NEUROTONE THR 00904/0005 UKPAR

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "NEUROTONE THR 00904/0005 UKPAR"

Transcription

1 NEUROTONE THR 00904/0005 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Summary of Product Characteristics Page 11 Product Information Leaflet Page 15 Labelling Page 18 MHRA PAR; NEUROTONE, THR 00904/0005 1

2 NEUROTONE THR 00904/0005 LAY SUMMARY The Medicines and Healthcare products Regulatory Agency (MHRA) granted Kerbina Limited (trading as Bio-Health Limited) a Traditional Herbal Registration Certificate for the traditional herbal medicinal product NEUROTONE (Traditional Herbal Registration number: THR 00904/0005) on 20 March NEUROTONE is available without prescription and can be bought from pharmacies and other outlets. NEUROTONE is a traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety, based on traditional use only. The active ingredients in NEUROTONE come from the strobile of the Hops plant (Humulus lupulus L.), the herb of the Scullcap plant (Scutellaria lateriflora L.) and the root of the Valerian plant (Valeriana officinalis L.). This registration is based exclusively upon evidence of the use of Hops strobile, Scullcap herb and Valerian root as traditional herbal medicines and not upon data generated from clinical trials. There is no requirement under the Traditional Herbal Registration Scheme to prove scientifically that the product works. No new or unexpected safety concerns arose from this application and it was, therefore, decided that a Traditional Herbal Registration Certificate could be granted. MHRA PAR; NEUROTONE, THR 00904/0005 2

3 NEUROTONE THR 00904/0005 SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 4 Pharmaceutical assessment Page 5 Preclinical assessment Page 7 Clinical assessment Page 8 Overall conclusions and risk assessment Page 9 MHRA PAR; NEUROTONE, THR 00904/0005 3

4 INTRODUCTION The MHRA granted a Traditional Herbal Registration Certificate for the traditional herbal medicinal product NEUROTONE (THR 00904/0005) to Kerbina Limited (trading as Bio-Health Limited) on 20 March This product is on the general sales list (GSL). A product licence of right (PLR) was originally granted to Kerbina Limited for this product. The PLR was reviewed and a product licence (PL 00904/5039R) was granted to Kerbina Limited on 21 April Kerbina Limited cancelled PL 00904/5039R following the grant of the Traditional Herbal Registration Certificate. This THR application was made under Article 16.c of Directive 2001/83 EC in accordance with arrangements to transfer certain herbal products with a Marketing Authorisation to a THR (according to MHRA Guidance dated January 2009). The application falls within the simplified THR application Category A, as no significant changes have been made to the formulation of the product. No new data were submitted, nor was it necessary for this application, as the data are essentially identical to those of the existing product. MHRA PAR; NEUROTONE, THR 00904/0005 4

5 PHARMACEUTICAL ASSESSMENT HERBAL SUBSTANCE: HOPS STROBILE Scientific name of the plant: Humulus lupulus L. Plant family: Cannabaceae The herbal substance complies with the Ph Eur monograph and is, therefore, acceptable. HERBAL PREPARATION: POWDERED HOPS STROBILE The herbal preparation consists simply of the powdered herbal substance; this is produced as part of the herbal substance manufacturing process. The herbal preparation is not stored. HERBAL SUBSTANCE: SCULLCAP HERB Scientific name of the plant: Scutellaria lateriflora L. Plant family: Lamiaceae The herbal substance is controlled in line with the BHP monograph; in the absence of a Ph Eur for this herbal substance this is acceptable. HERBAL PREPARATION: POWDERED SCULLCAP HERB The herbal preparation consists simply of the powdered herbal substance; this is produced as part of the herbal substance manufacturing process. The herbal preparation is not stored. HERBAL SUBSTANCE: VALERIAN ROOT Scientific name of the plant: Valeriana officinalis L. Plant family: Valerianaceae The herbal substance complies with the Ph Eur monograph and is, therefore, acceptable. HERBAL PREPARATION: VALERIAN ROOT DRY EXTRACT Drug extract ratio (DER): 5:1 Extraction solvent: Ethanol 60% v/v The herbal preparation specification is in line with that applied to the herbal preparation used in the already licensed product. It is, therefore, acceptable. MHRA PAR; NEUROTONE, THR 00904/0005 5

6 HERBAL PRODUCT: NEUROTONE Description and Composition of the Herbal Product The herbal product is a white, coated tablet. Each tablet contains 45mg Hops strobile, 45mg Scullcap herb and 100mg dry extract from Valerian root. The tablets also contain the pharmaceutical excipients maltodextrin, sucrose, starch, purified talc, magnesium stearate, titanium dioxide (E171) and sucrose. The formulation is in line with that of the already licensed product. It is, therefore, acceptable. Manufacture The manufacturing process is in line with that of the already licensed product and is satisfactory. Finished Product Specification The finished product specification is in line with that of the already licensed product and is satisfactory. Container Closure System The tablets are stored in 100ml HDPE polythene containers with a tamper evident cap closure. Pack sizes of 30 or 60 tablets have been authorised. This type of packaging has been used to store the already licensed product and is satisfactory. Stability The product has a shelf-life of 3 years when the storage precautions Store below 25ºC and Store in the original package are applied. This is in line with the already licensed product and is appropriate. Summary of Product Characteristics, product labels and Patient Information Leaflet All product literature is in line with that of the already licensed product, with some details amended in line with other products registered under the THR scheme. ASSESSOR S OVERALL CONCLUSION It is recommended that a Traditional Herbal Registration can be granted. MHRA PAR; NEUROTONE, THR 00904/0005 6

7 PRECLINICAL ASSESSMENT INTRODUCTION No new preclinical data have been supplied with this application and none are required for an application of this type. Assurance has been given that the results of genotoxicity testing will be provided by the renewal date of the Traditional Herbal Registration. PRODUCT LITERATURE All product literature is satisfactory from a preclinical point of view. ASSESSOR S OVERALL CONCLUSION It is recommended that a Traditional Herbal Registration can be granted. MHRA PAR; NEUROTONE, THR 00904/0005 7

