Summary of Product Characteristics (SMPC) Template: Paediatric Population

< INN/WHO Ref. No.
> WHO Prequalification Team: medicines ― WHOPAR part 4 <Date>
SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) TEMPLATE
[Should the product to which a completed summary of product characteristics (SmPC) be

prequalified, it will form Part 4 of the WHO Public Assessment Report that will be posted on the
website of the WHO Prequalification Team: medicines (PQTm).
Please also consult the prequalification guidance documents: Section Guidance for Part 4 —
Summary of Product Characteristics (SmPC) — of a WHO Public Assessment Report
(WHOPAR) and Annotated Summary of Product Characteristics (SmPC) Template and Ensuring
Consistency Between Product Information Documents.
<text> signifies text to be selected or deleted as appropriate.
{text} refers to information to be added.]
1. NAME OF THE MEDICINAL PRODUCT DO
{(Invented) name strength pharmaceutical form}1
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
<Excipient(s):>
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL form DO
<The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.>
<The tablet can be divided into equal halves.>
<The tablet should not be divided.>
4. Clinical particulars
4.1 Therapeutic indications DO
<{X} is indicated in <adults> <neonates> <infants> <children> <adolescents> <aged {x to y}> <years>
<months>>.>
4.2 Posology and method of administration DO only population stuff
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} <in the indication...>
1
Trade names are not prequalified by WHO. This is the national medicines regulatory authority’s responsibility.
Throughout a WHOPAR the proprietary name is given as an example only.
24 October 2016 1
< INN/WHO Ref. No.> WHO Prequalification Team: medicines ― WHOPAR part 4 <Date>
<{X} is contraindicated in children aged {x to y} <years> <months> {or any other relevant subsets e.g.
weight, pubertal age, gender} <in the indication...> (see Section 4.3).>
Method of administration
4.3 Contraindications DO
<Hypersensitivity to the active substance(s) or to any of the excipients <or {name of the residue(s)}>.>
4.4 Special warnings and precautions for use DO
4.5 Interaction with other medicinal products and other forms of interaction DO
<No interaction studies have been performed.>
<Interaction studies have only been performed in adults.>
4.6 Pregnancy and lactation DO summarize a lot
[See prequalification guidance: Section Guidance for Part 4 — Summary of Product Characteristics
(SmPC) — of a WHO Public Assessment Report (WHOPAR).]
<Women of childbearing potential>
<Contraception in males and females>
<Pregnancy>
<Breastfeeding>
<Fertility>
4.7 Effects on ability to drive and use machines DO
<{Invented name} has <no <or negligible> influence> <minor influence>, <moderate influence> <major
influence> on the ability to drive and use machines.>
<No studies on the effects on the ability to drive and use machines have been performed.>
<Not relevant.>
4.8 Undesirable effects ONLY DO summarized tables
[See prequalification guidance: Section Guidance for Part 4 — Summary of Product Characteristics
(SmPC) — of a WHO Public Assessment Report (WHOPAR).]
<Paediatric population>
4.9 Overdose DO
<No case of overdose has been reported.>
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties DO partly
Pharmacotherapeutic group: {group}, ATC code: {code}
<Mechanism of action> DO
<Pharmacodynamic effects> DO
24 October 2016 2
<Clinical efficacy and safety>
5.2 Pharmacokinetic properties DO
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
6.2 Incompatibilities DO
<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.>
6.3 Shelf life
<...> <6 months> <...> <1 year> <18 months> <2 years> <30 months> <3 years> <...>
6.4 Special precautions for storage
[For storage condition statements see prequalification guidance Section Guidance for Part 4 —
Summary of Product Characteristics (SmPC) — of a WHO Public Assessment Report (WHOPAR).]
<For storage conditions of the <reconstituted> <diluted> medicinal product, see Section 6.3.>
6.5 Nature and contents of container <and special equipment for use, administration or
implantation>
6.6
<Not all pack sizes may be marketed.>
6.6 Special precautions for disposal <and other handling>
<No special requirements.>
<Any unused product or waste material should be disposed of in accordance with local requirements.>
24 October 2016 3
7. <APPLICANT/SUPPLIER>
{Name and address}

<{tel}>
<{fax}>
<{email}>
8. WHO PREQUALIFICATION REFERENCE NUMBER
9. DATE OF <PREQUALIFICATION> / <RENEWAL OF PREQUALIFICATION>
<{DD/MM/YYYY}> <{DD month YYYY}>
10. DATE OF REVISION OF THE TEXT
{MM/YYYY}
Reference list
[This list provides references to relevant WHO guidelines and to relevant literature and
databases, in addition to the SmPC(s) of the innovator product(s). The list is compiled by WHO.]
Detailed information on this medicinal product is available on PQTm’s website (see:

http://www.who.int/prequal).
24 October 2016 4

Summary of Product Characteristics (SMPC) Template: Paediatric Population

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< INN/WHO Ref. No.

> WHO Prequalification Team: medicines ― WHOPAR part 4 <Date>

SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) TEMPLATE

[Should the product to which a completed summary of product characteristics (SmPC) be

<text> signifies text to be selected or deleted as appropriate.

{text} refers to information to be added.]

1. NAME OF THE MEDICINAL PRODUCT DO

{(Invented) name strength pharmaceutical form}1

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

<The tablet can be divided into equal halves.>

<The tablet should not be divided.>

4.1 Therapeutic indications DO

4.2 Posology and method of administration DO only population stuff

4.4 Special warnings and precautions for use DO

<No interaction studies have been performed.>

<Interaction studies have only been performed in adults.>

4.6 Pregnancy and lactation DO summarize a lot

<Women of childbearing potential>

<Contraception in males and females>

4.7 Effects on ability to drive and use machines DO

4.8 Undesirable effects ONLY DO summarized tables

<No case of overdose has been reported.>

5.1 Pharmacodynamic properties DO partly

Pharmacotherapeutic group: {group}, ATC code: {code}

<Clinical efficacy and safety>

5.2 Pharmacokinetic properties DO

5.3 Preclinical safety data

6.1 List of excipients

6.3 Shelf life

6.4 Special precautions for storage

<Not all pack sizes may be marketed.>

6.6 Special precautions for disposal <and other handling>

<No special requirements.>

{Name and address}

8. WHO PREQUALIFICATION REFERENCE NUMBER

9. DATE OF <PREQUALIFICATION> / <RENEWAL OF PREQUALIFICATION>

<{DD/MM/YYYY}> <{DD month YYYY}>

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on PQTm’s website (see:

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