RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 UKPAR TABLE OF CONTENTS
|
|
- Brent Harrington
- 7 years ago
- Views:
Transcription
1 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 Page 12 Summary of Product Characteristics Page 13 Patient Information Leaflet Page 17 Labelling Page
2 RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 LAY SUMMARY The Medicines and Healthcare products Regulatory Agency granted Relonchem Limited, a Marketing Authorisation for the medicinal product RelonChem Hayfever and Allergy 10 mg Tablets (PL 20395/0088) on 3 April The product is a general sales list (GSL) medicine and is available to the general public without prescription. RelonChem Hayfever and Allergy 10 mg Tablets contains the active ingredient, loratadine and belongs to a group of medicines called antihistamines. These medicines act to relieve the symptoms of allergies. It can be used to relieve the symptoms of sneezing, runny and itchy nose and eye irritation and other allergies such as pet and dust allergies. It can also be used to treat raised symptoms of urticaria which is often known as hives and nettle rash. No new or unexpected safety concerns arose from this application and it was, therefore, judged that the benefits of taking RelonChem Hayfever and Allergy 10 mg Tablets (PL 20395/0088) outweigh the risks; hence a Marketing Authorisation has been granted
3 RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 4 Pharmaceutical assessment Page 5 Non-Clinical assessment Page 8 Clinical assessment Page 9 Overall conclusions and risk benefit assessment Page
4 INTRODUCTION Based on the review of the data on quality, safety and efficacy, the MHRA granted Relonchem Limited, a Marketing Authorisation for the medicinal product, RelonChem Hayfever and Allergy 10 mg Tablets (PL 20395/0088), on 3 April The product is a general sales list (GSL) medicine and is available to the general public without prescription. This is a simple, abridged, informed consent application submitted according to Article 10c of EC Directive 2001/83 (as amended), cross-referencing the Marketing Authorisation for Loratidine 10 mg Tablets (PL 17743/0006) authorised to Medis-Danmark A/S authorised on 22 August 2002; the licence subsequently underwent a Change of Ownership on 27 March 2009 and is currently authorised to Relonchem Limited. The reference product has been authorised in the EEA for over 10 years. No new data were submitted nor was it necessary for this simple application as the data are identical to that of the previously granted cross-reference product. As the cross-reference product was granted prior to the introduction of current legislation, no Public Assessment Report (PAR) has been generated for it
5 PHARMACEUTICAL ASSESSMENT LICENCE NO: PL 20395/0088 PROPRIETARY NAME: RelonChem Hayfever and Allergy 10 mg Tablets ACTIVE: Loratadine COMPANY NAME: Relonchem Limited E.C. ARTICLE: Article 10c of Directive 2001/83/EC LEGAL STATUS: GSL 1. INTRODUCTION This is a simple, informed consent application for RelonChem Hayfever and Allergy 10 mg Tablets under Article 10c of Directive 2001/83/EC. The proposed Marketing Authorisation Holder is Relonchem Limited, 27 Old Gloucester Street, London, WC1 3XX, UK. The application cross-refers to Loratadine 10 mg Tablets (PL 17734/0006) authorised to Medis- Danmark A/S since 22 August The licence subsequently underwent a Change of Ownership on 27 March 2009 and is licenced to Relonchem Limited (PL 20395/0072). The current application is considered valid. 2. MARKETING AUTHORISATION APPLICATION FORM 2.1 Name The proposed name of the product is RelonChem Hayfeverr and Allergy 10 mg Tablets. The product has been named in line with current requirements. 2.2 Strength, pharmaceutical form, route of administration, container and pack sizes Each tablet contains 10 mg loratadine.the medicinal product is licensed for marketed in blister strips composed of aluminium and polyvinylchloride (PVC) which are packed with the Patient Information Leaflet (PIL) into cardboard outer cartons, in pack sizes of 7, 10 and 14 tablets. The container closures system and pack sizes are identical to those for the reference product. The approved shelf-life (3 years) is satisfactory. There are no special storage conditions for this product which is identical to the details registered for the cross-reference product. 2.3 Legal status This product is a general sales list (GSL) medicine. 2.4 Marketing authorisation holder/contact Persons/Company The proposed Marketing Authorisation Holder is Relonchem Limited, 27 Old Gloucester Street, London, WC1 3XX, UK. The Quality Person (QP) responsible for pharmacovigilance is stated and their curriculum vita has been included. 2.5 Manufacturers The proposed manufacturing sites are consistent with those registered for the cross-reference product and evidence of GMP compliance has been provided
