qanastek/EMEA-V3 huggingface dataset:
The paste is given by oral route.
Il- pejst jingħata b’ mod orali.
One syringe division of paste per 100 kg body weight (based on a recommended dosage of 200 microgram ivermectin per kg body weight).
Marka waħda ta ’ fuq is - siringa ta’ pejst għal kull 100 kg piż korporju (abbażi tad- doża irrakomandata ta ’ 200 mikrogramma ivermectin għal kull kg ta ’ piż korporju).
As above
Bħal hawn fuq
Ivermax 18.7 As above As above As above As above mg/ g Oral Paste for Horses
18. 7 mg/ g Pejst Orali għaż - Żwiemel
As above
fuq
Tizoval 18.7 As above As above As above As above mg/ g Oral Paste for Horses
Tizoval 18. 7 Bħal hawn fuq mg/ g Pejst Orali għaż - Żwiemel
As above
Bħal hawn Bħal hawn fuq Bħal hawn fuq fuq
Vetimec 18.7 As above As above As above As above mg/ g Oral Paste for Horses
Vetimec Bħal hawn fuq
As above
Bħal hawn Bħal hawn fuq Bħal hawn fuq
Denmark
Bħal hawn fuq
As above
Ċeka
Ecomectin As above As above As above As above 18.7 mg/ g Oral Paste for Horses
18. 7 mg/ g Pejst Orali għaż - Żwiemel
Finland
Ecomectin
Member State
Għamla
Marketing Authorisation Holder/ Applicant
Speċi ta ’
Product invented name
Doża irrakomandata
Pharmaceutical form
farmaċewtika
Strength
Annimali
Animal species
Il- Finlandja
Frequency and route Recommended dose of administration
Bħal hawn fuq
France
Ecomectin
Divamectin As above As above As above As above 18.7 mg/ g Oral Paste for Horses
Bħal hawn
Germany
Bħal hawn fuq
Tizoval 18.7 As above As above As above As above mg/ g Oral Paste for Horses
18. 7 mg/ g Pejst Orali għaż - Żwiemel
Greece
Franza
Hungary
Il- Ġermanja
Ecomectin As above As above As above As above 18.7 mg/ g Oral Paste for Horses
Tizoval 18. 7 Bħal hawn fuq mg/ g Pejst Orali għaż - Żwiemel
Italy
Il- Greċja
The Netherlands
Bħal hawn fuq
Norway
L- Italja
Member State
Speċi ta ’
Marketing Authorisation Holder/ Applicant
ta ’ kif u mnejn jingħata
Product invented name
Bħal hawn fuq
Pharmaceutical form
Bħal hawn fuq
Strength
Bħal hawn
Animal species
Bħal hawn fuq
Frequency and route Recommended dose of administration
Bħal hawn Bħal hawn fuq Bħal hawn fuq fuq
Portugal
Bħal hawn fuq
Sweden
Ecomectin
United Kingdom
Bħal hawn fuq
Animec 18.7 As above As above As above As above mg/ g Oral Paste for Horses
18. 7 mg/ g Pejst Orali għaż - Żwiemel
EMEA/ CVMP/ 495339/ 2007-EN SCIENTIFIC CONCLUSIONS
EMEA/ CVMP/ 495339/ 2007- MT KONKLUŻJONIJIET XJENTIFIĊI
Ecomectin 18.7 mg/ g Oral Paste for Horses is intended to be used in horses for the treatment of nematode or arthropod infections caused by Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, Small strongyles (including benzimidazole resistant strains):
Ecomectin 18. 7 mg/ g Pejst Orali għaż- Żwiemel huwa maħsub sabiex jintuża fuq żwiemel għall- kura ta ’ infezzjonijiet b’ nematodi jew artropodi ikkaġunati minn Strongylus vulgaris, Strongylus edentatus, Strongylus equines, Strongyles żgħar (inklużi r- razez li huma reżistenti għal benzimidazole):
Onchocerca spp, Stomach bots:
Onchocerca spp, Stomach bots (dud ta ’ l- istonku):
Ireland notified the EMEA on 4 July 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement regarding Ecomectin 18.7 mg/ g Oral Paste for Horses.
Fl- 4 ta ’ Lulju 2007, l- Irlanda innotifikat lill- EMEA li l- Grupp ta ’ Koordinazzjoni għar- Rikonoxximent Reċiproku u Proċeduri Deċentralizzati – Veterinarji (CMD( v)) naqas milli jilħaq qbil dwar Ecomectin 18. 5 mg/ g Pejst Orali għaż- Żwiemel.
Pursuant to Article 33(4) of Council Directive 2001/ 82/ EC, as amended, the matter has been referred to the CVMP.
Skond l- Artikolu 33( 4) tad- Direttiva tal- Kunsill 2001/ 82/ KE, kif emendata, il- kwistjoni ġiet riferuta lill- CVMP.
The referral relates to the concerns raised by Germany that this veterinary medicinal product may present a potential serious risk to public health on the following grounds:
Ir- riferiment tikkonċerna t- tħassib imqajjem mill- Ġermanja li dan il- prodott veterinarju jista ’ jippreżenta riskju potenzjali serju għas- saħħa pubblika għar- raġunijiet li ġejjin:
An environmental risk was detected during the risk assessment Phase II Tier A for dung fauna organisms.
Waqt il- valutazzjoni tar- riskju fil- Fażi II Livell A instab riskju ambjentali għal organiżmi tal- fawna fid- demel.
No adequate data for Tier B were provided by the applicant to assess the long-term effects on dung fauna organisms caused by the use of the product.
L- ebda data adegwata għall- livell B ma kienet ipprovduta mill- applikant biex jiġu stmati l - effetti fuq tul ta ’ żmien fuq organiżmi tal- fawna fid- demel ikkaġunati mill- użu ta ’ dan il- prodott.
The referral procedure started on 11 July 2007.
Il- proċedura ta ’ riferenza bdiet fil- 11 ta ’ Lulju 2007.
The time frame agreed by the CVMP on 11 July 2007 was 58 days.
Il- perijodu ta ’ żmien maqbul mis- CVMP fil- 11 ta ’ Lulju 2007 kien ta ’ 58 jum.
On the basis of the grounds for referral, the points considered by the CVMP were:
Fuq il- bażi tar- raġunijiet għar- riferenza, il- punti ikkunsidrati mis- CVMP kienu:
The Marketing Authorisation Holder should provide complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment; 2.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jipprovdi tagħrif sħiħ sottomess lill- Istat Membru ta ’ Riferenza u s- CMD( v) fir- rigward tal- valutazzjoni tar- riskju ambjentali; 2.
