Summary Public Assessment Report. Generics. Amiodarona Aurobindo. 200 mg, Tablets. (Amiodarone hydrochloride) PT/H/1444/001/DC

Size: px
Start display at page:

Download "Summary Public Assessment Report. Generics. Amiodarona Aurobindo. 200 mg, Tablets. (Amiodarone hydrochloride) PT/H/1444/001/DC"

Transcription

1 Summary Public Assessment Report Generics 200 mg, Tablets (Amiodarone hydrochloride) Summary PAR Generics 1/9

2 Summary Public Assessment Report Generics 200 mg, Tablets Amiodarone hydrochloride 200 mg, Tablets This is a summary of the public assessment report (PAR) for. It explains how was assessed and its authorisation recommended as well as its conditions of use. It is not intended to provide practical advice on how to use. For practical information about using, patients should read the package leaflet or contact their doctor or pharmacist. What is and what is it used for? is a generic medicine. This means that is similar to a reference medicine already authorised in the European Union (EU) called Cordarone Amiodarone Aurobindo can be used to: Treat uneven heartbeats where other medicines either have not worked or cannot be used Treat an illness where your heart beats unusually fast (Wolff-Parkinson-White Syndrome), where other medicines either have not worked or cannot be used. Treat other types of fast or uneven heartbeats known as atrial flutter or atrial fibrillation. Amiodarone Aurobindo is used only when other medicines cannot be used. Treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone Aurobindo is used only when other medicines cannot be used. How does work? Amiodarone Aurobindo contain a medicine called Amiodarone hydrochloride. This belongs to a group of medicines called anti-arrhythmics. It works by controlling the uneven beating of your heart (called arrhythmias ). Taking the tablets helps your heartbeat to return to normal. How is used? The pharmaceutical form of Amiodarone Aurobindo is Tablets and the route of administration is oral. Please read section 3 of the PL for detailed information on dosing recommendations, the route of administration, and the duration of treatment. Summary PAR Generics 2/9

3 The medicine can only be obtained with a prescription. What benefits of have been shown in studies? Because is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Cordarone. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. The company provided data from the published literature on Amiodarone hydrochloride What are the possible side effects of? Because is a generic medicine and is bioequivalent to the reference medicine, its benefits and possible side effects are taken as being the same as the reference medicine. For the full list of restrictions, see the package leaflet. Why is approved? It was concluded that, in accordance with EU requirements, 200 mg, Tablets has been shown to have comparable quality and to be bioequivalent/be comparable to Cordarone 200 mg, Tablets. Therefore, the INFARMED, I.P. decided that, as for <reference medicine called Cordarone 200 mg, Tablets, the benefits are greater than its risk and recommended that it can be approved for use. What measures are being taken to ensure the safe and effective use of Amiodarona Aurobindo? A Risk Management Plan Version 1.0, DLP 05 March 2015 (date of final sign off 25 March 2015) - has been developed to ensure that is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously as well. Other information about The marketing authorisation for was granted on The full PAR for can be found on the website For more information about treatment with, read the package leaflet or contact your doctor or pharmacist. Summary PAR Generics 3/9

4 Public Assessment Report Scientific discussion 200 mg, Tablets (Amiodarone hydrochloride) This module reflects the scientific discussion for the approval of. The procedure was finalised at For information on changes after this date please refer to the module Update. Summary PAR Generics 4/9

5 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have agreed in granting a marketing authorisation for 200 mg, Tablets, from Aurobindo Pharma (Portugal) Unipessoal Limitada. The product is indicated for: Treatment should be initiated and normally monitored only under hospital or specialist supervision. Oral Amiodarone Aurobindo is indicated only for the treatment of severe rhythm disorders not responding to other therapies or when other treatments cannot be used. Tachyarrhythmias associated with Wolff-Parkinson-White Syndrome, when other drugs cannot be used. Atrial flutter and fibrillation when other drugs cannot be used. All types of tachyarrhythmias of paroxysmal nature including: supraventricular, nodal and ventricular tachycardias,ventricular fibrillation: when other drugs cannot be used. A comprehensive description of the indications and posology is given in the SmPC. This is an application for, using the decentralised procedure. The PT act as RMS and BE, CY, DE, ES and NL act as CMS. The marketing authorization was granted on based on Directive 2001/83/EC article 10.1 (a) (iii) first paragraph and the Marketing Authorisation Holder is Aurobindo Pharma (Portugal) Unipessoal Limitada. The application was submitted on the basis of Directive 2001/83/EC (as amended) Article 10(1) generic application. The applicant claims essential similarity to Cordarone 200 mg, Tablets (MA holder: Sanofi - Produtos Farmacêuticos, Lda.) authorised in PT on II. QUALITY ASPECTS II.1 Introduction Tablet. White to off-white round biconvex uncoated tablets debossed with 8 and 4 separated by a break line on one side and A on the other side. The tablet can be divided into equal doses. The excipients are: Lactose monohydrate, silica colloidal anhydrous, sodium starch glycolate (Type- A), povidone (K-30) and magnesium stearate. Summary PAR Generics 5/9