6 2.6 Qualitative and quantitative composition The proposed composition is consistent with the details registered for the cross-reference product. 2.7 Manufacturing process The proposed manufacturing process is consistent with the details registered for the cross-reference product and the maximum batch size is stated. 2.8 Finished product/shelf-life specification The proposed finished product specification is in-line with the details registered for the crossreference products. 2.9 Drug substance specification The proposed drug substance specification is consistent with the details registered for the crossreference products TSE Compliance With the exception of lactose monohydrate, no materials of animal or human origin are included in the product. This is consistent with the cross-reference product. A declaration has been provided that lactose used in lactose monohydrate is sourced from healthy animals under the same conditions as that for human consumption. No other material used in the manufacturing of this medicinal product is derived from animal or human origin or sourced from genticially modified organisms. This is consistent with the cross-reference product. 3. EXPERT REPORT A satisfactory quality overall summary has been prepared by an appropriately qualified expert. The CV of the expert was provided. 4. PRODUCT NAME & APPEARANCE See 2.1 for details of the proposed product name. The licenced product is a white, round, flat tablet with a scoreline and is identical to that of the cross-reference product. 5. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) The approved SmPC is consistent with the details registered for the cross-reference product. 6. PATIENT INFORMATION LEAFLET (PIL)/CARTON PIL The PIL is satisfactory and in line with the approved SmPC and has been prepared in the usertested format. The applicant has submitted results of PIL user testing. The results indicate that the PIL is wellstructured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that is contains. Labelling Mock-up of the labelling has been provided and are satisfactory. The approved artwork is comparable to the artwork registered for the cross-reference product and complies with statutory requirements
7 7. CONCLUSIONS The data submitted with is application is acceptable. A Marketing Authorisation was, therefore, granted
8 NON-CLINICAL ASSESSMENT This is a simple, abridged, informed consent application made under Article 10c of EC Directive 2001/83 (as amended). This application is identical to the reference product, Loratidine 10 mg Tablets (PL 20395/0072) authorised to Relonchem Ltd on 27 March 2009 in the UK, therefore, no new non-clinical data has been supplied with this application and none are required. A non-clinical overview report has been written by a suitably qualified person and is satisfactory. The CV of the non-clinical expert has been supplied. The marketing authorisation holder has provided adequate justification for not submitting an Environment Risk Assessment (ERA). As this application is identical to already authorised reference products, it is not expected that the environmental exposure to loratidine will increase following the marketing approval of the proposed product
9 CLINICAL ASSESSMENT This is a simple, abridged, informed consent application made under Article 10c of EC Directive 2001/83 (as amended), cross-referring to Loratidine 10 mg Tablets (PL 20395/0072) authorised by Relonchem Ltd since 27 March 2009 in the UK. No new clinical data has been supplied with this application and none are required. A clinical overview has been written by a suitably qualified person and is satisfactory. The CV of the clinical expert has been supplied. The marketing authorisation holder (MAH) has provided adequate justification for not submitting a Risk Management Plan (RMP). As this application is identical to already authorised reference product, for which safety concerns requiring additional risk minimisation have not been identified, a risk minimisation system is not considered necessary. The reference products have been in use for many years and the safety profile of the active is well-established. The MAH has provided a suitable pharmacovigilance system that fulfils the requirements and provides adequate evidence that the MAH has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country
10 OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT QUALITY The data for this application is consistent with those previously assessed for the cross-reference product and as such has been judged to be satisfactory. NON-CLINICAL No new non-clinical data were submitted and none are required for an application of this type. EFFICACY This application is considered identical to the previously granted licence for Loratidine 10 mg Tablets (PL 20395/0072) initially authorised to Medis-Danmark A/S on 22 August 2002, the licence subsequently underwent a Change of Ownership and is currently authorised to Relonchem Limited on 27 March The current application is considered valid. No new or unexpected safety concerns arise from this application. PRODUCT LITERATURE The approved SmPC, PIL and labelling are satisfactory, and consistent with those for the crossreference product. The applicant has submitted results of PIL user testing. The results indicate that the PIL is wellstructured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that is contains. Mock-ups of the labeling have been provided and are satisfactory. The labeling artwork complies with statutory requirements. RISK BENEFIT ASSESSMENT The quality of the product is acceptable and no new non-clinical or clinical safety concerns have been identified. The applicant s product is identical to the cross-reference product. The benefit; risk ratio is, therefore, considered to be positive