8 CLINICAL ASSESSMENT INTRODUCTION The clinical particulars for NEUROTONE are identical to those for the already licensed product. This is satisfactory. PRODUCT LITERATURE All product literature is medically satisfactory. ASSESSOR S OVERALL CONCLUSION It is recommended that a Traditional Herbal Registration can be granted. MHRA PAR; NEUROTONE, THR 00904/0005 8

9 OVERALL CONCLUSION AND BENEFIT-RISK ASSESSMENT QUALITY NEUROTONE is identical to an already licensed product. It is, therefore, pharmaceutically satisfactory. PRECLINICAL No new preclinical data were submitted and none are required for an application of this type. The results of genotoxicity testing will be provided before the THR is renewed. EFFICACY No clinical efficacy data are required for registration of Traditional Herbal Medicinal Products. SAFETY No new or unexpected safety concerns arose from this application. BENEFIT-RISK ASSESSMENT The quality of the product is acceptable and no new preclinical or clinical safety concerns have been identified. The benefit: risk balance is acceptable and a THR should be granted. MHRA PAR; NEUROTONE, THR 00904/0005 9

10 NEUROTONE THR 00904/0005 STEPS TAKEN FOR ASSESSMENT 1 The MHRA received the Traditional Herbal Registration application on 24 January Following standard checks and communication with the applicant the MHRA considered the application valid on 30 January Following assessment of the application the MHRA requested further information relating to the dossier on 19 February The applicant responded to the MHRA s request, providing further information on the dossier on 19 March A THR was granted on 20 March 2013 MHRA PAR; NEUROTONE, THR 00904/

11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NEUROTONE 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains: 45mg Hops strobiles (Humulus lupulus L.) 45mg Scullcap herb (Scutellaria lateriflora L.) 100mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.)(5:1) Extraction solvent: Ethanol 60% v/v Each tablet contains: 188 mg of sucrose For full list of excipients, see section PHARMACEUTICAL FORM Coated Tablet, white 4 CLINICAL PARTICULARS 4.1 Therapeutic indications A traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety, based on traditional use only. 4.2 Posology and method of administration For oral short term use only Adults and the elderly: Take one or two tablets three times a day. As treatment effects may not be apparent immediately, Neurotone should be taken 2-4 weeks continuously. Duration of use: If symptoms persist or worsen after 4 weeks of using the product, a doctor or qualified healthcare practitioner should be consulted. The use in children or adolescents under 18 years of age is not recommended (see Section 4.4. Special warnings and precautions for use 4.3 Contraindications Hypersensitivity to the active ingredients or any of the excipients. 4.4 Special warnings and precautions for use Do not exceed stated dose The use of this product in children or adolescents under 18 years of age is not recommended because data is not sufficient and medical advice should be sought. MHRA PAR; NEUROTONE, THR 00904/

12 This product contains Sucrose. One coated tablet contains a maximum of 188 mg of sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. If symptoms persist or worsen after 4 weeks of using the product, a doctor or qualified healthcare practitioner should be consulted. 4.5 Interaction with other medicinal products and other forms of interaction Only limited data on pharmacological interactions with other medicinal products available. Clinically relevant interactions with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has not been observed. Additive effects with hypnotics and other sedatives cannot be excluded and therefore co-medication is not recommended as a general precaution. The effect of Neurotone may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided. 4.6 Fertility, pregnancy and lactation The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, the use in pregnancy and lactation is not recommended. Studies on fertility have not been performed. 4.7 Effects on ability to drive and use machines Neurotone may impair the ability to drive and use machines. Patients who are affected should not drive or operate machinery. 4.8 Undesirable effects Gastrointestinal symptoms (eg nausea, abdominal cramps) may occur after ingestion of Valerian root preparations. The frequency is not known. There are no known adverse reactions with the other active ingredients. If the other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted. 4.9 Overdose Valerian root at a dose of approximately 20g (equivalent to 40 tablets) caused benign symptoms (fatigue, abdominal cramps, chest tightness, light headedness, hand tremor and mydriasis) which disappeared within 24 hours. If symptoms arise, treatment should be supportive. After intake of very high doses of Valerian root over several years (daily consumption corresponding to approx. 30g of the drug) withdrawal symptoms (delirium) have been reported. No cases of overdose have been reported for the other active ingredients. Symptomatic and supportive measures should be taken as appropriate. 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Not required as per Article 16c(1)(a) (iii) of Directive 2001/83/EC as amended MHRA PAR; NEUROTONE, THR 00904/

13 5.2 Pharmacokinetic properties Not required as per Article 16c(1)(a) (iii) of Directive 2001/83/EC as amended 5.3 Preclinical safety data Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Extract excipients Maltodextrin Tablet core Sucrose Starch Purified Talc Magnesium Stearate Tablet Coating Titanium Dioxide (E171) Sucrose 6.2 Incompatibilities None Known 6.3 Shelf life 3 years 6.4 Special precautions for storage Store below 25ºC. Store in the original package 6.5 Nature and contents of container 100ml HDPE polythene tablet container and tamper evident cap closure Pack contains 60 tablets or Pack contains 30 tablets 6.6 Special precautions for disposal There are no special precautions for disposal 7 MARKETING AUTHORISATION HOLDER Kerbina Limited T/A Bio-Health Limited Culpeper Close Medway City Estate Rochester Kent MHRA PAR; NEUROTONE, THR 00904/

14 ME2 4HU 8 MARKETING AUTHORISATION NUMBER(S) THR 00904/ DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 20/03/ DATE OF REVISION OF THE TEXT 20/03/2013 MHRA PAR; NEUROTONE, THR 00904/

15 PRODUCT INFORMATION LEAFLET MHRA PAR; NEUROTONE, THR 00904/

16 MHRA PAR; NEUROTONE, THR 00904/

17 MHRA PAR; NEUROTONE, THR 00904/

18 LABELLING Labels: MHRA PAR; NEUROTONE, THR 00904/

19 Cartons: MHRA PAR; NEUROTONE, THR 00904/

20 MHRA PAR; NEUROTONE, THR 00904/

UKPAR Goodnight THR 00904/0003. Goodnight THR 00904/0003 UKPAR TABLE OF CONTENTS. Lay Summary Page 2. Scientific discussion Page 3