6 Amiodarone Aurobindo tablets are available in white opaque PVC - Aluminium foil blister pack and White opaque HDPE bottle pack with white opaque polypropylene closure. Pack sizes: Blisters: 5, 10, 20, 30, 50, 60, 90 and 100 tablets Bottles: 250 and 500 tablets Not all pack sizes may be marketed. II.2 Drug Substance NOMENCLATURE STRUCTURE Summary PAR Generics 6/9

7 GENERAL PROPERTIES The chemical-pharmaceutical documentation and Quality Overall Summary in relation to Amiodarona Aurobindo/ are of sufficient quality in view of the present European regulatory requirements. The control tests and specifications for drug substance product are adequately drawn up. Stability studies have been performed with the drug substance. No significant changes in any parameters were observed. The proposed retest period of 4 years is justified. II.3 Medicinal Product The development of the product has been described, the choice of excipients is justified and their functions explained. The product specifications cover appropriate parameters for this dosage form. Validations of the analytical methods have been presented. Batch analysis has been performed on 3 batches. The batch analysis results show that the finished products meet the specifications proposed. The conditions used in the stability studies are according to the ICH stability guideline. The control tests and specifications for drug product are adequately drawn up. The proposed shelf-life is of 24 months for the drug product. The RMS considers that storage condition Store below 30ºC are acceptable. Summary PAR Generics 7/9

8 III. NON-CLINICAL ASPECTS Pharmacodynamic, pharmacokinetic and toxicological properties of amiodarone are well known. As amiodarone is a widely used, well-known active substance, the applicant has not provided additional studies and further studies are not required. Overview based on literature review is, thus, appropriate. III.1 Ecotoxicity/environmental risk assessment (ERA) Since 200 mg, Tablets is intended for generic substitution, this will not lead to an increased exposure to the environment. An environmental risk assessment is therefore not deemed necessary. IV. CLINICAL ASPECTS To support the application, the Applicant has submitted as report a single dose bioequivalence study under fed conditions: An open label, randomized, two-treatment, single-period, parallel, single-dose oral bioequivalence study of Amiodarone Hydrochloride Tablets BP 200 mg (Test) of Aurobindo Pharma Limited, India and Cordarone Tablets 200 mg (Reference) of Sanofi Aventis France, in 84 healthy, adult, human subjects under fed conditions. Conclusion on bioequivalence studies: Based on the submitted bioequivalence study 200 mg, Tablets is considered bioequivalent with Cordarone 200 mg, Tablets. IV.1 Risk Management Plan The MAH has submitted a Risk Management Plan Version 1.0, DLP 05 March 2015 (date of final sign off 25 March 2015), in accordance with the requirements of Directive 2001/83/EC as amended, describing the pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to 200 mg, Tablets. Important identified risks - Conduction disturbances (sinoatrial block, AV block of various degrees) - Onset or worsening of arrhythmia - Torsade de pointes - Hypothyroidism/Hyperthyroidism - Interaction with substances which may induce QT prolongation and can cause Torsade de pointes - Use in Pregnancy and Lactation - Eye disorders such as blurred or decreased vision /Optic neuropathy/neuritis - Hepatic effects, including cirrhosis, hepatitis, jaundice and hepatic failure - Peripheral sensorimotor neuropathy and/or myopathy - Pulmonary toxicity - Photosensitivity - Use in patients under general anaesthesia Summary PAR Generics 8/9

