1686 results
-
List item
Veterinary medicine European public assessment report (EPAR): OvuGel
Triptorelin acetate, Pigs (sows for reproduction)
Date of authorisation: 10/11/2020, Authorised, Last updated: 07/05/2021used? OvuGel is a vaginal gel, which should be given to … used? OvuGel is a vaginal gel, which should be given to … used? OvuGel is a vaginal gel, which should be given to … -
List item
Orphan designation: naproxcinod for: Treatment of Duchenne muscular dystrophy
Date of designation: 07/10/2013, Withdrawn, Last updated: 23/01/2018the body into the medicine naproxen and a chemical that releases … damage and inflammation. Naproxen is a non-steroidal anti-inflammatory … production of prostaglandins, naproxen is expected to reduce the … -
List item
National expert: Daniel Lovell, European Medicines Agency (updated)
- Declaration of interests - 47.47 KB | PDF
- Curriculum Vitae - 65.43 KB | PDF
Delamater AM, DiMeglio LA, Gitelman SE, Gottlieb PA, Herold KC … Hudgins A, Ilowite NT, Klein_Gitelman M, Lindsley C, Lopez Benitez … -
List item
Veterinary medicine European public assessment report (EPAR): Purevax RCP FeLV
attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), Cats
Date of authorisation: 23/02/2005, Revision: 15, Authorised, Last updated: 07/04/2022application/pdf v-89-aa-ws1733-g_el.pdf PDF icon application/pdf … application/pdf v-89-aa-ws1733-g_it.pdf PDF icon application/pdf … -
List item
Veterinary medicine European public assessment report (EPAR): Purevax RCPCh
attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated Chlamydophila felis (905 strain), attenuated feline panleucopenia virus (PLI IV), Cats
Date of authorisation: 23/02/2005, Revision: 17, Authorised, Last updated: 06/04/2022 -
List item
Veterinary medicine European public assessment report (EPAR): NexGard Combo
eprinomectin, esafoxolaner, praziquantel, Cats
Date of authorisation: 06/01/2021, Revision: 1, Authorised, Last updated: 16/02/2022 -
List item
Veterinary medicine European public assessment report (EPAR): Sileo
Dexmedetomidine hydrochloride, Dogs
Date of authorisation: 10/06/2015, Revision: 8, Authorised, Last updated: 11/01/2021available as an oromucosal gel (a gel applied to the lining of … available as an oromucosal gel (a gel applied to the lining of … PRODUCT Sileo 0.1 mg/ml oromucosal gel for dogs 2. QUALITATIVE … -
List item
Summary of opinion: Hyftor
sirolimus, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023be available as a 2 mg/g gel. The The substance responsible … Hyftor is available as a gel intended for local administration … be available as a 2 mg/g gel. The active substance of Hyftor … -
List item
Human medicine European public assessment report (EPAR): Raplixa
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 19/03/2015,
, Revision: 6, Withdrawn, Last updated: 10/10/2018
combination with an approved gelatin sponge. Raplixa is indicated … approved type of sponge made of gelatin. How is Raplixa used? Raplixa … followed by application of the gelatin sponge. The powder can also … -
List item
Press release: European Medicines Agency finalises review of recent published data on cardiovascular safety of NSAIDs
CHMP, Last updated: 19/10/2012diclofenac, ibuprofen and naproxen. In relation to naproxen and ibuprofen, the CHMP was … diclofenac, ibuprofen and naproxen. In relation to naproxen and ibuprofen, the CHMP was … ketorolac, meloxicam, nabumetone, naproxen, nimesulide and piroxicam … -
List item
Human medicine European public assessment report (EPAR): Panretin
alitretinoin, Sarcoma, Kaposi
Date of authorisation: 11/10/2000, Revision: 17, Withdrawn, Last updated: 11/01/2021Therapeutic indication Panretin gel is indicated for the topical … Panretin is available as a gel to be applied to the skin … twice a day, using enough gel to cover each lesion with … -
List item
Referral: Compagel