11 RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 STEPS TAKEN FOR ASSESMENT 1 The MHRA received the marketing authorisation application on 8 July Following standard checks and communication with the applicant the MHRA considered the application valid on 12 July Following assessment of the application the MHRA requested further information relating to the quality dossier on 17 October 2011 and 13 March The applicant responded to the MHRA s requests, providing further information on 14 February 2012 and 14 March The application was determined on 3 April
12 RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 STEPS TAKEN AFTER ASSESSMENT Date submitted Application type Scope Outcome
13 RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 SUMMARY OF PRODUCT CHARACTERISTICS The UK Summary of Product Characteristics (SmPC) for Relonchem Hayfever and Allergy 10 mg Tablets (PL 20395/0088) is as follows: 1 NAME OF THE MEDICINAL PRODUCT RelonChem Hayfever and Allergy 10mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg loratadine. For excipients see PHARMACEUTICAL FORM Tablet. Appearance: white, round, flat tablets with a scoreline 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Relonchem Hayfever and Allergy 10mg tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria. 4.2 Posology and method of administration Adults, including the elderly, and children 12 years of age and over: One 10 mg tablet once daily Children 2 to 12 years of age with: Body weight more than 30 kg: 10 mg once daily (one tablet) Body weight 30 kg or less: 5 ml (5 mg) of the syrup once daily. The 10 mg strength tablet is not appropriate in children with a body weight less than 30 kg. Efficacy and safety of Loratadine 10 mg Tablets in children under 2 years of age has not been established in this age group. Patient with severe liver impairment should be administered a lower intial dose because they may have reduced clearance of loratadine. An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg, and for children weighing 30 kg or less, 5 ml (5 mg) every other day is recommended. No dosage adjustments are required in the elderly or in patients with renal insufficiency 4.3 Contraindications Relonchem Hayfever and Allergy 10mg tablets are contraindicated in patients who are hypersensitive to the active substance or to any of the excipients. 4.4 Special warnings and precautions for use Relonchem Hayfever and Allergy 10mg tablets should be administered with caution in patients with severe liver impairment (see 4.2) Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. The administration of Relonchem Hayfever and Allergy 10mg tablets should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index. 4.5 Interaction with other medicinal products and other forms of interaction When administered concomitantly with alcohol, Relonchem Hayfever and Allergy 10mg tablet has no potentiating effects as measured by psychomotor performance studies
14 Due to the wide therapeutic index of loratadine no clinically relevant interactions are expected and none were observed in the conducted clinical trials (see 5.2). Loratadine is metabolised by hepatic CYP3A4 and CYP2D6 isoenzymes. Increase in plasma concentrations of loratadine has been reported after concomitant use with ketoconazole, erythromycin and cimetidine in controlled trials, but without clinically significant changes (including electrocardiographic). 4.6 Fertility, pregnancy and lactation Loratadine was not teratogenic in animal studies. The safe use of loratadine during pregnancy has not been established. The use of Relonchem Hayfever and Allergy 10mg tablets during pregnancy is therefore not recommended. Loratadine is excreted in breast milk, therefore the use of loratadine is not recommended in breast-feeding women. 4.7 Effects on ability to drive and use machines In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine. However, patients should be informed that very rarely some people rarely experience drowsiness, which may affect their ability to drive or use machines. 4.8 Undesirable effects In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%). In clinical trials involving adults and adolescents in a range of indications including AR and CIU, at the recommended dose of 10 mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those treated with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%). Other adverse reactions reported very rarely during post marketing period are listed in the following table. Immune disorders Nervous System disorders Cardiac disorders Gastrointestinal disorders Hepato-bilary disorders Skin and subcutaneous tissue disorders General disorders and administration site Conditions Anaphylaxis Dizziness Tachycardia, palpitation Nausea, dry mouth, gastritis Abnormal hepatic function Rash, alopecia Fatigue 4.9 Overdose Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia and headache have been reported with overdoses. In the event of overdose, general symptomatic and supportive measures are to be instituted and maintained for as long as necessary. Administration of activated charcoal as a slurry with water may be attempted. Gastric lavage may be considered. Loratadine is not removed by haemodialysis and it is not known if loratadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment
15 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: antihistamines H1 antagonist, ATC code: R 06 AX 13 Loratadine the active ingredient in Relonchem Hayfever and Allergy 10mg tablets is a tricyclic antihistamine with selective, peripheral H1-receptors activity. Loratadine has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage. During long-term treatment there were no clinically significant changes in vital signs, laboratory test values, physical examinations of electrocardiograms. Loratadine has no significant H2-receptor activity. It does not inhibit noradrenaline uptake and has practically no influence on cardiovascular function or on intrinsic cardiac pacemaker activity. 5.2 Pharmacokinetic properties After oral administration, loratadine is rapidly and well and undergoes an extensive first pass metabolism, mainly by CYP 3A4 and CYP 2D6. The major metabolite desloratadine (DL) is pharmacologically active and responsible for a large part of clinical effect. Loratadine and DL achieve maximum plasma concentrations (Tmax) between hours and hours after administration, respectively. Increase in plasma concentrations of loratadine has been reported after concomitant use with ketoconazole, erythromycin and cimetidine in controlled trials, but without clinically significant changes (including electrocardiography). Loratadine is highly bound (97% to 99%) and its active metabolite moderately bound (73% to 76%) to plasma proteins. In healthy subjects, plasma distribution half-lives for loratadine and its active metabolite are approximately 1 and 2 hours, respectively. The mean elimination half-lives in healthy adult subjects were 8.4 hours (range = 3 to 20 hours) for loratadine and 28 hours (range = 8.8 to 92 hours) for the major active metabolite. Approximately 40% of the dose is excreted in the urine and 42% in the faeces over a 10-day period (mainly in the form of conjugated metabolites). Approximately 27% of the dose is eliminated in the urine during the first 24 hours. Less than 1% of the active substance is excreted unchanged in active form, as loratadine or DL. The bioavailability parameters of loratadine and of the active metabolite are dose proportional. The pharmacokinetic profile of loratadine and its metabolites is comparable in healthy adult volunteers and healthy geriatric volunteers. Concomitant ingestion of food can delay slightly the absorption of loratadine but without influencing the clinical effect. In patients with chronic renal impairment, both the AUC and the peak plasma levels (Cmax) increased for loratadine and its metabolite as compared with the AUCs and Cmax of patients with normal renal function. The mean elimination half-lives of loratadine and its metabolite were not significantly different from that observed in normal subjects. Haemodialysis does not have an effect on the pharmacokinetic profile of loratadine or its active metabolite in subjects with chronic renal impairment. In patients with chronic alcoholic liver disease, the AUC and Cmax of loratadine were double while the pharmacokinetic profile of the active metabolite was not significantly changed from that in patients with normal liver function. The elimination half-lives for loratadine and its metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease. Loratadine and its active metabolite are excreted in the breast milk of lactating women
16 5.3 Preclinical safety data Preclinical data reveal no special hazard based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. In reproductive toxicity studies, no teratogenic effects were observed. However, prolonged parturition and reduced viability of offspring were observed in rats at plasma levels (AUC) 10 times higher than those achieved with clinical doses. No evidence of mucous membrane irritation was observed after daily administration of up to 12 tablets (120 mg) of oral lyophilisates into the hamster cheek pouch for five days. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Lactose monohydrate Microcrystalline cellulose Maize starch Magnesium stearate 6.2 Incompatibilities Not applicable 6.3 Shelf life 3 years 6.4 Special precautions for storage None 6.5 Nature and contents of container Packages with 7, 10, 14 tablets in blister packs (PVC/aluminium) 6.6 Special precautions for disposal No special instructions 7 MARKETING AUTHORISATION HOLDER Relonchem Limited 27 Old Gloucester Street London WC1 3XX United Kingdom 8 MARKETING AUTHORISATION NUMBER(S) PL 20395/ DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 03/04/ DATE OF REVISION OF THE TEXT 03/04/
17 RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 PATIENT INFORMATION LEAFLET
18 - 18 -
19 RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 LABELLING Blister:
20 Please note that no carton mock ups were provided for the 10 tablet pack. In accordance with medicines legislation, the 10 tablet pack shall not be marketed in the UK until approval of the label mock-ups has been obtained. Cartons:
21 - 21 -
22 Cartons with Braille:
23 - 23 -