9 - Syndrome of inappropriate antidiuretic hormone secretion - Interaction with beta-blockers, heart rate lowering calciumchannel inhibitors (verapamil, diltiazem), stimulant laxative agents which may cause hypokalaemia - Interactions with substances that are substrates for CYP1A1, CYP1A2, CYP3A4, CYP2C9, CYP2D6 and Pglycoprotein and CYP3A4 and CYP2C8 inhibitors (increased amiodarone concentrations) - Pancreatitis (acute) - Adult respiratory distress syndrome (ARDS) - Thyroid disorders - Hepatoxicity - Pulmonary toxicity - Conduction disturbances - Proarrythmic disorders (including arrhythmia, torsade de pointes, cardiac arrest) - Muscular toxicity in combination with statins - Severe bullous reactions (SJS and TEN) Important potential risks - None Missing information - Use in the paediatric population IV.2 Discussion on the clinical aspects This type of application refers to information that is contained in the pharmacological-toxicological and clinical part of the dossier of the authorisation of the reference product. A reference product is a medicinal product authorised and marketed on the basis of a full dossier, i.e. including chemical, biological, pharmaceutical, pharmacological-toxicological and clinical data. This information is not fully available in the public domain. Authorisations for generic products are therefore linked to the original authorized medicinal product, which is legally allowed once the data protection time of the dossier of the reference product has expired. For this kind of application, it has to be demonstrated that the pharmacokinetic profile of the product is similar to the pharmacokinetic profile of the reference product. This generic product can be used instead of its reference product. V. USER CONSULTATION A user consultation with target patient groups on the package information leaflet (PIL) has been performed on the basis of a bridging report. The bridging report submitted by the applicant has been found acceptable. VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION The application for 200 mg, Tablets contains adequate quality, non-clinical and clinical data and the bioequivalence has been shown. A benefit/risk ratio comparable to the reference product can therefore be concluded. Summary PAR Generics 9/9

Summary Public Assessment Report. Generics. Fluoxetina Aurobindo PT/H/1137/ /DC. Date:

Summary 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 information

Summary 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. 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 information

Summary Public Assessment Report. Generics. Rosuvastatin Galenicum 5mg, 10mg, 20mg and 40mg film-coated tablets Rosuvastatin Calcium

Summary 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 information

Public Assessment Report. Scientific discussion. Bloxazoc 25 mg, 50 mg, 100 mg and 200 mg prolonged-release tablets Metoprolol succinate

Public 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 information

Summary Public Assessment Report. Generics. Triflu Paracetamol, Ascorbic acid, Pheniramine maleate MT/H/0172/001/DC

Summary 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 information

Summary Public Assessment Report. Generics. Pregabalina Biofarmoz PT/H/1292/ /DC

Summary Public Assessment Report. Generics. Pregabalina Biofarmoz PT/H/1292/ /DC Summary Public Assessment Report Generics 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, capsules, hard (Pregabalin) Summary PAR Generics 1/11 Summary Public Assessment Report Generics Pregabalin 25 mg, 50 mg, 75

More information

Public 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/ /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 information

Public Assessment Report. Scientific discussion. Kaliumklorid "EQL Pharma" (Potassium chloride) DK/H/2662/001/DC. Date:

Public 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 information

Public 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. 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 information

Public Assessment Report. Scientific discussion. Mogilarta. (Telmisartan and hydrochlorothiazide) DK/H/2306/ /DC.

Public 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 information

Public 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/ /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 information

Public 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. 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 information

Decentralised 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 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 information

Summary Public Assessment Report. non-generics. Folic acid Colonis Folic acid MT/H/0203/001/DC

Summary Public Assessment Report. non-generics. Folic acid Colonis Folic acid MT/H/0203/001/DC CMDh/233/2011 June 2014 Summary Public Assessment Report non-generics Folic acid Colonis Folic acid MT/H/0203/001/DC Date: 18 th November, 2016 Summary PAR non-generics 1/4 Summary Public Assessment Report

More information

Public 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) 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 information

Public Assessment Report. Scientific discussion. Granon (Acetylcysteine) DK/H/2352/ /MR. Date:

Public 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 information

Public 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 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 information

Decentralised 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 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 information

Public 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/ /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 information

Public Assessment Report. Scientific discussion. Etoricoxib Mylan 30 mg, 60 mg, 90 mg and 120 mg, film-coated tablets.

