Decentralised Procedure. Public Assessment Report. Budesonid Sandoz 32 / 64 Mikrogramm/Sprühstoß Nasenspray, Suspension.
|
|
- Blaise Byrd
- 6 years ago
- Views:
Transcription
1 Decentralised Procedure Public Assessment Report Budesonid Sandoz 32 / 64 Mikrogramm/Sprühstoß Nasenspray, Suspension Budesonide DE/H/0933/ /DC Applicant: Sandoz Pharmaceuticals GmbH Reference Member State DE
2 TABLE OF CONTENTS I. INTRODUCTION... 5 II. EXECUTIVE SUMMARY... 5 II.1 Problem statement... 5 II.2 About the product... 5 II.3 General comments on the submitted dossier... 5 II.4 General comments on compliance with GMP, GLP, GCP and agreed ethical principles.. 5 III. SCIENTIFIC OVERVIEW AND DISCUSSION... 5 III.1 Quality aspects... 5 III.2 Nonclinical aspects... 6 III.3 Clinical aspects... 6 IV. BENEFIT RISK ASSESSMENT... 7
3 ADMINISTRATIVE INFORMATION Proposed name of the medicinal product in the RMS INN (or common name) of the active substance(s): Pharmaco-therapeutic group (ATC Code): Pharmaceutical form(s) and strength(s): Reference Member State: Concerned Member States: Applicant: Budesonid Sandoz 32 / 64 Mikrogramm/Sprühstoß Nasenspray, Suspension Budesonide R01AD05 Nasal spray, suspension; 32 µg / 64 µg DE CZ, DK, FR, NL, NO, PL, SE, UK Sandoz Pharmaceuticals GmbH Dieselstr Gerlingen Germany Budesonide, DE/H/0933/ /DC Public AR 3/7
4 LIST OF ABBREVIATIONS AE BANS CI CMS EU GCP GLP GMP LoQ MedDRA NIS PAR PL PP RMS SAE SAR SmPC TEAE Adverse event Budesonide aqueous nasal spray Confidence interval Concerned Member State European Union Good clinical practice Good laboratory practice Good manufacturing practice List of questions Medical dictionary for regulatory activities Nasal index score Perennial allergic rhinitis Package leaflet Per protocol Reference Member State Serious adverse event Seasonal allergic rhinitis Summary of product characteristics Treatment-emergent adverse event Budesonide, DE/H/0933/ /DC Public AR 4/7
5 I. INTRODUCTION Based on the review of the data on quality, safety and efficacy, the application for Budesonid Sandoz 32 / 64 Mikrogramm/Sprühstoß Nasenspray, Suspension, indicated in the treatment and prevention of signs and symptoms of seasonal and perennial allergic rhinitis and in the treatment of signs and symptoms of nasal polyps, is approved. II. EXECUTIVE SUMMARY II.1 Problem statement Allergic rhinitis is a persistent (PAR) or seasonal (SAR) allergen induced condition affecting up to an estimated 40 % of the general population. Intranasal corticosteroids as well as systemic or topic anthistamines are accepted therapies of these diseases. Nasal corticosteroids are also commonly used to treat the signs and symptoms of nasal polyps. II.2 About the product The applied products (active ingredient: budesonide) are generic versions of Astra Zeneca s budesonide containing nasal spray, licensed in many member states of the EU. The applicant filed an application for two different strengths, 32 µg and 64 µg, respectively. The applicant states that the applied product is almost identical to the reference product, with the addition of ascorbic acid being the only difference. II.3 General comments on the submitted dossier The clinical overview and the clinical summary summarize the well-known properties of budesonide and the clinical program. II.4 General comments on compliance with GMP, GLP, GCP and agreed ethical principles The RMS has been assured that acceptable standards of GMP are in place for these product types at all sites responsible for the manufacture and assembly of this product. For manufacturing sites within the Community, the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those sites. No new preclinical studies have been performed. The applicant states that the clinical equivalence study has been conducted in accordance with GCP. III. SCIENTIFIC OVERVIEW AND DISCUSSION III.1 Quality aspects Drug substance Budesonide micronized is a well-known active substance described in the Ph. Eur. Active substance manufacturer A submitted an Active Substance Master File. Two certificates of suitability, due to different drug substance syntheses, are submitted by active substance manufacturer B. Relevant quality characteristics of the drug substance are specified. The batch results show compliance with the specifications. Stability studies have been performed with the drug substance. No significant changes of the parameters were observed. The stability data support retest-periods of 1 and 3 years, respectively, for the drug substance from manufacturer B. Drug Product The drug product is a nasal spray. The development of the product is described in detail and the choice of active substance and excipients is justified. The validation of the manufacturing process has been successfully performed for the manufacturer. The drug product specifications cover appropriate parameters for this dosage form. The analytical methods are validated. The batch analysis shows that the finished products manufactured meet the specifications. The stability data fully support the shelflife of 24 months. The shelf-life after first opening of the container has been confirmed for a period of three months. Budesonide, DE/H/0933/ /DC Public AR 5/7
