Drug Tariff Part VIIIA August 2021.Pdf
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(CD-P-PH/PHO) Report Classification/Justifica
COMMITTEE OF EXPERTS ON THE CLASSIFICATION OF MEDICINES AS REGARDS THEIR SUPPLY (CD-P-PH/PHO) Report classification/justification of medicines belonging to the ATC group D07A (Corticosteroids, Plain) Table of Contents Page INTRODUCTION 4 DISCLAIMER 6 GLOSSARY OF TERMS USED IN THIS DOCUMENT 7 ACTIVE SUBSTANCES Methylprednisolone (ATC: D07AA01) 8 Hydrocortisone (ATC: D07AA02) 9 Prednisolone (ATC: D07AA03) 11 Clobetasone (ATC: D07AB01) 13 Hydrocortisone butyrate (ATC: D07AB02) 16 Flumetasone (ATC: D07AB03) 18 Fluocortin (ATC: D07AB04) 21 Fluperolone (ATC: D07AB05) 22 Fluorometholone (ATC: D07AB06) 23 Fluprednidene (ATC: D07AB07) 24 Desonide (ATC: D07AB08) 25 Triamcinolone (ATC: D07AB09) 27 Alclometasone (ATC: D07AB10) 29 Hydrocortisone buteprate (ATC: D07AB11) 31 Dexamethasone (ATC: D07AB19) 32 Clocortolone (ATC: D07AB21) 34 Combinations of Corticosteroids (ATC: D07AB30) 35 Betamethasone (ATC: D07AC01) 36 Fluclorolone (ATC: D07AC02) 39 Desoximetasone (ATC: D07AC03) 40 Fluocinolone Acetonide (ATC: D07AC04) 43 Fluocortolone (ATC: D07AC05) 46 2 Diflucortolone (ATC: D07AC06) 47 Fludroxycortide (ATC: D07AC07) 50 Fluocinonide (ATC: D07AC08) 51 Budesonide (ATC: D07AC09) 54 Diflorasone (ATC: D07AC10) 55 Amcinonide (ATC: D07AC11) 56 Halometasone (ATC: D07AC12) 57 Mometasone (ATC: D07AC13) 58 Methylprednisolone Aceponate (ATC: D07AC14) 62 Beclometasone (ATC: D07AC15) 65 Hydrocortisone Aceponate (ATC: D07AC16) 68 Fluticasone (ATC: D07AC17) 69 Prednicarbate (ATC: D07AC18) 73 Difluprednate (ATC: D07AC19) 76 Ulobetasol (ATC: D07AC21) 77 Clobetasol (ATC: D07AD01) 78 Halcinonide (ATC: D07AD02) 81 LIST OF AUTHORS 82 3 INTRODUCTION The availability of medicines with or without a medical prescription has implications on patient safety, accessibility of medicines to patients and responsible management of healthcare expenditure. The decision on prescription status and related supply conditions is a core competency of national health authorities. -
Classification of Medicinal Drugs and Driving: Co-Ordination and Synthesis Report
Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Due date of deliverable: 21.07.2011 Actual submission date: 21.07.2011 Revision date: 21.07.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Page 1 of 243 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners - Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) - Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) - Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) - Katerina Touliou (CERT-HIT, Centre for Research and Technology Hellas, Greece) - Michael Hei βing (BASt, Bundesanstalt für Straßenwesen, Germany). -
Northern Ireland Prescription Code Book Drugs Section September 2021
Family Practitioner Services, Pharmaceutical Services, 2 Franklin Street, Belfast BT2 8DQ Telephone No. 028 9053 5613, Fax No. 028 9053 2963 Northern Ireland Prescription Code Book Drugs section September 2021 Page 1 of 587 Effective for prescriptions dispensed September 2021 BSO Code dm+d Pack Description Code Number Special ZD Of Container 38960 4SURE beta-ketone testing strips 4S-810-4183401-001 (Nipro Diagnostics (UK) Ltd) 10 strip strips 38961 4SURE testing strips (Nipro Diagnostics (UK) Ltd) 50 strip strips 4144 AAA 1.5mg/dose sore throat spray (Manx Healthcare Ltd) 60 dose [BSO pack = 1] BSO Unit Of Measure Code No. devices dispensed 70598 (DT) Abacavir 600mg / Lamivudine 300mg tablets 30 tablet tablets 9154 Abasaglar 100units/ml solution for injection 3ml cartridges (Eli Lilly and Company Ltd) 5 cartridge cartridges ZD 9038 Abasaglar KwikPen 100units/ml solution for injection 3ml pre-filled pens (Eli Lilly and Company Ltd) 5 pre- injections ZD filled disposable injection 70088 (DT) Abatacept 125mg/1ml solution for injection pre-filled disposable devices 4 pre-filled disposable injections ZD injection 70089 (DT) Abatacept 125mg/1ml solution for injection pre-filled syringes 4 pre-filled disposable injection injections ZD 70144 Abelcet 100mg/20ml concentrate for suspension for infusion vials (Teva UK Ltd) 10 vial vials Hospital Only 3303 Abidec Multivitamin drops (Omega Pharma Ltd) 25 ml mls 4043 Abilify 10mg orodispersible tablets (Otsuka Pharmaceuticals (U.K.) Ltd) 28 tablet 4 x 7 tablets tablets 3006 Abilify 10mg tablets (Otsuka -
