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31/10/2019 Referral: Methotrexate containing medicinal products , methotrexate , Jylamvo,Nordimet,Ledertrexate,Maxtrex,Metex,Metoject, Article 31 referrals, European Commission final decision, 22/08/2019, 21/10/2019, 31/10/2019
31/10/2019 Human medicines European public assessment report (EPAR): Binocrit, epoetin alfa, Anemia, Kidney Failure, Chronic, 28/08/2007, Biosimilar, 20, Authorised
31/10/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2019
31/10/2019 News and press releases: EMA closed 1 November 2019
31/10/2019 Other: Electronic registration process – EudraVigilance registration phases I, II and III
31/10/2019 Other: Required registration documents for EudraVigilance XCOMP
31/10/2019 Human medicines European public assessment report (EPAR): Modigraf, tacrolimus, Graft Rejection, 15/05/2009, 13, Authorised
30/10/2019 Periodic safety update single assessment: Botulinum toxin a - haemagglutinin complex : List of nationally authorised medicinal products - PSUSA/00000427/201812
30/10/2019 Periodic safety update single assessment: Botulinum toxin a - haemagglutinin complex : CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000427/201812
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Gilteritinib (as fumarate), PM: decision on the application for modification of an agreed PIP, P/0194/2019
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Imipenem (monohydrate),cilastatin (sodium),relebactam (MK-7655A), PM: decision on the application for modification of an agreed PIP, P/0173/2019
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, PM: decision on the application for modification of an agreed PIP, P/0196/2019
30/10/2019 ICH guideline E19 on optimisation of safety data collection - Step 2b
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Omecamtiv mecarbil, PM: decision on the application for modification of an agreed PIP, P/0172/2019
30/10/2019 Overview of comments: Overview of comments received on 'Draft ICH guideline E19 on optimisation of safety data collection - Step 2b'
30/10/2019 ICH M10 on bioanalytical method validation
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, baricitinib, PM: decision on the application for modification of an agreed PIP, P/0165/2019
30/10/2019 Overview of comments: Overview of comments received on 'Draft ICH guideline M10 on bioanalytical method validation - Step 2b'
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Deferiprone, PM: decision on the application for modification of an agreed PIP, P/0189/2019
30/10/2019 Human medicines European public assessment report (EPAR): Xadago, safinamide methanesulfonate, Parkinson Disease, 23/02/2015, 10, Authorised
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Strensiq, asfotase alfa, PM: decision on the application for modification of an agreed PIP, P/0176/2019
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Jakavi, Ruxolitinib (phosphate), PM: decision on the application for modification of an agreed PIP, P/0190/2019
30/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Humira, adalimumab, PM: decision on the application for modification of an agreed PIP, P/0174/2019
30/10/2019 Other: Informed consent for paediatric clinical trials in Europe 2015
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): colecalciferol, W: decision granting a waiver in all age groups for all conditions or indications, P/0182/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Amoxicillin (in combination with pantoprazole + clarithromycin), W: decision granting a waiver in all age groups for all conditions or indications, P/0184/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Clarithromycin (in combination with pantoprazole + amoxicillin), W: decision granting a waiver in all age groups for all conditions or indications, P/0183/2019
29/10/2019 Agenda: Agenda - CHMP agenda of the 14-17 October 2019 meeting
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Seladelpar, W: decision granting a waiver in all age groups for all conditions or indications, P/0192/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): salbutamol sulfate,budesonide, W: decision granting a waiver in all age groups for all conditions or indications, P/0185/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Candesartan,Atorvastatin,amlodipine, W: decision granting a waiver in all age groups for all conditions or indications, P/0187/2019
29/10/2019 Template or form: Day 80 assessment report - Non-clinical template with guidance rev. 10.19
29/10/2019 Template or form: Day 80 assessment report - Overview and D120 LOQ template with guidance rev. 10.19
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Mometasone (furoate monohydrate),Olopatadine (hydrochloride) (GSP 301 NS), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0170/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Pantoprazole (in combination with amoxicillin + clarithromycin), W: decision granting a waiver in all age groups for all conditions or indications, P/0188/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human lecithin cholesterol acyltransferase, W: decision granting a waiver in all age groups for all conditions or indications, P/0175/2019