Public Assessment Report. Scientific discussion. Etoricoxib Mylan 30 mg, 60 mg, 90 mg and 120 mg, film-coated tablets. Public Assessment Report Scientific discussion Etoricoxib Mylan 30 mg, 60 mg, 90 mg and 120 mg, film-coated tablets (etoricoxib) NL/H/3151/001-004/DC Date: 7 July 2016 This module reflects the scientific

More information

Public 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/ /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 information

Public Assessment Report. Scientific discussion. Midazolam Orpha 15 mg, film-coated tablets (midazolam maleate) NL/H/2815/001/DC.

Public Assessment Report. Scientific discussion. Midazolam Orpha 15 mg, film-coated tablets (midazolam maleate) NL/H/2815/001/DC. Public Assessment Report Scientific discussion Midazolam Orpha 15 mg, film-coated tablets (midazolam maleate) NL/H/2815/001/DC Date: 9 July 2014 This module reflects the scientific discussion for the approval

More information

Public Assessment Report. Scientific discussion MINOXIDIL AT/H/0638/ /DC. Date:

Public Assessment Report. Scientific discussion MINOXIDIL AT/H/0638/ /DC. Date: CMDh/223/2005 February 2014 Public Assessment Report Scientific discussion Alocutan 20 mg/ml Spray zur Anwendung auf der Haut, Lösung, Alocutan 50 mg/ml Spray zur Anwendung auf der Haut, Lösung MINOXIDIL

More information

Decentralised 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/ /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 information

Public 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 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 information

Decentralised 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 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 information

Public 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 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 information

Public Assessment Report Scientific discussion. Oxikodon Depot Actavis (oxycodone hydrochloride) SE/H/1313/01-08/DC

Public Assessment Report Scientific discussion. Oxikodon Depot Actavis (oxycodone hydrochloride) SE/H/1313/01-08/DC Public Assessment Report Scientific discussion Oxikodon Depot Actavis (oxycodone hydrochloride) SE/H/1313/01-08/DC This module reflects the scientific discussion for the approval of Oxikodon Depot Actavis.

More information

Public Assessment Report. Scientific discussion. Diliban Retard Tramadol/Paracetamol IS/H/0168/001/DC. Date:

Public Assessment Report. Scientific discussion. Diliban Retard Tramadol/Paracetamol IS/H/0168/001/DC. Date: CMDh/223/2005 February 2014 Public Assessment Report Scientific discussion Diliban Retard Tramadol/Paracetamol IS/H/0168/001/DC Date: 12.10.2015 This module reflects the scientific discussion for the approval

More information

Public 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: 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 information

Public Assessment Report. Scientific discussion. Risedronaatnatrium Aurobindo 75 mg, film-coated tablets. (risedronate sodium) NL/H/2263/004/DC

Public Assessment Report. Scientific discussion. Risedronaatnatrium Aurobindo 75 mg, film-coated tablets. (risedronate sodium) NL/H/2263/004/DC Public Assessment Report Scientific discussion Risedronaatnatrium Aurobindo 75 mg, film-coated tablets (risedronate sodium) NL/H/2263/004/DC Date: 13 January 2017 This module reflects the scientific discussion

More information

DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT

DECENTRALISED 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 information

Public Assessment Report. Scientific discussion. Colecalciferol Fresenius I.E./ml Tropfen zum Einnehmen, Lösung COLECALCIFEROL AT/H/0578/001/DC

Public 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 information

Eprosartan 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/ 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 information

Public 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 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 information

Public 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 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 information

Public 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. 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 information

Public 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 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 information

Public Assessment Report Scientific discussion. Ciprofloxacin Pfizer (Ciprofloxacin hydrochloride) SE/H/803/01-03/DC

Public Assessment Report Scientific discussion. Ciprofloxacin Pfizer (Ciprofloxacin hydrochloride) SE/H/803/01-03/DC Public Assessment Report Scientific discussion Ciprofloxacin Pfizer (Ciprofloxacin hydrochloride) SE/H/803/01-03/DC This module reflects the scientific discussion for the approval of Ciprofloxacin Pfizer.

More information

Public Assessment Report Scientific discussion. Metoclopramide Orion (metoclopramide hydrochloride) SE/H/1445/01/DC

Public Assessment Report Scientific discussion. Metoclopramide Orion (metoclopramide hydrochloride) SE/H/1445/01/DC Public Assessment Report Scientific discussion Metoclopramide Orion (metoclopramide hydrochloride) SE/H/1445/01/DC This module reflects the scientific discussion for the approval of Metoclopramide Orion.