209627Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209627Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review Reviewers of Multi-Disciplinary Review and Evaluation SECTIONS OFFICE/ AUTHORED/ ACKNOWLEDGED/ DISCIPLINE REVIEWER DIVISION APPROVED Mark Seggel, Ph.D. OPQ/ONDP/DNDP2 Authored: Section 4.2 Digitally signed by Mark R. Seggel -S CMC Lead DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Mark R. Signature: Mark R. Seggel -S Seggel -S, 0.9.2342.19200300.100.1.1=1300071539 Date: 2018.08.08 16:29:15 -04'00' Frederic Moulin, DVM, PhD OND/ODE3/DBRUP Authored: Section 5 Pharmacology/ Digitally signed by Frederic Moulin -S Toxicology DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Reviewer Signature: Frederic Moulin -S 0.9.2342.19200300.100.1.1=2001708658, cn=Frederic Moulin -S Date: 2018.08.08 15:26:57 -04'00' Kimberly Hatfield, PhD OND/ODE3/DBRUP Approved: Section 5 Pharmacology/ Toxicology Digitally signed by Kimberly P. Hatfield -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Team Leader Signature: Kimberly P. Hatfield -S 0.9.2342.19200300.100.1.1=1300387215, cn=Kimberly P. Hatfield -S Date: 2018.08.08 14:56:10 -04'00' Li Li, Ph.D. OCP/DCP3 Authored: Sections 6 and 17.3 Clinical Pharmacology Dig ta ly signed by Li Li S DN c=US o=U S Government ou=HHS ou=FDA ou=People Reviewer cn=Li Li S Signature: Li Li -S 0 9 2342 19200300 100 1 1=20005 08577 Date 2018 08 08 15 39 23 04'00' Doanh Tran, Ph.D. -
Wo 2010/075090 A2
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 1 July 2010 (01.07.2010) WO 2010/075090 A2 (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every C07D 409/14 (2006.01) A61K 31/7028 (2006.01) kind of national protection available): AE, AG, AL, AM, C07D 409/12 (2006.01) A61P 11/06 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (21) International Application Number: DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/US2009/068073 HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (22) International Filing Date: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, 15 December 2009 (15.12.2009) ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, (25) Filing Language: English SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, (26) Publication Language: English TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 61/122,478 15 December 2008 (15.12.2008) US kind of regional protection available): ARIPO (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, (71) Applicant (for all designated States except US): AUS- ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, PEX PHARMACEUTICALS, INC. -
Ophthalmic Antihistamines
Ophthalmics for Allergic Conjunctivitis Review 04/12/2011 Copyright © 2004 - 2011 by Provider Synergies, L.L.C. All rights reserved. Printed in the United States of America. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage and retrieval system without the express written consent of Provider Synergies, L.L.C. All requests for permission should be mailed to: Attention: Copyright Administrator Intellectual Property Department Provider Synergies, L.L.C. 10101 Alliance Rd, Ste 201 Cincinnati, Ohio 45242 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, -
Etats Rapides
List of European Pharmacopoeia Reference Standards Effective from 2015/12/24 Order Reference Standard Batch n° Quantity Sale Information Monograph Leaflet Storage Price Code per vial Unit Y0001756 Exemestane for system suitability 1 10 mg 1 2766 Yes +5°C ± 3°C 79 ! Y0001561 Abacavir sulfate 1 20 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001552 Abacavir for peak identification 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001551 Abacavir for system suitability 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0000055 Acamprosate calcium - reference spectrum 1 n/a 1 1585 79 ! Y0000116 Acamprosate impurity A 1 50 mg 1 3-aminopropane-1-sulphonic acid 1585 Yes +5°C ± 3°C 79 ! Y0000500 Acarbose 3 100 mg 1 See leaflet ; Batch 2 is valid until 31 August 2015 2089 Yes +5°C ± 3°C 79 ! Y0000354 