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 informationDonepezil 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 informationAciclovir 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 informationMemantine 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 informationFexofenadine 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 informationANASTROZOLE 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 informationLevonorgestrel/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 informationNEUROTONE THR 00904/0005 UKPAR
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
More informationMACROGOL 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 informationRILUZOLE 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 informationSTREPSILS 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 informationAscorbic 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 informationPublic 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 informationCETRABEN 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 informationMontelukast 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 informationPublic 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 informationOmeprazole 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 informationLEMSIP 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 informationUKPAR 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 informationBeclometasone 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 informationMucodyne-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 informationSODIUM 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 informationHYDROCORTISONE 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 informationHypromellose 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 informationPL 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 informationIbuprofen 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 informationCODEINE PHOSPHATE 15 MG TABLETS CODEINE PHOSPHATE 30 MG TABLETS CODEINE PHOSPHATE 60 MG TABLETS PL 24837/0023-5 UK PAR TABLE OF CONTENTS
CODEINE PHOSPHATE 15 MG TABLETS CODEINE PHOSPHATE 30 MG TABLETS CODEINE PHOSPHATE 60 MG TABLETS PL 24837/0023-5 UK PAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for
More informationDEXTROMETHORPHAN 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 informationKalms 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 informationISOPLEX 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 informationPARACETAMOL 500MG TABLETS B.P. (PARACETAMOL) PL 17907/0146 UKPAR TABLE OF CONTENTS
PARACETAMOL 500MG TABLETS B.P. (PARACETAMOL) PL 17907/0146 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Steps taken after authorisation Page
More informationGinkgoforce 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 informationArnicare 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 informationPublic 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 informationPublic 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 informationPublic 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 informationTRAMADOL 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 informationLacidipine 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 informationPublic 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 informationPublic 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 informationUrostemol 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 informationIbuprofen 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 informationCOMMITTEE 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 informationPublic Assessment Report Scientific discussion. Tenofovir disoproxil Teva (tenofovir disoproxil) SE/H/1432/01/DC
Public Assessment Report Scientific discussion Tenofovir disoproxil Teva (tenofovir disoproxil) SE/H/1432/01/DC This module reflects the scientific discussion for the approval of Tenofovir disoproxil Teva.
More informationDecentralised Procedure. Public Assessment Report
Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report ben-u-ron direkt Erdbeer/Vanille 250/500 mg Granulat in Beuteln ben-u-ron direkt Cappuccino 500/1000
More informationPublic Assessment Report. Decentralised Procedure PARACETAMOL 1000 MG TABLETS. Procedure No: UK/H/5004/01/DC. UK Licence No: PL 18866/0060
Public Assessment Report Decentralised Procedure PARACETAMOL 1000 MG TABLETS Procedure No: UK Licence No: PL 18866/0060 Rockspring Healthcare Ltd LAY SUMMARY On 17 January 2013 the Medicines and Healthcare
More informationMIGRAINE 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 informationDecentralised Procedure. Public Assessment Report. Paracetamol-ratiopharm 10 mg/ml Infusionslösung Paracetamol DE/H/1908/001/DC
Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Paracetamol-ratiopharm 10 mg/ml Infusionslösung Paracetamol DE/H/1908/001/DC Applicant: TEVA Pharma
More informationZOVIRAX Cold Sore Cream
Data Sheet ZOVIRAX Cold Sore Cream Aciclovir 5% w/w Presentation Topical cream Indications ZOVIRAX Cold Sore Cream is indicated for the treatment of Herpes simplex virus infections of the lips and face
More informationWhite, circular, biconvex, uncoated tablets with a score line on one side, plain on the other.
