Proteq West Nile

Glavna informacija

  • Trgovački naziv:
  • Proteq West Nile
  • Koristi za:
  • Životinje
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Proteq West Nile
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • Konji
  • Područje terapije:
  • Immunologicals
  • Terapijske indikacije:
  • Aktivna imunizacija konja od pet mjeseci starosti protiv bolesti zapadnog nila smanjenjem broja konjskih virusa. Ako je klinički znakovi su prisutni, njihova trajanja i težini smanjuje.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/V/C/002005
  • Datum autorizacije:
  • 05-08-2011
  • EMEA koda:
  • EMEA/V/C/002005
  • Zadnje ažuriranje:
  • 24-02-2018

Uputu o lijeku

B. UPUTA O VMP

UPUTA O VMP:

Proteq West Nile suspenzija za injekcije za konje

1.

NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I

NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE

PROIZVODNE SERIJE, AKO JE RAZLIČITO

Nositelj odobrenja za stavljanje u promet:

MERIAL,

29, avenue Tony Garnier,

69007 Lyon,

Francuska

Proizvođač odgovoran za puštanje serije u promet:

MERIAL,

Laboratoire Porte des Alpes,

Rue de l'Aviation,

69800 Saint Priest,

Francuska

2.

NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA

Proteq West Nile suspenzija za injekcije za konje

3.

NAVOĐENJE DJELATNE (IH)TVARI I DRUGIH SASTOJAKA

Homogena opalescentna suspenzija za injekciju

Svaka doza od 1 ml sadrži:

Djelatna tvar:

rekombinantni virus zapadnog Nila i boginja kanarinca (vCP2017): ............. 6,0 to 7,8 log10 CCID*

*količina virusa koja zarazi 50 % kulture stanica

Adjuvans:

Karbomer ......................................................................................................................................... 4 mg

4.

INDIKACIJE

Aktivna imunizacija konja starijih od 5 mjeseci protiv groznice zapadnog Nila smanjenjem broja

viremičnih konja. Ako su klinički znakovi prisutni, njihovo trajanje i ozbiljnost se smanjuju.

Početak imuniteta: 4 tjedna nakon prve doze primarnog cijepljenja. Za postizanje potpune zaštite,

moraju se dati dvije doze cjepiva.

Trajanje imuniteta: 1 godina nakon potpunog primarnog cijepljenja s dvije doze.

5.

KONTRAINDIKACIJE

Nema.

6.

NUSPOJAVE

Na mjestu injiciranja može se često pojaviti prolazni otok (promjera najviše 5 cm) koji tijekom 4 dana

nestaje.

U rijetkim slučajevima mogu se javiti bol i lokalna hipertermija.

Može se rijetko javiti malo povišenje tjelesne temperature (najviše 1,5 °C) tijekom jednog do najviše

dva dana nakon cijepljenja.

Apatija koja obično prestaje za dva dana i smanjeni tek mogu se primijetiti rijetko, dan nakon

cijepljenja.

Može se rijetko javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajući simptomatski

tretman.

Učestalost nuspojava je određena sukladno sljedećim pravilima:

vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana)

česte (više od 1 ali manje od 10 životinja na 100 životinja)

manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja)

rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja)

vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).

Ako zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo da se

javite veterinaru.

7.

CILJNE VRSTE ŽIVOTINJA

Konji.

8.

DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUTEVI

PRIMJENE

Primijenite dozu od 1 ml, intramuskularno , najbolje u području vrata, prema sljedećem rasporedu:

Prvo cijepljenje: prva injekcija u dobi 5 mjeseci, druga injekcija 4- 6 tjedana kasnije.

Docjepljivanje: dostatna zaštita bi se trebala postići docjepljivanjem godišnjom poticajnom

injekcijom, od jedne doze iako ovaj raspored nije u potpunosti validiran.

9.

SAVJETI ZA ISPRAVNU PRIMJENU

Prije primjene cjepivo lagano protresite.

10.

KARENCIJA

Nula dana.

11.

POSEBNE MJERE OPREZA ZA ČUVANJE

Čuvati izvan pogleda i dosega djece.

Čuvati i prevoziti rashlađeno (2 C-8 C).

Čuvati od zamrzavanja.

Zaštititi od svjetla.

Primijeniti odmah nakon otvaranja.

Ne primjenjivati ovaj veterinarsko-medicinski proizvod poslije isteka roka valjanosti koji je naznačen

na etiketi nakon EXP.

12.

POSEBNA(A) UPOZORENJA(A)

Posebne mjere opreza za primjenu na životinjama:

Cijepiti samo zdrave životinje.

Cijepljenje može utjecati na postojeća sero-epidemiološka ispitivanja. Međutim, kako IgM odgovor

nakon cijepljenja nije čest, pozitivan rezultat IgM-ELISA testa je čvrst indikator prirodne infekcije

virusom zapadnog Nila. Ako je sumnja na infekciju rezultat pozitivnog IgM odgovora, potrebno je

provesti dodatno ispitivanje kako bi se ustanovilo je li životinja zaražena ili je cijepljena.

