qanastek/EMEA-V3 huggingface dataset:
You should not take Zyrtec 1 mg/ ml oral solution:
Oqgħod attent ħafna b’ Zyrtec:
No interactions suceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine used at the normal doses.
Ma ġewx osservati ebda effetti li tinduna bihom fuq l- effett farmaċewtiku tal- prodott bl- alkoħol (fl - livell tad- demm ta ’ 0. 5 kull ml, ekwivalenti għal tazza nbid waħda) u cetirizine f’ dożi normali.
However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.
Iżda, bħal fil- każ ta ’ kull mediċina ta ’ kontra il- histamine, huwa rrakkomandat li tevita il- konsum ta ’ alkoħol fl- istess ħin.
82 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Driving and using machines Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Zyrtec at the recommended dose.
Studji kliniċi ma sabu ebda evidenza ta ’ indeboliment fl- attenzjoni, fil- viġilanża u l- abbilta ’ fis - sewqan wara li ttieħed Zyrtec fid- doża rrakkomandata.
If you are intending to drive, engage in potentially hazardous activities or operate machinery, you should not exceed the recommended dose.
Jekk inti bi ħsiebek issuq, tagħmel xi attivita` li tista ’ tkun ta ’ ħsara jew tħaddem magni, m’ għandekx teċċedi d- doża rrakkomandata.
Zyrtec oral solution contain methyl (4-hydroxybenzoate) E 218, propyl (4-hydroxybenzoate) E 216 that may cause allergic reactions (possibly delayed).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Zyrtec Zyrtec soluzzjoni ta ’ taqtir tal- ħalq fih methyl (4- hydroxybenzoate) E 218 u propyl (4 - hydroxybenzoate) E 216, li jistgħu jikkawżaw reazzjonijiet allerġiċi (li jistgħu jdumu biex joħorġu).
These guidelines apply unless your doctor has given you different instructions on how to use Zyrtec.
Dawn il- linji ta ’ gwida japplikaw sakemm it- tabib tiegħek ma jagħtikx struzzjonijiet oħra kif tuża {Zyrtec}.
The solution can be swallowed as such.
10 mg darba kuljum bħala 20 taqtira.
10 mg once daily as 10 ml oral solution (2 full measuring spoons)
5 mg darbtejn kuljum bħala 10 taqtiriet, darbtejn kuljum.
5 mg twice daily as 5 ml (one full measuring spoon) twice daily.
2. 5 mg darbtejn kuljum li jingħataw bħala 5 taqtiriet darbtejn kuljum.
Children between 2 and 6 years old 2.5 mg twice daily as 2.5 ml oral solution (a half-measuring spoon) twice daily
Pazjenti b’ indeboliment renali moderat għal sever:
Patients with moderate to severe renal impairment Patients with moderate renal impairment are recommended to take 5 mg once daily.
Huwa rrakkomandat li pazjenti b’ indeboliment renali moderat jieħdu 5 mg bħala 10 taqtiriet darba kuljum.
If you feel that the effect of Zyrtec is too weak or too strong, please consult your doctor.
Jekk tħoss li l- effett ta ’ Zyrtec huwa debboli jew qawwi wisq, tkellem lit- tabib tiegħek.
83 Duration of treatment:
Kemm idum it- trattament:
If you take more Zyrtec than you should If you think you have taken an overdose of Zyrtec please inform your doctor.
Jekk taħseb li ħadt aktar Zyrtec milli suppost jekk jogħġbok igħid lit- tabib tiegħek.
common: dizziness, headache uncommon: paresthesia (abnormal feelings of the skin), rare: convulsions, movements disorders very rare: syncope, tremor, dysgeusia (altered taste)
komuni: sturdament, uġigħ ta ’ ras mhux komuni: para- esteżija (sensazzjoni abnormali fil- ġilda) rari: aċċessjonijiet, mard tal- moviment, rari ħafna: sinkope, rogħda, disġewsja( tibdil fit- togħma)
Do not use Zyrtec after the expiry date which is stated on the box and bottle.
Tużax Zyrtec wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
- The active substance of Zyrtec Oral solution is cetirizine.
- Is- sustanza attiva ta ’ Zyrtec Soluzzjoni ta ’ taqtir tal- ħalq hija cetirizine dihydrochloride.
10 ml (equals to 2 measuring spoons)
Ml
contain 10 mg of cetirizine dihydrochloride.
wieħed (ekwivalenti għal 20 taqtira) fih 10 mg ta ’ cetirizine dihydrochloride taqtira waħda fiha 0. 5 mg ta ’ cetirizine dihydrochloride.
- The other ingredients are sorbitol (E 420), glycerol, propylene glycol, saccharine sodium,
- Is- sustanzi l- oħra huma glycerol, propylène glycol, saccharine sodium, methyl (4 -
methyl (4-hydroxybenzoate) / propyl (4-hydroxybenzoate) = E 218 / E 216, flavouring agent, sodium acetate, acetic acid, purified water.
hydroxybenzoate) / propyl (4- hydroxybenzoate) = E 218 / E 216, sodium acetate, acetic acid, ilma purifikat.
What Zyrtec looks like and contents of the pack
Id- Dehra ta ’ Zyrtec u l- kontenuti tal- pakkett:
Clear and colorless liquid with slightly sweet taste and a banana flavor
Zyrtec issibu bħala likwidu car u bla kulur.
85 Pack with a bottle of 60, 75, 100, 125, 150, or 200 mL solution.
Pakkett oriġinali b’ flixkun ta ’ 10, 15, 20, jew 30 ml ta ’ soluzzjoni.
Marketing Authorisation Holder and Manufacturer
81 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
Zyrtec 1 mg/ ml – orale Lösung Belgium:
Zyrtec 10 mg/ ml - Tropfen Il- Belġju:
Zyrtec Cyprus:
Zyrtec Ir- Repubblika Ċeka:
Virlix, Zyrtec Germany:
VirlixZyrtec Il- Ġermanja:
Zyrtec saft Hungary:
Ziptek L- Ungerija:
Zirtek oral solution 1mg/ ml Italy:
Zyrtec cseppek L- Italja:
Zirtec 1mg/ ml soluzione orale Latvia:
Formistin, Virlix, Zirtec 10mg/ ml gocce orali soluzione Il- Latvja:
Zyrtec Malta:
Zyrtec Il- Lussemburgu:
Zyrtec Norway:
Virlix, Zyrtec, Cetirizine- UCB In- Norveġja:
Virlix, Zyrtec Portugal:
Zyrtec Il- Portugall:
Zyrtec, Virlix Slovenia:
Zyrtec gtt por 10mg/ ml Slovenja:
Zyrtec1 mg/ ml peroralna raztopina Spain:
Zyrtec10 mg/ ml peroralne kapljice, raztopina Spanja:
Alerlisin, Virlix, Reactine 5mg/ 5ml solución oral, Zyrtec solución oral Sweden:
Alerlisin, Virdos, Zyrtec gotas orales en solución L- Isvezja:
87 PACKAGE LEAFLET:
82 FULJETT TA ’ TAGĦRIF:
Zyrtec and associated names (see Annex I) 1 mg/ ml oral solution
Zyrtec u ismijiet assoċjati miegħu (ara Anness I) 1 mg/ ml soluzzjoni orali [Ara Anness I - Biex timtela mill- pajjiż partikolari]
Possible side effects 10.
