natgillin/translations-raw huggingface dataset:
CVMP anbefalede udstedelse af markedsføringstilladelse for Doxyprex 100 mg/ g Premix til medicineret foder til svin til følgende indikation på baggrund af, at der er fremlagt en positiv benefit/ risk- analyse, og at der ikke er fundet nogen potentielt alvorlig risiko.
The CVMP recommended the granting of the marketing authorisation to Doxyprex 100 mg/ g Premix for medicated feeding stuff for pigs for the following indication because a positive benefit/ risk analysis has been demonstrated and no potential serious risk has been identified.
“ Til behandling og forebyggelse af luftvejssygdomme hos svin forårsaget af Pasteurella multocida og Bordetella bronchiseptica, som er følsomme over for doxycyclin, når sygdommen er blevet diagnosticeret i besætningen. ”
“ 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 .”
Der kunne ikke gennemføres en benefit/ risk- analyse på grund af manglende hoveddokumentation for klinisk effekt til indikationen M. hyopneumoniae.
A benefit-risk analysis could not be conducted due to the lack of pivotal evidence on clinical efficacy for the indication M. hyopneumoniae.
CVMP’ s udtalelse blev vedtaget den 14. februar 2007, og Kommissionens efterfølgende beslutning blev vedtaget den 22. maj 2007.
The CVMP Opinion was adopted on 14 February 2007 and the subsequent Commission Decision on 22 May 2007.
EMEA/ 532206/ 2007 - Rev. 1- DA
EMEA/ 532206/ 2007- Rev.1
London, den 18. februar 2008 EMEA/ 48261/ 2008
London, 18 February 2008 EMEA/ 48261/ 2008
UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 331 OM Ecomectin 18, 7 mg/ g, oral pasta til heste og tilknyttede navne Internationalt fællesnavn (INN):
OPINION FOLLOWING AN ARTICLE 33 1 REFERRAL FOR Ecomectin 18.7 mg/ g Oral Paste for Horses and its associated names International Non-Proprietary Name (INN):
Ecomectin 18, 7 mg/ g, oral pasta til heste er en hvid, ensartet pasta, der indeholder ivermectin.
Ecomectin 18.7 mg/ g Oral Paste for Horses is a white homogenous paste containing ivermectin.
Ivermectin tilhører klassen af makrocykliske lakton- endektocider.
Ivermectin is a member of the macrocyclic lactone class of endectocides.
Ecomectin 18, 7 mg/ g, oral pasta til heste kan anvendes til heste til behandling af rundorme - eller leddyrsinfektioner, der er forårsaget af Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, små blodorme (herunder benzimidazolresistente stammer):
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):
Cyathostomum spp., Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., spolorm:
Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., Ascarids:
Parascaris equorum, haleorm:
Parascaris equorum, Pinworms:
Oxyuris equi, filarier:
Oxyuris equim, Neck threadworms:
Onchocerca spp., mavebremselarver:
Onchocerca spp, Stomach bots:
Der er tidligere blevet udstedt en markedsføringstilladelse for Ecomectin 18, 7 mg/ g, oral pasta til heste til Eco Animal Health Ltd i Irland den 10. november 2006.
A marketing authorisation for Ecomectin 18.7 mg/ g Oral Paste for Horses was previously granted to Eco Animal Health Ltd in Ireland on 10 November 2006.
En gensidig anerkendelsesprocedure blev indledt den 1. februar 2007.
A mutual recognition procedure was started on 1 February 2007.
Referencemedlemsstaten var Irland, og de berørte medlemsstater var Belgien, Cypern, Tjekkiet, Tyskland, Danmark, Grækenland, Spanien, Finland, Frankrig, Ungarn, Italien, Nederlandene, Norge, Portugal, Sverige og Det Forenede Kongerige.
The Reference Member State was Ireland and the Concerned Member States were Belgium, Cyprus, Czech Republic, Germany, Denmark, Greece, Spain, Finland, France, Hungary, Italy, the Netherlands, Norway, Portugal, Sweden and the United Kingdom.