Posebna upozorenja za svaku od ciljnih vrsta životinja:

Neškodljivost cjepiva bila je dokazana na ždrebadi starijoj od 5 mjeseci. Međutim, cjepivo se također

pokazalo neškodljivim u terenskom ispitivanju na životinjama starim 2 mjeseca.

Graviditet i laktacija:

Ovo cjepivo se može primijeniti tijekom graviditeta i dojenja.

Predoziranje (simptomi, hitni postupci, antidoti):

Nakon primjene više od 10 doza cjepiva nisu primijećeni nikakvi neželjeni učinci osim onih već

spomenutih u odjeljku "Nuspojave".

Inkompatibilnosti:

Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom.

Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija:

Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kada se primjenjuje s bilo

kojim drugim veterinarsko-medicinskim proizvodom. Stoga se odluka o primjeni ovog cjepiva prije,

odnosno poslije primjene bilo kojeg drugog veterinarsko-medicinskog proizvoda mora donositi od

slučaja do slučaja.

Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na

životinjama:

U slučaju nehotičnog samoinjiciranja, odmah potražite pomoć liječnika i pokažite mu uputu o VMP ili

etiketu.

Proizvodnja, uvoz, prodaja, posjedovanje, opskrba i/ili primjena Proteq West Nile može biti

zabranjena u državi članici na cijelom teritoriju ili na jednom njegovom dijelu sukladno nacionalnim

propisima. Tko namjerava proizvesti, uvesti, posjedovati, prodavati, opskrbljivati i primjenjivati

Proteq West Nile mora konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi

o cijepljenju prije proizvodnje, uvoza, posjedovanja, prodaje, opskrbe i/ili primjene.

13.

POSEBNE MJERE OPREZA ZA ODLAGANJE NEUPOTREBLJENOG PROIZVODA

ILI OTPADNIH MATERIJALA, AKO IH IMA

Odlagati otpadne materijale uranjanjem u kipuću vodu, spaljivati, uranjati u prikladno dezinfekcijsko

sredstvo odobreno za upotrebu od strane nadležnog tijela.

14.

DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA

Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici

Europske agencije za lijekove http://www.ema.europa.eu/

15.

OSTALE INFORMACIJE

Za stimulaciju aktivnog imuniteta protiv virusa zapadnog Nila.

Cjepni soj vCP2017 je rekombinant s virusom boginja kanarinca koji izražava M/E gene virusa

zapadnog Nila. Nakon inokulacije virus se u konju ne množi, ali izražava zaštitne proteine. Posljedica

toga je da ti proteini induciraju zaštitni imunitet protiv virusa zapadnog Nila.

Kutija s 1, 2, 5 ili 10 bočica sa po jednom dozom.

Ne moraju sve veličine pakovanja biti u prometu.

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

J&J Snack Foods Handheld Corp. of Holly Ridge, NC is voluntarily recalling two lots of Fit & Active Southwest Veggie Stuffed Sandwiches due to potential contamination with Listeria monocytogenes and Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA - U.S. Food and Drug Administration

19-10-2018

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling six of its meat and potato products across its eight-state region due to possible contamination with Salmonella and Listeria monocytogenes. The potential for contamination was discovered after Hy-Vee’s supplier, McCain Foods, announced it was recalling its caramelized mushrooms and fire-roasted tomatoes, which are ingredients that are used in six Hy-Vee products. To date, no illnesses have been reported in connection with these prod...

FDA - U.S. Food and Drug Administration

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Garderie Dépôt recalls Dream on Me Portable Cribs

Garderie Dépôt recalls Dream on Me Portable Cribs

The distance between the top surface of the lowest fixed side and the top surface of the mattress support is lower than what is required by law, posing a fall hazard.

Health Canada

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

6-8-2018

August 3, 2018: Northwest ENT Associates, P.C. to Pay Approximately $1.2 Million to Resolve False Claims Act Allegations

August 3, 2018: Northwest ENT Associates, P.C. to Pay Approximately $1.2 Million to Resolve False Claims Act Allegations

August 3, 2018: Northwest ENT Associates, P.C. to Pay Approximately $1.2 Million to Resolve False Claims Act Allegations

FDA - U.S. Food and Drug Administration

18-7-2018

Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses

Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses

WEST DES MOINES, Iowa (July 17, 2018) — Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its Hy-Vee Spring Pasta Salad due to the potential that it may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention last night when approximately 20 illnesses in Minnesota, South Dakota, Nebraska and Iowa were potentially linked back to customers consuming the salad. The voluntary recall includes Hy-Vee Spring Pasta Salads in both 1 pound (16 oz.) an...