The Marketing Authorisation Holder should provide an updated Environmental Risk Assessment according to the CVMP guidelines on the matter, including any justification for exemption of Phase II; 3.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jipprovdi Valutazzjoni tar- Riskju Ambjentali aġġornata skond il- linji gwida tas- CVMP dwar dan is- suġġett, inkluż kwalunkwe ġustifikazzjoni għal eżenzjoni mill- Fażi II; 3.
The Marketing Authorisation Holder should discuss and propose, if considered appropriate, possible risk mitigation measures to be included in the SPC of the product.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiddiskuti u jipproponi, jekk ikkunsidrati adattati, miżuri possibbli għat- tnaqqis tar- riskju biex jiġu inklużi fl- SPC ta ’ dan il - prodott.
These points were included in the List of Questions that the Committee for Veterinary Medicinal Products adopted on 11 July 2007.
Dawn il- punti kienu mniżżla fil- Lista ta ’ Mistoqsijiet li l- Kumitat għal Prodotti Mediċinali Veterinarji adotta fil- 11 ta ’ Lulju 2007.
The List of Questions was sent to the Marketing Authorisation Holder.
Il- Lista ta ’ Mistoqsijiet intbagħtet lid- Detentur ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq.
The Marketing Authorisation Holder submitted written responses to the List of Questions on 12 September 2007.
Fit- 12 ta ’ Settembru 2007 id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq issottometta tweġibiet bil- miktub għal- Lista ta ’ Mistoqsijiet.
Oral explanations were heard on 10 October 2007.
L- ispjegazzjonijiet fil- fomm instemgħu fl- 10 ta ’ Ottubru 2007.
2 Information in respect to environmental risk assessment
2 Tagħrif fir- rigward tal- valutazzjoni tar- riskju ambjentali
The Marketing Authorisation Holder provided the following information: • An updated Environmental Risk Assessment • The complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ipprovda t- tagħrif li ġej: • Valutazzjoni tar- Riskju Ambjentali aġġornata • It- tagħrif sħiħ ippreżentat lill- Istat Membru ta ’ Riferenza u lis- CMD( v) fir- rigward tal - valutazzjoni tar- riskju ambjentali.
2.1 Updated Environmental Risk Assessment according to the CVMP guidelines on the matter, including any justification for exemption of Phase II
2. 1 Valutazzjoni tar- Riskju Ambjentali aġġornata skond il- linji gwida tas- CVMP dwar is- suġġett, inkluża kwalunkwe ġustifikazzjoni għal eżenzjoni mill- Fażi II
The Marketing Authorisation Holder provided an updated environmental risk assessment.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ipprovda valutazzjoni tar- riskju ambjentali aġġornat.
A separate file for justification of exemption from phase II was not specifically given.
Ma ngħatax speċifikament fajl separat għall- ġustifikazzjoni ta ’ eżenzjoni mill- fażi II.
However some consideration to this is given on the document that can be summarised as follows:
Madankollu, din il- kwistjoni ġiet ikkunsidrata b’ xi mod fid- dokument li jista ’ jiġi mqassar kif ġej:
Ecomectin 18.7 mg/ g Oral Paste for Horses is a generic product and as such an environmental risk assessment is now required under Directive 2001/ 82, as amended.
Ecomectin 18. 5 mg/ g Pejst Orali għaż- Żwiemel huwa prodott ġeneriku u għalhekk ma tinħtieġ l- ebda valutazzjoni tar- riskju ambjentali skond id- Direttiva 2001/ 82, kif emendata.
The Marketing Authorisation Holder considers that the guidelines were written primarily for new molecules where the risk to the environment has not been characterized and that it is not the case for ivermectin-containing veterinary medicinal products that have been in extensive worldwide use for nearly 25 years and that real risk or detrimental environmental effect attributable to ivermectin-based veterinary medicinal products would have been observed.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq iqis li l- linji gwida nkitbu primarjament għal molekuli ġodda fejn ir- riskju għall- ambjent ma kienx ġie ikkaratterizzat u li dan mhuwiex il- każ għal prodotti mediċinali veterinarji li fihom l- ivermectin li ilhom f’ użu estensiv madwar id- dinja għal kważi 25 sena u r- riskju efffettiv kif ukoll l- effett ambjentali ta ’ ħsara attribwiti għal prodotti mediċinali veterinarji ibbażati fuq l- ivermectin kienu jkunu ġew osservati.
The Marketing Authorisation Holder considers it inconceivable that the risks posed to the environment associated with the use of Ecomectin 18.7 mg/ g Oral Paste for Horses in particular are any greater than those posed by other ivermectin-based products, particularly as the concentration of the active ingredient and the proposed usage regime is identical to that of the reference and other similar products.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jikkunsidra li huwa inkonċepibbli li r- riskji fuq l- ambjent assoċjati b’ mod partikolari ma ’ l- użu ta ’ Ecomectin 18. 7 mg/ g Pejst Orali għaż- Żwiemel huma akbar minn dawk ikkaġunati minn prodotti oħra ibbażati fuq l- ivermectin, partikolarment peress li l- konċentrazzjoni tas- sustanza attiva u l- mod ta ’ l- użu propost huma identiċi għal dawk tal- prodott ta ’ riferenza u oħrajn simili.
The applicant considers that the level of use in horses in terms of animal numbers and dose level, compared to other pasture animals (cattle and sheep) is low and that consequently the use in the horse will have limited impact on the environment.
L- applikant jikkunsidra li l- livell ta ’ użu fiż- żwiemel f’ termini tan- numru ta ’ annimali u l- livell tad - doża meta mqabbel ma ’ annimali oħra li jimirgħu (baqar u ngħaġ) huwa baxx u li konsegwentement l - użu fiż- żwiemel ikollu impatt limitat fuq l- ambjent.
Based on this, the applicant argued that the horse should be classed as “ minor use/ minor species” and that no Phase II risk assessment is required.
Abbażi ta ’ dan, l- applikant argumenta li ż- żiemel għandu jiġi ikklassifikat bħala “ użu minuri/ speċi minuri ” u li l- ebda valutazzjoni tar- riskju fil- Fażi II ma hija meħtieġa.
In addition, he considers that since this is a generic, there will not be an additional risk to the environment.
Barra minn hekk, huwa jikkunsidra li minħabba li dan huwa prodott ġeneriku, ma jkunx hemm riskju addizjonali għall- ambjent.
The applicant does not provide a formal justification for exemption of Phase II.
L- applikant ma jipprovdix ġustifikazzjoni formali għall - eżenzjoni mill- Fażi II.