More information

Public Assessment Report Scientific discussion. Modafinil Bluefish (modafinil) SE/H/1325/01/DC

Public Assessment Report Scientific discussion. Modafinil Bluefish (modafinil) SE/H/1325/01/DC Public Assessment Report Scientific discussion Modafinil Bluefish (modafinil) SE/H/1325/01/DC This module reflects the scientific discussion for the approval of Modafinil Bluefish. The procedure was finalised

More information

Public 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 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 information

Public Assessment Report Scientific discussion. Heracillin, 1 g, film-coated tablet (flucloxacillin) Asp no:

Public Assessment Report Scientific discussion. Heracillin, 1 g, film-coated tablet (flucloxacillin) Asp no: Public Assessment Report Scientific discussion Heracillin, 1 g, film-coated tablet (flucloxacillin) Asp no: 2016-1464 This module reflects the scientific discussion for the approval of Heracillin. The

More information

Public 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. 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 information

Ciprofloxacin Bluefish (Ciprofloxacin hydrochloride)

Ciprofloxacin Bluefish (Ciprofloxacin hydrochloride) Public Assessment Report Scientific discussion Ciprofloxacin Bluefish (Ciprofloxacin hydrochloride) Asp. no: 2006-1626 - 1628 This module reflects the scientific discussion for the approval of Ciprofloxacin

More information

Public Assessment Report. Scientific discussion. Alfuzosine HCl Aurobindo 10 mg, prolonged-release tablets. (alfuzosin hydrochloride) NL/H/3015/001/MR

Public Assessment Report. Scientific discussion. Alfuzosine HCl Aurobindo 10 mg, prolonged-release tablets. (alfuzosin hydrochloride) NL/H/3015/001/MR Public Assessment Report Scientific discussion Alfuzosine HCl Aurobindo 10 mg, prolonged-release tablets (alfuzosin hydrochloride) NL/H/3015/001/MR Date: 9 September 2014 This module reflects the scientific

More information

Public 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 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 information

Public 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/ /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 information

Public Assessment Report. Scientific discussion. Enolwen (oxycodone hydrochloride and naloxone hydrochloride dehydrate) SE/H/1510/01-04/DC

Public Assessment Report. Scientific discussion. Enolwen (oxycodone hydrochloride and naloxone hydrochloride dehydrate) SE/H/1510/01-04/DC Public Assessment Report Scientific discussion Enolwen (oxycodone hydrochloride and naloxone hydrochloride dehydrate) SE/H/1510/01-04/DC This module reflects the scientific discussion for the approval

More information

United 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 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 information

Public 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 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 information

Public 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/ /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 information

Public Assessment Report Scientific discussion. Vixantus (tadalafil) SE/H/1532/01-04/DC

Public Assessment Report Scientific discussion. Vixantus (tadalafil) SE/H/1532/01-04/DC Public Assessment Report Scientific discussion Vixantus (tadalafil) SE/H/1532/01-04/DC This module reflects the scientific discussion for the approval of Vixantus. The procedure was finalised on 2016-04-20.

More information

Public Assessment Report. Scientific discussion. Ipratropiumbromide/Salbutamol Cipla 0.5 mg/2.5 mg per 2.5 ml, nebuliser solution

Public Assessment Report. Scientific discussion. Ipratropiumbromide/Salbutamol Cipla 0.5 mg/2.5 mg per 2.5 ml, nebuliser solution Public Assessment Report Scientific discussion Ipratropiumbromide/Salbutamol Cipla 0.5 mg/2.5 mg per 2.5 ml, nebuliser solution (ipratropium bromide/salbutamol) NL/H/3022/001/DC Date: 13 January 2015 This

More information

Decentralised Procedure. Public Assessment Report

Decentralised 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 information

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

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 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 information

Public Assessment Report Scientific discussion. Anastrozole Bluefish 1 mg film-coated tablets (anastrozole) SE/H/781/01/DC

Public Assessment Report Scientific discussion. Anastrozole Bluefish 1 mg film-coated tablets (anastrozole) SE/H/781/01/DC Public Assessment Report Scientific discussion Anastrozole Bluefish 1 mg film-coated tablets (anastrozole) SE/H/781/01/DC This module reflects the scientific discussion for the approval of Anastrozole

More information

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)

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) 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 information

Public Assessment Report. Scientific discussion. Levofloxacin Bluefish (levofloxacin hemihydrate) SE/H/889/01-02/DC

Public Assessment Report. Scientific discussion. Levofloxacin Bluefish (levofloxacin hemihydrate) SE/H/889/01-02/DC Public Assessment Report Scientific discussion Levofloxacin Bluefish (levofloxacin hemihydrate) SE/H/889/01-02/DC This module reflects the scientific discussion for the approval of Levofloxacin Bluefish.