6 III.2 Nonclinical aspects Pharmacodynamic, pharmacokinetic and toxicological properties of budesonide are well known. Since budesonide is a widely used, well known active substance, and the applicant is claiming essential similarity to an already approved product, no further non clinical studies have been submitted. Overview based on literature is thus acceptable. Considering that this application concerns a generic and no new indications are added in this application it is expected that the product will substitute parts of prescriptions of currently marketed drugs. Consequently, no changes in the environmental that are not already known for budesonide nasal spray are to be anticipated. III.3 Clinical aspects Pharmacokinetics The applicant conducted a clinical equivalence study instead of a bioequivalence study, because of the topical mode of action of the applied products. Pharmacodynamics N/A Clinical efficacy The applicant conducted a multicentre, randomised, double-blind, placebo- and active-controlled, fixed-dose, parallel group study (Study 1004/2) to compare efficacy and safety of BANS with European reference product Rhinocort Aqua nasal spray by Astra Zeneca from the polish market. Both treatments were administered at 256 µg/day. The study enrolled male and female patients aged 18 to 65 years with at least a 2-year history of seasonal allergic rhinitis and at least 2 out of three of the following symptoms: blocked nose, runny nose, sneezing during 4 out of 7 days during the 7- to 14 day baseline period. At least 1 out of 3 nasal symptoms were to have a score of 2 during 4 days of the run-in phase. Included patients also had to have a positive skin prick test to seasonal allergens present in the environment. 378 patients were randomised and received study medication. The primary efficacy analysis assessed the difference between active treatments in the change from baseline in nasal index score (NIS) which was calculated as the sum of nasal symptoms. The CI (-0.41, 0.27) for the treatment difference for the change from baseline in NIS in the PP population was within the pre-specified equivalence limits. Therefore equivalence was concluded. Most secondary parameters showed significantly improvements with both active treatments. In direct comparison, both active treatments were not significantly different. This study is considered suitable to establish equivalent efficacy. Clinical safety Treatment-emergent AEs (TEAE) were rather evenly distributed among groups with three patients reporting severe AEs (1 patient in the budesonide: severe dysmenorrhoea, 2 patients in the European reference product Rhinocort Aqua nasal spray group: severe somnolence, severe eye allergy). No deaths or SAEs were reported. The vital signs evaluation as well as the laboratory evaluation and the physical examination did not result in any concerns with regard to safety. Pharmacovigilance system The Pharmacovigilance system as described by the applicant fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. No special risk management plan has been submitted. Due to the well-known properties of budesonide this has been accepted. Budesonide, DE/H/0933/ /DC Public AR 6/7
7 IV. BENEFIT RISK ASSESSMENT The application contains an adequate review of published clinical data. The therapeutic equivalence study is acceptable. The risk benefit assessment is positive for the adult population. Because of a disagreement between the member states a referral to CMD(h) and an arbitration to CHMP were started on the grounds of potential serious risk to public health. The points to be considered concerned the benefit-risk ratio of Budesonid Sandoz in children. The EC decision was positive and concluded that the benefit-risk ratio is favourable for Budesonid Sandoz in children and that the objection raised by some member states should not prevent the granting of a Marketing Authorisation. The application is approved. For intermediate amendments see current product information. Budesonide, DE/H/0933/ /DC Public AR 7/7
Decentralised Procedure. Public Assessment Report. Memantin Orion 10/20 mg Filmtabletten. Memantine hydrochloride DE/H/3653/ /DC
Decentralised Procedure Public Assessment Report Memantin Orion 10/20 mg Filmtabletten Memantine hydrochloride DE/H/3653/001-002/DC Applicant: Orion Corporation, Finland Reference Member State DE TABLE
More informationDecentralised Procedure. Public Assessment Report
Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Clozapin Regiomedica 50 mg/ml Suspension zum Einnehmen Clozamedica 50 mg/ml Suspension zum Einnehmen
More informationDecentralised Procedure. Public Assessment Report. Zolmitriptan Renantos 2.5 mg Orodispersible film 5 mg Orodispersible film DE/H/2295/ /DC
Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Zolmitriptan Renantos 2.5 mg Orodispersible film 5 mg Orodispersible film DE/H/2295/001-002/DC Applicant:
More informationDecentralised Procedure. Public Assessment Report. Metamizol Midas / Metamizol STADA / Mimetanal 500 mg Tabletten. Metamizole sodium monohydrate
Decentralised Procedure Public Assessment Report Metamizol Midas / Metamizol STADA / Mimetanal 500 mg Tabletten Metamizole sodium monohydrate DE/H/4091-4093/001/DC Applicant: Midas Pharma GmbH, Germany
More informationDecentralised Procedure. Public Assessment Report
Decentralised Procedure Public Assessment Report Venlafaxin ratiopharm Venlafaxin AbZ-Pharma Venlafaxin CT-Arzneimittel prolonged-release capsule hard venlafaxine hydrochloride DE/H/3393-3395/01-03/DC
More informationDecentralised Procedure. Public Assessment Report. Memantin AbZ 10 mg/20 mg Filmtabletten ; Starterpack
Decentralised Procedure Public Assessment Report Memantin AbZ 10 mg/20 mg Filmtabletten ; Starterpack Memantin-ratiopharm Starterpackung 5 mg /10 mg /15 mg /20 mg Filmtabletten ;10 mg/20 mg Filmtabletten