The PEC in soil were calculated for intensively reared animals and pasture animals, according to 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-corr).
Il- PEC fil- ħamrija kienet ikkalkulata għall- annimali mrobbija b’ mod intensiv u għal annimali tal - mergħa, skond il- Linja Gwida tas- CVMP dwar il- Valutazzjoni ta ’ l- Impatt Ambjentali għal Prodotti Mediċinali
PECSOIL- Intensively reared animals = 1.036 µg. kg-1 PECSOIL- Pasture animals = 0.48 µg. kg-1 For two soil exposure scenarios the PECSOIL values did not exceed the 100 µg/ kg threshold value as stated in the VICH Guideline for Phase I assessments of veterinary medicines.
PECĦAMRIJA - Annimali mrobbija b’ mod intensiv = 1. 036 µg. kg- 1 PECĦAMRIJA - Annimali tal- mergħa = 0. 48 µg. kg- 1 Għaż- żewġ xenarji ta ’ espożizzjoni tal- ħamrija, il- valuri PECĦAMRIJA ma qabżux il- limitu iffissat ta ’ 100 µg/ kg kif iddikjarat fil- Linja Gwida tal- VICH għal Valutazzjonijiet tal- Fażi I ta ’ mediċini veterinarji.
Despite this, Step 16 of the Phase I decision tree would indicate that a Phase II assessment is required for a product of this nature i. e. ecto/ endoparasiticide for major species.
Minkejja dan, il- Pass 16 fill- fergħa tad- deċiżjoni għall- Fażi I jindika li hemm bżonn ta ’ valutazzjoni tal- Fażi II għal prodott ta ’ din in- natura i. e. ekto/ endoparasitiċida għal speċi maġġura.
The applicability of the following question of the VICH GL6 was considered:
L- applikabbilità tal- mistoqsija li ġejja tal- VICH GL6 kienet ikkunsidrata:
Question 4 - Is the VMP intended for use in a minor species that is reared and treated similarly to a major species for which an EIA (Environmental Impact Assessment) already exists?
Mistoqsija numru 4 – Il- prodott mediċinali veterinarju huwa intenzjonat għall- użu fi speċi minuri li hija mrobbija u ikkurata b’ mod simili għal speċi maġġura li għaliha diġà teżisti VIA (Valutazzjoni ta ’ l- Impatt Ambjentali)?
The product under referral is intended for horses only.
Il- prodott taħt ir- riferenza huwa intenzjonat għaż- żwiemel biss.
Although oral paste is not used in major species (cattle, sheep, pigs), oral forms exist.
Għalkemm pejst orali mhuwiex użat fi speċi maġġuri (baqar, ngħaġ, majjali), jeżistu forom orali.
Ivermectin-containing products are widely used in these species.
Prodotti li fihom l- Ivermectin jintużaw ħafna f’ dawn l- ispeċi.
Horses are reared under similar conditions to livestock or, alternatively to housed livestock such as pigs, for which species ivermectin has a well-established use, orally and by other routes of administration.
Iż- żwiemel jitrabbew taħt kondizzjonijiet simili għal dawk tal- bhejjem ta ’ l - irziezet jew, alternattivament għal bhejjem li jinżammu għall- kenn bħal ma ’ huma l- majjali, għal liema speċi l- ivermectin għandu użu stabbilit sewwa, sew jekk jingħata bil- ħalq jew permezz ta ’ rotot oħrajn.
EMEA/ CVMP/ 495339/ 2007-EN 3 Conclusions and recommendations
EMEA/ CVMP/ 495339/ 2007- MT
The Committee concludes that, since the product is intended for use in a minor species (horses) that is reared and treated similarly to a major species, the conclusions on the Environmental Risk Assessment of the major species apply, the product should be exempt from providing a Phase II assessment and that no risk mitigation measures should be included in the SPC of the product.
Il- Kumitat ikkonkluda li, peress li l- prodott huwa intenzjonat għal użu fi speċi minuri (żwiemel) li hija mrobbija u ittrattata bl- istess mod bħal speċi maġġura, japplikaw il- konklużjonijiet dwar il - Valutazzjoni tar- Riskju Ambjentali ta ’ l- ispeċi maġġuri, il- prodott għandu jkun eżentat milli jipprovdi valutazzjoni tal- Fażi II u li l- ebda miżuri għat- tnaqqis tar- riskju m’ għandhom jiġi inklużi fl- SPC tal - prodott.
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE INSERT
ĠABRA FIL- QOSOR TAL- KARATTERISTIĊI TAL- PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved at day 90 during the Coordination group procedure.
Il- Ġabra fil- qosor tal- Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif validi huma l- verżjonijiet finali milħuqa fid- 90 jum matul il- proċedura tal- grupp ta ’ Koordinament.
London, June 2008 EMEA/ 532222/ 2007 – Rev.1
Londra, Ġunju 2008 EMEA/ 532222/ 2007 – Rev. 1
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR ENURACE 50
OPINJONI WARA REFERENZA SKOND L- ARTIKOLU 33( 4) GĦAL ENURACE 50
Enurace 50 is a tablet formulation containing ephedrine as active ingredient and is indicated for treatment of urinary incontinence caused by urethral sphincter mechanism incompetence in ovario- hysterectomised dogs.
Enurace 50 hija formulazzjoni ta ’ pillola li fiha l- efedrina bħala sustanza attiva u hija indikata għat - trattament ta ’ inkontinenza ta ’ l- awrina kkawżata minn inkompetenza fil- mekkaniżmu ta ’ l- isfinteru ta ’ l- uretra fi klieb li tneħħewlhom l- ovarji.
In June 2006 a Mutual Recognition Procedure started with The Netherlands as Reference Member State and six Concerned Member States.
F’ Ġunju 2006 nbdiet Proċedura ta ’ Rikonoxximent Reċiproku ma ’ l- Olanda bħala l- Istat Membru ta ’ Referenza u sitt Stati Membri Konċernati.
France and Italy could not agree to the granting of a marketing authorisation as they considered there were potentially serious risks for animal health.
Franza u l- Italja ma setgħux jaqblu ma ’ l- għoti ta ’ awtorizzazzjoni għat- tqegħid fis- suq billi huma ħassew li kien hemm riskji potenzjali serji għas- saħħa ta ’ l- annimal.
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.
Il- kwistjoni ġiet riferuta lill - Grupp ta ’ Koordinazzjoni għal Proċeduri ta ’ Rikonoxximent Reċiproku u Deċentralizzati CMD( v) u wara, lill- Kumitat għal Prodotti Mediċinali għall- Użu Veterinarju.