FDA - U.S. Food and Drug Administration

1-7-2018

Allergy Alert Issued in Midwest Whole Foods Market Stores for Undeclared Soy in Oatmeal Raisin Cookies

Allergy Alert Issued in Midwest Whole Foods Market Stores for Undeclared Soy in Oatmeal Raisin Cookies

Whole Foods Market is voluntarily recalling Whole Foods Market brand oatmeal raisin cookies from stores in eight states because the products contained soy flour that was not listed on the product label. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

30-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo

Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo

FDA committed to helping the people of the Democratic Republic of Congo effectively confront and end the current Ebola virus outbreak

FDA - U.S. Food and Drug Administration

30-5-2018

Procleix West Nile Virus (WNV) Assay

Procleix West Nile Virus (WNV) Assay

Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.

FDA - U.S. Food and Drug Administration

23-5-2018

FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir (Juluca, Tivicay, Triumeq) used to treat human immunodeficiency virus (HIV).

FDA - U.S. Food and Drug Administration

19-4-2018

NxtGen Botanicals Maeng Da Kratom by NGB Corp.: Recall - Possible Salmonella Contamination

NxtGen Botanicals Maeng Da Kratom by NGB Corp.: Recall - Possible Salmonella Contamination

NGB Corp. of West Jordan, Utah is voluntarily recalling NxtGen Botanicals Maeng Da Kratom labeled bottles of encapsulated product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infec...

FDA - U.S. Food and Drug Administration

16-9-2015

2nd generation contraceptive pills associated with the lowest risk of blood clots

2nd generation contraceptive pills associated with the lowest risk of blood clots

The Danish Health and Medicines Authority still encourages women to use 2nd generation contraceptive pills instead of 3rd and 4th generation contraceptive pills.

Danish Medicines Agency

22-10-2018

EU/3/01/075 (Eisai GmbH)

EU/3/01/075 (Eisai GmbH)

EU/3/01/075 (Active substance: Denileukin diftitox) - Transfer of orphan designation - Commission Decision (2018)6991 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/038/01/T/02

Europe -DG Health and Food Safety

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

3-8-2018

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (Active substance: Adenovirus associated viral vector serotype 2/8 containing the human CNGA3 gene) - Orphan designation - Commission Decision (2018)5274 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/18

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

11-7-2018

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Active substance: Live gE- tk- double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL) - Centralised - Yearly update - Commission Decision (2018)4520 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Active substance: Inactivated porcine parvovirus, strain NADL-2 / Inactivated Erysipelothrix rhusiopathiae, strain R32E11) - Centralised - Yearly update - Commission Decision (2018) 4354 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

29-6-2018

Porcilis PCV M Hyo (Intervet International B.V.)

Porcilis PCV M Hyo (Intervet International B.V.)

Porcilis PCV M Hyo (Active substance: Porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)) - Centralised - 2-Monthly update - Commission Decision (2018)4166 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/3796/II/7

Europe -DG Health and Food Safety

19-6-2018

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Active substance: purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir, SAT2 Saudi Arabia) - Centralised - Renewal - Commission Decision (2018)3891 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2292/R/8

Europe -DG Health and Food Safety

1-6-2018

BTVPUR AlSap 2-4 (Merial)

BTVPUR AlSap 2-4 (Merial)

BTVPUR AlSap 2-4 (Active substance: Bluetongue Virus Serotype 2 antigen - Bluetongue Virus Serotype 4 antigen) - Withdrawal (sunset clause) - No Commission Decision

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2027 (Regeneron Ireland U.C.)

EU/3/18/2027 (Regeneron Ireland U.C.)

EU/3/18/2027 (Active substance: Three human monoclonal antibodies against the Ebola virus glycoprotein) - Orphan designation - Commission Decision (2018)3395 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/008/18

Europe -DG Health and Food Safety

16-5-2018

BTVPUR AlSap 8 (Merial)

BTVPUR AlSap 8 (Merial)

BTVPUR AlSap 8 (Active substance: Bluetongue virus Serotype 8 Antigen) - Centralised - Withdrawal - Commission Decision (2018)3018 of Wed, 16 May 2018

Europe -DG Health and Food Safety

16-5-2018

BTVPUR AlSap 1 (Merial)

BTVPUR AlSap 1 (Merial)

BTVPUR AlSap 1 (Active substance: Bluetongue Virus Serotype 1 antigen) - Centralised - Withdrawal - Commission Decision (2018)3017 of Wed, 16 May 2018

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (Active substance: Genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII) - Orphan designation - Commission Decision (2018)2408 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/17

Europe -DG Health and Food Safety

9-2-2018

Suvaxyn Circo (Zoetis Belgium S.A.)

Suvaxyn Circo (Zoetis Belgium S.A.)

Suvaxyn Circo (Active substance: Porcine circovirus vaccine (inactivated, recombinant)) - New authorisation - Commission Decision (2018)861 of Fri, 09 Feb 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4242

Europe -DG Health and Food Safety