More informationDecentralised Procedure. Public Assessment Report. Allopurinol tablets 100 mg Allopurinol tablets 300 mg Allopurinol DE/H/ / /DC
Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Allopurinol tablets 100 mg Allopurinol tablets 300 mg Allopurinol DE/H/1354-1356/001-002/DC Applicant:
More informationDecentralised Procedure. Public Assessment Report. Lorazepam-neuraxpharm 1/ 2,5 mg Schmelztabletten. Lorazepam DE/H/4558/ /DC
Decentralised Procedure Public Assessment Report Lorazepam-neuraxpharm 1/ 2,5 mg Schmelztabletten Lorazepam DE/H/4558/001-002/DC Applicant: neuraxpharm Arzneimittel GmbH, Germany Reference Member State
More informationDecentralised Procedure. Public Assessment Report. Pramipexol-neuraxpharm 0,26 / 0,52 / 1,05 / 1,57 / 2,1 / 2,62 / 3,15 mg Retardtabletten
Decentralised Procedure Public Assessment Report Pramipexol-neuraxpharm 0,26 / 0,52 / 1,05 / 1,57 / 2,1 / 2,62 / 3,15 mg Retardtabletten Pramipexole dihydrochloride monohydrate DE/H/4703/001-007/DC Applicant:
More informationDecentralised Procedure. Public Assessment Report. ALGOTRA 37.5 mg/325 mg überzogene Tabletten Tramadol/Paracetamol DE/H/3688/001/DC
Decentralised Procedure Public Assessment Report ALGOTRA 37.5 mg/325 mg überzogene Tabletten Tramadol/Paracetamol DE/H/3688/001/DC Applicant: Laboratoires SMB S.A. Reference Member State DE TABLE OF CONTENTS
More informationDecentralised Procedure. Public Assessment Report. Memantin Pharmascope 10 / 20 mg Filmtabletten Memantine hydrochloride DE/H/3673/ /DC
Decentralised Procedure Public Assessment Report Memantin Pharmascope 10 / 20 mg Filmtabletten Memantine hydrochloride DE/H/3673/001-002/DC Applicant: Pharmascope Limited, Ireland; DAWA Limited, United
More informationDecentralised Procedure. Public Assessment Report. Nurofen Immedia 200mg Weichkapseln Ibuprofen DE/H/1482/001/DC
Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Nurofen Immedia 200mg Weichkapseln Ibuprofen DE/H/1482/001/DC Applicant: Reckitt Benckiser Reference
More informationDecentralised Procedure. Public Assessment Report. Buprenorphine SUN 2 mg/ 8 mg Sublingual tablets Buprenorphine hydrochloride DE/H/1577/ /DC
Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Buprenorphine SUN 2 mg/ 8 mg Sublingual tablets Buprenorphine hydrochloride DE/H/1577/001-002/DC Applicant:
More informationPublic Assessment Report. Scientific discussion. Desloratadine Lek 5 mg film-coated tablets. (Desloratadine) DK/H/2041/001/DC.
Public Assessment Report Scientific discussion Desloratadine Lek 5 mg film-coated tablets (Desloratadine) DK/H/2041/001/DC 29 February 2016 This module reflects the scientific discussion for the approval
More informationDecentralised Procedure. Public Assessment Report
Decentralised Procedure Public Assessment Report Oxycodon-HCl Sandoz 5/10/20 mg Retardtabletten Kancodal HEXAL 5/10/20 Retardtabletten Oxycodonhydrochlorid- 1 A Pharma 5/10/20 mg Retardtabletten Oxycodone
More informationDecentralised Procedure. RMS Day 210 Assessment Report OVERVIEW. Budenofalk 9 mg gastro-resistant granules (Budesonide) UK/H/2778/001/DC
Decentralised Procedure RMS Day 210 Assessment Report OVERVIEW Budenofalk 9 mg gastro-resistant granules (Budesonide) UK/H/2778/001/DC Applicant: Dr. Falk Pharma GmbH Reference Member State UK Start of
More informationDecentralised Procedure. Public Assessment Report. Oxycodon-ratiopharm 20, 40, 80 mg Retardtablette. Oxycodone hydrochloride DE/H/0790/01-03/DC
Decentralised Procedure Public Assessment Report Oxycodon-ratiopharm 20, 40, 80 mg Retardtablette Oxycodone hydrochloride DE/H/0790/01-03/DC Applicant: ratiopharm GmbH Reference Member State Germany The
More informationPublic Assessment Report. Scientific discussion. Tevalukast Film-coated tablets 10 mg. Montelukast sodium DK/H/1332/001/DC
Public Assessment Report Scientific discussion Tevalukast Film-coated tablets 10 mg Montelukast sodium DK/H/1332/001/DC This module reflects the scientific discussion for the approval of Tevalukast. The
More informationPublic Assessment Report. Scientific discussion. Elisox 50 microgram/actuation, nasal spray, suspension. (mometasone furoate) NL/H/2672/001/DC
Public Assessment Report Scientific discussion Elisox 50 microgram/actuation, nasal spray, suspension (mometasone furoate) NL/H/2672/001/DC Date: 24 September 2014 This module reflects the scientific discussion
More informationDecentralised Procedure. Public Assessment Report
Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report IBU-Lysin-ratiopharm 342 mg Filmtabletten IBU-Lysin-ratiopharm 684 mg Filmtabletten Ibu-Lysin AbZ Migräne
More informationPublic Assessment Report. Scientific discussion. Rabeprazolnatrium Torrent Pharma. 10 mg and 20 mg gastro-resistant tablets. Rabeprazole sodium
Public Assessment Report Scientific discussion Rabeprazolnatrium Torrent Pharma 10 mg and 20 mg gastro-resistant tablets Rabeprazole sodium DK/H/1819/001-002/DC This module reflects the scientific discussion
More informationPublic Assessment Report. Scientific discussion. Kaliumklorid "EQL Pharma" (Potassium chloride) DK/H/2662/001/DC. Date:
CMDh/223/2005 February 2014 Public Assessment Report Scientific discussion Kaliumklorid "EQL Pharma" (Potassium chloride) DK/H/2662/001/DC Date: 16-06-2017 This module reflects the scientific discussion
More informationPublic Assessment Report. Scientific discussion. Mogilarta. (Telmisartan and hydrochlorothiazide) DK/H/2306/ /DC.