Effetti sekondarji li jista ’ jkollu 5.
In adults and children aged 2 year and above, Zyrtec is indicated
Fl- adulti, u tfal ta ’ sentejn ‘ l fuq, Zyrtec huwa indikat
You should not take Zyrtec 1 mg/ ml oral solution:
M’ għandekx tieħu Zyrtec 1 mg/ ml soluzzjoni orali:
- if you have rare hereditary problems of fructose intolerance
- jekk inti għandek problema ereditarja rari ta ’ intolleranza għal fructose
No interactions suceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and cetirizine used at the normal doses.
83 Ma ġewx osservati ebda effetti li tinduna biħom fuq l- effett farmaċewtiċi tal- prodott,, bl- alkoħol (fl - livell tad- demm ta ’ 0. 5 kull ml, ekwivalenti għal tazza nbid waħda) u cetirizine f’ dożi normali.
However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.
Iżda, bħal fil- każ ta ’ kull mediċina ta ’ kontra l- istamina, huwa rrakkomandat li tevita il- konsum ta ’ alkoħol fl- istess ħin.
88 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Driving and using machines Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Zyrtec at the recommended dose.
Studji kliniċi ta ’ tqabbil ma sabu ebda evidenza ta ’ impediment fl- attenzjoni, fil- viġilanża u l- abbilta` fis- sewqan wara li ttieħed Zyrtec fid- doża rrakkomandata.
Important information about some of the ingredients of Zyrtec Zyrtec oral solution contains sorbitol; if you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Zyrtec Zyrtec soluzzjoni orali fih sorbitol; jekk it- tabib tiegħek qallek li inti ma jaqblux miegħek xi tipi ta ’ zokkor, jekk jogħġbok kellem lit- tabib tiegħek qabel ma tieħu din il- mediċina.
Zyrtec oral solution contain methyl (4-hydroxybenzoate) E 218, propyl (4-hydroxybenzoate) E 216 that may cause allergic reactions (possibly delayed).
Zyrtec soluzzjoni orali fih methyl (4- hydroxybenzoate) E 218 u propyl (4- hydroxybenzoate) E 216, li jistgħu jikkawżaw reazzjonijiet allerġiċi (li jistgħu jdumu biex joħorġu).
Please follow these instructions, otherwise Zyrtec may not be fully effective.
Dawn il- linji ta ’ gwida japplikaw sakemm it- tabib tiegħek ma jagħtikx struzzjonijiet oħra kif tuża Zyrtec Segwi dawn l- istruzzjonijiet, għaliex jekk le, Zyrtec jista ’ ma jkunx effettiv daqs kemm suppost.
The solution can be swallowed as such.
Is- soluzzjoni orali tista ’ tittieħed kif inhi.
10 mg once daily as 10 ml oral solution (2 full measuring spoons)
10 mg darba kuljum bħala 10 ml ta ’ soluzzjoni orali (2 imgħaref tal- kejl mimlijin)
5 mg twice daily as 5 ml (one full measuring spoon) twice daily.
5 mg darbtejn kuljum bħala 5 ml (mgħarfa waħda tal- kejl mimlija) darbtejn kuljum.
Children between 2 and 6 years old 2.5 mg twice daily as 2.5 ml oral solution (a half-measuring spoon) twice daily
2. 5 mg darbtejn kuljum bħala 2. 5 ml soluzzjoni orali (nofs mgħarfa tal- kejl) darbtejn kuljum.
Patients with moderate to severe renal impairment Patients with moderate renal impairment are recommended to take 5 mg once daily.
Huwa rrakkomandat li pazjenti b’ indeboliment renali moderat jieħdu 5 mg darba kuljum.
89 If you feel that the effect of Zyrtec is too weak or too strong, please consult your doctor.
Jekk tħoss li l- effett ta ’ Zyrtec huwa debboli jew qawwi wisq, kellem lit- tabib tiegħek.
The duration of treatment depends on the type, duration and course of your complaints and is determined by your doctor.
It- trattament idum skond it- tip, it- tul u n- natura tal- problema u jiġi deċiż mit- tabib tiegħek.
Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, ailing, dilating of pupil, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.
Ġew rapportati effetti mhux mixtieqa bħal konfużjoni, dijareja, sturdament, għeja, uġigħ ta ’ ras, tħossok ma tiflaħx, tkabbir tal- pupilla, ħakk, irrekwitezza, sedazzjoni, ngħas tqil, sturdament, il- qalb tħabbat aktar mis- soltu, rogħda, u ma tistax tgħaddi awrina.
- The active substance of Zyrtec Oral solution is cetirizine.
- Is- sustanza attiva ta ’ Zyrtec Soluzzjoni orali hija cetirizine dihydrochloride.
10 ml (equals to 2 measuring spoons)
10 ml (= żewġ
contain 10 mg of cetirizine dihydrochloride.
imgħaref ta ’ kejl) fih 10 mg ta’ cetirizine hydrochloride.
- The other ingredients are sorbitol (E 420), glycerol, propylene glycol, saccharine sodium,
- Is- sustanzi l- oħra huma Sorbitol (E420), glycerol, propylène glycol, saccharine sodium, methyl
methyl (4-hydroxybenzoate) / propyl (4-hydroxybenzoate) = E 218 / E 216, flavouring agent, sodium acetate, acetic acid, purified water.
(4- hydroxybenzoate) / propyl (4- hydroxybenzoate) = E 218 / E 216, sustanza għat- togħma, sodium acetate, acetic acid, ilma purifikat.
- 10 ml Zyrtec oral solution (=2 measuring spoons) contain:
- 10 ml ta ’ Zyrtec soluzzjoni orali (= żewġ imgħaref ta ’ kejl) fih: ekwivalenti ta ’ 3. 15 g ta ’
3.15 g glucose equivalents (sorbitol).
glucose (sorbitol).
What Zyrtec looks like and contents of the pack
86 Id- Dehra ta ’ Zyrtec u l- kontenuti tal- pakkett:
91 Clear and colorless liquid with slightly sweet taste and a banana flavor
Likwidu car u bla kulur kemmxejn ħelu u b’ togħma ta ’ banana.
Pack with a bottle of 60, 75, 100, 125, 150, or 200 mL solution.
Pakkett oriġinali b’ flixkun ta ’ 60, 75, 100, 125, 150, jew 200 mL ta ’ soluzzjoni.
