1. NAME OF THE MEDICINAL PRODUCT {trade name strength pharmaceutical form} 2. QUALITATIVE AND QUANTITATIVE COMPOSITION <Excipient(s) with known effect> <For the full list of excipients, see section 6.1.> 3. PHARMACEUTICAL FORM <The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.> <The score line is not intended for breaking the tablet.> <The tablet can be divided into equal doses.> 4. CLINICAL PARTICULARS 4.1 Therapeutic indications <This medicinal product is for diagnostic use only.> <{X} is indicated in <adults><neonates><infants><children><adolescents><aged {x to y}><years><months>.> 4.2 Posology and method of administration Posology Paediatric population <The <safety><and><efficacy> of {X}in children aged {x to y}<months><years>[or any other relevant subsets, e.g. weight, pubertal age, gender]<has><have> not <yet> been established.> <No data are available.> <Currently available data are described in section <4.8><5.1><5.2>but no recommendation on a posology can be made.> <{X}should not be used in children aged {x to y}<years><months>[or any other relevant subsets, e.g. weight, pubertal age, gender] because of <safety><efficacy> concern(s).> <There is no relevant use of {X}<in the paediatric population><in children aged {x to y}<years><months>[or any other relevant subsets, e.g. weight, pubertal age, gender]<for the indication of...>.> <{X}is contraindicated in children aged {x to y}<years><months>[or any other relevant subsets,e.g. weight, pubertal age, gender]<for the indication of...> (see section4.3).> Method of administration <Precautions to be taken before handling or administering the medicinal product> <For instructions on <reconstitution><dilution> of the medicinal product before administration, see section <6.6><and><12>.> 4.3 Contraindications <Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 <or {name of the residue(s)}>.> 4.4 Special warnings and precautions for use <Paediatric population> 4.5 Interaction with other medicinal products and other forms of interaction <No interaction studies have been performed.> <Paediatric population> <Interaction studies have only been performed in adults.> 4.6 Fertility, pregnancy and lactation <Pregnancy> <Breast-feeding> <Fertility> 4.7 Effects on ability to drive and use machines <{(trade name} has <no or negligible influence><minor influence><moderate influence><major influence> on the ability to drive and use machines.> <Not relevant.> 4.8 Undesirable effects <Paediatric population> Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. 4.9 Overdose <Paediatric population> 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: {group}, ATC code: <{code}><not yet assigned> <Mechanism of action> <Pharmacodynamic effects> <Clinical efficacy and safety> <Paediatric population> <This medicinal product has been authorised under a so-called ‘conditional approval’ scheme.This means that further evidence on this medicinal product is awaited. The authority/EFDA will review new information on this medicinal product at least every year and this SmPC will be updated as necessary.> 5.2 Pharmacokinetic properties <Absorption> <Distribution> <Biotransformation> <Elimination> <Linearity/non-linearity> <Pharmacokinetic/pharmacodynamic relationship(s)> 5.3 Preclinical safety data <Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.> <Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.> <Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:> 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients <excipient nam 6.2 Incompatibilities <Not applicable.> <In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.> <This medicinal product must not be mixed with other medicinal products except those mentioned in section <6.6><and><12>.> 6.3 Shelf life <...><6 months><...><1 year><18 months><2 years><30 months><3 years><...> 6.4 Special precautions for storage <For storage conditionsafter <reconstitution><dilution><first opening> of the medicinal product, see section 6.3.> 6.5 Nature and contents of container <and special equipment for use, administration or implantation> <Not all pack sizes may be marketed.> 6.6 Special precautions for disposal <and other handling> <Use in the paediatric population/ steps in extemporaneous preapartion > <No special requirements <for disposal>.> <Any unused medicinal product or waste material should be disposed of in accordance with local requirements.> 7. MARKETING AUTHORISATION HOLDER {Name and address} <{tel}> <{fax}> <{e-mail}> 8. MARKETING AUTHORISATION NUMBER(S) 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}> 10. DATE OF REVISION OF THE TEXT <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}> <11. Reference