to be completed

To be completed nationally See Annex I To be completed nationally

Complete where appropriate.

To be completed nationally

GENERAL CLASSIFICATION FOR SUPPLY 29 To be completed nationally

To be completed nationally Name

To be completed nationally.

To be completed on finalisation of the procedure

to be completed nationally

To be completed nationally

Marketing Authorisation Holder To be completed nationally.

58 To be completed nationally

37 To be completed nationally

222 To be completed nationally

240 To be completed nationally

279 To be completed nationally

285 To be completed nationally

See Annex I To be completed nationally

To be completed nationally

To be completed nationally 12.

To be completed nationally PACKAGE LEAFLET PACKAGE LEAFLET

16 24 To be completed nationally

14 24 To be completed nationally

43 To be completed nationally

To be completed nationally See Annex I To be completed nationally For referral procedures

30 What X looks like and contents of the pack

Marketing Authorisation Holder and Manufacturer

GENERAL CLASSIFICATION FOR SUPPLY 32 To be completed nationally

21 To be completed nationally

32 To be completed nationally

54 To be completed nationally

21 LABELLING

To be completed nationally 1.

To be completed nationally LABELLING PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

To be completed nationally PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

To be completed nationally MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

INFORMATION IN BRAILLE

To be completed nationally

To be completed nationally

6.1 List of excipients To be completed nationally

MARKETING AUTHORISATION NUMBER(S) To be completed nationally

29 To be completed nationally

42 To be completed nationally

The other ingredients are To be completed nationally .

To be completed nationally Not all pack sizes may be marketed