UKPAR Goodnight THR 00904/0003. Goodnight THR 00904/0003 UKPAR TABLE OF CONTENTS. Lay Summary Page 2. Scientific discussion Page 3 Goodnight THR 00904/0003 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after authorisation Page 13 Summary of Product Characteristics

More information

Kalms Tablets THR 01074/0235 UKPAR

Kalms Tablets THR 01074/0235 UKPAR Kalms Tablets THR 01074/0235 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Summary of Product Characteristics Page 11 Patient Information Leaflet

More information

Boots Pharmaceuticals Bruise Relief Arnica cream THR 01175/0398 UKPAR TABLE OF CONTENTS. Lay summary Page 2. Scientific discussion Page 3

Boots Pharmaceuticals Bruise Relief Arnica cream THR 01175/0398 UKPAR TABLE OF CONTENTS. Lay summary Page 2. Scientific discussion Page 3 Boots Pharmaceuticals Bruise Relief Arnica cream UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Summary of Product Characteristics Page 11 Patient

More information

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL COMMUNITY HERBAL MONOGRAPH ON HYPERICUM PERFORATUM L., HERBA (TRADITIONAL USE)

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL COMMUNITY HERBAL MONOGRAPH ON HYPERICUM PERFORATUM L., HERBA (TRADITIONAL USE) European Medicines Agency Evaluation of Medicines for Human Use London, 12 November 2009 Doc. Ref.: EMEA/HMPC/745582/2009 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL COMMUNITY HERBAL MONOGRAPH

More information

Stress Relief Daytime Valerian-Hops oral drops THR 13668/0027 UKPAR

Stress Relief Daytime Valerian-Hops oral drops THR 13668/0027 UKPAR Stress Relief Daytime Valerian-Hops oral drops THR 13668/0027 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 14 Summary of Product Characteristics

More information

Holland & Barrett Dandelion Capsules. GNC Live Well Dandelion Capsules. Lifecycle Dandelion Capsules. Nature s Garden Dandelion Capsules

Holland & Barrett Dandelion Capsules. GNC Live Well Dandelion Capsules. Lifecycle Dandelion Capsules. Nature s Garden Dandelion Capsules Holland & Barrett Dandelion Capsules GNC Live Well Dandelion Capsules Lifecycle Dandelion Capsules Nature s Garden Dandelion Capsules Nature s Bounty Dandelion Capsules UKPAR TABLE OF CONTENTS Lay summary

More information

Arnicare Arnica 30c pillules NR 01175/0181 UKPAR

Arnicare Arnica 30c pillules NR 01175/0181 UKPAR Arnicare Arnica 30c pillules NR 01175/0181 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of product characteristics Page 12 Product

More information

Dormeasan Sleep Valerian-Hops oral drops THR 13668/0017 UKPAR

Dormeasan Sleep Valerian-Hops oral drops THR 13668/0017 UKPAR Dormeasan Sleep Valerian-Hops oral drops THR 13668/0017 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 14 Summary of product characteristics Page

More information

Urostemol capsules THR 02855/0239

Urostemol capsules THR 02855/0239 Urostemol capsules THR 02855/0239 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after initial registration Page 13 Summary of Product

More information

Phynova Joint and Muscle Relief Tablets THR 41783/0001 UKPAR

Phynova Joint and Muscle Relief Tablets THR 41783/0001 UKPAR Phynova Joint and Muscle Relief Tablets THR 41783/0001 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Summary of Product Characteristics Page

More information

Ginkgoforce Ginkgo biloba tablets THR 13668/0016 UKPAR

Ginkgoforce Ginkgo biloba tablets THR 13668/0016 UKPAR Ginkgoforce Ginkgo biloba tablets THR 13668/0016 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 13 Summary of product characteristics Page 14 Product

More information

Hypromellose Eye Drops BP 0.3% w/v PL 23097/0006

Hypromellose Eye Drops BP 0.3% w/v PL 23097/0006 Hypromellose Eye Drops BP 0.3% w/v PL 23097/0006 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 9 Summary of product characteristics Page 10 Patient

More information

EMCREM CREAM (White soft paraffin 15.0% w/w, Liquid paraffin 6.0% w/w) PL 19876/0013

EMCREM CREAM (White soft paraffin 15.0% w/w, Liquid paraffin 6.0% w/w) PL 19876/0013 EMCREM CREAM (White soft paraffin 15.0% w/w, Liquid paraffin 6.0% w/w) PL 19876/0013 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Steps taken

More information

Urostemol Men capsules THR 02855/0240

Urostemol Men capsules THR 02855/0240 Urostemol Men capsules THR 02855/0240 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 14 Steps taken after initial registration Page 15 Summary of

More information

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL COMMUNITY HERBAL MONOGRAPH ON AVENA SATIVA L., FRUCTUS

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL COMMUNITY HERBAL MONOGRAPH ON AVENA SATIVA L., FRUCTUS European Medicines Agency Evaluation of Medicines for Human Use London, 4 September 2008 Doc. Ref. EMEA/HMPC/368600/2007 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL COMMUNITY HERBAL MONOGRAPH ON

More information

Draft presentation: Summary of product characteristics

Draft presentation: Summary of product characteristics Draft presentation: Summary of product characteristics What is it and what does it contain? Olayinka Fasanya Medical information - Information compliance and consistency An agency of the European Union

More information

Weleda Hayfever Relief Oromucosal Spray NR 00298/0275 UKPAR

Weleda Hayfever Relief Oromucosal Spray NR 00298/0275 UKPAR Weleda Hayfever Relief Oromucosal Spray NR 00298/0275 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 14 Summary of Product Characteristics Page

More information

Community herbal monograph on Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl.

