463 results
-
List item
Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009,
, Revision: 6, Authorised, Last updated: 18/01/2019
demic Influenza Vaccine H5N1 Baxter AG Respiratory Tract Infections Infections Respiratory … demic Influenza Vaccine H5N1 Baxter AG … Pandemic Influenza Vaccine H5N1 Baxter AG whole virion influenza … -
List item
Referral: Baxter dialysis solutions
Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/10/2011, EC decision date: 16/12/2011, Last updated: 20/11/2013Baxter dialysis solutions … the production processes at Baxter's manufacturing plant in Castlebar … dialysis solutions produced at Baxter's Castlebar plant. These include … -
List item
Press release: European Medicines Agency finalises review of Baxter's dialysis solutions
CHMP, Last updated: 23/09/2011Agency finalises review of Baxter's dialysis solutions … Agency finalises review of Baxter's dialysis solutions … Agency finalises review of Baxter’s dialysis solutions … -
List item
Press release: Review of the manufacture of Baxter's peritoneal dialysis solutions initiated over potential presence of endotoxins in some batches
CHMP, Last updated: 21/01/2011Review of the manufacture of Baxter's peritoneal dialysis solutions … Review of the manufacture of Baxter's peritoneal dialysis solutions … Review of the manufacture of Baxter’s peritoneal dialysis solutions … -
List item
Press release: European Medicines Agency recommends action plan to deal with possible presence of endotoxins in Baxter peritoneal dialysis solutions
CHMP, Last updated: 17/12/2010presence of endotoxins in Baxter peritoneal dialysis solutions … Agency has been informed by Baxter of the potential presence … problem was detected when Baxter found during routine testing … -
List item
News: Public Statement on Trovan IV and Turvel IV
CHMP, Last updated: 25/02/1999for infusion with lactated Ringer's injection. The need to introduce … normal saline and lactated Ringer's injection. Specific changes … be diluted with lactated Ringer's normal saline, 0.9% sodium … -
List item
Human medicine European public assessment report (EPAR): Caelyx pegylated liposomal
doxorubicin hydrochloride, Sarcoma, Kaposi; Multiple Myeloma; Ovarian Neoplasms; Breast Neoplasms
Date of authorisation: 20/06/1996, Revision: 33, Authorised, Last updated: 08/09/2021Marketing-authorisation holder Baxter Holding B.V. Revision 33 … 20/06/1996 Contact address Baxter Holding B.V. Kobaltweg 49 … -
List item
Veterinary medicine European public assessment report (EPAR): Oxyglobin
haemoglobin glutamer-200 (bovine), Dogs
Date of authorisation: 29/11/1999, Revision: 16, Authorised, Last updated: 20/10/2020diluted in a standard solution (Ringer’s lactate) used to replace … diluted in a standard solution (Ringer’s lactate) used to replace … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): paracetamol
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pain
PIP number: EMEA-000130-PIP01-07, Route(s) of administration: Intravenous, Pharmaceutical form(s): Solution for infusion
Decision date: 03/11/2008, Last updated: 07/01/2009, Compliance check: Xpain and fever Intravenous Baxter World Trade SA/NV E-mail … application submitted by Baxter World Trade SA/NV on 11 January … decision is addressed to Baxter World Trade SA/NV, Boulevard … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001637-PIP01-13, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 11/03/2014, Last updated: 16/04/2014, Compliance check: V, 16/01/2015Immunodeficiency (PID) Subcutaneous use Baxter Innovations GmbH Ausria E-mail … application submitted by Baxter Innovations GmbH on 10 April … decision is addressed to Baxter Innovations GmbHm, Industriestrasse … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Antigen of pre-pandemic strain A/Vietnam/1203/2004 propagated in Vero cells
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000156-PIP01-07-M02, Route(s) of administration: Intramuscular injection, Pharmaceutical form(s): Suspension for injection
Decision date: 11/03/2011, Last updated: 08/04/2011, Compliance check: V, 17/01/2013vaccine Intramuscular injection Baxter Innovations GmbH E-mail … application submitted by Baxter Innovations GmbH on 3 December … decision is addressed to Baxter Innovations GmbH, Industriestraße … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Advate, octocog alfa
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: Octocog alfa, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 04/05/2010, Last updated: 28/07/2010, Compliance check: XContact for public enquiries Baxter AG E-mail: juliana_brankova@baxter.com … application submitted by Baxter AG on 10 December 2009 under … decision is addressed to Baxter AG, Industriestrasse 67 … -
