601 results
-
List item
National expert: Paola Minghetti, Italian Medicines Agency (updated)
- Declaration of interests - 81.41 KB | PDF
- Curriculum Vitae - 62.13 KB | PDF
-
List item
Veterinary medicine European public assessment report (EPAR): Convenia
cefovecin (as sodium salt), Dogs; Cats
Date of authorisation: 19/06/2006, Revision: 13, Authorised, Last updated: 08/12/2020Usobacterium … -
List item
Direct healthcare professional communications
Last updated: 14/02/2020 -
List item
Human medicine European public assessment report (EPAR): Ratiograstim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,
, Revision: 15, Authorised, Last updated: 23/01/2023
the EU for Ratiograstim to ratiopharm GmbH on 15 September 2008 … -
List item
Human medicine European public assessment report (EPAR): Pazenir
paclitaxel, Breast Neoplasms
Date of authorisation: 06/05/2019,
, Revision: 7, Authorised, Last updated: 15/03/2022
-
List item
National expert: Constanze Freiler, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 80.3 KB | PDF
- Curriculum Vitae - 17.86 KB | PDF
Manager Pharmacovigilance TEVA ratiopharm, Vienna (Austria) Head of … Indication 04/2013-08/2018 TEVA ratiopharm Cross product responsibility … -
List item
Human medicine European public assessment report (EPAR): Eporatio
epoetin theta, Kidney Failure, Chronic; Anemia; Cancer
Date of authorisation: 29/10/2009, Revision: 12, Authorised, Last updated: 11/01/2022European Union for Eporatio to ratiopharm GmbH on 29 October 2009 … European Union for Eporatio to ratiopharm GmbH on 29 October 2009 … -
List item
National expert: Antonio Portolés, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 82.88 KB | PDF
- Curriculum Vitae - 43.11 KB | PDF
-
List item
Press release: European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection
Last updated: 19/11/2013bromazepam, calcitriol, carvedilol, ceftriaxone, cilazapril/cilazapril hydrochlorothiazide … bromazepam, calcitriol, carvedilol, ceftriaxone, cilazapril/cilazapril hydrochlorothiazide … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): epoetin theta
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: Epoetin theta, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 20/07/2008, Last updated: 08/09/2008, Compliance check: XIntravenous use Subcutaneous use Ratiopharm GmbH E-mail: info ratiopharm.de Country: Germany Phone … application submitted by Ratiopharm GmbH on 6 March 2008 under … decision is addressed to Ratiopharm GmbH, Graf-Arco-Strasse 3 … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): epoetin theta
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: Epoetin theta, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 20/07/2008, Last updated: 08/09/2008, Compliance check: XIntravenous use Subcutaneous use Ratiopharm GmbH E-mail: info ratiopharm.de Country: Germany Phone … application submitted by Ratiopharm GmbH on 6 March 2008 under … decision is addressed to Ratiopharm GmbH, Graf-Arco-Strasse 3 … -
List item
Press release: European Medicines Agency recommends precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH
Last updated: 25/03/2010Clopidogrel Hexal, Clopidogrel Ratiopharm, Clopidogrel Ratiopharm GmbH and Clopidogrel Sandoz … Clopidogrel Hexal: EPAR Clopidogrel ratiopharm: EPAR Clopidogrel ratiopharm GmbH: EPAR Clopidogrel Sandoz … Clopidogrel Hexal, Clopidogrel Ratiopharm, Clopidogrel Ratiopharm GmbH and Clopidogrel Sandoz … -
List item
National expert: Katharina Dirmeier, Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 16.65 KB | PDF
Germany) November 2010-April 2011 Trainee ratiopharm GmbH (Germany) August 2011-December … -
List item
Referral: Escitalopram
escitalopram, Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 18/02/2010, Last updated: 29/09/2010Escitalopram Hexal Escitalopram Ratiopharm, Escitalopram Sandoz, Escitalopram … CT-Arzneimittel GmbH, Hexal AG, Ratiopharm GmbH Ratiopharm Nederland B.V., Sandoz B.V … Escitalopram Hexal Escitalopram Ratiopharm, Escitalopram Sandoz, Escitalopram … -
List item
Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 24-27 May 2006
CHMP, Last updated: 02/06/2006Ceftriaxone Tyrol 1g and 2g … procedure for the generic product Ceftriaxone Tyrol 1g and 2g ceftriaxone) from Sandoz Ltd, recommending … -
List item
National expert: Maria Jose Otero Lopez, European Medicines Agency (updated)
- Declaration of interests - 79.94 KB | PDF
- Curriculum Vitae - 23.19 KB | PDF
coordinator). Recomendaciones para el Uso Seguro del Potasio Intravenoso … SENSAR) e Instituto para el Uso Seguro de los Medicamentos … Lopez Organisation/Company: Instituto para el Uso Seguro de los Medicamentos Country … -
List item
National expert: Irja Lutsar, State Agency of Medicines (updated)
- Declaration of interests - 81.68 KB | PDF
- Curriculum Vitae - 65.59 KB | PDF
K, Sanchez L, Sharland M, Usonis V, Warris A, Aboulker JP … -
List item
National expert: Alicia Rodriguez Gascon, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 44.26 KB | PDF
-
List item
National expert: Raffaella Sardelli, Italian Medicines Agency (updated)
- Declaration of interests - 80.05 KB | PDF
- Curriculum Vitae - 22.93 KB | PDF
quot;Contaminazione da alluminio in soluzioni di albumina umana: un monitoraggio … dell'attivatore della precallicreina in soluzioni di albumina umana" (Abs … -
List item
Withdrawn application: Pioglitazone ratio
pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012Overview On 3 February 2012, ratiopharm GmbH officially notified … this medicinal product is ratiopharm GmbH. They may request … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 December 2014
CHMP, Last updated: 19/12/2014Clopidogrel ratiopharm … -
List item
Referral: Valproate
valproic acid, valproate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 17/12/2009, EC decision date: 26/08/2010, Last updated: 29/04/2011company that markets Valproat Ratiopharm Chrono, a generic medicine … medicines, including Valproat Ratiopharm Chrono. Because bipolar disorder … company that markets Valproat Ratiopharm Chrono, a generic medicine … -
List item
Referral: Gadolinium-containing contrast agents
gadodiamide, gadopentetic acid, gadobenic acid, gadoxetic acid, gadoteridol, gadobutrol, gadoteric acid, associated names: Omniscan, Magnevist, Magnegita, Gado-MRT ratiopharm, Primovist, MultiHance, Dotarem, ProHance, Gadovist, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 06/12/2010Magnevist, Magnegita, and Gado-MRT-ratiopharm … Magnevist, Magnegita, and Gado-MRT-ratiopharm); • medium risk: gadofosveset … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human granulocyte colony stimulating factor coupled with recombinant human albumin fusion protein
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001042-PIP02-11, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 20/12/2011, Last updated: 19/01/2012, Compliance check: XPharma B.V. E-mail: info@ratiopharm.de Tel. : +49 73140202 Fax … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human granulocyte colony stimulating factor, recombinant human albumin fusion protein
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Oncology
PIP number: P/36/2011, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 28/01/2011, Last updated: 24/02/2011, Compliance check: XPharmaceuticals Europe B.V info@ratiopharm.de Germany Phone: +49 73140202 …