heparin sodium, levomenthol, hydroxyethyl salicylate, Article 33
Status: European Commission final decision, opinion/position date: 13/02/2008, EC decision date: 02/04/2008, Last updated: 07/12/2011decision Overview Compagel Gel for Horses contains heparin … hydroxyethyl salicylates. The gel is applied on the skin and … thrombophlebitis). Compagel Gel for Horses is a generic product … -
List item
Referral: Nimesulide
nimesulide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 20/01/2012, Last updated: 19/04/2012diclofenac, ibuprofen and naproxen. In terms of safety, the Committee … diclofenac, ibuprofen and naproxen. In terms of safety, the … -
List item
Referral: Basiron AC and associated names
benzoyl peroxide, Article 13 referrals
Status: European Commission final decision, opinion/position date: 28/03/2019, EC decision date: 04/07/2019, Last updated: 19/07/2019benzoyl peroxide 5% and 10% gel) in the EU … -
List item
Referral: Daivobet
calcipotriol, betamethasone, associated names: Dovobet, Article 30 referrals
Status: European Commission final decision, opinion/position date: 22/07/2010, EC decision date: 30/09/2010, Last updated: 26/04/2011skin). It is available as a gel and ointment and is used … national procedures. Daivobet gel was authorised via a decentralised … calcipotriol/betamethasone gel and ointment, 50 micrograms/0.5 … -
List item
Orphan designation: paclitaxel for: Treatment of oesophagus carcinoma
Date of designation: 23/02/2011, Positive, Last updated: 04/03/2011Kingdom, for paclitaxel (aqueous gel) for the treatment of oesophagus … that paclitaxel (aqueous gel) might be of significant benefit … die. Paclitaxel (aqueous gel) is a depot formulation of … -
List item
Human medicine European public assessment report (EPAR): Firmagon
degarelix, Prostatic Neoplasms
Date of authorisation: 17/02/2009, Revision: 19, Authorised, Last updated: 04/10/2022When injected, Firmagon forms a gel under the skin that releases … injected, Firmagon forms a gel under the skin that releases … -
List item
National expert: Francesco Onida, Italian Medicines Agency (updated)
- Declaration of interests - 42.89 KB | PDF
- Curriculum Vitae - 66.85 KB | PDF
-
List item
Electronic product information (ePI) (updated)
Last updated: 30/05/2023ePI Common Standard (on GitHub) The EU ePI Common Standard …
-
List item
Press release: European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection
Last updated: 19/11/2013lactulose, mefloquine, midazolam, naproxen, phytomenadione, pyrimethamine/sulfadoxine … lactulose, mefloquine, midazolam, naproxen, phytomenadione, pyrimethamine/sulfadoxine … -
List item
Press release: European Medicines Agency starts new review of cardiovascular risks of non-selective NSAIDs
CHMP, Last updated: 21/10/2011ketoprofen, meloxicam, nabumetone, naproxen, nimesulide and piroxicam … ketoprofen, meloxicam, nabumetone, naproxen, nimesulide and piroxicam … -
List item
Press release: European Medicines Agency concludes review of systemic nimesulide-containing medicines
CHMP, Last updated: 23/06/2011diclofenac, ibuprofen and naproxen. In terms of safety, the CHMP … diclofenac, ibuprofen and naproxen. In terms of safety, the … -
List item
Veterinary medicine European public assessment report (EPAR): ProZinc
insulin human, Cats; Dogs
Date of authorisation: 12/07/2013, Revision: 9, Authorised, Last updated: 14/01/2020glucose containing solution or gel and/or food is required to … -
List item
Press release: European Medicines Agency update on non-selective NSAIDs
Last updated: 17/10/2005ketoprofen, meloxicam, nabumetone, naproxen, nimesulide and piroxicam … ketoprofen, meloxicam, nabumetone, naproxen, nimesulide and piroxicam … ketoprofen, meloxicam, nabumetone, naproxen, nimesulide and piroxicam … -
List item
National expert: Claas Hinze, European Medicines Agency (updated)
- Declaration of interests - 40.87 KB | PDF
- Curriculum Vitae - 44.06 KB | PDF