Zyrtec 1 mg/ ml – orale Lösung Belgium:
Zyrtec 1 mg/ ml – orale Lösung Il- Belġju:
Zyrtec saft Hungary:
Zyrtec saft L- Ungerija:
Zyrtec oldat Ireland:
Zyrtec oldat L- Irlanda:
Zirtek oral solution 1mg/ ml Italy:
Zirtek oral solution 1mg/ ml L- Italja:
Zirtec 1mg/ ml soluzione orale Latvia:
Zirtec 1mg/ ml soluzione orale Il- Latvja:
Zyrtec Norway:
Zyrtec In- Norveġja:
Virlix, Zyrtec Portugal:
Virlix, Zyrtec Il- Portugall:
Zyrtec, Virlix Slovenia:
Zyrtec, Virlix Slovenja:
Zyrtec1 mg/ ml peroralna raztopina Spain:
Zyrtec1 mg/ ml peroralna raztopina Spanja:
Alerlisin, Virlix, Reactine 5mg/ 5ml solución oral, Zyrtec solución oral Sweden:
Alerlisin, Virlix, Reactine 5mg/ 5ml solución oral, Zyrtec solución oral L- Isvezja:
Zyrlex United Kingdom:
Zyrlex Ir- Renju Unit:
London, 6 October 2008 Doc.
Londra, 6 ta ’ Ottubru 2008 Dok.
EMEA/ CHMP/ 541853/ 2008
EMEA/ CHMP/ 541630/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Zyrtec and associated names
OPINJONI WARA REFERENZA SKONT L- ARTIKOLU 30 GĦAL Zyrtec u ismijiet assoċjati
International Non-Proprietary Name (INN): cetirizine
Denominazzjoni Komuni Internazzjonali (DKI): cetirizine
Zyrtec and associated names, 10 mg film coated tablets, 10 mg/ ml oral drops, 1 mg/ ml oral solution, is an anti-allergic drug indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and for the relief of chronic idiopathic urticaria.
Zyrtec u ismijiet assoċjati, pilloli ta ’ 10mg miksija b’ rita, 10mg/ ml taqtir orali, 1mg/ ml soluzzjoni orali, huwa mediċina għal kontra l- allerġiji indikat sabiex itaffi s- sintomi nażali u okulari ta ’ rinite allerġika staġjonali jew perenni u dawk tal- urtikarja idjopatika kronika.
On 9 October 2007 the Commission presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Zyrtec and associated names.
Fid- 9 ta ’ Ottubru 2007 il- Kummissjoni ppreżentat referenza lill- EMEA skont l- Artikolu 30 tad - Direttiva 2001/ 83/ KE, kif emendata, sabiex tarmonizza s- Sommarji tal- Karatteristiċi tal- Prodott (SPC) u t- Tikketta u l- Fuljett ta 'Tagħrif (it- tnejn huma awtorizzati fuq livell nazzjonali) għall- prodott mediċinali Zyrtec u ismijiet assoċjati.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Zyrtec and associated names approved across EU Member States, in particular with respect to the indications, the posology, the contra-indications and the special warnings.
Il- bażi għar- referenza kienet li kien hemm diverġenzi fis- Sommarji tal- Karatteristiċi tal- Prodott (SPC) ta ’ Zyrtec u l- ismijiet assoċjati approvati fi ħdan l- Istati Membri ta ’ l- Unjoni Ewropea, b’ mod partikolari fir- rigward tal- indikazzjonijiet, il- pożoloġija, il- kontraindikazzjonijiet u t- twissijiet speċjali.
This medicinal product belongs to the 2007 list of products identified for SPC harmonisation.
Il- prodott mediċinali jagħmel parti mil- lista ta ’ prodotti tal- 2007 li huma identifikati għall - armonizzazzjoni tal- SPC.
The procedure started on 18 October 2007.
Il- proċedura bdiet fit- 18 ta ’ Ottubru 2007.
The Marketing Authorisation Holder provided supplementary information on 28 January 2008.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ipprovda tagħrif supplimentari fit- 28 ta ’ Jannar 2008.
During its May 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Waqt il- laqgħa tiegħu f’ Mejju 2008, is- CHMP, fid- dawl tat- tagħrif globali sottomess u d- diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- opinjoni li l- proposta għall- armonizzazzjoni ta ’ l- SPC, it - Tikketta u l- Fuljett ta ’ Tagħrif kienet aċċettabbli u li dawn għandhom jiġu emendati.
The CHMP gave a positive opinion on 30 May 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Zyrtec and associated names.
Fit- 30 ta ’ Mejju 2008, is- CHMP ta opinjoni pożittiva fejn irrakkomanda l- armonizzazzjoni tal- SPC, it - Tikketta u l- Fuljett ta ’ Tagħrif għal Zyrtec u ismijiet assoċjati.
The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Il- konklużjonijiet xjentifiċi huma pprovduti fl- Anness II flimkien mal- SPC, it- Tikketta u l- Fuljett ta 'Tagħrif emendati f' Anness III.
A Decision was issued by the European Commission on 6 October 2008.
Id- Deċiżjoni nħarġet mill- Kummissjoni Ewropea fis- 6 ta ’ Ottubru 2008.
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 DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - KUMMERĊ
1/ 12 Member State Applicant
1/ 12 Stat Membru
or
Applikant jew Detentur ta ’ l - Isem inventat Awtorizzazzjoni għat- Tqegħid tal- prodott fis- Suq
Pharmaceutical Strength
Għamla farmaċewtika
Animal
Qawwa
Authorisation Holder
Speċi ta ’ annimal
invented name form
Frekwenza u mnejn jingħata
of administration
Doża rakkomandata
Per 2 ml dose:
Għal kull doża ta ’ Frat 2 ml:
50 ELISA units, inducing ≥ 4.6 log2 VN units
50 unitajiet
Intramuscular injection.
Injezzjoni għal ġol - muskoli.