Community herbal monograph on Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl. 22 November 2011 EMA/HMPC/722367/2010 Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Final

More information

Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130

Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130 Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 12 Summary of Product Characteristics

More information

Public Assessment Report

Public Assessment Report Public Assessment Report Sodium Chloride 1 mmol/ml Oral Solution (sodium chloride) UK Licence No: PL 20346/0008 Viridian Pharma Ltd LAY SUMMARY Sodium Chloride 1 mmol/ml Oral Solution (sodium chloride)

More information

Mucodyne-Clear 250 mg/5 ml Syrup PL 04425/0665

Mucodyne-Clear 250 mg/5 ml Syrup PL 04425/0665 Mucodyne-Clear 250 mg/5 ml Syrup PL 04425/0665 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 9 Summary of product characteristics Page 10 Patient

More information

Sterilised Water for Injections PL 08801/0057 UKPAR

Sterilised Water for Injections PL 08801/0057 UKPAR Sterilised Water for Injections PL 08801/0057 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 11 Summary of Product Characteristics Page 12 Patient

More information

Community herbal monograph on Commiphora molmol Engler, gummi-resina

Community herbal monograph on Commiphora molmol Engler, gummi-resina 12 July 2011 EMA/HMPC/96911/2010 Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Commiphora molmol Engler, gummi-resina Final Discussion in Working Party on Community monographs

More information

Paracetamol 1000 mg Effervescent Tablets PL 31388/0005

Paracetamol 1000 mg Effervescent Tablets PL 31388/0005 Paracetamol 1000 mg Effervescent Tablets PL 31388/0005 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 12 Summary of Product Characteristics Page

More information

POTASSIUM NITRATE AND SODIUM FLUORIDE 5/0.315% W/W TOOTHPASTE PL 00036/ UKPAR TABLE OF CONTENTS

POTASSIUM NITRATE AND SODIUM FLUORIDE 5/0.315% W/W TOOTHPASTE PL 00036/ UKPAR TABLE OF CONTENTS POTASSIUM NITRATE AND SODIUM FLUORIDE 5/0.315% W/W TOOTHPASTE PL 00036/0307-9 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of Product

More information

Public Assessment Report. Loperamide 2mg Capsules. Loperamide hydrochloride PL 31308/ Max Remedies Ltd. Table of Contents

Public Assessment Report. Loperamide 2mg Capsules. Loperamide hydrochloride PL 31308/ Max Remedies Ltd. Table of Contents Public Assessment Report Loperamide 2mg Capsules Loperamide hydrochloride PL 31308/0002-3 Max Remedies Ltd Table of Contents Page Lay Summary 2 Scientific Discussion 3 Overall Conclusion And Risk Benefit/Analysis

More information

Nicotine 1 mg Compressed Lozenge Nicotine 2 mg Compressed Lozenge PL 00030/0463-0468

Nicotine 1 mg Compressed Lozenge Nicotine 2 mg Compressed Lozenge PL 00030/0463-0468 Nicotine 1 mg Compressed Lozenge Nicotine 2 mg Compressed Lozenge PL 00030/0463-0468 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 5 Steps Taken for Assessment Page 13 Summary of

More information

Community herbal monograph on Panax ginseng C.A. Meyer, radix

Community herbal monograph on Panax ginseng C.A. Meyer, radix 12 March 2013 EMA/HMPC/321233/2012 Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Panax ginseng C.A. Meyer, radix Draft Discussion in Working Party on Community monographs

More information

PAROXETINE 20 MG TABLETS PAROXETINE 30 MG TABLETS PL 40378/ UKPAR TABLE OF CONTENTS

PAROXETINE 20 MG TABLETS PAROXETINE 30 MG TABLETS PL 40378/ UKPAR TABLE OF CONTENTS PAROXETINE 20 MG TABLETS PAROXETINE 30 MG TABLETS PL 40378/0101-0102 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 11 Summary of Product Characteristics

More information

DEXAMETHASONE 0.5 MG TABLETS PL 17507/0052 TABLE OF CONTENTS

DEXAMETHASONE 0.5 MG TABLETS PL 17507/0052 TABLE OF CONTENTS DEXAMETHASONE 0.5 MG TABLETS PL 17507/0052 TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 11 Steps taken after authorisation summary Page 12 Summary of

More information

Memantine hydrochloride 20 mg film-coated tablets PL 17907/0291

Memantine hydrochloride 20 mg film-coated tablets PL 17907/0291 Memantine hydrochloride 20 mg film-coated tablets PL 17907/0291 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 5 Steps Taken for Assessment Page 13 Summary of Product Characteristics

More information

Community herbal monograph on Oenothera biennis L.; Oenothera lamarckiana L., oleum

Community herbal monograph on Oenothera biennis L.; Oenothera lamarckiana L., oleum 16 December 2011 EMA/HMPC/277792/2009 Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Oenothera biennis L.; Oenothera lamarckiana L., Final Discussion in Working Party on Community

More information

Community herbal monograph on Cucurbita pepo L., semen

Community herbal monograph on Cucurbita pepo L., semen 20 November 2012 EMA/HMPC/136024/2010 Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Cucurbita pepo L., semen Final Discussion in Working Party on Community monographs and

More information

STREPSILS BLACKCURRANT FLAVOUR LOZENGES STREPSILS DRY & SORE THROAT BLACKCURRANT FLAVOUR LOZENGES

STREPSILS BLACKCURRANT FLAVOUR LOZENGES STREPSILS DRY & SORE THROAT BLACKCURRANT FLAVOUR LOZENGES STREPSILS BLACKCURRANT FLAVOUR LOZENGES STREPSILS DRY & SORE THROAT BLACKCURRANT FLAVOUR LOZENGES (amylmetacresol, 2,4-dichlorobenzyl alcohol, ascorbic acid and sodium ascorbate) PL 00063/0692 UKPAR TABLE

More information

Ibuprofen 200mg Soft Capsules PL 03105/0105 UKPAR

Ibuprofen 200mg Soft Capsules PL 03105/0105 UKPAR Ibuprofen 200mg Soft Capsules PL 03105/0105 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 13 Summary of Product Characteristics Page 14 Patient

More information

GAVISCON ADVANCE MINT CHEWABLE TABLETS PL 00063/0613 UKPAR TABLE OF CONTENTS

GAVISCON ADVANCE MINT CHEWABLE TABLETS PL 00063/0613 UKPAR TABLE OF CONTENTS GAVISCON ADVANCE MINT CHEWABLE TABLETS PL 00063/0613 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of Product Characteristics Page 12