Lægemidlet blev godkendt af Belgien, Cypern, Tjekkiet, Danmark, Grækenland, Spanien, Finland, Frankrig, Ungarn, Italien, Nederlandene, Norge, Portugal, Sverige og Det Forenede Kongerige.
The product was accepted by the Belgium, Cyprus, Czech Republic, Denmark, Greece, Spain, Finland, France, Hungary, Italy, the Netherlands, Norway, Portugal, Sweden and the United Kingdom.
Tyskland havde betænkeligheder med hensyn til, hvorvidt dette veterinærlægemiddel kan udgøre en potentiel alvorlig risiko for folkesundheden af følgende grunde:
Concerns were raised by Germany regarding that this veterinary medicinal product may present a potential serious risk to public health on the following grounds:
Der blev påvist en miljørisiko under fase II- risikovurderingen, gruppe A vedrørende organismer, der lever i gødningsfaunaen.
An environmental risk was detected during the risk assessment Phase II Tier A for dung fauna organisms;
Ansøgeren forelagde ikke fyldestgørende data for gruppe B til vurdering af de langsigtede virkninger på organismer, der lever i gødningsfaunaen, som følge af anvendelsen af lægemidlet.
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.
Den 4. juli 2007 underrettede Irland EMEA om, at den veterinærmedicinske koordinationsgruppe for den gensidige anerkendelsesprocedure og den decentraliserede godkendelsesprocedure (CMD( v)) ikke var nået til enighed om Ecomectin 18, 7 mg/ g, oral pasta til heste og tilknyttede navne.
On 4 July 2007, Ireland notified EMEA 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 and its associated names.
4, i Europa- Parlamentets og Rådets direktiv 2001/ 82/ EF som ændret, blev sagen henvist til CVMP.
Pursuant to Article 33(4) of Council Directive 2001/ 82/ EC, as amended, the matter has been referred to the CVMP.
Indbringelsen skulle afdække, om den miljørisiko, der blev påvist under fase II- risikovurderingen, gruppe A vedrørende organismer, der lever i gødningsfaunaen, kunne udgøre en potentiel, alvorlig risiko for folkesundheden.
The scope of the referral was to whether the environmental risk detected during the risk assessment Phase II Tier A for dung fauna organisms would present a potential serious risk to public health.
1 Artikel 33 i direktiv 2001/ 82/ EF som ændret 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
1 Article 33 of Directive 2001/ 82/ EC, as amended 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Voldgiftssagen indledtes den 11. juli 2007 med vedtagelse af listen med spørgsmål.
The arbitration procedure started on 11 July 2007 with the adoption of list of questions.
Dr.
The rapporteur was Dr.
Urbain var rapportør, og professor S.
Urbain and the co-rapporteur was Prof.
Srčič var medrapportør.
Srč ič.
Indehaveren af markedsføringstilladelsen indsendte skriftlige forklaringer den 12. september 2007.
The Marketing Authorisation Holder provided written explanations on 12 September 2007.
Indehaveren af markedsføringstilladelsen fremsatte den mundtlige redegørelse for udvalget den 10. oktober 2007.
Oral explanations were presented on 10 October 2007 by the Marketing Authorisation Holder to the Committee.
På sit møde den 6. - 8. november 2007 vedtog CVMP, på baggrund af de samlede forelagte oplysninger og den faglige drøftelse i udvalget, en udtalelse ved konsensus om, at da lægemidlet skal anvendes til en mindre udbredt art (hest), der opdrættes og behandles på samme måde som en mere udbredt art, finder konklusionerne med hensyn til miljørisikovurderingen for mere udbredte arter anvendelse, og lægemidlet skal derfor fritages for at fremlægge en fase II- vurdering, og lægemidlets produktresumé skal ikke indeholde nogen foranstaltninger til risikonedsættelse.
During its 6-8 November 2007 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion 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, and therefore the product should be exempt from providing a Phase II assessment and no risk mitigation measures should be included in the SPC of the product.
