508 results
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National expert: Ivana Golabova, State Institute for Drug Control (updated)
- Declaration of interests - 39.19 KB | PDF
- Curriculum Vitae - 22.91 KB | PDF
Ivana Golabova … Ivana Golabova … Vitae Personal information Ivana Golabova Work experience … -
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Referral: Diclofenac Sodium Spray Gel 4%
diclofenac sodium, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 18/01/2019, Last updated: 14/02/2019Diclofenac Sodium Spray Gel 4 … review of Diclofenac Sodium Spray Gel 4% following a disagreement … What is Diclofenac Sodium Spray Gel 4%? Diclofenac Sodium Spray Gel 4% contains the active … -
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Referral: Fibrinogen-containing solutions for sealant authorised for administration by spray application
fibrin, associated names: Quixil, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/11/2012, EC decision date: 13/02/2013, Last updated: 02/04/2013authorised for administration by spray application … Evicel and Quixil given by spray application, following cases … these medicines given by spray application continue to outweigh … -
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Referral: Fibrinogen-containing solutions for sealant authorised for administration by spray application
fibrin, associated names: Tisseel, Tissucol, Artiss, Beriplast P, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2012, EC decision date: 15/03/2013, Last updated: 02/04/2013authorised for administration by spray application … these medicines are given by spray application. The Agency's … when they are applied as a spray during surgery. What are … -
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Press release: CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections
CMDh, Last updated: 01/04/2016authorisations for fusafungine sprays used to treat airway infectio … authorisations for fusafungine sprays in the EU. This follows a … anti-inflammatory nose and mouth spray used to treat upper airway … -
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Press release: PRAC recommends that fusafungine nose and mouth sprays are no longer marketed
PRAC, Last updated: 12/02/2016fusafungine nose and mouth sprays are no longer marketed … anti-inflammatory nose and mouth spray used to treat upper airway … fusafungine nose and mouth sprays are no longer marketed Committee … -
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Press release: European Medicines Agency recommends new advice on safer use of fibrin sealant spray applications
Last updated: 14/12/2012safer use of fibrin sealant spray applications … risk of gas embolism during spray application … safer use of fibrin sealant spray applications Updated advice … -
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Human medicine European public assessment report (EPAR): Instanyl
Fentanyl citrate, Pain; Cancer
Date of authorisation: 20/07/2009, Revision: 35, Authorised, Last updated: 17/01/2023Instanyl is available as a nasal spray (50, 100 and 200 micrograms … Instanyl is 50 micrograms (one spray of the lowest strength) in … Instanyl is 50 micrograms (one spray of the lowest strength) in … -
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Human medicine European public assessment report (EPAR): Fortacin
lidocaine, prilocaine, Sexual Dysfunction, Physiological
Date of authorisation: 15/11/2013, Revision: 11, Authorised, Last updated: 20/09/2022prescription and is available as a spray-on solution that supplies 7.5 … 2.5 mg of prilocaine per spray. The recommended dose is 3 sprays onto the head (glans) of … medicine with a placebo (dummy) spray over 12 weeks. The main measures … -
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Veterinary medicine European public assessment report (EPAR): Nobilis IB Primo QX
live avian infectious bronchitis virus, strain D388, Chicken
Date of authorisation: 04/09/2014, Revision: 5, Authorised, Last updated: 26/04/20211 day of age or older by spraying onto the chickens or by applying … chickens bred for meat) were spray vaccinated with both Nobilis … 42 broiler chickens were spray vaccinated at 1 day old and … -
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Human medicine European public assessment report (EPAR): Avamys
fluticasone furoate, Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial
Date of authorisation: 11/01/2008, Revision: 22, Authorised, Last updated: 29/03/2022Avamys? Avamys is a nasal spray that contains the active … 12 years and over is two sprays in each nostril once a day … This can be reduced to one spray in each nostril once symptoms … -
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Human medicine European public assessment report (EPAR): Evicel (updated)
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 05/10/2008, Revision: 18, Authorised, Last updated: 11/05/2023Evicel is then dripped or sprayed on the surface of the wound … when Evicel was applied as spray. For the full list of all … must not be applied as a spray. Evicel must also not be used … -
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Veterinary medicine European public assessment report (EPAR): Hydrocortisone aceponate Ecuphar (previously Cortacare)
hydrocortisone aceponate, Dogs