Public Assessment Report Scientific discussion Mogilarta 40 mg/12.5 mg, 80 mg/12.5 mg and 80 mg/25 mg tablets (Telmisartan and hydrochlorothiazide) DK/H/2306/001-003/DC 17 November 2014 This module reflects
More informationPublic Assessment Report. Scientific discussion. Lorazepam GenRx 1 mg and 2.5 mg tablets. (lorazepam) NL/H/3485/ /DC
Public Assessment Report Scientific discussion Lorazepam GenRx 1 mg and 2.5 mg tablets (lorazepam) NL/H/3485/001-002/DC Date: 13 March 2015 This module reflects the scientific discussion for the approval
More informationPublic Assessment Report. Scientific discussion. Granon (Acetylcysteine) DK/H/2352/ /MR. Date:
Public Assessment Report Scientific discussion Granon (Acetylcysteine) DK/H/2352/001-002/MR Date: 25-06-2015 This module reflects the scientific discussion for the approval of Granon. The procedure was
More informationPUBLIC ASSESSMENT REPORT. Decentralised Procedure DE/H/2858/001/DC. Calcium 1000 mg / Vitamin D3 880 I.U. chewable tablets
Federal Institute for Drugs and Medical Devices PUBLIC ASSESSMENT REPORT Decentralised Procedure DE/H/2858/001/DC Calcium 1000 mg / Vitamin D3 880 I.U. chewable tablets Calcium carbonate, Cholecalciferol
More informationPublic Assessment Report. Scientific discussion. Aktiprol 50 mg, 100 mg, 200 mg and 400 mg tablets. (Amisulpride) DK/H/2386/ /DC
Public Assessment Report Scientific discussion Aktiprol 50 mg, 100 mg, 200 mg and 400 mg tablets (Amisulpride) DK/H/2386/001-004/DC 21 January 2016 This module reflects the scientific discussion for the
More informationSummary Public Assessment Report. Generics. Triflu Paracetamol, Ascorbic acid, Pheniramine maleate MT/H/0172/001/DC
CMDh/305/2013 July 2014, Rev.01 Summary Public Assessment Report Generics Triflu Paracetamol, Ascorbic acid, Pheniramine maleate MT/H/0172/001/DC Date: 17 th August, 2016 Summary PAR Generics 1/3 Summary
More informationPublic Assessment Report. Scientific discussion. Tevaltan comp. Film-coated tablets 80 mg/12.5 mg and 160 mg/25 mg. Valsartan and hydrochlorothiazide
Public Assessment Report Scientific discussion Tevaltan comp. Film-coated tablets 80 mg/12.5 mg and 160 mg/25 mg Valsartan and hydrochlorothiazide DK/H/1524/001-002/DC This module reflects the scientific
More informationDecentralised Procedure. Public Assessment Report. Methylphenidate hydrochloride DE/H/2222/ /DC DE/H/2223/ /DC
Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Medikinet 5, 10, 20 mg Medikinet retard 5, 10, 20, 30, 40 mg Methylphenidate hydrochloride DE/H/2222/001-003/DC
More informationPublic Assessment Report. Scientific discussion. Leflunomide Apotex 10 mg and 20 mg, tablets. (leflunomide) NL/H/2548/ /DC
Public Assessment Report Scientific discussion Leflunomide Apotex 10 mg and 20 mg, tablets (leflunomide) 001-002/DC Date: 3 August 2015 This module reflects the scientific discussion for the approval of
More informationPublic Assessment Report. Scientific discussion. Tevalukast Chewable tablets 4 mg and 5 mg. Montelukast sodium DK/H/1331/ /DC
Public Assessment Report Scientific discussion Tevalukast Chewable tablets 4 mg and 5 mg Montelukast sodium DK/H/1331/001-002/DC This module reflects the scientific discussion for the approval of Tevalukast.
