1231 results
-
List item
Human medicine European public assessment report (EPAR): Arava (updated)
leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic
Date of authorisation: 02/09/1999, Revision: 40, Authorised, Last updated: 09/03/2023Arava Musculoskeletal Diseases Joint … assessment report (EPAR) for Arava. It explains how the The committee … the conditions of use for Arava. What is Arava? Arava is a medicine that contains … -
List item
News: Public Statement on Leflunomide (Arava) - Pancytopenia and Serious Skin Reactions
Last updated: 25/10/1999Statement on Leflunomide (Arava) - Pancytopenia and Serious … for the medicinal product Arava, which contains the active … active substance leflunomide. Arava is not yet marketed in the … -
List item
News: European Medicines Agency public statement on Leflunomide (Arava) - Severe and serious hepatic reactions
Last updated: 12/03/2001statement on Leflunomide (Arava) - Severe and serious hepatic … statement on Leflunomide (Arava) - Severe and serious hepatic … STATEMENT ON LEFLUNOMIDE (ARAVA) - SEVERE AND SERIOUS HEPATIC … -
List item
Human medicine European public assessment report (EPAR): Leflunomide ratiopharm
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 28/11/2010,
, Revision: 16, Authorised, Last updated: 17/05/2022
European Union (EU) called Arava. What is Leflunomide ratiopharm … to the reference medicine, Arava. Two medicines are bioequivalent … and to be bioequivalent to Arava. Therefore, the CHMP’s view … -
List item
Human medicine European public assessment report (EPAR): Zometa
zoledronic acid, zoledronic acid monohydrate, Cancer; Fractures, Bone
Date of authorisation: 20/03/2001, Revision: 36, Authorised, Last updated: 09/07/2021breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … any fractures or any spinal compression. Zometa has also been compared … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
List item
Human medicine European public assessment report (EPAR): Leflunomide medac (updated)
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 27/07/2010,, Revision: 18, Authorised, Last updated: 09/03/2023
European Union (EU) called Arava. What is Leflunomide medac … to the reference medicine, Arava. Two medicines are bioequivalent … and to be bioequivalent to Arava. Therefore, the Committee … -
List item
Human medicine European public assessment report (EPAR): Zoledronic Acid Accord
zoledronic acid monohydrate, Hypercalcemia; Fractures, Bone; Cancer
Date of authorisation: 16/01/2014,, Revision: 9, Authorised, Last updated: 24/01/2022
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
List item
Human medicine European public assessment report (EPAR): Zoledronic acid medac
zoledronic acid monohydrate, Fractures, Bone; Cancer
Date of authorisation: 03/08/2012,, Revision: 13, Authorised, Last updated: 20/11/2020
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
List item
Human medicine European public assessment report (EPAR): Zoledronic acid Mylan
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 13, Authorised, Last updated: 24/06/2022
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
List item
Human medicine European public assessment report (EPAR): Zoledronic acid Actavis
zoledronic acid monohydrate, Fractures, Bone
Date of authorisation: 20/04/2012,, Revision: 14, Authorised, Last updated: 05/01/2022
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … pathological fractures, spinal compression, radiation or surgery to … -
List item
Human medicine European public assessment report (EPAR): Zoledronic Acid Hospira
zoledronic acid monohydrate, Hypercalcemia
Date of authorisation: 19/11/2012,, Revision: 18, Authorised, Last updated: 09/11/2021
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
List item
Human medicine European public assessment report (EPAR): Zoledronic acid Teva
zoledronic acid, Fractures, Bone; Cancer
Date of authorisation: 16/08/2012,, Revision: 14, Authorised, Last updated: 11/10/2021
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … pathological fractures, spinal compression, radiation or surgery to … -
List item
Human medicine European public assessment report (EPAR): VeraSeal
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 10/11/2017, Revision: 7, Authorised, Last updated: 12/01/2023worked better than manual compression, with 76% of patients having … compared with 23% after manual compression (13 out of 57). In a second … intermittent application of compresses, swabs, use of suction devices … -