Date of authorisation: 27/08/2018, Revision: 3, Authorised, Last updated: 04/01/2022Ecuphar is available as a spray and can only be obtained … is needed. The medicine is sprayed on the affected area, avoiding … The pump delivers in two sprays enough medicine to treat … -
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Veterinary medicine European public assessment report (EPAR): Nobilis IB 4-91
live attenuated avian infectious bronchitis virus variant strain 4-91, Chicken
Date of authorisation: 09/06/1998, Revision: 15, Authorised, Last updated: 26/04/2021older chickens by coarse spray or by intranasal (breathed … ocular route or coarse spray. The vaccine can be administered … vaccine was given by coarse spray to chicken of various ages … -
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Veterinary medicine European public assessment report (EPAR): Poulvac E. coli
Live aroA gene deleted Escherichia coli, type 078, strain EC34195, Chicken; Turkeys
Date of authorisation: 15/06/2012, Revision: 10, Authorised, Last updated: 11/02/2022as a single dose either by spray application from one day … In turkeys it is given by spray application from one day … weeks later. When given by spray application, the reconstituted … -
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Human medicine European public assessment report (EPAR): PecFent
fentanyl, Pain; Cancer
Date of authorisation: 31/08/2010, Revision: 23, Authorised, Last updated: 08/11/2022mouth, PecFent is given as a spray into the nose. PecFent contains … PecFent is available as a nasal spray (100 and 400 micrograms per spray) and can only be obtained … always be 100 micrograms (one spray into one nostril). The patient … -
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Veterinary medicine European public assessment report (EPAR): Nasym
live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56, Cattle
Date of authorisation: 29/07/2019, Revision: 3, Authorised, Last updated: 10/02/2021solvent to make either a nasal spray or an injection. For cattle … days of age, the vaccine is sprayed into each of the animal’s … Nasym, either using the nasal spray route or injection into the … -
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Human medicine European public assessment report (EPAR): Nyxoid
Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 09/11/2017, Revision: 8, Authorised, Last updated: 24/02/2023injection, Nyxoid is given as a spray into the nose. How is Nyxoid … Nyxoid used? Nyxoid is a nasal spray available in single-dose … The recommended dose is one spray into one nostril given immediately … -
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Human medicine European public assessment report (EPAR): Fluenz Tetra
A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444, Influenza, Human
Date of authorisation: 04/12/2013, Revision: 23, Authorised, Last updated: 09/02/2023Tetra is available as a nasal spray. The recommended dose is one … recommended dose is one nasal spray (0.1 ml) per nostril. Children … vaccine is given by nasal spray and not by injection and … -
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Veterinary medicine European public assessment report (EPAR): Cortavance
hydrocortisone aceponate, Dogs
Date of authorisation: 09/01/2007, Revision: 9, Authorised, Last updated: 24/09/2021is needed. The medicine is sprayed on the affected area, avoiding … The pump delivers in two sprays enough medicine to treat … needed. The medicine is sprayed on the affected area, avoiding … -
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Human medicine European public assessment report (EPAR): Spravato
esketamine hydrochloride, Depressive Disorder
Date of authorisation: 18/12/2019,
, Revision: 7, Authorised, Last updated: 01/03/2023
Spravato is available as a nasal spray to be used by the patient … starting dose is one or two sprays in each nostril (depending … is followed by 1, 2 or 3 sprays in each nostril twice a week … -
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Veterinary medicine European public assessment report (EPAR): Evalon
vaccine against coccidiosis in chickens, Chicken
Date of authorisation: 18/04/2016, Revision: 2, Authorised, Last updated: 26/02/2021one-day-old chicks by coarse spray vaccination. The vaccine … to dosing instructions and sprayed onto the birds so that each … one-day-old chicks by coarse spray vaccination. The vaccine … -
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Summary of opinion: Bovilis Nasalgen-C
bovine coronavirus, strain CA25, live, opinion date: 15/02/2023, Positive, Last updated: 17/02/2023Bovilis Nasalgen-C, nasal spray, lyophilisate and solvent … Bovilis Nasalgen-C, nasal spray, lyophilisate and solvent … -
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Summary of opinion: Neoleish
bacterial DNA plasmid containing LACK gene from Leishmania infantum, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022medicinal product Neoleish, nasal spray, solution, for dogs. The applicant … product Neoleish, nasal spray, solution, for dogs. The applicant … -
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Referral: Flurbiprofen Geiser
flurbiprofen, associated names: Flurbiprofen Sejmet, Mentocaína Spray, Flurbiprofeno Geiser, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 17/10/2019, EC decision date: 16/12/2019, Last updated: 20/01/2020flurbiprofen, 8.75 mg, oromucosal spray) in the EU On 17 October 2019 … as lozenges, granules and spray, behave the same way in the … flurbiprofen, 8.75 mg, oromucosal spray) in the EU PDF icon application/pdf …