More information

Omeprazole 20 mg gastro-resistant tablets PL 14017/0277

Omeprazole 20 mg gastro-resistant tablets PL 14017/0277 Omeprazole 20 mg gastro-resistant tablets PL 14017/0277 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 11 Steps Taken After Initial Authorisation

More information

PL 17871/0208 UKPAR TABLE OF CONTENTS

PL 17871/0208 UKPAR TABLE OF CONTENTS Fultium-D 3 3,200 IU Capsules PL 17871/0208 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 11 Summary of Product Characteristics Page 12 Patient

More information

Montelukast 10mg film-coated tablets PL 17907/0474

Montelukast 10mg film-coated tablets PL 17907/0474 Montelukast 10mg film-coated tablets PL 17907/0474 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 11 Steps Taken After Initial Authorisation Page

More information

MACROGOL COMPOUND ORAL POWDER (sodium chloride, sodium hydrogen carbonate, potassium chloride, macrogol 3350) PL 33579/0001 UKPAR TABLE OF CONTENTS

MACROGOL COMPOUND ORAL POWDER (sodium chloride, sodium hydrogen carbonate, potassium chloride, macrogol 3350) PL 33579/0001 UKPAR TABLE OF CONTENTS MACROGOL COMPOUND ORAL POWDER (sodium chloride, sodium hydrogen carbonate, potassium chloride, macrogol 3350) PL 33579/0001 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps

More information

Community herbal monograph on Lavandula angustifolia Miller, aetheroleum

Community herbal monograph on Lavandula angustifolia Miller, aetheroleum 27 March 2012 EMA/HMPC/143181/2010 Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Lavandula angustifolia Miller, aetheroleum Final Discussion in Working Party on Community

More information

Public Assessment Report

Public Assessment Report Public Assessment Report SoLo Prep PL 11847/0013 MHRA: PAR SoLo Prep PL 11847/0013 1 SOLO PREP PL 11847/0013 UKPAR TABLE OF CONTENTS Page Lay Summary 3 Scientific discussion 4 Steps taken for assessment

More information

Community herbal monograph on Primula veris L. and/or Primula elatior (L.) Hill, flos

Community herbal monograph on Primula veris L. and/or Primula elatior (L.) Hill, flos 19 September 2012 EMA/HMPC/136582/2012 Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Primula veris L. and/or Primula elatior (L.) Hill, flos Final Initial assessment Discussion

More information

Community herbal monograph on Panax ginseng C.A.Meyer, radix

Community herbal monograph on Panax ginseng C.A.Meyer, radix 25 March 2014 EMA/HMPC/321233/2012 Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Panax ginseng C.A.Meyer, radix Final Discussion in Working Party on Community monographs and

More information

Public Assessment Report for a. Traditional Herbal Medicinal Product for Human Use

Public Assessment Report for a. Traditional Herbal Medicinal Product for Human Use IPAR Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use Name of Product: Urostemol Men capsules TR1186/7/1 TR holder Chefaro Ireland Limited I INTRODUCTION Date March 2016

More information

Community herbal monograph on Arnica montana L., flos

Community herbal monograph on Arnica montana L., flos 6 May 2014 EMA/HMPC/198793/2012 Committee on Herbal Medicinal Products (HMPC) Final Discussion in Working Party on Community monographs and Community March 2012 list (MLWP) May 2012 November 2012 March

More information

InVita D3 25,000 IU oral solution PL 24837/0039

InVita D3 25,000 IU oral solution PL 24837/0039 InVita D3 25,000 IU oral solution PL 24837/0039 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 5 Steps taken for assessment Page 12 Summary of Product Characteristics Page 13 Patient

More information

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL COMMUNITY HERBAL MONOGRAPH ON HYPERICUM PERFORATUM L., HERBA (WELL-ESTABLISHED MEDICINAL USE)

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL COMMUNITY HERBAL MONOGRAPH ON HYPERICUM PERFORATUM L., HERBA (WELL-ESTABLISHED MEDICINAL USE) European Medicines Agency Evaluation of Medicines for Human Use London, 12 November 2009 Doc. Ref.: EMA/HMPC/101304/2008 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL COMMUNITY HERBAL MONOGRAPH ON

More information

Lacidipine 2 mg Film-Coated Tablets PL 08553/0502. Lacidipine 4 mg Film-Coated Tablets PL 08553/0503. UK Public Assessment Report

Lacidipine 2 mg Film-Coated Tablets PL 08553/0502. Lacidipine 4 mg Film-Coated Tablets PL 08553/0503. UK Public Assessment Report Lacidipine 2 mg Film-Coated Tablets PL 08553/0502 Lacidipine 4 mg Film-Coated Tablets PL 08553/0503 UK Public Assessment Report TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken

More information

Levonorgestrel/Ethinylestradiol 150/30 Microgram Coated Tablets PL 20117/0044

Levonorgestrel/Ethinylestradiol 150/30 Microgram Coated Tablets PL 20117/0044 Levonorgestrel/Ethinylestradiol 150/30 Microgram Coated Tablets PL 20117/0044 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of Product

More information

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof; DIRECTIVE 65/65/EEC Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ L No 22 of

More information

Ascorbic Acid 50 mg Tablets. Ascorbic Acid 100 mg Tablets. Ascorbic Acid 200 mg Tablets. Ascorbic Acid 500 mg Tablets PL 20416/0286 PL 20416/0287

Ascorbic Acid 50 mg Tablets. Ascorbic Acid 100 mg Tablets. Ascorbic Acid 200 mg Tablets. Ascorbic Acid 500 mg Tablets PL 20416/0286 PL 20416/0287 Ascorbic Acid 50 mg Tablets Ascorbic Acid 100 mg Tablets Ascorbic Acid 200 mg Tablets Ascorbic Acid 500 mg Tablets PL 20416/0286 PL 20416/0287 PL 20416/0288 PL 20416/0289 UKPAR TABLE OF CONTENTS Lay Summary

More information

LEMSIP MAX DAY & NIGHT COLD & FLU RELIEF CAPSULES. (paracetamol, caffeine and phenylephrine hydrochloride)

LEMSIP MAX DAY & NIGHT COLD & FLU RELIEF CAPSULES. (paracetamol, caffeine and phenylephrine hydrochloride) LEMSIP MAX DAY & NIGHT COLD & FLU RELIEF CAPSULES (paracetamol, caffeine and phenylephrine hydrochloride) PL 00063/0529 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 5 Summary of