More informationSYNOPSIS. A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Phase II Study to Assess the Efficacy and Safety of RHINOCORT
Drug product: RHINOCORT AQUA Drug substance(s): Budesonide Edition No.: Final Study code: D5360C00703 Date: 8 November 2005 SYNOPSIS A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel
More informationUnited Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS DECENTRALISED PROCEDURE
United Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT Thyforon
More informationPublic Assessment Report. Scientific discussion. Bloxazoc 25 mg, 50 mg, 100 mg and 200 mg prolonged-release tablets Metoprolol succinate
CMDh/223/2005 February 2014 Public Assessment Report Scientific discussion Bloxazoc 25 mg, 50 mg, 100 mg and 200 mg prolonged-release tablets Metoprolol succinate HR/H/0103/001-004/DC Date: 16.2.2016 This
More informationDecentralised Procedure. Public Assessment Report
Decentralised Procedure Public Assessment Report Targin 2,5mg/1,25 mg, 15mg/7,5mg, 30mg/15mg Retardtabletten Oxycodone hydrochloride / Naloxone hydrochloride dihydrate DE/H/1612/005-007/DC Applicant: Mundipharma
More informationDECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT
BASG - Federal Office for Safety in Health Care AGES - Austrian Agency for Health and Food Safety Traisengasse 5, A-1200 Vienna www.basg.gv.at DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT
More informationPublic Assessment Report. Scientific discussion. Venlafaxin SUN 37.5 mg, 75 mg and 150 mg prolonged-release tablets. (venlafaxine hydrochloride)
Public Assessment Report Scientific discussion Venlafaxin SUN 37.5 mg, 75 mg and 150 mg prolonged-release tablets (venlafaxine hydrochloride) NL/H/3948/001-003/DC Date: 6 January 2016 This module reflects
More informationPublic Assessment Report. Scientific discussion. Pentasa Compact 4 g, prolonged-release granules. (mesalazine) NL License RVG:
Public Assessment Report Scientific discussion Pentasa Compact 4 g, prolonged-release granules (mesalazine) NL License RVG: 114015 Date: 30 March 2015 This module reflects the scientific discussion for
More informationPublic Assessment Report Scientific discussion. Rosuvastatin/Amlodipine 10 mg/5 mg, 10 mg/10 mg, 20 mg/5 mg and 20 mg/10 mg film-coated tablets
Public Assessment Report Scientific discussion Rosuvastatin/Amlodipine 10 mg/5 mg, 10 mg/10 mg, 20 mg/5 mg and 20 mg/10 mg film-coated tablets (Rosuvastatin calcium and Amlodipine besilate) ES/H/0320/001-004/DC
More informationPublic Assessment Report. Scientific discussion. Propofol Hospira 10 mg/ml emulsion for injection/infusion. (Propofol) DK/H/2311/001/DC
Public Assessment Report Scientific discussion Propofol Hospira 10 mg/ml emulsion for injection/infusion (Propofol) DK/H/2311/001/DC 18 September 2015 This module reflects the scientific discussion for
More informationSYNOPSIS. The study results and synopsis are supplied for informational purposes only.
SYNOPSIS INN : FEXOFENADINE Study number : PJPR0024 Study title : A double-blind, randomized, placebo-controlled, parallel study comparing the efficacy and safety of three dosage strengths of MDL 16,455A
More informationPublic Assessment Report. Scientific discussion. Tadalafil 1A Pharma 2.5 mg, 5 mg, 10 mg and 20 mg, film-coated tablets.
Public Assessment Report Scientific discussion Tadalafil 1A Pharma 2.5 mg, 5 mg, 10 mg and 20 mg, film-coated tablets (tadalafil) NL/H/3634/001-004/DC Date: 24 May 2017 This module reflects the scientific
More informationUnited Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS DECENTRALISED PROCEDURE
United Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT Forthyron
More informationPublic Assessment Report. Scientific discussion. Acetylsalicylzuur Disphar 500 mg and 1000 mg, oral powder. (acetylsalicylic acid)
Public Assessment Report Scientific discussion Acetylsalicylzuur Disphar 500 mg and 1000 mg, oral powder (acetylsalicylic acid) NL/H/3464/001-002/DC Date: 21 June 2017 This module reflects the scientific
More informationPublic Assessment Report. Scientific discussion. Rizatriptan Apotex disper 5 mg and 10 mg, orodispersible tablets. (rizatriptan benzoate)
Public Assessment Report Scientific discussion Rizatriptan Apotex disper 5 mg and 10 mg, orodispersible tablets (rizatriptan benzoate) NL/H/3152/001-002/DC Date: 4 July 2016 This module reflects the scientific
More informationPublic Assessment Report Scientific discussion. Ivabradine Grindeks 5 mg and 7.5 mg and filmcoated. Ivabradine hydrochloride ES/H/0375/ /DC
Public Assessment Report Scientific discussion Ivabradine Grindeks 5 mg and 7.5 mg and filmcoated tablets Ivabradine hydrochloride ES/H/0375/001-002/DC Registration number in Spain: 81.898, 81.899 This
More informationReport from the CMD(h) meeting held on 17 th and 18 th March 2008
Report from the CMD(h) meeting held on 17 th and 18 th March 2008 CMD(h)/EMEA Sub-Group on Paediatric Regulation Further to the line listings received for authorised medicinal products (including purely
More informationDECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT DERMIPRED/PREDNISOLONE CEVA 10 MG DATE : JULY 2016
FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS AGENCE NATIONALE DU MEDICAMENT VETERINAIRE 8 rue Claude Bourgelat Parc d activités de la grande Marche Javené CS 70611 35306 FOUGERES DECENTRALISED PROCEDURE
More informationPublic Assessment Report. Mebeverine hydrochloride 50mg/5ml Oral Suspension. (Mebeverine hydrochloride) UK Licence No: PL 44710/0024
Public Assessment Report Mebeverine hydrochloride 50mg/5ml Oral Suspension (Mebeverine hydrochloride) UK Licence No: PL 44710/0024 Kinedexe UK Limited 1 LAY SUMMARY Mebeverine hydrochloride 50mg/5ml Oral
More informationDECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) Federal Office of Consumer Protection and Food Safety Mauerstraße 39-42 10117 Berlin (Germany) DECENTRALISED PROCEDURE PUBLICLY AVAILABLE
More informationHealth Products Regulatory Authority IPAR. Public Assessment Report for a Medicinal Product for Human Use. Scientific discussion
IPAR Public Assessment Report for a Medicinal Product for Human Use Scientific discussion Advil Cold & Flu Coated Tablets Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg PA0822/164/001 The Public Assessment
More informationSummary Public Assessment Report. Generics. Rosuvastatin Galenicum 5mg, 10mg, 20mg and 40mg film-coated tablets Rosuvastatin Calcium
CMDh/305/2013 July 2014, Rev.01 Summary Public Assessment Report Generics Rosuvastatin Galenicum 5mg, 10mg, 20mg and 40mg film-coated tablets Rosuvastatin Calcium MT/H/0202/001-004/DC Date: June 2017 Summary
More informationPublic Assessment Report. Scientific discussion. Citalopram Jubilant 10 mg, 20 mg, 30 mg and 40 mg, film-coated tablets.