Acarbose for identification 1 10 mg 1 2089 Yes +5°C ± 3°C 79 ! Y0000427 Acarbose for peak identification 3 20 mg 1 Batch 2 is valid until 31 January 2015 2089 Yes +5°C ± 3°C 79 ! A0040000 Acebutolol hydrochloride 1 50 mg 1 0871 Yes +5°C ± 3°C 79 ! Y0000359 Acebutolol impurity B 2 10 mg 1 -[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino] propoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! acetamide (diacetolol) Y0000127 Acebutolol impurity C 1 20 mg 1 N-(3-acetyl-4-hydroxyphenyl)butanamide 0871 Yes +5°C ± 3°C 79 ! Y0000128 Acebutolol impurity I 2 0.004 mg 1 N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! butanamide Y0000056 Aceclofenac - reference spectrum 1 n/a 1 1281 79 ! Y0000085 Aceclofenac impurity F 2 15 mg 1 benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate -
EAR, NOSE and OROPHARYNX Updated: October 2020
Derbyshire Medicines Management, Prescribing and Guidelines DERBYSHIRE PRIMARY CARE FORMULARY CHAPTER 12: EAR, NOSE AND OROPHARYNX Updated: October 2020 The following prescribing guidelines are relevant to the ENT chapter and can be found here: • Allergic Rhinitis in adults and adolescents over 12 years of age • Management of chronic rhinosinusitis with or without nasal polyps 12.1 DRUGS ACTING ON THE EAR 12.1.1 Otitis externa Investigation is not routinely recommended for the initial diagnosis of otitis externa. Group Drug Astringent/acidic Acetic acid 2% ear spray preparations Self-care: patients are advised to purchase this over the counter Gentamicin 0.3% ear/eye drops* Antibiotic preparations Ciprofloxacin 2mg/ml ear drops 0.25ml unit dose PF Betnesol-N ear/eye/ nose drops* Combined corticosteroid (Betamethasone 0.1% & neomycin 0.5%) and aminoglycoside Otomize ear spray* antibiotic preparations (Dexamethasone 0.1%, neomycin 0.5% & acetic acid 2%) Corticosteroid Prednisolone 0.5% ear/eye drops Lower potency preparations Betamethasone 0.1% ear/eye/ nose drops Higher potency Antifungal preparations Clotrimazole 1% solution 20ml (with dropper) * In view of reports of ototoxicity, manufacturers contra-indicate treatment with topical aminoglycosides in patients with a perforated tympanic membrane (eardrum) or patent grommet. 1. The following are GREY, not for first line empirical use, and should only be used when sensitivity is confirmed through swab results- • Hydrocortisone acetate 1%/gentamicin 0.3% ear drops • Flumetasone pivalate 0.02%/clioquinol 1% ear drops 2. How should I treat acute diffuse otitis externa? (CKS) • Remove or treat any precipitating or aggravating factors. • Prescribe or recommend a simple analgesic for symptomatic relief. -
Minutes of PRAC Meeting on 09-12 July 2018
6 September 2018 EMA/PRAC/576790/2018 Inspections, Human Medicines Pharmacovigilance and Committees Division Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of the meeting on 09-12 July 2018 Chair: June Raine – Vice-Chair: Almath Spooner Health and safety information In accordance with the Agency’s health and safety policy, delegates were briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in the minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scope listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also change during the course of the review. Additional details on some of these procedures will be published in the PRAC meeting highlights once the procedures are finalised. Of note, the minutes are a working document primarily designed for PRAC members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006, Rev. 1). 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2018. -
Epinastine Hcl Ophthalmic Solution) 0.05% Sterile