More information

Public 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 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 information

Public 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) 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 information

Decentralised 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 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 information

Public Assessment Report. Scientific discussion. Abacavir/Lamivudine/Zidovudine Mylan 300 mg/ 150 mg/300 mg, film-coated tablets

Public Assessment Report. Scientific discussion. Abacavir/Lamivudine/Zidovudine Mylan 300 mg/ 150 mg/300 mg, film-coated tablets Public Assessment Report Scientific discussion Abacavir/Lamivudine/Zidovudine Mylan 300 mg/ 150 mg/300 mg, film-coated tablets (abacavir/lamivudine/zidovudine) NL/H/2864/001/DC Date: 29 July 2014 This

More information

Public Assessment Report Scientific discussion. Methylphenidate E Consult (methylphenidate hydrochloride) Asp no: , ,

Public Assessment Report Scientific discussion. Methylphenidate E Consult (methylphenidate hydrochloride) Asp no: , , Public Assessment Report Scientific discussion Methylphenidate E Consult (methylphenidate hydrochloride) Asp no: 2014-1206, 2014-1207, 2014-1208 This module reflects the scientific discussion for the approval

More information

Public 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. 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 information

United 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 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 information

Public Assessment Report Scientific discussion. Ciprofloxacin Accord (ciprofloxacin hydrochloride) SE/H/1026/01-03/DC

Public Assessment Report Scientific discussion. Ciprofloxacin Accord (ciprofloxacin hydrochloride) SE/H/1026/01-03/DC Public Assessment Report Scientific discussion Ciprofloxacin Accord (ciprofloxacin hydrochloride) SE/H/1026/01-03/DC This module reflects the scientific discussion for the approval of Ciprofloxacin Accord.

More information

VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology VI.2.2 Summary of treatment benefits

VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology VI.2.2 Summary of treatment benefits VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Nausea and vomiting are common ailments had by many individuals. Nausea is defined as the unpleasant, painless sensation that

More information

Public Assessment Report Scientific discussion. Dexametason Abcur Dexamethasone SE/H/1260/01-02/DC

Public Assessment Report Scientific discussion. Dexametason Abcur Dexamethasone SE/H/1260/01-02/DC Public Assessment Report Scientific discussion Dexametason Abcur Dexamethasone SE/H/1260/01-02/DC This module reflects the scientific discussion for the approval of Dexametson Abcur. The procedure was

More information

Public Assessment Report Scientific discussion. Aspirin (acetylsalicylic acid) Asp no:

Public Assessment Report Scientific discussion. Aspirin (acetylsalicylic acid) Asp no: Public Assessment Report Scientific discussion Aspirin (acetylsalicylic acid) Asp no: 2015-0454 This module reflects the scientific discussion for the approval of Aspirin. The procedure was finalised on

More information

Public Assessment Report. Scientific discussion. Pregabalin Orion (pregabalin) SE/H/1440/01-07/DC

Public Assessment Report. Scientific discussion. Pregabalin Orion (pregabalin) SE/H/1440/01-07/DC Public Assessment Report Scientific discussion Pregabalin Orion (pregabalin) SE/H/1440/01-07/DC This module reflects the scientific discussion for the approval of Pregabalin Orion. The procedure was finalised

More information

Public 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 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 information

Public 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) 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 information

Public Assessment Report Scientific discussion. Rizatriptan Orifarm (rizatriptan) SE/H/1104/01-02/DC

Public Assessment Report Scientific discussion. Rizatriptan Orifarm (rizatriptan) SE/H/1104/01-02/DC Public Assessment Report Scientific discussion Rizatriptan Orifarm (rizatriptan) SE/H/1104/01-02/DC This module reflects the scientific discussion for the approval of Rizatriptan Orifarm. The procedure

More information

Health Products Regulatory Authority IPAR. Public Assessment Report. Scientific discussion