Public Assessment Report Scientific discussion Citalopram Jubilant 10 mg, 20 mg, 30 mg and 40 mg, film-coated tablets (citalopram) NL/H/2919/001-004/DC Date: 28 October 2014 This module reflects the scientific
More informationDE/H/0763/01-04 / MR DE/H/0764/01-04 / MR DE/H/0765/01-05 / MR
PUBLIC ASSESSMENT REPORT Mutual Recognition Procedure Module 5 Scientific discussion during the initial procedure Fenta Regiomedica Matrix 25 / 50 / 75 and 100 µg/h transdermal patch Fentapatch Matrix
More informationSummary Public Assessment Report. Generics. Fluoxetina Aurobindo PT/H/1137/ /DC. Date:
Summary Public Assessment Report Generics 20 mg, 60mg Capsules, hard (fluoxetine hydrochloride) PT/H/1137/001-002/DC Date: 11-11-2014 1/7 Summary Public Assessment Report Generics Fluoxetin hydrochloride,
More informationEprosartan 300 mg, 400 mg and 600 mg Film-coated Tablets. (Eprosartan mesilate) PL 37222/
Eprosartan 300 mg, 400 mg and 600 mg Film-coated Tablets (Eprosartan mesilate) PL 37222/0027-29 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 5 Steps taken for assessment Steps
More informationPublic Assessment Report for a Traditional Herbal Medicinal Product for Human Use
IPAR Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use Ginkgoforce Memory & Circulation Ginkgo Tablets Extract (as dry extract) from fresh leaves of Ginkgo biloba (Ginkgo
More informationHealth Products Regulatory Authority IPAR. Public Assessment Report for a. Traditional Herbal Medicinal Product
IPAR Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use Ginkgo-Biloba Pharma Nord film-coated tablets Ginkgo dry extract TR 1242/1/1 TR holder Pharma Nord ApS March 2018
More informationMeda Pharmaceuticals
MP03-33 Nasal Spray Page 1 of 9 Meda Pharmaceuticals Active-Controlled Trial of the Safety and Tolerability of MP03-33 in Patients with Chronic Allergic or Nonallergic Rhinitis (MP432) FINAL CLINICAL STUDY
More informationPublic Assessment Report. Scientific discussion. Thyrofix 25, 50, 75 and 100 micrograms tablets. (levothyroxine sodium) NL/H/3039/ /DC
Public Assessment Report Scientific discussion Thyrofix 25, 50, 75 and 100 micrograms tablets (levothyroxine sodium) NL/H/3039/001-004/DC Date: 19 February 2015 This module reflects the scientific discussion
More informationPublic Assessment Report. Scientific discussion. Hydroxyzinhydrochlorid EQL Pharma (Hydroxyzine hydrochloride) Film-coated tablet, 25 mg
Public Assessment Report Scientific discussion Hydroxyzinhydrochlorid EQL Pharma (Hydroxyzine hydrochloride) Film-coated tablet, 25 mg DK/H/2313/001/DC Date: 04-06-2014 This module reflects the scientific
More informationPublic Assessment Report Scientific discussion. Trelema (lacosamide) SE/H/1648/01-07/DC
Public Assessment Report Scientific discussion Trelema (lacosamide) SE/H/1648/01-07/DC This module reflects the scientific discussion for the approval of Trelema. The procedure was finalised on 2018-03-08.
More informationReport from the CMD(h) meeting held from 20 th to 22 nd March 2006
Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human General Issues Report from the CMD(h) meeting held from 20 th to 22 nd March 2006 Meeting on Harmonisation of SPCs with Interested
More informationPublic Assessment Report. Scientific discussion
Public Assessment Report Scientific discussion Palonosetron Fresenius Kabi 250 micrograms, solution for injection Palonosetron Fresenius Kabi 250 micrograms, solution for injection in pre-filled syringe
More informationInstitute for State Control of Veterinary Biologicals and Medicines Ústav pro státní kontrolu veterinárních biopreparátů a léčiv
Institute for State Control of Veterinary Biologicals and Medicines Ústav pro státní kontrolu veterinárních biopreparátů a léčiv DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY
More informationPublic Assessment Report. Scientific discussion. Celecoxib Apotex 100 mg and 200 mg, capsules, hard (celecoxib) NL/H/2760/ /DC
Public Assessment Report Scientific discussion Celecoxib Apotex 100 mg and 200 mg, capsules, hard (celecoxib) NL/H/2760/001-002/DC Date: 29 April 2014 This module reflects the scientific discussion for
More informationPublic Assessment Report. Scientific discussion. Acetylcysteine YES 600 mg, effervescent tablets. (acetylcysteine) NL/H/2975/001/DC
Public Assessment Report Scientific discussion Acetylcysteine YES 600 mg, effervescent tablets (acetylcysteine) NL/H/2975/001/DC Date: 4 March 2015 This module reflects the scientific discussion for the
More informationPublic Assessment Report Scientific discussion. Orest Easyhaler (budesonide, formoterol fumarate dihydrate) SE/H/1214/02-03/DC
Public Assessment Report Scientific discussion Orest Easyhaler (budesonide, formoterol fumarate dihydrate) SE/H/1214/02-03/DC This module reflects the scientific discussion for the approval of Orest Easyhaler.