France considered the benefit/ risk analysis unfavourable for the animal when the adverse effects were weighed against the potential benefits of effective treatment of incontinence.
Franza kkunsidrat l- analiżi tal- benefiċċju/ riskju bħala waħda mhux favorevoli għall- annimal meta l - effetti ħżiena ġew evalwati kontra l- benefiċċji potenzjali tat- trattament effettiv għall- inkontinenza.
Italy could have accepted the application but with revised wording in the SPC.
L - Italja setgħet taċċetta l- applikazzjoni iżda b’ formolazzjoni riveduta ta ’ l- SPC.
The CVMP during its meeting of December 2006 started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC as amended for Enurace 50.
Matul il- laqgħa tiegħu ta ’ Diċembru 2006, is- CVMP beda proċedura ta ’ referenza skond l- Artikolu 33( 4) tad- Direttiva 2001/ 82/ KE kif emendata għal Enurace 50.
The Marketing Authorisation Holder was requested to provide all supporting data to justify a positive benefit/ risk ratio for the treated animal.
Id- Detentur ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq ġie mitlub jipprovdi d- dejta kollha ta ’ appoġġ biex jiġġustifika l- proporzjon pożittiv tal- benefiċċju/ riskju għall- annimal ittrattat.
In response to the questions related to toxicity, the applicant argued that due to the pharmacologic effect of ephedrine and the individual variation in receptor density no safety margin could be determined and increasing doses will be associated to increased intensity and frequency of well known adverse effects.
Bi tweġiba għall- mistoqsijiet relatati mat- tossiċità, l- applikant argumenta li minħabba l- effett farmakoloġiku ta ’ l- efedrina u l- varjazzjoni individwali fid- densità tar- riċevitur, ma seta ’ jiġi stabbilit l- ebda marġinu ta ’ sigurtà u ż- żieda fid- dożi tkun assoċjata ma ’ żieda fl- intensità u fil- frekwenza ta ’ effetti ħżiena magħrufin sewwa.
This conclusion was accepted.
Din il- konklużjoni ġiet aċċettata.
Although toxicity data for the target animal may be scarce, the adverse effects connected to ephedrine treatment are well known from human use, and the applicant had provided some post-marketing information regarding the use in dogs.
Għalkemm id- dejta dwar it- tossiċità għall- annimal fil- mira tista ’ tkun limitata, l- effetti ħżiena marbuta ma ’ trattament bl- efedrina huma magħrufin sewwa mill- użu fil- bniedem, u l- applikant kien ipprovda xi informazzjoni mill- esperjenza ta ’ wara t- tqegħid fis- suq dwar l- użu fil- klieb.
At the recommended dose level, which according to the suggested SPC should be individually adjusted, safety is ensured to a reasonable level.
Fil- livell tad- doża rakkomandata, li skond l- SPC għandha tiġi aġġustata b’ mod individwali, is- sigurtà hija assigurata f’ livell raġonevoli.
With regard to the related to cardiovascular diseases, the SPC is to be modified under section 4.5 to include the sentence “ the dog’ s cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment”.
Fir- rigward tal- mard kardjovaskulari relatat, l- SPC għandu jiġi modifikat taħt is- sezzjoni 4. 5 biex jinkludi s- sentenza “ il- funzjonalità kardjovaskulari tal- kelb għandha tiġi evalwata sewwa qabel ma jinbeda t- trattament b’ Enurace 50 u għandha tiġi mmonitorjata kull tant żmien matul it- trattament ”.
Efficacy data are connected to several shortcomings and the amount of data available is sparse.
Id - dejta dwar l- effikaċja hija marbuta ma ’ diversi nuqqasijiet u l- ammont ta ’ dejta disponibbli huwa wieħed limitat.
However, the study where Enurace 50 is compared to Propaline (ACE129802) is convincing although a non-inferiority analysis has not been performed.
Madankollu, l- istudju fejn Enurace 50 tqabbel ma ’ Propaline (ACE129802) huwa konvinċenti għalkemm ma saritx analiżi ta ’ non- inferjorità.
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Ir- riżultat bażiku juri effett tajjeb kemm 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. fil- gruppi tat- test kif ukoll f’ dawk ta ’ kontroll, effett li jista ’ jkun kemmxejn ogħla fl- annimali li ma ħadux trattament.
These results were convincing when compared to the 20% placebo treated animals that became continent in study ACE129801.
Dawn ir- riżultati kienu konvinċenti meta mqabbla ma ’ l- 20% ta ’ l- annimali ttrattati bil- plaċebo li saru kontinenti fl- istudju ACE129801.
The CVMP, therefore, concluded that the benefit/ risk for this product was favourable.
Għalhekk, is- CVMP ikkonkluda li l- benefiċċju/ riskju għal dan il- prodott kien favorevoli.
The CVMP Opinion was adopted on 18 April 2007 and the subsequent Commission Decision on 10 July 2007.
L- Opinjoni tas- CVMP ġiet adottata fit- 18 ta ’ April 2007 u d- Deċiżjoni sussegwenti tal- Kummissjoni ġiet adottata fl- 10 ta ’ Lulju 2007.
EMEA/ 532222/ 2007 – Rev.1
EMEA/ 532222/ 2007 – Rev. 1- MT
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
ISEM, GĦAMLA FARMAĊEWTIKA, QAWWA TAL- PRODOTT MEDIĊINALI, SPEĊI TA ’ ANNIMALI, MNEJN JINGĦATA, U SID TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel:
1/ 7 Stat Membru
Applicant or Marketing Authorisation Holder
Applikant jew Sid ta ’ l - Awtorizzazzjoni għat - Tqegħid fis- Suq
Animal species
Speċi ta ’ annimal
Frequency and route of administration
Frekwenza u mnejn jingħata
The Netherlands, Belgium, Germany, France, Italy, Spain and the United Kingdom.
L- Olanda, il- Belġju, il - Ġermanja, Franza, l- Italja, Spanja u r- Renju Unit.
Female dogs
Klieb nisa
A starting dose of 2 mg Ephedrine HCl per kg of bodyweight per day, divided in two oral doses is recommended.
Għal għoti fil- ħalq biss, Doża tal- bidu ta ’ 2 mg Ephedrine HCl għandha tingħata ma ’ l - għal kull kg tal- piż tal- ġisem kuljum, ikel maqsuma f’ żewġ dożi orali.
Introduction and background
Introduzzjoni u Sfond
Enurace 50 was first authorised in The Netherlands on 15 September 2000.
Enurace 50 ġie awtorizzat għall- ewwel darba fl- Olanda fil- 15 ta ’ Settembru 2000.