Health 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 information

Public Assessment Report Scientific discussion. Lamotrigin Medartuum Lamotrigine SE/H/728/01-04/MR

Public Assessment Report Scientific discussion. Lamotrigin Medartuum Lamotrigine SE/H/728/01-04/MR Public Assessment Report Scientific discussion Lamotrigin Medartuum Lamotrigine SE/H/728/01-04/MR This module reflects the scientific discussion for the approval of Lamotrigin Medartuum. The procedure

More information

Public Assessment Report Scientific discussion. Divisun (colecalciferol) SE/H/1122/02-04/DC

Public Assessment Report Scientific discussion. Divisun (colecalciferol) SE/H/1122/02-04/DC Public Assessment Report Scientific discussion Divisun (colecalciferol) SE/H/1122/02-04/DC This module reflects the scientific discussion for the approval of Divisun. The procedure was finalised on 2015-10-22.

More information

Amiodarone. Traffic light classification- Amber 2 Information sheet for Primary Care Prescribers

Amiodarone. Traffic light classification- Amber 2 Information sheet for Primary Care Prescribers Amiodarone Traffic light classification- Amber 2 Information sheet for Primary Care Prescribers Licensed Indications Tachyarrhythmias associated with Wolff-Parkinson-White syndrome All types of tachyarrhythmias

More information

Public Assessment Report Scientific discussion. Sumatriptan Pfizer (sumatriptan succinate) SE/H/973/01-02/DC

Public Assessment Report Scientific discussion. Sumatriptan Pfizer (sumatriptan succinate) SE/H/973/01-02/DC Public Assessment Report Scientific discussion Sumatriptan Pfizer (sumatriptan succinate) SE/H/973/01-02/DC This module reflects the scientific discussion for the approval of Sumatriptan Pfizer. The procedure

More information

Public Assessment Report. Scientific discussion

Public 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 information

Public Assessment Report Scientific discussion. Flucloxacillin Orion (flucloxacillin sodium) SE/H/981/03/DC

Public Assessment Report Scientific discussion. Flucloxacillin Orion (flucloxacillin sodium) SE/H/981/03/DC Public Assessment Report Scientific discussion Flucloxacillin Orion (flucloxacillin sodium) SE/H/981/03/DC This module reflects the scientific discussion for the approval of Flucloxacillin Orion. The procedure

More information

Public Assessment Report Scientific discussion SE/H/1689/01/DC

Public 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 information

Public Assessment Report Scientific discussion. Acetylsalicylsyra Actavis (acetylsalicylic acid) SE/H/1020/ /DC

Public Assessment Report Scientific discussion. Acetylsalicylsyra Actavis (acetylsalicylic acid) SE/H/1020/ /DC Public Assessment Report Scientific discussion Acetylsalicylsyra Actavis (acetylsalicylic acid) SE/H/1020/002-005/DC This module reflects the scientific discussion for the approval of Acetylsalicylsyra

More information

Public Assessment Report. Scientific discussion. Ropinirol Actavis. Ropinirole hydrochloride DK/H/1212/ /DC

Public Assessment Report. Scientific discussion. Ropinirol Actavis. Ropinirole hydrochloride DK/H/1212/ /DC Public Assessment Report Scientific discussion Ropinirol Actavis Ropinirole hydrochloride DK/H/1212/001-007/DC This module reflects the scientific discussion for the approval of Ropinirole film-coated

More information

Public Assessment Report. Scientific discussion. Amlodipine/Valsartan Apotex 5 mg/80 mg, 5 mg/160 mg and 10 mg/160 mg, film-coated tablets

Public Assessment Report. Scientific discussion. Amlodipine/Valsartan Apotex 5 mg/80 mg, 5 mg/160 mg and 10 mg/160 mg, film-coated tablets C Public Assessment Report Scientific discussion Amlodipine/Valsartan Apotex 5 mg/80 mg, 5 mg/160 mg and 10 mg/160 mg, film-coated tablets (amlodipine besilate/valsartan) NL/H/3447/001-003/DC Date: 13

More information

Decentralised Procedure. Public Assessment Report

Decentralised 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 information

Public Assessment Report. Scientific discussion

Public Assessment Report. Scientific discussion Public Assessment Report Scientific discussion Valbanatan 320 mg/25 mg; 160 mg/12,5 mg; 160 mg/25 mg; 320 mg/12,5 mg; 320 mg/25 mg Filmtabletten Valbacomp 320 mg/25 mg; 160 mg/12,5 mg; 160 mg/25 mg; 320

