Search results with tag "Public assessment report"
Paediatric Public Assessment Report - Heads of …
www.hma.euPaediatric Public Assessment Report EU Worksharing Project Losec/Losec MUPS ... This is a paediatric data assessment for Losec through worksharing with Sweden as Rapporteur ... FIRST ROUND, DRAFT ASSESSMENT REPORT (PPDAR) II.1 Recommendation ediatric data on pharmacokinetics, safety and efficacy, for Losec ...
UK Public Assessment Report - APILAM
e-lactancia.orgUKPAR Valsartan 40mg, 80mg, & 160mg film-coated tablets PL 20092/0045-7 ... PL 20092/0045-7 UK Public Assessment Report TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 15 Steps taken after authorisation Page 16 Summary of Product Characteristics ... (RMP) and Environmental Risk Assessment …
The European regulatory system for medicines
www.ema.europa.euA European Public Assessment Report, or EPAR, is published for every human or veterinary medicine that has been granted or refused a marketing authorisation following an assessment by EMA. For a medicine that is authorised by a Member State, details on the assessment of the medicine are also available in a Public Assessment Report. 1.
MHRA PUBLIC ASSESSMENT REPORT - sefap.it
www.sefap.itMHRA PUBLIC ASSESSMENT REPORT Oral liquid cough medicines containing codeine: should not be used in children and young people under 18 years October 2010 Plain language summary 2 1. Introduction 4 2. Efficacy data on codeine as an antitussive in children 5 3. Safety data on codeine in children: 7
Australian public assessment report for BNT162b2 (mRNA)
www.tga.gov.au• An Australian Public Assessment Re port (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. • AusPARs are prepared and published by the TGA.
QUALITY ASSESSMENT LICENSED MEDICINE - …
www.sps.nhs.ukMHRA Public Assessment Report, UKPAR, Potassium Chloride 0.4mmol/mL Solution for Infusion, UK Licence No: PL 40739/0044 Summary of Product Characteristics, Vers.
Lisinopril 2-5, 5, 10 and 20 mg Tablets PL 17907 …
www.shijiebiaopin.netLisinopril 20 mg Tablets PL 17907/0236-9 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after authorisation Page 13 Summary of Product Characteristics Page 14 ... no Public Assessment Report (PAR) was generated for them.
Eprosartan 300 mg, 400 mg and 600 mg Film …
e-lactancia.orgThis is a summary of the Public Assessment Report (PAR) for Eprosartan 300mg film-coated tablets (PL 37222/0027, previously PL 31746/0006), Eprosartan 400mg
Public Assessment Report UKPAR Arthriex 1500 mg …
assets.publishing.service.gov.ukPublic Assessment Report UKPAR Prescription Only to Pharmacy Reclassification Arthriex 750 mg Film Coated Tablets - PL 36549/0001 Arthriex 1500 mg Film Coated Tablets - PL 36549/0002 CF PHARMA LIMITED PUBLIC ASSESSMENT REPORT ... Assessment of suitability for pharmacy availability 5.1.
PUBLIC ASSESSMENT REPORT …
db.cbg-meb.nlThis assessment report shall be updated by a following addendum whenever new information becomes available. General information on the Public Assessment Reports can be found on the website of the MEB.
PUBLIC ASSESSMENT REPORT of the Medicines ... - …
db.cbg-meb.nlThis assessment report shall be updated by a following addendum whenever new information becomes available. General information on the Public Assessment Reports can be found on the website of the MEB.
Public Assessment Report - GOV.UK
assets.publishing.service.gov.ukThe full public assessment report for BNT162b2 follows this summary. ... granted in the UK on 1 December 2020. This report covers data received and reviewed for this authorisation only. This authorisation is valid until expressly withdrawn by MHRA or upon issue of …
Public Assessment Report - GOV.UK
www.mhra.gov.ukPL 00030/0215 Scientific Discussion Introduction This Public Assessment report is for Fenistil Cold Sore Cream and is based on the reports for
Public Assessment Report - GOV.UK
www.mhra.gov.ukThis is a summary of the Public Assessment Report (PAR) for Flucloxacillin 250 mg and 500 mg Capsules (PL 21880/0017-0018; UK/H/1101/001-002/DC).
Public Assessment Report Decentralised Procedure ...
www.mhra.gov.ukPAR Zoledronic Acid 4mg/5ml concentrate for solution for infusion UK/H/ 5370/001/DC 1. Public Assessment Report . Decentralised Procedure . Zoledronic Acid 4mg/5ml concentrate for solution for infusion
Public Assessment Report - GOV.UK
www.mhra.gov.ukThis is a summary of the public assessment report (PAR) for Pantoprazole 40 mg powder for solution for injection (PL 01656/0198; UK/H/5517/001/DC).
Public Assessment Report - GOV.UK
www.mhra.gov.ukThis is a summary of the Public Assessment Report (PAR) for Omega-3-acid ethyl esters 1000 mg Capsules, Soft (PL 40120/0001-0003; UK/H/5143, 5303 and 5350/001/DC).
Public Assessment Report Esomeprazole 20 mg …
www.mhra.gov.ukThis is a summary of the public assessment report (PAR) for Esomeprazole 20 mg and 40 mg gastro-resistant tablets (PL 36390/0159-0160). It explains how
Public Assessment Report - GOV.UK
www.mhra.gov.ukThis is a summary of the Public Assessment Report (PAR) for Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution (PL 36390/0083; UK/H/5289/001/DC).
Public Assessment Report - GOV.UK
www.mhra.gov.ukPublic Assessment Report Decentralised Procedure Acamprosate 333 mg Gastro-resistant Tablets (acamprosate calcium) Procedure No: UK/H/5445/001/DC
Public Assessment Report - GOV.UK
www.mhra.gov.ukMHRA: PAR – Oxymetazoline 0.05%w/v Nasal Spray PL 16028/0110 1 Public Assessment Report Oxymetazoline 0.05%w/v Nasal Spray PL 16028/0110
Public Assessment Report - GOV.UK
www.mhra.gov.ukDCPAR Sativex Oromucosal Spray UK/H/2462/001/DC 1 . Public Assessment Report . Decentralised Procedure . Sativex Oromucosal Spray . UK/H/2462/001/DC
Public Assessment Report Scientific discussion …
m.cdn.blog.huFollowing a discussion in CMDhand assessment of the full study report for the Warriner (Nepal) study, it was concluded that Medabon has an acceptably highefficacy rateand a side effectand bleeding patternthat is comparable with …
Public Assessment Report - GOV.UK
www.mhra.gov.ukPAR Mitomycin 40 mg powder for solution for injection/infusion UK/H/5178/001/DC 6 II QUALITY ASPECTS II.1 Introduction Mitomycin is a powder which is mixed before injection.
Public Assessment Report - GOV.UK
www.mhra.gov.ukPAR Rectogesic 0.4% Rectal Ointment UK/H/0823/001/MR 4.5 Interaction with other medicinal products and other forms of interaction Concomitant treatment with other vasodilators, calcium channel blockers, ACE inhibitors, beta blockers,
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