A Mutual Recognition Procedure started on 29 June 2006 with The Netherlands as Reference Member State and Belgium, Germany, Spain, France, Italy and the United Kingdom as Concerned Member States.
Fid- 29 ta ’ Ġunju 2006 inbdiet Proċedura tar- Rikonoxximent Reċiproku (MRP) bl- Olanda bħala l- Istat Membru ta ’ Referenza u l- Belġju, il- Ġermanja, Spanja, Franza, l- Italja u r- Renju Unit bħala Stati Membri Konċernati.
The application was made in accordance with Article 12.3 of Directive 2001/ 82/ EC as a stand alone application.
L- applikazzjoni saret skond l- Artikolu 12. 3 tad- Direttiva 2001/ 82/ KE bħala applikazzjoni weħidha.
At Day 90 of the MRP, 27 September 2006, France and Italy could not agree to the granting of a marketing authorization as they consider there are potentially serious risks for animal health.
Fid- disgħin jum ta ’ l- MRP, fis- 27 ta ’ Settembru 2006, Franza u l- Italja ma setgħux jaqblu ma ’ l- għoti ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għax qiesu li kien hemm riskji potenzjali serji għas- saħħa ta ’ l- annimali.
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) for a 60 day procedure in accordance with Article 33(1) of Directive 2001/ 82/ EC, as amended.
Il- kwistjoni ġiet riferuta lill- Grupp ta ’ Koordinazzjoni għar- Rikonoxximent Reċiproku u l - Proċeduri Deċentralizzati (CMD( v)) għal perjodu ta ’ 60 jum skond l- Artikolu 33( 1) tad- Direttiva 2001/ 82/ KE, kif emendata.
This procedure ended on 28 November 2006.
Din il- proċedura ntemmet fit- 28 ta ’ Novembru 2006.
CMD(v) could not reach an agreement by day 60 of this procedure, as France and Italy maintained their concerns.
Is- CMD( v) ma setax jilħaq qbil sas- sittin jum ta ’ din il- proċedura, billi Franza u l- Italja baqgħu jsostnu t- tħassib tagħhom.
Consequently the matter was referred to the CVMP.
Konsegwentament il- kwistjoni ġiet riferuta lis- CVMP.
France considers the risk/ benefit analysis unfavourable for the animal when the adverse effects (in very rare cases atrium fibrillation and tachycardia) are weighed against the potential benefits of effective treatment of incontinence.
Franza tqis li l- analiżi tar- riskju meta mqabbel mal- benefiċċju huwa wieħed sfavorevoli għall- annimali meta l- effetti sekondarji (każijijiet rari ħafna ta ’ fibrazzjoni atrijali u takikardija) jitqabblu mal - benefiċċji potenzjali ta ’ trattament effettiv ta ’ l- inkontinenza.
Italy could accept the application with revised wording in the SPC.
L- Italja tista ’ taċċetta l- applikazzjoni b’ formolazzjoni riveduta ta ’ l- SPC.
The CVMP during its meeting of December 2006 started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC as amended for Enurace 50.
Is- CVMP waqt il- laqgħa tiegħu ta ’ Diċembru ta ’ l- 2006 beda proċedura ta ’ riferiment skond l- Artikolu 33( 4) tad- Direttiva 2001/ 82/ KE kif emendata għal Enurace 50.
The Marketing Authorisation Holder should provide all supporting data (preclinical and clinical documentation, including the expert reports, efficacy and tolerance studies conducted), to justify a positive benefit-risk ratio for the treated animal.
Is- Sid ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq irid jipprovdi d- dejta kollha relevanti (dokumentazzjoni klinika u preklinika, inkluż rapporti ta ’ esperti, l- istudji tat- tolleranza u ta ’ l- effikaċja li jkunu saru), biex jiġġustifika proporzjon favorevoli tal- benefiċċju- riskju għall- annimal taħt il- kura.
For the reason of very limited treatment options, high risk of euthanasia if treatment fails or is not affordable, ephedrine is a substance of other eventual choice - Propalin instead Enurace and vice versa, considering that sympathicomimetic treatment of urinary incontinence is far better than hormonal treatment (an alternative is surgical therapies as colposuspension, urethropexy and the endoscopic injection of collagen in refractory cases).
Minħabba l- għażliet limitati ħafna ta ’ trattament, riskju qawwi ta ’ ewtanasija jekk it- trattament ma jirnexxix jew jekk dan ma jkunx finanzjarjament sostenibbli, l- efedrina hija sustanza oħra li tista ’ tkun għażla eventwali – Propalin minflok Enurace u viċi versa, meta wieħed jikkonsidra li trattament simpatikomimetiku ta ’ l- inkontinenza awrinarja hu ferm aħjar minn trattament ormonali (alternattivi oħra huma terapiji kirurġiċi bħal colposuspension, urethropexy u l- injezzjoni endoskopika tal- kollaġen f’ każijiet refrattorji).
Proposed dose of 1 – 3 mg Ephedrine HCl / kg/ day, divided in two oral doses is effective and safe, but some animals may need a higher dose, which is associated with individual variation in the response to ephedrine.
Id- doża proposta ta ’ 1 – 3 mg Ephedrine HCl/ kg kuljum, diviża f’ żewġ dożi orali hi effettiva u sigura, iżda xi annimali jista ’ jkollhom bżonn dożi ikbar, li jkunu assoċjati ma ’ varjazzjoni individwali fir- rispons għall- efedrina.
Indeed, treatment is not successful in all animals, but the level of efficacy is such that there is an advantage in treatment.
Fil- fatt, it- trattament ma jirnexxix fl- annimali kollha, iżda l- livell ta ’ effikaċja hu tali li jagħti vantaġġ għat- trattament.
Taking the benefit of the treatment into account and the relatively low level of adverse effects, as it appears from PMS studies, the risk/ benefit balance is considered favourable.
Meta wieħed jikkonsidra l- benefiċċju tat- trattament u l- livell relattivament baxx ta ’ l- effetti sekondarji, kif jidher mill- istudji PMS, ir- riskju/ benefiċċju hu meqjus wieħed favorevoli.
Enurace has been officially authorised since 2000 (since 1995 available in the Netherlands).
Enurace ilu awtorizzat uffiċjalment sa mill- 2000 (disponibbli fl- Olanda sa mill- 1995).
Since 1998 post-marketing studies have been performed as well as regular monitoring of adverse effects by FAQ system.
Mill- 1998 bdew isiru studji ta ’ wara t- tqegħid fis- suq kif ukoll sorveljanza regolari ta ’ l- effetti sekondarji permezz ta ’ sistema ta ’ tweġibiet ta ’ l- iktar mistoqsijiet komuni dwar il- prodott.