More informationSummary Public Assessment Report. Generics. Amiodarona Aurobindo. 200 mg, Tablets. (Amiodarone hydrochloride) PT/H/1444/001/DC
Summary Public Assessment Report Generics 200 mg, Tablets (Amiodarone hydrochloride) Summary PAR Generics 1/9 Summary Public Assessment Report Generics 200 mg, Tablets Amiodarone hydrochloride 200 mg,
More informationAnnex II. Scientific conclusions
Annex II Scientific conclusions 5 Scientific conclusions Beclometasone dipropionate (BDP) is a glucocorticoid and a prodrug of the active metabolite, beclometasone-17-monopropionate. Beclometasone dipropionate
More informationPublic Assessment Report for a Traditional Herbal Medicinal Product for Human Use
IPAR Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use Agnus castus oral drops Tincture of Agnus castus fruit TR2309/017/001 A. Vogel Ireland Limited 28 November 2018 CRN008R68
More informationClinical Trials in Third Countries
Clinical Trials in Third Countries meeting, 29 January 2015 Presented by Fergus Sweeney European Medicines Agency An agency of the European Union Overview Distribution of clinical trials submitted in support
More informationMutual Recognition Procedure. Public Assessment Report. Valproat Orion 300 / 500 mg Retardtabletten. Sodium valproate DE/H/1910/ /MR
Mutual Recognition Procedure Public Assessment Report Valproat Orion 300 / 500 mg Retardtabletten Sodium valproate DE/H/1910/001-002/MR (former FI/H/0608/001-002/MR) Applicant: Orion Corporation Date:
More informationMUTUAL RECOGNITION PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT
FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS AGENCE NATIONALE DU MEDICAMENT VETERINAIRE 8 rue Claude Bourgelat Parc d activités de la grande Marche Javené CS 70611 35306 FOUGERES MUTUAL RECOGNITION
More informationHealth Products Regulatory Authority IPAR. Public Assessment Report. Scientific discussion
IPAR Public Assessment Report Scientific discussion Magnaspartate 243mg Powder for Oral Solution MAGNESIUM ASPARTATE DIHYDRATE IE/H/436/001/DC Date: 3 rd November 2014 This module reflects the scientific
More informationPublic Assessment Report Scientific discussion. Pramipexole Orion (pramipexole) SE/H/1672/01-07/DC
Public Assessment Report Scientific discussion Pramipexole Orion (pramipexole) SE/H/1672/01-07/DC This module reflects the scientific discussion for the approval of Pramipexole Orion. The procedure was
More informationPublic Assessment Report. Scientific discussion. Colecalciferol Fresenius I.E./ml Tropfen zum Einnehmen, Lösung COLECALCIFEROL AT/H/0578/001/DC
CMDh/223/2005 February 2014 Public Assessment Report Scientific discussion Colecalciferol Fresenius 14.400 I.E./ml Tropfen zum Einnehmen, Lösung COLECALCIFEROL AT/H/0578/001/DC Date: 21.12.2016 This module
More informationAnnex I. List of the names, pharmaceutical forms, strength of the medicinal product, route of administration, applicant in the Member States
Annex I List of the names, pharmaceutical forms, strength of the medicinal product, route of administration, applicant in the Member States 1 Member State EU/EEA Applicant Name Strength Pharmaceutic al
More informationPublic Assessment Report. Scientific discussion. Carvedilol Aurobindo 6.25 mg and 25 mg, film-coated tablets (carvedilol) NL/H/2609/ /MR
Public Assessment Report Scientific discussion Carvedilol Aurobindo 6.25 mg and 25 mg, film-coated tablets (carvedilol) NL/H/2609/001-002/MR Date: 26 May 2014 This module reflects the scientific discussion
More informationPublic Assessment Report for a Homeopathic Medicinal Product for Human Use
IPAR Public Assessment Report for a Homeopathic Medicinal Product for Human Use Teetha Teething Gel HOA1149/007/001 HOA holder: A. Nelson & Company Limited Date: 16 November 2018 16 November 2018 CRN008K7Z
More informationClinical Endpoint Bioequivalence Study Review in ANDA Submissions. Ying Fan, Ph.D.