One dose = 2 ml
Doża waħda = 2 ml
As above
l- istess bħal fuq
As above
l- istess bħal fuq l- istess bħal fuq
As above As above As above As above
l- istess bħal fuq l- istess bħal fuq
As above
l- istess l- istess bħal fuq bħal fuq
Medivet Suppliers Ltd 87c Aglandjias Avenue PO Box 20932 CY-1665 Nicosia Cyprus Tel: +357 223 366 05 Fax: +357 223 366 07
Medivet Suppliers Ltd 87c Aglandjias Avenue PO Box 20932 CY- 1665 Nicosia Cyprus Tel: +357 223 366 05 Fax: +357 223 366 07
2/ 12 Member State Applicant
2/ 12 Stat Membru
Zlicin Business Centre Na Radosti 413 CZ-155 21 Prague 5 Czech Republic Tel: +420 (2) 333 440 25 Fax: +420 (2) 333 440 22
Bovilis BVD Zlicin Business Centre Na Radosti 413 CZ- 155 21 Prague 5 Czech Republic Tel: +420 (2) 333 440 25 Fax: +420 (2) 333 440 22
Bovilis BVD
l- istess bħal fuq
As above As above As above As above
l- istess bħal fuq
Intervet Danmark AS PO Box 66 Literbuen 9 DK-2740 Skovlunde Denmark Tel: +45 (44) 546 900 Fax: +45 (44) 531 955
Intervet Danmark AS PO Box 66 Literbuen 9 DK- 2740 Skovlunde Denmark Tel: +45 (44) 546 900 Fax: +45 (44) 531 955
Intervet Baltic States Vasario 16-osios 9-6A LT-Kauna 3000 Lithuania Tel: +370 373 216 60 Fax: +370 372 012 93
Intervet Baltic States Vasario 16- osios 9- 6A LT- Kauna 3000 Lithuania Tel: +370 373 216 60 Fax: +370 372 012 93
Rue Olivier de Serres Angers Technopole BP 17144 FR-49071 Beaucouzé Cedex France Tel: +33 (2) 412 283 83 Fax: +33 (2) 412 283 00
Rue Olivier de Serres Angers Technopole BP 17144 FR- 49071 Beaucouzé Cedex France Tel: +33 (2) 412 283 83 Fax: +33 (2) 412 283 00
3/ 12
3/ 12 Stat Membru
Member State Applicant
Applikant jew Detentur ta ’ l - Isem inventat Awtorizzazzjoni għat- Tqegħid tal- prodott fis- Suq
Frequency and route Recommended
Speċi ta ’ annimal
Authorisation Holder
Frekwenza u mnejn jingħata
invented name form
Doża rakkomandata
of administration
Il- Ġermanja
Intervet Deutschland GmbH Feldstrasse 1a DE-85716 Unterschleissheim Germany Tel: +49 (89) 310 062 59 Fax: +49 (89) 310 03 27
Intervet Deutschland GmbH Feldstrasse 1a DE- 85716 Unterschleissheim Germany Tel: +49 (89) 310 062 59 Fax: +49 (89) 310 03 27
3, Paparigopoulou Street GR-152 32 Halandri Athens Greece Tel: +30 (210) 689 0411 Fax: +30 (210) 683 2523
3, Paparigopoulou Street GR- 152 32 Halandri Athens Greece Tel: +30 (210) 689 0411 Fax: +30 (210) 683 2523
7. e.13 Hungary Tel: +36 (1) 456 3090 Fax: +36 (1) 456 3099
7. e. 13 Hungary Tel: +36 (1) 456 3090 Fax: +36 (1) 456 3099
Magna Drive Magna Business Park Citywest Road IR-Dublin 24 Ireland Tel: +353 (1) 463 7330 Fax: +353 (1) 451 1906
Magna Drive Magna Business Park Citywest Road IR- Dublin 24 Ireland Tel: +353 (1) 463 7330 Fax: +353 (1) 451 1906
4/ 12
4/ 12 Stat Membru
species
L- Italja
Tobagi 7 IT-20068 Peschiera Borromeo – Milano Italy Tel: +39 (02) 516 861 Fax: +39 (02) 516 866 87
Tobagi 7 IT- 20068 Peschiera Borromeo – Milano Italy Tel: +39 (02) 516 861 Fax: +39 (02) 516 866 87
5/ 12
5/ 12 Stat Membru
species
L- Olanda
Wim de Korverstraat 35 NL-5831 AN Boxmeer The Netherlands Tel: + 31 485 587 652 Fax: + 31 485 587 653
Bovilis BVD Wim de Korverstraat 35 NL- 5831 AN Boxmeer The Netherlands Tel: + 31 485 587 652 Fax: + 31 485 587 653
Wybrzeze Gdynskie 6c PL-01-531 Warszawa Poland Tel: +48 (22) 620 1147 Fax: +48 (22) 620 2935
Wybrzeze Gdynskie 6c PL- 01- 531 Warszawa Poland Tel: +48 (22) 620 1147 Fax: +48 (22) 620 2935
Estrada Nacional 249, Km 14,2 PT-2725-397 Mem Martins Codes Portugal Tel: +351 (21) 922 83 00 Fax: +351 (21) 920 22 31
Estrada Nacional 249, Km 14, 2 PT- 2725- 397 Mem Martins Codes Portugal Tel: +351 (21) 922 83 00 Fax: +351 (21) 920 22 31
Palarikova 16 SK-040 01 Kosice Slovak Republic Tel: +421 (55) 676 9405 Fax: +421 (55) 676 9873
Palarikova 16 SK- 040 01 Kosice Slovak Republic Tel: +421 (55) 676 9405 Fax: +421 (55) 676 9873
6/ 12
6/ 12 Stat Membru
Intervet International Podruznica Krizna 10 SI-1000 Ljubljana Slovenija Tel: +386 (15) 417 567 Fax: +386 (15) 233 567
Intervet International Bovilis BVD Podruznica Krizna 10 SI- 1000 Ljubljana Slovenija Tel: +386 (15) 417 567 Fax: +386 (15) 233 567
Poligono Industrial “ El Montalva” Apartado 3006 ES-37080 Salamanca Spain Tel: +34 (923) 190 345 Fax: +34 (923) 190 347
Poligono Industrial “ El Montalva ” Apartado 3006 ES- 37080 Salamanca Spain Tel: +34 (923) 190 345 Fax: +34 (923) 190 347
UK
Ir- Renju Unit
Walton Manor Walton Milton Keynes Buckinghamshire MK7 7AJ UK Tel: +44 (1908) 665 050 Fax: +44 (1908) 664 778
Walton Manor Walton Milton Keynes Buckinghamshire MK7 7AJ UK Tel: +44 (1908) 665 050 Fax: +44 (1908) 664 778
ANNEX II
l- istess bħal fuq
7/ 12
7/ 12 ANNESS II
8/ 12 SCIENTIFIC CONCLUSIONS
8/ 12 KONKLUŻJONIJIET XJENTIFIĊI
Introduction and background
Introduzzjoni u sfond
Bovilis BVD was first authorised in Germany on 6 May 1998 (as Bovilis BVD-MD).
Bovilis BVD kien awtorizzat għall- ewwel darba fil- Ġermanja fis- 6 ta ’ Mejju 1998 (bħala Bovilis BVD- MD).
The initial mutual recognition procedure was finalised on 24 June 1999, and 11 other Member States authorised the product at this time.
Il- proċedura inizjali ta ’ għarfien reċiproku ntemmet fl- 24 ta ’ Ġunju 1999, u 11- il Stat Membru ieħor awtorizzaw il- prodott f’ dan iż- żmien.
The first renewal procedure for the vaccine was finalised in June 2004.
L- ewwel proċedura ta ’ tiġdid għall- vaċċin ġiet finalizzata f’ Ġunju ta ’ l- 2004.