There is no doubt that treatment of the dog with Enurace may involve an occurrence of adverse reactions due to peculiar activity of ephedrine.
M’ hemmx dubju li t- trattament tal- kelb b’ Enurace jista ’ jwassal għal reazzjonijiet sekondarji minħabba l- attività partikolari ta ’ l- efedrina.
The use of human labelled preparations or dosage forms obtained from a compounding pharmacy which contain ephedrine constitute a much more dangerous alternative for treatment of urinary incontinence in dogs if the product with a marketing authorisation and a proved efficacious use in the RMS for many years is not available.
L- użu ta ’ preparazzjonijiet ittikkettjati għall- bniedem jew forom ta ’ dożi miksubin mill- ispiżeriji li fihom jitħalltu l- farmaċewtiċi li jkun fihom l- efedrina, jikkostitwixxi alternattiva ħafna iktar perikoluża għat- trattament ta ’ l- inkontinenza awrinarja fil- klieb jekk il- prodott bl- awtorizzazzjoni għat- tqegħid fis- suq u li jkun ġie ppruvat bħala wieħed effikaċi fl - RMS għal ħafna snin, ma jkunx disponibbli.
The data provided by the applicant show that Enurace 50 is an effective medicinal product for treatment of urinary incontinence in ovariohysterectomised bitches.
4/ 7 Id- dejta pprovduta mill- applikant turi li Enurace 50 hu prodott mediċinali effettiv għat- trattament ta ’ l - inkontinenza awrinarja fi klieb nisa li jkunu tneħħewlhom l- ovarji u l- utru.
4/ 7 Considering safety, the product seems not to create a considerable risk to young and healthy animals.
Meta wieħed iqis is- sigurtà, il- prodott jidher li ma joħloqx riskju konsiderevoli fuq annimali żgħar u b’ saħħithom.
However, in Europe ovariohysterectomy is most frequently performed in middle aged and old bitches.
Madankollu, fl- Ewropa it- tneħħija ta ’ l- ovarji u ta ’ l- utru issir frekwentament fi klieb nisa ta ’ mezza età jew xjuħ.
Taking into account that urinary incontinence may occur even several years after the operation it can be suspected that Enurace would be used mostly in older animals, more frequently suffering form cardiovascular, liver, renal and other diseases.
Meta wieħed jikkonsidra li l- inkontinenza awrinarja tista ’ sseħħ wara numru ta ’ snin wara l- operazzjoni wieħed jista ’ jissuspetta li Enurace jista ’ jintuża l- iktar minn annimali ixjeħ, li ħafna drabi jkollhom mardiet kardjovaskulari, tal- fwied, tal- kliewi jew mardiet oħra.
Although the influence of age was not reflected in the tolerance studies, it was taken into account in the efficacy and post- marketing studies.
Għalkemm l- influwenza ta ’ l- età ma kinitx riflessa fl- istudji tat- tolleranza, din ġiet ikkunsidrata fl - istudji dwar l- effikaċja u ta ’ wara t- tqegħid fis- suq.
Regarding cardiac dysfunction, this was one of the exclusion criteria so the studies give no information on use of the product in animals with such a condition but there is also no data suggesting that the cardiac patients must not be treated with the substance.
Dwar il- problemi tal- qalb, din kienet waħda mill - kriterji ta ’ esklużjoni u allura l- istudji ma jagħtu ebda tagħrif dwar l- użu tal- prodott f’ annimali b’ kondizzjonijiet bħal dawn, iżda lanqas ma hemm dejta li tissuġġerixxi li l- pazjenti bi problemi tal - qalb m’ għandhomx jingħataw is- sustanza.
Possible risk connected with the use of ephedrine in this group of animals can be reduced by appropriate management measures.
Ir- riskju marbut ma ’ l- użu ta ’ l- efedrina f’ dan il- grupp ta ’ annimali jista ’ jitnaqqas b’ miżuri ta ’ ġestjoni xierqa.
3 Conclusion and Recommendation
3 Konklużjonijiet u Rakkomandazzjonijiet
In response to the questions related to toxicity, the applicant argues that due to the pharmacologic effect of ephedrine and the individual variation in receptor density no safety margin can be determined and increasing doses will be associated to increased intensity and frequency of well known adverse effects.
Bi tweġiba għall- mistoqsijiet relatati mat- tossiċità, l- applikant argumenta li minħabba l- effett farmakoloġiku ta ’ l- efedrina u l- varjazzjoni individwali fid- densità tar- riċetturi, ma jista ’ jkun stabbilit l- ebda limitu ta ’ sigurtà u żidiet fid- dożi huma assoċjati ma ’ żieda fl- intensità u l- frekwenza ta ’ effetti sekondarji magħrufa.
This conclusion is accepted.
Din il- konklużjoni hija aċċettata.
Although toxicity data for the target animal may be scarce, the adverse effects connected to ephedrine treatment are well known from human use, and the applicant has provided some post-marketing information regarding the use in dogs.
Għalkemm id- dejta dwar it- tossiċità għall - annimal partikolari tista ’ tkun skarsa, l- effetti sekondarji marbuta mat- trattament bl- efedrina huma magħrufa sew mill- użu fuq il- bniedem, u l- applikant ipprovda tagħrif ta ’ wara t- tqegħid fis- suq dwar l - użu tiegħu fuq il- klieb.
At the recommended dose level, which according to the suggested SPC should be individually adjusted, safety is ensured to a reasonable level.
Fil- livell tad- doża rakkomandata, li skond l- SPC huwa ssuġġerit li din trid tkun aġġustata individwalment, is- sigurtà hija raġjonevolment assigurata.
With regard to the related to cardiovascular diseases, the SPC is to be modified under section 4.5 to include the sentence “ the dog’ s cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment”.
Dwar il- mard kardjovaskulari, l- SPC irid jiġi modifikat f’ Sezzjoni 4. 5 biex jinkludi s- sentenza “ il - funzjonalità kardjovaskulari tal- kelb trid tiġi vvalutata b’ attenzjoni qabel il- bidu tat- trattament b’ Enurace 50 u trid tiġi sorveljata perjodikament waqt it- trattament ”.
Efficacy data are connected to several shortcomings and the amount of data available is sparse.
Id- data dwar l- Effikaċja fiha bosta limitazzjonijiet u l- ammont ta ’ dejta disponibbli huwa skars.
However, the study where Enurace 50 is compared to Propaline (ACE129802) is convincing although a non-inferiority analysis has not been performed.
