1297 results
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Withdrawn application: Doxorubicin Hydrochloride Tillomed
doxorubicin, date of withdrawal: 02/03/2020, Initial authorisation, Last updated: 27/07/2020Doxorubicin Hydrochloride Tillomed: Withdrawn application … Doxorubicin Hydrochloride Tillomed: Withdrawal of the marketing … Doxorubicin hydrochloride Tillomed (doxorubicin hydrochloride … -
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Human medicine European public assessment report (EPAR): Cinacalcet Mylan
cinacalcet hydrochloride, Hyperparathyroidism, Secondary; Hypercalcemia
Date of authorisation: 19/11/2015,
, Revision: 15, Authorised, Last updated: 26/04/2023
Cinacalcet Mylan Nutritional and Metabolic … Authorised cinacalcet Overview This is a summary … assessment report (EPAR) for Cinacalcet Mylan. It explains how the … -
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Human medicine European public assessment report (EPAR): Cinacalcet Accordpharma (updated)
cinacalcet hydrochloride, Hyperparathyroidism
Date of authorisation: 03/04/2020,, Revision: 3, Authorised, Last updated: 16/05/2023
Cinacalcet Accordpharma Endocrine System … Authorised cinacalcet Overview Cinacalcet Accordpharma is a medicine … there is no other cause. Cinacalcet Accordpharma contains the … -
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Human medicine European public assessment report (EPAR): Mimpara
cinacalcet hydrochloride, Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism
Date of authorisation: 22/10/2004, Revision: 25, Authorised, Last updated: 29/03/2023Authorised cinacalcet Overview This is a summary … medicine. active substance cinacalcet. How is Mimpara used? Mimpara … active substance in Mimpara, cinacalcet, is a calcimimetic agent … -
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Human medicine European public assessment report (EPAR): Parareg
cinacalcet, Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism
Date of authorisation: 22/10/2004, Revision: 6, Withdrawn, Last updated: 14/05/2009Withdrawn cinacalcet Overview The marketing authorisation … STATEMENT ON Parareg (cinacalcet) WITHDRAWAL OF THE … medicinal product Parareg, cinacalcet. Parareg is approved for the … -
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Opinion/decision on a Paediatric investigation plan (PIP): Mimpara, cinacalcet hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000078-PIP01-07-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate dosage form, other
Decision date: 12/05/2017, Last updated: 02/03/2018, Compliance check: V, 19/05/2017Mimpara Active substance cinacalcet hydrochloride Therapeutic … paediatric investigation plan for cinacalcet (hydrochloride) (Mimpara … paediatric investigation plan for cinacalcet (hydrochloride) (Mimpara … -
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Referral: Carbamazepin Tillomed
carbamazepin, associated names: Carbamazepin Tillomed, Carbamazepina Tillomed, Karbamazepin Tillomed, Karbamazepina Tillomed, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 25/06/2020, Last updated: 21/07/2020Carbamazepin Tillomed … authorisation of Carbamazepin Tillomed (carbamazepine, 200 and 400 … -
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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 … -
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Human medicine European public assessment report (EPAR): Parsabiv
etelcalcetide hydrochloride, Hyperparathyroidism, Secondary
Date of authorisation: 11/11/2016, Revision: 9, Authorised, Last updated: 23/09/2021third study compared it with cinacalcet, another calcimimetic medicine … at least as effective as cinacalcet: in 68% (232 out of 340) patients … out of 343) patients given cinacalcet. What are the risks associated … -
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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 … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Actavis (updated)
zoledronic acid monohydrate, Fractures, Bone
Date of authorisation: 20/04/2012,, Revision: 15, Authorised, Last updated: 01/06/2023
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 … -
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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 … -
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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 … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 14, Authorised, Last updated: 20/04/2023
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 … -
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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 … -
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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 … -
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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: 11/05/2023compared 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 … -
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Orphan designation: acetazolamide for: Treatment of periodic paralysis
Date of designation: 21/08/2019, Positive, Last updated: 14/01/2020Commission to Laboratorios Tillomed Spain, S.L.U, Spain, for … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020 (updated)
CHMP, Last updated: 27/03/2020Doxorubicin Hydrochloride Tillomed … -
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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 … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020
CHMP, Last updated: 31/01/2020Cinacalcet Accordpharma … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020
CHMP, Last updated: 30/04/2020Carbamazepin Tillomed … -
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Human medicine European public assessment report (EPAR): Camcevi (updated)
leuprorelin mesilate, Prostatic Neoplasms
Date of authorisation: 24/05/2022, Revision: 1, Authorised, Last updated: 12/05/2023patients with spinal cord compression or those whose cancer has … patients with spinal cord compression or those whose cancer has … -
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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 … -
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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 …