Nausicalm Cyclizine hydrochloride Ph. Eur. 50 mg Presentation White, circular, biconvex, uncoated tablets with a score line on one side, plain on the other. Uses Actions The active ingredient-cyclizine
More informationPublic Assessment Report. Table of Contents
Public Assessment Report Lidocaine Injection BP with preservative 1% Lidocaine Injection BP with preservative 2% PL 01502/0070 PL 01502/0071 Hameln Pharmaceuticals Limited Table of Contents Page Lay Summary
More informationPublic Assessment Report. Pharmacy to General Sales List Reclassification. Pirinase Hayfever Relief for Adults 0.05% Nasal Spray.
Public Assessment Report Pharmacy to General Sales List Reclassification Pirinase Hayfever Relief for Adults 0.05% Nasal Spray (Fluticasone) PL 00079/0688 Glaxo Wellcome UK Limited TABLE OF CONTENTS Introduction
More informationLOPERAMIDE 2MG TABLETS. (Loperamide hydrochloride) PL 33410/0023 PL 33410/0063 UKPAR TABLE OF CONTENTS
LOPERAMIDE 2MG TABLETS (Loperamide hydrochloride) PL 33410/0023 PL 33410/0063 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after
More informationPublic Assessment Report
Public Assessment Report Decentralised Procedure Zoledronic Acid 4mg/5ml Concentrate for Solution for Infusion Procedure No: UK Licence No: PL 24598/0029 Noridem Enterprises Limited LAY SUMMARY On 25 January
More informationZOPICLONE 7.5MG FILM-COATED TABLETS (ZOPICLONE) PL 19156/0015 UKPAR TABLE OF CONTENTS
ZOPICLONE 7.5MG FILM-COATED TABLETS (ZOPICLONE) PL 19156/0015 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 14 Steps taken after authorisation
More informationThioctacid 600 T Solution for Injection contains 600 mg alpha-lipoic acid
Package Leaflet: Information for the User Thioctacid 600 T Solution for Injection contains 600 mg alpha-lipoic acid For use in adults Active substance: Alpha-lipoic acid, Trometamol salt (1:1) Read all
More information2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trihexyphenidyl 2mg Tablets BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of trihexyphenidyl hydrochloride BP
More informationPhynova 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 informationPublic Assessment Report. Scientific discussion. Desloracell 5 mg, film-coated tablet. (desloratadine) NL License RVG: 112807
Public Assessment Report Scientific discussion Desloracell 5 mg, film-coated tablet (desloratadine) NL License RVG: 112807 Date: 6 July 2015 This module reflects the scientific discussion for the approval
More informationPublic Assessment Report UKPAR
Public Assessment Report UKPAR Amitriptyline 10 mg film-coated tablets Amitriptyline 25 mg film-coated tablets Amitriptyline 50 mg film-coated tablets (Amitriptyline hydrochloride) UK Licence No: PL 17907/0131-133
More informationSalbutamol 1mg/ml Nebuliser Solution. Salbutamol 2mg/ml Nebuliser Solution PL 36390/0035 PL 36390/0036
Salbutamol 1mg/ml Nebuliser Solution Salbutamol 2mg/ml Nebuliser Solution PL 36390/0035 PL 36390/0036 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment
More informationPACKAGE LEAFLET: INFORMATION FOR THE USER. /.../ 2.5 mg orodispersible tablets. Desloratadine
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER /.../ 2.5 mg orodispersible tablets Desloratadine Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet.