More information

TRAMADOL HYDROCHLORIDE AND PARACETAMOL 37.5 MG/325 MG FILM-COATED TABLETS (tramadol hydrochloride and paracetamol ) PL 30684/0222 UKPAR

TRAMADOL HYDROCHLORIDE AND PARACETAMOL 37.5 MG/325 MG FILM-COATED TABLETS (tramadol hydrochloride and paracetamol ) PL 30684/0222 UKPAR TRAMADOL HYDROCHLORIDE AND PARACETAMOL 37.5 MG/325 MG FILM-COATED TABLETS (tramadol hydrochloride and paracetamol ) PL 30684/0222 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4

More information

DEXTROMETHORPHAN HYDROBROMIDE 10MG/5ML ORAL SOLUTION PL 17907/0314

DEXTROMETHORPHAN HYDROBROMIDE 10MG/5ML ORAL SOLUTION PL 17907/0314 DEXTROMETHORPHAN HYDROBROMIDE 10MG/5ML ORAL SOLUTION PL 17907/0314 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Summary of Product Characteristics

More information

Fexofenadine Hydrochloride 120 mg Film-coated Tablets Fexofenadine Hydrochloride 180 mg Film-coated Tablets PL 36390/0053-4 UKPAR TABLE OF CONTENTS

Fexofenadine Hydrochloride 120 mg Film-coated Tablets Fexofenadine Hydrochloride 180 mg Film-coated Tablets PL 36390/0053-4 UKPAR TABLE OF CONTENTS Fexofenadine Hydrochloride 120 mg Film-coated Tablets Fexofenadine Hydrochloride 180 mg Film-coated Tablets PL 36390/0053-4 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 5 Steps

More information

HYDROCORTISONE 10 MG TABLETS

HYDROCORTISONE 10 MG TABLETS HYDROCORTISONE 10 MG TABLETS (Hydrocortisone) PL 20072/0238 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after authorisation summary

More information

Public Assessment Report UKPAR. Nurofen Joint & Back Pain Relief 5% Gel Nurofen Muscular Pain Relief Gel Pharmacy Only. Ibuprofen

Public Assessment Report UKPAR. Nurofen Joint & Back Pain Relief 5% Gel Nurofen Muscular Pain Relief Gel Pharmacy Only. Ibuprofen Public Assessment Report UKPAR Nurofen Joint & Back Pain Relief 5% Gel Ibuprofen UK Licence No: Reckitt Benckiser Healthcare (UK) Limited 1 LAY SUMMARY Nurofen Joint & Back Pain Relief 5% Gel (ibuprofen)

More information

CETRABEN ORIGINAL EMOLLIENT CREAM (PL 06831/0262) UKPAR TABLE OF CONTENTS

CETRABEN ORIGINAL EMOLLIENT CREAM (PL 06831/0262) UKPAR TABLE OF CONTENTS CETRABEN ORIGINAL EMOLLIENT CREAM (PL 06831/0262) UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after authorisation summary Page

More information

Public Assessment Report UKPAR. Levonorgestrel 1.5 mg tablet. (levonorgestrel). UK Licence No: PL 41947/0006. ELC Group s.r.o.

Public Assessment Report UKPAR. Levonorgestrel 1.5 mg tablet. (levonorgestrel). UK Licence No: PL 41947/0006. ELC Group s.r.o. Public Assessment Report UKPAR Levonorgestrel 1.5 mg tablet (levonorgestrel). UK Licence No: PL 41947/0006 ELC Group s.r.o. 1 LAY SUMMARY Levonorgestrel 1.5 mg tablet (Levonorgestrel, tablet, 1.5 mg) This

More information

(paracetamol and caffeine) PL 00071/0659

(paracetamol and caffeine) PL 00071/0659 Paracetamol and Caffeine 500 mg/65 mg Tablets (paracetamol and caffeine) PL 00071/0659 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 14 Steps taken

More information

Public Assessment Report UKPAR. Fluoride 2800 ppm Toothpaste Fluoride 5000 ppm Toothpaste. (Sodium fluoride) UK Licence No: PL 20117/

Public Assessment Report UKPAR. Fluoride 2800 ppm Toothpaste Fluoride 5000 ppm Toothpaste. (Sodium fluoride) UK Licence No: PL 20117/ Public Assessment Report UKPAR Fluoride 2800 ppm Toothpaste Fluoride 5000 ppm Toothpaste (Sodium fluoride) UK Licence No: PL 20117/0239-0240 Morningside Healthcare Limited 1 LAY SUMMARY Fluoride 2800 ppm

More information

Public Assessment Report. UK National Procedure. (colecalciferol) PL 16508/0047 PL 16508/0048. ProStrakan Ltd.

Public Assessment Report. UK National Procedure. (colecalciferol) PL 16508/0047 PL 16508/0048. ProStrakan Ltd. Public Assessment Report UK National Procedure STEXEROL-D 3 1,000 IU FILM-COATED TABLETS STEXEROL-D 3 25,000 IU FILM-COATED TABLETS (colecalciferol) PL 16508/0047 PL 16508/0048 ProStrakan Ltd. 1 LAY SUMMARY

More information

Aciclovir 200mg Tablets Aciclovir 400mg Tablets Aciclovir 800mg Tablets PL 29831/0517 PL 29831/0518 PL 29831/0519 UKPAR

Aciclovir 200mg Tablets Aciclovir 400mg Tablets Aciclovir 800mg Tablets PL 29831/0517 PL 29831/0518 PL 29831/0519 UKPAR Aciclovir 200mg Tablets Aciclovir 400mg Tablets Aciclovir 800mg Tablets PL 29831/0517 PL 29831/0518 PL 29831/0519 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for

More information

CETIRIZINE DIHYDROCHLORIDE 10MG FILM-COATED TABLETS PL 40378/0140-1 UKPAR TABLE OF CONTENTS

CETIRIZINE DIHYDROCHLORIDE 10MG FILM-COATED TABLETS PL 40378/0140-1 UKPAR TABLE OF CONTENTS CETIRIZINE DIHYDROCHLORIDE 10MG FILM-COATED TABLETS PL 40378/0140-1 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 8 Steps taken after authorisation

More information

ANASTROZOLE 1 MG FILM-COATED TABLETS. (Anastrozole) PL 40378/0123 UKPAR TABLE OF CONTENTS

ANASTROZOLE 1 MG FILM-COATED TABLETS. (Anastrozole) PL 40378/0123 UKPAR TABLE OF CONTENTS ANASTROZOLE 1 MG FILM-COATED TABLETS (Anastrozole) PL 40378/0123 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of Product Characteristics

More information

Public Assessment Report. Scientific discussion. Paracetamol Orifarm 500 mg film-coated tablets. (Paracetamol) DK/H/2271/001/DC.