Listen over berørte produktnavne fremgår af bilag I.
The list of product names concerned is given in Annex I.
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa- Kommissionen den 17. januar 2008.
The final opinion was converted into a Decision by the European Commission on 17 January 2008.
EMEA/ 48261/ 2008- DA
EMEA/ 48261/ 2008
LÆGEMIDLETS NAVN, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/ APPLICANT(S)
EMEA/ CVMP/ 495339/ 2007- DA
EMEA/ CVMP/ 495339/ 2007-EN
Indehaver af markedsføringstilladelse/ ansøger
Marketing Authorisation Holder/ Applicant
Produktets handels - betegnelse
Product invented name
Dyreart
Strength
Doseringshyppighed og indgivelsesvej
Animal species
Anbefalet dosis
Frequency and route Recommended dose of administration
78 Coombe Road New Malden Surrey KT3 4QS Det Forenede Kongerige
78 Coombe Road New Malden Surrey KT3 4QS United Kingdom
Ecomectin 18, 7 Oral pasta. mg/ g, oral pasta En hvid, homogen til heste pasta
Ecomectin 18.7 mg/ g Oral Paste for Horses
100 kg legemsvægt (baseret på den anbefalede dosis på 200 mikrogram ivermectin pr. kg. legemsvægt).
One syringe division of paste per 100 kg body weight (based on a recommended dosage of 200 microgram ivermectin per kg body weight).
Som Som Som ovenstående ovenstående ovenstående
Ivermax 18.7 As above As above As above As above mg/ g Oral Paste for Horses
Som Som Som ovenstående ovenstående ovenstående
Tizoval 18.7 As above As above As above As above mg/ g Oral Paste for Horses
Som Som Som ovenstående ovenstående ovenstående
Vetimec 18.7 As above As above As above As above mg/ g Oral Paste for Horses
Som Som Som ovenstående ovenstående ovenstående
Ecomectin As above As above As above As above 18.7 mg/ g Oral Paste for Horses
Lægemiddelform Styrke
Product invented name
Anbefalet dosis
Pharmaceutical form
Som ovenstående
Animal species
Tizoval 18, 7 Som ovenstående mg/ g, oral pasta til heste
Frequency and route Recommended dose of administration
Som Som Som ovenstående ovenstående ovenstående
Divamectin As above As above As above As above 18.7 mg/ g Oral Paste for Horses
Spanien
The Netherlands
Doseringshyppighed og indgivelsesvej
Frequency and route Recommended dose of administration
Anbefalet dosis
Portugal
Det Forenede
As above
Animec 18, 7
As above
Som ovenstående Som
Ecomectin As above As above As above As above 18.7 mg/ g Oral Paste for Horses
Som
As above
mg/ g, oral pasta til heste
As above
ovenstående ovenstående
Animec 18.7 As above As above As above As above mg/ g Oral Paste for Horses
EMEA/ CVMP/ 495339/ 2007- DA FAGLIGE KONKLUSIONER
EMEA/ CVMP/ 495339/ 2007-EN SCIENTIFIC CONCLUSIONS
Ecomectin 18, 7 mg/ g, oral pasta til heste, er bestemt til behandling af infektioner hos heste med rundorme eller leddyr forårsaget af Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, små strongylider (herunder benzimidazol- resistente stammer):
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):
Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., spolorm:
Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., Ascarids:
Oxyuris equim, filarier:
Oxyuris equim, Neck threadworms:
Onchocerca spp. og mavebremselarver:
Onchocerca spp, Stomach bots:
Irland meddelte den 4. juli 2007 til EMEA, at der ikke var opnået enighed om Ecomectin 18, 7 mg/ g, oral pasta til heste, i koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer – veterinær (CMD( v)).
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.
4, i Rådets direktiv 2001/ 82/ EF, med senere ændringer, blev sagen indbragt for CVMP.
Pursuant to Article 33(4) of Council Directive 2001/ 82/ EC, as amended, the matter has been referred to the CVMP.