More information

Public 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) 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 information

Public Assessment Report. Scientific discussion. Sertraline Apotex 50 mg and 100 mg, film-coated tablets (sertraline hydrochloride)

Public Assessment Report. Scientific discussion. Sertraline Apotex 50 mg and 100 mg, film-coated tablets (sertraline hydrochloride) Public Assessment Report Scientific discussion Sertraline Apotex 50 mg and 100 mg, film-coated tablets (sertraline hydrochloride) NL/H/2800/001-002/DC Date: 6 May 2014 This module reflects the scientific

More information

PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT

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 information

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/ /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 information

Public Assessment Report Scientific discussion. Deferiprone DOC (deferiprone) SE/H/1687/01-02/DC

Public Assessment Report Scientific discussion. Deferiprone DOC (deferiprone) SE/H/1687/01-02/DC Public Assessment Report Scientific discussion Deferiprone DOC (deferiprone) SE/H/1687/01-02/DC This module reflects the scientific discussion for the approval of Deferiprone DOC. The procedure was finalised

More information

Public 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 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 information

Public Assessment Report Scientific discussion

Public Assessment Report Scientific discussion Public Assessment Report Scientific discussion Sertralin Actavis (Sertralpharm) Sertraxea Tifisertral Sertraparma Applicant: Alfred E. Tiefenbacher (GmbH & Co.) Hamburg, Germany Ziral Applicant: A.V.I.

More information

Public Assessment Report. Scientific discussion. Rispalan film-coated tablets Risperidone SE/H/685/01-07/MR

Public Assessment Report. Scientific discussion. Rispalan film-coated tablets Risperidone SE/H/685/01-07/MR Public Assessment Report Scientific discussion Rispalan film-coated tablets Risperidone SE/H/685/01-07/MR This module reflects the scientific discussion for the approval of Rispalan film-coated tablets.

More information

Public Assessment Report. Scientific discussion. Rivaroxaban Denk 2.5 mg, 10 mg, 15 mg and 20 mg, film-coated tablets.

Public Assessment Report. Scientific discussion. Rivaroxaban Denk 2.5 mg, 10 mg, 15 mg and 20 mg, film-coated tablets. Public Assessment Report Scientific discussion Rivaroxaban Denk 2.5 mg, 10 mg, 15 mg and 20 mg, film-coated tablets (rivaroxaban) NL/H/3972/001-004/DC Date: 24 April 2018 This module reflects the scientific

More information

Public Assessment Report Scientific discussion. Levodopa/Carbidopa/Entacapone Mylan (levodopa, carbidopa, entacapone) SE/H/1548/01-06/DC

Public Assessment Report Scientific discussion. Levodopa/Carbidopa/Entacapone Mylan (levodopa, carbidopa, entacapone) SE/H/1548/01-06/DC Public Assessment Report Scientific discussion Levodopa/Carbidopa/Entacapone Mylan (levodopa, carbidopa, entacapone) SE/H/1548/01-06/DC This module reflects the scientific discussion for the approval of

More information

Mutual 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/ /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 information

Public Assessment Report. Scientific discussion. Metoprololsuccinat Actavis. Prolonged release tablets 25 mg, 50 mg, 100 mg and 200 mg

Public Assessment Report. Scientific discussion. Metoprololsuccinat Actavis. Prolonged release tablets 25 mg, 50 mg, 100 mg and 200 mg Public Assessment Report Scientific discussion Metoprololsuccinat Actavis Prolonged release tablets 25 mg, 50 mg, 100 mg and 200 mg Metoprolol succinate This module reflects the scientific discussion for

More information

Public Assessment Report. Scientific discussion. Valganciclovir Mylan 450 mg, film-coated tablets. (valganciclovir hydrochloride) NL/H/3035/001/DC

Public Assessment Report. Scientific discussion. Valganciclovir Mylan 450 mg, film-coated tablets. (valganciclovir hydrochloride) NL/H/3035/001/DC Public Assessment Report Scientific discussion Valganciclovir Mylan 450 mg, film-coated tablets (valganciclovir hydrochloride) NL/H/3035/001/DC Date: 4 May 2015 This module reflects the scientific discussion

More information