Public Assessment Report. Scientific discussion. Paracetamol Orifarm 500 mg film-coated tablets. (Paracetamol) DK/H/2271/001/DC. Public Assessment Report Scientific discussion Paracetamol Orifarm 500 mg film-coated tablets (Paracetamol) DK/H/2271/001/DC 15 October 2014 This module reflects the scientific discussion for the approval

More information

Community herbal monograph on Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos

Community herbal monograph on Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos 1 July 2014 EMA/HMPC/137299/2013 Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos Final Discussion in Working

More information

SODIUM CHLORIDE 0.9% W/V SOLUTION FOR INJECTION PL 01502/0068 UKPAR TABLE OF CONTENTS

SODIUM CHLORIDE 0.9% W/V SOLUTION FOR INJECTION PL 01502/0068 UKPAR TABLE OF CONTENTS SODIUM CHLORIDE 0.9% W/V SOLUTION FOR INJECTION PL 01502/0068 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Steps taken after authorisation

More information

European Union herbal monograph on Carum carvi L., aetheroleum

European Union herbal monograph on Carum carvi L., aetheroleum 7 July 2015 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Carum carvi L., aetheroleum Final Discussion in Working Party on European Union monographs and list (MLWP) Adoption

More information

Beclometasone Dipropionate 50 micrograms per spray Aqueous Nasal Spray PL 16431/0178

Beclometasone Dipropionate 50 micrograms per spray Aqueous Nasal Spray PL 16431/0178 Beclometasone Dipropionate 50 micrograms per spray Aqueous Nasal Spray PL 16431/0178 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 5 Steps Taken for Assessment Page 11 Steps Taken

More information

Public Assessment Report Scientific discussion. Amitriptylin Abcur (amitriptyline hydrochloride) Asp no : 2013-0678 2013-0679 2013-0680

Public Assessment Report Scientific discussion. Amitriptylin Abcur (amitriptyline hydrochloride) Asp no : 2013-0678 2013-0679 2013-0680 Public Assessment Report Scientific discussion Amitriptylin Abcur (amitriptyline hydrochloride) Asp no : 2013-0678 2013-0679 2013-0680 This module reflects the scientific discussion for the approval of

More information

Ibuprofen 10% w/w gel Nurofen Maximum Strength 10 % Gel

Ibuprofen 10% w/w gel Nurofen Maximum Strength 10 % Gel Ibuprofen 10% w/w gel Nurofen Maximum Strength 10 % Gel PL 10972/0089 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of Product Characteristics

More information

CANESTEN DUAL ACTION 1% W/W CREAM (PL 00010/0645) UKPAR TABLE OF CONTENTS

CANESTEN DUAL ACTION 1% W/W CREAM (PL 00010/0645) UKPAR TABLE OF CONTENTS CANESTEN DUAL ACTION 1% W/W CREAM (PL 00010/0645) UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after authorisation summary Page

More information

European Union herbal monograph on Carum carvi L., aetheroleum

European Union herbal monograph on Carum carvi L., aetheroleum 24 November 2014 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Carum carvi L., aetheroleum Draft Discussion in Working Party on European Union monographs and European

More information

Summary Public Assessment Report. Generics

Summary Public Assessment Report. Generics Summary Public Assessment Report Generics 875 mg + 125 mg, Film-coated tablets (Amoxicillin Trihydrate + Potassium Clavulanate) Date: 29-12-2014 1/7 Summary Public Assessment Report Generics Amoxicillin

More information

MIGRAINE RELIEF 342 MG FILM-COATED TABLETS PL 20154/0030 UKPAR TABLE OF CONTENTS

MIGRAINE RELIEF 342 MG FILM-COATED TABLETS PL 20154/0030 UKPAR TABLE OF CONTENTS MIGRAINE RELIEF 342 MG FILM-COATED TABLETS PL 20154/0030 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 13 Steps taken after authorisation summary

More information

Public Assessment Report. UK National Procedure. Perindopril 2 mg Tablets. Perindopril 4 mg Tablets. Perindopril 8 mg Tablets PL 20075/0294-0296

Public Assessment Report. UK National Procedure. Perindopril 2 mg Tablets. Perindopril 4 mg Tablets. Perindopril 8 mg Tablets PL 20075/0294-0296 Public Assessment Report UK National Procedure Perindopril 2 mg Tablets Perindopril 4 mg Tablets Perindopril 8 mg Tablets PL 20075/0294-0296 Accord Healthcare Limited 1 LAY SUMMARY This is a summary of

More information

Summary Public Assessment Report. Generics. Amoxicilina + Ácido Clavulânico Ranbaxy,

Summary Public Assessment Report. Generics. Amoxicilina + Ácido Clavulânico Ranbaxy, Summary Public Assessment Report Generics Amoxicilina + Ácido Clavulânico Ranbaxy 875 mg + 125 mg, Film-coated tablets (Amoxicillin Trihydrate + Potassium Clavulanate) Date: 29-12-2014 1/7 Summary Public

More information

Public Assessment Report Scientific discussion. Prednisolon Alternova (previous Prednisolon E Consult) (prednisolone) Asp no: 2011-0921

Public Assessment Report Scientific discussion. Prednisolon Alternova (previous Prednisolon E Consult) (prednisolone) Asp no: 2011-0921 Public Assessment Report Scientific discussion Prednisolon Alternova (previous Prednisolon E Consult) (prednisolone) Asp no: 2011-0921 This module reflects the scientific discussion for the approval of

