Annex B
National MAs authorised via MRP/DCP
MRP/DCP no. 1 |
Member State EU/EEA2 |
National MA number |
Marketing Authorisation Holder3 |
(Invented) name4 |
Active substance(s) |
Strength(s)5 |
Pharmaceutical Form6 |
<Content (concentration)>7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purely-national MAs
Member State EU/EEA8 |
National MA number |
National variation no. 9 |
Marketing Authorisation Holder10 |
(Invented) name11 |
Active substance(s) |
Strength(s) 12 |
Pharmaceutical Form13 |
<Content (concentration)>14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 MRP/DCP no. of initial marketing authorisation
2 List all the EEA Countries where the medicinal product(s) included in the worksharing are authorised, grouped by MRP/DCP no., with countries in alphabetical order (i.e. all medicinal products authorised in Austria, followed by all medicinal products authorised in Belgium, etc.)
3 Name and address of the Marketing Authorisation Holder in the EEA Countries where the medicinal product is authorised
4 As registered in the respective official language of the EEA Country (no strength or pharmaceutical form should be mentioned unless it is an integral part of the authorised (invented) name)
5 It is possible to combine in the same row several strengths for the medicinal product in each Country. A separate row should however be used for each pharmaceutical form.
6 Information in English - use current standard terms from the Ph. Eur.
7 Complete only if applicable (only for liquids, creams and solid multidose forms, e.g. granules, powder, etc – not for tablets and capsules)
8 List all the EEA Countries where the medicinal product(s) included in the worksharing are authorised, in alphabetical order (i.e. all medicinal products authorised in Austria, followed by all medicinal products authorised in Belgium, etc.)
9 If applicable
10 Name and address of the Marketing Authorisation Holder in the EEA Countries where the medicinal product is authorised
11 As registered in the respective official language of the EEA Country (no strength or pharmaceutical form should be mentioned unless it is an integral part of the authorised (invented) name)
12 It is possible to combine in the same row several strengths for the medicinal product in each Country. A separate row should however be used for each pharmaceutical form.
13 Information in English - use current standard terms from the Ph. Eur.
14 Complete only if applicable (only for liquids, creams and solid multidose forms, e.g. granules, powder, etc – not for tablets and capsules)
ANNEX B2 PRODUCT ENVIRONMENTAL ATTRIBUTES COMPUTERS AND
ANNEX NO 1 TITLE NAME AND SURNAME OF
COMUNICAT DE PREMSA ANNEX DESCRIPCIÓ DELS
Tags: mrpdcp, annex, authorised, national