NDA 21-565/S-005 Page 2 ELESTAT™ (epinastine HCl ophthalmic solution) 0.05% Sterile DESCRIPTION ELESTAT™ (epinastine HCl ophthalmic solution) 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes. Epinastine HCl is represented by the following structural formula: C16H15N3 • HCl Mol. Wt. 285.78 Chemical Name: 3-Amino-9, 13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride Each mL contains: Active: Epinastine HCl 0.05% (0.5 mg/mL) equivalent to epinastine 0.044% (0.44mg/mL); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetate disodium; purified water; sodium chloride; sodium phosphate, monobasic; and sodium hydroxide and/or hydrochloric acid (to adjust the pH). ELESTAT™ has a pH of approximately 7 and an osmolality range of 250 to 310 mOsm/kg. CLINICAL PHARMACOLOGY Epinastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from the mast cell. Epinastine is selective for the histamine H1-receptor and has affinity for the histamine H2 receptor. Epinastine also possesses affinity for the α1-, α2-, and 5-HT2 –receptors. Epinastine does not penetrate the blood/brain barrier and, therefore, is not expected to induce side effects of the central nervous system. Fourteen subjects, with allergic conjunctivitis, received one drop of ELESTAT™ in each eye twice daily for seven days. On day seven average maximum epinastine plasma concentrations of 0.04 ± 0.014 ng/ml were reached after about two hours indicating low systemic exposure. -
Ear, Nose and Oral Cavity
NHS Borders Joint Prescribing Formulary Ear, nose, and oral cavity Black Text Drugs which may be prescribed by all prescribers Drugs which are either for specialist only prescription or for specialist Pink Text initiation, with prescribing transfer to GP Important Information: In addition to the disclaimer on NHS Borders website the following information is included confirming that the information contained in NHS Borders Joint Prescribing formulary is drawn from several sources, including BNF & BNF for children, product SPCs, local and national guidelines, local expert opinion, Lothian Joint Formulary and these are all gratefully acknowledged here. NHS Borders has done its utmost to ensure the information in the BJF is accurate and reliable, but NHS Borders cannot guarantee that the information is complete and accurate. Prescribers are referred to the SPCs, BNF and BNF for children to confirm prescribing information. June 2021 Contents Page Table of Contents 12.1 Drugs acting on the ear ................................................................................................ 3 Otitis externa ................................................................................................................ 3 Otitis media .................................................................................................................. 3 Removal of ear wax ..................................................................................................... 3 12.2 Drugs acting on the nose ............................................................................................ -
Allergy Skin Testing: Patient Instructions and Consent Form
ALLERGY SKIN TESTING: PATIENT INSTRUCTIONS AND CONSENT FORM Skin tests are a method of testing for allergic reactions to substances, or allergens, in the environment. A test consists of introducing small amounts of allergens into the skin and noting the development of a positive reaction, which consists of a wheal (swelling) and flare (surrounding area of redness). We employ the prick method, where the skin is pricked with a sharp device that introduces the allergen into the skin. Other allergy testing options include injecting the allergen with needles or going to a lab for blood tests. The entire testing process will take about 30 minutes. We test a variety of important allergens that are found in the Central Florida area including trees, grasses, weeds, molds, dust mites, and animal dander. After administering the allergens, we wait approximately 20 minutes to review the results. A positive reaction occurs when the skin becomes red, raised, and itchy. This skin reaction will gradually dissipate within 30‐60 minutes. Some people will experience local swelling beginning 4‐8 hours after testing. This is not serious and typically no treatment is required. It should disappear in the next few days. Less than 1% of patients may develop a systemic reaction to skin testing, which may consist of any or all of the following symptoms: itchy eyes, nose, or throat, nasal congestion, runny nose, tightness in the throat or chest, wheezing, lightheadedness, nausea or vomiting, hives, or anaphylactic shock. This is very rare, but in the event of such reactions, the staff is fully prepared and emergency equipment is readily available.