Clinical Endpoint Bioequivalence Study Review in ANDA Submissions Ying Fan, Ph.D. 1 Disclaimer This presentation constitutes an informal communication that represents the best judgment of the speaker at
More informationDecentralised Procedure. Public Assessment Report. Levofloxacin HEC Pharm 250 mg / 500mg Filmtabletten. Levofloxacin DE/H/3929/ /DC
Decentralised Procedure Public Assessment Report Levofloxacin HEC Pharm 250 mg / 500mg Filmtabletten Levofloxacin DE/H/3929/001-002/DC Applicant: HEC Pharm GmbH Gabriele-Teregit-Promenade 17 D-10963 Berlin
More informationPublic Assessment Report Scientific discussion SE/H/1689/01/DC
Public Assessment Report Scientific discussion Budesonide/Formoterol Sandoz (budesonide, formoterol fumarate dehydrate) SE/H/1689/01/DC This module reflects the scientific discussion for the approval of
More informationPUBLIC ASSESSMENT REPORT Scientific Discussion
Direction de l Evaluation des Médicaments et des Produits Biologiques PUBLIC ASSESSMENT REPORT Scientific Discussion Tramadol hydrochloride + paracetamol 37.5 mg-325 mg Grünenthal film coated tablets Bonoc
More informationCommission. Product. Notification. Decision. Issued 2 / affected 3 amended on. 18/08/2017 SmPC and PL. 24/05/2017 SmPC, Annex II, Labelling
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected
More informationPublic Assessment Report Scientific discussion. Ibuprofen 400 mg/100 ml solution for infusion & Ibuprofen 600 mg/100 ml solution for infusion
Public Assessment Report Scientific discussion Ibuprofen 400 mg/100 ml solution for infusion & Ibuprofen 600 mg/100 ml solution for infusion Ibuprofen arginine ES/H/0390/001/DC ES/H/0392/001/DC Applicant:
More informationPublic Assessment Report Scientific discussion. Salmeterol/Fluticasone Sandoz (salmeterol xinafoate, fluticasone propionate) SE/H/1323/03/DC
Public Assessment Report Scientific discussion Salmeterol/Fluticasone Sandoz (salmeterol xinafoate, fluticasone propionate) SE/H/1323/03/DC This module reflects the scientific discussion for the approval
More informationPublic Assessment Report. Scientific discussion. Budesonide Teva Steri-Neb 0.25 mg/2 ml, 0.5 mg/2 ml and 1 mg/2 ml, nebuliser suspension (budesonide)
Public Assessment Report Scientific discussion Budesonide Teva Steri-Neb 0.25 mg/2 ml, 0.5 mg/2 ml and 1 mg/2 ml, nebuliser suspension (budesonide) NL/H/2714/001-003/DC Date: 5 August 2014 This module
More informationPublic Assessment Report. Scientific discussion. Etoricoxib Glenmark 30 mg, 60 mg, 90 mg and 120 mg, film-coated tablets.
Public Assessment Report Scientific discussion Etoricoxib Glenmark 30 mg, 60 mg, 90 mg and 120 mg, film-coated tablets (etoricoxib) NL/H/3576/001-004/DC Date: 5 July 2017 This module reflects the scientific
More informationPublic Assessment Report. Scientific discussion. Sildenafil CF 20 mg, film-coated tablets. (sildenafil citrate) NL/H/3630/001/DC
Public Assessment Report Scientific discussion Sildenafil CF 20 mg, film-coated tablets (sildenafil citrate) NL/H/3630/001/DC Date: 12 December 2017 This module reflects the scientific discussion for the
More informationDecentralised Procedure. Public Assessment Report
Decentralised Procedure Public Assessment Report Caspofungin Wockhardt/ Caspofungin Inresa 50 / 70 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung Caspofungin DE/H/4672+4794/001-002/DC
More informationFRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT
FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE FOR A VETERINARY MEDICINAL PRODUCT Colistin 2MIU/mL concentrate for oral solution for calves, lambs, pigs, chickens and turkeys(fr)
More informationOther EU Activities Contributing to Harmonization of Labeling
Other EU Activities Contributing to Harmonization of Labeling Dr Laurent Brassart European Medicines Agency Medical Information Sector DIA Labeling Harmonisation 2011 Workshop October 13-14. 2011 Disclaimer
More informationGuidance document on the content of the <Co-> Rapporteur day 80 critical assessment report
Guidance document on the content of the Rapporteur day 80 critical EMEA/H/C/ Applicant: Rapporteur: Co-rapporteur: EPL: PM: Start of the procedure: Date
More informationDecentralised Procedure. Public Assessment Report. Nasenspray sine AL 0,5 mg/ml Nasenspray, Lösung Nasenspray sine AL 1 mg/ml Nasenspray, Lösung
Decentralised Procedure Public Assessment Report Nasenspray sine AL 0,5 mg/ml Nasenspray, Lösung Nasenspray sine AL 1 mg/ml Nasenspray, Lösung Xylometazoline hydrochloride DE/H/4485/001-002/DC Applicant:
More informationSummary Public Assessment Report. Generics. Etoricoxib Aurobindo. 30 mg, 60 mg, 90 mg, 120 mg Film-coated tablet (Etoricoxib) PT/H/1603/ /DC
Summary Public Assessment Report Generics 30 mg, 60 mg, 90 mg, 120 mg Film-coated tablet (Etoricoxib) Date: 08-03-2017 Summary PAR Generics 1/10 Summary Public Assessment Report Generics 30 mg, 60 mg,
More informationSCIENTIFIC DISCUSSION
SCIENTIFIC DISCUSSION 1 INTRODUCTION This application has been submitted to the EMEA for the CHMP to issue a scientific opinion in accordance with Article 58 of Regulation (EC) No 726/2004, in the context
More informationPublic Assessment Report Scientific discussion. Mycophenolic Acid Accord Healthcare 180 mg and 360 mg gastro-resistant tablets. Mycophenolate sodium
Public Assessment Report Scientific discussion Mycophenolic Acid Accord Healthcare 180 mg and 360 mg gastro-resistant tablets Mycophenolate sodium ES/H/0275/001-002/DC Applicant: Accord Healthcare Limited
More informationAgencia Española de Medicamentos y Productos Sanitarios C/Campezo 1, Edificio Madrid España (Reference Member State)
DEPARTAMENTO DE MEDICAMENTOS VETERINARIOS Medicamentos y Productos C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State) DECENTRALISED PROCEDURE FINAL PUBLICLY AVAILABLE ASSESSMENT REPORT
More information