More informationPublic Assessment Report. Decentralised Procedure. Cefadroxil 250 mg/5 ml granules for oral. (Cefadroxil monohydrate)
Public Assessment Report Decentralised Procedure Cefadroxil 250 mg/5 ml granules for oral suspension (Cefadroxil monohydrate) UK licence no: PL 34088/0033 Alkaloid-INT d.o.o. 1 Cefadroxil 250 mg/5 ml granules
More information4 Clinical Particulars
SUMMARY OF PRODUCT CHARACTERISTICS 1 Name of the Medicinal Product Procyclidine Syrup 5mg/5ml 2. Qualitative and Quantitative Composition Each 5ml dose contains 5mg Procyclidine Hydrochloride BP. 3. Pharmaceutical
More informationSummary 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 informationPublic Assessment Report. Decentralised Procedure. Sildenafil Dr. Reddy s 25, 50 and 100mg Filmcoated. Sildenafil citrate UK/H/4855/001-3/DC
Public Assessment Report Decentralised Procedure Sildenafil Dr. Reddy s 25, 50 and 100mg Filmcoated Sildenafil citrate UK licence no: PL 08553/0468-70 DR Reddy s Laboratories (UK) Limited 1 LAY SUMMARY
More informationPublic 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 informationSR 5. W2364A_NT.XATRAL SR5 PAK/SA 5/12/05 9:47 Page 1
W2364A_NT.XATRAL SR5 PAK/SA 5/12/05 9:47 Page 1 alfuzosin SR 5 mg (Alfuzosin HCI) COMPOSITION Each sustained-release, film-coated tablet contains: Alfuzosin hydrochloride......... 5 mg Excipients... q.s.
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Progit 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of itopride hydrochloride.
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diazepam Tablets BP 2mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diazepam BP 2.00mg 3 PHARMACEUTICAL FORM Tablet 4. CLINICAL PARTICULARS
More informationOMNIC OCAS Film coated Tablets SAJA PHARMA
08-15 OMNIC OCAS Film coated Tablets SAJA PHARMA Tamsulosin Hydrochloride 0.4 mg film-coated prolonged release tablets 1. NAME OF THE MEDICINAL PRODUCT OMNIC OCAS, 0.4 mg prolonged release tablets, film-coated.
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eskazole Tablets 400 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Albendazole 400 mg Excipients with known effect: Lactose, sunset yellow
More informationHaving 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 informationLOPERAMIDE 2MG TABLETS. (Loperamide hydrochloride) PL 20117/0087 UKPAR TABLE OF CONTENTS
LOPERAMIDE 2MG TABLETS (Loperamide hydrochloride) PL 20117/0087 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after authorisation
More informationPublic 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 informationAdjunctive psychosocial intervention. Conditions requiring dose reduction. Immediate, peak plasma concentration is reached within 1 hour.
Shared Care Guideline for Prescription and monitoring of Naltrexone Hydrochloride in alcohol dependence Author(s)/Originator(s): (please state author name and department) Dr Daly - Consultant Psychiatrist,
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methadone 10mg/ml Injection / Physeptone 10mg/ml Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains: Methadone Hydrochloride
More informationCOMMITTEE 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 informationDoxylamine succinate belongs to the ethanolamine class of antihistamines with sedative properties.
Data Sheet MERSYNDOL Tablet Paracetamol 450mg per tablet Codeine Phosphate 9.75mg per tablet Doxylamine Succinate 5mg per tablet MERSYNDOL FORTE Tablet Paracetamol 450mg per tablet Codeine Phosphate 30mg
More informationPublic Assessment Report. Decentralised Procedure
Public Assessment Report Decentralised Procedure Levetiracetam 250 mg film-coated tablets PL 36390/0168; UK/H/5630/001/DC Levetiracetam 500 mg film-coated tablets PL 36390/0169; UK/H/5630/002/DC Levetiracetam
More informationCOMMITTEE 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 informationOne vial contains 500 U* of C1-inhibitor** After reconstitution the product contains 500 U/5 ml which correspond to a concentration of 100 U/ml.