List item
National expert: Ulrich Russ, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 21.94 KB | PDF
184: 105-112 4. U. Russ, T. Ringer and D. Siemen: A voltage-dependent … 1999) 56: 955-961 12. E. Ringer, U. Russ and D. Siemen: b3-Adrenergic … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Alanine, arginine, aspartic acid, cysteine, cystine, glutamic acid, glycine, Histidine, isoleucine, Leucine, lysine monohydrate, Methionine, ornithine hydrochloride, phenylalanine, Proline, serine, taurine, threonine, Tryptophan, Tyrosine, Valine, sodium chloride, potassium acetate, magnesium acetate tetrahydrate, calcium chloride, sodium glycerophosphate, glucose, soya bean oil, Olive oil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Nutrition
PIP number: Alanine, arginine, aspartic acid, cysteine/cystine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine; sod..., Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 02/10/2009, Last updated: 07/12/2009, Compliance check: V, 16/10/2009nutrition Intravenous use Baxter World Trade SPRL E-mail … application submitted by Baxter World Trade SA/NV on 7 August … P/86/2008, is addressed to Baxter World Trade SA/NV, Boulevard … -
List item
Orphan designation: 5-hydroxymethyl-2-furfural for: Treatment of sickle cell disease
Date of designation: 12/02/2015, Withdrawn, Last updated: 10/02/2016the European Commission to Baxter Innovations GmbH, Austria … cell disease. In May 2015, Baxter Innovations GmbH changed … the European Commission to Baxter Innovations GmbH, Austria … -
List item
Human medicine European public assessment report (EPAR): Ceprotin
human protein C, Purpura Fulminans; Protein C Deficiency
Date of authorisation: 15/07/2001, Revision: 15, Authorised, Last updated: 27/11/2020European Union for Ceprotin to Baxter AG on 16 July 2001. The marketing … European Union for CEPROTIN to Baxter AG on 16 July 2001. The marketing … -
List item
Plasma master file certificates (updated)
Last updated: 23/11/2021(ref. EMA/H/PMF/000002/04) Baxter (ref. EMA/H/PMF/000003/04 …
-
List item
National expert: Maria-Dimokleia Ziotopoulou, National Organization for Medicines (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 19.01 KB | PDF
E. Papathanassoglou, S. A. Ringer, C. Mantzoros "Cord blood … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 October 2013
CHMP, Last updated: 25/10/2013Pandemic Influenza Vaccine Baxter H5N1 … -
List item
Press release: PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl starch
PRAC, Last updated: 14/06/2013Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis … Hydroxyethyl Starch 130/0.42 versus Ringer’s acetate in severe sepsis … saline (salt) solutions or Ringer acetate, contain smaller … -
List item
Referral: Preflucel
influenza vaccine, purified antigen, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 10/12/2012, Last updated: 20/07/2012company that markets Preflucel, Baxter, had voluntarily recalled … that markets Preflucel, Baxter, had voluntarily recalled … -
List item
Press release: European Medicines Agency recommends authorisation of additional vaccine for influenza pandemic (H1N1) 2009
Last updated: 02/10/2009039;swine flu'), Celvapan from Baxter, be granted a marketing authorisation … Agency has requested that Baxter implement the same plans … ‘swine flu’), Celvapan from Baxter, be granted a marketing authorisation … -
List item
Orphan designation: Recombinant human von Willebrand factor for: Treatment of von Willebrand disease
Date of designation: 26/11/2010, Withdrawn, Last updated: 21/09/2018the European Commission to Baxter Innovations GmbH, Austria … Willebrand disease. In May 2015, Baxter Innovations GmbH changed … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human A disintegrin and metalloprotease with thrombospind type-1 motifs 13
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001160-PIP01-11-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for infusion
Decision date: 31/10/2017, Last updated: 15/02/2018, Compliance check: Xpurpura (TTP) Intravenous use Baxter Innovations GmbH Tel. +43 … -
List item
Press release: Hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients – CMDh endorses PRAC recommendations
CMDh, Last updated: 25/10/2013saline (salt) solutions or Ringer's acetate, contain smaller … Hydroxyethyl starch 130/0.42 versus ringer’s acetate in severe sepsis … saline (salt) solutions or Ringer’s acetate, contain smaller …