29/10/2019 Human medicines European public assessment report (EPAR): Controloc Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 12, Authorised
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Humanized antibody targeting B cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F, W: decision granting a waiver in all age groups for all conditions or indications, P/0168/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): ofatumumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0122/2019
29/10/2019 Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Hyperuricemia, Gout, 28/03/2019, Generic, 1, Authorised
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ibandronic acid (in the form of ibandronate sodium monohydrate), W: decision granting a waiver in all age groups for all conditions or indications, P/0180/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Dusquetide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0177/2019
29/10/2019 News and press releases: Regulatory update - EMA encourages companies to submit type I variations for 2019 by end of November 2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Zejula, Niraparib, W: decision granting a waiver in all age groups for all conditions or indications, P/0167/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Efpeglenatide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0181/2019
29/10/2019 Periodic safety update single assessment: Testosterone (all formulations apart from topical use) : List of nationally authorised medicinal products - PSUSA/00010631/201812
29/10/2019 Periodic safety update single assessment: Testosterone (all formulations apart from topical use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010631/201812
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Stelara, Ustekinumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0178/2019
29/10/2019 Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib, W: decision granting a waiver in all age groups for all conditions or indications, P/0171/2019
29/10/2019 Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Leukemia, Myeloid, Leukemia, Lymphoid, 01/07/2013, Orphan, Accelerated assessment, Additional monitoring, 20, Authorised
29/10/2019 Overview of comments: Overview of comments received on draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms
29/10/2019 Pharmacokinetic and clinical evaluation of modified-release dosage forms
29/10/2019 Report: Outcome of public consultation on draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms
29/10/2019 Leaflet: Biosimilars in the EU - Information guide for healthcare professionals
28/10/2019 Pharmacovigilance Risk Assessment Committee (PRAC): 28-31 October 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 28/10/2019 to 31/10/2019
28/10/2019 Agenda: Agenda - PRAC draft agenda of meeting 28-31 October 2019
28/10/2019 Periodic safety update single assessment: Testosterone (topical use) : List of nationally authorised medicinal products - PSUSA/00002908/201812
28/10/2019 Periodic safety update single assessment: Testosterone (topical use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002908/201812
28/10/2019 Other: The role of members representing patients' and healthcare professionals' organisations on EMA scientific committees
28/10/2019 Other: PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 30 September-3 October 2019
28/10/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 30 September-3 October 2019 PRAC meeting
28/10/2019 Periodic safety update single assessment: Botulinum neurotoxin type a (150 kD) free from complexing proteins: List of nationally authorised medicinal products - PSUSA/00009084/201812
28/10/2019 Notifying a change of marketing status
28/10/2019 Template or form: Step 1 - Risk identified response template
28/10/2019 Template or form: Step 1 - Risk identified response template
28/10/2019 Template or form: Step 2 - Nitrosamine detected response template
28/10/2019 Template or form: Step 2 Nitrosamine detected response template
25/10/2019 Periodic safety update single assessment: Botulinum toxin a: List of nationally authorised medicinal products - PSUSA/00000426/201812
25/10/2019 Periodic safety update single assessment: Botulinum toxin a: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000426/201812
25/10/2019 News and press releases: Dialogue with Chinese authorities on medicine regulation
24/10/2019 Human medicines European public assessment report (EPAR): Thorinane, enoxaparin sodium, Venous Thromboembolism, 14/09/2016, Additional monitoring, Biosimilar, 2, Withdrawn
24/10/2019 Orphan designation: Larotrectinib for the: Treatment of salivary gland cancer, 21/03/2018, Withdrawn
24/10/2019 Orphan designation: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate (larotrectinib) for the: Treatment of soft tissue sarcoma, 11/01/2016, Withdrawn
24/10/2019 Orphan designation: Larotrectinib for the: Treatment of glioma, 19/11/2018, Withdrawn
24/10/2019 Orphan designation: Larotrectinib for the: Treatment of papillary thyroid cancer, 19/11/2018, Withdrawn