In March 2006 Intervet then submitted an application for a marketing authorisation for this vaccine following a repeat use mutual recognition procedure, with Germany acting as Reference Member State, for Denmark, Poland, Slovakia and Slovenia.
F’ Marzu ta ’ l- 2006, Intervet issottomettew applikazzjoni għall- awtorizzazzjoni għat- tqegħid fis- suq ta ’ din it- tilqima wara proċedura ta ’ rikonoxximent reċiproku għal użu ripetut, bil- Ġermanja taġixxi bħala Stat Membru ta ’ Referenza, għad- Danimarka, għall- Polonja, għas- Slovakja u għas- Slovenja.
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 għaliha.
The procedure started on 13 March 2006.
Il - proċedura bdiet fit- 13 ta ’ Marzu 2006.
At day 90 of the MRP, 2 August 2006, Denmark could not agree to the granting of a marketing authorization as they considered the product to present a potential serious risk for animal health.
Fid- disgħin jum tal- MRP, fit- 2 ta ’ Awwissu 2006, id- Danimarka ma setgħetx taqbel ma ’ l- għoti ta ’ awtorizzazzjoni għat- tqegħid fis- suq għax ħassetw li l- prodott kien 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), for a 60 day procedure in accordance with Article 33(1) of Directive 2001/ 82/ EC, as amended.
Il- materja ġiet riferuta lill- Grupp ta ’ Ko- ordinazzjoni għar- Rikonoxximent Reċiproku u l- Proċeduri Deċentralizzati, is- CMD( v), għal perjodu ta ’ 60 jum skond l- Artikolu 33( 1) tad- Direttiva 2001/ 82/ KE, kif emendata.
This procedure started on 21 August 2006 and ended on 20 October 2006.
Din il- proċedura bdiet fil- 21 ta ’ Awwissu 2006 u ntemmet fl - 20 ta ’ Ottubru 2006.
The CMD(v) could not reach an agreement by day 60 of this procedure, as to where Denmark maintained their concerns.
Is- CMD( v) ma setax jasal għal ftehim sas- sittin jum ta ’ din il- proċedura, billi d - Danimarka sostniet it- tħassib tagħha.
Consequently Germany notified the EMEA, on 31 October 2006, that the CMD(v) failed to reach an agreement regarding Bovilis BVD.
Konsegwentament il- Ġermanja għarrfet lill- EMEA, fil- 31 ta ’ Ottubru 2006, li s- CMD( v) naqas milli jilħaq ftehim dwar Bovilis BVD.
Pursuant to Article 33(4) of Council Directive 2001/ 82/ EC, as amended, the matter has been referred to CVMP.
Kif preskritt fl- Artikolu 33( 4) tad- Direttiva tal- Kunsill 2001/ 82/ KE, kif emendata, il- materja ġiet riferuta lis- CVPM.
Denmark considers that the proposed testing regime to demonstrate freedom from extraneous agents is insufficient to ensure that Bovilis BVD would not interfere with their national eradication campaigns for certain animal diseases and that therefore the benefit: risk assessment for Bovilis BVD is negative and authorisation of the product would represent a potential serious risk to animal health.
Id- Danimarka tqis li l- metodu propost għall- ittestjar biex juri l- ħelsien minn aġenti barranin ma jistax jiżgura li Bovilis BVD m’ hiex se tinterferixxi mal- kampanji nazzjonali tagħhom għall- eradikazzjoni ta ’ ċerti mardiet ta ’ l- annimali u li għalhekk, il- valutazzjoni tar- relazzjoni bejn il- benefiċċju u r- riskju għal Bovilis BVD hi waħda negattiva u li l- awtorizzazzjoni tal- prodott tirrappreżenta riskju potenzjali serju għas- saħħa ta ’ l- annimali.
During its meeting of November 2006, the CVMP started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC as amended for Bovilis BVD.
Matul il- laqgħa tiegħu ta ’ Novembru ta ’ l- 2006, is- CVMP beda proċedura ta ’ riferiment skond l - Artikolu 33( 4) tad- Direttiva 2001/ 82/ KE kif emendata għal Bovilis BVD.
The Marketing Authorisation Holder should provide all supporting data to justify a positive benefit-risk ratio for the treated animal.
Id- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jipprovdi d- dejta ta ’ sostenn kollha relevanti biex jiġġustifika li l- benefiċċji jegħlbu r- riskji għall- annimal trattat.
Discussion
Diskussjoni
The benefits of Bovilis BVD vaccine are accepted.
Il- benefiċċji ta ’ Bovilis BVD huma aċċettati.
The risk of accidental contamination with FMDV, IBRV, BLV and BTV is concluded to be low; consequently the risk of seroconversion against the listed agents is also concluded to be low.
Ir- riskji ta ’ kontaminazzjoni aċċidentali b’ FMDV, IBRV, BLV u BTV huma baxxi; konsegwentament ir- riskju tas- serokonverżjoni kontra s- sustanzi elenkati huwa meqjus baxx ukoll.
Although the consequences of an accidental seroconversion against the listed extraneous agents would damage the animal health status of a country free from the four specified diseases, the benefit: risk evaluation remains positive due to the low risk of contamination of the product.
Għalkemm il- konsegwenzi ta ’ serokonverżjoni aċċidentali kontra l- aġenti barranin elenkati kienu jagħmlu ħsara għall- istat tas- saħħa ta ’ l- annimal f’ pajjiż ħieles mill- erba ’ mardiet speċifikati, l - evalwazzjoni tal- benefiċċju: riskju tibqa ’ pożittiva minħabba r- riskju baxx tal- kontaminazzjoni tal - prodott.
It is worthy of note that the first EU marketing authorisation for Bovilis BVD was granted in 1998, and the vaccine is currently authorised in 14 EU Member States.
Ta ’ min isemmi li l- ewwel awtorizzazzjoni għat- tqegħid fis- suq ta ’ l- UE għal Bovilis BVD ingħatat fl - 1998, u t- tilqima bħalissa hija awtorizzata f’ 14- il Stat Membru ta ’ l- UE.
There are many years of experience with the use of this vaccine, and there are no known adverse reactions associated with the vaccine.
Hemm ħafna snin ta ’ esperjenza fl- użu ta ’ din it- tilqima, u ma huma magħrufa l- ebda reazzjonijiet ħżiena assoċjati mat - tilqima.
There is always a small risk of extraneous agent contamination from a variety of sources.
Dejjem jibqa ’ riskju żgħir ta ’ kontaminazzjoni minn sustanza barranija minn varjetà ta ’ sorsi.
The factors which determine the safety of a product are the measures applied in the production and control procedures.
Il- fatturi li jiddeterminaw is- sigurtà tal- prodott huma l- miżuri applikati fil- proċeduri tal- produzzjoni u l - kontroll.
With regard to the potential benefit or otherwise from conducting additional tests, it is known that the efficiency of final batch testing in revealing defects is highly variable, depending on the type of defect, and that it is preferable to build quality into the whole process rather than rely on end product testing.
