SUMMARY OF PRODUCT CHARACTERISTICS

1-Name of the Medicinal Product :

1.1 Product Name

1.2 Strength

1.3 Pharmaceutical Dosage Form

2-Quality and Quantitative Composition :

2.1 Qualitative Declaration

The active substance should be declared by its recommended INN,
accompanied by its salt or hydrate form if relevant

2.2 Quantitative Declaration

The quantity of the active substance must be expressed per
dosage unit (for metered dose inhalation products, per puff) per unit
volume or per unit of weight).

3-Pharmaceutical Form :

Visual description of the appearance of the product (colour,

markings, etc).
e.g.: “ Tablet White, circular flat beveled edge tablets marked ‘100’
on one side “

4-Clinical Particulars

4.1 Therapeutic indications

4.2 Posology and method of administration

- Recommended doses :
Adults and adolescents ( 12 years and older ) ,
Children under 12 years ,
Special patient groups ,
Instruction for correct use .

4.3 Contraindications

4.4 Special warning and precautions for use

4.5 Interaction with other medicinal products and other forms of

Interactions

Page 1 of 3
 4.6 Pregnancy and lactation

4.7 Effects on ability to drive and use machine

4.8 Undesirable effects

4.9 Overdose and special antidotes .

5-Pharmacological Properties :

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical safety Data

6-Pharmaceutical Particulars :

6.1 List of excipients

6.2 Incompatibilities

6.3 Shelf life

Shelf life of the medicinal product as packages for sale. Shelf life
after dilution or reconstitution according to directions. Shelf-life
after first opening the container

6.4 Special precautions for storage

6.5 Nature and contents of container

7-Marketing Authorization Holder :

Name :……………………………………

Address : ……………………………….

8-Manufacturer Name :

Name :………………………………………

Address : ………………………………….

Page 2 of 3
9-Date of first authorization/renewal of the authorization :

…………………………………….

10-Date of revision of the text :

……………………………………………

Page 3 of 3