Our laboratory contacted 35 companies in the period from December 2014 to April 2015. The purpose was to examine whether the companies had made sure to seal their packages with addictive drugs (cf. section 14 of Executive order no. 849 of 25 June 2013 on the labelling etc. of medicinal products).
17 companies did not comply with the rule
We found one or more medicine packages without a seal in 17 of the 35 companies. The 17 companies are now taking action to ensure that their packages are sealed as soon as possible. By the end of 2015, all new productions of these medicine packages will be sealed in accordance with Danish regulatory requirements. However, for a period of time packages without seals may be available in the market until all packages from previous productions have been sold.
List of medicinal products without a seal at the time of investigation:
|
Medicinal product name |
Pharmaceutical form |
Strength |
Marketing authorisation holder |
|
Concerta |
prolonged-release tablets |
18 mg |
Janssen-Cilag A/S |
|
Concerta |
prolonged-release tablets |
36 mg |
Janssen-Cilag A/S |
|
Concerta |
prolonged-release tablets |
54 mg |
Janssen-Cilag A/S |
|
Jurnista |
prolonged-release tablets |
8 mg |
Janssen-Cilag A/S |
|
Jurnista |
prolonged-release tablets |
16 mg |
Janssen-Cilag A/S |
|
Jurnista |
prolonged-release tablets |
32 mg |
Janssen-Cilag A/S |
|
S-ketamin "Pfizer" |
solution for injection |
5 mg/ml |
Pfizer ApS |
|
S-ketamin "Pfizer" |
solution for injection |
25 mg/ml |
Pfizer ApS |
|
Ketador Vet. |
solution for injection |
100 mg/ml |
Richter Pharma AG (Danish representative Salfarm Danmark A/S) |
|
Oxycodone hydrochloride "Orion" |
solution for injection/infusion |
10 mg/ml |
Orion Corporation Orion Pharma (Danish representative Orion Pharma A/S) |
|
Medikinet |
tablets |
5 mg |
MEDICE Arzneimittel Pütter GmbH & Co. KG |
|
Medikinet |
tablets |
10 mg |
MEDICE Arzneimittel Pütter GmbH & Co. KG |
|
Medikinet |
tablets |
20 mg |
MEDICE Arzneimittel Pütter GmbH & Co. KG |
|
Medikinet CR |
modified-release capsules, hard |
10 mg |
MEDICE Arzneimittel Pütter GmbH & Co. KG |
|
Medikinet CR |
modified-release capsules, hard |
20 mg |
MEDICE Arzneimittel Pütter GmbH & Co. KG |
|
Medikinet CR |
modified-release capsules, hard |
30 mg |
MEDICE Arzneimittel Pütter GmbH & Co. KG |
|
Medikinet CR |
modified-release capsules, hard |
40 mg |
MEDICE Arzneimittel Pütter GmbH & Co. KG |
|
Medikinet CR |
modified-release capsules, hard |
5 mg |
MEDICE Arzneimittel Pütter GmbH & Co. KG |
|
Medikinet CR |
modified-release capsules, hard |
50 mg |
MEDICE Arzneimittel Pütter GmbH & Co. KG |
|
Medikinet CR |
modified-release capsules, hard |
60 mg |
MEDICE Arzneimittel Pütter GmbH & Co. KG |
|
Oxycodone hydrochloride "Actavis" |
capsules, hard |
5 mg |
Actavis Group PTC ehf. (Danish representative Actavis A/S) |
|
Oxycodone hydrochloride "Actavis" |
capsules, hard |
10 mg |
Actavis Group PTC ehf. (Danish representative Actavis A/S) |
|
Oxycodone hydrochloride "Actavis" |
capsules, hard |
20 mg |
Actavis Group PTC ehf. (Danish representative Actavis A/S) |
|
Reltebon Depot |
prolonged-release tablets |
5 mg |
Actavis Group PTC ehf. (Danish representative Actavis A/S) |
|
Reltebon Depot |
prolonged-release tablets |
10 mg |
Actavis Group PTC ehf. (Danish representative Actavis A/S) |
|
Reltebon Depot |
prolonged-release tablets |
20 mg |
Actavis Group PTC ehf. (Danish representative Actavis A/S) |
|
Reltebon Depot |
prolonged-release tablets |
40 mg |
Actavis Group PTC ehf. (Danish representative Actavis A/S) |
|
Malfin |
prolonged-release tablets |
10 mg |
Teva Denmark A/S |
|
Malfin |
prolonged-release tablets |
30 mg |
Teva Denmark A/S |
|
Malfin |
prolonged-release tablets |
60 mg |
Teva Denmark A/S |