List item
Human medicine European public assessment report (EPAR): Evicel (updated)
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 05/10/2008, Revision: 17, Authorised, Last updated: 21/03/2023compared Evicel with manual compression (applying direct pressure … received Evicel or manual compression. The second study compared … patients treated with manual compression (28 out of 72). During abdominal … -
List item
Human medicine European public assessment report (EPAR): Camcevi
leuprorelin mesilate, Prostatic Neoplasms
Date of authorisation: 24/05/2022, Authorised, Last updated: 20/06/2022patients with spinal cord compression or those whose cancer has … patients with spinal cord compression or those whose cancer has … -
List item
Human medicine European public assessment report (EPAR): Leflunomide Zentiva (previously Leflunomide Winthrop)
leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic
Date of authorisation: 08/01/2010, Revision: 18, Authorised, Last updated: 17/05/2022authorisation granted to Arava in 1999 (‘informed consent’ … -
List item
Human medicine European public assessment report (EPAR): Xgeva
denosumab, Fractures, Bone; Neoplasm Metastasis
Date of authorisation: 13/07/2011, Revision: 23, Authorised, Last updated: 21/07/2022breaks in the bone), spinal compression (pressure on the spinal cord … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), or complications … -
List item
Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide) for: Treatment of achondroplasia
Date of designation: 24/01/2013, Positive, Last updated: 09/09/2021bowed legs, ear problems, compression of the spinal cord, as well … length, to correct spinal compression or to correct bowed legs … bowed legs, ear problems, compression of the spinal cord, as well … -
List item
Human medicine European public assessment report (EPAR): IntronA
interferon alfa-2b, Carcinoid Tumor; Leukemia, Hairy Cell; Lymphoma, Follicular; Hepatitis B, Chronic; Hepatitis C, Chronic; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Melanoma; Multiple Myeloma
Date of authorisation: 09/03/2000, Revision: 34, Withdrawn, Last updated: 15/12/2022major organ obstruction or compression syndrome, orbital or epidural … -
List item
Orphan designation: C-type natriuretic peptide conjugated to multi-arm polyethylene glycol carrier through a cleavable linker for: Treatment of achondroplasia
Date of designation: 27/07/2020, Positive, Last updated: 19/11/2020bowed legs, ear problems, compression of the spinal cord, as well … -
List item
Press release: Novartis withdraws its application to extend the marketing authorisation for Zometa
CHMP, Last updated: 20/11/2007pathological fractures, spinal compression, radiation or surgery to bone … pathological fractures, spinal compression, radiation or surgery to … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Argon, oxygen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002921-PIP01-20, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Medicinal gas, compressed
Decision date: 07/05/2021, Last updated: 15/02/2022, Compliance check: XNeurologyP/0187/2021EMEA-002921-PIP01-20 Medicinal gas, compressed Treatment of acute ischaemic … oxygen, medicinal gas, compressed, inhalation use, the details … form(s): Medicinal gas, compressed Route(s) of administration … -
List item
Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2010
CHMP, Last updated: 17/12/2010Leflunomide Teva is a generic of Arava. … Leflunomide Teva is a generic of Arava. • Repso (leflunomide … arthritis. Repso is a generic of Arava. Positive opinion for extension … -
List item
Press release: Novartis Europharm Ltd. withdraws its application for an extension of indication for Zometa (zoledronic acid)
Last updated: 15/12/2010pathological fractures, spinal compression, radiation or surgery to bone … pathological fractures, spinal compression, radiation or surgery to … -
List item
Herbal medicinal product: Hippocastani semen
Aesculus hippocastanum L., Horse-Chestnut Seed, F: Assessment finalised, Last updated: 24/07/2020both with placebo and with compression stockings and led to a significant … comparable to the effect of compression stockings. The Committee …