Indehaveren af markedsføringstilladelsen skal forelægge samtlige oplysninger, der er forelagt referencemedlemsstaten og CMD( v) vedrørende miljørisikovurderingen.
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.
Indehaveren af markedsføringstilladelsen skal forelægge en ajourført miljørisikovurdering i overensstemmelse med CVMP' s retningslinjer herfor, herunder en eventuel begrundelse for undtagelse fra fase II; 3.
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.
Indehaveren af markedsføringstilladelsen fremsendte følgende oplysninger: • En ajourført miljørisikovurdering • Alle de oplysninger, der var forelagt referencemedlemsstaten og CMD( v) vedrørende miljørisikovurderingen.
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.
2. 1 Ajourført miljørisikovurdering i overensstemmelse med CVMP' s retningslinjer herfor, herunder eventuel begrundelse for undtagelse fra fase II
2.1 Updated Environmental Risk Assessment according to the CVMP guidelines on the matter, including any justification for exemption of Phase II
Ecomectin 18, 7 mg/ g, oral pasta til heste, er et generisk produkt og som sådant nu omfattet af kravet om en miljørisikovurdering i direktiv 2001/ 82, med senere ændringer.
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.
veterinærmedicinske lægemidler har fundet udstrakt anvendelse verden over i næsten 25 år, ville en eventuel reel risiko eller miljøskadelig virkning knyttet til sådanne produkter være blevet opdaget.
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.
Indehaveren af markedsføringstilladelsen finder det utænkeligt, at de miljørisici, der specielt er forbundet med anvendelsen af Ecomectin 18, 7 mg/ g, oral pasta til heste, skulle være større end dem, der er forbundet med andre ivermectin- baserede produkter, navnlig da koncentrationen af det aktive indholdsstof og den påtænkte anvendelse er identisk med, hvad der gælder for referencelægemidlet og andre tilsvarende lægemidler.
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.
Ansøgeren hævdede, at heste derfor bør betragtes som en "mindre udbredt art", og at en fase II- risikovurdering er unødvendig.
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.
PEC i jord for intensivt opdrættede dyr og græsædende dyr blev beregnet i henhold til CVMP' s "Guideline on Environmental Impact Assessment for Veterinary medicinal Products in Support of the VICH Guidelines GL6 and GL38" (EMEA/ CVMP/ ERA/ 418282/ 2005- corr).
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).
PECJORD for intensivt opdrættede dyr = 1, 036 µg. kg- 1 PECJORD for græsædende dyr = 0, 48 µg. kg- 1 For to jordeksponeringsscenarier oversteg PECJORD ikke den tærskelværdi på 100 µg/ kg, der angives i VICH' s retningslinjer for fase I- vurdering af veterinære lægemidler.
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.
På trods heraf synes trin 16 i beslutningstræet i fase I at pege på, at en fase II- vurdering er nødvendig for et produkt af denne art, dvs. et ekto - / endoparasiticid til vigtige arter.
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.
Spørgsmål 4 – Er veterinærlægemidlet bestemt til anvendelse i en mindre udbredt art, der opdrættes og behandles på samme måde som en vigtig art, for hvilken der i forvejen foreligger en VVM (vurdering af virkninger på miljøet)?
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?
Heste opdrættes under betingelser svarende til kvægbesætninger, eller alternativt svarende til besætninger på stald som f. eks. svin, til hvilke arter ivermectin finder almindelig anvendelse såvel ad oral vej som ad andre administrationsveje.
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.
Anvendelsen af Ecomectin 18, 7 mg/ g, oral pasta til heste, medfører ikke en større indvirkning på miljøet end den, der forårsages af produkter til vigtige arter.
The use of Ecomectin 18.7 Oral Paste for Horses does not result in an increase of the exposure to the environment compared to products for major species and therefore the conclusions of their environmental impact assessment is applicable for this product for horses.
Konklusionerne af vurderingen af miljøvirkningerne for sådanne arter finder derfor anvendelse på dette produkt til heste.
