SUMMARY OF PRODUCT CHARACTERISTICS

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 name>

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