Dwar l- eżistenza jew le ta ’ benefiċċju potenzjali mill- eżekuzzjoni ta ’ testijiet addizzjonali, hu magħruf li l- effiċjenza tal- provi finali tal- grupp fil- wiri ta ’ difetti tvarja ħafna, skond it- tip ta ’ difett, u
No scientific arguments are available concerning how the additional testing would minimise the risk of possible seroconversion induced by the vaccine.
9/ 12 li jkun aħjar li tiġi żviluppata l- kwalità fil- proċess kollu hu ppreferut milli li wieħed jibbaża fuq il - provi tal- prodott aħħari.
On the contrary it is known that extremely high numbers of samples must be tested in order to detect a low level of defects.
L- ebda argumenti xjentifiċi magħrufa ma juru kif il- provi addizzjonali jistgħu jnaqqsu r- riskju ta ’ serokonverżjoni possibbli li jirriżulta mill- vaċċin.
Considering all the measures taken, it is very unlikely that any contamination of Bovilis BVD could
Għall- kuntrarju hu magħruf li jridu jsiru provi fuq numru estremament kbir ta ’ kampjuni biex jinstab livell baxx ta ’ difetti.
9/ 12 firstly occur, and secondly that such contamination would eventually lead to seroconversion, even in a small number of vaccinated animals.
Meta jiġu kkunsidrati l- miżuri kollha meħuda, hu improbabbli ħafna li l- ewwelnett isseħħ xi forma ta ’ kontaminazzjoni ta ’ Bovilis BVD u t- tieni li kontaminazzjoni bħal din tista ’ twassal għal serokonverżjoni, anke f’ numru żgħir ta ’ annimali mlaqqma.
The probability that any such contamination would be identified in the test proposed by the Danish Medicines Agency is even smaller.
Il- probabilità li kwalunkwe kontaminazzjoni bħal din tista ’ tiġi identifikata mit- test propost mill- Aġenzija Daniża dwar il - Mediċini hi saħansitra iċken.
The added value of retesting for this feature in inactivated viral vaccines is extremely small.
Il- valur miżjud tal- provi mill- ġdid għal din il- karatteristika f’ vaċċini virali inattivati hi żgħira immens.
Based on the current requirements and the relevant safeguards (e. g., GMP) the CVMP concludes that the Applicant has taken adequate measures to guarantee the quality and safety of Bovilis BVD.
GMP), is- CVMP ikkonkluda li l- Applikant irid ikun ħa l- miżuri adegwati biex jiggarantixxi l- kwalità tas- sigurtà ta ’ Bovilis BVD.
Conclusions and Recommendations
Konklużjonijiet u Rakkomandazzjonijiet
As the likelihood of contamination of Bovilis BVD vaccine, and the subsequent probability of seroconversion by such contaminants is extremely low, the advantage of additional final product testing for extraneous agents (serological method) is considered to be negligible.
Billi l- probabilità ta ’ kontaminazzjoni tat- tilqima ta ’ Bovilis BVD, u l- probabilità sussegwenti ta ’ serokonverżjoni b’ kontaminanti bħal dawn hija estremament baxxa, il- vantaġġ ta ’ provi addizzjonali tal- prodott finali għal aġenti barranin (bil- metodu seroloġiku) huwa kkunsidrat wieħed negleġibbli.
The extra testing (which requires the use of animals) would therefore be a disproportionate measure when balanced against the positive effects which can be obtained for this vaccine.
Il- provi addizzjonali (li jeħtieġu l- użu ta ’ annimali) ikunu għalhekk miżura sproporzjonata meta mqabbla ma ’ l- effetti pożittivi li jistgħu jinkisbu minn din it- tilqima.
Therefore the Danish testing requirement is considered to be unjustified.
Għalhekk il- proposta Daniża għal iktar prova m’ hijiex ikkunsidrata ġustifikata.
Foot and Mouth virus is virtually exotic to Western Europe and Bluetongue, although of a recent change in status, is not ubiquitous or endemic in the majority of the EU, so for these 2 agents the practical risks should be lower.
Il- virus ta ’ l- Ilsien u d- Dwiefer hu virtwalment eżotiku għall- Ewropa tal- Punent u Bluetongue, għalkemm b’ tibdila riċenti fl- istat, mhuwiex mifrux jew endemiku fil- biċċa l- kbira ta ’ l- UE, u allura għal dawn iż- żewġ aġenti r- riskji prattiċi għandhom ikunu iktar baxxi.
BLV and IBRV are more ubiquitous but the measures summarised below have generally been accepted in the majority of member states to be adequate to ensure negligible risk.
BLV u IBRV huma iktar mifruxa iżda l- miżuri mogħtija fil- qosor hawn taħt, fil- biċċa l- kbira ta ’ l- Istati Membri, ġew meqjusa b’ mod ġenerali li huma biżżejjed biex jiżguraw riskju negliġibbli.
1.
B’ mod ġenerali, in- nuqqas ta ’ aġenti barranin fit- tilqimiet jista ’ jiġi żgurat b ’:
Extraneous agents testing of batches of finished product, if required.
1. konformità tal- GMP tas- sistema tal- produzzjoni 2. l- ittestjar tal- materja prima għal aġenti barranin 3. l- ittestjar ta ’ gruppi ta ’ prodotti lesti għal aġenti barranin, jekk dan ikun meħtieġ.
The production and testing of Bovilis BVD vaccine are in accordance with the relevant requirements of Directive 2001/ 82/ EC, the relevant EU guidelines and the relevant monographs of the Ph. Eur.
Il- produzzjoni u l- prova tat- tilqima ta ’ Bovilis BVD huma skond il- ħtiġijiet relevanti tad- Direttiva 2001/ 82/ KE, il- linji gwida relevanti ta ’ l- UE u l- monografi relevanti tal- Ph. Eur.
In conclusion, CVMP is of the opinion that:
Bħala konklużjoni, is- CVMP hu tal- fehma li:
• the production of Bovilis BVD vaccine is in compliance with GMP requirements
• Il- produzzjoni tat- tilqima ta ’ Bovilis BVD hi konformi mal- ħtiġiet tal- GMP
• extraneous agents testing of raw materials are carried out according to the relevant requirements
• L- ittestjar ta ’ materja prima għal aġenti barranin qed isiru skond il- ħtiġiet relevanti
• extraneous agents testing of finished batches of Bovilis BVD for FMDV, BLV, BTV and IBRV is not required in the relevant monographs
• l- ittestjar ta ’ gruppi lesti ta ’ tilqimiet ta ’ Bovilis BVD għall- aġenti barranin FMDV, BLV, BTV u IBRV mhux meqjus meħtieġ skond il- monografi relevanti
Therefore the requested additional specified extraneous testing requirement is scientifically not justified for Bovilis BVD.