No risk mitigation measures are considered appropriate.
EMEA/ CVMP/ 495339/ 2007- DA Foranstaltninger til risikonedsættelse anses
EMEA/ CVMP/ 495339/ 2007-EN 3 Conclusions and recommendations
November 2007 ikke for påkrævet.
November 2007
Udvalget konkluderede, at da produktet er bestemt til anvendelse i en mindre udbredt art (hest), som opdrættes og behandles på samme måde som en vigtig art, er konklusionerne i miljørisikovurderingen for vigtige arter gyldige, produktet bør undtages fra fremlæggelse af en fase II- vurdering, og produktresuméet bør ikke indeholde foranstaltninger til risikonedsættelse.
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.
London, juni 2008 EMEA/ 532222/ 2007 – Rev. 1
London, June 2008 EMEA/ 532222/ 2007 – Rev.1
4 VEDRØRENDE ENURACE 50
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR ENURACE 50
Enurace 50 er et præparat i tabletform, der indeholder ephedrin som aktivt indholdsstof og er indiceret til behandling af urininkontinens forårsaget af insufficiens i den uretrale sfinkters funktion hos ovariohysterektomerede hunde.
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.
Sagen blev indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede procedurer – veterinære anliggender (CMD( v)) og efterfølgende for Udvalget for Veterinærlægemidler.
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.
Frankrig mente, at benefit/ risk- analysen var ugunstig for dyret, når bivirkningerne blev opvejet mod de mulige fordele ved effektiv behandling af inkontinens.
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.
4, i direktiv 2001/ 82/ EF, med senere ændringer.
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.
Indehaveren af markedsføringstilladelsen blev anmodet om at fremlægge alle oplysninger, der kunne understøtte et positivt benefit/ risk- forhold for det behandlede dyr.
The Marketing Authorisation Holder was requested to provide all supporting data to justify a positive benefit/ risk ratio for the treated animal.
Med hensyn til sikkerheden relateret til kardiovaskulære sygdomme skal produktresuméet ændres under punkt 4. 5, så det indeholder sætningen “ hundens kardiovaskulære funktion skal nøje vurderes, før behandling med Enurace 50 indledes, og den skal jævnligt overvåges under behandlingen ”.
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”.
Rådataene for
The raw outcome shows good effect in both test and control groups, an effect that might be somewhat higher in treatment naïve animals.
Reproduction is authorised provided the source is acknowledged. resultatet viser god effekt hos både test - og kontrolgrupper.
Reproduction is authorised provided the source is acknowledged.
Disse resultater var overbevisende ved sammenligning med de 20% placebo- behandlede dyr, som blev kontinente i undersøgelse ACE129801.
These results were convincing when compared to the 20% placebo treated animals that became continent in study ACE129801.
CVMP konkluderede derfor, at benefit/ risk- forholdet for dette produkt var gunstigt.
The CVMP, therefore, concluded that the benefit/ risk for this product was favourable.
CVMP’ s udtalelse blev vedtaget den 18. april 2007, og Kommissionens efterfølgende beslutning blev vedtaget den 10. juli 2007.
The CVMP Opinion was adopted on 18 April 2007 and the subsequent Commission Decision on 10 July 2007.
EMEA/ 532222/ 2007 – Rev. 1- DA
EMEA/ 532222/ 2007 – Rev.1
1/ 7 Medlemsstat
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel:
Styrke Dyreart
Animal species
ACE Pharmaceuticals BV Schepenveld 41 3891 ZK Zeewolde Nederlandene + 31 36 522 7201 + 31 36 522 9096 fs@ ace- pharm. nl
ACE Pharmaceuticals BV Schepenveld 41 3891 ZK Zeewolde The Netherlands + 31 36 522 7201 + 31 36 522 9096 fs@ace-pharm. nl
50 mg Tæver
50 mg
Kun til oral administration, indgives sammen med foderet
For oral administration only, to be administered with food