Madankollu, l- istudju li fih, Enurace 50 tqabbel ma ’ Propaline (ACE129802) huwa wieħed konvinċenti għalkemm ma saritx analiżi non- inferiority.
The raw outcome shows good effect in both test and control groups (87% vs 85.5%), an effect that might be somewhat higher in treatment naïve animals (93.7% vs 88.9%).
Ir- riżultati qabel l- analiżi wrew effett tajjeb kemm fil- grupp ittestjat kif ukoll fil- grupp ta ’ kontroll (87% vs 85. 5%), effett li jaf ikun ftit jew wisq ikbar fit- trattament ta ’ annimali naïve (93. 7% vs 88. 9%).
These figures seem highly convincing when compared to the 20% placebo treated animals that became continent in study ACE129801.
Dawn il- figuri jidhru konvinċenti ħafna meta mqabbla ma ’ l- 20% ta ’ l- annimali ttrattati bil- plaċebo li saru kontinenti fl- istudju ACE129801.
The CVMP has concluded that the risk/ benefit for this product is favourable.
Is- CVMP ikkonkluda li r- riskju/ benefiċċju għal dan il- prodott huwa wieħed favorevoli.
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendment:
Is- Sommarju tal- Karatteristiċi tal- Prodott, l- ittikkettar u l- fuljett ta ’ tagħrif validi huma l- verżjonijiet finali miksuba waqt il- proċedura tal- Grupp tal- Koordinazzjoni bl- emendi li ġejjin:
Section 4.5 of the SPC and Section 12 of the Package Leaflet:
Sezzjoni 4. 5 ta ’ l- SPC u s- Sezzjoni 12 tal- Fuljett ta ’ Tagħrif:
Special precautions for use
6/ 7 4. 5 Prekawzjonijiet Speċjali għall- Użu
The dog’ s cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment.
Il- funzjonalità kardjovaskulari tal- kelb għandha tkun assessjata bir- reqqa qabel il- bidu tat- trattament bl- Enurace 50 u għandha tkun monitorjata perjodikament matul it- trattament.
SPECIAL WARNING(S)
TAGĦRIF SPEĊJALI GĦALL- ĦAŻNA
London, August 2008 EMEA/ 455918/ 2008
Londra, Awwissu 2008 EMEA/ 455918/ 2008
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR EQUIBACTIN VET.
OPINJONI WARA RIFERIMENT SKONT L- ARTIKOLU 33 (4) GĦAL EQUIBACTIN VET.
Equibactin vet. is a paste for oral use containing trimethoprim and sulfadiazine as active ingredients and is indicated for treatment of infections in horses caused by bacteria sensitive to the combination of trimethoprim and sulfadiazine, particularly: • Respiratory tract infections associated with Streptococcus spp. and Staphylococcus aureus; • Gastrointestinal infections associated with E. coli; • Urogenital infections associated with beta-hemolytic streptococci; • Wound infections and open or drained abscesses associated with Streptococcus spp. and Staphylococcus aureus.
Equibactin vet. huwa pejst għall- użu orali li fih trimethoprim u sulfadiazine bħala sustanzi attivi u huwa indikat għat- trattament ta ’ infezzjonijiet fiż- żwiemel ikkawżati minn batterji sensittivi għall - kombinazzjoni ta ’ trimethoprim u sulfadiazine, b’ mod partikolari: • Infezzjonijiet tal- passaġġ respiratorju assoċjati ma ’ Streptococcus spp. u Staphylococcus aureus; • Infezzjonijiet gastrointestinali assoċjati ma ’ E. coli; • Infezzjonijiet uroġenitali assoċjati ma ’ beta- hemolytic streptococci; • Infezzjonijiet fil- ġrieħi u axxessi miftuħin jew bil- materja maħruġa assoċjati ma ’ Streptococcus spp. u Staphylococcus aureus.
Equibactin vet. is a generic product.
Equibactin vet. huwa prodott ġeneriku.
In August 2006 a decentralised procedure started with The Netherlands as Reference Member State and 17 Concerned Member States.
F’ Awwissu 2006 nbdiet proċedura deċentralizzata bl- Olanda bħala Stat Membru ta ’ Referenza u 17- il Stat Membru Konċernat.
France could not agree to the granting of a marketing authorisation as it considered there were potential serious risks to animal health.
Franza ma setgħetx taqbel fuq l- għoti ta ’ awtorizzazzjoni għat- tqegħid fis- suq għax qieset li kien hemm riskji serji potenzjali għas- saħħa tal- annimali.
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the CVMP.
Il- kwistjoni ġiet riferuta lill- Grupp ta ’ Koordinazzjoni għall- Għarfien Reċiproku u l- Proċeduri Deċentralizzati CMD( v) u sussegwentament lis- CVMP.
France considered that the dosing regime of the product is not correct.
Franza ikkunsidrat li r- reġim tad- dożaġġ tal- prodott mhuwiex korrett.
It considered this may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.
Qieset li dan jista ’ jwassal għal nuqqas ta ’ effikaċja u jista ’ jsaħħaħ l- iżvilupp tar - reżistenza fil- patoġeni fil- mira, li possibilment jista ’ jwassal għal riskji għas- saħħa tal- bniedem fejn għandhom x’ jaqsmu batterji żoonotiċi.
The CVMP started the referral procedure during its meeting of 6-8 November 2007.
Is- CVMP beda proċedura ta ’ riferiment waqt il- laqgħa tiegħu ta ’ bejn is- 6 u t- 8 ta ’ Novembru 2007.
The Marketing Authorisation Holder was requested to provide a copy of the dossier and, in view of the concerns raised by France, to indicate and to substantiate where necessary, any differences between Equibactin vet. and the reference product Tribrissen Oral Paste that could justify different conclusions on the safety or efficacy.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq intalab jipprovdi kopja tad- dokumentazzjoni u, minħabba t- tħassib imqajjem minn Franza, biex jindika u jissustanzja fejn meħtieġ, kwalunkwe differenza bejn Equibactin vet. u l- prodott ta ’ referenza Pejst Orali Tribrissen li tista ’ tiġġustifika l - konklużjonijiet differenti fuq is- sigurtà u l- effikaċja.
In response to the questions, the applicant submitted the dossier and argued on the basis of a comparison of compositions and pharmacokinetic data, that there are no differences between Equibactin vet. and the reference product that would justify different conclusions on the safety and efficacy for the two products.