More information

Public Assessment Report UKPAR. Galpharm Nicotine Replace 2 mg and 4 mg Gum. (Nicotine resinate) UK Licence No: PL 12063/

Public Assessment Report UKPAR. Galpharm Nicotine Replace 2 mg and 4 mg Gum. (Nicotine resinate) UK Licence No: PL 12063/ Public Assessment Report UKPAR Galpharm Nicotine Replace 2 mg and 4 mg Gum (Nicotine resinate) UK Licence No: PL 12063/0133-0134 Wrafton Laboratories Limited 1 LAY SUMMARY Galpharm Nicotine Replace 2 mg

More information

Summary Public Assessment Report. Generics. Escitalopram Ratiopharm PT/H/0846/01-04/DC. Date:

Summary Public Assessment Report. Generics. Escitalopram Ratiopharm PT/H/0846/01-04/DC. Date: Summary Public Assessment Report Generics 5 mg, 10 mg, 15 mg, 20 mg, Orodisperdible tablets (escitalopram, oxalate) PT/H/0846/001-004/DC Date: 07-11-2014 1/7 Summary Public Assessment Report Generics Escitalopram,

More information

SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Driclor Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Aluminium Chloride Hexahydrate 20% w/w For a full list of excipients, see

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Thorens 10 000 I.U. /ml oral drops, solution Thorens 25 000 I.U. /2.5 ml oral solution Deltius 10 000 I.U. /ml oral drops, solution Deltius 25 000 I.U.

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cephacare Flavour 250 mg Tablets for Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance:

More information

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory EMODERM CREAM. White Soft Paraffin Cream

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory EMODERM CREAM. White Soft Paraffin Cream For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory EMODERM CREAM White Soft Paraffin Cream QUALITATIVE AND QUANTITATIVE COMPOSITION Emollient Cream base of White Soft Paraffin

More information

Community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium

Community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium 24 January 2012 EMA/HMPC/573460/2009 Rev.1 Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium Final Discussion in Working Party on

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aknemycin Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 10 g of solution contains 0.2 g of erythromycin. Structural formula of

More information

Public Assessment Report UKPAR. Clobetasol Propionate 0.05% w/w Cream Clobetasol Propionate 0.05% w/w Ointment. (Clobetasol propionate).

Public Assessment Report UKPAR. Clobetasol Propionate 0.05% w/w Cream Clobetasol Propionate 0.05% w/w Ointment. (Clobetasol propionate). Public Assessment Report UKPAR Clobetasol Propionate 0.05% w/w Cream Clobetasol Propionate 0.05% w/w Ointment (Clobetasol propionate). UK Licence No: PL 17507/0235-0236 Auden Mckenzie (Pharma Division)

More information

Public Assessment Report. (Budesonide) PL 17901/0254. AstraZeneca UK Ltd

Public Assessment Report. (Budesonide) PL 17901/0254. AstraZeneca UK Ltd Public Assessment Report Rhinocort Hay Fever 64 micrograms, Nasal Spray (Budesonide) PL 17901/0254 AstraZeneca UK Ltd 1 LAY SUMMARY Rhinocort Hay Fever 64 micrograms, Nasal Spray (Budesonide) This is a

More information

European Union herbal monograph on Salvia officinalis L., folium

European Union herbal monograph on Salvia officinalis L., folium 2 February 2016 EMA/HMPC/277152/2015 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Salvia officinalis L., folium Draft - Revision Initial assessment Discussion in Working

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Linezolid 2 mg/ml solution for infusion Linezolid 600mg film coated tablets Linezolid 100mg/5ml granules for oral suspension Procedure No: UK Licence No:

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Olopatadine Zentiva 1 mg/ml eye drops, solution (olopatadine hydrochloride) Procedure No: UK Licence No: PL 17780/0568 Winthrop Pharmaceuticals UK Limited

More information

Summary of Product Characteristics

Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Librium 10mg Hard capsule Summary of Product Characteristics 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg of chlordiazepoxide hydrochloride. Excipients:

More information

RILUZOLE LUPIN 50 MG FILM-COATED TABLETS PL 35507/0120 UKPAR TABLE OF CONTENTS

RILUZOLE LUPIN 50 MG FILM-COATED TABLETS PL 35507/0120 UKPAR TABLE OF CONTENTS RILUZOLE LUPIN 50 MG FILM-COATED TABLETS PL 35507/0120 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 9 Steps taken after authorisation summary

More information

ISOPLEX 4% W/V SOLUTION FOR INFUSION (Succinylated gelatin) PL 13538/0017 UKPAR TABLE OF CONTENTS

ISOPLEX 4% W/V SOLUTION FOR INFUSION (Succinylated gelatin) PL 13538/0017 UKPAR TABLE OF CONTENTS ISOPLEX 4% W/V SOLUTION FOR INFUSION (Succinylated gelatin) PL 13538/0017 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Steps taken after authorisation

More information

Public Assessment Report. Decentralised Procedure. CosmoCol Half 6.9 g, powder for oral solution CosmoCol Paediatric 6.9 g, powder for oral solution

Public Assessment Report. Decentralised Procedure. CosmoCol Half 6.9 g, powder for oral solution CosmoCol Paediatric 6.9 g, powder for oral solution Public Assessment Report Decentralised Procedure CosmoCol Half 6.9 g, powder for oral solution CosmoCol Paediatric 6.9 g, powder for oral solution (Macrogol, sodium chloride, sodium hydrogen carbonate

More information

Public Assessment Report. Scientific discussion. Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules

Public Assessment Report. Scientific discussion. Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules Public Assessment Report Scientific discussion Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules (calcium carbonate and cholecalciferol) NL License RVG: 111783 Date: 12 March 2015 This

More information

RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 UKPAR TABLE OF CONTENTS

RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 UKPAR TABLE OF CONTENTS RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Steps taken after authorisation summary

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure TELMISARTAN DR REDDY S 20 MG TABLETS TELMISARTAN DR REDDY S 40 MG TABLETS TELMISARTAN DR REDDY S 80 MG TABLETS (telmisartan) Procedure No: UK/H/5034/001-003/DC

More information