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cetor 100 U/ml powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 500 U* of
More informationSee 17 for PATIENT COUNSELING INFORMATION. Revised: 3/2016 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK OR
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LYSODREN safely and effectively. See full prescribing information for LYSODREN. LYSODREN (mitotane)
More informationUK Public Assessment Report
MAX STRENGTH DECONGESTANT TABLETS (PHENYLEPHRINE HYDROCHLORIDE) PL 16028/0114 UK Public Assessment Report TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page
More informationPublic Assessment Report. Decentralised Procedure
Public Assessment Report Decentralised Procedure FOSFOMYCIN 3G GRANULES FOR ORAL SOLUTION Procedure No: UK Licence No: PL 31513/0007 Temapharm Sp. z.o.o. LAY SUMMARY On 17 April 2013, Czech Republic, Estonia,
More informationPublic Assessment Report. Decentralised Procedure. Cefuroxime 250mg and 500mg film-coated tablets. Cefuroxime 500mg film-coated tablets
Public Assessment Report Decentralised Procedure Cefuroxime 250mg film-coated tablets Cefuroxime 500mg film-coated tablets Procedure No: UK Licence No: PL 35646/0020-0021 Alkem Pharma GmbH 1 LAY SUMMARY
More information1. NAME OF THE MEDICINAL PRODUCT. Impavido 10 mg capsules Impavido 50 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION. 1 capsule contains:
1. NAME OF THE MEDICINAL PRODUCT Impavido 10 mg capsules Impavido 50 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 capsule contains: Impavido 10 mg capsules 10 mg Miltefosine. Impavido 50 mg
More informationSummary 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 informationSummary 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 informationSUMMARY 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 informationPublic Assessment Report. Decentralised Procedure. Alimemazine tartrate 7.5mg/5ml Syrup. Alimemazine tartrate 30mg/5ml Syrup
Public Assessment Report Decentralised Procedure Alimemazine tartrate 7.5mg/5ml Syrup Alimemazine tartrate 30mg/5ml Syrup Procedure No: UK Licence No: PL 41830/0029-0030 NRIM Limited 1 LAY SUMMARY Alimemazine
More informationDechra Veterinary Products Limited (A business unit of Dechra Pharmaceuticals PLC) Sansaw Business Park Hadnall, Shrewsbury Shropshire SY4 4AS
Dechra Veterinary Products Limited (A business unit of Dechra Pharmaceuticals PLC) Sansaw Business Park Hadnall, Shrewsbury Shropshire SY4 4AS Tel: 01939 211200 Fax: 01939 211201 Email: info.uk@dechra.com
More informationFLOMAX RELIEF MR (PL 00015/0280) UKPAR TABLE OF CONTENTS
FLOMAX RELIEF MR (PL 00015/0280) UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 14 Steps taken after authorisation summary Page 15 Summary of Product
More informationPackage leaflet: Information for the patient. Desloratadine Actavis 5 mg orodispersible tablets desloratadine
Package leaflet: Information for the patient Desloratadine Actavis 5 mg orodispersible tablets desloratadine Read all of this leaflet carefully before you start taking this medicine because it contains
More informationPublic Assessment Report. Decentralised Procedure
Public Assessment Report Decentralised Procedure Amlodipine Pfizer 5 mg tablets Amlodipine Pfizer 10 mg tablets Amlodipine Pfizer 5 mg hard capsules Amlodipine Pfizer 10 mg hard capsules Procedure No:
More informationThe format of this leaflet was determined by the Ministry of Health and its content was checked and approved in May 2013.
The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in May 2013 Havrix 720 Junior 1 NAME OF THE MEDICINAL PRODUCT Havrix 720 Junior 2 QUALITATIVE
More informationPublic Assessment Report. Decentralised Procedure
Public Assessment Report Decentralised Procedure PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE HYDROCHLORIDE 500 MG/200 MG/10 MG POWDER FOR ORAL SOLUTION UK Licence No: PL 12063/0118 WRAFTON LABORATORIES
More informationNōdia DESCRIPTION PHARMACOLOGY. Loperamide hydrochloride USP 2 mg Tablets. Pharmacological classification - antidiarrhoeal.
Nōdia Loperamide hydrochloride USP 2 mg Tablets DESCRIPTION Nōdia 2 mg tablets are green, capsule-shaped tablets with a break-line on one side. Each tablet contains 2 mg loperamide hydrochloride and typically
More informationStress 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 informationPARACETAMOL REXIDOL. 600 mg Tablet. Analgesic-Antipyretic. Paracetamol 600 mg
(Insert Text) UL Consumer Health PARACETAMOL REXIDOL 600 mg Tablet Analgesic-Antipyretic FORMULATION Each tablet contains: Paracetamol 600 mg PRODUCT DESCRIPTION Rexidol is a round, yellow, flat, bevel-edged
More information