Għalhekk it- talba għal provi addizzjonali għal aġenti barranin speċifikati mhijiex xjentifikament ġustifikata għal Bovilis BVD.
CVMP have noted the inconsistencies (with regard to extraneous agents testing) in the Ph. Eur. monographs for inactivated bovine vaccines and have written to the EDQM and asked them to address this.
Is- CVMP innota inkonsistenzi (dwar il- provi għal aġenti barranin) fil- monografi tal- Ph. Eur. għal tilqimiet inattivati fuq annimali bovini u kiteb lil EDQM u talabhom jindirizzaw dawn l- inkonsistenzi.
The CVMP has concluded that the risk/ benefit for Bovilis BVD is favourable.
Is- CVMP ikkonkluda li r- riskju/ benefiċċju għal Bovilis BVD huwa wieħed favorevoli.
10/ 12 ANNEX III
10/ 12 ANNESS III
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE INSERT
KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR, TIKKETTA U L- FULJETT TA ’ TAGĦRIF FIL- PAKKETT
11/ 12 The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
11/ 12 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.
London, June 2008 EMEA/ 532090/ 2007– Rev.1
Londra, Ġunju 2008 EMEA/ 532090/ 2007 – Rev. 1
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
KUMITAT GĦALL- PRODOTTI MEDIĊINALI GĦAL UŻU VETERINARJU (CVMP)
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR BOVILIS BVD/ BOVILIS BVD-MD
OPINJONI WARA REFERENZA SKOND L- ARTIKOLU 33 (4) GĦAL BOVILIS BVD/ BOVILIS BVD- MD
Bovilis BVD/ Bovilis BVD-MD is an inactivated virus vaccine containing the inactivated antigen of cytopathic BVD virus strain C-86.
Bovilis BVD/ Bovilis BVD- MD huwa vaċċin b’ vajrus inattivat li fih l- antiġen inattivat tar- razza tal - vajrus BVD ċitopatiku C- 86.
The product is indicated for the active immunisation of cows and heifers from eight months of age onwards to protect the foetus against transplacental infection with BVDV.
Il- prodott huwa indikat għat- tilqim attiv ta ’ baqar u għoġol li jkollhom tmien xhur u aktar sabiex jipproteġi lill- fetu kontra infezzjoni transplaċentali b’ BVDV.
Bovilis BVD was first authorised in Germany as Bovilis BVD-MD.
Bovilis BVD ġie l- ewwel awtorizzat fil- Ġermanja bħala Bovilis BVD- MD.
The initial mutual recognition procedure was finalised on 24 June 1999 and eleven other Member States authorised the product at this time.
Il- proċedura ta ’ rikonoxximent reċiproku inizjali ġiet iffinalizzata fl- 24 ta ’ Ġunju 1999 u ħdax- il Stat Membru ieħor awtorizzaw il - prodott f’ dan iż- żmien.
The first renewal procedure for the vaccine was finalised in June 2004.
L- ewwel proċedura ta ’ tiġdid għat- tilqima ġiet iffinalizzata f’ Ġunju 2004.
In March 2006 an application for a marketing authorisation for this vaccine was submitted, following a repeat use mutual recognition procedure, with Germany acting as Reference Member State.
F’ Marzu ta ’ l- 2006, ġiet ippreżentata applikazzjoni għall- awtorizzazzjoni għat- tqegħid fis- suq għal dan il- vaċċin, wara proċedura ta ’ rikonoxximent reċiproku ta ’ użu ripetut, bil- Ġermanja tkun l- Istat Membru ta ’ Referenza.
Denmark could not agree with the granting of the marketing authorisation and the matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v) and subsequently the Committee for Medicinal Products for Veterinary Use (CVMP).
Id- Danimirka ma setgħetx taqbel ma ’ l- għoti ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- kwistjoni ġiet riferuta lill- Grupp ta ’ Koordinazzjoni għall- Proċeduri ta ’ Rikonoxximent Reċiproku u ta ’ Proċeduri Deċentralizzati, CMD( v) u sussegwentament lill- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP).
Denmark considered that the proposed testing regime to demonstrate freedom from extraneous agents was insufficient to ensure that Bovilis BVD/ Bovilis BVD-MD would not interfere with their national eradication campaigns for certain animal diseases and that, therefore, the benefit/ risk assessment for Bovilis BVD/ Bovilis BVD-MD was unfavourable, authorisation of the product representing a potential serious risk to animal health.
Id- Danimarka qieset li r- reġim tal- provi proposti sabiex jintwera l- ħelsien minn sustanzi barranin ma kinitx biżżejjed biex tiżgura li Bovilis BVD/ Bovilis BVD- MD ma jinterferixxix mal- kampanji nazzjonali tagħhom ta ’ qerda ta ’ ċertu mard ta ’ l- annimali u li, għalhekk, il- valutazzjoni tal - benefiċċju/ riskju għal Bovilis BVD/ Bovilis BVD- MD kienet waħda mhux favorevoli, l - awtorizzazzjoni tal- prodott tirrappreżenta riskju serju potenzjali għas- saħħa ta ’ l- annimal.
During its meeting of November 2006, the CVMP started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC as amended for Bovilis BVD/ Bovilis BVD-MD.
Fil- laqgħa tiegħu ta ’ Novembru 2006, il- CVMP beda proċedura ta ’ referenza skond l- Artikolu 33( 4) tad- Direttiva 2001/ 82/ KE kif emendata għal Bovilis BVD/ Bovilis BVD- MD.
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 kien mitlub jipprovdi d- dejta kollha ta ’ appoġġ sabiex jiġġustifika proporzjon pożittiv bejn il- benefiċċju u r- riskju għall- annimal ikkurat.
The CVMP considered that in general, the absence of extraneous agents in vaccines can be ensured by:
Is- CVMP ikkunsidra li b’ mod ġenerali, in- nuqqas ta ’ sustanzi barranin fit- tilqim jista ’ jiġi żgurat permezz ta ’:
GMP compliance of the production system 2.
Konformità tas- sistema ta ’ produzzjoni mal- GMP 2.
Extraneous agents testing of raw materials 3.
Provi għal sustanzi barranin fuq materja prima 3.
Extraneous agents testing of batches of finished product, if required.
Provi għal sustanzi barranin fuq lottijiet tal- prodott lest, jekk ikun hemm bżonn.
The CVMP concluded that the production of Bovilis BVD vaccine is in compliance with GMP requirements, that extraneous agent testing of raw materials are carried out according to the relevant requirements and that extraneous agent testing of finished batches of Bovilis BVD for FMDV, BLV, BTV and IBRV is not required in the relevant monographs.
Is- CVMP ikkonkluda li l- produzzjoni tal- vaċċin tal- Bovilis BVD hija konformi mar- rekwiżiti tal - GMP, li l- provi għal sustanza barranija fuq materja prima huma mwettqa skond ir- rekwiżiti relevanti u li l- provi għal sustanza barranija ta ’ lottijiet lesti ta ’ Bovilis BVD għal FMDV, BLV, BTV u IBRV mhijiex meħtieġa fil- monografi relevanti.