|
Malfin |
prolonged-release tablets |
100 mg |
Teva Denmark A/S |
|
Malfin |
prolonged-release tablets |
200 mg |
Teva Denmark A/S |
|
Methylphenidat "Orifarm" |
tablets |
10 mg |
Orifarm Generics A/S |
|
Oxycodone "Orifarm" |
prolonged-release tablets |
5 mg |
Orifarm Generics A/S |
|
Oxycodone "Orifarm" |
prolonged-release tablets |
10 mg |
Orifarm Generics A/S |
|
Oxycodone "Orifarm" |
prolonged-release tablets |
40 mg |
Orifarm Generics A/S |
|
Oxycodone "Orifarm" |
prolonged-release tablets |
80 mg |
Orifarm Generics A/S |
|
Anesketin |
solution for injection |
100 mg/ml |
Eurovet Animal Health B.V. (Danish representative Dechra Veterinary Products A/S) |
|
Comfortan Vet. |
solution for injection |
10 mg/ml |
Eurovet Animal Health B.V. (Danish representative Dechra Veterinary Products A/S) |
|
Fentadon Vet. |
solution for injection |
50 microgram/ml |
Eurovet Animal Health B.V. (Danish representative Dechra Veterinary Products A/S) |
|
Medicebran |
tablets |
20 mg |
2care4 ApS |
|
Ritalin LA |
modified-release capsules, hard |
10 mg |
2care4 ApS |
|
Ritalin LA |
modified-release capsules, hard |
20 mg |
2care4 ApS |
|
Ritalin LA |
modified-release capsules, hard |
30 mg |
2care4 ApS |
|
Ritalin LA |
modified-release capsules, hard |
40 mg |
2care4 ApS |
|
Equasym Depot |
modified-release capsules, hard |
10 mg |
Shire Pharmaceuticals Ireland L |
|
Equasym Depot |
modified-release capsules, hard |
20 mg |
Shire Pharmaceuticals Ireland L |
|
Equasym Depot |
modified-release capsules, hard |
30 mg |
Shire Pharmaceuticals Ireland L |
|
Palexia |
film-coated tablets |
50 mg |
Grünenthal GmbH (Danish representative Grünenthal Denmark ApS) |
|
Palexia Depot |
prolonged-release tablets |
50 mg |
Grünenthal GmbH (Danish representative Grünenthal Denmark ApS) |
|
Palexia Depot |
prolonged-release tablets |
100 mg |
Grünenthal GmbH (Danish representative Grünenthal Denmark ApS) |
|
Palexia Depot |
prolonged-release tablets |
150 mg |
Grünenthal GmbH (Danish representative Grünenthal Denmark ApS) |
|
Palexia Depot |
prolonged-release tablets |
200 mg |
Grünenthal GmbH (Danish representative Grünenthal Denmark ApS) |
|
Palexia Depot |
prolonged-release tablets |
250 mg |
Grünenthal GmbH (Danish representative Grünenthal Denmark ApS) |
|
Recivit |
sublingual tablets |
67 microgram |
Grünenthal Denmark ApS |
|
Recivit |
sublingual tablets |
133 microgram |
Grünenthal Denmark ApS |
|
Recivit |
sublingual tablets |
267 microgram |
Grünenthal Denmark ApS |
|
Recivit |
sublingual tablets |
400 microgram |
Grünenthal Denmark ApS |
|
Recivit |
sublingual tablets |
533 microgram |
Grünenthal Denmark ApS |
|
Recivit |
sublingual tablets |
800 microgram |
Grünenthal Denmark ApS |
|
Metadon "Evolan" |
oral solution |
1 mg/ml |
Evolan Pharma AB (Danish representative Matrix Pharmaceuticals A/S) |
|
Medicebran |
tablets |
20 mg |
EuroPharma.DK ApS |
|
Medikinet CR |
modified-release capsules, hard |
10 mg |
EuroPharma.DK ApS |
|
Medikinet CR |
modified-release capsules, hard |
20 mg |
EuroPharma.DK ApS |
|
Medikinet CR |
modified-release capsules, hard |
30 mg |
EuroPharma.DK ApS |
|
Medikinet CR |
modified-release capsules, hard |
40 mg |
EuroPharma.DK ApS |
|
Ketaminol Vet. |
solution for injection |
50 mg/ml |
Intervet International B.V. (Danish representative Intervet Danmark A/S) |
|
Ketaminol Vet. |
solution for injection |
100 mg/ml |
Intervet International B.V. (Danish representative Intervet Danmark A/S) |
|
Oramorph |
oral drops, solution |
20 mg/ml |
L. Molteni & C. dei F.lli Alitti Societa di Esercizio S.p.A. (Danish representative Tabs n Caps Pack ApS) |
|
Oramorph |
oral solution |
2 mg/ml |
L. Molteni & C. dei F.lli Alitti Societa di Esercizio S.p.A. (Danish representative Tabs n Caps Pack ApS) |