due to the lack of pivotal evidence on clinical efficacy for the indication M. hyopneumoniae.
“ Għat- trattament u l- prevenzjoni tal- marda respiratorja fil- majjali ikkaġunata minn Pasteurella multocida u Bordetella bronchiseptica, suxxettibbli għal doxycycline, meta l- marda ġiet djanjostikata fil- merħla. ” Ma setgħetx titwettaq analiżi tar- riskju: benefiċċju minħabba nuqqas ta ’ provi ewlenin dwar l- effikaċja klinika għall- indikazzjoni M. hyopneumoniae.
Therefore, the recommendation is to remove this pathogen from the indications.
Għalhekk, ir- rakkomandazzjoni hija li dan il- patoġen jitneħħa mill- indikazzjonijiet.
7/ 21 ANNEX III
7/ 21 ANNESS III
8/ 21 SUMMARY OF PRODUCT CHARACTERISTICS
8/ 21 KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR
NAME OF THE VETERINARY MEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDIĊINALI VETERINARJU
Doxyprex 100 mg/ g Premix
Doxyprex 100 mg/ g Taħlita għall- Lest
Each gram contains:
Kull gramma fiha:
100 mg of Doxycycline base as hyclate Excipients:
100 mg ta ’ bażi ta ’ Doxycycline bħala hyclate Sustanzi mhux attivi:
Semoline q. s.
Semoline q. s.
For a full list of excipients, see section 6.1.
Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
Premix for medicated feeding stuff Doxyprex is presented as yellow granules.
Ikel imħallat mal- mediċina għal- lest Doxyprex hu fornut fi granuli sofor.
Target species
Speċi li fuqhom ser jintuża l- prodott
Pigs (after weaning)
Qżieqeż (wara l- ftim)
Indications for use, specifying the target species
Indikazzjonijiet għal użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l- prodott.