Bi tweġiba għall- mistoqsijiet, l- applikant issottometta d- dokumentazzjoni u argumenta li abbażi tat - tqabbil tad- dejta tal- kompożizzjonijiet u d- dejta farmakokinetika, ma hemmx differenzi bejn Equibactin vet. u l- prodott ta ’ referenza li jista ’ jiġġustifika konklużjonijiet differenti fuq is- sigurtà u l - effikaċja għaż- żewġ prodotti.
CVMP agreed that Equibactin vet. proved to be essentially similar to reference product Tribrissen Oral Paste.
Is- CVMP qabel li ngħatat prova li Equibactin vet. kien essenzjalment simili għall- prodott ta ’ referenza Pejst Orali Tribrissen.
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Għalhekk l- istess konklużjonijiet dwar l- effikaċja u s- sigurtà japplikaw indaqs 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. għaż- żewġ prodotti u l- oġġezzjonijiet imqajma minn Franza m’ għandhomx jipprevjenu l- għoti ta ’ awtorizzazzjoni għat- tqegħid fis- suq.
Being aware of a referral ongoing at the time under Article 35 of Directive 2001/ 82/ EC, as amended, for reference product Tribrissen Oral Paste, CVMP recommended that the outcome of that referral procedure (EMEA/ V/ 023) should apply to the marketing authorisation of Equibactin vet.
Konxju mir- riferiment kontinwu f’ dak iż- żmien skont l- Artikolu 35 tad- Direttiva 2001/ 82/ KE, kif emendata, għall- prodott ta ’ referenza Pejst Orali Tribrissen, is- CVMP irrakkomanda li r- riżultat tal - proċedura ta ’ riferiment (EMEA/ V/ 023) għandu japplika għall- awtorizzazzjoni għat- tqegħid fis- suq ta ’ Equibactin vet.
The CVMP Opinion was adopted on 12 December 2007 and the subsequent Commission Decision on 3 March 2008.
L- Opinjoni tas- CVMP ġiet adottata fit- 12 ta ’ Diċembru 2007 u d- Deċiżjoni sussegwenti tal - Kummissjoni fit- 3 ta ’ Marzu 2008.
EMEA/ 455818/ 2008-EN
EMEA/ 455818/ 2008- MT
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
ISEM, GĦAMLA FARMAĊEWTIKA, QAWWA TAL- PRODOTT MEDIĊINALI, SPEĊI TA ’ ANNIMAL, MNEJN JINGĦATA, U DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
1/ 7 Applicant or Marketing Authorisation Holder
1/ 7 Applikant jew Detentur ta ’ l- Awtorizzazzjoni Għat - Tqegħid fis- Suq
Product invented name
Isem invetat tal - prodott
Willeskop 212 3421 GW Oudewater The Netherlands
Willeskop 212 3421 GW Oudewater L- Olanda
(333 mg/ g + 67 mg/ g) Oral Paste for Horses.
(333 mg/ g + 67 mg/ g) Pejst Orali għaż- Żwiemel.
paste
pejst
333.3 mg/ g sulfadiazine and 66.7 mg/ g trimethoprim.
333. 3 mg/ g sulfadiazine and 66. 7 mg/ g trimethoprim.
horse
żiemel
5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days.
5 mg trimethoprim u 25 mg sulfadiazine għal kull kg ta ’ piż tal - ġisem kuljum għal massimu ta ’ 5t’ ijiem.
The Netherlands, reference member state in the decentralised procedure, notified the EMEA on 24 September 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement for Equibactin vet.
Fl- 24 ta ’ Settembru 2007, l- Olanda, Stat Membru ta ’ referenza fil- proċedura deċentralizzata, innotifikat lill- EMEA li l- Grupp ta ’ Koordinament għal Rikonoxximent Reċiproku u Proċeduri Deċentralizzati – Veterinarji (CMD( v)) ma rnexxielhomx jilħqu ftehim fuq Pejst Orali għaż- Żwiemel Equibactin vet.
(333 mg/ g + 67 mg/ g) Oral Paste for Horses.
(333 mg/ g + 67 mg/ g).
Pursuant to Article 33(4) of Council Directive 2001/ 82/ EC, as amended, the matter was referred to the CVMP.
B’ mod konformi ma ’ l- Artikolu 33( 4) tad- Direttiva tal- Kunsill 2001/ 82/ KE, kif emendat, il- kwistjoni kienet riferuta lis- CVMP.
France considers that the dosing regime of the product is not correct.
Franza tikkunsidra li r- reġim ta ’ l- iddożar tal- prodott mhijiex korretta.
This may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.
Dan jista ’ jwassal għal nuqqas ta ’ effikaċja u jkompli jżid l- iżvilupp ta ’ reżistenza fil- patoġeni fil- mira, li jista ’ possibbilment iwassal għal riskji għas- saħħa tal- bniedem fejn huma ikkonċernati batterji żoonotiċi.
CVMP noted that Equibactin vet.
Is- CVMP innota li Pejst Orali għaż- Żwiemel Equibactin vet.
(333 mg/ g + 67 mg/ g) Oral Paste for Horses is a generic of Tribrissen oral paste (authorised in the Netherlands) and that the concerns raised by France can only be addressed in the framework of this procedure, in case any differences between both products would justify different conclusions on the safety or efficacy.
(333 mg/ g + 67 mg/ g) huwa ġeneriku ta ’ pejst orali Tribrissen (awtorizzat fl- Olanda) u li tħassib imqajjem minn Franza jista ’ jkun biss indirizzat fil- qafas ta ’ din il- proċedura, f’ każ li xi differenzi bejn il- prodotti jistgħu jiġġustifikaw konklużjonijiet differenti fuq is- sigurtà jew l- effikaċja.
CVMP started the procedure on 6 November 2007.
Is- CVMP beda l- proċedura fis- 6 ta ’ Novembru 2007.
A list of questions was adopted on 8 November 2007 and sent to the marketing authorisations holders (MAH), by which the procedure clock was stopped.
Lista ta ’ mistoqsijiet kienet adottata fit- 8 ta ’ Novembru 2007 u din intbagħtet lid- detenturi ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq (MAH), sa liema żmien l- proċedura twaqqfet.
On 16 November 2007 responses to the questions were received from MAH and the clock restarted.
Fis- 16 ta ’ Novembru 2007 kienu rċevuti reazzjonijiet għall - mistoqsijiet mingħand l- MAH u l- proċedura ssoktat.
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.
Il- mira ta ’ l- istima hija li tistabbilixxi jekk awtorizzazzjonijiet għat- tqegħid fis- suq ta ’ prodotti mediċinali veterinarji inklużi fil- proċedura ta ’ referenza għandhomx jinżammu, jiġu sospiżi, varjati jew irrevokati minħabba r- raġunijiet għar- referenza.