Therefore the requested additional specified extraneous testing requirement was not scientifically justified for Bovilis BVD.
Għaldaqstant, ir- rekwiżit mitlub ta ’ provi addizzjonali għal sustanzi barranin speċifikati ma kienx iġġustifikat xjentifikament għal Bovilis BVD.
CVMP have noted the inconsistencies (with regard to extraneous agents testing) in the Ph. Eur. monographs for inactivated bovine vaccines and have written to the EDQM and asked them to address this.
Is- CVMP innota l- inkonsistenzi (fir- rigward tal- provi ta ’ sustanzi barranin) fil- monografi tal- Ph. Eur. għal vaċċini bovini inattivati u kiteb lill- EDQM u talabhom jindirizzaw din il- kwistjoni.
The CVMP concluded that the benefit - risk assessment for Bovilis BVD was favourable.
Il- CVMP ikkonkluda li l- valutazzjoni tal- benefiċċju – riskju għal Bovilis BVD kienet waħda favorevoli.
The CVMP Opinion was adopted on 17 April 2007 and the subsequent Commission Decision on 29 June 2007.
L- Opinjoni tal- CVMP ġiet adottata fis- 17 ta ’ April 2007 u d- Deċiżjoni tal- Kummissjoni sussegwenti ġiet adottata fid- 29 ta ’ Ġunju 2007.
EMEA/ 532090/ 2007-Rev.1
EMEA/ 532090/ 2007- Rev. 1- MT
London, August 2008 EMEA/ 459391/ 2008
Londra, Awwissu 2008 EMEA/ 459391/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
IL- KUMITAT GĦALL- PRODOTTI MEDIĊINALI GĦALL- UŻU VETERINARJU (CVMP)
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR COMPAGEL GEL FOR HORSES
OPINJONI WARA RIFERIMENT SKONT L- ARTIKOLU 33 (4) GĦALL- ĠEL GĦAŻ- ŻWIEMEL COMPAGEL
BACKGROUND INFORMATION
TAGĦRIF TAL- ISFOND
Compagel Gel for Horses contains heparin sodium, levomenthol and hydroxyethyl salicylates.
Il- Ġel għaż- Żwiemel Compagel fih heparin sodium, levomenthol u hydroxyethyl salicylates.
The gel is applied on the skin and its indications are: • Haematoma, tendinitis, tendovaginitis, bursitis, capped hock, saddle sore, sprain, torsion, contusion, bruising, inflammation of the joint capsule (synovitis), muscle rupture, after nerve block anaesthesia, after paravenous injection. • To accelerate the absorption of infiltrates (e. g. postoperative swelling, penile paralysis). • To treat inflammations of superficial veins (e. g. phlebitis, thrombophlebitis, infusion thrombophlebitis).
Il- ġel jiġi applikat fuq il- ġilda u l- indikazzjonijiet tiegħu huma: • Ematoma, tendinite, tendovaġinite, bursite, infjammazzjoni tal- irkoppa (capped hock), uġigħ minħabba s- sarġ (saddle sore), liwi, torsjoni, kontużjoni, tbenġil, infjammazzjoni tal- kapsula tal - ġog (sinovite), tiċrit ta ’ muskoli, sitwazzjonijiet ta ’ wara l- anesteżija bl- imblokk tan- nervituri, sitwazzjonijiet ta ’ wara injezzjonijiet paravenużi. • Biex jaċċelera l- assorbiment ta ’ infiltrati (eż. infiħ postoperattiv, paraliżi tal- pene). • Biex jittratta l- infjammazzjonijiet tal- vini superfiċjali (eż. flebite, tromboflebite, tromboflebite tal - infużjoni).
Compagel Gel for Horses is a generic product.
Il- Ġel għaż- Żwiemel Compagel huwa prodott ġeneriku.
In June 2007 a mutual recognition procedure started with Germany as Reference Member State and 5 Concerned Member States.
F’ Ġunju 2007 nbdiet proċedura ta ’ għarfien reċiproku bil- Ġermanja bħala Stat Membru ta ’ Referenza u 5 Stati Membri Konċernati.
France and Sweden could not agree to the granting of a marketing authorisation as they considered there were potential serious risks to animal health.
Franza u l- Iżvezja ma setgħux jaqblu fuq l- għoti ta ’ awtorizzazzjoni għat- tqegħid fis- suq għax qiesu 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 Proċeduri Deċentralizzati CMD( v) u sussegwentament lis - CVMP.
France and Sweden considered 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 kkunsidraw li minħabba n- nuqqas ta ’ dokumentazzjoni dwar l- effikaċja wieħed ma jistax jassumi li l- prodott huwa effikaċi u li dan, minħabba f’ hekk, jippreżenta riskju potenzjali serju għas- saħħa tal- annimali.
The CVMP started the referral procedure during its meeting of 15-17 January 2008.
Is- CVMP beda l- proċedura ta ’ riferiment waqt il- laqgħa tiegħu ta ’ bejn il- 15 u s- 17 ta ’ Jannar 2008.
The Marketing Authorisation Holder was requested to provide a copy of the dossier and, 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 the reference product that could justify different conclusions on the safety or efficacy for the two products.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq intalab jipprovdi kopja tad- dokumentazzjoni u, fid- dawl tat- tħassib imqajjem minn Franza u l- Iżvezja, biex jindika u jissostanzja fejn meħtieġ xi differenzi li jista ’ jkun hemm bejn il- Ġel għaż- Żwiemel Compagel u l- prodott ta ’ referenza li jistgħu jiġġustifikaw konklużjonijiet differenti dwar is- sigurtà u l- effikaċja taż- żewġ prodotti.
In response to the questions, the applicant submitted the dossier and argued on the basis of a comparison of the compositions that there are no differences between Compagel Gel for Horses and the reference product that could justify different conclusions on the safety and efficacy.
Bi tweġiba għall- mistoqsijiet, l- applikant issottometta d- dokumentazzjoni u argumenta abbażi tat - tqabbil tal- kompożizzjonijiet li ma hemmx differenzi bejn il- Ġel għaż- Żwiemel Compagel u l- prodott ta ’ referenza li jistgħu jiġġustifikaw konklużjonijiet differenti fuq is- sigurtà u l- effikaċja.
Having considered the referral notification and responses of the applicant, the CVMP concluded that all concerned member states in the mutual recognition procedure agreed that Compagel Gel for Horses is essentially similar to Tensolvet 50000.
Wara li qies in- notifika tar- riferiment u t- tweġibiet tal- applikant, is- CVMP ikkonkluda li l- Istati Membri kollha kkonċernati fil- proċedura ta ’ għarfien reċiproku qablu li l- Ġel għaż- Żwiemel Compagel huwa essenzjalment simili għal Tensolvet 50000.