Annex B_worksharing
Annex B
National MAs authorised via MRP/DCP
MRP/DCP no. [1] |Member State EU/EEA[2] |National MA number |Marketing Authorisation Holder[3] |(Invented) name[4] |Active substance(s) |Strength(s)[5] |Pharmaceutical Form[6] |[7] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Purely-national MAs
Member State EU/EEA[8] |National MA number |National variation no. [9] |Marketing Authorisation Holder[10] |(Invented) name[11] |Active substance(s) |Strength(s) [12] |Pharmaceutical Form[13] |[14] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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[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)
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